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>> WELCOME, EVERYBODY TO
SESSION

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2 OF OUR ETHICAL ASPECTS OF 

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CLINICAL RESEARCH AND I'M HOLLY 

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HERE AT THE DEPARTMENT OF 

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BIOETHICS AND HAVE A COUPLE 

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REALLY QUICK REMINDERS.

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THAT'S MY DISCLAIMER.

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IF YOU JUST ENROLLED I KNOW SOME

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OUT IN VIDEO LAND HAVE JUST 

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ENROLLED IN THE COURSE.

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THE RECORDING OF SESSION 1 IS IN

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THE SESSION 1 MODULE SO PLEASE 

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GO AND REVIEW THAT.

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PLEASE ALSO REVIEW THE WELCOME 

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MESSAGE AND THE COURSE BASICS IN

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THE KEY DOCUMENTS MODULE.

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THOSE SHOULD COVER ANY BURNING 

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QUESTIONS YOU MIGHT HAVE ABOUT 

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THE COURSE.

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IF YOU DON'T FIND AN ANSWER 

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THERE, YOU CAN REACH OUT TO ME 

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OR TO ALEX.

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AND TODAY AND TODAY AND MOVING 

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FORWARD TO ASK QUESTIONS AND 

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THERE'S TWO WAYS TO DO THAT.

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ONE IS TO GO TO THE DISCUSSION 

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SESSION SECTION THAT I'VE 

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CREATED ON THE DISCUSSION BOARD.

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YOU CAN POST QUESTIONS THERE.

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YOU CAN ALSO E-MAIL TO BIOETHICS

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INQUIRIES AT MAIL AT NIH 

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DOT-GOV.

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THEY'LL GO TO ALEX AND HE'LL 

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FORWARD THEM TO ME DURING THE 

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COURSE.

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AND THREE OTHER QUICK THINGS.

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FIRST, IF YOU SELF ENROLL YOU 

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NEED TO SELF REGISTER TO GET THE

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CERTIFICATE OF COMPLETION.

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YOU HAVE TO GO TO CANVAS TO DO 

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THAT.

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WE DON'T SEND THAT OUT TO YOU.

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IT'S POSTED IN CANVAS.

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THE SESSION QUIZZES ARE ALSO ON 

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CAMPUS.

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WE DON'T SEND THAT OUT TO YOU.

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YOU JUST HAVE TO GO INTO THE 

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MODULE.

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IT'S POSTED AT THE BOTTOM.

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AND THEN YOU'LL ALSO GET SESSION

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EVALUATIONS AND THOSE COME BY 

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E-MAIL AND THEY'RE A SURVEY 

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MONKEY QUIZ.

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THE QUIZZES ARE THE ONES THAT 

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YOU NEED TO COMPLETE TO GET THE 

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CERTIFICATE.

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AND WITH THAT, I'M GOING TO HAND

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IT OVER.

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TODAY IS INFORMED CONSENT DAY 

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AND WE'RE GOING TO START OFF AS 

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WE DID LAST WEEK WITH DR. GRADY 

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WHO IS GOING TO GIVE US AN 

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INTRODUCTION TO INFORMED 

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CONSENT.

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DR. GRADY IS THE CHAIR OF THE 

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DEPARTMENT HERE AT THE CLINICAL 

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CENTER AND SHE WILL BE FOLLOWED 

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BY SCOTT KIM, WE'LL HAVE A BREAK

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AND THEN CAROL SQUIRE'S FROM 

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NIHM WILL JOIN US.

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WITH THAT I'LL HAND IT OVER TO 

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CHRISTINE.

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>> THANK YOU, HOLLY.

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GOOD MORNING TO EVERYBODY.

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HANDFUL OF PEOPLE IN THE ROOM.

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EVERYBODY WHO'S OUT THERE IN 

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CYBER SPACE.

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I'LL TALK ABOUT INFORMED CONSENT

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TODAY.

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THIS IS MY DISCLAIMER AND I HAVE

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FROM CONFLICTS.

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WHAT I THOUGHT I WOULD DO IN THE

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TIME I HAVE IS A LITTLE BIT 

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ABOUT THE BASICS.

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FOR SOME IT WILL BE A LITTLE BIT

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ABOUT REVIEW AND CHALLENGES AND 

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A LITTLE BIT ABOUT CHANGES WE'RE

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DEALING WITH, I GUESS, IS THE 

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RIGHT WORD NOW.

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AND THOSE ARE BOTH CHANGES IN 

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RESEARCH AND CHANGES IN HOW WE 

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GET INFORMED CONSENT.

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SO TO START WITH AS A BASIC 

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IDEA, CONSENT IS SOMETHING 

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THAT'S VERY FAMILIAR TO ALL OF 

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US.

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IT'S A MORAL AND LEGAL 

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PROTECTION FROM UNAUTHORIZED 

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INVASIONS OF ONE'S BODY OR ONE'S

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PROPERTY.

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IT HAS A VERY STRONG 

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FACILITATIVE MORAL POWER.

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IT MAKES THINGS PERMISSIBLE THAT

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OTHERWISE WOULD NOT BE.

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FOR EXAMPLE, I COULD BORROW YOUR

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CAR AND CAN AGREE TO HAVE MY 

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BLOOD DRAWN, ALL THOSE THINGS 

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WITHOUT MY CONSENT WOULD BE 

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ROBBERY, RAPE AND BODILY 

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ASSAULT.

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AND IT'S A VERY WELL ENTRENCHED 

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CONCEPT IN OUR SOCIETY AND MANY 

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SOCIETIES AROUND THE WORLD.

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AND IN OUR VALUES AND 

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JURISPRUDENCE AND IN HEALTH 

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CARE.

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IT'S A COMMON CONCEPT.

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INTERESTINGLY IN HEALTH CARE IN 

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MEDICAL CARE AND RESEARCH, WE 

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DON'T JUST TALK ABOUT CONSENT 

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BUT WE TALK ABOUT INFORMED 

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CONSENT.

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THAT MEANS BASICALLY THE 

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AUTHORIZATION, THE CONSENT WE 

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GIVE IS BASED ON UNDERSTANDING 

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WHAT THE ACTIVITY ENTAILS.

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YOU MIGHT WISH THAT WAS TRUE FOR

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ALL CONSENT AND MAYBE IT IS TRUE

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FOR MOST KINDS OF CONSENT BUT IN

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HEALTH CARE WITH DON'T TALK 

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ABOUT CONSENT WE TALK ABOUT 

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INFORMED CONSENT.

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YOU PROBABLY KNOW IT IS A LEGAL 

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REGULATORY AND ETHICAL 

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REQUIREMENT IN BOTH HEALTH CARE 

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AND IN MOST RESEARCH WITH HUMAN 

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SUBJECTS.

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IT'S ALSO AND YOU'VE HEARD THIS 

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I'M SURE BEFORE, A PROCESS.

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A PROCESS OF REASONED DECISION 

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MAKING.

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IT'S NOT A FORM OR A SINGLE 

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EPISODE IN THE TRAJECTORY OF 

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DELIVERY OF HEALTH CARE OR 

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RESEARCH.

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IN A CLASSIC TEXTBOOK TODD 

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BEACHAM WROTE 30 YEARS AGO IT'S 

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CALLED THE HISTORY AND THEORY OF

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INFORMED CONSENT.

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THEY DESCRIBE IT AS AUTONOMOUS 

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AUTHORIZATION.

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THAT'S AN IMPORTANT CONCEPT TO 

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KEEP IN MIND.

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ETHICALLY IT'S BASED ON THE 

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NOTION OF AUTONOMY.

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FOR PEOPLE'S CAPACITY AND RIGHT 

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TO DEFINE THEIR OWN GOALS AND 

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MAKE CHOICES CONSISTENT WITH 

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THOSE GOALS.

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IN A LOT OF THE LITERATURE THE 

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SECOND QUOTE IS FROM THE BELMONT

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REPORT, THIS SORT OF IDEA IS 

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REITERATED IN ONE WAY OR ANOTHER

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BUT TIED TO INFORMED CONSENT AND

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THE BELMONT REPORT EXPLICITLY 

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AND SUBJECTS BE GIVEN THE 

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OPPORTUNITY TO DECIDE WHAT SHALL

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OR SHALL NOT HAPPEN TO THEM 

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THROUGH INFORMED CONSENT.

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THERE'S A SPECIAL INJUNCTION 

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WITH USING PEOPLE FOR THE 

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BENEFIT OF CONSENT.

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SOMEBODY YOU CAN DO SOMETHING 

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FOR SOMEBODY FOR THEIR BENEFIT 

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BUT SOMETIMES IT'S FOR THE 

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BENEFIT OF OTHERS SO YOU NEED 

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THEIR CONSENT TO DO SO.

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AND INFORMED CONSENT THOUGH 

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CRITICALLY IMPORTANT FOR ETHICAL

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RESEARCH IS ONLY ONE ASPECT OF 

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CONDUCTING ETHICAL RESEARCH AND 

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IF YOU REMEMBER MY EIGHT 

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PRINCIPLES IS THE SEVEN OUT OF 

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EIGHT IN ORDER.

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IT IS REQUIRED BY VIRTUALLY ALL 

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CODES OF RESEARCH ETHICS AND 

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REGULATIONS AND LAWS THOUGH 

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THERE ARE SOME SOME EXCEPTIONS.

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I WON'T TALK MUCH ABOUT THE 

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EXCEPTIONS BUT HAPPY TO ANSWER 

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QUESTIONS ABOUT THOSE AND I'M 

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SURE HOLLY WILL TOO LATER.

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THAT INCLUDES THE U.S. FEDERAL 

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REGULATIONS, THE ICHDP, HELSINKI

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AND MOST NATIONAL, STATE AND 

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INSTITUTIONAL REQUIREMENTS TALK 

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ABOUT CONSENT IN RESEARCH.

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IT'S INTERESTING TO LOOK AT THE 

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LANGUAGE OF THE U.S. FEDERAL 

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REGULATIONS BECAUSE IT HELPS US 

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UNDERSTAND WHAT CERTAIN 

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EXPECTATIONS OF THE REQUIREMENT.

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THIS BASICALLY SAYS YOU CAN'T 

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ENROLL SOMEBODY IN RESEARCH 

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UNLESS YOU OBTAIN THEY'RE 

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LEGALLY VALID INFORMED CONSENT.

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THAT HAS TO BE PROSPECTIVE AND 

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HAS TO BE DOCUMENTED.

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SO THOSE ARE IMPORTANT THINGS.

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THIS IS A STATEMENT FROM AN FDA 

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GUIDANCE THAT CAME OUT A FEW 

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YEARS AGO, I GUESS LAST YEAR -- 

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IT WAS REVISED LAST YEAR.

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AND I LIKE IT BECAUSE IT GIVES 

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YOU THE SORT OF FULL FLAVOR OF 

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WHAT'S INVOLVED IN THE PROCESS.

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IT'S PROVIDING A PROSPECTIVE 

218
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SUBJECT OR LEGALLY AUTHORIZED 

219
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REPRESENTATIVE WITH ADEQUATE 

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INFORMATION TO MAKE A DECISION.

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FACILITATING THEIR 

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UNDERSTANDING, GIVING THEM AN 

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OPPORTUNITY TO ASK QUESTIONS AND

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TO CONSIDER WHETHER TO 

225
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PARTICIPATE, OBTAINING THEIR 

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VOLUNTARY AGREEMENT AND 

227
00:08:56,206 --> 00:08:57,207
CONTINUED TO PROVIDE INFORMATION

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AS INDICATED AS THINGS CHANGE 

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ONE WAY OR ANOTHER.

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SO IF YOU FAKE THE PARAGRAPH, IT

231
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BOILS DOWN TO THE THREE THINGS 

232
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IN THE MIDDLE.

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AND THAT IS INFORMATION DISC

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DISCLOSURE AND VOLUNTARY 

235
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INFORMATION.

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I PUT MORE DOWN MORE AND YOU 

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HAVE TO MAKE SURE THE PERSONS 

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YOU'RE TALKING TO HAVE CAPACITY 

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TO GIVE CONSENT AND YOU'LL HEAR 

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FROM SCOTT AFTER ME SO I WON'T 

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TALK ABOUT THAT AT ALL.

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AS THE YOU SAW IN THE REGULATORY

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LANGUAGE, THERE NEEDS TO BE 

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DOCUMENTATION.

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THERE NEEDS TO BE SOME 

246
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AUTHORIZATION OF CONSENT, 

247
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USUALLY IT'S A WRITTEN 

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SIGNATURE.

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THERE'S DEBATE ABOUT THAT AND 

250
00:09:48,925 --> 00:09:53,397
OTHER OPTIONS BUT IT'S AN 

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00:09:53,397 --> 00:09:55,565
IMPORTANT THING THERE NEEDS TO 

252
00:09:55,565 --> 00:09:56,933
BE SOME DOCUMENTATION.

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I'LL TALK ABOUT THE THREE IN THE

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MIDDLE.

255
00:10:00,303 --> 00:10:03,273
START STARTING WITH INFORMATION 

256
00:10:03,273 --> 00:10:03,573
DISCLOSURE.

257
00:10:03,573 --> 00:10:04,474
THERE'S AN INTERESTING CHALLENGE

258
00:10:04,474 --> 00:10:05,809
IN TRYING TO DECIDE WHAT 

259
00:10:05,809 --> 00:10:07,978
INFORMATION SHOULD BE DISCLOSED.

260
00:10:07,978 --> 00:10:08,845
WHAT IS IMPORTANT -- WHAT'S 

261
00:10:08,845 --> 00:10:11,181
ADEQUATE FOR THE PERSON TO MAKE 

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A DECISION, WHAT'S 

263
00:10:12,749 --> 00:10:13,950
UNDERSTANDABLE AND RELEVANT TO 

264
00:10:13,950 --> 00:10:16,053
THEM AND WHAT'S ACCESSIBLE TO 

265
00:10:16,053 --> 00:10:18,722
THEM AND THIS IS AN 

266
00:10:18,722 --> 00:10:19,289
INTERESTINGLY DIFFICULT 

267
00:10:19,289 --> 00:10:20,624
CHALLENGE IN THE CONTEXT OF 

268
00:10:20,624 --> 00:10:22,993
RESEARCH WHICH IS OFTEN QUITE 

269
00:10:22,993 --> 00:10:27,531
COMPLEX.

270
00:10:27,531 --> 00:10:29,366
THEN THERE'S A SECOND PART OF 

271
00:10:29,366 --> 00:10:30,534
DISCLOSURE AND HOW SHOULD THAT 

272
00:10:30,534 --> 00:10:31,868
INFORMATION BE PRESENTED?

273
00:10:31,868 --> 00:10:33,703
OFTEN WE SEE WRITTEN CONSENT 

274
00:10:33,703 --> 00:10:33,970
DOCUMENTS.

275
00:10:33,970 --> 00:10:36,640
THAT'S ONE WAY OF PRESENTING 

276
00:10:36,640 --> 00:10:36,940
INFORMATION.

277
00:10:36,940 --> 00:10:39,009
ALMOST ALWAYS ACCOMPANIED BY 

278
00:10:39,009 --> 00:10:42,546
SOMEBODY TALKING TO THE 

279
00:10:42,546 --> 00:10:43,146
PARTICIPANT, SOMETIMES OTHER 

280
00:10:43,146 --> 00:10:44,915
KINDS OF INFORMATIONAL, 

281
00:10:44,915 --> 00:10:46,983
EDUCATIONAL MATERIALS, VIDEOS, 

282
00:10:46,983 --> 00:10:47,250
WHATEVER.

283
00:10:47,250 --> 00:10:48,485
IT COULD BE ONE-ON-ONE OR GROUPS

284
00:10:48,485 --> 00:10:51,555
OR ALL KINDS OF THINGS AND THOSE

285
00:10:51,555 --> 00:10:52,889
ALL MATTER IN TERMS OF HOW 

286
00:10:52,889 --> 00:10:54,858
INFORMATION IS DISCLOSED AND HOW

287
00:10:54,858 --> 00:10:58,628
A PERSON MIGHT RECEIVE IT.

288
00:10:58,628 --> 00:11:01,331
THE REGULATORY LANGUAGE AGAIN 

289
00:11:01,331 --> 00:11:04,067
GOES BACK FOR TWO REASONS.

290
00:11:04,067 --> 00:11:06,002
ONE, IT SAYS IT SHOULD BE IN 

291
00:11:06,002 --> 00:11:07,104
LANGUAGE UNDERSTANDABLE TO THE 

292
00:11:07,104 --> 00:11:09,039
SUBJECT OR THE LAR AND HOW DO 

293
00:11:09,039 --> 00:11:10,107
YOU FIGURE THAT OUT?

294
00:11:10,107 --> 00:11:12,109
YOU HAVE TO FIGURE WHAT A 

295
00:11:12,109 --> 00:11:13,710
REASONABLE PERSON THAT'S LIKE 

296
00:11:13,710 --> 00:11:17,814
THE PEOPLE YOU'RE INVITING TO 

297
00:11:17,814 --> 00:11:18,982
PARTICIPATE IN RESEARCH MIGHT 

298
00:11:18,982 --> 00:11:20,450
WANT TO KNOW AND MIGHT BE ABLE 

299
00:11:20,450 --> 00:11:21,118
TO UNDERSTAND AND PRESENT IT IN 

300
00:11:21,118 --> 00:11:25,188
THAT WAY.

301
00:11:25,188 --> 00:11:31,461
THE REGULATIONS ALSO REVISED IN 

302
00:11:31,461 --> 00:11:34,731
2018 ADDED AN ADDITIONAL 

303
00:11:34,731 --> 00:11:36,066
REQUIREMENT FOR INFORMED CONSENT

304
00:11:36,066 --> 00:11:39,636
AND HAS TO BEGIN WITH A CONCISE 

305
00:11:39,636 --> 00:11:41,972
AND FOCUSSED PRESENTATION OF THE

306
00:11:41,972 --> 00:11:47,110
KEY INFORMATION ORGANIZATION -- 

307
00:11:47,110 --> 00:11:50,046
ORGANIZED IN A WAY PEOPLE CAN 

308
00:11:50,046 --> 00:11:51,214
COMPREHEND BUT IN SUFFICIENT 

309
00:11:51,214 --> 00:11:52,916
DETAIL THEY GET THE WHOLE LIST.

310
00:11:52,916 --> 00:11:54,584
IT'S NOT JUST A LIST.

311
00:11:54,584 --> 00:11:57,320
IT'S A DETAILED LIST OF FACTS.

312
00:11:57,320 --> 00:12:00,590
SO THIS IS AN INTERESTING SORT 

313
00:12:00,590 --> 00:12:07,264
OF A LITTLE BIT OF A CONFLICTUAL

314
00:12:07,264 --> 00:12:07,764
CHALLENGE.

315
00:12:07,764 --> 00:12:11,001
YOU WANT MANY SUFFICIENT DETAIL 

316
00:12:11,001 --> 00:12:13,036
AND CONCISE AND THIS WAS 

317
00:12:13,036 --> 00:12:14,671
PUBLISHED BY THE WORLD HEALTH 

318
00:12:14,671 --> 00:12:19,876
ORGANIZATION RECENTLY THAT 

319
00:12:19,876 --> 00:12:21,545
BASICALLY SAYS AND A LOT OF 

320
00:12:21,545 --> 00:12:27,717
PEOPLE AGREE IT'S ESSENTIAL 

321
00:12:27,717 --> 00:12:29,419
THEY'RE INFORMED BUT EXHAUSTIVE 

322
00:12:29,419 --> 00:12:31,121
DETAIL CAN WORK AGAINST THIS 

323
00:12:31,121 --> 00:12:32,989
OBJECTIVE BY OVERWHELMING, 

324
00:12:32,989 --> 00:12:36,359
CONFUSING OR DISCONCERTING 

325
00:12:36,359 --> 00:12:36,826
PARTICIPANTS.

326
00:12:36,826 --> 00:12:40,964
THAT'S THE SORT OF CHALLENGE IN 

327
00:12:40,964 --> 00:12:42,365
TERMS OF DISCLOSURE.

328
00:12:42,365 --> 00:12:44,701
SO, HOW ARE WE DOING?

329
00:12:44,701 --> 00:12:46,336
AS THE BEEN RESEARCH IN HOW WE 

330
00:12:46,336 --> 00:12:48,972
ARE DOING IN RESEARCH INFORMED 

331
00:12:48,972 --> 00:12:49,206
CONSENT.

332
00:12:49,206 --> 00:12:52,676
I PUT SOME REFERENCES BUT THE 

333
00:12:52,676 --> 00:12:54,444
OVER ALL CONCLUSION ABOUT 

334
00:12:54,444 --> 00:12:55,912
CONSENT IS THAT UP CONSENT FORMS

335
00:12:55,912 --> 00:12:58,815
THE READING LEVEL IS USUALLY 

336
00:12:58,815 --> 00:13:02,452
HIGH.

337
00:13:02,452 --> 00:13:06,957
AND HIGHER THAN WHAT PEOPLE 

338
00:13:06,957 --> 00:13:08,391
BELIEVE IS THE HIGHER READING 

339
00:13:08,391 --> 00:13:09,693
LEVEL THAN THE U.S. POPULATION 

340
00:13:09,693 --> 00:13:11,695
AND HIGHER THAN 8th GRADE WHICH 

341
00:13:11,695 --> 00:13:13,964
IS WHAT THE GUIDANCE RECOMMENDS 

342
00:13:13,964 --> 00:13:15,265
WE WRITE AT THAT LEVEL.

343
00:13:15,265 --> 00:13:17,000
SO READING LEVEL IS HIGH.

344
00:13:17,000 --> 00:13:18,702
CONSENT FORMS ARE LONG AND 

345
00:13:18,702 --> 00:13:19,336
THEY'VE INCREASED IN LENGTH OVER

346
00:13:19,336 --> 00:13:26,209
TIME.

347
00:13:26,209 --> 00:13:28,778
IF YOU LOOK AT CONSENT FORMS 

348
00:13:28,778 --> 00:13:31,248
FROM YEARS AGO NOW THEY'RE 25 OR

349
00:13:31,248 --> 00:13:33,016
SOMETIMES HIGHER.

350
00:13:33,016 --> 00:13:34,851
THEY'RE QUITE LONG AND TAKE A 

351
00:13:34,851 --> 00:13:37,387
WHILE TO READ AND ABSORB.

352
00:13:37,387 --> 00:13:41,124
AND THEN THERE'S BEEN A FEW 

353
00:13:41,124 --> 00:13:43,560
STUDIES THAT HAVE LOOKED AT 

354
00:13:43,560 --> 00:13:44,761
BEING LONG AND COMPLEX DO THEY 

355
00:13:44,761 --> 00:13:47,831
DO THEY HAVE TO HAVE AND THE 

356
00:13:47,831 --> 00:13:51,434
ANSWER IS, NO.

357
00:13:51,434 --> 00:13:52,836
THEY'RE SOMETIMES MISSING 

358
00:13:52,836 --> 00:13:54,704
INFORMATION REQUIRED BY 

359
00:13:54,704 --> 00:13:55,138
REGULATIONS.

360
00:13:55,138 --> 00:13:57,007
WE'RE NOT DOING SO GREAT ON THE 

361
00:13:57,007 --> 00:13:57,440
CONSENT FORMS.

362
00:13:57,440 --> 00:13:58,975
THERE'S INTERESTING AND 

363
00:13:58,975 --> 00:14:01,878
UNANSWERED QUESTIONS ABOUT THE 

364
00:14:01,878 --> 00:14:03,947
EFFECT OF HOW INFORMATION IS 

365
00:14:03,947 --> 00:14:05,382
DISCLOSED ON HOW PEOPLE 

366
00:14:05,382 --> 00:14:10,320
UNDERSTAND OR RECEIVE IT.

367
00:14:10,320 --> 00:14:16,559
YOU MIGHT TO THE IDEAL IS 

368
00:14:16,559 --> 00:14:19,729
SOMEONE SITTING DOWN ONE-ON-ONE 

369
00:14:19,729 --> 00:14:20,730
AND DISCUSSING AND GIVING 

370
00:14:20,730 --> 00:14:22,365
INFORMATION AND THAT DOES HAPPEN

371
00:14:22,365 --> 00:14:24,034
BUT NOT ALWAYS.

372
00:14:24,034 --> 00:14:26,903
I LOVE TO TELL A STORY THAT 

373
00:14:26,903 --> 00:14:28,405
HAPPENED TO ME ON A CONSULT.

374
00:14:28,405 --> 00:14:34,978
A YOUNG MAN HAD COME FROM FAR 

375
00:14:34,978 --> 00:14:44,154
AWAY FOR A COMPLICATED PROTOCOL 

376
00:14:44,154 --> 00:14:45,655
TO TREAT HIS CANCER AND REQUIRE 

377
00:14:45,655 --> 00:14:46,956
HIM TO BE HOSPITALIZED FOR WEEKS

378
00:14:46,956 --> 00:14:52,996
AND RECEIVE INFUSIONS OF THIS 

379
00:14:52,996 --> 00:14:59,436
NOVEL SUBSTANCE BUT THE IDEA IS 

380
00:14:59,436 --> 00:15:01,004
IT MIGHT SPARE HIS ARM AND HE 

381
00:15:01,004 --> 00:15:06,376
WAS AN ARTIST AND DIDN'T CARE 

382
00:15:06,376 --> 00:15:07,143
ANYTHING ABOUT PRESERVING HIS 

383
00:15:07,143 --> 00:15:08,345
ARM FOR HIS ART.

384
00:15:08,345 --> 00:15:09,646
THE SCENARIO WAS HE WAS SITTING 

385
00:15:09,646 --> 00:15:10,780
IN A ROOM.

386
00:15:10,780 --> 00:15:12,048
I WAS THERE WITH HIM.

387
00:15:12,048 --> 00:15:13,817
THERE WERE THREE INVESTIGATORS 

388
00:15:13,817 --> 00:15:16,152
WHO CAME IN.

389
00:15:16,152 --> 00:15:18,254
THEY ALL STOOD, HE SAT.

390
00:15:18,254 --> 00:15:20,423
THEY ARE DAVE HIM LOTS OF 

391
00:15:20,423 --> 00:15:20,724
INFORMATION.

392
00:15:20,724 --> 00:15:21,958
THEY BOMBARDED HIM WITH 

393
00:15:21,958 --> 00:15:23,560
INFORMATION IN A CERTAIN WAY AND

394
00:15:23,560 --> 00:15:27,230
IN THE MIDDLE OF THIS 

395
00:15:27,230 --> 00:15:28,998
CONVERSATION THEY EACH HAD 

396
00:15:28,998 --> 00:15:31,701
PAGERS ON AND THEY WOULD GO OUT 

397
00:15:31,701 --> 00:15:32,969
AND ANSWER THE PAGER AND COME 

398
00:15:32,969 --> 00:15:38,041
BACK AND IN AND OUT.

399
00:15:38,041 --> 00:15:39,409
IT FELT LIKE DUMPING INFORMATION

400
00:15:39,409 --> 00:15:42,479
ON THIS GUY WHO WAS SITTING 

401
00:15:42,479 --> 00:15:42,679
DOWN.

402
00:15:42,679 --> 00:15:44,013
THEN WHEN THEY WERE FINISHED 

403
00:15:44,013 --> 00:15:49,319
THEY SAID DO YOU WANT TO DO IT?

404
00:15:49,319 --> 00:15:53,490
I REMEMBER FEELING LIKE WHOA, 

405
00:15:53,490 --> 00:15:54,257
TOO MUCH INFORMATION, TOO MUCH 

406
00:15:54,257 --> 00:15:55,191
AGGRESSIVE INFORMATION.

407
00:15:55,191 --> 00:15:58,595
HE NEEDS TIME AND SPACE TO JUST 

408
00:15:58,595 --> 00:16:00,330
SIT WITH IT, ASK QUESTIONS, 

409
00:16:00,330 --> 00:16:02,399
THINK ABOUT IT, ETCETERA.

410
00:16:02,399 --> 00:16:09,005
THAT WASN'T THE PLAN AT THAT 

411
00:16:09,005 --> 00:16:09,239
MOMENT.

412
00:16:09,239 --> 00:16:10,540
THE REALITY OF HOW INFORMATION 

413
00:16:10,540 --> 00:16:12,542
IS PRESENTED IS VERY CRITICAL.

414
00:16:12,542 --> 00:16:13,777
THEN THE OTHER THING IS OF 

415
00:16:13,777 --> 00:16:15,111
COURSE WE HAVE PEOPLE, MANY 

416
00:16:15,111 --> 00:16:17,080
PEOPLE PARTICIPATING IN RESEARCH

417
00:16:17,080 --> 00:16:19,115
WHO ARE IN DIRE STRAITS.

418
00:16:19,115 --> 00:16:21,017
THEY'RE IN DISTRESS, THEY'RE IN 

419
00:16:21,017 --> 00:16:23,520
PAIN.

420
00:16:23,520 --> 00:16:24,354
THEY HAVE HEADACHES, THEY'RE 

421
00:16:24,354 --> 00:16:24,621
CONFUSED.

422
00:16:24,621 --> 00:16:25,955
THESE ARE ALL REALITIES OF THE 

423
00:16:25,955 --> 00:16:27,690
CLINICAL SITUATIONS IN WHICH 

424
00:16:27,690 --> 00:16:29,926
WE'RE OFTEN PRESENTING 

425
00:16:29,926 --> 00:16:31,094
INFORMATION TO PEOPLE AND HOPING

426
00:16:31,094 --> 00:16:33,029
THEY CAN THEN USE IT TO MAKE A 

427
00:16:33,029 --> 00:16:33,296
DECISION.

428
00:16:33,296 --> 00:16:40,970
THESE ARE REALLY CRITICAL 

429
00:16:40,970 --> 00:16:42,839
QUESTIONS ABOUT WHO DOES IT, 

430
00:16:42,839 --> 00:16:44,240
WHEN, WHERE AND HOW.

431
00:16:44,240 --> 00:16:50,213
UP RECENT YEARS THIS CAME OUT OF

432
00:16:50,213 --> 00:16:52,081
A FEDERAL REGISTER GUIDANCE 

433
00:16:52,081 --> 00:16:55,084
ABOUT EIGHT YEARS AGO THAT 

434
00:16:55,084 --> 00:16:55,752
BASICALLY SAID INFORMED CONSENT 

435
00:16:55,752 --> 00:16:57,720
DOESN'T HAVE TO BE ON A PIECE OF

436
00:16:57,720 --> 00:16:57,921
PAPER.

437
00:16:57,921 --> 00:17:02,325
DOESN'T HAVE STO START WITH A 

438
00:17:02,325 --> 00:17:03,593
PIECE OF PAPER YOU TALK TO 

439
00:17:03,593 --> 00:17:06,596
SOMEBODY ABOUT.

440
00:17:06,596 --> 00:17:12,135
IT CAN BE ELECTRONIC, PODCASTS, 

441
00:17:12,135 --> 00:17:13,503
INTERACTIVE SITES, ETCETERA.

442
00:17:13,503 --> 00:17:19,108
THIS IS ANOTHER WAY TO DISCLOSE 

443
00:17:19,108 --> 00:17:21,344
INFORMATION AND THE QUESTION IS 

444
00:17:21,344 --> 00:17:22,579
HOW DOES THIS HELP PEOPLE 

445
00:17:22,579 --> 00:17:26,249
UNDERSTAND BETTER OR NOT SO MUCH

446
00:17:26,249 --> 00:17:27,450
BETTER?

447
00:17:27,450 --> 00:17:30,253
WHAT ARE SOME CHALLENGES WITH 

448
00:17:30,253 --> 00:17:30,620
DISCLOSURE?

449
00:17:30,620 --> 00:17:32,322
I MENTIONED DETERMINING WHAT IS 

450
00:17:32,322 --> 00:17:33,890
THE RELEVANT INFORMATION IN 

451
00:17:33,890 --> 00:17:37,327
CONTEXT TO DISCLOSE UNDERSTOOD 

452
00:17:37,327 --> 00:17:38,862
TO FACILITATE DECISION MAKING IS

453
00:17:38,862 --> 00:17:40,897
A CHALLENGE.

454
00:17:40,897 --> 00:17:41,431
RESEARCH INFORMATION IS 

455
00:17:41,431 --> 00:17:44,234
SOMETIMES QUITE COMPLICATED.

456
00:17:44,234 --> 00:17:46,703
ANOTHER THING IS WRITTEN CONSENT

457
00:17:46,703 --> 00:17:47,670
DOCUMENTS SERVE MULTIPLE 

458
00:17:47,670 --> 00:17:47,937
PURPOSES.

459
00:17:47,937 --> 00:17:50,773
THEY NOT ONLY ARE DESIGN TO HELP

460
00:17:50,773 --> 00:17:51,641
SOMEBODY GET INFORMATION THEY 

461
00:17:51,641 --> 00:17:54,844
NEED, BUT THEY ALSO PROTECT THE 

462
00:17:54,844 --> 00:17:56,346
INSTITUTION AND INVESTIGATORS.

463
00:17:56,346 --> 00:17:58,982
SO THAT'S A REALLY IMPORTANT 

464
00:17:58,982 --> 00:18:03,319
THING TO KEEP IN MIND.

465
00:18:03,319 --> 00:18:07,190
SOMEONE SAID BASICALLY EASY 

466
00:18:07,190 --> 00:18:10,527
READING IS DAMN HARD WRITING.

467
00:18:10,527 --> 00:18:14,297
I DON'T KNOW IF SOMEONE TRIED 

468
00:18:14,297 --> 00:18:19,469
WRITING ONE PARAGRAPH WHAT YOU 

469
00:18:19,469 --> 00:18:20,703
HAVE IN FOUR PAGES IT'S HARD TO 

470
00:18:20,703 --> 00:18:22,238
MAKE IT UNDERSTANDABLE.

471
00:18:22,238 --> 00:18:24,741
AND NOT SURPRISINGLY, 

472
00:18:24,741 --> 00:18:27,176
INSTITUTION, SPONSORS AND 

473
00:18:27,176 --> 00:18:30,280
INVESTIGATORS AND EVEN IRBs 

474
00:18:30,280 --> 00:18:33,049
OFTEN WANT MORE INFORMATION AND 

475
00:18:33,049 --> 00:18:34,450
THEREFORE CONCEPT FORMS GET 

476
00:18:34,450 --> 00:18:35,752
LONGER AND MORE COMPLEX BASED ON

477
00:18:35,752 --> 00:18:39,556
THOSE INPUTS.

478
00:18:39,556 --> 00:18:40,990
THE SECOND INFORMATION IS 

479
00:18:40,990 --> 00:18:41,758
DISCLOSED.

480
00:18:41,758 --> 00:18:43,226
THE SECOND IMPORTANT PART OF 

481
00:18:43,226 --> 00:18:45,695
INFORMED CONSENT IS 

482
00:18:45,695 --> 00:18:46,029
UNDERSTANDING.

483
00:18:46,029 --> 00:18:48,598
AND WE ALL KNOW THAT WHEN YOU 

484
00:18:48,598 --> 00:18:49,499
HEAR INFORMATION EVEN WHEN 

485
00:18:49,499 --> 00:18:54,304
YOU'RE LISTENING THERE'S ONLY A 

486
00:18:54,304 --> 00:18:59,976
SORT OF A LITTLE BIT, I GUESS IS

487
00:18:59,976 --> 00:19:09,018
THE RIGHT WORD WHERE YOU REALLY 

488
00:19:09,018 --> 00:19:10,954
UNDERSTAND.

489
00:19:10,954 --> 00:19:12,789
AND IT CAN'T BE EXPECTED 

490
00:19:12,789 --> 00:19:13,523
EVERYTHING YOU'RE TOLD IS 

491
00:19:13,523 --> 00:19:16,192
SOMETHING YOU UNDERSTAND.

492
00:19:16,192 --> 00:19:21,264
THE QUESTIONS THAT REALLY PLAGUE

493
00:19:21,264 --> 00:19:22,999
THE PROCESS OF INFORMED CONSENT 

494
00:19:22,999 --> 00:19:33,443
IS HOW MUCH IS NEEDED FOR 

495
00:19:35,078 --> 00:19:35,311
CONSENT.

496
00:19:35,311 --> 00:19:39,349
JOE MILLON WHO USED TO BE IN OUR

497
00:19:39,349 --> 00:19:44,053
GROUP WITH DANIEL BRUM SUGGESTED

498
00:19:44,053 --> 00:19:45,121
A MINIMAL UNDERSTANDING 

499
00:19:45,121 --> 00:19:46,222
CONSISTENT WITH VALID INFORMED 

500
00:19:46,222 --> 00:19:46,656
CONSENT.

501
00:19:46,656 --> 00:19:49,726
THERE'S ALSO A QUESTION ABOUT 

502
00:19:49,726 --> 00:19:54,030
HOW SHOULD WE AND HOW DO WE 

503
00:19:54,030 --> 00:19:55,632
ASSESS WHETHER PEOPLE DO 

504
00:19:55,632 --> 00:19:56,032
UNDERSTAND.

505
00:19:56,032 --> 00:20:02,271
I'VE SEEN THE FULL GAMUT OF THE 

506
00:20:02,271 --> 00:20:03,606
EXAMPLE, ARE YOU COME, DO YOU 

507
00:20:03,606 --> 00:20:06,376
WANT TO DO OUT WITHOUT 

508
00:20:06,376 --> 00:20:06,643
QUESTIONS.

509
00:20:06,643 --> 00:20:08,778
SOMETIMES PEOPLE SAY DO YOU HAVE

510
00:20:08,778 --> 00:20:10,079
ANY QUESTIONS.

511
00:20:10,079 --> 00:20:10,913
SOMETIMES INVESTIGATORS AND 

512
00:20:10,913 --> 00:20:13,983
RESEARCH TEAMS USE QUIZZES.

513
00:20:13,983 --> 00:20:15,518
THEY HAVE WRITTEN QUIZZES AND 

514
00:20:15,518 --> 00:20:18,454
PEOPLE HAVE TO GET A CERTAIN 

515
00:20:18,454 --> 00:20:19,656
PERCENTAGE RIGHT TO DEMONSTRATE 

516
00:20:19,656 --> 00:20:21,858
UNDERSTANDING.

517
00:20:21,858 --> 00:20:23,359
THERE'S A WIDE RANGE OF WHY AND 

518
00:20:23,359 --> 00:20:25,461
HOW SHOULD WE DO IT AND A 

519
00:20:25,461 --> 00:20:28,197
QUESTION ON WHAT HAPPENS OR WHAT

520
00:20:28,197 --> 00:20:31,034
SHOULD HAPPEN WHEN PARTICIPANTS 

521
00:20:31,034 --> 00:20:32,035
DON'T UNDERSTAND AND WHAT IF 

522
00:20:32,035 --> 00:20:33,102
THEY DON'T UNDERSTAND WHAT?

523
00:20:33,102 --> 00:20:34,904
THEY DON'T UNDERSTAND ANYTHING?

524
00:20:34,904 --> 00:20:35,505
THEY ARE UNDERSTAND CERTAIN 

525
00:20:35,505 --> 00:20:36,572
THINGS BUT NOT OTHER THINGS AND 

526
00:20:36,572 --> 00:20:38,207
SHOULD THEY BE ABLE TO 

527
00:20:38,207 --> 00:20:39,642
PARTICIPATE OR NOT AND DOES IT 

528
00:20:39,642 --> 00:20:40,877
DEPEND ON THE STUDY?

529
00:20:40,877 --> 00:20:42,145
THESE ARE HARD QUESTIONS TO 

530
00:20:42,145 --> 00:20:43,279
ANSWER.

531
00:20:43,279 --> 00:20:45,815
AGAIN, THERE'S BEEN A FAIR 

532
00:20:45,815 --> 00:20:46,449
AMOUNT OF RESEARCH ON INFORMED 

533
00:20:46,449 --> 00:20:51,621
CONSENT WHICH IS BASICALLY 

534
00:20:51,621 --> 00:20:52,989
CONCLUDED OVER ALL THAT RESEARCH

535
00:20:52,989 --> 00:20:54,290
PATIENTS HAVE VARIABLE 

536
00:20:54,290 --> 00:20:55,058
UNDERSTANDING OF THE STUDIES 

537
00:20:55,058 --> 00:20:56,059
THEY CONSENTED TO.

538
00:20:56,059 --> 00:20:58,394
THEY CONSENTED, THEY'RE IN THE 

539
00:20:58,394 --> 00:21:00,229
STUDY, SOMEBODY INTERVIEWS OR 

540
00:21:00,229 --> 00:21:02,765
SURVEYS THEM TO FIGURE OUT WHAT 

541
00:21:02,765 --> 00:21:03,599
THEY'VE UNDERSTAND AND 

542
00:21:03,599 --> 00:21:05,968
UNDERSTAND SOME THINGS AND NOT 

543
00:21:05,968 --> 00:21:07,970
OTHER THINGS AND THAT'S 

544
00:21:07,970 --> 00:21:10,206
BASICALLY ALL THE DATA SUGGESTED

545
00:21:10,206 --> 00:21:11,007
THAT'S THE CASE.

546
00:21:11,007 --> 00:21:12,075
AND THE RANGE IS QUITE STRIKING 

547
00:21:12,075 --> 00:21:15,545
IF YOU LOOK AT SOME OF THESE 

548
00:21:15,545 --> 00:21:16,546
DOWN HERE.

549
00:21:16,546 --> 00:21:17,647
RESEARCH PURPOSE AND NATURE 

550
00:21:17,647 --> 00:21:19,582
SOMETIMES AS LOW AS 27% 

551
00:21:19,582 --> 00:21:21,417
UNDERSTAND AND SOMETIMES 100% 

552
00:21:21,417 --> 00:21:22,118
UNDERSTAND IT.

553
00:21:22,118 --> 00:21:25,021
OF RISKS, THE SAME KIND OF 

554
00:21:25,021 --> 00:21:25,755
RANGE.

555
00:21:25,755 --> 00:21:27,623
OF RANDOMIZATION AND PLACEBO USE

556
00:21:27,623 --> 00:21:30,393
IS OFTEN LOWER.

557
00:21:30,393 --> 00:21:32,495
PEOPLE UNDERSTAND THAT LESS WELL

558
00:21:32,495 --> 00:21:33,563
IN GENERAL THAN OTHER THINGS BUT

559
00:21:33,563 --> 00:21:34,997
STILL QUITE A RANGE.

560
00:21:34,997 --> 00:21:39,035
THERE'S ALSO BEEN A COUPLE OF 

561
00:21:39,035 --> 00:21:40,203
META-ANALYSES OF THE INFORMED 

562
00:21:40,203 --> 00:21:41,704
CONSENT STUDIES TO TRY TO SHOW 

563
00:21:41,704 --> 00:21:42,638
WHAT PEOPLE DO OR DO NOT 

564
00:21:42,638 --> 00:21:42,972
UNDERSTAND.

565
00:21:42,972 --> 00:21:44,774
THIS IS A BUSY SLIDE AND I'M 

566
00:21:44,774 --> 00:21:47,510
GOING TO SHOW YOU ANOTHER BUSY 

567
00:21:47,510 --> 00:21:47,877
SLIDE.

568
00:21:47,877 --> 00:21:49,812
TWO TAKEAWAYS, NOTHING REALLY 

569
00:21:49,812 --> 00:21:53,216
APPROACHES 100%.

570
00:21:53,216 --> 00:21:55,284
THAT'S ONE THING TO NOTICE AND 

571
00:21:55,284 --> 00:21:59,489
SEE THERE ARE SEVERAL THINGS 

572
00:21:59,489 --> 00:22:02,859
LIKE PLACEBO RANDOMIZATION AND 

573
00:22:02,859 --> 00:22:07,096
ALTERNATIVE TREATMENTS CLOSER TO

574
00:22:07,096 --> 00:22:07,263
50%.

575
00:22:07,263 --> 00:22:10,900
THAT'S A LITTLE BIT DISCONCERT 

576
00:22:10,900 --> 00:22:11,100
ARING.

577
00:22:11,100 --> 00:22:12,502
THIS WAS A META-ANALYSIS 

578
00:22:12,502 --> 00:22:14,137
PUBLISHED IN 2015 BASED ON DATA 

579
00:22:14,137 --> 00:22:15,505
THAT HAD BEEN COLLECTED TO DATE.

580
00:22:15,505 --> 00:22:18,107
THERE WAS A SECOND ONE PUBLISHED

581
00:22:18,107 --> 00:22:19,475
JUST THIS YEAR WHICH USED SOME 

582
00:22:19,475 --> 00:22:24,313
OF THE SAME METHODOLOGY AND 

583
00:22:24,313 --> 00:22:25,748
BASICALLY SEE THE NUMBERS.

584
00:22:25,748 --> 00:22:29,018
THERE'S NOT MUCH DIFFERENT THAN 

585
00:22:29,018 --> 00:22:36,325
THE OTHER META-ANALYSES.

586
00:22:36,325 --> 00:22:38,728
AND THE RESULTS SHOW MOST 

587
00:22:38,728 --> 00:22:39,462
PARTICIPANTS UNDERSTAND THE 

588
00:22:39,462 --> 00:22:41,364
FUNDAMENTAL COMPONENTS OF 

589
00:22:41,364 --> 00:22:43,032
INFORMED CONSENT.

590
00:22:43,032 --> 00:22:45,034
MEANING STUDY NATURE, 

591
00:22:45,034 --> 00:22:46,469
VOLUNTARINESS AND FREEDOM TO 

592
00:22:46,469 --> 00:22:48,638
WITHDRAW MOST AS A QUESTION MARK

593
00:22:48,638 --> 00:22:50,273
AND OTHER THINGS LIKE PLACEBO 

594
00:22:50,273 --> 00:22:53,209
AND THE ABILITY TO NAME AT LEAST

595
00:22:53,209 --> 00:23:02,919
ONE RISK WAS MUCH LOWER.

596
00:23:02,919 --> 00:23:05,087
WHAT AFFECTS UNDERSTANDING?

597
00:23:05,087 --> 00:23:08,724
THERE'S PROCESS RELATED FACTORS 

598
00:23:08,724 --> 00:23:11,027
AND WHAT INFORMATION THEY'RE 

599
00:23:11,027 --> 00:23:15,364
GIVEN AFFECTS HOW THEY 

600
00:23:15,364 --> 00:23:19,902
UNDERSTAND AND AS WELL BY HOW 

601
00:23:19,902 --> 00:23:21,671
WELL THEY PROCESS AND LEARN AND 

602
00:23:21,671 --> 00:23:24,440
LISTEN AND THERE'S FACTORS THAT 

603
00:23:24,440 --> 00:23:27,076
INFLUENCE THE UNDERSTANDING OF 

604
00:23:27,076 --> 00:23:29,011
RESEARCH PARTICIPANTING INCLUDE 

605
00:23:29,011 --> 00:23:31,047
SOME OF THOSE WON'T SURPRISE YOU

606
00:23:31,047 --> 00:23:33,783
AT ALL, AGE, OLDER PEOPLE 

607
00:23:33,783 --> 00:23:35,051
UNDERSTAND LESS AND LESS 

608
00:23:35,051 --> 00:23:36,652
EDUCATED PEOPLE UNDERSTAND LESS.

609
00:23:36,652 --> 00:23:37,820
PEOPLE IN PAIN.

610
00:23:37,820 --> 00:23:40,790
PEOPLE WHO HAVE COGNITIVE 

611
00:23:40,790 --> 00:23:41,090
IMPAIRMENT.

612
00:23:41,090 --> 00:23:43,159
PEOPLE UNDER STRESS.

613
00:23:43,159 --> 00:23:45,528
THOSE HOST FACTORS ARE 

614
00:23:45,528 --> 00:23:46,162
ASSOCIATED WITH LOWER LEVELS OF 

615
00:23:46,162 --> 00:23:54,503
UNDERSTANDING.

616
00:23:54,503 --> 00:23:57,039
THERE'S UNEXPLORED ASPECTS OF 

617
00:23:57,039 --> 00:24:00,710
WHAT IMPACTS UNDERSTANDING 

618
00:24:00,710 --> 00:24:07,250
RESEARCH PARTICIPANTS AND 

619
00:24:07,250 --> 00:24:08,618
EXPECTATIONS AND WHAT DO PEOPLE 

620
00:24:08,618 --> 00:24:10,853
THINK WILL HAPPEN BEFORE THEY 

621
00:24:10,853 --> 00:24:11,387
GET ANY INFORMATION.

622
00:24:11,387 --> 00:24:12,889
WHY DO THEY DO IT?

623
00:24:12,889 --> 00:24:14,290
THAT INFLUENCES WHAT THEY LISTEN

624
00:24:14,290 --> 00:24:19,195
TO AND END UP UNDERSTANDING.

625
00:24:19,195 --> 00:24:20,463
THERE'S CULTURAL VIEWS.

626
00:24:20,463 --> 00:24:21,831
THERAPEUTIC MISCONCEPTIONS AND 

627
00:24:21,831 --> 00:24:28,938
OTHER RELATED UNDERSTANDINGS.

628
00:24:28,938 --> 00:24:30,406
IMPORTANTLY THINKING ABOUT 

629
00:24:30,406 --> 00:24:33,009
DISCLOSURE AND UNDERSTANDING 

630
00:24:33,009 --> 00:24:35,077
IT'S IMPORTANT TO THINK ABOUT 

631
00:24:35,077 --> 00:24:36,412
HEALTH LITERACY.

632
00:24:36,412 --> 00:24:38,381
THIS IS U.S. DATA COMING FROM 

633
00:24:38,381 --> 00:24:39,682
BOTH THE NATIONAL LIBRARY OF 

634
00:24:39,682 --> 00:24:40,917
MEDICINE AND THE OTHER 

635
00:24:40,917 --> 00:24:42,251
ORGANIZATION I CAN'T THINK OF 

636
00:24:42,251 --> 00:24:44,020
THE NAME OF, CHCS.

637
00:24:44,020 --> 00:24:45,321
THEY GRADE ON THE NUMBERS SO I 

638
00:24:45,321 --> 00:24:50,593
PUT THEM BOTH DOWN THERE.

639
00:24:50,593 --> 00:24:52,361
BASICALLY THEY SAY NINE OUT OF 

640
00:24:52,361 --> 00:24:56,465
TEN ADULTS STRUGGLE WITH HEALTH 

641
00:24:56,465 --> 00:24:56,732
LITERACY.

642
00:24:56,732 --> 00:24:59,068
EVEN PEOPLE WITH OTHERWISE GOOD 

643
00:24:59,068 --> 00:25:00,937
LITERACY SKILLS, PEOPLE WHO CAN 

644
00:25:00,937 --> 00:25:03,472
READ AND WRITE AND CALCULATE 

645
00:25:03,472 --> 00:25:05,141
PLAY HAVE LOW HEALTH LITERACY.

646
00:25:05,141 --> 00:25:07,043
I FIND THAT REALLY INTERESTING.

647
00:25:07,043 --> 00:25:09,345
I EXPECT YOU ALL KNOW PEOPLE 

648
00:25:09,345 --> 00:25:13,149
LIKE I DO, SMART PEOPLE WHO ARE 

649
00:25:13,149 --> 00:25:16,018
MASTER'S IN THEIR DOMAIN OF THE 

650
00:25:16,018 --> 00:25:18,154
WORLD WHO DON'T UNDERSTAND MUCH 

651
00:25:18,154 --> 00:25:20,990
ABOUT HEALTH.

652
00:25:20,990 --> 00:25:22,291
IT'S QUITE INTERESTING BUT THIS 

653
00:25:22,291 --> 00:25:23,526
HAS TO INFLUENCE HOW PEOPLE 

654
00:25:23,526 --> 00:25:25,027
UNDERSTAND THE KINDS OF 

655
00:25:25,027 --> 00:25:25,695
INFORMATION WE'RE PROVIDING IN 

656
00:25:25,695 --> 00:25:28,798
THE CONTEXT OF MAKING DECISIONS 

657
00:25:28,798 --> 00:25:39,308
ABOUT RESEARCH PARTICIPATION.

658
00:25:39,842 --> 00:25:42,945
HOW MUCH PEOPLE UNDERSTAND AND 

659
00:25:42,945 --> 00:25:44,513
HOW WE ASSESS UNDERSTANDING 

660
00:25:44,513 --> 00:25:49,719
SHOULD VARY BY THE LEVEL OF RISK

661
00:25:49,719 --> 00:26:00,062
TO THE PARTICIPANT.

662
00:26:06,268 --> 00:26:10,840
IF YOU LOOK AT THE ROW, THE 

663
00:26:10,840 --> 00:26:12,942
RECOMMENDED IF IT'S LOW RISK YOU

664
00:26:12,942 --> 00:26:13,743
CAN ASSUME PEOPLE UNDERSTAND IT 

665
00:26:13,743 --> 00:26:15,745
AND COMPETENT TO UNDERSTAND IT.

666
00:26:15,745 --> 00:26:18,681
IF IT'S MODERATE OR HIGH RISK 

667
00:26:18,681 --> 00:26:21,017
WITH POTENTIAL BENEFIT YOU MAY 

668
00:26:21,017 --> 00:26:23,552
DO A BRIEF OR INFORMAL 

669
00:26:23,552 --> 00:26:24,787
ASSESSMENT OF HOW MUCH THEY 

670
00:26:24,787 --> 00:26:26,822
UNDERSTAND BUT HIGHER THE RISK 

671
00:26:26,822 --> 00:26:28,090
OR HIGH RISK WITH LITTLE OR NO 

672
00:26:28,090 --> 00:26:31,460
POTENTIAL BENEFIT YOU NEED A 

673
00:26:31,460 --> 00:26:33,662
HIGHER THRESHOLD OF KNOWING THE 

674
00:26:33,662 --> 00:26:35,164
PERSON UNDERSTAND THE DETAILS OF

675
00:26:35,164 --> 00:26:36,999
THE STUDY DATA PRESENTED TO 

676
00:26:36,999 --> 00:26:37,199
THEM.

677
00:26:37,199 --> 00:26:47,710
I AGREE WITH THAT, BY THE WAY.

678
00:26:48,477 --> 00:26:49,311
AS THE DIFFERENT KINDS OF 

679
00:26:49,311 --> 00:26:50,980
MISUNDERSTANDING AND THAT'S 

680
00:26:50,980 --> 00:26:52,481
HELPFUL TO THINK THROUGH.

681
00:26:52,481 --> 00:26:54,050
PEOPLE FOCUS ON THERAPEUTIC 

682
00:26:54,050 --> 00:26:55,217
MISCONCEPTION WHICH IS BASICALLY

683
00:26:55,217 --> 00:26:57,987
NOT RECOGNIZING PEOPLE IS 

684
00:26:57,987 --> 00:27:00,389
DIFFERENT THAN REGULAR CLINICAL 

685
00:27:00,389 --> 00:27:01,991
CARE AND GIVE A DEFINITION IN A 

686
00:27:01,991 --> 00:27:02,558
MINUTE.

687
00:27:02,558 --> 00:27:04,794
THERE'S OTHER KIND OF 

688
00:27:04,794 --> 00:27:05,194
MISUNDERSTANDINGS.

689
00:27:05,194 --> 00:27:09,765
SOME PEOPLE UNDERSTAND RESEARCH 

690
00:27:09,765 --> 00:27:11,033
IS RESEARCH BUT MISS ESTIMATE 

691
00:27:11,033 --> 00:27:13,002
THE LEVEL OF BENEFIT OR RISK OR 

692
00:27:13,002 --> 00:27:23,112
BOTH.

693
00:27:24,280 --> 00:27:27,049
THE EXPECTATION IS IT WILL BE 5%

694
00:27:27,049 --> 00:27:28,217
BENEFICIAL OR WHATEVER.

695
00:27:28,217 --> 00:27:29,752
UNDERSTANDING THAT 

696
00:27:29,752 --> 00:27:30,886
MISUNDERSTANDING IS IMPORTANT 

697
00:27:30,886 --> 00:27:31,053
TOO.

698
00:27:31,053 --> 00:27:33,823
THEN THERE'S BEEN A WHOLE BUNCH 

699
00:27:33,823 --> 00:27:37,026
OF LITERATURE ON THE INFLUENCE 

700
00:27:37,026 --> 00:27:39,962
OF OPTIMISM.

701
00:27:39,962 --> 00:27:44,500
THERE ARE PEOPLE WHO BECAUSE OF 

702
00:27:44,500 --> 00:27:45,968
EXPECTATIONS A GUY SAID I GET 

703
00:27:45,968 --> 00:27:46,402
IT.

704
00:27:46,402 --> 00:27:48,137
IT'S BRAND NEW, FIRST IN HUMAN.

705
00:27:48,137 --> 00:27:50,172
DON'T KNOW IF IT WILL HELP ME AT

706
00:27:50,172 --> 00:27:52,408
ALL OR WORK IN ANYBODY BUT I'LL 

707
00:27:52,408 --> 00:27:53,909
BE THE ONE.

708
00:27:53,909 --> 00:27:59,315
SO THAT KIND OF OPTIMISM CAN BE 

709
00:27:59,315 --> 00:28:00,883
NATURE FOR CERTAIN PEOPLE AND 

710
00:28:00,883 --> 00:28:02,518
ALSO CAN ACCOMPANY 

711
00:28:02,518 --> 00:28:05,421
MISUNDERSTANDING OF THE DETAILS.

712
00:28:05,421 --> 00:28:07,756
SEPARATING WHAT IS HOPE THAT'S 

713
00:28:07,756 --> 00:28:08,257
OKAY WITH HOPE THAT'S 

714
00:28:08,257 --> 00:28:14,730
UNREALISTIC.

715
00:28:14,730 --> 00:28:17,566
THERE'S ALSO BEEN AN IMPORTANT 

716
00:28:17,566 --> 00:28:19,869
DISTINCTION WHICH IS HELPFUL TO 

717
00:28:19,869 --> 00:28:21,337
TO THE WHEN KNOWLEDGE OF 

718
00:28:21,337 --> 00:28:22,505
RELATIVE INFORMATION WHICH CAN 

719
00:28:22,505 --> 00:28:24,373
BE SEEN AS UNDERSTANDING AND 

720
00:28:24,373 --> 00:28:26,876
APPRECIATION OF HOW IT APPLIES.

721
00:28:26,876 --> 00:28:31,213
THE CLASSIC EXAMPLE IS A STUDY 

722
00:28:31,213 --> 00:28:33,516
THAT LED TO THE TERMINOLOGY OF 

723
00:28:33,516 --> 00:28:37,019
THERAPEUTIC MISCONCEPTION.

724
00:28:37,019 --> 00:28:39,989
A GROUP OF PEOPLE WITH 

725
00:28:39,989 --> 00:28:40,656
SCHIZOPHRENIA JOINING A PLACEBO 

726
00:28:40,656 --> 00:28:42,925
TRIAL INTERVENTION AND THE 

727
00:28:42,925 --> 00:28:43,826
INTERVIEWS DONE WITH THE 

728
00:28:43,826 --> 00:28:44,493
INDIVIDUALS AFTER THE CONSENT 

729
00:28:44,493 --> 00:28:46,729
PROCESS WAS FINISHED, THEY HAD A

730
00:28:46,729 --> 00:28:48,998
PRETTY GOOD UNDERSTANDING OF THE

731
00:28:48,998 --> 00:28:49,632
FACTS.

732
00:28:49,632 --> 00:28:51,100
THIS IS A RANDOMIZED TRIAL.

733
00:28:51,100 --> 00:28:53,602
HALF THE PEOPLE WILL GET THE 

734
00:28:53,602 --> 00:28:55,571
EXPERIMENTAL DRUG AND HALF WILL 

735
00:28:55,571 --> 00:28:55,905
GET PLACEBO.

736
00:28:55,905 --> 00:28:58,174
I FORGET THE OTHER FACTS BUT 

737
00:28:58,174 --> 00:28:59,341
THEY HAD A PRETTY GOOD 

738
00:28:59,341 --> 00:29:00,476
UNDERSTANDING OF THE FACTS AND 

739
00:29:00,476 --> 00:29:03,078
COULD RECITE THEM BACK THEN THEY

740
00:29:03,078 --> 00:29:06,015
SAID, OH, BUT MY DOCTOR WILL 

741
00:29:06,015 --> 00:29:07,750
MAKE SURE I GET THE DRUG.

742
00:29:07,750 --> 00:29:08,717
THAT'S THE DIFFERENCE BETWEEN 

743
00:29:08,717 --> 00:29:10,519
KNOWLEDGE AND FACTS OR THE 

744
00:29:10,519 --> 00:29:12,154
ABILITY TO RECITE THE FACTS AND 

745
00:29:12,154 --> 00:29:15,090
APPRECIATION OF HOW THE FACTS 

746
00:29:15,090 --> 00:29:21,130
MIGHT APPLY TO AN INDIVIDUAL 

747
00:29:21,130 --> 00:29:22,298
THEMSELVES.

748
00:29:22,298 --> 00:29:25,701
AND PAUL APPLEBAUM COINED THE 

749
00:29:25,701 --> 00:29:28,037
TERM THERAPEUTIC MISCONCEPTION 

750
00:29:28,037 --> 00:29:30,005
AND SAID WHEN A RECENT 

751
00:29:30,005 --> 00:29:31,473
PARTICIPANT FAILS TO RECOGNIZE 

752
00:29:31,473 --> 00:29:33,576
HOW INDIVIDUALIZED MEDICAL CARE,

753
00:29:33,576 --> 00:29:35,311
THAT IS THE PHYSICIAN'S 

754
00:29:35,311 --> 00:29:37,012
OBLIGATION TO MAKE MEDICAL 

755
00:29:37,012 --> 00:29:38,581
DECISIONS IN THE PATIENT'S BEST 

756
00:29:38,581 --> 00:29:41,317
INTEREST, MAY BE COMPROMISED BY 

757
00:29:41,317 --> 00:29:41,984
RESEARCH PROCEDURES BECAUSE 

758
00:29:41,984 --> 00:29:44,286
RESEARCH OFTEN HAS A PROTOCOL 

759
00:29:44,286 --> 00:29:46,155
WHICH DICTATES WHO GETS WHAT AND

760
00:29:46,155 --> 00:29:47,256
WHAT DOSES.

761
00:29:47,256 --> 00:29:47,523
ETCETERA.

762
00:29:47,523 --> 00:29:50,159
IT'S NOT DECIDED BY THE 

763
00:29:50,159 --> 00:29:51,260
INDIVIDUAL PHYSICIAN BASED ON 

764
00:29:51,260 --> 00:29:54,463
THE INDIVIDUAL PERSON'S NEEDS.

765
00:29:54,463 --> 00:29:55,931
AND APPLEBAUM AND COLLEAGUES GO 

766
00:29:55,931 --> 00:29:58,867
ON TO MAKE THE POINT IN MANY 

767
00:29:58,867 --> 00:30:01,237
PAPERS FAILURE TO RECOGNIZE 

768
00:30:01,237 --> 00:30:04,707
THESE DIFFERENCES NEGATES THE 

769
00:30:04,707 --> 00:30:06,008
ABILITY TO PROVIDE MEANINGFUL 

770
00:30:06,008 --> 00:30:07,409
INFORMED CONSENT.

771
00:30:07,409 --> 00:30:10,346
THIS IS A TYPE OF 

772
00:30:10,346 --> 00:30:15,985
MISUNDERSTANDING THAT MAKES IT 

773
00:30:15,985 --> 00:30:18,954
IMPOSSIBLE TO REPRESENT.

774
00:30:18,954 --> 00:30:20,923
AND STUDIES THAT LOOKED AT 

775
00:30:20,923 --> 00:30:26,095
IMPROVING THE UNDERSTANDING OF 

776
00:30:26,095 --> 00:30:26,695
INFORMED CONSENT.

777
00:30:26,695 --> 00:30:30,966
THERE'S TWO SYSTEMATIC REVIEWS 

778
00:30:30,966 --> 00:30:33,669
THAT CATEGORIZED THE TYPES OF 

779
00:30:33,669 --> 00:30:35,738
STUDIES INTO THESE GROUPS.

780
00:30:35,738 --> 00:30:38,307
I THINK THEY'RE QUITE TELLING 

781
00:30:38,307 --> 00:30:39,975
EVEN TODAY THOUGH THESE ARE BOTH

782
00:30:39,975 --> 00:30:42,077
OLD STUDIES SO WE NEED A NEW 

783
00:30:42,077 --> 00:30:42,244
ONE.

784
00:30:42,244 --> 00:30:45,581
BUT THEY COMPARED STUDIES THAT 

785
00:30:45,581 --> 00:30:48,117
TESTED MULTI-MEDIA INTERVENTION 

786
00:30:48,117 --> 00:30:50,252
TO TRY TO IMPROVE UNDERSTANDING 

787
00:30:50,252 --> 00:30:52,655
WITH ENHANCED CONSENT FORMS 

788
00:30:52,655 --> 00:30:53,555
MEETING DIFFERENT STYLES OR 

789
00:30:53,555 --> 00:30:55,791
SHORTER, EXTENDED DISCUSSION, 

790
00:30:55,791 --> 00:30:59,561
TEST FEEDBACK AND A BUNCH OF 

791
00:30:59,561 --> 00:31:02,398
OTHER MISCELLANEOUS ITEMS.

792
00:31:02,398 --> 00:31:05,000
WHAT DO YOU THINK WORKED THE 

793
00:31:05,000 --> 00:31:15,077
BEST?

794
00:31:15,077 --> 00:31:16,478
EXTENDED DISCUSSION.

795
00:31:16,478 --> 00:31:17,546
SHOCKING, RIGHT?

796
00:31:17,546 --> 00:31:18,781
THE MORE YOU TALK TO SOMEBODY 

797
00:31:18,781 --> 00:31:19,848
ABOUT WHAT'S HAPPENING THE MORE 

798
00:31:19,848 --> 00:31:20,449
THEY UNDERSTAND.

799
00:31:20,449 --> 00:31:22,985
THERE WERE ONLY A FEW STUDY IN 

800
00:31:22,985 --> 00:31:23,786
THAT CATEGORY.

801
00:31:23,786 --> 00:31:26,121
THERE WAS CLEARLY BETTER 

802
00:31:26,121 --> 00:31:27,423
UNDERSTANDING FROM THAT THAN 

803
00:31:27,423 --> 00:31:28,657
ANYTHING ELSE.

804
00:31:28,657 --> 00:31:30,125
THERE ARE WAYS IN WHICH THAT 

805
00:31:30,125 --> 00:31:31,627
MAKES SENSE.

806
00:31:31,627 --> 00:31:32,795
THERE'S RESOURCE QUESTIONS THAT 

807
00:31:32,795 --> 00:31:38,167
LIMIT HOW MUCH TIME WE CAN SPEND

808
00:31:38,167 --> 00:31:39,968
TALKING TO PEOPLE IT'S NOT LIKE 

809
00:31:39,968 --> 00:31:43,639
NOW WE KNOW WHAT TO DO, LET'S DO

810
00:31:43,639 --> 00:31:44,373
IT.

811
00:31:44,373 --> 00:31:47,076
ONE INTERESTING THING IS BOTH 

812
00:31:47,076 --> 00:31:48,510
THESE META-ANALYSES SAID 

813
00:31:48,510 --> 00:31:49,511
ENHANCED CONSENT FORMS MIGHT 

814
00:31:49,511 --> 00:31:52,514
WORK BUT WE NEED A RANDOMIZED 

815
00:31:52,514 --> 00:31:52,715
TRIAL.

816
00:31:52,715 --> 00:31:54,450
SO OUR GROUP DID A NUMBER OF 

817
00:31:54,450 --> 00:31:57,853
RANDOMIZED STUDIES WHERE WE TOOK

818
00:31:57,853 --> 00:32:01,623
AND DID THREE VERSIONS OF IT 

819
00:32:01,623 --> 00:32:05,994
WITH HEALTHY VOLUNTEERS IN PHASE

820
00:32:05,994 --> 00:32:10,065
1 DRUG STUDIES WITH HEALTHY 

821
00:32:10,065 --> 00:32:13,068
VOLUNTEERS IN FLU STUDIES AND 

822
00:32:13,068 --> 00:32:14,903
PEOPLE WITH HIV AND 

823
00:32:14,903 --> 00:32:16,805
MULTI-NATIONAL TREATMENT STUDY.

824
00:32:16,805 --> 00:32:19,341
ALTOGETHER THE HEALTHY VOLUNTEER

825
00:32:19,341 --> 00:32:22,745
STUDIES WERE 130 IN EACH ONE IN 

826
00:32:22,745 --> 00:32:24,780
THE HIV STUDY WAS ABOUT 4,000 

827
00:32:24,780 --> 00:32:25,013
PEOPLE.

828
00:32:25,013 --> 00:32:28,584
WE RANDOMIZED THEM TO GET THE 

829
00:32:28,584 --> 00:32:32,654
STANDARD CONCEPT FORM OR A 

830
00:32:32,654 --> 00:32:34,556
SHORTER SIM POLICE OFFICER LOWER

831
00:32:34,556 --> 00:32:35,324
READING LEVEL CONCEPT FORM AND 

832
00:32:35,324 --> 00:32:39,294
THE AMAZING THING IS DIDN'T MAKE

833
00:32:39,294 --> 00:32:43,198
A DIFFERENCE.

834
00:32:43,198 --> 00:32:46,402
MOST PEOPLE UNDERSTAND CERTAIN 

835
00:32:46,402 --> 00:32:47,669
THINGS BETTER THAN OTHER THINGS 

836
00:32:47,669 --> 00:32:49,138
BUT THE SHORTER FORMS DIDN'T 

837
00:32:49,138 --> 00:32:51,340
HELP THEM UNDERSTAND MORE WHICH 

838
00:32:51,340 --> 00:32:52,875
IS QUITE INTERESTING.

839
00:32:52,875 --> 00:32:55,043
THERE'S ALSO BEEN STUDIES DONE 

840
00:32:55,043 --> 00:32:56,211
MORE RECENTLY.

841
00:32:56,211 --> 00:32:57,112
HOLLY WAS INVOLVED WITH ONE 

842
00:32:57,112 --> 00:33:01,016
WHERE THEY RANDOM I'VEED PEOPLE 

843
00:33:01,016 --> 00:33:03,919
TO THREE FORMATS AND PEOPLE 

844
00:33:03,919 --> 00:33:07,389
EXPOSED TO VIDEO HAD MORE SATS 

845
00:33:07,389 --> 00:33:07,723
SATISFACTION.

846
00:33:07,723 --> 00:33:13,962
OTHER STUDIES SIMILARLY SHOWED 

847
00:33:13,962 --> 00:33:19,101
THOUGH DATA DOESN'T ALWAYS 

848
00:33:19,101 --> 00:33:22,571
IMPROVE UNDERSTANDING AS THE 

849
00:33:22,571 --> 00:33:25,374
TESTS THAT MEASURE THEM BUT 

850
00:33:25,374 --> 00:33:30,813
IMPROVES SATS FAC AND ENGAGEMENT

851
00:33:30,813 --> 00:33:33,282
WITH THE INFORMATION.

852
00:33:33,282 --> 00:33:34,583
THAT'S INTERESTING TOO AND 

853
00:33:34,583 --> 00:33:39,054
PEOPLE LOOK AT THE WEB BASED AND

854
00:33:39,054 --> 00:33:40,489
INTERACTIVE METHODS AND HOW MUCH

855
00:33:40,489 --> 00:33:48,997
THEY INCREASE UNDERSTANDING.

856
00:33:48,997 --> 00:33:51,967
THE THIRD PILLAR IS VOLUNTARY 

857
00:33:51,967 --> 00:33:52,868
CHOICE.

858
00:33:52,868 --> 00:33:53,402
DISCLOSE INFORMATION.

859
00:33:53,402 --> 00:33:56,738
PEOPLE UNDERSTAND HOPEFULLY 

860
00:33:56,738 --> 00:34:06,281
ENOUGH TO MAKE AN INFORMED 

861
00:34:06,281 --> 00:34:08,851
DECISION AND THIS HAS GOTTEN THE

862
00:34:08,851 --> 00:34:10,052
LEAST ATTENTION AND IT'S 

863
00:34:10,052 --> 00:34:11,820
INTERESTING TO THINK OF WHAT A 

864
00:34:11,820 --> 00:34:12,287
VOLUNTARY CHOICE.

865
00:34:12,287 --> 00:34:15,824
WE MAKE CHOICES EVERY DAY.

866
00:34:15,824 --> 00:34:18,694
WE MAKE CHOICES HOPEFULLY 

867
00:34:18,694 --> 00:34:22,498
VOLUNTARILY BUT THEY'RE BASED ON

868
00:34:22,498 --> 00:34:23,632
OUR EXPERIENCES OUR 

869
00:34:23,632 --> 00:34:25,167
EXPECTATIONS, THE KINDS OF 

870
00:34:25,167 --> 00:34:27,803
THINGS THAT OUR NETWORK OF 

871
00:34:27,803 --> 00:34:29,104
SUPPORTERS PUSH FOR.

872
00:34:29,104 --> 00:34:30,105
THERE'S A LOT OF THINGS THAT 

873
00:34:30,105 --> 00:34:30,973
INFLUENCE HOW WE MAKE DECISIONS 

874
00:34:30,973 --> 00:34:32,541
EVERY DAY AND YET I WOULDN'T 

875
00:34:32,541 --> 00:34:37,079
CALL THEM NOT VOLUNTARY.

876
00:34:37,079 --> 00:34:38,547
THINKING ABOUT HOW DO YOU THINK 

877
00:34:38,547 --> 00:34:40,516
OF A VOLUNTARY CHOICE WITHIN THE

878
00:34:40,516 --> 00:34:44,753
CONTEXT OF RESEARCH IS NOT 

879
00:34:44,753 --> 00:34:45,821
COMPLETELY STRAIGHTFORWARD.

880
00:34:45,821 --> 00:34:49,691
THE REGULATORY LANGUAGE AND THE 

881
00:34:49,691 --> 00:34:50,325
LITERATURE SUGGEST THERE'S THREE

882
00:34:50,325 --> 00:34:52,895
THINGS WE HAVE TO AVOID IN ORDER

883
00:34:52,895 --> 00:34:54,796
FOR CHOICE TO BE VOLUNTARY.

884
00:34:54,796 --> 00:34:57,799
THERE SHOULD BE NO DECEPTION, NO

885
00:34:57,799 --> 00:35:03,338
COERCION, THERE SHOULD BE NO 

886
00:35:03,338 --> 00:35:05,541
UNDUE INFLUENCE.

887
00:35:05,541 --> 00:35:07,442
UNDERSTANDING WHAT THOSE TERMS 

888
00:35:07,442 --> 00:35:11,847
MEAN HELP UNDERSTAND WHAT IS 

889
00:35:11,847 --> 00:35:12,114
VOLUNTARY.

890
00:35:12,114 --> 00:35:17,019
CONCEPTION IS DISTORTING THE 

891
00:35:17,019 --> 00:35:19,988
TRUTH IN ORDER TO MISLEAD AND 

892
00:35:19,988 --> 00:35:24,159
THERE'S SOMETHING CALLED 

893
00:35:24,159 --> 00:35:25,027
FRAUDULENT DISCLOSURE 

894
00:35:25,027 --> 00:35:25,928
WITHHOLDING INFORMATION OR 

895
00:35:25,928 --> 00:35:31,333
PRESENTING IN A WAY THAT IS NOT 

896
00:35:31,333 --> 00:35:34,102
FACTUALLY INCORRECT BUT 

897
00:35:34,102 --> 00:35:34,403
MISLEADING.

898
00:35:34,403 --> 00:35:35,737
THAT'S DECEPTION.

899
00:35:35,737 --> 00:35:36,939
COERCION IS COMPELLING SOMEBODY 

900
00:35:36,939 --> 00:35:38,640
TO DO SOMETHING AGAINST THEIR 

901
00:35:38,640 --> 00:35:40,576
WILL BY THREATENING THEM.

902
00:35:40,576 --> 00:35:41,209
THREATENING TO MAKE THEM WORSE 

903
00:35:41,209 --> 00:35:46,515
OFF.

904
00:35:46,515 --> 00:35:47,849
THERE'S EXAMPLES OF COERCION IN 

905
00:35:47,849 --> 00:35:49,851
RESEARCH BUT PROBABLY NOT THAT 

906
00:35:49,851 --> 00:35:56,992
MANY WITH COULD IDENTIFY.

907
00:35:56,992 --> 00:35:58,460
AND THIS IS UNDUE INFLUENCE 

908
00:35:58,460 --> 00:35:59,661
PEOPLE DEFINE AS AN OFFER.

909
00:35:59,661 --> 00:36:01,630
NOT A THREAT.

910
00:36:01,630 --> 00:36:03,031
IT'S NOT COERCIVE.

911
00:36:03,031 --> 00:36:06,535
IT'S AN OFFER THAT DISTORTS 

912
00:36:06,535 --> 00:36:09,071
SOMEBODY'S JUDGMENT OR ENTICES 

913
00:36:09,071 --> 00:36:10,839
THEM TO DO SOMETHING THAT IS 

914
00:36:10,839 --> 00:36:11,573
AGAINST THEIR INTEREST SO THEY 

915
00:36:11,573 --> 00:36:13,809
DON'T WANT TO DO IT.

916
00:36:13,809 --> 00:36:16,912
AND THIS IS TRICKY TOO BECAUSE 

917
00:36:16,912 --> 00:36:18,747
IF YOU THINK ABOUT IF YOU GIVE 

918
00:36:18,747 --> 00:36:24,219
SOMEBODY AN INNOCCENTIVE TO DO 

919
00:36:24,219 --> 00:36:27,990
SOMETHING IT'S NOT AN UNDUE 

920
00:36:27,990 --> 00:36:29,891
INCENTIVE, IF YOU GET PAID TO 

921
00:36:29,891 --> 00:36:33,829
WORK YOU'RE NOT BEING UNDULY 

922
00:36:33,829 --> 00:36:34,329
INFLUENCED.

923
00:36:34,329 --> 00:36:35,263
THERE'S A LINE BETWEEN WHAT'S 

924
00:36:35,263 --> 00:36:38,266
OKAY AND WHAT IS EXCESSIVE OR 

925
00:36:38,266 --> 00:36:41,903
INAPPROPRIATE OR MAKES PEOPLE DO

926
00:36:41,903 --> 00:36:44,306
THINGS AGAINST THEIR OWN 

927
00:36:44,306 --> 00:36:46,174
INTEREST OR DISTORTS THEIR 

928
00:36:46,174 --> 00:36:47,409
JUDGMENT.

929
00:36:47,409 --> 00:36:58,053
WHAT COULD INFLUENCE VOL -- 

930
00:36:58,053 --> 00:36:59,488
VOLUNTARINESS MAYBE YOUR BOSS OR

931
00:36:59,488 --> 00:37:00,722
DOCTOR ASKS YOU TO PARTICIPATE 

932
00:37:00,722 --> 00:37:03,291
IN A STUDY OR SOMEBODY YOU FEEL 

933
00:37:03,291 --> 00:37:09,164
SUB SERVANT TO IN SOME WAY.

934
00:37:09,164 --> 00:37:17,706
PRESSURE.

935
00:37:17,706 --> 00:37:21,009
THAT COULD BE FROM A NUMBER OF 

936
00:37:21,009 --> 00:37:21,276
SOURCES.

937
00:37:21,276 --> 00:37:24,046
IT COULD BE FROM A RESEARCH TEAM

938
00:37:24,046 --> 00:37:25,380
AND FROM FAMILY AND FRIENDS AND 

939
00:37:25,380 --> 00:37:30,018
THE FACT YOU HAVE NO MONEY.

940
00:37:30,018 --> 00:37:30,852
THERE ARE WAYS IN WHICH PRESSURE

941
00:37:30,852 --> 00:37:32,621
COMES FROM LOTS OF THINGS.

942
00:37:32,621 --> 00:37:33,455
TRUST IN HEALTH CARE PROVIDERS 

943
00:37:33,455 --> 00:37:35,891
IS SOMETHING PEOPLE WORRY ABOUT.

944
00:37:35,891 --> 00:37:37,993
THERE'S SEVERAL STUDIES TO 

945
00:37:37,993 --> 00:37:38,894
SUGGEST PEOPLE WHO MAKE 

946
00:37:38,894 --> 00:37:41,630
DECISIONS ABOUT PARTICIPATING IN

947
00:37:41,630 --> 00:37:42,864
RESEARCH MAKE THEM BASED ON MY 

948
00:37:42,864 --> 00:37:44,766
DOCTOR TOLD ME TO DO IT AND 

949
00:37:44,766 --> 00:37:46,435
WITHOUT REALLY PAYING ATTENTION 

950
00:37:46,435 --> 00:37:47,602
TO WHAT'S BEING ASKED OF THEM OR

951
00:37:47,602 --> 00:37:49,304
WHAT THE RISKS AND BENEFITS 

952
00:37:49,304 --> 00:37:51,573
MIGHT ENTAIL.

953
00:37:51,573 --> 00:37:54,176
AND THIS IS -- THERE'S AGAIN A 

954
00:37:54,176 --> 00:37:57,412
SMALL AMOUNT OF LITERATURE ON 

955
00:37:57,412 --> 00:37:58,280
THE DUAL ROLE OF A PHYSICIAN 

956
00:37:58,280 --> 00:38:00,916
ALSO PART OF A STUDY INVITING 

957
00:38:00,916 --> 00:38:08,857
THEIR PATIENTS TO BE PART OF THE

958
00:38:08,857 --> 00:38:16,865
STUDY PRECARIOUSLY INFLUENCED 

959
00:38:16,865 --> 00:38:19,735
VOLUNTARINESS AND THERE'S LESS 

960
00:38:19,735 --> 00:38:21,369
DIRECT WORTHINESS ON 

961
00:38:21,369 --> 00:38:22,504
VOLUNTARINESS AND THERE'S 

962
00:38:22,504 --> 00:38:23,705
RESTRICTED VOICES.

963
00:38:23,705 --> 00:38:26,174
IF YOU DON'T HAVE A LOT OF 

964
00:38:26,174 --> 00:38:26,808
ALTERNATIVES FOR DOING SOMETHING

965
00:38:26,808 --> 00:38:28,376
AND DECIDE THIS IS WHAT I WANT 

966
00:38:28,376 --> 00:38:30,946
TO DO, DOES THAT MAKE IT LESS 

967
00:38:30,946 --> 00:38:32,314
VOLUNTARY THAN WITH A BUNCH OF 

968
00:38:32,314 --> 00:38:32,848
CHOICES?

969
00:38:32,848 --> 00:38:35,050
I DON'T THINK SO BUT SOME PEOPLE

970
00:38:35,050 --> 00:38:36,218
DO.

971
00:38:36,218 --> 00:38:39,454
YOU HAVE TO SORT OF PUT THE 

972
00:38:39,454 --> 00:38:40,822
CONTEXT UP THERE AND SAME WITH 

973
00:38:40,822 --> 00:38:41,056
ILLNESS.

974
00:38:41,056 --> 00:38:44,860
IF YOU'RE SICK, YOU MAY HAVE 

975
00:38:44,860 --> 00:38:45,660
LESS CHOICES.

976
00:38:45,660 --> 00:38:48,063
YOU MAY HAVE LESS INTEREST IN 

977
00:38:48,063 --> 00:38:50,165
MAKING CHOICES.

978
00:38:50,165 --> 00:38:51,933
YOU MAY PUT MORE TRUST IN YOUR 

979
00:38:51,933 --> 00:38:52,234
PROVIDERS.

980
00:38:52,234 --> 00:38:55,337
THERE COULD BE LOTS OF THINGS 

981
00:38:55,337 --> 00:38:56,671
THAT WOULD INFLUENCE YOUR 

982
00:38:56,671 --> 00:38:58,774
ABILITY TO MAKE A VOLUNTARY 

983
00:38:58,774 --> 00:38:59,107
CHOICE.

984
00:38:59,107 --> 00:39:02,110
IN ADDITION TO NOT CONFUSION BUT

985
00:39:02,110 --> 00:39:03,712
LESS CLARITY ON THE CONCEPTS 

986
00:39:03,712 --> 00:39:07,282
IT'S LESS CLEAR HOW YOU MEASURE 

987
00:39:07,282 --> 00:39:07,883
VOLUNTARINESS.

988
00:39:07,883 --> 00:39:08,884
THERE'S SOME STUDIES USEFUL FOR 

989
00:39:08,884 --> 00:39:10,519
A COUPLE THINGS TO THINK ABOUT 

990
00:39:10,519 --> 00:39:13,388
TO EVEN FIND IN STUDIES.

991
00:39:13,388 --> 00:39:15,757
ONE IS DO PEOPLE REPORT FEELING 

992
00:39:15,757 --> 00:39:16,625
PRESSURE FROM OTHERS.

993
00:39:16,625 --> 00:39:18,794
AND FOR THE MOST PART THE NUMBER

994
00:39:18,794 --> 00:39:19,961
OF PEOPLE REPORT PRESSURE FROM 

995
00:39:19,961 --> 00:39:21,863
OTHERS INCLUDING FAMILY MEMBERS 

996
00:39:21,863 --> 00:39:30,739
AND DOCTORS IS PRETTY LOW.

997
00:39:30,739 --> 00:39:34,142
AND THEY PEEL THEY HAVE DO DO 

998
00:39:34,142 --> 00:39:36,244
SOMETHING AND THAT FEELS LIKE 

999
00:39:36,244 --> 00:39:36,978
PRESSURE.

1000
00:39:36,978 --> 00:39:38,013
THERE'S A QUESTION DO PEOPLE 

1001
00:39:38,013 --> 00:39:40,015
KNOW THEY CAN QUIT OR IT'S A 

1002
00:39:40,015 --> 00:39:40,649
VOLUNTARY CHOICE.

1003
00:39:40,649 --> 00:39:44,986
THE RANGE IS ALL OVER THE PLACE.

1004
00:39:44,986 --> 00:39:48,523
AND YOU CAN LOOK AT NUMBER OF 

1005
00:39:48,523 --> 00:39:56,998
WHO DECLINES OR DOESN'T 

1006
00:39:56,998 --> 00:39:59,034
PARTICIPATE.

1007
00:39:59,034 --> 00:40:01,536
AND THERE WAS AN INTERESTING 

1008
00:40:01,536 --> 00:40:08,710
PAPER IN THE JOURNAL OF 

1009
00:40:08,710 --> 00:40:10,212
EMPIRICAL PAPER WHERE THEY 

1010
00:40:10,212 --> 00:40:13,849
MEASURED VOLUNTARINESS AND THEY 

1011
00:40:13,849 --> 00:40:16,351
SAID THERE'S SOME INDICATION BUT

1012
00:40:16,351 --> 00:40:22,457
WE DON'T HAVE CONSENSUS ON HOW 

1013
00:40:22,457 --> 00:40:23,191
WE UNDERSTAND WHETHER SOMETHING 

1014
00:40:23,191 --> 00:40:24,125
IS VOLUNTARY OR NOT.

1015
00:40:24,125 --> 00:40:27,195
AND IF YOU LOOK AT THE TWO 

1016
00:40:27,195 --> 00:40:33,001
INSIDE THAT CIRCLE, VOLUNTARY 

1017
00:40:33,001 --> 00:40:34,769
NATURE OF PARTICIPATION AND 

1018
00:40:34,769 --> 00:40:37,906
FREEDOM TO WITHDRAW AT ANY TIME,

1019
00:40:37,906 --> 00:40:40,108
25% DON'T KNOW IT'S TRUE.

1020
00:40:40,108 --> 00:40:45,013
IS THAT GOOD ENOUGH OR SHOULD WE

1021
00:40:45,013 --> 00:40:46,314
BE DOING BETTER ON THAT?

1022
00:40:46,314 --> 00:40:47,616
SO INFORMED CONSENT IS COMPLEX.

1023
00:40:47,616 --> 00:40:50,986
THERE'S ENDURING CHALLENGES AND 

1024
00:40:50,986 --> 00:40:52,520
IT'S AFFECTED BY A NUMBER OF 

1025
00:40:52,520 --> 00:40:52,988
DIFFERENT THINGS.

1026
00:40:52,988 --> 00:40:56,992
SOME OF WHICH I MENTIONED AND 

1027
00:40:56,992 --> 00:40:57,492
YOU'LL HEAR ABOUT MORE.

1028
00:40:57,492 --> 00:40:59,594
I JUST WANT TO SPEND FIVE 

1029
00:40:59,594 --> 00:41:02,864
MINUTES TO TALK ABOUT THE FIVE 

1030
00:41:02,864 --> 00:41:03,331
CHANGES.

1031
00:41:03,331 --> 00:41:04,666
WE'VE HAD LOTS OF KINDS OF 

1032
00:41:04,666 --> 00:41:07,068
RESEARCH THAT HAVE GROWN IN 

1033
00:41:07,068 --> 00:41:09,137
RECENT YEARS LIKE BIO BANKS AND 

1034
00:41:09,137 --> 00:41:11,573
DATA REPOSITORY AND PRAGMATIC 

1035
00:41:11,573 --> 00:41:16,678
TRIALS AND DECENTRALIZED TRIALS.

1036
00:41:16,678 --> 00:41:19,514
ALL THESE POSE WE HAVE TO THINK 

1037
00:41:19,514 --> 00:41:21,016
CAREFULLY HOW WE GET CONSENT IN 

1038
00:41:21,016 --> 00:41:23,084
THE CONTEXT WHICH IS DIFFERENT 

1039
00:41:23,084 --> 00:41:24,085
THAN THE TRADITIONAL SIT DOWN 

1040
00:41:24,085 --> 00:41:27,555
WITH SOMEBODY IN A CLINIC TO ASK

1041
00:41:27,555 --> 00:41:33,828
THEM TO JOIN A CLINICAL TRIAL 

1042
00:41:33,828 --> 00:41:35,030
AND THERE'S WAYS TO EXCHANGE 

1043
00:41:35,030 --> 00:41:36,264
INFORMATION AND GET VERIFICATION

1044
00:41:36,264 --> 00:41:38,566
AND AUTHORIZATION OF CONSENT 

1045
00:41:38,566 --> 00:41:40,535
INCLUDING ELECTRONIC DEVICES, 

1046
00:41:40,535 --> 00:41:47,108
APPS, WEB INTERFACES, ETCETERA.

1047
00:41:47,108 --> 00:41:48,710
ALL THESE ARE OFFER ADVANTAGES 

1048
00:41:48,710 --> 00:41:54,316
IN CERTAIN WAYS BUT ALSO OFFER 

1049
00:41:54,316 --> 00:41:55,684
CHALLENGES IN CERTAIN WAYS.

1050
00:41:55,684 --> 00:41:58,186
I THINK I'LL SKIP THE REST AND 

1051
00:41:58,186 --> 00:42:08,096
GO TO THE LAST SLIDE WHICH IS 

1052
00:42:08,096 --> 00:42:10,098
DESPITE THE WAY CONSENT IS 

1053
00:42:10,098 --> 00:42:12,067
OBTAINED ON THE OLD FASHIONED 

1054
00:42:12,067 --> 00:42:15,770
PAPER SITTING WITH A PARTICIPANT

1055
00:42:15,770 --> 00:42:19,140
UP A ROOM OR THROUGH A 

1056
00:42:19,140 --> 00:42:20,108
DECENTRALIZED TRIAL AND AN APP 

1057
00:42:20,108 --> 00:42:21,242
AND REMOTE INTERACTION.

1058
00:42:21,242 --> 00:42:23,912
YOU STILL HAVE TO THINK THROUGH 

1059
00:42:23,912 --> 00:42:25,914
WHAT HES THE INFORMATION WE'LL 

1060
00:42:25,914 --> 00:42:30,952
BE GIVING AND DISCLOSURE ELEMENT

1061
00:42:30,952 --> 00:42:35,056
S AND HOW MUCH PEOPLE HAVE TO 

1062
00:42:35,056 --> 00:42:36,191
UNDERSTAND AND HOW TO ASSESS 

1063
00:42:36,191 --> 00:42:37,926
WHETHER THEY ARE UNDERSTANDING 

1064
00:42:37,926 --> 00:42:44,366
AND HOW DO WE KNOW IF IT IS 

1065
00:42:44,366 --> 00:42:46,267
VOLUNTARY.

1066
00:42:46,267 --> 00:42:48,470
AND SOME OFFER CONVENIENCE AND 

1067
00:42:48,470 --> 00:42:50,839
OPPORTUNITIES THEY MAY NOT 

1068
00:42:50,839 --> 00:42:52,140
OTHERWISE HAVE AND OFFERS 

1069
00:42:52,140 --> 00:42:54,776
CHALLENGES IN THESE DOMAINS 

1070
00:42:54,776 --> 00:42:55,877
BECAUSE YOU CAN'T SEE THE PERSON

1071
00:42:55,877 --> 00:43:00,348
OR READ THEIR BODY LANGUAGE.

1072
00:43:00,348 --> 00:43:03,885
YOU HAVE TO VERIFY THEIR 

1073
00:43:03,885 --> 00:43:04,152
IDENTITY.

1074
00:43:04,152 --> 00:43:06,421
HOW DO YOU KNOW SOMETHING IS 

1075
00:43:06,421 --> 00:43:08,757
VOLUNTARY WHEN YOU CAN'T EVEN 

1076
00:43:08,757 --> 00:43:10,859
SEE THE PERSON?

1077
00:43:10,859 --> 00:43:11,693
THAT'S THE END.

1078
00:43:11,693 --> 00:43:12,794
I'M GOING TO STOP.

1079
00:43:12,794 --> 00:43:21,169
I'LL LET YOU READ THESE TWO.

1080
00:43:21,169 --> 00:43:22,904
>> A REMINDER IF YOU HAVE
A 

1081
00:43:22,904 --> 00:43:24,606
QUESTION HERE IN THE AUDITORIUM,

1082
00:43:24,606 --> 00:43:27,876
PLEASE TWO TO A MIKE SO THE FOKZ

1083
00:43:27,876 --> 00:43:31,713
OUT IN VIDEO LAND CAN HEAR YOU.

1084
00:43:31,713 --> 00:43:32,747
FOLKS IN VIDEO LAND CAN HEAR 

1085
00:43:32,747 --> 00:43:32,914
YOU.

1086
00:43:32,914 --> 00:43:35,183
I HAVE A QUESTION FROM VIDEO 

1087
00:43:35,183 --> 00:43:35,950
LAND.

1088
00:43:35,950 --> 00:43:36,851
KIM ASKS AND SAYS FIRST THANKS 

1089
00:43:36,851 --> 00:43:39,921
FOR THE LECTURE, IS THERE SPACE 

1090
00:43:39,921 --> 00:43:44,225
FOR GROUP EDUCATION SESSIONS 

1091
00:43:44,225 --> 00:43:46,027
PRIOR TO THE INDIVIDUAL INFORMED

1092
00:43:46,027 --> 00:43:48,063
CONSENT PROCESS.

1093
00:43:48,063 --> 00:43:48,696
PROTECT PARTICULARLY IF THE 

1094
00:43:48,696 --> 00:43:50,498
LENGTH AND DETAIL OF THE STUDY 

1095
00:43:50,498 --> 00:43:53,868
AND THE CONSENT FORM ITSELF IS 

1096
00:43:53,868 --> 00:43:54,169
PROHIBITIVE.

1097
00:43:54,169 --> 00:43:56,237
IF YES, CAN THE GROUP AWARENESS 

1098
00:43:56,237 --> 00:44:00,742
SESSION BE SEEN AS A RECRUITMENT

1099
00:44:00,742 --> 00:44:02,844
VERSUS EDUCATION TOOL AND DOES 

1100
00:44:02,844 --> 00:44:05,013
IT NEED IRB APPROVAL.

1101
00:44:05,013 --> 00:44:08,683
THERE'S A LOT PACKED IN THERE.

1102
00:44:08,683 --> 00:44:09,884
>> CERTAINLY THERE ARE 

1103
00:44:09,884 --> 00:44:10,618
SITUATIONS, TYPES OF TRIALS AND 

1104
00:44:10,618 --> 00:44:13,154
POPULATIONS IN WHICH TRIALS ARE 

1105
00:44:13,154 --> 00:44:14,055
BEING DONE WHERE GROUP EDUCATION

1106
00:44:14,055 --> 00:44:17,459
ABOUT WHAT THE STUDY IS ABOUT IS

1107
00:44:17,459 --> 00:44:18,626
CRITICAL AND HELPFUL.

1108
00:44:18,626 --> 00:44:20,061
IT'S BOTH EDUCATION FOR THE 

1109
00:44:20,061 --> 00:44:22,430
INDIVIDUALS WHO ARE PART OF THE 

1110
00:44:22,430 --> 00:44:24,032
GROUP BUT ALSO SOMETIMES ONE 

1111
00:44:24,032 --> 00:44:27,669
PERSON WILL ASK A QUESTION 

1112
00:44:27,669 --> 00:44:28,636
ANOTHER QUESTION WOULDN'T HAVE 

1113
00:44:28,636 --> 00:44:30,538
THOUGHT OF SO IT'S A GOOD WAY TO

1114
00:44:30,538 --> 00:44:32,874
GET PEOPLE TO ENGAGE.

1115
00:44:32,874 --> 00:44:35,743
MY OWN VIEW IN MOST CASES MRAB 

1116
00:44:35,743 --> 00:44:42,884
ALL BUT MOST -- MAYBE ALL BUT 

1117
00:44:42,884 --> 00:44:45,019
MOST SHOULD HAVE OF MEET WITH 

1118
00:44:45,019 --> 00:44:46,354
THE INDIVIDUAL BECAUSE SOMETIMES

1119
00:44:46,354 --> 00:44:47,689
PEOPLE FEEL PRESSURE FROM THE 

1120
00:44:47,689 --> 00:44:49,157
GROUP BUT THAT'S NOT WHAT YOU 

1121
00:44:49,157 --> 00:44:49,357
WANT.

1122
00:44:49,357 --> 00:44:55,029
YOU WANT EACH INDIVIDUAL TO MAKE

1123
00:44:55,029 --> 00:44:58,533
THEIR OWN DECISION.

1124
00:44:58,533 --> 00:44:59,968
AND THERE'S PARTS THE IRB DOES 

1125
00:44:59,968 --> 00:45:01,002
REVIEW BUT DON'T KNOW IF IT'S 

1126
00:45:01,002 --> 00:45:10,778
ALWAYS REQUIRED.

1127
00:45:10,778 --> 00:45:12,780
>> I'M WONDER IF AN
EDUCATION 

1128
00:45:12,780 --> 00:45:13,915
MODULE IS SOMETHING THE 

1129
00:45:13,915 --> 00:45:16,284
INVESTIGATORS WILL DIRECTLY 

1130
00:45:16,284 --> 00:45:19,654
ENGAGE THE PARTICIPANT WITH I 

1131
00:45:19,654 --> 00:45:24,659
WOULD THINK IT NEED TO BE AND IT

1132
00:45:24,659 --> 00:45:26,995
BEGS THE QUESTION OF SOME MIGHT 

1133
00:45:26,995 --> 00:45:30,932
NEED IRB APPROVAL BUT MAYBE AN 

1134
00:45:30,932 --> 00:45:32,400
INTRODUCTION TO THE TYPES OF 

1135
00:45:32,400 --> 00:45:37,605
RESEARCH GOING ON OR EDUCATION 

1136
00:45:37,605 --> 00:45:40,575
ABOUT THE INTERVENTION THINGS 

1137
00:45:40,575 --> 00:45:41,843
THAT ARE LESS AFTER THIS I'M 

1138
00:45:41,843 --> 00:45:42,710
GOING TO ASK YOU A QUESTION 

1139
00:45:42,710 --> 00:45:53,087
ABOUT YOUR ENROLLMENT.

1140
00:45:54,422 --> 00:46:04,899
AND COGNITIVE OF THE POTENTIAL.

1141
00:46:05,400 --> 00:46:06,868
>> IT HAS TO DO WITH THE
PEOPLE 

1142
00:46:06,868 --> 00:46:08,002
THAT GET THROUGH THE DOOR.

1143
00:46:08,002 --> 00:46:09,971
I WAS WORKING ON A PROJECT A 

1144
00:46:09,971 --> 00:46:12,140
NUMBER OF YEARS AGO AT PENN 

1145
00:46:12,140 --> 00:46:14,642
WHERE AT THE ALZHEIMER'S CENTER 

1146
00:46:14,642 --> 00:46:18,279
THEY HAD SORT OF OPEN HOUSES FOR

1147
00:46:18,279 --> 00:46:19,247
INDIVIDUALS WHO HAD ALZHEIMER'S 

1148
00:46:19,247 --> 00:46:21,249
AND OR THEIR PARTNERS COME AND 

1149
00:46:21,249 --> 00:46:24,586
LEARN ABOUT THE CENTER, LEARN 

1150
00:46:24,586 --> 00:46:25,753
ABOUT THEIR RESEARCH AND I 

1151
00:46:25,753 --> 00:46:28,723
REMEMBER THINKING THIS IS A VERY

1152
00:46:28,723 --> 00:46:29,490
PARTICULAR GROUP OF PEOPLE 

1153
00:46:29,490 --> 00:46:30,758
COMING.

1154
00:46:30,758 --> 00:46:31,726
THEY KNOW ABOUT IT.

1155
00:46:31,726 --> 00:46:33,595
THEY CAN AFFORD TO GET 

1156
00:46:33,595 --> 00:46:35,063
THEMSELVES HERE AND HAVE A 

1157
00:46:35,063 --> 00:46:36,998
PARTNER WHO CAN BRING THEM.

1158
00:46:36,998 --> 00:46:41,836
NOT TO SAY IT'S BAD BUT DOES 

1159
00:46:41,836 --> 00:46:43,004
SORT OF ONLY SOME PEOPLE WILL 

1160
00:46:43,004 --> 00:46:43,805
MAKE THAT MOVE.

1161
00:46:43,805 --> 00:46:45,006
HI, DANIEL, THANKS.

1162
00:46:45,006 --> 00:46:50,245
>> THANKS FOR THE LECTURE.

1163
00:46:50,245 --> 00:46:58,886
SO I WAS WONDERING IF THERE'S NO

1164
00:46:58,886 --> 00:47:07,762
DECEPTION OR COERCION OR UNDUE 

1165
00:47:07,762 --> 00:47:09,297
INFLUENCE AND SEEMS THE PRESSURE

1166
00:47:09,297 --> 00:47:16,271
CAN BE NOT DECEPTIVE OR COERCIVE

1167
00:47:16,271 --> 00:47:19,540
OR LIKE GUILT TRIPPING OR 

1168
00:47:19,540 --> 00:47:20,375
MANIPULATION.

1169
00:47:20,375 --> 00:47:21,409
I'M WONDERING HOW THEY FIGURE 

1170
00:47:21,409 --> 00:47:27,282
INTO DECIDING IF THE CHOICE IS 

1171
00:47:27,282 --> 00:47:27,548
VOLUNTARY.

1172
00:47:27,548 --> 00:47:29,284
>> GREAT QUESTION.

1173
00:47:29,284 --> 00:47:30,752
THE UNDUE INFLUENCE IS LANGUAGE 

1174
00:47:30,752 --> 00:47:31,919
THAT COMES IN REGULATION.

1175
00:47:31,919 --> 00:47:33,388
THERE'S A WAY IN WHICH SOME 

1176
00:47:33,388 --> 00:47:36,024
PEOPLE SAY IT'S VOLUNTARY IF 

1177
00:47:36,024 --> 00:47:41,496
THERE'S NO COERCION OR UNDUE 

1178
00:47:41,496 --> 00:47:42,330
INFLUENCE.

1179
00:47:42,330 --> 00:47:52,874
I PERSONALLY AND SOME HAVE SAID 

1180
00:47:53,341 --> 00:47:58,579
I DON'T WANT DO BUT MY SPOUSE IS

1181
00:47:58,579 --> 00:48:00,014
MAKING ME OR MY PARENTS EXPECT 

1182
00:48:00,014 --> 00:48:00,982
ME TO.

1183
00:48:00,982 --> 00:48:05,019
THAT PRESSURE NEEDS TO BE 

1184
00:48:05,019 --> 00:48:12,427
RECOGNIZED AND DEALT WITH.

1185
00:48:12,427 --> 00:48:14,562
AND SOME SAY I FEEL PRESSURE 

1186
00:48:14,562 --> 00:48:18,032
FROM LIFE AND ONE STORY, ONE GUY

1187
00:48:18,032 --> 00:48:20,535
AN ADOLESCENT WHO SAID HE 

1188
00:48:20,535 --> 00:48:22,870
DOESN'T WANT TO PARTICIPATE AND 

1189
00:48:22,870 --> 00:48:24,472
WAS FEELING LIKE HIS PARENTS 

1190
00:48:24,472 --> 00:48:25,940
WERE FORCING HIM AND WE TALKED 

1191
00:48:25,940 --> 00:48:27,141
TO HIM FOR HOURS ABOUT YOU DON'T

1192
00:48:27,141 --> 00:48:29,010
HAVE TO DO THIS.

1193
00:48:29,010 --> 00:48:32,413
WE CAN FIND A WAY TO GET YOU TO 

1194
00:48:32,413 --> 00:48:39,754
SAY NO AND IT WILL BE OKAY.

1195
00:48:39,754 --> 00:48:42,323
IN THE END HE SAID I'LL DO IT 

1196
00:48:42,323 --> 00:48:44,826
AND WE SAID WHY DID YOU CHANGE 

1197
00:48:44,826 --> 00:48:45,960
YOUR MIND AND HE SAID I HAVE TO 

1198
00:48:45,960 --> 00:48:46,561
LIVE WITH THEM.

1199
00:48:46,561 --> 00:48:48,863
I DON'T KNOW HOW YOU PUT THAT IN

1200
00:48:48,863 --> 00:48:51,332
THE RUBRIC OF WAS THAT VOLUNTARY

1201
00:48:51,332 --> 00:48:52,734
OR NOT.

1202
00:48:52,734 --> 00:48:57,004
I THINK IT WAS BUT IT WAS A 

1203
00:48:57,004 --> 00:49:03,878
COMPLICATED CHOICE.

1204
00:49:03,878 --> 00:49:14,188
PRESSURE MATTERS.

1205
00:49:14,455 --> 00:49:16,991
>> I'M WONDERING IF
ALTERNATIVE 

1206
00:49:16,991 --> 00:49:17,725
DECISIONS MATTER.

1207
00:49:17,725 --> 00:49:19,694
IN THE CASE WHERE HE HAS TO LIVE

1208
00:49:19,694 --> 00:49:20,728
WITH HIS PARENTS AND THEN HAS TO

1209
00:49:20,728 --> 00:49:26,634
LIVE WITH THE DECISION TO NOT 

1210
00:49:26,634 --> 00:49:37,178
ENROLL IN THE STUDY AND THERE'S 

1211
00:49:38,179 --> 00:49:39,881
ALTERNATIVES THAT DOESN'T SEEM 

1212
00:49:39,881 --> 00:49:44,986
THAT GREAT SO I'LL CHOOSE IT 

1213
00:49:44,986 --> 00:49:47,722
HAVE A JOB AND MAYBE 

1214
00:49:47,722 --> 00:49:48,990
VOLUNTARINESS DEALS WITH LIFE 

1215
00:49:48,990 --> 00:49:50,558
OUTCOMES AND WHAT WE'RE GIVEN 

1216
00:49:50,558 --> 00:49:52,293
AND MAKING A CHOICE IN THAT TYPE

1217
00:49:52,293 --> 00:49:53,094
OF CONTEXT.

1218
00:49:53,094 --> 00:49:55,329
I NEED A JOB TO HAVE MONEY, TO 

1219
00:49:55,329 --> 00:49:57,398
LIVE WITH MY PARENT SO I NEED TO

1220
00:49:57,398 --> 00:49:59,267
ALSO RESPECT MAYBE WHAT THEY 

1221
00:49:59,267 --> 00:49:59,534
WANT.

1222
00:49:59,534 --> 00:50:04,105
OR IN THE CASE OF OTHER 

1223
00:50:04,105 --> 00:50:05,006
PATIENTS, THE RESEARCH PROGRAM 

1224
00:50:05,006 --> 00:50:06,741
IS A WAY TO GET NEW TREATMENTS 

1225
00:50:06,741 --> 00:50:09,177
OR ONLY WAY WHERE I CAN GET 

1226
00:50:09,177 --> 00:50:13,080
MONEY.

1227
00:50:13,080 --> 00:50:14,882
AND IT MATTERS FOR VOLUNTARY 

1228
00:50:14,882 --> 00:50:17,018
DECISION MAKING AND WONDERING IF

1229
00:50:17,018 --> 00:50:19,587
IT'S RELEVANT IN THE FIELD OR A 

1230
00:50:19,587 --> 00:50:20,855
CORRECT INTERPRETATION.

1231
00:50:20,855 --> 00:50:31,265
>> I THINK IT'S CORRECT.

1232
00:50:42,276 --> 00:50:43,077
AND VEEP THE PRESSURE AND 

1233
00:50:43,077 --> 00:50:45,112
INFLUENCE THAT IS NOT COMPLETELY

1234
00:50:45,112 --> 00:50:50,017
EVER GONE BUT IN THE CASE I JUST

1235
00:50:50,017 --> 00:50:51,919
DESCRIBED, I FEEL LIKE THIS 

1236
00:50:51,919 --> 00:50:52,453
PARTICULAR INDIVIDUAL WAS 

1237
00:50:52,453 --> 00:50:54,589
FEELING PRESSURE.

1238
00:50:54,589 --> 00:50:56,858
WE ADDRESSED IT DIRECTLY, GAVE 

1239
00:50:56,858 --> 00:50:58,459
HIM PERMISSION TO NOT 

1240
00:50:58,459 --> 00:50:59,760
PARTICIPATE AND THEN DECIDED I'M

1241
00:50:59,760 --> 00:51:03,164
GOING TO DO IT ANYWAY BECAUSE I 

1242
00:51:03,164 --> 00:51:08,669
HAVE TO LIVE WITH THESE PEOPLE 

1243
00:51:08,669 --> 00:51:19,013
THEY'RE MY PARENTS.

1244
00:51:19,814 --> 00:51:21,215
WHAT WE NEED TO FIGURE OUT IS 

1245
00:51:21,215 --> 00:51:23,651
WHAT'S ADEQUATELY VOLUNTARY SO 

1246
00:51:23,651 --> 00:51:24,719
WE'RE NOT FINDING SOMEBODY 

1247
00:51:24,719 --> 00:51:25,319
FEELING PRESSURE THEY CANNOT 

1248
00:51:25,319 --> 00:51:35,463
RESIST.

1249
00:51:38,399 --> 00:51:39,767
THERE ARE TYPES OF PRESSURE THAT

1250
00:51:39,767 --> 00:51:40,701
ARE OVER BEARING AND PEOPLE 

1251
00:51:40,701 --> 00:51:41,235
SHOULD BE ABLE TO DECIDE 

1252
00:51:41,235 --> 00:51:49,210
THEMSELVES.

1253
00:51:49,210 --> 00:51:52,113
>> IF YOU DON'T LET HIM
ENROLL 

1254
00:51:52,113 --> 00:51:53,614
IS ALSO A FORM OF COERCION AND 

1255
00:51:53,614 --> 00:51:57,351
NOT RESPECTING THE POSITION.

1256
00:51:57,351 --> 00:52:04,058
THANK YOU.

1257
00:52:04,058 --> 00:52:12,099
>> THIS IS A MINOR EXAMPLE
BUT 

1258
00:52:12,099 --> 00:52:14,502
PEOPLE SCORE HIGH ON I KNOW I 

1259
00:52:14,502 --> 00:52:15,937
CAN LEAVE AND KNOW NO BAD THINGS

1260
00:52:15,937 --> 00:52:21,175
WILL HAPPEN IF I DO BUT SAY I'LL

1261
00:52:21,175 --> 00:52:30,451
NEVER LEAVE.

1262
00:52:30,451 --> 00:52:32,620
THEY WENT TO BE A GOOD RESEARCH 

1263
00:52:32,620 --> 00:52:34,021
SUBJECT BIT WE DON'T KNOW WHAT 

1264
00:52:34,021 --> 00:52:44,332
THE PRESSURES ARE.

1265
00:52:44,932 --> 00:52:49,370
PEOPLE WILL SAY I KNOW IT'S MY 

1266
00:52:49,370 --> 00:52:50,037
CHOICE BUT WHAT OTHER CHOICE DO 

1267
00:52:50,037 --> 00:53:00,181
I HAVE.

1268
00:53:03,451 --> 00:53:04,885
IT'S COMMON PRACTICE TO GET 

1269
00:53:04,885 --> 00:53:05,720
UNDERGRADS TO ENROLL BY 

1270
00:53:05,720 --> 00:53:13,094
INCLUDING THAT AS PART OF YOUR 

1271
00:53:13,094 --> 00:53:17,665
GRADE AND TEAR USUALLY MINIMAL 

1272
00:53:17,665 --> 00:53:19,400
RISK BUT BENEFITS THE PROFESSOR 

1273
00:53:19,400 --> 00:53:21,302
IN THAT DEPARTMENT TO HAVE MORE 

1274
00:53:21,302 --> 00:53:22,870
PEOPLE ENROLL.

1275
00:53:22,870 --> 00:53:26,974
WHAT MAKES THAT OKAY IN TERMS 

1276
00:53:26,974 --> 00:53:28,309
OF -- THEIR GRADES ARE BEING 

1277
00:53:28,309 --> 00:53:29,176
INFLUENCED.

1278
00:53:29,176 --> 00:53:30,845
THEY HAVE A PROFESSOR TELLING 

1279
00:53:30,845 --> 00:53:32,179
THEM TO DO IT.

1280
00:53:32,179 --> 00:53:35,116
>> CORRECT ME IF I'M
WRONG, MY 

1281
00:53:35,116 --> 00:53:36,250
UNDERSTANDING WHEN A PROFESSOR 

1282
00:53:36,250 --> 00:53:38,019
HAS THAT AS A POSSIBLE WAY TO 

1283
00:53:38,019 --> 00:53:40,755
GET A GRADE, THERE NEEDS TO BE 

1284
00:53:40,755 --> 00:53:41,889
AN ALTERNATIVE FOR PEOPLE WHO 

1285
00:53:41,889 --> 00:53:52,333
DON'T WANT TO PARTICIPATE.

1286
00:53:56,103 --> 00:53:58,072
DO YOU HAVE AN OPTION NOT TO 

1287
00:53:58,072 --> 00:53:59,607
TAKE THE COURSE?

1288
00:53:59,607 --> 00:54:03,778
>> WHEN I WAS AN UNDERGRAD
MANY 

1289
00:54:03,778 --> 00:54:04,412
YEARS AGO THE EXPECTATION WAS 

1290
00:54:04,412 --> 00:54:05,546
EVERYBODY PARTICIPATE IN A 

1291
00:54:05,546 --> 00:54:05,746
TRIAL.

1292
00:54:05,746 --> 00:54:11,118
THERE WAS NO OPTION.

1293
00:54:11,118 --> 00:54:13,320
MY ASSUMPTION IS THAT THAT'S 

1294
00:54:13,320 --> 00:54:13,554
CHANGED.

1295
00:54:13,554 --> 00:54:16,991
THE EXPECTATION IS IT'S 

1296
00:54:16,991 --> 00:54:17,491
RECOMMENDED.

1297
00:54:17,491 --> 00:54:21,362
THERE'S AN ALTERNATIVE YOU COULD

1298
00:54:21,362 --> 00:54:22,096
WRITE A PAPER.

1299
00:54:22,096 --> 00:54:22,830
PERHAPS WE HAVE TO LOOK INTO 

1300
00:54:22,830 --> 00:54:33,040
THAT AGAIN.

1301
00:54:34,675 --> 00:54:36,210
IN RESEARCH THERE'S SOMETIMES A 

1302
00:54:36,210 --> 00:54:37,611
LEGITIMATE CASE FOR SOME KINDS 

1303
00:54:37,611 --> 00:54:39,547
OF DECEPTION.

1304
00:54:39,547 --> 00:54:44,985
THAT'S VERY DIFFICULT THAN 

1305
00:54:44,985 --> 00:54:45,820
MISLEADING SOMEBODY AND GIVING 

1306
00:54:45,820 --> 00:54:52,326
THEM INFORMATION.

1307
00:54:52,326 --> 00:54:55,429
>> THANK YOU.

1308
00:54:55,429 --> 00:54:56,464
THANKS AGAIN.

1309
00:54:56,464 --> 00:54:59,133
SO, IT'S ME AGAIN AND IT'S MY 

1310
00:54:59,133 --> 00:55:01,402
PLEASURE TO INTRODUCE DR. SCOTT 

1311
00:55:01,402 --> 00:55:01,902
KIM.

1312
00:55:01,902 --> 00:55:03,871
HE'S A SENIOR INVESTIGATOR IN 

1313
00:55:03,871 --> 00:55:08,375
THE DEPARTMENT OF BIOETHICS AND 

1314
00:55:08,375 --> 00:55:11,445
HE DOES BOTH PHILOSOPHICAL AND 

1315
00:55:11,445 --> 00:55:15,149
EMPIRICAL RESEARCH IN A WHOLE 

1316
00:55:15,149 --> 00:55:16,717
VARIETY OF ISSUES AND LUCKY FOR 

1317
00:55:16,717 --> 00:55:19,053
US IS AN EXPERT IN DECISION 

1318
00:55:19,053 --> 00:55:20,254
MAKING CAPACITY AND WILL TELL US

1319
00:55:20,254 --> 00:55:22,223
WHAT WE NEED TO KEEP IN MIND 

1320
00:55:22,223 --> 00:55:24,225
WHEN WE'RE THINKING ABOUT 

1321
00:55:24,225 --> 00:55:26,894
CONDUCTING RESEARCH WITH THOSE 

1322
00:55:26,894 --> 00:55:28,996
WHO HAVE IMPAIRED DECISION 

1323
00:55:28,996 --> 00:55:39,273
MAKING CAPACITY.

1324
00:55:53,587 --> 00:55:55,556
>> ALL RIGHT.

1325
00:55:55,556 --> 00:55:56,991
CAN YOU HEAR ME?

1326
00:55:56,991 --> 00:56:00,561
OKAY.

1327
00:56:00,561 --> 00:56:04,431
ME WIFE SAYS MY VOICE IS SOFT.

1328
00:56:04,431 --> 00:56:05,966
I DON'T TALK LOUD ENOUGH SO I'LL

1329
00:56:05,966 --> 00:56:12,006
TRY MY BEST SO YOU CAN HEAR ME.

1330
00:56:12,006 --> 00:56:22,550
THANK YOU, HOLLY AND LET'S START

1331
00:56:26,487 --> 00:56:31,325
IN 1966.

1332
00:56:31,325 --> 00:56:33,027
HOW MANY PEOPLE HERE HAVE HEARD 

1333
00:56:33,027 --> 00:56:38,332
OF THIS ARTICLE.

1334
00:56:38,332 --> 00:56:39,934
I'M SURE MANY ONLINE MAY HAVE 

1335
00:56:39,934 --> 00:56:42,837
HEARD OF THIS ARTICLE BECAUSE 

1336
00:56:42,837 --> 00:56:44,104
IT'S HISTORICALLY QUITE 

1337
00:56:44,104 --> 00:56:44,538
SIGNIFICANT.

1338
00:56:44,538 --> 00:56:45,806
ONE OF THOSE THINGS WE MENTION 

1339
00:56:45,806 --> 00:56:48,909
WHEN WE TALK ABOUT THE HISTORY 

1340
00:56:48,909 --> 00:56:59,420
OF RESEARCH ETHICS REGULATION.

1341
00:57:03,691 --> 00:57:07,161
MAYBE A LITTLE OVER A THIRD OF 

1342
00:57:07,161 --> 00:57:08,128
EXAMPLES INVOLVE SOME WHO HAD 

1343
00:57:08,128 --> 00:57:18,572
DIFFICULTY GIVING CONCEPT.

1344
00:57:23,043 --> 00:57:27,982
THOSE GIVEN TOXIC DRUG OR 

1345
00:57:27,982 --> 00:57:28,983
BIOPSIES TAKEN.

1346
00:57:28,983 --> 00:57:31,085
ANOTHER STUDY IN WHICH THEY ARE 

1347
00:57:31,085 --> 00:57:32,920
INDUCED CONFUSION AND MANY 

1348
00:57:32,920 --> 00:57:34,688
PEOPLE IT'S NOT CLEAR IF THEY 

1349
00:57:34,688 --> 00:57:38,325
ARE WERE ABLE DURING THE STUDY 

1350
00:57:38,325 --> 00:57:41,629
TO SAY LOOK, I DON'T WANT TO DO 

1351
00:57:41,629 --> 00:57:42,663
THIS ANYMORE.

1352
00:57:42,663 --> 00:57:47,835
EXPERIMENTS ON UNCONSCIOUS 

1353
00:57:47,835 --> 00:57:51,972
PATIENTS WAS COMMON AND STUDY OF

1354
00:57:51,972 --> 00:57:54,475
COMA IN SICK PEOPLE WITH FAILING

1355
00:57:54,475 --> 00:57:54,675
LIVER.

1356
00:57:54,675 --> 00:57:59,146
THEY WERE QUITE INVASIVE 

1357
00:57:59,146 --> 00:57:59,747
PROCEDURES AU CAN SEE.

1358
00:57:59,747 --> 00:58:04,018
AS YOU CAN SEE.

1359
00:58:04,018 --> 00:58:06,720
AND DR. BEECHER FOUND THOSE 

1360
00:58:06,720 --> 00:58:07,788
STUDIES.

1361
00:58:07,788 --> 00:58:09,490
THERE'S SEVERAL EXAMPLES 

1362
00:58:09,490 --> 00:58:20,034
INVOLVING CHILDREN AND INFANTS.

1363
00:58:23,137 --> 00:58:26,440
AND LED TO ISSUES AS WHAT WE 

1364
00:58:26,440 --> 00:58:28,609
ACCEPT AS LAWS THAT REGULATE THE

1365
00:58:28,609 --> 00:58:32,980
ETHICAL PRINCIPLES OF HUMAN 

1366
00:58:32,980 --> 00:58:43,290
SUBJECT RESEARCH.

1367
00:58:45,059 --> 00:58:45,659
AND THERE WERE ISSUES THAT 

1368
00:58:45,659 --> 00:58:47,161
WEREN'T RESOLVED IN THE 

1369
00:58:47,161 --> 00:58:47,728
BEGINNING.

1370
00:58:47,728 --> 00:58:49,997
LET ME GO THROUGH SOME HISTORY 

1371
00:58:49,997 --> 00:58:50,230
QUICKLY.

1372
00:58:50,230 --> 00:58:55,736
 THE NATIONAL COMMISSION IS THE 

1373
00:58:55,736 --> 00:58:58,038
BELMONT COMMISSION THAT'S 

1374
00:58:58,038 --> 00:58:59,606
ANOTHER TERM PEOPLE USE.

1375
00:58:59,606 --> 00:59:04,979
THEY PUBLISH BOOKS OR MONOGRAPHS

1376
00:59:04,979 --> 00:59:06,046
REGARDING DIFFERENT TOPICS AND 

1377
00:59:06,046 --> 00:59:07,815
IT'S INTERESTING, ALL OF THEM 

1378
00:59:07,815 --> 00:59:09,450
BECAME THE FOUNDATION FOR THE 

1379
00:59:09,450 --> 00:59:13,354
REGULATIONS THAT WE HAVE NOW.

1380
00:59:13,354 --> 00:59:16,590
AND IF YOU READ THOSE AND READ 

1381
00:59:16,590 --> 00:59:18,759
THE REGULATIONS YOU'LL SEE THAT 

1382
00:59:18,759 --> 00:59:20,194
EXCEPT FOR ONE WHERE RESEARCH 

1383
00:59:20,194 --> 00:59:21,595
INVOLVING THOSE 

1384
00:59:21,595 --> 00:59:26,967
INSTITUTIONALIZED AS MENTALLY 

1385
00:59:26,967 --> 00:59:28,335
INFIRMED REALLY THAT QUESTION 

1386
00:59:28,335 --> 00:59:29,670
REMAINED OPEN.

1387
00:59:29,670 --> 00:59:33,474
IT WAS AGAIN DEBATED IN 1982 IN 

1388
00:59:33,474 --> 00:59:36,977
THE BROADER CONTEXT OF MAKING 

1389
00:59:36,977 --> 00:59:40,981
HEALTH CARE AND RESEARCH 

1390
00:59:40,981 --> 00:59:43,784
DECISIONS IN AMONG PEOPLE WHO 

1391
00:59:43,784 --> 00:59:45,919
HAVE TROUBLE GETTING THEIR OWN 

1392
00:59:45,919 --> 00:59:46,153
CONSENT.

1393
00:59:46,153 --> 00:59:54,361
199 8 WAS AN ACTIVE YEAR WITH 

1394
00:59:54,361 --> 00:59:56,797
SCANDALS, CONTROVERSIES EAST AND

1395
00:59:56,797 --> 01:00:00,300
WEST COAST AROUND THE TIME I WAS

1396
01:00:00,300 --> 01:00:00,934
GETTING INTO DOING WORK IN THIS 

1397
01:00:00,934 --> 01:00:11,045
AREA.

1398
01:00:11,045 --> 01:00:13,914
THERE WAS ONE BY THE MARYLAND 

1399
01:00:13,914 --> 01:00:15,749
ATTORNEY'S WORKING GROUP.

1400
01:00:15,749 --> 01:00:20,988
A FAMOUS ONE WAS THE NATIONAL 

1401
01:00:20,988 --> 01:00:25,893
BIOETHICS ADVISORY COMMISSION.

1402
01:00:25,893 --> 01:00:26,527
NEW YORK DEPARTMENT OF HEALTH 

1403
01:00:26,527 --> 01:00:28,762
ALSO HAD A WORKING GROUP AND 

1404
01:00:28,762 --> 01:00:29,430
ISSUED A REPORT THE YEAR AFTER 

1405
01:00:29,430 --> 01:00:37,504
THAT.

1406
01:00:37,504 --> 01:00:39,740
AND THERE'S DEBATES AND STUDIES 

1407
01:00:39,740 --> 01:00:44,211
I HELPED CONTRIBUTE TO DURING 

1408
01:00:44,211 --> 01:00:46,513
THE INTERVENING YEARS AND IN 

1409
01:00:46,513 --> 01:00:50,751
2009 THERE WAS RECOMMENDATIONS 

1410
01:00:50,751 --> 01:00:56,523
MADE BUT SACHRP MEANING ADVISING

1411
01:00:56,523 --> 01:01:06,433
THE DHHS SECRETARY.

1412
01:01:06,433 --> 01:01:12,372
IN 2005 DURING PRESIDENT OBAMA'S

1413
01:01:12,372 --> 01:01:22,883
YEARS, THERE WAS A NOTICE FOR 

1414
01:01:29,089 --> 01:01:31,825
PUBLIC -- I WORK FOR THE 

1415
01:01:31,825 --> 01:01:32,960
GOVERNMENT.

1416
01:01:32,960 --> 01:01:35,195
I KNEW HOLLY WOULD KNOW BECAUSE 

1417
01:01:35,195 --> 01:01:38,732
SHE KNOWS ALL THESE TECHNICAL 

1418
01:01:38,732 --> 01:01:38,932
TERMS.

1419
01:01:38,932 --> 01:01:41,001
SO THE COMMON RULE HAD BEEN IN 

1420
01:01:41,001 --> 01:01:44,404
PLACE FOR DECADES.

1421
01:01:44,404 --> 01:01:47,040
AND IT RECEIVED A REVISION AND 

1422
01:01:47,040 --> 01:01:48,375
ONE OF THE THINGS THAT IT 

1423
01:01:48,375 --> 01:01:50,644
ADDRESSED WAS THIS TOPIC.

1424
01:01:50,644 --> 01:01:53,380
AND I'LL TELL YOU SOMETHING 

1425
01:01:53,380 --> 01:01:56,083
ABOUT THE CHANGE THAT TOOK 

1426
01:01:56,083 --> 01:01:56,283
PLACE.

1427
01:01:56,283 --> 01:01:58,886
SO THROUGHOUT ALL THIS, I WOULD 

1428
01:01:58,886 --> 01:02:04,391
SAY THE MOST SIGNIFICANT INSIGHT

1429
01:02:04,391 --> 01:02:05,626
OR AGREEMENT THAT THE FIELD 

1430
01:02:05,626 --> 01:02:07,561
AMONG RESEARCHERS, REGULATORS 

1431
01:02:07,561 --> 01:02:12,299
AND ETHICISTS IS THIS AGREEMENT 

1432
01:02:12,299 --> 01:02:14,535
WHICH IS THAT IF YOU'RE GOING TO

1433
01:02:14,535 --> 01:02:17,504
INVOLVE THOSE LACKING OR AT RISK

1434
01:02:17,504 --> 01:02:22,776
FOR LACKING DECISION MAKING 

1435
01:02:22,776 --> 01:02:26,613
CAPACITY YOU NEED TO 

1436
01:02:26,613 --> 01:02:27,881
SPECIFICALLY JUSTIFY WHAT IT IS 

1437
01:02:27,881 --> 01:02:28,515
YOU ARE DOING BY MEETING THESE 

1438
01:02:28,515 --> 01:02:35,322
CONDITIONS.

1439
01:02:35,322 --> 01:02:36,156
THAT RESEARCH CAN'T BE DONE 

1440
01:02:36,156 --> 01:02:37,624
WITHOUT THE POPULATION.

1441
01:02:37,624 --> 01:02:39,927
IF YOU CAN DO IT WITH OTHER 

1442
01:02:39,927 --> 01:02:42,930
OPTIONS EVEN LESS CONVENIENTLY, 

1443
01:02:42,930 --> 01:02:44,498
THERE'S NO INTRINSIC 

1444
01:02:44,498 --> 01:02:48,402
JUSTIFICATION FOR HAVING TO USE 

1445
01:02:48,402 --> 01:02:49,536
THE POPULATION.

1446
01:02:49,536 --> 01:02:50,704
THAT'S RELATED TO THE SECOND 

1447
01:02:50,704 --> 01:02:55,709
POINT, RESEARCH MUST BE FOCUSSED

1448
01:02:55,709 --> 01:02:59,680
ON THE DISORDER CAUSING THE 

1449
01:02:59,680 --> 01:03:00,681
INCAPACITY AND IF THAT 

1450
01:03:00,681 --> 01:03:01,348
POPULATION WILL BENEFIT IN SOME 

1451
01:03:01,348 --> 01:03:08,255
BROAD SENSE.

1452
01:03:08,255 --> 01:03:09,122
IT BENEFITS PEOPLE IN OUR 

1453
01:03:09,122 --> 01:03:10,591
CURRENT GENERATION AND PEOPLE 

1454
01:03:10,591 --> 01:03:15,696
WHO HAVE THE FEATURE.

1455
01:03:15,696 --> 01:03:23,737
NOW, I WANT TO SAY IT'S 

1456
01:03:23,737 --> 01:03:24,972
IMPORTANT TO INVOLVE PERSONS 

1457
01:03:24,972 --> 01:03:28,075
WITH DIFFICULTIES FOR OTHER 

1458
01:03:28,075 --> 01:03:28,375
DISORDERS.

1459
01:03:28,375 --> 01:03:30,777
THESE WILL BE SITUATIONS WHERE 

1460
01:03:30,777 --> 01:03:32,646
IF YOU EXCLUDE THEM BASED ON THE

1461
01:03:32,646 --> 01:03:35,949
FIRST TWO BULLET POINTS, IT CAN 

1462
01:03:35,949 --> 01:03:37,150
ACTUALLY AMOUNT TO A KIND OF 

1463
01:03:37,150 --> 01:03:40,554
DISCRIMINATION.

1464
01:03:40,554 --> 01:03:43,156
THIS IMPLIES THERE ARE SOME TYPE

1465
01:03:43,156 --> 01:03:45,359
OF RESEARCH THAT HAS MORE OR 

1466
01:03:45,359 --> 01:03:47,828
LESS POTENTIAL FOR BENEFIT.

1467
01:03:47,828 --> 01:03:51,999
AND WE ALL RECOGNIZE THAT.

1468
01:03:51,999 --> 01:03:57,170
SO FOR EXAMPLE IF THEY'RE 

1469
01:03:57,170 --> 01:04:04,478
TESTING A PROMISE  PROMISING SA 

1470
01:04:04,478 --> 01:04:06,313
MONOCLONAL TREATMENT FOR 

1471
01:04:06,313 --> 01:04:07,681
MELANOMA AND A PERSON WITH 

1472
01:04:07,681 --> 01:04:08,382
DISABILITY MAY NOT BE ABLE TO 

1473
01:04:08,382 --> 01:04:10,517
GIVE CONSENT OR BE AT RISK FOR 

1474
01:04:10,517 --> 01:04:16,356
GIVING CONSENT HAS THE SAME 

1475
01:04:16,356 --> 01:04:18,458
CANCER TO EXCLUDE THEM MERELY 

1476
01:04:18,458 --> 01:04:19,660
BASED ON DISABILITY IN THAT CASE

1477
01:04:19,660 --> 01:04:24,798
COULD BE DISCRIMINATION.

1478
01:04:24,798 --> 01:04:26,800
THIS THINKING BECOMING MORE 

1479
01:04:26,800 --> 01:04:28,969
PROMINENT IN RESEARCH ETHICS IS 

1480
01:04:28,969 --> 01:04:29,603
A SIGN OF TREMENDOUS PROGRESS IN

1481
01:04:29,603 --> 01:04:33,807
THIS AREA.

1482
01:04:33,807 --> 01:04:36,710
WE NOW THE FIRST TWO BULLET 

1483
01:04:36,710 --> 01:04:42,883
POINTS IS WIDELY ACCEPTED.

1484
01:04:42,883 --> 01:04:45,252
AS ANY POLICY SHOULD WE SHOULD 

1485
01:04:45,252 --> 01:04:50,223
BE SENSITIVE TO DEVELOPMENT AND 

1486
01:04:50,223 --> 01:04:56,997
UNINTENDED CONSEQUENCES.

1487
01:04:56,997 --> 01:05:00,267
AND I'M GOING TO TALK ABOUT 

1488
01:05:00,267 --> 01:05:01,468
DECISION MAKING CAPACITY 

1489
01:05:01,468 --> 01:05:11,978
IMPAIRMENT AS A TOPIC.

1490
01:05:11,978 --> 01:05:13,180
AND THEN TALK ABOUT TALK ABOUT 

1491
01:05:13,180 --> 01:05:15,215
THE NOTION THAT IN THEORY, 

1492
01:05:15,215 --> 01:05:16,550
STUDIES INVOLVING PEOPLE WHO 

1493
01:05:16,550 --> 01:05:18,585
CAN'T CONSENT IS PERMISSIBLE.

1494
01:05:18,585 --> 01:05:20,420
NOW, THE QUESTION IS HOW DO YOU 

1495
01:05:20,420 --> 01:05:20,987
DO IT.

1496
01:05:20,987 --> 01:05:22,589
WHO SHOULD GIVE CONSENT AND 

1497
01:05:22,589 --> 01:05:25,859
SHOULD THERE BE LIMITS TO RISK?

1498
01:05:25,859 --> 01:05:28,161
THOSE ARE THE TWO FUNDAMENTAL 

1499
01:05:28,161 --> 01:05:30,130
QUESTIONS WHEN YOU SAY, I SHOULD

1500
01:05:30,130 --> 01:05:35,869
BE OKAY BUT -- SO BUT HAS AT 

1501
01:05:35,869 --> 01:05:38,205
LEAST TWO MAJOR BULLET POINTS.

1502
01:05:38,205 --> 01:05:40,974
I'M GOING TO GIVE YOU EVIDENCE 

1503
01:05:40,974 --> 01:05:43,410
THAT WE'VE GATHERED BEFORE I 

1504
01:05:43,410 --> 01:05:46,346
CAME TO NIH AT MICHIGAN WE DID A

1505
01:05:46,346 --> 01:05:52,352
LOT OF STUDIES ON THIS TOPIC 

1506
01:05:52,352 --> 01:05:59,226
THAT REALLY INFORMS HOW WE MIGHT

1507
01:05:59,226 --> 01:06:00,360
MAKE POLICY AND THE MORAL 

1508
01:06:00,360 --> 01:06:01,828
PERSPECTIVES OF THE PUBLIC THAT 

1509
01:06:01,828 --> 01:06:06,099
THESE KINDS OF DECISION MAKING.

1510
01:06:06,099 --> 01:06:07,667
THEN I'LL CLOSE WITH ADDITIONAL 

1511
01:06:07,667 --> 01:06:10,404
PROTECTS OR SAFEGUARDS IRB AND 

1512
01:06:10,404 --> 01:06:11,405
INVESTIGATORS MIGHT CONSIDER 

1513
01:06:11,405 --> 01:06:16,643
DEPENDING ON THE CONTEXT.

1514
01:06:16,643 --> 01:06:21,681
AND WHAT IS THE DECISION 

1515
01:06:21,681 --> 01:06:25,819
CAPACITY AND IMPAIRMENT?

1516
01:06:25,819 --> 01:06:27,421
HAVING GONE TO COURSE MAKING 

1517
01:06:27,421 --> 01:06:28,355
DECISION WHETHER THE PERSON HAS 

1518
01:06:28,355 --> 01:06:30,824
CAPACITY OR NOT.

1519
01:06:30,824 --> 01:06:33,393
WE OFTEN USE THE TERMS CAPACITY 

1520
01:06:33,393 --> 01:06:35,195
AND COMPETENCE INTERCHANGEABLY.

1521
01:06:35,195 --> 01:06:37,798
THE MEANING IS DO THEY HAVE THE 

1522
01:06:37,798 --> 01:06:42,869
ABILITY SUFFICIENT TO MAKE A 

1523
01:06:42,869 --> 01:06:47,407
DECISION AND IT'S THE JUDGE WHO 

1524
01:06:47,407 --> 01:06:48,942
MAKES THE DECISION.

1525
01:06:48,942 --> 01:06:52,612
IT HAS A SPECIAL LEGAL FORCE.

1526
01:06:52,612 --> 01:06:53,513
NOTICE I DON'T DISTINGUISH 

1527
01:06:53,513 --> 01:06:55,982
BETWEEN CAPACITY AND COMPETENCE 

1528
01:06:55,982 --> 01:06:58,385
AS LYING BETWEEN CLINICAL AND 

1529
01:06:58,385 --> 01:06:59,219
LEGAL.

1530
01:06:59,219 --> 01:07:01,822
I JUST WANT TO WARN YOU, MANY 

1531
01:07:01,822 --> 01:07:03,490
PEOPLE WILL TELL YOU THAT'S HOW 

1532
01:07:03,490 --> 01:07:05,892
THE WORLD IS AND HOW YOU'RE 

1533
01:07:05,892 --> 01:07:07,294
SUPPOSED TO USE IT.

1534
01:07:07,294 --> 01:07:09,563
THAT IS OUT RIGHT NOT TRUE.

1535
01:07:09,563 --> 01:07:15,435
WE CAN TALK ABOUT THAT IF YOU 

1536
01:07:15,435 --> 01:07:18,438
WANT BUT DON'T GET MISLED BY 

1537
01:07:18,438 --> 01:07:19,005
THAT DISTINCTION.

1538
01:07:19,005 --> 01:07:21,741
WHEN WE ORDINARILY TALK ABOUT 

1539
01:07:21,741 --> 01:07:24,845
THE TERMS IN A CLINICAL SETTING 

1540
01:07:24,845 --> 01:07:26,746
IT'S AN APPROXIMATION OF WHAT 

1541
01:07:26,746 --> 01:07:28,949
THE COURTS MIGHT OR WOULD SAY.

1542
01:07:28,949 --> 01:07:37,524
USUALLY THE CARRIES THE DAY.

1543
01:07:37,524 --> 01:07:38,658
WHY?

1544
01:07:38,658 --> 01:07:40,026
IT GIVES THE PERSONS THE 

1545
01:07:40,026 --> 01:07:42,395
DECISION UNLESS THERE'S A 

1546
01:07:42,395 --> 01:07:45,432
CHALLENGE WHEN IT GO GOES TO 

1547
01:07:45,432 --> 01:07:48,935
COURT AND IF YOU HAVE A 

1548
01:07:48,935 --> 01:07:51,071
SUFFICIENT AMOUNT YOU COULD BE 

1549
01:07:51,071 --> 01:07:53,640
DEEMED COMPETENT OR HAVE 

1550
01:07:53,640 --> 01:07:55,375
SUFFICIENT CAPACITY TO MAKE YOUR

1551
01:07:55,375 --> 01:07:57,477
OWN DECISIONS.

1552
01:07:57,477 --> 01:07:59,813
NOW, THE ABILITIES COME 

1553
01:07:59,813 --> 01:08:00,146
UNDEGREES.

1554
01:08:00,146 --> 01:08:01,815
THEY GO BY THE NAME OF THINGS 

1555
01:08:01,815 --> 01:08:04,050
LIKE UNDERSTANDING, 

1556
01:08:04,050 --> 01:08:05,685
APPRECIATING, REASONING AND 

1557
01:08:05,685 --> 01:08:08,455
COMMUNICATING A SAFE CHOICE.

1558
01:08:08,455 --> 01:08:10,690
THESE ARE PSYCHO METRIC 

1559
01:08:10,690 --> 01:08:10,957
CONCEPTS.

1560
01:08:10,957 --> 01:08:13,426
YOU CAN HAVE WELL TRAINED PEOPLE

1561
01:08:13,426 --> 01:08:15,662
WHO CAN OPERATIONALIZE THESE SO 

1562
01:08:15,662 --> 01:08:18,598
YOU CAN ACTUALLY DEVELOP TOOLS 

1563
01:08:18,598 --> 01:08:19,332
TO MEASURE THEM.

1564
01:08:19,332 --> 01:08:21,268
OF COURSE THE CAVEAT IS BECAUSE 

1565
01:08:21,268 --> 01:08:23,403
AS YOU'LL SEE THE CONCEPT IS 

1566
01:08:23,403 --> 01:08:25,438
DECISION SPECIFIC.

1567
01:08:25,438 --> 01:08:29,242
YOU HAVE TO MODIFY THEM FOR EACH

1568
01:08:29,242 --> 01:08:31,645
CONTEXT WHICH KIND OF PUTS SOME 

1569
01:08:31,645 --> 01:08:34,848
PRESSURE ON WHAT DOES IT MEAN TO

1570
01:08:34,848 --> 01:08:36,650
HAVE A VALIDATED INSTRUMENT AND 

1571
01:08:36,650 --> 01:08:43,056
SUCH BECAUSE YOU HAVE TO 

1572
01:08:43,056 --> 01:08:53,533
CUSTOMIZE TO EACH SITUATION.

1573
01:08:58,738 --> 01:09:03,843
YOU CAN DECIDE TO BRING THE 

1574
01:09:03,843 --> 01:09:06,646
ASTRONAUTS BACK USING THEIR 

1575
01:09:06,646 --> 01:09:07,747
VEHICLE OR NOT SURE HOW SAFE IT 

1576
01:09:07,747 --> 01:09:09,416
IS SO YOU HAVE TO MAKE ANOTHER 

1577
01:09:09,416 --> 01:09:09,683
DECISION.

1578
01:09:09,683 --> 01:09:10,850
YOU CAN'T JUST SORT OF DO IT OR 

1579
01:09:10,850 --> 01:09:13,219
NOT DO IT AT THE PSALM TIME.

1580
01:09:13,219 --> 01:09:13,920
-- SAME TIME.

1581
01:09:13,920 --> 01:09:15,255
SAME THING.

1582
01:09:15,255 --> 01:09:16,690
YOU HAVE TO USE ALL THAT 

1583
01:09:16,690 --> 01:09:19,125
INFORMATION AND REDUCE IT TO 

1584
01:09:19,125 --> 01:09:26,866
YES, NO.

1585
01:09:26,866 --> 01:09:28,268
IT'S PART OF THE DOCTRINE OF 

1586
01:09:28,268 --> 01:09:28,935
INFORMED CONSENT.

1587
01:09:28,935 --> 01:09:34,474
THE ABILITY OR CAPACITY TO MAKE 

1588
01:09:34,474 --> 01:09:36,610
THE DECISION.

1589
01:09:36,610 --> 01:09:37,344
HAVING RECEIVED RELEVANT 

1590
01:09:37,344 --> 01:09:41,548
INFORMATION AND TO MAKE THE 

1591
01:09:41,548 --> 01:09:43,783
DECISION WITHOUT DURESS, 

1592
01:09:43,783 --> 01:09:50,056
COERCION, UNDUE INFLUENCE.

1593
01:09:50,056 --> 01:09:54,294
THE MODEL OF DECISION-MAKING 

1594
01:09:54,294 --> 01:09:55,061
CAPACITY HAS SEVERAL COMPONENTS.

1595
01:09:55,061 --> 01:09:56,262
ONE IS THE DECISION OF CAPACITY.

1596
01:09:56,262 --> 01:10:01,835
WE USUALLY SAY ADULTS ARE 

1597
01:10:01,835 --> 01:10:03,637
PRESUMED TO BE CAPABLE UNLESS 

1598
01:10:03,637 --> 01:10:06,306
HAVE YOU A REASON TO SUSPEND 

1599
01:10:06,306 --> 01:10:07,507
THAT PRESUMPTION.

1600
01:10:07,507 --> 01:10:08,642
IT DOESN'T MEAN THEY'RE NOT 

1601
01:10:08,642 --> 01:10:10,176
CAPABILITY IT JUST MEANS YOU 

1602
01:10:10,176 --> 01:10:12,212
HAVE A REASON TO INVESTIGATE 

1603
01:10:12,212 --> 01:10:14,114
WHETHER OR NOT WE NEED MAKE A 

1604
01:10:14,114 --> 01:10:17,050
DECISION WHETHER THIS PERSON HAS

1605
01:10:17,050 --> 01:10:23,657
CAPACITY OR NOT.

1606
01:10:23,657 --> 01:10:30,563
WE NO LONGER USE TERMS LIKE 

1607
01:10:30,563 --> 01:10:33,133
SENILE, UNSOUND MIND.

1608
01:10:33,133 --> 01:10:35,769
IF YOU GO BACK TO THE WRITINGS 

1609
01:10:35,769 --> 01:10:38,304
OF THE EARLY 20th CENTURY 

1610
01:10:38,304 --> 01:10:40,240
DOCTORS USE TERMS LIKE THIS TO 

1611
01:10:40,240 --> 01:10:41,641
SAY THAT PERSON CAN'T MAKE THEIR

1612
01:10:41,641 --> 01:10:44,978
OWN DECISION BECAUSE THEIR MIND 

1613
01:10:44,978 --> 01:10:55,188
IS UNSOUND.

1614
01:10:58,491 --> 01:11:05,732
 THE THRESHOLD AND IF A PERSON 

1615
01:11:05,732 --> 01:11:07,600
EVEN WITH MILD DEMENTIA IS IN 

1616
01:11:07,600 --> 01:11:09,602
THE HOSPITAL BECAUSE THEY HAVE 

1617
01:11:09,602 --> 01:11:11,438
AN IN SECTION AND SOMEBODY COMES

1618
01:11:11,438 --> 01:11:14,274
IN AND SAYS, MR. JONES, WE'RE 

1619
01:11:14,274 --> 01:11:17,077
GOING TO DRAW BLOOD FOR LABS AND

1620
01:11:17,077 --> 01:11:21,481
HE PUTS HIS ARM OUT.

1621
01:11:21,481 --> 01:11:23,616
ARE YOU GOING TO USE A FULL 

1622
01:11:23,616 --> 01:11:24,551
COMPLICATED ASSESSMENT TO MAKE 

1623
01:11:24,551 --> 01:11:27,487
SURE HE'S GIVEN CONSENT?

1624
01:11:27,487 --> 01:11:32,692
PROBABLY NOT BECAUSE IT MAY BE 

1625
01:11:32,692 --> 01:11:32,992
APPROPRIATE.

1626
01:11:32,992 --> 01:11:34,060
AND IF THE SAME PERSON IS ASKED 

1627
01:11:34,060 --> 01:11:40,433
TO PARTICIPATE IN A CLINICAL 

1628
01:11:40,433 --> 01:11:44,971
TRIAL OF NEURAL SURGICAL IMPLANT

1629
01:11:44,971 --> 01:11:48,408
OF GENE THERAPY AND SAYS DOC, 

1630
01:11:48,408 --> 01:11:50,176
YOU KNOW BEST AND ARTICULATES IT

1631
01:11:50,176 --> 01:11:51,611
CLEARLY I WOULD THINK WE HOLD 

1632
01:11:51,611 --> 01:11:53,146
THAT PERSON TO A HIGHER 

1633
01:11:53,146 --> 01:11:57,984
STANDARD.

1634
01:11:57,984 --> 01:11:59,052
AND IS THE TASK DECISION 

1635
01:11:59,052 --> 01:11:59,319
SPECIFIC.

1636
01:11:59,319 --> 01:12:02,155
I WANT TO SPEND A COUPLE MINUTES

1637
01:12:02,155 --> 01:12:06,593
ON THIS SLIDE BECAUSE DEPENDING 

1638
01:12:06,593 --> 01:12:10,463
ON WHERE YOU'RE LISTENING TO ME 

1639
01:12:10,463 --> 01:12:12,565
AT THIS MOMENT YOU'RE MORE OR 

1640
01:12:12,565 --> 01:12:13,133
LESS FAMILIAR WITH THIS CON 

1641
01:12:13,133 --> 01:12:18,404
SENSE.

1642
01:12:18,404 --> 01:12:23,910
2008 WAS A CONVENTION THAT 

1643
01:12:23,910 --> 01:12:27,580
OUTLINED THE HUMAN RIGHTS BASED 

1644
01:12:27,580 --> 01:12:30,116
RIGHTS OF PERSONS WITH 

1645
01:12:30,116 --> 01:12:30,450
DISABILITIES.

1646
01:12:30,450 --> 01:12:31,518
VERY IMPORTANT.

1647
01:12:31,518 --> 01:12:35,789
THERE WAS A PROBLEM WITH IT IN 

1648
01:12:35,789 --> 01:12:40,994
THAT THERE WAS AN ARTICLE AMONG 

1649
01:12:40,994 --> 01:12:45,465
IN THE CONVENTION THAT BASICALLY

1650
01:12:45,465 --> 01:12:51,404
STRONGLY IMPLIED THAT REGARDLESS

1651
01:12:51,404 --> 01:12:54,407
OF YOUR ABILITYIES WHAT I LAID 

1652
01:12:54,407 --> 01:12:55,975
OUT AT THE FUNCTIONAL ABILITIES,

1653
01:12:55,975 --> 01:13:06,519
YOU HAVE LEGAL CAPACITY.

1654
01:13:06,519 --> 01:13:10,690
IT WAS CHALLENGING FUNCTIONAL 

1655
01:13:10,690 --> 01:13:11,291
CAPACITY.

1656
01:13:11,291 --> 01:13:14,227
CONSEQUENTLY SAYING WE HAVE TO 

1657
01:13:14,227 --> 01:13:15,562
GET RID OF ALL SURROGATE 

1658
01:13:15,562 --> 01:13:18,097
DECISION MAKING REGIMES.

1659
01:13:18,097 --> 01:13:23,002
I'M NOT GOING INTO THE 

1660
01:13:23,002 --> 01:13:23,703
COMPLICATED, POLITICAL AND 

1661
01:13:23,703 --> 01:13:25,171
HISTORY OF WHY THIS CAME TO BE 

1662
01:13:25,171 --> 01:13:26,873
IN THE CONVENTION.

1663
01:13:26,873 --> 01:13:28,374
THERE WAS A GENERAL COMMENT 

1664
01:13:28,374 --> 01:13:29,375
EXPLAINING IT IN THIS SENSE I 

1665
01:13:29,375 --> 01:13:39,819
JUST TALKED TO YOU ABOUT.

1666
01:13:41,054 --> 01:13:43,323
EVEN COMPANIES THAT ACCEPTED 

1667
01:13:43,323 --> 01:13:46,459
THIS CONVENTION ALMOST ALWAYS 

1668
01:13:46,459 --> 01:13:47,327
INSERT WHAT IN MEMORIAL WE CALL 

1669
01:13:47,327 --> 01:13:55,635
SIGNING STATEMENTS.

1670
01:13:55,635 --> 01:13:57,971
WE THINK IT'S A GREAT CONVENTION

1671
01:13:57,971 --> 01:14:02,141
AND AS IT IMPLIES SUCH AND SUCH 

1672
01:14:02,141 --> 01:14:04,677
WE REFER THE RIGHT TO X, Y, Z.

1673
01:14:04,677 --> 01:14:07,981
IT'S A VERY IMPORTANT TOPIC BUT 

1674
01:14:07,981 --> 01:14:18,424
I'M GOING TO PUT IT ASIDE.

1675
01:14:21,694 --> 01:14:23,830
BECAUSE WE'RE USING THE CONCEPT 

1676
01:14:23,830 --> 01:14:28,902
THAT THE GENERAL COMMENT NUMBER 

1677
01:14:28,902 --> 01:14:32,805
ONE OF THE CONVENTION SAYS WE 

1678
01:14:32,805 --> 01:14:34,641
SHOULD BE USING WE ARE AND 

1679
01:14:34,641 --> 01:14:35,541
VIRTUALLY EVERY JURISDICTION I 

1680
01:14:35,541 --> 01:14:36,843
KNOW DOES.

1681
01:14:36,843 --> 01:14:41,948
SOME DISORDERS ELEVATE THE RISK 

1682
01:14:41,948 --> 01:14:47,387
FOR INCAPACITY AND SOME AFFECT 

1683
01:14:47,387 --> 01:14:50,890
NEURAL DEGENERATIVE DISORDERS, 

1684
01:14:50,890 --> 01:14:52,959
ALZHEIMER'S FROM THE TEMPORAL 

1685
01:14:52,959 --> 01:14:54,027
DEMENTIAS.

1686
01:14:54,027 --> 01:15:01,334
NEURAL  -- NEURODEVELOPMENT 

1687
01:15:01,334 --> 01:15:03,970
DISORDERS AND INTELLECTUAL 

1688
01:15:03,970 --> 01:15:05,138
DISABILITIES DISORDERS AND 

1689
01:15:05,138 --> 01:15:08,508
STROKES, TRAUMATIC BRAIN INJURY.

1690
01:15:08,508 --> 01:15:10,677
PEOPLE WHO SUFFER TRAUMA FROM 

1691
01:15:10,677 --> 01:15:11,411
WAR ACCIDENTS, WAR OR 

1692
01:15:11,411 --> 01:15:15,982
INFECTIONS.

1693
01:15:15,982 --> 01:15:18,818
PEOPLE WHO COME IN WITH ACUTE 

1694
01:15:18,818 --> 01:15:21,521
SITUATIONS WHO HAVE TEMPORARY 

1695
01:15:21,521 --> 01:15:28,094
LOSS OF COGNITIVE FUNCTION.

1696
01:15:28,094 --> 01:15:30,697
WHAT WE CALL DELIRIUM AND 

1697
01:15:30,697 --> 01:15:33,333
PSYCHOTIC DISORDERS I CONSIDER 

1698
01:15:33,333 --> 01:15:35,335
MANIC STATES OF BIPOLAR DISORDER

1699
01:15:35,335 --> 01:15:39,639
AS FALLING UNDER PSYCHOTIC 

1700
01:15:39,639 --> 01:15:39,939
SITUATIONS.

1701
01:15:39,939 --> 01:15:42,742
MOOD DISORDERS WHEN SEVERE.

1702
01:15:42,742 --> 01:15:44,978
EATING DISORDERS WHEN SEVERE 

1703
01:15:44,978 --> 01:15:47,280
DOES AFFECT DECISION MAKING 

1704
01:15:47,280 --> 01:15:47,547
CAPACITY.

1705
01:15:47,547 --> 01:15:48,982
THERE'S OTHER AREAS OF 

1706
01:15:48,982 --> 01:15:52,819
CONTROVERSY.

1707
01:15:52,819 --> 01:15:59,292
FOR INSTANCE, PEOPLE WHO HAVE 

1708
01:15:59,292 --> 01:16:01,894
PERSONALITY DISORDERS UNDER 

1709
01:16:01,894 --> 01:16:03,496
DISTRESS OR DECOMPENSATING 

1710
01:16:03,496 --> 01:16:06,466
THOUGH THEY DON'T HAVE A MAJOR 

1711
01:16:06,466 --> 01:16:15,475
SEVERE PSYCHOTIC DISORDER.

1712
01:16:15,475 --> 01:16:20,980
THERE'S RISK FACTORS NOT 

1713
01:16:20,980 --> 01:16:31,457
DEFINING AND IT'S COMMON IN 

1714
01:16:34,360 --> 01:16:36,229
HOSPITAL AND PATIENTS DOING A 

1715
01:16:36,229 --> 01:16:38,831
SURVEY ROOM TO ROOM, RESEARCHERS

1716
01:16:38,831 --> 01:16:42,568
FIND ABOUT 30% TO 40% CAN'T QUIV

1717
01:16:42,568 --> 01:16:43,803
THEIR OWN CONSENT.

1718
01:16:43,803 --> 01:16:44,904
IT'S PROBABLY HIGHER BECAUSE A 

1719
01:16:44,904 --> 01:16:47,407
LOT OF THE STUDIES ARE BASED ON 

1720
01:16:47,407 --> 01:16:52,645
INTERVIEWS OF PEOPLE WHO ARE 

1721
01:16:52,645 --> 01:16:56,649
ABLE TO BE INTERVIEWED.

1722
01:16:56,649 --> 01:17:01,387
IF YOU COUNT PEOPLE WHO CAN'T DO

1723
01:17:01,387 --> 01:17:02,922
INTERVIEWS IS HIGHER AND IT 

1724
01:17:02,922 --> 01:17:04,190
DEPENDS ON THE KIND OF UNIT 

1725
01:17:04,190 --> 01:17:14,700
YOU'RE RUNNING WHETHER IT'S A 

1726
01:17:17,904 --> 01:17:22,542
DIFFERENT SEVERITY OF ILLNESS, 

1727
01:17:22,542 --> 01:17:24,744
DISTRESSING BUT DIFFERENT TIME 

1728
01:17:24,744 --> 01:17:27,346
VERSUS A STATE-RUN HOSPITAL 

1729
01:17:27,346 --> 01:17:31,217
WHERE YOU HOSPITALIZE PEOPLE WHO

1730
01:17:31,217 --> 01:17:33,352
HAVE NO OTHER RESOURCES PUTTING 

1731
01:17:33,352 --> 01:17:35,288
THEMSELVES OR OTHERS IN DANGER.

1732
01:17:35,288 --> 01:17:36,622
IT WILL VARY.

1733
01:17:36,622 --> 01:17:40,693
IF YOU JUST LOOK AT PEOPLE WITH 

1734
01:17:40,693 --> 01:17:42,795
CHRONIC PSYCHOSIS IT VARIES 

1735
01:17:42,795 --> 01:17:48,434
QUITE A BIT BUT ONLY ABOUT HALF 

1736
01:17:48,434 --> 01:17:51,637
AT MAXIMUM.

1737
01:17:51,637 --> 01:17:59,278
CHRONIC PSYCHOSIS DON'T CREATE 

1738
01:17:59,278 --> 01:18:04,383
SEVERE ZAMENT EXCEPT UNDER 

1739
01:18:04,383 --> 01:18:12,391
SUBSET MILD DEPRESSION DOESN'T 

1740
01:18:12,391 --> 01:18:13,626
REALLY AFFECT CAPACITY GIVEN THE

1741
01:18:13,626 --> 01:18:15,561
TYPES OF ASSESSMENTS WE NOW 

1742
01:18:15,561 --> 01:18:17,296
STANDARDLY DO.

1743
01:18:17,296 --> 01:18:22,602
WE GENERALLY -- THESE 

1744
01:18:22,602 --> 01:18:27,406
ASSESSMENTS AREN'T SO 

1745
01:18:27,406 --> 01:18:34,881
DEMANDING -- WE KIND OF BUILD IN

1746
01:18:34,881 --> 01:18:37,116
AND LIVE IN A SOCIETY THAT 

1747
01:18:37,116 --> 01:18:44,323
VALUES AUTONOMY AND IT'S WRONG 

1748
01:18:44,323 --> 01:18:48,261
IF IN A CERTAIN RAGE BUT IF 

1749
01:18:48,261 --> 01:18:48,995
YOU'RE VERY DEPRESSED CERTAIN 

1750
01:18:48,995 --> 01:18:50,630
PEOPLE WILL HAVE INCAPACITY.

1751
01:18:50,630 --> 01:18:54,500
LET ME TALK ABOUT TWO DISORDERS 

1752
01:18:54,500 --> 01:18:56,435
BECAUSE THEY HAVE -- THEY'RE 

1753
01:18:56,435 --> 01:18:58,437
VERY COMMON BOTH AND THERE'S 

1754
01:18:58,437 --> 01:18:59,972
BEEN A LOT OF RESEARCH SO THIS 

1755
01:18:59,972 --> 01:19:01,174
ISSUE COMES UP A LOT IN RESEARCH

1756
01:19:01,174 --> 01:19:07,113
ETHICS.

1757
01:19:07,113 --> 01:19:11,651
SO ALZHEIMER'S DISEASE AND SOME 

1758
01:19:11,651 --> 01:19:14,654
WITH MILD COGNITIVE IMPAIRMENT 

1759
01:19:14,654 --> 01:19:17,023
WHERE TECHNICALLY THEY MIGHT 

1760
01:19:17,023 --> 01:19:19,091
FALL ON THE BORDER WITHIN RANGE 

1761
01:19:19,091 --> 01:19:20,560
OF CERTAIN COGNITIVE TESTS ARE 

1762
01:19:20,560 --> 01:19:24,096
FOUND TO LACK CAPACITY TO GIVE 

1763
01:19:24,096 --> 01:19:28,968
CONSENT TO LIKE A DRUG OR CT.

1764
01:19:28,968 --> 01:19:32,972
IN OUR STUDY TWO-THIRDS TO 

1765
01:19:32,972 --> 01:19:34,574
THREE-QUARTERS OF PATIENTS WITH 

1766
01:19:34,574 --> 01:19:36,475
MANY MENTAL SKILLS.

1767
01:19:36,475 --> 01:19:39,679
IT'S A COGNITIVE TEST 0 TO 30.

1768
01:19:39,679 --> 01:19:44,684
30 IS PERFECT, 0 IS -- 22-23 IS 

1769
01:19:44,684 --> 01:19:45,618
ON THE BORDER.

1770
01:19:45,618 --> 01:19:48,821
YOU WOULD SAY A PERSON HAS 

1771
01:19:48,821 --> 01:19:52,959
MODERATE DEMENTIA BUT YOU GET 

1772
01:19:52,959 --> 01:19:53,726
MODERATE DEMENTIA AND MOST WILL 

1773
01:19:53,726 --> 01:19:55,428
LACK THE ABILITY TO CONSENT TO A

1774
01:19:55,428 --> 01:20:05,705
CLINICAL TRIAL.

1775
01:20:12,945 --> 01:20:19,151
WHERE I DID THE CLINICAL TRIAL 

1776
01:20:19,151 --> 01:20:21,887
CALLED CATTIE ON THE 

1777
01:20:21,887 --> 01:20:22,788
UNDERSTANDING SCORE ON THE TOOL 

1778
01:20:22,788 --> 01:20:25,891
USED THE VAST MAJORITY ARE ABOVE

1779
01:20:25,891 --> 01:20:32,965
THE CUT OFF AT LEAST THE EXPERTS

1780
01:20:32,965 --> 01:20:41,607
WHO CAME WITH THIS THOUGHT THE 

1781
01:20:41,607 --> 01:20:43,276
PERSON DIDN'T UNDERSTAND 

1782
01:20:43,276 --> 01:20:44,810
SUFFICIENT AMOUNT AND THIS IS A 

1783
01:20:44,810 --> 01:20:45,211
LITTLE BIT LESS.

1784
01:20:45,211 --> 01:20:47,413
THAT'S JUST TO GIVE YOU AN IDEA.

1785
01:20:47,413 --> 01:20:51,784
A CONTRAST.

1786
01:20:51,784 --> 01:20:55,154
IF STUDIES WITH PEOPLE LACKING 

1787
01:20:55,154 --> 01:20:57,490
ARE PERMISSIBLE, WHO GIVES 

1788
01:20:57,490 --> 01:20:57,757
CONSENT?

1789
01:20:57,757 --> 01:20:59,525
IF YOU CAN'T GIVE CONSENT HOI 

1790
01:20:59,525 --> 01:21:01,861
ARE THEY GOING TO PARTICIPATE?

1791
01:21:01,861 --> 01:21:12,405
SOMEBODY HAS TO GIVE PERMISSION.

1792
01:21:15,241 --> 01:21:17,410
AND A COMMON RULE SAID YOU WILL 

1793
01:21:17,410 --> 01:21:20,012
OFTEN HERE LAR, LEGALLY 

1794
01:21:20,012 --> 01:21:21,380
AUTHORIZED REPRESENTATIVE.

1795
01:21:21,380 --> 01:21:26,619
THIS IS A SPECIFIC REGULATORY 

1796
01:21:26,619 --> 01:21:30,056
TERM WHERE THEY'RE REFERRING TO 

1797
01:21:30,056 --> 01:21:31,357
PEOPLE TO BE AUTHORIZED WITHIN 

1798
01:21:31,357 --> 01:21:33,693
THE REGULATIONS TO GIVE CONSENT 

1799
01:21:33,693 --> 01:21:36,696
FOR SOMEBODY ELSE TO BE IN 

1800
01:21:36,696 --> 01:21:36,962
RESEARCH.

1801
01:21:36,962 --> 01:21:38,764
HOW DO THEY DEFINE IT?

1802
01:21:38,764 --> 01:21:44,970
THEY ARE DEFINE IT AS PEOPLE 

1803
01:21:44,970 --> 01:21:55,514
AUTHORIZED UNDER APPLICABLE LAW 

1804
01:21:57,616 --> 01:22:01,654
AND THERE'S STATE AND LOCAL LAWS

1805
01:22:01,654 --> 01:22:05,591
THAT PLAY BE RELEVANT ON THE 

1806
01:22:05,591 --> 01:22:07,059
PARTICIPANT INVOLVED IN 

1807
01:22:07,059 --> 01:22:07,326
RESEARCH.

1808
01:22:07,326 --> 01:22:11,330
YOU MIGHT ASK WHAT DOES 

1809
01:22:11,330 --> 01:22:18,471
APPLICABLE LAW LOOK LIKE?

1810
01:22:18,471 --> 01:22:21,374
BEFORE 2018, EVEN NOW FEW HAVE 

1811
01:22:21,374 --> 01:22:22,575
ADDRESSED THIS IN THEIR STATE 

1812
01:22:22,575 --> 01:22:22,975
LAWS.

1813
01:22:22,975 --> 01:22:25,077
IT'S NOT HIGH ON THE AGENDA OF 

1814
01:22:25,077 --> 01:22:25,745
LEGISLATORS BECAUSE IT'S A NICHE

1815
01:22:25,745 --> 01:22:31,617
TOPIC.

1816
01:22:31,617 --> 01:22:32,952
CALIFORNIA, NEW JERSEY, VIRGINIA

1817
01:22:32,952 --> 01:22:34,553
HAVE HAD ENACTMENT OF WHAT I 

1818
01:22:34,553 --> 01:22:39,692
CALL MODERN LAWS.

1819
01:22:39,692 --> 01:22:46,399
YOU CAN WHOEVER WROTE THIS 

1820
01:22:46,399 --> 01:22:49,969
UNDERSTOOD FEDERAL ETHICS AND 

1821
01:22:49,969 --> 01:22:50,569
WROTE THAT IN THEIR KNOWLEDGE 

1822
01:22:50,569 --> 01:22:55,107
BASE.

1823
01:22:55,107 --> 01:23:00,913
AND THEY WERE GENERALLY WRITTEN 

1824
01:23:00,913 --> 01:23:04,950
GENERALLY OR INDEPENDENT OF 

1825
01:23:04,950 --> 01:23:05,317
RESEARCH ETHICS.

1826
01:23:05,317 --> 01:23:10,423
THE REVISED COMMON RULE WHICH 

1827
01:23:10,423 --> 01:23:12,992
REALLY SORT OF FOR MOST 

1828
01:23:12,992 --> 01:23:14,026
SITUATIONS HELP RESOLVE THE 

1829
01:23:14,026 --> 01:23:15,561
UNCERTAIN TIP BECAUSE THE 

1830
01:23:15,561 --> 01:23:18,063
QUESTION WAS IF YOU DON'T LIVE 

1831
01:23:18,063 --> 01:23:24,403
IN NEW JERSEY, VIRGINIA OR OTHER

1832
01:23:24,403 --> 01:23:25,404
PLACES WHERE THE ATTORNEY 

1833
01:23:25,404 --> 01:23:26,572
GENERAL HAS ISSUED A STATEMENT 

1834
01:23:26,572 --> 01:23:37,116
OR THINGS LIKE THIS, WHO IS LAR?

1835
01:23:37,383 --> 01:23:39,919
THAT WAS A DEBATABLE QUESTION 

1836
01:23:39,919 --> 01:23:42,221
UNTIL THE REVISED COMMON RULE 

1837
01:23:42,221 --> 01:23:45,724
SAYS THIS, IF THERE'S NO 

1838
01:23:45,724 --> 01:23:49,161
APPLICABLE LAW THEN IT MEANS AN 

1839
01:23:49,161 --> 01:23:50,696
INDIVIDUAL RECOGNIZED BY 

1840
01:23:50,696 --> 01:23:51,664
INSTITUTIONAL POLICY.

1841
01:23:51,664 --> 01:24:00,940
IT ACTUALLY GIVES AUTHORITIES TO

1842
01:24:00,940 --> 01:24:01,974
ACADEMIC AND RESEARCH 

1843
01:24:01,974 --> 01:24:03,542
INSTITUTIONS AND OTHER SETTINGS 

1844
01:24:03,542 --> 01:24:04,243
IN WHICH A PERSON IS INVOLVED IN

1845
01:24:04,243 --> 01:24:14,420
RESEARCH.

1846
01:24:15,588 --> 01:24:20,960
PUTTING ASIDE THAT SPECIAL -- 

1847
01:24:20,960 --> 01:24:31,504
NOT PUTTING ASIDE AND I HAVE TO 

1848
01:24:33,038 --> 01:24:33,572
GO THROUGH POSSIBILITIES.

1849
01:24:33,572 --> 01:24:34,807
ONE IS LEGAL GUARDIANS.

1850
01:24:34,807 --> 01:24:36,976
THEY'RE PEOPLE APPOINTED BY 

1851
01:24:36,976 --> 01:24:47,119
JUDGES.

1852
01:24:47,386 --> 01:24:50,089
THERE'S REAL LEGAL CLARITY AND 

1853
01:24:50,089 --> 01:24:54,226
SOMETIMES IT'S PEOPLE WHO ARE 

1854
01:24:54,226 --> 01:24:54,860
STRANGERS TO THE PERSON WHO LOST

1855
01:24:54,860 --> 01:25:05,037
CAPACITY.

1856
01:25:05,471 --> 01:25:09,742
AND SECOND TYPE IS HEALTH CARE 

1857
01:25:09,742 --> 01:25:15,948
PROXIES OR POWER OF ATTORNEYS 

1858
01:25:15,948 --> 01:25:16,982
WHERE THE SUBJECT PICKS OUT WHO 

1859
01:25:16,982 --> 01:25:27,259
PLAYS THAT ROLE.

1860
01:25:27,593 --> 01:25:29,094
AND THE FACT OF FAMILY IS THE 

1861
01:25:29,094 --> 01:25:37,570
MOST COMMON.

1862
01:25:37,570 --> 01:25:39,738
AND RESEARCH PROXIES ARE A GREAT

1863
01:25:39,738 --> 01:25:39,939
IDEA.

1864
01:25:39,939 --> 01:25:43,676
EVERYBODY FILLED OUT IF I GET 

1865
01:25:43,676 --> 01:25:45,110
INCAPACITATED AND COULD BE 

1866
01:25:45,110 --> 01:25:46,779
ELIGIBLE FOR RESEARCH I WOULD 

1867
01:25:46,779 --> 01:25:48,681
LIKE THIS TO BE DONE.

1868
01:25:48,681 --> 01:25:51,717
VIRTUALLY NO ONE FILLS THAT OUT 

1869
01:25:51,717 --> 01:25:52,952
UNLESS THEY'RE ASKED TO AFTER 

1870
01:25:52,952 --> 01:26:02,528
DIAGNOSIS IN A SPECIAL SETTING.

1871
01:26:02,528 --> 01:26:05,898
IF YOU'RE DIAGNOSED WITH AN 

1872
01:26:05,898 --> 01:26:08,834
ILLNESS LIKE ALZHEIMER'S BUT 

1873
01:26:08,834 --> 01:26:09,935
STILL ABLE TO MAKE OTHER TYPES 

1874
01:26:09,935 --> 01:26:12,104
OF DECISIONS, ONE OF THOSE 

1875
01:26:12,104 --> 01:26:14,073
DECISIONS WOULD BE TO APPOINT 

1876
01:26:14,073 --> 01:26:14,340
SOMEBODY.

1877
01:26:14,340 --> 01:26:16,976
YOU KNOW, THAT PERSON MIGHT BE 

1878
01:26:16,976 --> 01:26:18,944
FULLY CAPABLE OF THINKING 

1879
01:26:18,944 --> 01:26:19,211
FOLLOWING.

1880
01:26:19,211 --> 01:26:29,488
I CAN SEE THAT.

1881
01:26:35,995 --> 01:26:41,333
AND YOU CAN CONSULT OR SOMETHING

1882
01:26:41,333 --> 01:26:42,768
LIKE THAT.

1883
01:26:42,768 --> 01:26:45,004
THIS IS A LIST FROM SACHRP 

1884
01:26:45,004 --> 01:26:50,576
PROPOSED WHICH I THINK IS A GOOD

1885
01:26:50,576 --> 01:26:51,076
ONE.

1886
01:26:51,076 --> 01:26:56,448
SO YOU GO WITH THE STATE LAW AND

1887
01:26:56,448 --> 01:26:57,016
EXTRAPOLATE TO THE RESEARCH 

1888
01:26:57,016 --> 01:27:07,159
CONTEXT.

1889
01:27:07,459 --> 01:27:09,695
YOU'RE HOPING THE HEALTH CARE 

1890
01:27:09,695 --> 01:27:14,667
ZIG  -- DECISIONS EXTENDS TO 

1891
01:27:14,667 --> 01:27:15,134
RESEARCH.

1892
01:27:15,134 --> 01:27:16,402
NOT UNREASONABLE GIVEN THAT 

1893
01:27:16,402 --> 01:27:17,503
PERSON IS SUPPOSED TO REPRESENT 

1894
01:27:17,503 --> 01:27:20,005
YOUR VALUES OR VIEWS OR 

1895
01:27:20,005 --> 01:27:20,539
INTEREST.

1896
01:27:20,539 --> 01:27:22,608
THE LEGAL GUARDIAN NOTICE IS 

1897
01:27:22,608 --> 01:27:24,977
THIRD NOT IN THE TOP.

1898
01:27:24,977 --> 01:27:27,946
AND THEN THE REST IS HIERARCHY 

1899
01:27:27,946 --> 01:27:30,516
FOR DE FACTO FAMILY MEMBERS 

1900
01:27:30,516 --> 01:27:32,985
THOUGH EIGHT -- IF YOU DON'T 

1901
01:27:32,985 --> 01:27:36,321
HAVE FAMILY MEMBERS IT'S SIMILAR

1902
01:27:36,321 --> 01:27:37,823
TO WHAT WE HAVE IN THE CLINICAL 

1903
01:27:37,823 --> 01:27:39,925
CENTER AT THE NIH.

1904
01:27:39,925 --> 01:27:42,294
I SUSPECT THIS IS VIRTUALLY 

1905
01:27:42,294 --> 01:27:45,497
IDENTICAL CROSS STATES.

1906
01:27:45,497 --> 01:27:47,332
VIRTUALLY EVERY STATE HAS A DE 

1907
01:27:47,332 --> 01:27:48,701
FACTO FAMILY SURROGATE LAW FOR 

1908
01:27:48,701 --> 01:27:59,044
CLINICAL SITUATIONS.

1909
01:28:00,813 --> 01:28:04,516
MOST RECAPITULATE THE ORDER.

1910
01:28:04,516 --> 01:28:06,785
YOU SHOULD READ IT.

1911
01:28:06,785 --> 01:28:10,322
IT'S A HORRIFYING EXPOSÉ OF HOW 

1912
01:28:10,322 --> 01:28:12,558
GUARDIAN LOSS COULD BE 

1913
01:28:12,558 --> 01:28:12,958
EXPLOITED.

1914
01:28:12,958 --> 01:28:17,963
I'LL MENTION THIS BECAUSE IT'S 

1915
01:28:17,963 --> 01:28:24,436
IMPORTANT TO REALIZE GUARDIAN 

1916
01:28:24,436 --> 01:28:26,405
LAWS ARE SUPPOSED TO PROTECT 

1917
01:28:26,405 --> 01:28:27,740
PEOPLE BUT IF YOU READ THIS 

1918
01:28:27,740 --> 01:28:29,475
YOU'LL VALUE THE IMPORTANCE OF 

1919
01:28:29,475 --> 01:28:30,175
UNDERSTANDING HOW IT WILL PLAY 

1920
01:28:30,175 --> 01:28:31,677
OUT AND HOW TO MONITOR AND KEEP 

1921
01:28:31,677 --> 01:28:36,181
PEOPLE SAFE.

1922
01:28:36,181 --> 01:28:46,725
IT'S WRITTEN BY RACHEL AVIVE AND

1923
01:28:47,426 --> 01:28:50,763
HER WORK HAS AFFECTED HEALTH 

1924
01:28:50,763 --> 01:28:54,433
CARE POLICIES IN MANY WAYS.

1925
01:28:54,433 --> 01:28:58,470
SO WHAT PROPORTION OF ADULTS 

1926
01:28:58,470 --> 01:29:00,939
PREPARE AN ADVANCED DIRECTIVE?

1927
01:29:00,939 --> 01:29:03,408
THIS IS A SYSTEMATIC REVIEW AND 

1928
01:29:03,408 --> 01:29:05,043
THE BOTTOM LINE IS ABOUT A 

1929
01:29:05,043 --> 01:29:05,778
THIRD.

1930
01:29:05,778 --> 01:29:07,646
IT DOESN'T MATTER HOW CHRONIC 

1931
01:29:07,646 --> 01:29:08,747
YOUR ILLNESS IS OR WHETHER 

1932
01:29:08,747 --> 01:29:09,581
YOU'RE HEALTHY.

1933
01:29:09,581 --> 01:29:15,487
IT'S NOT SOMETHING PEOPLE DO.

1934
01:29:15,487 --> 01:29:17,956
YOU'LL HAVE TO FALL BACK TOWARD 

1935
01:29:17,956 --> 01:29:19,725
MOST SITUATIONS THE FACT OF 

1936
01:29:19,725 --> 01:29:20,959
SURROGATE FAMILY DECISION 

1937
01:29:20,959 --> 01:29:21,193
MAKING.

1938
01:29:21,193 --> 01:29:23,729
I'M GOING TO SPEED UP A LITTLE 

1939
01:29:23,729 --> 01:29:29,635
BIT.

1940
01:29:29,635 --> 01:29:31,570
DE FACTO SURROGATES WILL HAVE TO

1941
01:29:31,570 --> 01:29:32,237
BE LARs.

1942
01:29:32,237 --> 01:29:34,239
IT USUALLY MEANS FAMILY MEMBERS 

1943
01:29:34,239 --> 01:29:35,340
BUT IT'S ACCEPTABLE.

1944
01:29:35,340 --> 01:29:37,409
WE DID RESEARCH ON THE QUESTION 

1945
01:29:37,409 --> 01:29:43,282
COMBINING IT WITH THE RISK 

1946
01:29:43,282 --> 01:29:44,883
BENEFIT LIMITS.

1947
01:29:44,883 --> 01:29:47,853
MOST COMMON APPROACH IS BY THIS.

1948
01:29:47,853 --> 01:29:56,728
PROSPECT FOR DIRECT BENEFIT?

1949
01:29:56,728 --> 01:29:58,163
HOW MUCH RISK?

1950
01:29:58,163 --> 01:30:00,766
MINIMAL AND THIS SHOULD BE 

1951
01:30:00,766 --> 01:30:02,901
FAMILIAR IF YOU HAVE OR WILL 

1952
01:30:02,901 --> 01:30:05,170
HAVE SOME OVERVIEW OF THE 

1953
01:30:05,170 --> 01:30:06,138
PEDIATRIC RESEARCH REGULATIONS.

1954
01:30:06,138 --> 01:30:09,341
THIS DOESN'T APPLY TO ADULTS 

1955
01:30:09,341 --> 01:30:09,808
ACTUALLY.

1956
01:30:09,808 --> 01:30:11,977
BUT PEOPLE HAVE IMPORTED THIS 

1957
01:30:11,977 --> 01:30:14,346
FROM THE PEDIATRIC AND TO HOW TO

1958
01:30:14,346 --> 01:30:16,215
THINK ABOUT THIS INCAPACITATED 

1959
01:30:16,215 --> 01:30:16,949
PERSON'S PARTICIPATION IN 

1960
01:30:16,949 --> 01:30:19,618
RESEARCH.

1961
01:30:19,618 --> 01:30:22,955
NOW, SO HOW DOES THE PUBLIC VIEW

1962
01:30:22,955 --> 01:30:24,156
RESEARCH AND WHAT LEVEL OF RISK 

1963
01:30:24,156 --> 01:30:25,357
IS ACCEPTABLE?

1964
01:30:25,357 --> 01:30:27,159
WE DO THE SURVEY.

1965
01:30:27,159 --> 01:30:29,361
THIS IS A NATIONALLY 

1966
01:30:29,361 --> 01:30:30,762
REPRESENTATIVE SAMPLE OF 

1967
01:30:30,762 --> 01:30:33,065
U.S. PUBLIC 50 AND OLDER AND WE 

1968
01:30:33,065 --> 01:30:36,134
FOUND THAT IF YOU ASK THE 

1969
01:30:36,134 --> 01:30:37,236
QUESTION, IF PATIENTS CAN'T MAKE

1970
01:30:37,236 --> 01:30:38,136
THEIR OWN DECISIONS ABOUT BEING 

1971
01:30:38,136 --> 01:30:40,572
IN A STUDY AND SEE THE SCENARIOS

1972
01:30:40,572 --> 01:30:42,674
AND THE FOUR COLUMNS, SHOULD 

1973
01:30:42,674 --> 01:30:44,276
SOCIETY ALLOW FAMILIES TO MAKE 

1974
01:30:44,276 --> 01:30:48,113
THE DECISION IN THEIR PLACE, YES

1975
01:30:48,113 --> 01:30:49,114
OR NO?

1976
01:30:49,114 --> 01:30:51,617
I'M ONLY GIVING THE YES.

1977
01:30:51,617 --> 01:30:53,352
DEFINITELY PROBABLY YES.

1978
01:30:53,352 --> 01:30:54,519
IT'S INTERESTING THE MAJORITY 

1979
01:30:54,519 --> 01:30:59,291
SAY YES.

1980
01:30:59,291 --> 01:31:02,227
LUMBAR PUNCTURE, A PHYSIOLOGICAL

1981
01:31:02,227 --> 01:31:02,494
STUDY.

1982
01:31:02,494 --> 01:31:05,397
DRUG RCT.

1983
01:31:05,397 --> 01:31:06,198
WE USED SOMETHING FOR 

1984
01:31:06,198 --> 01:31:07,799
ALZHEIMER'S SIMILAR TO SOMETHING

1985
01:31:07,799 --> 01:31:12,604
AS RISKY AS TAKING MOTRIN, 

1986
01:31:12,604 --> 01:31:14,539
NSAID, ASPIRIN.

1987
01:31:14,539 --> 01:31:17,876
VACCINE RCT, THERE WAS AN 

1988
01:31:17,876 --> 01:31:22,581
ATTEMPT TO DEVELOP ANTIBODIES TO

1989
01:31:22,581 --> 01:31:28,220
TO YOUR OWN PATH LOGIC MATERIALS

1990
01:31:28,220 --> 01:31:37,930
IN THE BRAIN.

1991
01:31:37,930 --> 01:31:39,564
AND THEN GENE THERAPY.

1992
01:31:39,564 --> 01:31:42,601
THIS WAS A NATIONAL SAMPLE YOUR 

1993
01:31:42,601 --> 01:31:47,940
TYPICAL CROSS-SECTIONAL NOT VERY

1994
01:31:47,940 --> 01:31:49,508
WE'RE NOT ASKING THEM TO THINK 

1995
01:31:49,508 --> 01:31:55,247
ABOUT IT OR DON'T DO ANY OF 

1996
01:31:55,247 --> 01:31:55,447
THAT.

1997
01:31:55,447 --> 01:32:00,552
HOWEVER WE HAVE DONE A STUDY A 

1998
01:32:00,552 --> 01:32:02,988
WEDDING BANQUET RESEARCH AND WE 

1999
01:32:02,988 --> 01:32:05,891
HAVE IT IN WEDDING BANQUET ROOMS

2000
01:32:05,891 --> 01:32:09,895
WITH SIX TO EIGHT, NINE, PEOPLE 

2001
01:32:09,895 --> 01:32:12,631
A ROOM FULL OF 60 PEOPLE, MAYBE 

2002
01:32:12,631 --> 01:32:15,033
EIGHT, NINE TABLE AND SPEND THE 

2003
01:32:15,033 --> 01:32:16,969
DAY WITH EXPERTS TALKING ON 

2004
01:32:16,969 --> 01:32:27,179
EITHER SIDE.

2005
01:32:31,216 --> 01:32:35,754
THIS IS UNDER THE DEMOCRATIC 

2006
01:32:35,754 --> 01:32:37,522
DELIBERATE RESEARCH AND I DID A 

2007
01:32:37,522 --> 01:32:38,757
LOT OF THIS IN MICHIGAN.

2008
01:32:38,757 --> 01:32:39,524
IT'S INTERESTING.

2009
01:32:39,524 --> 01:32:41,360
WHEN HAVE YOU PEOPLE DEBATE 

2010
01:32:41,360 --> 01:32:46,365
THIS, HEAR PEOPLE TALK BIT AT 

2011
01:32:46,365 --> 01:32:54,106
THE TABLE PEOPLE DON'T KNOW 

2012
01:32:54,106 --> 01:32:56,041
THERE'S REGULATORY COMPONENTS 

2013
01:32:56,041 --> 01:32:59,845
AND YOU HEAR THINGS THE HISTORY 

2014
01:32:59,845 --> 01:33:03,181
OF THE REGULATIONS AND THE NEED 

2015
01:33:03,181 --> 01:33:04,549
FOR THE RESEARCH.

2016
01:33:04,549 --> 01:33:07,919
YOU'LL SEE IN EVERY CASE PRE, 

2017
01:33:07,919 --> 01:33:09,821
POST THERE'S A SHIFT TO GREATER 

2018
01:33:09,821 --> 01:33:12,257
ACCEPTANCE OF FAMILY SURROGATE 

2019
01:33:12,257 --> 01:33:12,824
CONSENT FOR THOSE TYPES OF 

2020
01:33:12,824 --> 01:33:17,829
RESEARCH.

2021
01:33:17,829 --> 01:33:27,105
JUST NOTICE THE TREND.

2022
01:33:27,105 --> 01:33:28,907
AND COMMON DELIBERATIONS WERE 

2023
01:33:28,907 --> 01:33:29,274
FASCINATING.

2024
01:33:29,274 --> 01:33:30,742
.

2025
01:33:30,742 --> 01:33:33,612
THE RESEARCH ETHICS TOPICS WE 

2026
01:33:33,612 --> 01:33:36,381
THINK WE NEED EXPERTS TO GET 

2027
01:33:36,381 --> 01:33:39,184
THEIR INTUITION AND SO FORTH.

2028
01:33:39,184 --> 01:33:40,118
HONESTLY A LOT OF THESE 

2029
01:33:40,118 --> 01:33:45,490
QUESTIONS MOST PEOPLE CAN 

2030
01:33:45,490 --> 01:33:52,964
READILY UNDERSTAND AND PEOPLE 

2031
01:33:52,964 --> 01:33:56,034
ARE QUICK TO SEE THE DILEMMA AND

2032
01:33:56,034 --> 01:33:58,570
THAT'S IMPRESSIVE WHEN YOU 

2033
01:33:58,570 --> 01:34:00,772
ENGAGE THE PUBLIC IN THIS KIND 

2034
01:34:00,772 --> 01:34:01,940
OF RESEARCH.

2035
01:34:01,940 --> 01:34:03,108
FOR EXAMPLE, PARTICIPANT A SAYS 

2036
01:34:03,108 --> 01:34:06,845
IF THE ANSWER NO, YOU CAN'T LET 

2037
01:34:06,845 --> 01:34:09,247
FAMILIES DO THIS AND THAT 

2038
01:34:09,247 --> 01:34:11,316
SURROGATES CAN'T GET CONSENT 

2039
01:34:11,316 --> 01:34:13,418
THERE'S NO HOPE FOR GETTING 

2040
01:34:13,418 --> 01:34:14,519
ANYWHERE AND SEEN THE DATA AND 

2041
01:34:14,519 --> 01:34:14,986
LIKELY NEED.

2042
01:34:14,986 --> 01:34:16,822
THE ANSWER HAS BEEN NO IN MY 

2043
01:34:16,822 --> 01:34:18,857
MIND -- YES, MEANING THEY HAVE 

2044
01:34:18,857 --> 01:34:20,459
TO BE ALLOWED.

2045
01:34:20,459 --> 01:34:22,360
PARTICIPANT B SAYS BY VOTING NO 

2046
01:34:22,360 --> 01:34:24,496
AGAINST SURROGATE IMPARTMENT 

2047
01:34:24,496 --> 01:34:28,533
YOU'RE VOTING NO TO EVERY OTHER 

2048
01:34:28,533 --> 01:34:28,767
FAMILY.

2049
01:34:28,767 --> 01:34:31,603
YOU'RE PUTTING YOURSELF IN UP A 

2050
01:34:31,603 --> 01:34:33,605
POSITION OF EVERYBODY WITH ABLE 

2051
01:34:33,605 --> 01:34:34,406
ALZHEIMER'S PATIENT.

2052
01:34:34,406 --> 01:34:36,274
I FOUND THAT AN INTERESTING WAY 

2053
01:34:36,274 --> 01:34:38,310
TO ARTICULATE WHAT A POLICY 

2054
01:34:38,310 --> 01:34:38,577
DOES.

2055
01:34:38,577 --> 01:34:40,512
HE'S SAYING IT'S A POLICY AND 

2056
01:34:40,512 --> 01:34:50,889
POLICY WORKS THIS WAY.

2057
01:34:53,492 --> 01:34:55,927
AND WE HAVE NO HOPE BUT 

2058
01:34:55,927 --> 01:34:58,029
SURROGATE CONCEPT BUT HOW DO WE 

2059
01:34:58,029 --> 01:34:59,664
MAKE IT WORK AND BUILD PROTECTS 

2060
01:34:59,664 --> 01:35:01,032
FOR PEOPLE WITH ALZHEIMER'S AND 

2061
01:35:01,032 --> 01:35:02,801
THEIR FAMILIES?

2062
01:35:02,801 --> 01:35:06,404
ONE OF THE INTERESTING THINGS 

2063
01:35:06,404 --> 01:35:08,373
WAS WHEN WE ASKED PEOPLE SHOULD 

2064
01:35:08,373 --> 01:35:09,941
THERE BE LEEWAY, A PERSON SAYS 

2065
01:35:09,941 --> 01:35:12,744
TO YOU, YEAH, I WANT TO BE IN 

2066
01:35:12,744 --> 01:35:13,345
RESEARCH OR NOT.

2067
01:35:13,345 --> 01:35:18,183
AFTER YOU SAY THAT TO THEM IF 

2068
01:35:18,183 --> 01:35:20,452
YOU LATER BECAME INCAPACITATED 

2069
01:35:20,452 --> 01:35:22,587
HOW MUCH LEEWAY SHOULD YOUR 

2070
01:35:22,587 --> 01:35:25,157
FAMILY MEMBERS HAVE IN GOING TO 

2071
01:35:25,157 --> 01:35:26,892
WITH WHAT YOU SAID NOW OR VEEP 

2072
01:35:26,892 --> 01:35:29,594
GOING AGAINST IT BASED ON WHAT 

2073
01:35:29,594 --> 01:35:40,038
THEY KNOW THEN VERSUS NOW?

2074
01:35:40,906 --> 01:35:41,439
MOST PEOPLE UNDERSTAND THE 

2075
01:35:41,439 --> 01:35:43,441
COMPLEXITY AND LIMITATIONS OF 

2076
01:35:43,441 --> 01:35:45,944
CURRENT KNOWLEDGE WHEN YOU TRY 

2077
01:35:45,944 --> 01:35:48,947
TO PIN DOWN THE FUTURE OF I WANT

2078
01:35:48,947 --> 01:35:56,888
THIS, I DON'T WANT THAT.

2079
01:35:56,888 --> 01:35:59,090
WE OFTEN UNDERESTIMATE THE 

2080
01:35:59,090 --> 01:36:01,226
WISDOM OF THE PUBLIC IN THESE 

2081
01:36:01,226 --> 01:36:01,826
ISSUES.

2082
01:36:01,826 --> 01:36:11,369
I'LL RUN DOWN THE LIST OF OTHER 

2083
01:36:11,369 --> 01:36:16,841
POTENTIAL SITUATIONS.

2084
01:36:16,841 --> 01:36:19,644
PATIENT A IS FINANCIALLY STABLE 

2085
01:36:19,644 --> 01:36:21,246
AND FAMILY ARE SUPPORTIVE AND 

2086
01:36:21,246 --> 01:36:23,882
INVOLVED AND IS A PROFESSOR AND 

2087
01:36:23,882 --> 01:36:26,017
ENROLLS IN A MINOR INTERVENTION 

2088
01:36:26,017 --> 01:36:28,720
AND MINOR EFFECTS SEEN AND HAS A

2089
01:36:28,720 --> 01:36:29,888
GOAL OF SLOWING DOWN THE 

2090
01:36:29,888 --> 01:36:30,155
DISEASE.

2091
01:36:30,155 --> 01:36:32,958
HE WANTS TO BE IN THE STUDY.

2092
01:36:32,958 --> 01:36:40,699
HE HAS AN ALTRUISTIC MOTIVE AND 

2093
01:36:40,699 --> 01:36:42,367
DESIRED BENEFIT IS PERCEIVED TO 

2094
01:36:42,367 --> 01:36:44,536
BE WORTH THE GAMBLE.

2095
01:36:44,536 --> 01:36:46,171
THIS PERSON IS VULNERABLE BUT 

2096
01:36:46,171 --> 01:36:48,873
IT'S VERY DIFFERENT FROM THE 

2097
01:36:48,873 --> 01:36:50,475
FOLLOWING PERSON.

2098
01:36:50,475 --> 01:36:51,810
THIS PERSON DOES HAVE -- 

2099
01:36:51,810 --> 01:36:53,111
REMEMBER, THIS PERSON IS DEEMED 

2100
01:36:53,111 --> 01:36:56,848
NOT TO HAVE CONSENT BECAUSE HE'S

2101
01:36:56,848 --> 01:36:59,184
QUITE IMPAIRED.

2102
01:36:59,184 --> 01:37:00,418
THIS PERSON MEETS THE THRESHOLD 

2103
01:37:00,418 --> 01:37:03,421
FOR CAPACITY AND IN THEORY CAN 

2104
01:37:03,421 --> 01:37:06,358
CONSENT FOR HIM OR HERSELF BUT 

2105
01:37:06,358 --> 01:37:09,060
UNEMPLOYED AND ISOLATED IN A 

2106
01:37:09,060 --> 01:37:12,964
MINORITY GROUP, RCT OF A 

2107
01:37:12,964 --> 01:37:14,699
COMPOUND ALREADY MARKETED BEING 

2108
01:37:14,699 --> 01:37:21,106
STUDIED AND IT'S NOT A NEW 

2109
01:37:21,106 --> 01:37:31,283
PARADIGM.

2110
01:37:32,617 --> 01:37:34,819
I WOULD SAY THIS PERSON IS MORE 

2111
01:37:34,819 --> 01:37:35,553
VULNERABLE THOUGH THEY HAVE 

2112
01:37:35,553 --> 01:37:36,955
CAPACITY.

2113
01:37:36,955 --> 01:37:47,432
IT'S IMPORTANT TO REMEMBER.

2114
01:37:49,334 --> 01:37:50,869
HOW WE SPELL OUT THE CAPACITY 

2115
01:37:50,869 --> 01:37:52,404
AND IS THERE WAY TO WORK WITH 

2116
01:37:52,404 --> 01:38:02,781
THE PRESERVED ABILITY?

2117
01:38:04,349 --> 01:38:06,885
WE HAVE MONITORS AND ASSESSMENT 

2118
01:38:06,885 --> 01:38:08,653
OF APPROPRIATE SURROGATES.

2119
01:38:08,653 --> 01:38:10,155
SOMETIMES SURROGATES MAY ALSO BE

2120
01:38:10,155 --> 01:38:20,365
95 YEARS OLD.

2121
01:38:20,365 --> 01:38:23,368
THERE MAY BE A NEED TO ASSESS 

2122
01:38:23,368 --> 01:38:29,674
INCREASED RISK.

2123
01:38:29,674 --> 01:38:31,343
IT SHOULD BE TAILORED TO 

2124
01:38:31,343 --> 01:38:31,576
CONTEXT.

2125
01:38:31,576 --> 01:38:40,719
I'M THREE MINUTES EARLY.

2126
01:38:40,719 --> 01:38:41,386
THANK YOU, SCOTT.

2127
01:38:41,386 --> 01:38:42,954
I HAVE A QUESTION FROM VIDEO 

2128
01:38:42,954 --> 01:38:44,956
LAND AND THOSE IN THE ROOM HEAD 

2129
01:38:44,956 --> 01:38:48,026
TO THE MICROPHONES IF YOU HAVE A

2130
01:38:48,026 --> 01:38:48,593
QUESTION.

2131
01:38:48,593 --> 01:38:52,964
THIS ONE REFLECTS SOME COMMENTS 

2132
01:38:52,964 --> 01:38:57,535
YOU MADE EARLIER.

2133
01:38:57,535 --> 01:38:59,104
ESTER SAID CAN YOU SAY MORE ON 

2134
01:38:59,104 --> 01:39:02,140
THE DISTINCTION BETWEEN 

2135
01:39:02,140 --> 01:39:04,843
COMPETENCE AND CAPACITY?

2136
01:39:04,843 --> 01:39:06,544
I'VE FINANCE TAUGHT THAT 

2137
01:39:06,544 --> 01:39:09,681
COMPETENCE IS A LEGAL 

2138
01:39:09,681 --> 01:39:11,349
DETERMINATION OF BROAD 

2139
01:39:11,349 --> 01:39:12,484
INCAPACITY WHERE CAPACITY IS A 

2140
01:39:12,484 --> 01:39:12,984
CLINICAL DETERMINATION.

2141
01:39:12,984 --> 01:39:23,128
>> YES.

2142
01:39:26,097 --> 01:39:27,632
I'VE GIVEN TALKS AND PEOPLE HAVE

2143
01:39:27,632 --> 01:39:29,501
COME UP AND TOLD ME I'M WRONG 

2144
01:39:29,501 --> 01:39:32,103
AND I HAVE A SLIDE DOCUMENTS 

2145
01:39:32,103 --> 01:39:34,973
WHERE I SAY THE FOLLOWING.

2146
01:39:34,973 --> 01:39:38,743
AND DECISIONAL CAPACITY, MENTAL 

2147
01:39:38,743 --> 01:39:43,448
CAPACITY, COMPETENCE, ALL THOSE 

2148
01:39:43,448 --> 01:39:52,957
TERMS REFER TO AUTHORITY TO SEEK

2149
01:39:52,957 --> 01:39:53,425
FUNCTIONAL ABILITIES.

2150
01:39:53,425 --> 01:39:55,760
THEY ARE MEAN THE SAME THING.

2151
01:39:55,760 --> 01:39:56,694
THE DISTINCTION BETWEEN LEGAL 

2152
01:39:56,694 --> 01:39:58,496
AND CLINICAL BEFORE ADJUDICATED 

2153
01:39:58,496 --> 01:40:03,935
OR DEEMED TO HAVE CAPACITY OR 

2154
01:40:03,935 --> 01:40:10,975
NOT BASED ON LAWS DECISIONS ARE 

2155
01:40:10,975 --> 01:40:14,712
ALLOWED TO MAKE AND THAT SHOULD 

2156
01:40:14,712 --> 01:40:15,780
BE DETERMINED IF IT'S DETERMINED

2157
01:40:15,780 --> 01:40:16,915
BY COURT.

2158
01:40:16,915 --> 01:40:22,954
ADJUDICATED OR A CLINICAL 

2159
01:40:22,954 --> 01:40:28,026
DETERMINATION.

2160
01:40:28,026 --> 01:40:31,529
TO SAY IT'S A LEGAL TERM IS 

2161
01:40:31,529 --> 01:40:32,964
CONTRADICTORY TO LAWS THAT USE 

2162
01:40:32,964 --> 01:40:33,898
CAPACITY, MENTAL CAPACITY, 

2163
01:40:33,898 --> 01:40:35,099
DECISION MAKING CAPACITIES IN 

2164
01:40:35,099 --> 01:40:35,567
THE LAWS THEMSELVES.

2165
01:40:35,567 --> 01:40:45,743
>> GREAT.

2166
01:40:46,110 --> 01:40:47,712
>> YOU HAD A SLIDE OF
TERMS 

2167
01:40:47,712 --> 01:40:50,048
RELEVANT TO CAPACITY AND ONE IS 

2168
01:40:50,048 --> 01:40:51,316
COMMUNICATING A STABLE 

2169
01:40:51,316 --> 01:40:54,085
PREFERENCE OR DECISION OR 

2170
01:40:54,085 --> 01:40:54,319
CHOICE.

2171
01:40:54,319 --> 01:41:04,496
[NO AUDIO]

2172
01:41:17,008 --> 01:41:19,878
>> AND YOU SAY CAN YOU DO
THE 

2173
01:41:19,878 --> 01:41:20,678
PROCEDURE AND YOU TAKE HIM TO 

2174
01:41:20,678 --> 01:41:25,917
THE O.R. THE NEXT MORNING AND HE

2175
01:41:25,917 --> 01:41:28,953
SAID I DON'T WANT TO DO THAT AND

2176
01:41:28,953 --> 01:41:29,921
THE ATTENDING SHOWS UP AND HE 

2177
01:41:29,921 --> 01:41:32,457
SAYS I WANT THE PROCEDURE AND 

2178
01:41:32,457 --> 01:41:34,192
THE NEXT MORNING YOU TRY TO DO 

2179
01:41:34,192 --> 01:41:36,361
IT AGAIN AND HE SAYS NO.

2180
01:41:36,361 --> 01:41:37,762
THIS IS AN EXAMPLE THAT NEEDS 

2181
01:41:37,762 --> 01:41:38,429
MORE CONTEXT TO UNDERSTAND 

2182
01:41:38,429 --> 01:41:42,634
BECAUSE OF HIS BACKGROUND OF HIS

2183
01:41:42,634 --> 01:41:45,770
ILLNESS PUT SO THE DEFINITION IS

2184
01:41:45,770 --> 01:41:48,940
STABLE ENOUGH SO YOU CAN CARRY 

2185
01:41:48,940 --> 01:41:50,041
OUT THE PROCEDURE THAT HE 

2186
01:41:50,041 --> 01:41:51,342
EXPRESSED PREFERENCES FOR.

2187
01:41:51,342 --> 01:41:54,279
IF YOU CAN'T DO THAT, YOU CAN'T 

2188
01:41:54,279 --> 01:41:56,781
REALLY SAY YOU'VE MET THE 

2189
01:41:56,781 --> 01:41:57,048
CRITERION.

2190
01:41:57,048 --> 01:42:01,252
>> SO THE STABILITY HAS TO
DO 

2191
01:42:01,252 --> 01:42:03,054
WITH THE SPECIFIC PROCEDURE?

2192
01:42:03,054 --> 01:42:04,956
>> YEAH.

2193
01:42:04,956 --> 01:42:07,825
AND IT DOES VARY.

2194
01:42:07,825 --> 01:42:08,726
DEPENDING THE EXAMPLE.

2195
01:42:08,726 --> 01:42:15,099
A RECENT CASE IN GERMANY A DOCK 

2196
01:42:15,099 --> 01:42:15,433
TO

2197
01:42:15,433 --> 01:42:17,669
 -- THE DOCTOR WAS CONVICTED 

2198
01:42:17,669 --> 01:42:19,671
BECAUSE HE ASSISTED SUICIDE AND 

2199
01:42:19,671 --> 01:42:21,239
THE COURT WANTED EVIDENCE THE 

2200
01:42:21,239 --> 01:42:22,173
PERSON HAD A STABLE PREFERENCE 

2201
01:42:22,173 --> 01:42:25,843
FOR AN EXTENDED PERIOD AND THEY 

2202
01:42:25,843 --> 01:42:28,012
DISAGREED WITH THE DOCTOR'S 

2203
01:42:28,012 --> 01:42:28,913
ATTESTATION WAS THE CASE.

2204
01:42:28,913 --> 01:42:30,915
SO IT VARIES.

2205
01:42:30,915 --> 01:42:32,951
>> I THINK MY QUESTION IS 

2206
01:42:32,951 --> 01:42:35,386
RELATED TO A NUMBER OF THINGS IN

2207
01:42:35,386 --> 01:42:40,191
YOUR TALK.

2208
01:42:40,191 --> 01:42:48,967
AT SOME POINT AREN'T OF 

2209
01:42:48,967 --> 01:42:52,804
CAPACITORS AND PSYCHO METRICS OF

2210
01:42:52,804 --> 01:42:53,171
CAPACITY.

2211
01:42:53,171 --> 01:42:53,972
>> TO A SUFFICIENT DEGREE
TO 

2212
01:42:53,972 --> 01:42:54,305
HAVE CAPACITY.

2213
01:42:54,305 --> 01:43:04,482
>> RIGHT.

2214
01:43:10,722 --> 01:43:12,624
SOMEONE FOR INSTANCE WHO HAS 

2215
01:43:12,624 --> 01:43:14,392
REALLY HAS WHACKY BELIEFS ABOUT 

2216
01:43:14,392 --> 01:43:16,160
A CERTAIN STANDARD PROCEDURE 

2217
01:43:16,160 --> 01:43:19,530
THIS PREVENTS THAT PERSON FROM 

2218
01:43:19,530 --> 01:43:20,965
UNDERSTANDING WHAT THE ACTUAL 

2219
01:43:20,965 --> 01:43:22,900
TREATMENT WILL ENTAIL OR FROM 

2220
01:43:22,900 --> 01:43:23,534
RAISING WITH WHAT IMPLICATIONS 

2221
01:43:23,534 --> 01:43:26,037
ARE.

2222
01:43:26,037 --> 01:43:27,939
HOW DO WE NAVIGATE IN THOSE 

2223
01:43:27,939 --> 01:43:28,973
TYPES OF CASES.

2224
01:43:28,973 --> 01:43:31,275
>> IT'S A QUESTION OF
SOMETHING 

2225
01:43:31,275 --> 01:43:33,811
LIKE HOW DO YOU KNOW THIS ISN'T 

2226
01:43:33,811 --> 01:43:37,882
A PERSON WHO IS A JEHOVAH'S 

2227
01:43:37,882 --> 01:43:39,951
WITNESSES HAS AN ESTABLISHED 

2228
01:43:39,951 --> 01:43:41,319
UNDERSTANDING OF DIVERSE VIEWS 

2229
01:43:41,319 --> 01:43:44,055
VERSUS SOMEBODY UNDER A 

2230
01:43:44,055 --> 01:43:55,066
RELIGIOUS DILUT ILLUSION AND THE

2231
01:44:03,408 --> 01:44:04,942
DEFINITIONS AND PROCEDURES AND 

2232
01:44:04,942 --> 01:44:07,211
JUDGMENTS THAT YOU HAVE TO MAKE 

2233
01:44:07,211 --> 01:44:08,079
TO DISTINGUISH BETWEEN THE TWO.

2234
01:44:08,079 --> 01:44:15,153
YES.

2235
01:44:15,153 --> 01:44:18,389
I HAVE A QUESTION ABOUT CONCEPT 

2236
01:44:18,389 --> 01:44:24,962
FORTUNE CAL PROCEDURES AND 

2237
01:44:24,962 --> 01:44:34,605
THINGS LIKE THEY'RE BLEEDING OUT

2238
01:44:34,605 --> 01:44:38,576
AND EMTs TAKE THEM TO THE 

2239
01:44:38,576 --> 01:44:41,379
EMERGENCY ROOM AND THEY ARE 

2240
01:44:41,379 --> 01:44:43,181
DON'T WANT ANYTHING THAT WOULD 

2241
01:44:43,181 --> 01:44:46,718
PREVENT ME FROM BLEEDING OUT BUT

2242
01:44:46,718 --> 01:44:48,953
IF YOU DON'T DO THAT THEY'LL DIE

2243
01:44:48,953 --> 01:44:51,289
IN THAT SITUATION WOULD YOU BE 

2244
01:44:51,289 --> 01:44:52,090
ABLE TO OVERRIDE THEIR CLEAR 

2245
01:44:52,090 --> 01:44:53,558
LACK OF CONSENT?

2246
01:44:53,558 --> 01:44:55,326
>> THAT'S A GREAT
QUESTION.

2247
01:44:55,326 --> 01:44:57,729
>> THIS WILL TAKE LONGER
TO 

2248
01:44:57,729 --> 01:44:59,363
ANSWER IT FULLY BECAUSE THERE'S 

2249
01:44:59,363 --> 01:45:04,702
A VARIETY OF SITUATIONS LIKE 

2250
01:45:04,702 --> 01:45:04,969
THIS.

2251
01:45:04,969 --> 01:45:07,238
AND ONE SOMETIMES THE LACK OF 

2252
01:45:07,238 --> 01:45:08,372
CONSENT SEEMS OBVIOUS BUT MAY 

2253
01:45:08,372 --> 01:45:10,174
NOT BE.

2254
01:45:10,174 --> 01:45:11,943
THERE COULD BE UNDERLYING -- FOR

2255
01:45:11,943 --> 01:45:14,178
EXAMPLE, I HAD AN EXPERIENCE 

2256
01:45:14,178 --> 01:45:15,146
WITH THE PERSON SEEMED LIKE THEY

2257
01:45:15,146 --> 01:45:21,886
WERE MAKING A CLEAR PREFERENCE 

2258
01:45:21,886 --> 01:45:24,956
AND THREE DAYS LATER SHE SAID 

2259
01:45:24,956 --> 01:45:30,428
ARE YOU KIDDING, I WAS ON 

2260
01:45:30,428 --> 01:45:31,863
ANOTHER PLANET AND OTHER TIMES 

2261
01:45:31,863 --> 01:45:33,765
THEY PLAY HAVE A PARTICULAR VIEW

2262
01:45:33,765 --> 01:45:36,667
IN WHICH THAT MAKES SENSE AND 

2263
01:45:36,667 --> 01:45:39,570
YOU MAY NOT BE ABLE TO OVERRIDE.

2264
01:45:39,570 --> 01:45:41,372
IT'S FACT SENSITIVE.

2265
01:45:41,372 --> 01:45:42,240
>> OKAY.

2266
01:45:42,240 --> 01:45:43,775
>> AND IT WOULD BE
DIFFERENT IN 

2267
01:45:43,775 --> 01:45:46,310
A CLINICAL SETTING VERSUS A 

2268
01:45:46,310 --> 01:45:47,612
RESEARCH SETTING.

2269
01:45:47,612 --> 01:45:48,412
>> RIGHT.

2270
01:45:48,412 --> 01:45:52,450
THOUGH AS HOLLY KNOWS VERY WELL 

2271
01:45:52,450 --> 01:45:53,885
THERE ARE RESEARCH THAT'S DONE 

2272
01:45:53,885 --> 01:45:58,656
IN EMERGENCY SETTINGS AND THIS 

2273
01:45:58,656 --> 01:46:00,491
ISSUE -- THERE'S A COMPLICATED 

2274
01:46:00,491 --> 01:46:04,862
SET OF ISSUES THAT COME UP.

2275
01:46:04,862 --> 01:46:10,468
BECAUSE EMERGENCY MEANS A BROAD 

2276
01:46:10,468 --> 01:46:11,836
SET OF THINGS A PERSON BLEEDING 

2277
01:46:11,836 --> 01:46:14,205
OUT IS A SUPER EMERGENCY BUT A 

2278
01:46:14,205 --> 01:46:16,541
PERSON COMING IN WITH A HEART 

2279
01:46:16,541 --> 01:46:18,309
ATTACK.

2280
01:46:18,309 --> 01:46:21,612
IT'S ACUTE BUT NOT TWO MINUTES.

2281
01:46:21,612 --> 01:46:24,115
UNLESS THEY GET AN ARRHYTHMIA 

2282
01:46:24,115 --> 01:46:26,217
IT'S MORE OF AN EVOLVING THING 

2283
01:46:26,217 --> 01:46:29,987
IN WHICH YOU CAN GET CONCEPT.

2284
01:46:29,987 --> 01:46:31,022
THE QUESTION IS HOW DO YOU 

2285
01:46:31,022 --> 01:46:31,255
ASSESS.

2286
01:46:31,255 --> 01:46:39,931
>> DANIEL.

2287
01:46:39,931 --> 01:46:42,233
>> MY QUESTION IS
HIERARCHY FOR 

2288
01:46:42,233 --> 01:46:46,170
DECISION MAKERS AND THE ANSWER 

2289
01:46:46,170 --> 01:46:47,405
MAY BE IT VARIES STATE TO STATE 

2290
01:46:47,405 --> 01:46:52,243
BUT WONDER IF THERE'S A PATTERN 

2291
01:46:52,243 --> 01:46:53,578
OR IF WE HAVE REASON TO SKIP 

2292
01:46:53,578 --> 01:46:56,380
OVER SOMEONE ON THE HIERARCHY 

2293
01:46:56,380 --> 01:47:00,751
THAT WOULD BE A PERFECTLY 

2294
01:47:00,751 --> 01:47:02,253
CAPABLE DECISION MAKER.

2295
01:47:02,253 --> 01:47:05,489
NOT EXTREMELY OLD OR KNOWS THE 

2296
01:47:05,489 --> 01:47:06,958
PATIENT'S WISHES BUT MAY HAVE 

2297
01:47:06,958 --> 01:47:08,259
OTHER REASONS TO SKIM OVER THEM 

2298
01:47:08,259 --> 01:47:12,897
LIKE THEY MAY NOT HAVE THE 

2299
01:47:12,897 --> 01:47:13,865
PATIENT'S BEST INTEREST.

2300
01:47:13,865 --> 01:47:15,566
IS THAT A REASON TO SKIP OVER 

2301
01:47:15,566 --> 01:47:18,970
THEM LIKE IF A SPOUSE OR MRAB 

2302
01:47:18,970 --> 01:47:19,937
THEY'RE MARRIAGE SON THE ROCKS 

2303
01:47:19,937 --> 01:47:23,674
OR HEADING TOWARDS A MESSY 

2304
01:47:23,674 --> 01:47:25,743
DIVORCE YOU MAY SKIP OVER THEM 

2305
01:47:25,743 --> 01:47:28,079
AND TAKE AN ADULT CHILD WHO 

2306
01:47:28,079 --> 01:47:30,314
SIMILARLY KNOWS THE WISHES OF 

2307
01:47:30,314 --> 01:47:30,715
THE PATIENT.

2308
01:47:30,715 --> 01:47:32,583
>> THAT'S A GOOD QUESTION.

2309
01:47:32,583 --> 01:47:33,818
IT VARE YES ON CONTEXT AND WHAT 

2310
01:47:33,818 --> 01:47:36,954
KERPZ YOU HAVE.

2311
01:47:36,954 --> 01:47:37,488
-- WHAT CONCERNS YOU HAVE.

2312
01:47:37,488 --> 01:47:47,164
 AND YOUR OVER ALL POINT HOW DO 

2313
01:47:47,164 --> 01:47:48,699
APPLY THE HIERARCHY IS WHAT YOUR

2314
01:47:48,699 --> 01:47:49,934
QUESTION IS.

2315
01:47:49,934 --> 01:47:51,235
AND YOU DON'T JUST BLINDLY 

2316
01:47:51,235 --> 01:47:55,206
FOLLOW IT.

2317
01:47:55,206 --> 01:47:58,576
IF YOU HAVE REASON TO SUSPECT 

2318
01:47:58,576 --> 01:48:01,779
THE SPOUSE WHO IS 95 AND SHE 

2319
01:48:01,779 --> 01:48:02,647
HERSELF SEEMS IMPAIRED WHEN YOU 

2320
01:48:02,647 --> 01:48:05,449
TALK TO HER TO GET CONSENT THEN 

2321
01:48:05,449 --> 01:48:15,826
YOU NEED TO PURSUE THAT.

2322
01:48:15,826 --> 01:48:20,231
EVEN IN THIS HOSPITAL AND HIS 

2323
01:48:20,231 --> 01:48:23,467
COMES FOR CLINICAL THAN RESEARCH

2324
01:48:23,467 --> 01:48:27,638
CONCEPT IS AVAILABILITY IS A BIG

2325
01:48:27,638 --> 01:48:27,872
FACTOR.

2326
01:48:27,872 --> 01:48:30,074
 YOU'RE NOT REQUIRED TO HIRE A 

2327
01:48:30,074 --> 01:48:40,184
PRIVATE SINGLE DIGIT ER  BEING -

2328
01:48:40,184 --> 01:48:42,353
PRIVATE INVESTIGATOR.

2329
01:48:42,353 --> 01:48:51,562
SO YOU HAVE TO EXERCISE SOME 

2330
01:48:51,562 --> 01:48:53,597
GENERAL RULES OF APPLICATION.

2331
01:48:53,597 --> 01:48:55,666
OTHER COMMENTS, QUESTIONS HERE 

2332
01:48:55,666 --> 01:48:56,968
OR IN CYBER SPACE.

2333
01:48:56,968 --> 01:48:59,270
>> NONE APPARENTLY HERE OR
IN 

2334
01:48:59,270 --> 01:49:00,638
CYBER SPACE SO WE'RE GOING TO 

2335
01:49:00,638 --> 01:49:04,942
SEND YOU ON YOUR WAY WITH A 

2336
01:49:04,942 --> 01:49:05,409
GREAT ROUND OF PLAUS.

2337
01:49:05,409 --> 01:49:06,510
THANK YOU, SCOTT.

2338
01:49:06,510 --> 01:49:09,313
SO WE'RE TAKING OUR 15-MINUTE 

2339
01:49:09,313 --> 01:49:13,451
BREAK NOW SO IF FOLKS CAN GO GET

2340
01:49:13,451 --> 01:49:16,253
A CUP OF COFFEE OR WHATEVER YOU 

2341
01:49:16,253 --> 01:49:21,454
NEED, WE'LL RECONVENE AT 10:35
AND CAROL SQUIRES WILL BE
JOINING US.

2342
01:49:21,454 --> 01:49:22,121
>> WELCOME BACK.

2343
01:49:22,121 --> 01:49:24,324
IT'S MY PLEASURE TO INTRODUCE 

2344
01:49:24,324 --> 01:49:34,867
CARE -- CAROL SQUIRES AND SHE'S 

2345
01:49:37,070 --> 01:49:37,737
DEVELOPED INTEREST AND EXPERTISE

2346
01:49:37,737 --> 01:49:42,375
IN FACILITATING, ASSESSING AND 

2347
01:49:42,375 --> 01:49:43,009
UNDERSTANDING INFORMED CONSENT 

2348
01:49:43,009 --> 01:49:45,011
OF FOLKS SIMILAR TO THE ONES 

2349
01:49:45,011 --> 01:49:46,379
SCOTT WAS TALKING ABOUT AS WELL 

2350
01:49:46,379 --> 01:49:48,314
AS THOSE WITH OTHER MENTAL 

2351
01:49:48,314 --> 01:49:49,349
HEALTH ISSUES.

2352
01:49:49,349 --> 01:49:52,318
SO I'M GOING TO HAND IT OVER TO 

2353
01:49:52,318 --> 01:49:58,891
CAROL.

2354
01:49:58,891 --> 01:50:00,960
>> THANK YOU VERY MUCH I'M
WITH 

2355
01:50:00,960 --> 01:50:02,495
THE NATIONAL INSTITUTE OF MENTAL

2356
01:50:02,495 --> 01:50:04,931
HEALTH, CAROL SQUIRES, HUMAN 

2357
01:50:04,931 --> 01:50:05,732
SUBJECTS PROTECTION UNIT.

2358
01:50:05,732 --> 01:50:06,999
I'LL GO AHEAD AND MAKE SURE I 

2359
01:50:06,999 --> 01:50:15,375
CAN GET THE SLIDES GOING.

2360
01:50:15,375 --> 01:50:18,978
UME WITH HSPU HUMAN SUBJECTS 

2361
01:50:18,978 --> 01:50:20,847
PROTECTION UNIT WORKING UNDER 

2362
01:50:20,847 --> 01:50:21,280
DR. POWE.

2363
01:50:21,280 --> 01:50:24,751
THE OFFICE OF THE CLINICAL.

2364
01:50:24,751 --> 01:50:28,121
SHE IS THE CLINICAL DIRECTOR OF 

2365
01:50:28,121 --> 01:50:30,890
NIMH AND OUR DIRECTOR 

2366
01:50:30,890 --> 01:50:31,190
SUPERVISOR.

2367
01:50:31,190 --> 01:50:33,960
THERE'S THREE OF US.

2368
01:50:33,960 --> 01:50:40,633
MYSELF, KATHERINE TODDMAN AND 

2369
01:50:40,633 --> 01:50:43,002
BRITTANY HERE FOR MORAL SUPPORT 

2370
01:50:43,002 --> 01:50:45,338
AND YEAR SOCIAL WORKERS AND 

2371
01:50:45,338 --> 01:50:46,873
LICENSED IN THE AREA.

2372
01:50:46,873 --> 01:50:48,975
WE'RE CLINICIANS INDEPENDENT OF 

2373
01:50:48,975 --> 01:50:50,076
THE RESEARCHERS.

2374
01:50:50,076 --> 01:50:52,145
BASICALLY BEING INDEPENDENT OF 

2375
01:50:52,145 --> 01:50:57,417
THE RESEARCH TEAM DOES ALLOW US 

2376
01:50:57,417 --> 01:51:01,087
A LEVEL OF NEUTRALITY AND 

2377
01:51:01,087 --> 01:51:02,989
OBJECTIVITY BECAUSE WE'RE NOT 

2378
01:51:02,989 --> 01:51:05,091
INTERESTED WHETHER SOMEONE 

2379
01:51:05,091 --> 01:51:06,225
PARTICIPATES BUT ENSURE THEY GET

2380
01:51:06,225 --> 01:51:14,901
THE INFORMATION THEY NEED TO 

2381
01:51:14,901 --> 01:51:17,970
MAKE AN INFORMED DECISION AND WE

2382
01:51:17,970 --> 01:51:20,306
ARE IN COMBINATION WITH THE 

2383
01:51:20,306 --> 01:51:22,308
BIOETHICS DEPARTMENT AND WORK 

2384
01:51:22,308 --> 01:51:24,277
COLLABORATIVELY WITH THEM AND 

2385
01:51:24,277 --> 01:51:28,314
WORK ON ISSUES AROUND 

2386
01:51:28,314 --> 01:51:30,416
INDIVIDUALS, RESEARCHERS, GET IN

2387
01:51:30,416 --> 01:51:32,084
TOUCH WITH US WHEN THEY HAVE 

2388
01:51:32,084 --> 01:51:36,322
CONCERN ABOUT ABILITY TO GIVE 

2389
01:51:36,322 --> 01:51:39,258
CONSENT AT THE CLINICAL CENTER.

2390
01:51:39,258 --> 01:51:42,562
OUR OVERARCHING FUNCTION IN HBSU

2391
01:51:42,562 --> 01:51:44,297
IS WE PROVIDE PROTECTION AND 

2392
01:51:44,297 --> 01:51:44,997
ADVOCACY.

2393
01:51:44,997 --> 01:51:48,000
WE FOCUS ON WHAT WE REFER TO AS 

2394
01:51:48,000 --> 01:51:51,170
INDIVIDUALS WHO ARE POTENTIALLY 

2395
01:51:51,170 --> 01:51:52,271
VULNERABLE PARTICIPANTS.

2396
01:51:52,271 --> 01:51:54,207
A LITTLE BIT OF BACKGROUND, 

2397
01:51:54,207 --> 01:51:55,708
WE'LL HAVE CASE STUDIES LATER 

2398
01:51:55,708 --> 01:51:56,709
AND TALK ABOUT THIS A BIT MORE 

2399
01:51:56,709 --> 01:51:58,978
BUT THE FOLKS THAT COME INTO OUR

2400
01:51:58,978 --> 01:51:59,812
STUDIES, WE SEE CHILDREN AS WELL

2401
01:51:59,812 --> 01:52:00,980
AS ADULTS.

2402
01:52:00,980 --> 01:52:03,749
THEY CAN HAVE MOOD AND ANXIETY 

2403
01:52:03,749 --> 01:52:04,617
DISORDERS, MAJOR DEPRESSION, WE 

2404
01:52:04,617 --> 01:52:07,954
HAVE A STUDY THAT LOOKS AT FOLKS

2405
01:52:07,954 --> 01:52:10,156
WITH SCHIZOPHRENIA, PSYCHOTIC 

2406
01:52:10,156 --> 01:52:12,258
DISORDERS AND CHILDREN WITH AN 

2407
01:52:12,258 --> 01:52:13,359
ARRAY OF DIFFERENT MOOD 

2408
01:52:13,359 --> 01:52:14,060
DISORDERS AS WELL.

2409
01:52:14,060 --> 01:52:16,529
I THINK ONE OF THE THINGS THAT 

2410
01:52:16,529 --> 01:52:18,998
WE HAVE ALL COME TO RECOGNIZE IS

2411
01:52:18,998 --> 01:52:20,333
THAT THE TERM VULNERABILITY CAN 

2412
01:52:20,333 --> 01:52:22,201
APPLY TO ALL OF US.

2413
01:52:22,201 --> 01:52:25,505
IT DOESN'T MEAN YOU HAVE TO HAVE

2414
01:52:25,505 --> 01:52:26,906
A BEHAVIORAL HEALTH DIAGNOSIS IN

2415
01:52:26,906 --> 01:52:28,207
ORDER TO BE VULNERABLE.

2416
01:52:28,207 --> 01:52:30,209
ONE EXAMPLE LIKE I IF WERE TO 

2417
01:52:30,209 --> 01:52:32,278
FALL DOWN THE STAIRS AND END UP 

2418
01:52:32,278 --> 01:52:35,581
IN THE E.D. ACROSS THE STRESS, 

2419
01:52:35,581 --> 01:52:37,250
PEOPLE WOULD PUT PAPERWORK IN 

2420
01:52:37,250 --> 01:52:40,286
FRONT OF MY FACE, I'LL SIGN 

2421
01:52:40,286 --> 01:52:42,321
EVERYTHING AND I MAY NOT NEED MY

2422
01:52:42,321 --> 01:52:43,456
HUSBAND TO HELP OUT BUT IT'S 

2423
01:52:43,456 --> 01:52:46,259
IMPORTANT TO BEAR IN MIND THE 

2424
01:52:46,259 --> 01:52:48,594
TERM VULNERABLE CAN BE APPLIED 

2425
01:52:48,594 --> 01:52:51,364
TO ALL OF US AT ANY POTENTIAL 

2426
01:52:51,364 --> 01:52:51,564
TIME.

2427
01:52:51,564 --> 01:52:54,667
WE ASSESS, DEVELOP AND INTIMATE 

2428
01:52:54,667 --> 01:52:54,967
PROTECTION.

2429
01:52:54,967 --> 01:53:00,306
THE THINGS WE DO AS CLINICAL 

2430
01:53:00,306 --> 01:53:04,310
RESEARCH ADVOCATES WE PROVIDER 

2431
01:53:04,310 --> 01:53:06,746
CONSENT MONITORING FOR ALL THE 

2432
01:53:06,746 --> 01:53:08,314
NIMHD STUDIES WE'RE SITTING 

2433
01:53:08,314 --> 01:53:11,584
THERE WHEN THE CONSENT IS BEING 

2434
01:53:11,584 --> 01:53:13,085
DISCUSSED WITH THEM AND BEING 

2435
01:53:13,085 --> 01:53:14,153
INFORMED ON WHAT WILL BE DONE 

2436
01:53:14,153 --> 01:53:15,988
BEFORE THEY SIGN IT.

2437
01:53:15,988 --> 01:53:17,557
WE DO PARTICIPATE MONITORING 

2438
01:53:17,557 --> 01:53:21,794
WHICH MEANS WE GO SEE THE PEOPLE

2439
01:53:21,794 --> 01:53:24,997
IN PATIENTS AT NIMHD STUDIES ON 

2440
01:53:24,997 --> 01:53:26,232
A REGULAR BASIS AND DO ROUNDS 

2441
01:53:26,232 --> 01:53:28,100
AND TALK TO THE CLINICAL STAFF 

2442
01:53:28,100 --> 01:53:29,802
AND HAVE A RELATIONSHIP WITH ALL

2443
01:53:29,802 --> 01:53:33,439
OF THEM TO MAKE SURE PEOPLE ARE 

2444
01:53:33,439 --> 01:53:35,041
CONTINUING TO BE INFORMED IN 

2445
01:53:35,041 --> 01:53:37,143
WHAT THEY ARE DOING AND DO THEY 

2446
01:53:37,143 --> 01:53:38,444
STILL WANT TO PARTICIPATE AND 

2447
01:53:38,444 --> 01:53:40,046
HELP IN ASSIST IN APLAYING THE 

2448
01:53:40,046 --> 01:53:43,249
DIFFERENT REGULATIONS AND 

2449
01:53:43,249 --> 01:53:44,617
POLICIES LIKE CLINICAL CENTER 

2450
01:53:44,617 --> 01:53:47,553
POLICY AND FEDERAL POLICIES, 

2451
01:53:47,553 --> 01:53:49,021
THAT SORT OF THING.

2452
01:53:49,021 --> 01:53:52,491
AND WE PROVIDE A CONSENT SORT OF

2453
01:53:52,491 --> 01:53:56,996
TRAINING IT'S CALLED ELEMENTS OF

2454
01:53:56,996 --> 01:54:00,299
A SUCCESSFUL INFORMED MANDATORY 

2455
01:54:00,299 --> 01:54:03,669
FOR ALL NIMHD INVESTIGATORS 

2456
01:54:03,669 --> 01:54:05,104
OBTAINING CONSENT AND ANYONE CAN

2457
01:54:05,104 --> 01:54:07,006
TAKE IT ANY TIME.

2458
01:54:07,006 --> 01:54:12,311
IT'S ONLY PLANNED TRY FOR NIMHD.

2459
01:54:12,311 --> 01:54:13,045
HOPEFULLY TODAY OBJECTIVE WISE 

2460
01:54:13,045 --> 01:54:17,183
WE'LL TALK ABOUT KNOWING WHAT 

2461
01:54:17,183 --> 01:54:18,684
THE CONSENT CAPACITY IS AND WHAT

2462
01:54:18,684 --> 01:54:21,220
WE DO WITHIN HSPU.

2463
01:54:21,220 --> 01:54:24,457
AGAIN, MORE DETAIL HOW WE ASSESS

2464
01:54:24,457 --> 01:54:30,563
FOR CAPACITY, CONSENT CAPACITY 

2465
01:54:30,563 --> 01:54:32,298
AND WHAT CONTRIBUTES TO A GOOD 

2466
01:54:32,298 --> 01:54:33,733
CAPACITY ASSESSMENT IN TERMS OF 

2467
01:54:33,733 --> 01:54:36,002
IT GOING WELL AND WHAT THE 

2468
01:54:36,002 --> 01:54:37,937
PITFALLS CAN BE.

2469
01:54:37,937 --> 01:54:43,442
IT CAN BE AN ANXIETY PRODUCING 

2470
01:54:43,442 --> 01:54:44,310
MOMENTS AND I'LL TALK WHAT ABOUT

2471
01:54:44,310 --> 01:54:46,278
WHAT OUR EXPERIENCES ARE AND 

2472
01:54:46,278 --> 01:54:47,913
TALK ABOUT THINGS TO CONSIDER 

2473
01:54:47,913 --> 01:54:49,749
WHEN ENROLLING POTENTIALLY 

2474
01:54:49,749 --> 01:54:50,249
VULNERABLE POPULATIONS.

2475
01:54:50,249 --> 01:54:51,817
ALSO ONE OF THE THINGS I WANT TO

2476
01:54:51,817 --> 01:54:55,187
GIVE A SHOUT OUT TO AS WELL I 

2477
01:54:55,187 --> 01:54:57,390
MENTIONED TO HOLLY BEFORE HAND 

2478
01:54:57,390 --> 01:54:58,624
SHE SAID SHE HAS UPLOADED THE 

2479
01:54:58,624 --> 01:55:06,365
LINK AND YOU HAVE ACCESS TO THE 

2480
01:55:06,365 --> 01:55:11,671
POWER POINT AND WE ENCOURAGE 

2481
01:55:11,671 --> 01:55:13,973
PEOPLE TO TAKE A LOOK IF SOMEONE

2482
01:55:13,973 --> 01:55:16,609
IS THINKING OF DEVELOPING 

2483
01:55:16,609 --> 01:55:20,846
RESEARCH PROCESS AND WHERE ANY 

2484
01:55:20,846 --> 01:55:22,915
INDIVIDUAL PARTICIPATING IT 

2485
01:55:22,915 --> 01:55:25,017
TALKS YOU THROUGH AND THINGS TO 

2486
01:55:25,017 --> 01:55:28,320
CONSIDER IN THE CONCEPT PROCESS 

2487
01:55:28,320 --> 01:55:29,388
AND I THINK IT'S REALLY IF.

2488
01:55:29,388 --> 01:55:33,559
REAR PROUD OF THAT.

2489
01:55:33,559 --> 01:55:35,828
-- WE'RE PROUD OF THAT.

2490
01:55:35,828 --> 01:55:40,433
THIS IS OUR NIMHD CONCEPT 

2491
01:55:40,433 --> 01:55:41,300
PROCESS.

2492
01:55:41,300 --> 01:55:46,005
I'LL GIVE A SHOUT OUT TO 

2493
01:55:46,005 --> 01:55:47,473
KATHERINE TODDMAN SHE PUT THIS 

2494
01:55:47,473 --> 01:55:52,344
TOGETHER AND WHEN YOU'RE 

2495
01:55:52,344 --> 01:55:55,014
THINKING ABOUT INCLUDING PEOPLE 

2496
01:55:55,014 --> 01:55:57,483
WHO MAY NOT HAVE CONSENT PROCESS

2497
01:55:57,483 --> 01:55:59,685
AND DOES THE PROTOCOL ALLOW WHAT

2498
01:55:59,685 --> 01:56:02,321
YOU DO AN IF IT DOESN'T WHAT CAN

2499
01:56:02,321 --> 01:56:04,190
YOU DO AT THAT POINT.

2500
01:56:04,190 --> 01:56:06,559
I WON'T GO THROUGH THIS AT THIS 

2501
01:56:06,559 --> 01:56:08,127
POINT IN TIME BUT IT'S THERE AND

2502
01:56:08,127 --> 01:56:12,298
IT'S A GOOD REASON TO TAKE A 

2503
01:56:12,298 --> 01:56:15,501
LOOK AT THE POWER POINT.

2504
01:56:15,501 --> 01:56:17,503
THIS IS A CAPACITY ASSESSMENT 

2505
01:56:17,503 --> 01:56:22,742
ALGORITHM WHICH IS HELPFUL AS 

2506
01:56:22,742 --> 01:56:23,008
WELL.

2507
01:56:23,008 --> 01:56:26,979
AT THE TOP IT TALKS ABOUT BEFORE

2508
01:56:26,979 --> 01:56:28,280
GOING IN TO ASSESS SOMEBODY'S 

2509
01:56:28,280 --> 01:56:30,750
CONSENT CAPACITY WE WANT TO MAKE

2510
01:56:30,750 --> 01:56:31,851
SURE THE RESEARCHER HE'S 

2511
01:56:31,851 --> 01:56:32,985
EDUCATED THE PARTICIPANT ABOUT 

2512
01:56:32,985 --> 01:56:34,220
THE PROTOCOL.

2513
01:56:34,220 --> 01:56:36,322
WE ALWAYS SAY IT'S NOT FAIR TO 

2514
01:56:36,322 --> 01:56:37,990
ASK QUESTIONS OF A PERSON ABOUT 

2515
01:56:37,990 --> 01:56:40,292
A STUDY IF THEY HAVEN'T REALLY 

2516
01:56:40,292 --> 01:56:42,094
HAD AN OPPORTUNITY TO TALK WITH 

2517
01:56:42,094 --> 01:56:44,463
THE RESEARCHER OR SOMEBODY FROM 

2518
01:56:44,463 --> 01:56:47,399
THE STUDY TEAM, ENLIGHTENING 

2519
01:56:47,399 --> 01:56:48,300
THEM, EDUCATING THEM ABOUT WHAT 

2520
01:56:48,300 --> 01:56:49,668
THE STUDY ENTAILS.

2521
01:56:49,668 --> 01:56:51,537
WE'RE INTERESTED IN YOU BECAUSE 

2522
01:56:51,537 --> 01:56:52,772
YOU HAVE THIS CONDITION THAT'S 

2523
01:56:52,772 --> 01:56:53,105
GOING ON.

2524
01:56:53,105 --> 01:56:54,640
THESE ARE THE TASKS OR THE 

2525
01:56:54,640 --> 01:56:56,308
PROCEDURES WE'RE GOING TO ASK 

2526
01:56:56,308 --> 01:56:57,643
YOU TO DO.

2527
01:56:57,643 --> 01:56:59,411
WHAT THE POTENTIAL RISKS ARE OF 

2528
01:56:59,411 --> 01:57:00,780
EACH OF THOSE PROCEDURES.

2529
01:57:00,780 --> 01:57:03,282
GOING OVER THAT.

2530
01:57:03,282 --> 01:57:04,583
THEY NEED TO HAVE THAT EDUCATION

2531
01:57:04,583 --> 01:57:09,188
BEFORE WE CAN GO IN AND REALLY 

2532
01:57:09,188 --> 01:57:09,822
PROPERLY ASSESS THEM.

2533
01:57:09,822 --> 01:57:13,192
THE NEXT CATEGORY DOWN IS HSPU 

2534
01:57:13,192 --> 01:57:14,460
ADMINISTERS THE CAPACITY 

2535
01:57:14,460 --> 01:57:14,760
ASSESSMENT.

2536
01:57:14,760 --> 01:57:17,363
WHAT WE ALWAYS DO IS WE MAKE IT 

2537
01:57:17,363 --> 01:57:18,464
A CONVERSATION.

2538
01:57:18,464 --> 01:57:19,732
I'LL GO THROUGH THE DIFFERENT 

2539
01:57:19,732 --> 01:57:23,269
DOMAINS THAT WE USE AND HOW WE 

2540
01:57:23,269 --> 01:57:24,970
STRUCTURE OUR CAPACITY 

2541
01:57:24,970 --> 01:57:25,271
ASSESSMENT.

2542
01:57:25,271 --> 01:57:26,972
THE ACTUAL TOOL ITSELF.

2543
01:57:26,972 --> 01:57:29,375
BUT AGAIN WE'RE INTERESTED IN 

2544
01:57:29,375 --> 01:57:32,311
WHAT PEOPLE KNOW AND UNDERSTAND 

2545
01:57:32,311 --> 01:57:36,081
ABOUT THE STUDY AND WE ALWAYS 

2546
01:57:36,081 --> 01:57:37,583
ENCOURAGE OR CLARIFY WITH PEOPLE

2547
01:57:37,583 --> 01:57:39,451
BECAUSE WE'RE ASKING THEM A LOT 

2548
01:57:39,451 --> 01:57:40,052
OF QUESTIONS.

2549
01:57:40,052 --> 01:57:43,022
IT'S JUST SPECIFICALLY ABOUT THE

2550
01:57:43,022 --> 01:57:44,089
STUDY.

2551
01:57:44,089 --> 01:57:45,124
WHAT WE'RE DETERMINING AND 

2552
01:57:45,124 --> 01:57:45,891
ASKING ABOUT.

2553
01:57:45,891 --> 01:57:47,459
WE'RE NOT CONCERNED WHETHER THEY

2554
01:57:47,459 --> 01:57:49,028
LIVE ALONE IN THE COMMUNITY OR 

2555
01:57:49,028 --> 01:57:51,230
IF THEY CAN MANAGE THEIR OWN 

2556
01:57:51,230 --> 01:57:55,935
FINANCE OR HAVE A JOB.

2557
01:57:55,935 --> 01:57:58,070
WE WANT TO KNOW AND IT'S A 

2558
01:57:58,070 --> 01:57:58,871
SNAPSHOT OF WHAT THEIR 

2559
01:57:58,871 --> 01:58:00,206
UNDERSTANDING IS ABOUT THE 

2560
01:58:00,206 --> 01:58:00,773
STUDY.

2561
01:58:00,773 --> 01:58:02,241
AGAIN, I'LL TALK MORE ABOUT THIS

2562
01:58:02,241 --> 01:58:03,409
ACTUAL QUESTIONS AND HOW WE SET 

2563
01:58:03,409 --> 01:58:05,377
THIS UP BUT AFTER WE'VE HAD TIME

2564
01:58:05,377 --> 01:58:09,748
TO TALK WITH THEM, AND DEPENDING

2565
01:58:09,748 --> 01:58:13,919
ON TE -- THE PERSON IT COULD BE 

2566
01:58:13,919 --> 01:58:15,921
10 OR 15 MINUTES AND IF I THAT 

2567
01:58:15,921 --> 01:58:18,324
WANT TO TALK MORE THAT'S FINE.

2568
01:58:18,324 --> 01:58:19,725
TYPICALLY THERE'S TWO OF US THAT

2569
01:58:19,725 --> 01:58:20,626
DO THE ASSESSMENT.

2570
01:58:20,626 --> 01:58:22,228
ONE IS THE INTERVIEWER AND ONE 

2571
01:58:22,228 --> 01:58:24,930
IS THE PERSON WHO IS TAKING 

2572
01:58:24,930 --> 01:58:27,933
NOTES AND WATCHING AND ADDING 

2573
01:58:27,933 --> 01:58:30,302
WHAT THEY NEED TO AT THE TIME 

2574
01:58:30,302 --> 01:58:31,637
BUT THEY'RE ALSO TAKING IN WHAT 

2575
01:58:31,637 --> 01:58:33,105
THE PERSON IS SAYING.

2576
01:58:33,105 --> 01:58:34,073
TYPICALLY WE'LL HAVE A FEW 

2577
01:58:34,073 --> 01:58:35,841
MINUTES OUTSIDE THE ROOM AFTER 

2578
01:58:35,841 --> 01:58:36,842
WE'RE FINISHED WITH THE PERSON 

2579
01:58:36,842 --> 01:58:38,110
AND CAN HAVE A DISCUSSION.

2580
01:58:38,110 --> 01:58:41,413
DO WE HAVE CONCERNS ABOUT THIS 

2581
01:58:41,413 --> 01:58:42,381
PERSON.

2582
01:58:42,381 --> 01:58:43,582
A LOT OF TIMES THERE'S NOT EVEN 

2583
01:58:43,582 --> 01:58:45,484
A QUESTION AND WE CAN GO 

2584
01:58:45,484 --> 01:58:48,687
STRAIGHT INTO THE CONSENT 

2585
01:58:48,687 --> 01:58:48,921
PROCESS.

2586
01:58:48,921 --> 01:58:50,923
AND WITHIN NIMHD WE'RE PROVIDING

2587
01:58:50,923 --> 01:58:51,624
CONSENT MONITORING FOR THOSE 

2588
01:58:51,624 --> 01:58:51,857
PEOPLE.

2589
01:58:51,857 --> 01:58:54,260
AND WHAT WE'RE LOOKING AT AND IT

2590
01:58:54,260 --> 01:58:56,729
TALKS ABOUT THE THREE CATEGORIES

2591
01:58:56,729 --> 01:58:59,298
WE HAVE AFTER WE'VE DONE THE 

2592
01:58:59,298 --> 01:58:59,598
ASSESSMENT.

2593
01:58:59,598 --> 01:59:03,202
IS THE PERSON ABLE TO GIVE THEIR

2594
01:59:03,202 --> 01:59:03,502
OWN CONSENT?

2595
01:59:03,502 --> 01:59:06,338
NO QUESTION.

2596
01:59:06,338 --> 01:59:08,307
ARE WE CONCERNED THERE'S A 

2597
01:59:08,307 --> 01:59:09,275
QUESTIONABLE ABILITY.

2598
01:59:09,275 --> 01:59:10,876
MAYBE THEY GET THE OVER ARCHING 

2599
01:59:10,876 --> 01:59:12,311
UNDERSTANDING BUT THERE MAY BE 

2600
01:59:12,311 --> 01:59:12,978
SPECIFICS ABOUT IT.

2601
01:59:12,978 --> 01:59:14,146
IT'S A LITTLE BIT QUESTIONABLE 

2602
01:59:14,146 --> 01:59:15,681
AND WE THEN ARE GOING TO TAKE 

2603
01:59:15,681 --> 01:59:17,349
THAT TO THE RESEARCHER AND TALK 

2604
01:59:17,349 --> 01:59:19,952
TO THEM ABOUT IS WHAT WE FOUND 

2605
01:59:19,952 --> 01:59:22,087
AT THIS POINT IN TIME.

2606
01:59:22,087 --> 01:59:24,723
WE DO FEEL LIKE, YES, CLINICALLY

2607
01:59:24,723 --> 01:59:26,859
THESE PEOPLE GET MOST OF IT BUT 

2608
01:59:26,859 --> 01:59:29,461
MAY NEED SOME HELP, SOME 

2609
01:59:29,461 --> 01:59:31,030
GUIDANCE, SOME REMINDERS FROM 

2610
01:59:31,030 --> 01:59:33,432
FOLKS AS WELL OR DO WE FIND THE 

2611
01:59:33,432 --> 01:59:34,199
PERSON ABSOLUTELY DOES NOT HAVE 

2612
01:59:34,199 --> 01:59:37,836
CAPACITY AT THIS TIME AND AGAIN 

2613
01:59:37,836 --> 01:59:39,038
IT SAYS THE RESEARCHER DECIDES 

2614
01:59:39,038 --> 01:59:41,140
AND THE DIFFERENT OPTIONS UNDER 

2615
01:59:41,140 --> 01:59:43,709
THAT THEN DO THEY WANT TO SPEND 

2616
01:59:43,709 --> 01:59:45,511
MORE TIME EDUCATING THE 

2617
01:59:45,511 --> 01:59:45,811
PARTICIPANT?

2618
01:59:45,811 --> 01:59:48,681
IT COULD BE GIVEN MORE TIME, 

2619
01:59:48,681 --> 01:59:50,049
MORE INFORMATION THEY MIGHT 

2620
01:59:50,049 --> 01:59:52,084
ACTUALLY HAVE CAPACITY TO GIVE 

2621
01:59:52,084 --> 01:59:53,085
THEIR OWN CONSENT.

2622
01:59:53,085 --> 01:59:55,621
IF THE PROTOCOL ALLOWS IT AT 

2623
01:59:55,621 --> 01:59:57,990
THIS POINT, DO WE WANT TO PURSUE

2624
01:59:57,990 --> 02:00:00,225
AND MAKE SURE IT'S A LEGALLY 

2625
02:00:00,225 --> 02:00:01,727
AUTHORIZED REPRESENTATIVE OR 

2626
02:00:01,727 --> 02:00:04,096
SURROGATE GIVING CONSENT ON 

2627
02:00:04,096 --> 02:00:04,596
THEIR BEHAVE.

2628
02:00:04,596 --> 02:00:05,898
SOMETIMES IT'S YES, THEY HAVE 

2629
02:00:05,898 --> 02:00:07,967
CAPACITY BUT THEY COULD BENEFIT 

2630
02:00:07,967 --> 02:00:08,934
FROM REMINDERS AND THIS PERSON 

2631
02:00:08,934 --> 02:00:10,269
HELPING THEM BUT STILL HAVE THE 

2632
02:00:10,269 --> 02:00:12,338
ABILITY TO GIVE THEIR OWN 

2633
02:00:12,338 --> 02:00:13,439
CONSENT OR THEY'RE NOT GOING TO 

2634
02:00:13,439 --> 02:00:15,507
BE ENROLLED AT ALL.

2635
02:00:15,507 --> 02:00:19,011
SO AGAIN IT'S A CONVERSATION 

2636
02:00:19,011 --> 02:00:20,312
WITH THE INVESTIGATORS, WE'RE 

2637
02:00:20,312 --> 02:00:21,513
TALKING AMONGST OURSELVES ABOUT 

2638
02:00:21,513 --> 02:00:23,515
THAT AND WE ALWAYS WANT TO MAKE 

2639
02:00:23,515 --> 02:00:24,950
SURE THAT PEOPLE ARE AWARE.

2640
02:00:24,950 --> 02:00:26,518
WE WANT TO NORMALIZE THE PROCESS

2641
02:00:26,518 --> 02:00:29,321
AND MAKE SURE THAT PARTICIPANTS 

2642
02:00:29,321 --> 02:00:31,657
KNOW THIS IS PART OF THE STUDY.

2643
02:00:31,657 --> 02:00:33,826
IN OUR CASES A LOT OF TIMES IT'S

2644
02:00:33,826 --> 02:00:34,927
PROTOCOL MANDATED.

2645
02:00:34,927 --> 02:00:37,930
THEY HAVE WRITTEN IT TO THE 

2646
02:00:37,930 --> 02:00:38,897
PROTOCOL WE'LL BE ASSESSING 

2647
02:00:38,897 --> 02:00:39,131
PEOPLE.

2648
02:00:39,131 --> 02:00:39,865
WE DON'T WANT SURPRISES.

2649
02:00:39,865 --> 02:00:41,033
WE WANT PEOPLE TO KNOW THIS IS 

2650
02:00:41,033 --> 02:00:42,167
GOING TO HAPPEN AND THESE ARE 

2651
02:00:42,167 --> 02:00:44,870
THE POTENTIAL OUTCOMES.

2652
02:00:44,870 --> 02:00:48,307
SO, THIS IS JUST MORE 

2653
02:00:48,307 --> 02:00:49,908
INFORMATION ABOUT TYPICALLY WHAT

2654
02:00:49,908 --> 02:00:52,311
HAPPENS HERE AT THE CLINICAL 

2655
02:00:52,311 --> 02:01:00,285
CENTER AND SPECIFICALLY TALKING 

2656
02:01:00,285 --> 02:01:04,289
AT LENGTH AT WHAT DO AT NIMHD.

2657
02:01:04,289 --> 02:01:07,026
ADULT PARTICIPANTS HAVE TO HAVE 

2658
02:01:07,026 --> 02:01:09,128
CAPACITY TO GIVE CONSENT.

2659
02:01:09,128 --> 02:01:10,462
OFTEN WHAT HAPPENS IN THE 

2660
02:01:10,462 --> 02:01:11,296
CLINICAL CENTER IS THE 

2661
02:01:11,296 --> 02:01:12,998
INVESTIGATORS OBTAINING CONCEPT 

2662
02:01:12,998 --> 02:01:15,134
ARE USING THEIR OWN CLINICAL 

2663
02:01:15,134 --> 02:01:16,301
JUDGMENT.

2664
02:01:16,301 --> 02:01:19,004
THEY DON'T NECESSARILY HAVE A 

2665
02:01:19,004 --> 02:01:20,239
SEPARATE ASSESSMENT TOOL THEY 

2666
02:01:20,239 --> 02:01:21,373
USE.

2667
02:01:21,373 --> 02:01:22,307
THEY'RE USING THEIR OWN CLINICAL

2668
02:01:22,307 --> 02:01:23,742
JUDGMENT AND ACUMEN.

2669
02:01:23,742 --> 02:01:27,479
THAT'S BEEN APPROVED BY THE IRB,

2670
02:01:27,479 --> 02:01:29,014
THAT'S FINE.

2671
02:01:29,014 --> 02:01:31,016
A MORE FORMAL PROCESS CAN 

2672
02:01:31,016 --> 02:01:33,218
INCLUDE OURSELVES OR THE TEAM 

2673
02:01:33,218 --> 02:01:40,159
AND JUST AS A REMINDER WE HAVE 

2674
02:01:40,159 --> 02:01:42,027
AN OUT PATIENT AND IN PATIENT 

2675
02:01:42,027 --> 02:01:45,230
STUDY WHERE HSBU IS WRITTEN INTO

2676
02:01:45,230 --> 02:01:48,033
THE PROTOCOL TO ASSESS 

2677
02:01:48,033 --> 02:01:50,803
INDEPENDENTLY SOMEONE'S CONCEPT 

2678
02:01:50,803 --> 02:01:52,037
CAPACITY.

2679
02:01:52,037 --> 02:01:53,038
FOR A PROTOCOL SPECIFIC CAPACITY

2680
02:01:53,038 --> 02:01:54,873
ASSESSMENT IS USED WHEN THE 

2681
02:01:54,873 --> 02:01:56,308
PROTOCOL REQUIRES THEY NEED TO 

2682
02:01:56,308 --> 02:01:58,544
BE NORMALLY AND INDEPENDENTLY 

2683
02:01:58,544 --> 02:01:58,944
ASSESSED.

2684
02:01:58,944 --> 02:02:04,149
WE CREATE THE TOOL IN ADVANCE.

2685
02:02:04,149 --> 02:02:08,287
WHAT WE DO IS CREATE THE 

2686
02:02:08,287 --> 02:02:09,455
QUESTIONS, WE DEVELOP THE 

2687
02:02:09,455 --> 02:02:11,356
EXPECTED ANSWERS FOR THOSE 

2688
02:02:11,356 --> 02:02:12,357
QUESTIONS AND SHARE THAT WITH 

2689
02:02:12,357 --> 02:02:14,093
THE INVESTIGATOR, THE P.I. OF 

2690
02:02:14,093 --> 02:02:15,194
THE PROTOCOL AHEAD OF TIME.

2691
02:02:15,194 --> 02:02:16,662
THIS IS WHAT WE'RE GOING TO ASK.

2692
02:02:16,662 --> 02:02:18,997
ARE THESE THE ANSWERS WE WOULD 

2693
02:02:18,997 --> 02:02:19,398
EXPECT.

2694
02:02:19,398 --> 02:02:20,566
THESE ARE THE MINIMUM 

2695
02:02:20,566 --> 02:02:22,701
REQUIREMENTS WE'RE LOOKING AT TO

2696
02:02:22,701 --> 02:02:25,170
THINK ABOUT SO WE CAN ENSURE 

2697
02:02:25,170 --> 02:02:28,073
SOMEBODY DOES HAVE CONSENT 

2698
02:02:28,073 --> 02:02:28,340
CAPACITY.

2699
02:02:28,340 --> 02:02:30,075
AND AS I SAID WE HAVE EXPECTED 

2700
02:02:30,075 --> 02:02:31,276
RESPONSES TO THE QUESTIONS WE 

2701
02:02:31,276 --> 02:02:34,513
DEVELOPED AND WE ALSO CAN USE 

2702
02:02:34,513 --> 02:02:34,746
PROMPTS.

2703
02:02:34,746 --> 02:02:39,685
ESPECIALLY WITH SOME FOLKS FOR 

2704
02:02:39,685 --> 02:02:46,558
EXAMPLE WE HAVE AN OUT PATIENT 

2705
02:02:46,558 --> 02:02:49,228
STUDY AND MAY MIGHT HAVE MEMORY 

2706
02:02:49,228 --> 02:02:50,496
PROBLEMS AND GIVING THEM A 

2707
02:02:50,496 --> 02:02:52,898
PROMPT LIKE ARE YOU GOING TO 

2708
02:02:52,898 --> 02:02:55,000
HAVE SCANS AND THEY PLAY NOT SAY

2709
02:02:55,000 --> 02:02:57,569
IT'S A PET SCAN OR TOMOGRAPHY 

2710
02:02:57,569 --> 02:02:59,171
BUT THEY CAN SAY IT'S A SCAN 

2711
02:02:59,171 --> 02:03:01,006
WHERE I LAY DOWN FLAT.

2712
02:03:01,006 --> 02:03:02,407
WE KNOW THEY DO GET THAT.

2713
02:03:02,407 --> 02:03:04,643
THOSE ARE THE KINDS OF THINGS WE

2714
02:03:04,643 --> 02:03:06,245
FEEL LIKE IS PERFECTLY 

2715
02:03:06,245 --> 02:03:08,714
ACCEPTABLE TO TALK TO THEM 

2716
02:03:08,714 --> 02:03:08,914
ABOUT.

2717
02:03:08,914 --> 02:03:11,950
THE DIFFERENCE THEN IS GENERIC 

2718
02:03:11,950 --> 02:03:12,851
CAPACITY ASSESSMENTS.

2719
02:03:12,851 --> 02:03:14,620
AS IT SAID, IT USES A GUIDE FOR 

2720
02:03:14,620 --> 02:03:16,255
THE UNEXPECTED ENROLLMENT OF 

2721
02:03:16,255 --> 02:03:19,024
PEOPLE WHO MAY NOT HAVE CONCEPT 

2722
02:03:19,024 --> 02:03:22,861
CAPACITY AND IT CAN OCCUR IN A 

2723
02:03:22,861 --> 02:03:24,296
SITUATION WHERE THE RESEARCHERS 

2724
02:03:24,296 --> 02:03:25,931
HAVE SOMEBODY WHO COMES IN AND 

2725
02:03:25,931 --> 02:03:28,300
THIS ISN'T A REGULAR PART OF 

2726
02:03:28,300 --> 02:03:34,173
WHAT THEY SEE WITH THE ILLNESS 

2727
02:03:34,173 --> 02:03:35,574
AND THEY'RE NOT EXPECTING 

2728
02:03:35,574 --> 02:03:36,375
SOMEBODY TO HAVE DIFFICULTY BUT 

2729
02:03:36,375 --> 02:03:41,213
MAYBE THEY WANT ADDED HELP.

2730
02:03:41,213 --> 02:03:42,915
THEIR OWN CLINICAL ASSESSMENT.

2731
02:03:42,915 --> 02:03:45,884
THEY KIND OF WANT AN OUTSIDE 

2732
02:03:45,884 --> 02:03:47,853
OPINION AND CAN CONTACT THE TEAM

2733
02:03:47,853 --> 02:03:49,755
AND BIOETHICS DEPARTMENT AND ONE

2734
02:03:49,755 --> 02:03:52,024
OF US MAY GO OR IT MAY BE 

2735
02:03:52,024 --> 02:03:52,891
BIOETHICS DEPARTMENT THAT GOES 

2736
02:03:52,891 --> 02:03:54,159
OR IT MAY BE US.

2737
02:03:54,159 --> 02:03:58,430
THAT SORT OF THING.

2738
02:03:58,430 --> 02:04:00,432
SO THEY'RE GENERIC QUESTIONS.

2739
02:04:00,432 --> 02:04:02,267
NOT SPECIFIC TO THE PROTOCOL BUT

2740
02:04:02,267 --> 02:04:03,869
LOOKING TO SEE IF THE PERSON HAS

2741
02:04:03,869 --> 02:04:05,337
INFORMATION ABOUT THE STUDY 

2742
02:04:05,337 --> 02:04:08,173
ITSELF THAT LENDS ITSELF TO YOUR

2743
02:04:08,173 --> 02:04:08,840
UNDERSTANDING.

2744
02:04:08,840 --> 02:04:10,309
YES, THEY'VE BEEN EDUCATED ABOUT

2745
02:04:10,309 --> 02:04:12,311
THIS AND UNDERSTAND WHAT'S GOING

2746
02:04:12,311 --> 02:04:16,782
TO HAPPEN.

2747
02:04:16,782 --> 02:04:20,085
SO, THESE ARE THE TOOLS IN 

2748
02:04:20,085 --> 02:04:20,719
TALKING ABOUT THE CAPACITY 

2749
02:04:20,719 --> 02:04:23,755
ASSESSMENT WITH HSPU.

2750
02:04:23,755 --> 02:04:24,823
THEY'RE CLINICALLY DERIVED AND 

2751
02:04:24,823 --> 02:04:26,625
HAVE NOT BEEN VALIDATED.

2752
02:04:26,625 --> 02:04:30,128
THEY DO USE FOUR DIFFERENT 

2753
02:04:30,128 --> 02:04:31,029
DOMAINS AND WE HAVE 

2754
02:04:31,029 --> 02:04:32,297
APPROXIMATELY NINE TO 11 

2755
02:04:32,297 --> 02:04:32,564
QUESTIONS.

2756
02:04:32,564 --> 02:04:33,966
THEY'RE OPEN-ENDED BECAUSE WE 

2757
02:04:33,966 --> 02:04:35,467
WANT THIS TO BE MORE OF A 

2758
02:04:35,467 --> 02:04:36,301
CONVERSATION RATHER THAN A 

2759
02:04:36,301 --> 02:04:39,871
CHECKLIST.

2760
02:04:39,871 --> 02:04:42,241
WE WANT TO BE ABLE TO TALK TO 

2761
02:04:42,241 --> 02:04:43,008
SOMEBODY.

2762
02:04:43,008 --> 02:04:47,045
SOMETIMES DEPENDING ON WHETHER 

2763
02:04:47,045 --> 02:04:48,080
IT'S OUT PATIENT OR COMING BACK 

2764
02:04:48,080 --> 02:04:50,415
OVER TIME YOU MAY NOT HAVE -- 

2765
02:04:50,415 --> 02:04:51,984
THEY HAVEN'T HAD A LOT OF TIME 

2766
02:04:51,984 --> 02:04:53,352
TO HAVE THE EDUCATION PIECE.

2767
02:04:53,352 --> 02:04:55,721
AND YOU WANT THEM -- THEY'VE 

2768
02:04:55,721 --> 02:04:56,355
GONE THROUGH AND DRIVEN HERE 

2769
02:04:56,355 --> 02:04:58,790
WITH A FAMILY MEMBER PERHAPS OR 

2770
02:04:58,790 --> 02:05:00,892
MAYBE ON THEIR OWN.

2771
02:05:00,892 --> 02:05:01,893
THEY'VE ALSO VOLUNTEERED 

2772
02:05:01,893 --> 02:05:03,362
ADMISSIONS AND TRYING TO MAKE 

2773
02:05:03,362 --> 02:05:05,697
SURE THEY'RE IN THE RIGHT SPOT, 

2774
02:05:05,697 --> 02:05:06,565
RIGHT LOCATION.

2775
02:05:06,565 --> 02:05:08,700
IF THERE'S A LITTLE 

2776
02:05:08,700 --> 02:05:09,901
UNDERSTANDABLE ANXIETY AND 

2777
02:05:09,901 --> 02:05:11,203
GETTING SETTLED YOU WANT TO GIVE

2778
02:05:11,203 --> 02:05:13,005
THAT PERSON TIME TO GET SETTLED 

2779
02:05:13,005 --> 02:05:14,006
ENOUGH AND GET COMFORTABLE 

2780
02:05:14,006 --> 02:05:16,308
ENOUGH WITH YOU TO HAVE THE 

2781
02:05:16,308 --> 02:05:18,176
CONVERSATION AND NOT FEEL LIKE 

2782
02:05:18,176 --> 02:05:20,746
THEY'RE BEING QUIZZED.

2783
02:05:20,746 --> 02:05:21,813
USUALLY WE HAVE TWO EVALUATORS.

2784
02:05:21,813 --> 02:05:24,816
WE CAN DO IT WITH ONE.

2785
02:05:24,816 --> 02:05:26,852
IT DOES WORK WELL WITH TWO 

2786
02:05:26,852 --> 02:05:28,387
BECAUSE THEN CLINICALLY 

2787
02:05:28,387 --> 02:05:30,355
AFTERWARDS PEOPLE CAN TALK WITH 

2788
02:05:30,355 --> 02:05:31,456
EACH OTHER AND SHARE THEIR 

2789
02:05:31,456 --> 02:05:33,158
THOUGHTS AND OPINIONS ABOUT WHAT

2790
02:05:33,158 --> 02:05:35,927
THEY'VE SEEN AND MAKE SURE THAT 

2791
02:05:35,927 --> 02:05:38,297
WE'RE BOTH COMFORTABLE WITH 

2792
02:05:38,297 --> 02:05:39,131
MOVING AHEAD.

2793
02:05:39,131 --> 02:05:40,699
IT CONSISTS OF TAILORED 

2794
02:05:40,699 --> 02:05:41,867
QUESTIONS TO EACH DOMAIN.

2795
02:05:41,867 --> 02:05:45,837
I THINK THIS IS REALLY HELPFUL.

2796
02:05:45,837 --> 02:05:50,542
WE DEVELOPED A SHORTER VERSION 

2797
02:05:50,542 --> 02:05:55,013
OF THE MACARTHUR COMPETENCE 

2798
02:05:55,013 --> 02:06:00,585
ASSESSMENT TOOL DEVELOPED BY TWO

2799
02:06:00,585 --> 02:06:03,822
DOCTORS AND THEY CREATED THE 

2800
02:06:03,822 --> 02:06:05,490
DOMAINS AND INDIVIDUALS WITH 

2801
02:06:05,490 --> 02:06:07,693
SCHIZOPHRENIA AND WE TAILORED IT

2802
02:06:07,693 --> 02:06:09,528
DOWN TO FEWER QUESTIONS BUT 

2803
02:06:09,528 --> 02:06:12,264
STILL USE THE DOMAIN CONCEPT 

2804
02:06:12,264 --> 02:06:14,166
WHICH I THINK IS REALLY 

2805
02:06:14,166 --> 02:06:14,766
VALUABLE.

2806
02:06:14,766 --> 02:06:16,201
UNDERSTANDING IS THE FIRST 

2807
02:06:16,201 --> 02:06:16,435
DOMAIN.

2808
02:06:16,435 --> 02:06:19,104
AS IT SAYS HERE UNDERSTANDING OF

2809
02:06:19,104 --> 02:06:20,605
THE POTENTIAL PARTICIPANT'S 

2810
02:06:20,605 --> 02:06:22,541
PERSON SITUATION AND STUDY 

2811
02:06:22,541 --> 02:06:24,309
SPECIFIC PROCEDURE.

2812
02:06:24,309 --> 02:06:25,911
THE QUESTIONS THAT WE ASK 

2813
02:06:25,911 --> 02:06:29,147
UNDERNEATH THAT DOMAIN TYPICALLY

2814
02:06:29,147 --> 02:06:30,782
ARE WHAT DO YOU HAVE THE 

2815
02:06:30,782 --> 02:06:33,985
RESEARCHERS ARE INTERESTED IN 

2816
02:06:33,985 --> 02:06:34,252
STUDYING?

2817
02:06:34,252 --> 02:06:34,886
FOR EXAMPLE SOMEBODY COMES IN 

2818
02:06:34,886 --> 02:06:35,587
WITH ALZHEIMER'S DISEASE THEY 

2819
02:06:35,587 --> 02:06:38,857
DON'T HAVE TO SAY ALZHEIMER'S 

2820
02:06:38,857 --> 02:06:41,793
DISEASE BUT IF THEY CAN CONVEY 

2821
02:06:41,793 --> 02:06:42,394
THEY'RE HAVING MEMORY 

2822
02:06:42,394 --> 02:06:42,994
DIFFICULTIES.

2823
02:06:42,994 --> 02:06:44,629
I'M WORRIED ABOUT THIS AND 

2824
02:06:44,629 --> 02:06:46,498
SOMETIMES SAY IT'S IN THEIR 

2825
02:06:46,498 --> 02:06:46,765
FAMILY.

2826
02:06:46,765 --> 02:06:48,367
YOU'RE ASKING QUESTIONS ON WHAT 

2827
02:06:48,367 --> 02:06:49,601
BRINGS YOU HERE AND WHAT THEY'LL

2828
02:06:49,601 --> 02:06:52,938
ASK YOU TO DO AS PART OF THE 

2829
02:06:52,938 --> 02:06:54,773
STUDY HERE AT NIH YOU'LL BE 

2830
02:06:54,773 --> 02:06:56,007
INVOLVED IN?

2831
02:06:56,007 --> 02:06:58,310
THEN IF THAT SEEMS CLEAR THEY 

2832
02:06:58,310 --> 02:07:04,049
HAVE A GOOD UNDERSTANDING OF WHY

2833
02:07:04,049 --> 02:07:05,117
THEY'RE HERE AND WHAT THEY'LL BE

2834
02:07:05,117 --> 02:07:06,017
ASKED TO DO AND THE APPRECIATION

2835
02:07:06,017 --> 02:07:09,621
OF THE EFFECTS OF STUDY 

2836
02:07:09,621 --> 02:07:11,390
PARTICIPATION ON THE POTENTIAL 

2837
02:07:11,390 --> 02:07:12,257
PARTICIPANT.

2838
02:07:12,257 --> 02:07:14,092
WHAT THAT TRANSLATES TO THEN IN 

2839
02:07:14,092 --> 02:07:17,929
QUESTIONS IS WHAT ARE YOU GOING 

2840
02:07:17,929 --> 02:07:19,931
TO HAVE TO DO IN WHY YOU ARE 

2841
02:07:19,931 --> 02:07:21,433
LIFE TO BE HERE?

2842
02:07:21,433 --> 02:07:23,769
FOR EXAMPLE, WE HAVE A STUDY ON 

2843
02:07:23,769 --> 02:07:25,837
THE 7th FLOOR WITH PEOPLE WHO 

2844
02:07:25,837 --> 02:07:30,976
HAVE PSYCHOTIC DISORDERS.

2845
02:07:30,976 --> 02:07:32,277
THEY HAVE TO COME AND STAY FOR 

2846
02:07:32,277 --> 02:07:33,745
MANY MONTHS AT A TIME.

2847
02:07:33,745 --> 02:07:36,314
ARE YOU GOING TO COME OFF YOUR 

2848
02:07:36,314 --> 02:07:36,815
MEDICATIONS?

2849
02:07:36,815 --> 02:07:38,717
DID YOU HAVE TO TRAVEL HERE?

2850
02:07:38,717 --> 02:07:40,318
IF YOU'RE AN OUT PATIENT, ARE 

2851
02:07:40,318 --> 02:07:42,587
YOU GOING TO BE DRIVING YOURSELF

2852
02:07:42,587 --> 02:07:42,788
HERE?

2853
02:07:42,788 --> 02:07:44,289
HOW ARE YOU GOING TO GET BACK 

2854
02:07:44,289 --> 02:07:46,358
AND FORM AND HOW WILL IT AFFECT 

2855
02:07:46,358 --> 02:07:48,293
YOUR LIFE AND WE TALK TO PEOPLE 

2856
02:07:48,293 --> 02:07:49,594
ABOUT THEIR PETS PAUSE THAT'S A 

2857
02:07:49,594 --> 02:07:51,463
CONCERN FOR PEOPLE IF THEY'LL BE

2858
02:07:51,463 --> 02:07:52,130
HERE A LONG TIME.

2859
02:07:52,130 --> 02:07:53,665
DO THEY HAVE SOMEBODY TO TAKE 

2860
02:07:53,665 --> 02:07:55,000
CARE OF THEIR ANIMALS FOR THEM.

2861
02:07:55,000 --> 02:07:56,101
IT'S APPRECIATING WHAT IT MEANS 

2862
02:07:56,101 --> 02:07:57,636
TO BE HERE AT THE CLINICAL 

2863
02:07:57,636 --> 02:08:00,305
CENTER AND HOW THAT MAY IMPACT 

2864
02:08:00,305 --> 02:08:00,705
YOUR LIFE.

2865
02:08:00,705 --> 02:08:03,608
THE NEXT DOMAIN THEN IS 

2866
02:08:03,608 --> 02:08:04,042
REASONING.

2867
02:08:04,042 --> 02:08:05,210
IT SAYS THE REASONING OF WHY 

2868
02:08:05,210 --> 02:08:08,747
POTENTIAL PARTICIPANTS WANT TO 

2869
02:08:08,747 --> 02:08:09,581
BE IN RESEARCH.

2870
02:08:09,581 --> 02:08:11,149
ONE OF THE THINGS WE ALWAYS SAY 

2871
02:08:11,149 --> 02:08:14,286
TO PEOPLE IS WE'RE NOT THE 

2872
02:08:14,286 --> 02:08:14,986
MOTIVATION POLICE.

2873
02:08:14,986 --> 02:08:16,221
THERE'S A LOT OF DIFFERENT 

2874
02:08:16,221 --> 02:08:17,923
REASONS WHY PEOPLE WANT TO COME 

2875
02:08:17,923 --> 02:08:19,691
TO THE NIH TO PARTICIPATE IN A 

2876
02:08:19,691 --> 02:08:19,891
STUDY.

2877
02:08:19,891 --> 02:08:22,661
WHAT WE WANT TO MAKE SURE ABOUT 

2878
02:08:22,661 --> 02:08:31,736
IS ENSURING PEOPLE ARE USING THE

2879
02:08:31,736 --> 02:08:35,474
INFORMATION TO MAKE A DECISION 

2880
02:08:35,474 --> 02:08:37,943
AND THEY MAY NOT GET A 

2881
02:08:37,943 --> 02:08:38,510
MEDICATION TO TREAT THEIR 

2882
02:08:38,510 --> 02:08:43,014
CONDITION YOU WANT TO MAKE SURE 

2883
02:08:43,014 --> 02:08:44,850
THEY'RE NOT COMING HERE THINKING

2884
02:08:44,850 --> 02:08:45,684
YOU'RE GOING TO CURE THEM.

2885
02:08:45,684 --> 02:08:48,987
THE LAST DOMAIN IS CHOICE.

2886
02:08:48,987 --> 02:08:49,921
HOW MANY -- IF YOU'RE DECIDING 

2887
02:08:49,921 --> 02:08:52,057
YES I WANT TO DO THIS WE'RE LIKE

2888
02:08:52,057 --> 02:08:56,495
THAT'S FINE BUT WE ALSO WANT YOU

2889
02:08:56,495 --> 02:08:57,662
TO TAKE SERIOUSLY WHEN PEOPLE 

2890
02:08:57,662 --> 02:08:58,997
DON'T WANT TO PARTICIPATE AND 

2891
02:08:58,997 --> 02:09:00,298
HOW WOULD YOU LET THE 

2892
02:09:00,298 --> 02:09:02,901
RESEARCHERS KNOW IF YOU CHANGED 

2893
02:09:02,901 --> 02:09:04,302
YOUR MIND ABOUT BEING IN THE 

2894
02:09:04,302 --> 02:09:05,136
STUDY.

2895
02:09:05,136 --> 02:09:07,739
THESE ARE THIS DIFFERENT 

2896
02:09:07,739 --> 02:09:08,039
HIERARCHIES.

2897
02:09:08,039 --> 02:09:09,374
I BELIEVE DR. KIM SPOKE ABOUT 

2898
02:09:09,374 --> 02:09:11,109
THIS A LITTLE BIT SO I WON'T GO 

2899
02:09:11,109 --> 02:09:14,779
IN GREAT DETAIL BUT WE HAVE 

2900
02:09:14,779 --> 02:09:17,082
LEGAL GUARDIANS AND INDIVIDUALS 

2901
02:09:17,082 --> 02:09:18,984
COME WITH A LEGAL GUARDIANSHIP.

2902
02:09:18,984 --> 02:09:21,586
THAT HAS TO BE REVIEWED BY THE 

2903
02:09:21,586 --> 02:09:22,787
OFFICE OF GENERAL COUNCIL AT 

2904
02:09:22,787 --> 02:09:22,954
NIH.

2905
02:09:22,954 --> 02:09:24,856
I'M A SOCIAL WORKER, THE 

2906
02:09:24,856 --> 02:09:30,428
RESEARCHERS -- WE NEED TO MAKE 

2907
02:09:30,428 --> 02:09:32,297
SURE IT COVERS RESEARCHERS AND 

2908
02:09:32,297 --> 02:09:34,966
SOME COME FROM OUTSIDE DURABLE 

2909
02:09:34,966 --> 02:09:37,035
POWERS OF ATTORNEY, IF NOT THEY 

2910
02:09:37,035 --> 02:09:42,707
CAN FILL OUT AN NIH FORM 200 

2911
02:09:42,707 --> 02:09:44,276
ADVANCED DIRECTIVE OR NEXT OF 

2912
02:09:44,276 --> 02:09:45,844
KIN DEPENDING ON THE RISK 

2913
02:09:45,844 --> 02:09:48,413
BENEFIT LEVEL OF A STUDY.

2914
02:09:48,413 --> 02:09:53,485
BEING ABLE TO ASSIGN AN NIH 

2915
02:09:53,485 --> 02:09:55,053
ADVANCE DIRECTIVE OBLIGATED TO 

2916
02:09:55,053 --> 02:09:57,255
COME IN IF SOMEBODY DOESN'T HAVE

2917
02:09:57,255 --> 02:09:58,456
CONCEPT CAPACITY AND HAVEN'T AND

2918
02:09:58,456 --> 02:10:03,328
IT'S A PROTOCOL THAT ALLOWS FOR 

2919
02:10:03,328 --> 02:10:05,130
SURROGATE CONSENT BUT DON'T HAVE

2920
02:10:05,130 --> 02:10:07,032
SOMEBODY THEY'VE NAMED THEY NEED

2921
02:10:07,032 --> 02:10:10,101
TO ASSESS TO MAKE SURE THOUGH 

2922
02:10:10,101 --> 02:10:10,969
ASSIGNING SOMEBODY TO MAKE 

2923
02:10:10,969 --> 02:10:13,705
DECISIONS ON YOUR BEHALF IS KIND

2924
02:10:13,705 --> 02:10:16,041
OF A LOWER BAR THAN HAVING 

2925
02:10:16,041 --> 02:10:16,608
CONSENT CAPACITY.

2926
02:10:16,608 --> 02:10:19,477
YOU WANT TO MAKE SURE THIS 

2927
02:10:19,477 --> 02:10:20,712
PERSON IS CLEAR ABOUT WHAT THIS 

2928
02:10:20,712 --> 02:10:23,148
INDIVIDUAL'S GOING TO DO FOR 

2929
02:10:23,148 --> 02:10:23,582
THEM.

2930
02:10:23,582 --> 02:10:25,483
YOU WANT TO MAKE SURE THEY'RE 

2931
02:10:25,483 --> 02:10:26,384
AWARE THEY'RE GIVING THE 

2932
02:10:26,384 --> 02:10:27,852
AUTHORITY TO SOMEBODY ELSE.

2933
02:10:27,852 --> 02:10:31,022
SO THE TEAM CAN COME IN AND 

2934
02:10:31,022 --> 02:10:34,225
ASSESS FOR THAT.

2935
02:10:34,225 --> 02:10:36,294
THE VALIDITY OF THE LAR.

2936
02:10:36,294 --> 02:10:38,997
YOU WANT TO MAKE SURE THOSE 

2937
02:10:38,997 --> 02:10:44,302
INDIVIDUALS -- YOU WANT TO 

2938
02:10:44,302 --> 02:10:44,970
CONFIRM THIS IS THE INDIVIDUAL 

2939
02:10:44,970 --> 02:10:47,238
THE PERSON WANTS AND ALLOWED 

2940
02:10:47,238 --> 02:10:48,773
UNDER THE DIFFERENT CATEGORIES.

2941
02:10:48,773 --> 02:10:52,143
THEY THEMSELVES HAVE CAPACITY TO

2942
02:10:52,143 --> 02:10:54,245
GIVE CONSENT ON BEHALF OF 

2943
02:10:54,245 --> 02:10:55,814
SOMEBODY ELSE ON RESEARCH AND 

2944
02:10:55,814 --> 02:10:56,715
REPRESENTING THE BEST WISHES OF 

2945
02:10:56,715 --> 02:10:57,515
THE INDIVIDUAL.

2946
02:10:57,515 --> 02:10:58,850
ONE OF THE THINGS WE WILL ASK 

2947
02:10:58,850 --> 02:11:00,852
PEOPLE IS ARE YOU COMFORTABLE 

2948
02:11:00,852 --> 02:11:03,054
SPECKING UP ON BEHALF OF THIS 

2949
02:11:03,054 --> 02:11:03,288
PERSON?

2950
02:11:03,288 --> 02:11:05,056
YOU MAY VERY WELL HAVE TO SAY TO

2951
02:11:05,056 --> 02:11:07,025
THE RESEARCH TEAM, WE CAN'T DO 

2952
02:11:07,025 --> 02:11:07,892
THIS ANYMORE.

2953
02:11:07,892 --> 02:11:08,660
IT'S TOO DIFFICULT FOR THE 

2954
02:11:08,660 --> 02:11:10,362
PERSON AND ARE YOU COMFORTABLE 

2955
02:11:10,362 --> 02:11:11,396
DOING THAT AND ASKING QUESTIONS 

2956
02:11:11,396 --> 02:11:13,031
ON THEIR BEHALF.

2957
02:11:13,031 --> 02:11:15,400
ONE OF THE THINGS WE'VE ASKED 

2958
02:11:15,400 --> 02:11:17,035
PEOPLE IS HOW WOULD YOU KNOW IF 

2959
02:11:17,035 --> 02:11:18,203
THIS INDIVIDUAL DIDN'T WANT TO 

2960
02:11:18,203 --> 02:11:19,070
DO SOMETHING AND THAT SEEMS TO 

2961
02:11:19,070 --> 02:11:21,806
BE A HELPFUL QUESTION FOR THE 

2962
02:11:21,806 --> 02:11:22,207
TEAM.

2963
02:11:22,207 --> 02:11:25,076
ARE THEY GOING TO -- A LOT OF 

2964
02:11:25,076 --> 02:11:30,148
TIMES YOU'LL GET AN ANSWER RIGHT

2965
02:11:30,148 --> 02:11:34,352
AWAY AND THEY MAY SPEAK UP AND 

2966
02:11:34,352 --> 02:11:38,223
SOME MAY BEHAVIORALLY DISSENT 

2967
02:11:38,223 --> 02:11:40,992
AND STOMP OFF BUT YOU WANT TO BE

2968
02:11:40,992 --> 02:11:42,293
SURE THEY KNOW THEIR OBLIGATIONS

2969
02:11:42,293 --> 02:11:43,895
IN DOING SO.

2970
02:11:43,895 --> 02:11:45,163
THIS IS A BIT MORE INFORMATION 

2971
02:11:45,163 --> 02:11:48,833
WHEN CAPACITY ASSESSMENTS GO 

2972
02:11:48,833 --> 02:11:49,067
WELL.

2973
02:11:49,067 --> 02:11:51,136
WHEN PEOPLE KNOW IT'S GOING TO 

2974
02:11:51,136 --> 02:11:52,303
HAPPEN, WHEN THE PAPERWORK HAS 

2975
02:11:52,303 --> 02:11:55,073
BEEN LOOKED AT AHEAD OF TIME.

2976
02:11:55,073 --> 02:11:58,143
YOU MAKE SURE YOU'VE ARRANGED 

2977
02:11:58,143 --> 02:12:02,047
PLENTY OF TIME TO MAKE ANY AND 

2978
02:12:02,047 --> 02:12:03,548
ALL ASSESSMENTS BEFORE THE 

2979
02:12:03,548 --> 02:12:06,284
CONSENT IS SIGNED AND MAKING 

2980
02:12:06,284 --> 02:12:12,290
SURE THE INVESTIGATOR HOW THEY 

2981
02:12:12,290 --> 02:12:17,829
GET ALONG AND HOW THEY'VE MADE 

2982
02:12:17,829 --> 02:12:21,266
DECISIONS IN THE PAST AND 

2983
02:12:21,266 --> 02:12:22,233
DOCUMENTING WHAT THE DECISIONS 

2984
02:12:22,233 --> 02:12:23,535
ARE AND WHO THE PERSON IS GOING 

2985
02:12:23,535 --> 02:12:24,302
TO BE.

2986
02:12:24,302 --> 02:12:26,104
THESE ARE SOME OF THE PITFALLS.

2987
02:12:26,104 --> 02:12:28,139
IT CAN BE VERY ANXIETY 

2988
02:12:28,139 --> 02:12:28,740
PROVOKING.

2989
02:12:28,740 --> 02:12:31,109
OUR GROUP IS LESS SO BECAUSE 

2990
02:12:31,109 --> 02:12:32,277
WE'RE WRITTEN INTO PROTOCOLS AND

2991
02:12:32,277 --> 02:12:36,314
THEY KNOW THEY HAVE TO SCHEDULE 

2992
02:12:36,314 --> 02:12:38,183
US AHEAD OF TIME AND KNOW THE 

2993
02:12:38,183 --> 02:12:39,350
TEAMS WELL AND HAVE GOTTEN TO 

2994
02:12:39,350 --> 02:12:41,553
KNOW THE PARTICIPANTS WE'RE 

2995
02:12:41,553 --> 02:12:42,120
FOLLOWING AS WELL BUT IF 

2996
02:12:42,120 --> 02:12:47,492
SOMEBODY DOESN'T FLOW -- KNOW A 

2997
02:12:47,492 --> 02:12:48,293
CAPACITY ASSESSMENT IS REQUIRED 

2998
02:12:48,293 --> 02:12:50,195
AND NOT TALKING ABOUT IT AHEAD 

2999
02:12:50,195 --> 02:12:53,231
OF TIME AND NOT NORMALIZED AND 

3000
02:12:53,231 --> 02:12:54,632
SOMETHING WE DO FOR EVERYBODY 

3001
02:12:54,632 --> 02:12:56,301
DEPENDING ON THE PROTOCOL, THE 

3002
02:12:56,301 --> 02:12:59,070
ASSESSMENT GETS DONE AFTER THE 

3003
02:12:59,070 --> 02:13:00,772
CONSENT IS SIGNED, NOT EDUCATING

3004
02:13:00,772 --> 02:13:04,309
THE PARTICIPANT AHEAD OF TIME.

3005
02:13:04,309 --> 02:13:09,214
WE'VE HAD THAT HAPPEN.

3006
02:13:09,214 --> 02:13:10,849
IT'S NOT FAIR TO ASK QUESTIONS 

3007
02:13:10,849 --> 02:13:12,650
IF THEY HAVEN'T LAD AN 

3008
02:13:12,650 --> 02:13:16,221
OPPORTUNITY TO -- HAD AN 

3009
02:13:16,221 --> 02:13:17,288
OPPORTUNITY TO UNDERSTAND AND 

3010
02:13:17,288 --> 02:13:19,124
THERE'S POOR COMMUNICATION AND 

3011
02:13:19,124 --> 02:13:21,860
PEOPLE CAN GET VERY ANXIOUS, THE

3012
02:13:21,860 --> 02:13:23,795
TEAM AS WELL AS THE PARTICIPANT.

3013
02:13:23,795 --> 02:13:25,096
THESE ARE CONSIDERATIONS IF 

3014
02:13:25,096 --> 02:13:27,899
YOU'RE WRITING A PROTOCOL.

3015
02:13:27,899 --> 02:13:30,869
ARE YOU GOING TO ALLOW PEOPLE 

3016
02:13:30,869 --> 02:13:32,737
WHO HAVE LEGAL GUARDIANS, ARE 

3017
02:13:32,737 --> 02:13:36,307
YOU GOING TO ALLOW SURROGATES.

3018
02:13:36,307 --> 02:13:39,144
WHEN MINORS AGE OUT MAYBE THEY 

3019
02:13:39,144 --> 02:13:41,613
ARE HAVE CAPACITY ISSUES AND ANY

3020
02:13:41,613 --> 02:13:43,114
ADDITIONAL PROTECTS, DETERMINES 

3021
02:13:43,114 --> 02:13:44,282
WHO ADMINISTERS THE ASSESSMENT, 

3022
02:13:44,282 --> 02:13:48,286
POLICY VERSUS PROTOCOL, ONGOING 

3023
02:13:48,286 --> 02:13:51,790
CONSENT AS WELL.

3024
02:13:51,790 --> 02:13:54,058
I THINK WE'RE UP TO CASE 

3025
02:13:54,058 --> 02:13:55,126
EXAMPLES NOW.

3026
02:13:55,126 --> 02:14:05,136
>> THANK YOU FOR THAT.

3027
02:14:05,136 --> 02:14:15,647
>> WE'LL TALK ABOUT THE
CASES.

3028
02:14:19,717 --> 02:14:21,953
>> AN ADULT THAT PRESENTS
AT THE

3029
02:14:21,953 --> 02:14:25,590
CLINICAL CENTER TO PARTS OPERATE

3030
02:14:25,590 --> 02:14:27,892
AND HIS MEANS MINOR INCREMENT 

3031
02:14:27,892 --> 02:14:34,032
OVER MINIMAL RISK NOT FOR DIRECT

3032
02:14:34,032 --> 02:14:38,469
BENEFIT AND THE DAY BEFORE THE 

3033
02:14:38,469 --> 02:14:39,070
INVESTIGATOR CALLED THE 

3034
02:14:39,070 --> 02:14:40,238
PARTICIPANT TO MAKE SURE WHEN 

3035
02:14:40,238 --> 02:14:43,107
THEY COME IN THEY HAVE MORE 

3036
02:14:43,107 --> 02:14:44,275
INFORMATION AND HAVE HAD AN 

3037
02:14:44,275 --> 02:14:45,510
OPPORTUNITY TO ASK HIM 

3038
02:14:45,510 --> 02:14:45,777
QUESTIONS.

3039
02:14:45,777 --> 02:14:49,414
THE STUDY DOES ALLOW FOR LAR 

3040
02:14:49,414 --> 02:14:53,017
CONSENT AND BRINGS HER ADULT 

3041
02:14:53,017 --> 02:14:55,119
DAUGHTER WITH HER AS SHE ALREADY

3042
02:14:55,119 --> 02:14:58,556
ASSIGNS A DURABLE POWER OF 

3043
02:14:58,556 --> 02:14:58,823
ATTORNEY.

3044
02:14:58,823 --> 02:14:59,958
IF SHE DOESN'T HAVE CAPACITY WE 

3045
02:14:59,958 --> 02:15:02,694
CAN GO TO THE ADULT DAUGHTER.

3046
02:15:02,694 --> 02:15:04,629
THE STUDY REQUIRES TO COME IN 

3047
02:15:04,629 --> 02:15:07,999
AND DO THE CAPACITY ASSESSMENT.

3048
02:15:07,999 --> 02:15:09,667
WE DETERMINED SHE DOESN'T HAVE 

3049
02:15:09,667 --> 02:15:12,303
CAPACITY WHICH MEANS WE CAN GO 

3050
02:15:12,303 --> 02:15:14,706
TO SURROGATE BUT THE DAUGHTER 

3051
02:15:14,706 --> 02:15:18,476
ALSO INDICATES SHE IS ELIGIBLE 

3052
02:15:18,476 --> 02:15:21,980
TO ENROLL IN AN MRI STUDY OF 

3053
02:15:21,980 --> 02:15:24,916
MINIMAL RISK, LONGITUDINAL STUDY

3054
02:15:24,916 --> 02:15:26,150
WITH ANOTHER NIH INSTITUTE.

3055
02:15:26,150 --> 02:15:28,286
SO WHAT ARE SOME OF THE THINGS 

3056
02:15:28,286 --> 02:15:30,588
PEOPLE THINK ABOUT HOW WE WOULD 

3057
02:15:30,588 --> 02:15:31,823
PROCEED AT THIS POINT?

3058
02:15:31,823 --> 02:15:32,824
I GAVE ONE AWAY.

3059
02:15:32,824 --> 02:15:34,525
>> AND DON'T FEEL LIKE YOU
HAVE 

3060
02:15:34,525 --> 02:15:40,265
TO RUN OVER TO THE MIKE FOR 

3061
02:15:40,265 --> 02:15:44,302
THIS.

3062
02:15:44,302 --> 02:15:46,704
IMAGINE THIS IS A SITUATION 

3063
02:15:46,704 --> 02:15:47,705
YOU'RE FACED WITH.

3064
02:15:47,705 --> 02:15:48,473
SHOULD WE ENROLL HER?

3065
02:15:48,473 --> 02:15:50,041
RAISE YOUR LAND IF YOU WANT TO 

3066
02:15:50,041 --> 02:15:52,277
GO AHEAD AND ENROLL HER?

3067
02:15:52,277 --> 02:15:54,779
ANYONE?

3068
02:15:54,779 --> 02:15:56,314
ALEX, YOU WANT TO GO AHEAD AND 

3069
02:15:56,314 --> 02:16:00,285
YEP ROLL HER.

3070
02:16:00,285 --> 02:16:10,528
-- ENROLL HER.

3071
02:16:30,481 --> 02:16:32,050
BE BEING -- IN THIS CASE WE GO 

3072
02:16:32,050 --> 02:16:34,185
TO THE DAUGHTER AND THE STUDY 

3073
02:16:34,185 --> 02:16:36,287
ALLOWS FOR AN LAR CONSENT.

3074
02:16:36,287 --> 02:16:40,291
TELL ME, CAROL, SO THE LAST 

3075
02:16:40,291 --> 02:16:41,826
BULLET HERE ABOUT SHE'S ALSO 

3076
02:16:41,826 --> 02:16:47,298
ELIGIBLE TO ENROLL IN ANOTHER 

3077
02:16:47,298 --> 02:16:53,071
STUDY HOW WOULD THAT COME IN TO 

3078
02:16:53,071 --> 02:16:54,005
YOUR CONSIDERATION?

3079
02:16:54,005 --> 02:16:56,107
>> THE DAUGHTER DISCOVERED
SHE 

3080
02:16:56,107 --> 02:16:57,809
DIDN'T HAVE CAPACITY AT THAT 

3081
02:16:57,809 --> 02:16:58,042
MOMENT.

3082
02:16:58,042 --> 02:17:00,244
AS YOU MENTIONED THE DAUGHTER 

3083
02:17:00,244 --> 02:17:02,113
HAS BPA AND THE PARTICIPANT WAS 

3084
02:17:02,113 --> 02:17:04,515
FINE WITH THE DAUGHTER GIVE 

3085
02:17:04,515 --> 02:17:07,118
SURROGATE CONCEPT FOR THE NIMHD 

3086
02:17:07,118 --> 02:17:08,152
STUDY, HOWEVER, THE DAUGHTER WAS

3087
02:17:08,152 --> 02:17:13,825
CONCERNED ABOUT THE OTHER STUDY.

3088
02:17:13,825 --> 02:17:15,493
COULD SHE PARTICIPATE AND WE 

3089
02:17:15,493 --> 02:17:17,195
DON'T HAVE DECISIONS OR SWAY OR 

3090
02:17:17,195 --> 02:17:18,629
ASSESSMENT ONE THING WE TALK 

3091
02:17:18,629 --> 02:17:25,103
ABOUT IS IT'S A MINIMAL RISK 

3092
02:17:25,103 --> 02:17:29,607
STUDY.

3093
02:17:29,607 --> 02:17:30,274
SOMEBODY COULD HAVE CAPACITY FOR

3094
02:17:30,274 --> 02:17:32,777
ONE AND NOT FOR THE OTHER AND 

3095
02:17:32,777 --> 02:17:34,645
MAKE A DETERMINATION WHETHER SHE

3096
02:17:34,645 --> 02:17:36,280
HAD CAPACITY TO MAKE HER OWN 

3097
02:17:36,280 --> 02:17:37,315
CONCEPT OR NOT.

3098
02:17:37,315 --> 02:17:40,985
WE WOULD BE DOCUMENTING AND OUR 

3099
02:17:40,985 --> 02:17:42,854
RESEARCHER WOULD BE DOCUMENTING 

3100
02:17:42,854 --> 02:17:44,322
OUR FINDING AND WE USED A 

3101
02:17:44,322 --> 02:17:45,289
SURROGATE AND THAT WOULD BE 

3102
02:17:45,289 --> 02:17:47,592
AVAILABLE AND COULD SEE THAT BUT

3103
02:17:47,592 --> 02:17:48,659
AGAIN IT SHOULDN'T HAVE AN 

3104
02:17:48,659 --> 02:17:49,994
AFFECT ON THE OTHER STUDY.

3105
02:17:49,994 --> 02:17:52,730
THEY NEED TO MAKE THEIR OWN 

3106
02:17:52,730 --> 02:17:56,267
DETERMINATION BECAUSE IT'S A 

3107
02:17:56,267 --> 02:17:58,169
DIFFERENT STUDY AND SHE PLAY 

3108
02:17:58,169 --> 02:17:59,437
VERY WE WILL HAVE A BACK SEAT.

3109
02:17:59,437 --> 02:18:00,304
>> MAYBE ANOTHER WAY OF
SAYING 

3110
02:18:00,304 --> 02:18:02,840
THAT IS THE FIRST ONE TO REMIND 

3111
02:18:02,840 --> 02:18:05,243
FOLKS IT'S A MINIMAL INCREASE 

3112
02:18:05,243 --> 02:18:08,546
OVER MINOR RISK AND NO DIRECT 

3113
02:18:08,546 --> 02:18:10,715
BENEFIT TO THE PARTICIPANT.

3114
02:18:10,715 --> 02:18:12,717
I DON'T MEAN TO PUT WORDS IN 

3115
02:18:12,717 --> 02:18:19,123
YOUR MOUTH BUT THAT STUDY IS 

3116
02:18:19,123 --> 02:18:23,795
RISKIER AND THE DAUGHTER MAY BE 

3117
02:18:23,795 --> 02:18:25,029
UNCOMFORTABLE PUT HER MOTHER AT 

3118
02:18:25,029 --> 02:18:30,635
RISK BUT MAY BE MORE COMFORTABLE

3119
02:18:30,635 --> 02:18:37,108
WITH THE LOWER RISK IN THE SENSE

3120
02:18:37,108 --> 02:18:41,479
THAT HUR BURDEN MAY BE LESS IF 

3121
02:18:41,479 --> 02:18:42,480
SOMETHING WENT WRONG.

3122
02:18:42,480 --> 02:18:43,481
ARE YOU SAYING THE CAPACITY IS 

3123
02:18:43,481 --> 02:18:45,349
DIFFERENT BECAUSE IT'S RISKIER 

3124
02:18:45,349 --> 02:18:47,852
OR SAYING THE GROUP WHO IS 

3125
02:18:47,852 --> 02:18:49,120
ASSESSING IN THE SECOND STUDY 

3126
02:18:49,120 --> 02:18:50,588
PLAY HAVE A DIFFERENT WAY OF 

3127
02:18:50,588 --> 02:18:51,656
ASSESSING CAPACITY?

3128
02:18:51,656 --> 02:18:53,124
>> I THINK BOTH.

3129
02:18:53,124 --> 02:18:59,564
THE RISKIER STUDY THAT WOULD BE 

3130
02:18:59,564 --> 02:19:01,966
OURS DOES HAVE LIKE A PET SCAN 

3131
02:19:01,966 --> 02:19:07,105
AND CAN STAY ON MEDICATIONS BUT 

3132
02:19:07,105 --> 02:19:10,041
IT'S MORE INVOLVED.

3133
02:19:10,041 --> 02:19:13,478
THERE CAN BE A HIGHER RISK AND 

3134
02:19:13,478 --> 02:19:17,181
NOT FOR DIRECT BENEFIT OR GIVING

3135
02:19:17,181 --> 02:19:20,818
HER MEDICATION OR A PROCEDURE 

3136
02:19:20,818 --> 02:19:22,720
WHERE HER MEMORY MIGHT IMPROVE.

3137
02:19:22,720 --> 02:19:23,855
IT'S FOR CLINICAL RESEARCH AND A

3138
02:19:23,855 --> 02:19:25,590
LOT OF TIMES WHAT WE HEAR FROM 

3139
02:19:25,590 --> 02:19:27,091
FOLKS IS THEY HAVE AN 

3140
02:19:27,091 --> 02:19:27,892
UNDERSTANDING THIS ISN'T GOING 

3141
02:19:27,892 --> 02:19:29,127
TO HELP THEM.

3142
02:19:29,127 --> 02:19:31,729
WE DON'T JUST SAY NOT FOR DIRECT

3143
02:19:31,729 --> 02:19:31,963
BENEFIT.

3144
02:19:31,963 --> 02:19:33,464
THEY'RE VERY GOOD ABOUT 

3145
02:19:33,464 --> 02:19:35,500
EXPLAINING WHAT THAT MEANS.

3146
02:19:35,500 --> 02:19:36,601
YOU'RE HELPING THE FUTURE AND A 

3147
02:19:36,601 --> 02:19:39,403
LOT OF THESE FOLKS WILL COME IN 

3148
02:19:39,403 --> 02:19:41,873
SEVERAL IN THE LAST COUPLE 

3149
02:19:41,873 --> 02:19:42,240
WEEKS.

3150
02:19:42,240 --> 02:19:44,308
I KNOW THIS ISN'T GOING TO HELP 

3151
02:19:44,308 --> 02:19:48,279
ME BUT MY MOTHER HAD THIS AND 

3152
02:19:48,279 --> 02:19:50,548
ANOTHER HAD IT AND THEY PASSED 

3153
02:19:50,548 --> 02:19:52,583
AND WERE WORRIED ABOUT THEIR 

3154
02:19:52,583 --> 02:19:54,385
CHILDREN AND GRANDCHILDREN AND A

3155
02:19:54,385 --> 02:19:57,321
BIG PART OF THEIR MOTIVATION WAS

3156
02:19:57,321 --> 02:19:58,022
CONTRIBUTING TO THE FUTURE AND 

3157
02:19:58,022 --> 02:20:00,224
HOPEFULLY HELP THEIR FAMILY 

3158
02:20:00,224 --> 02:20:01,692
MEMBERS AND THE OTHER MINIMAL 

3159
02:20:01,692 --> 02:20:07,131
RISK, LONGITUDINAL STUDY MAY BE 

3160
02:20:07,131 --> 02:20:09,534
SOMETHING ELSE ENTIRELY.

3161
02:20:09,534 --> 02:20:10,902
IT WOULD BE IMPORTANT FOR THE 

3162
02:20:10,902 --> 02:20:12,069
TEAM TO DO THEIR OWN ASSESSMENT 

3163
02:20:12,069 --> 02:20:14,338
AND FOR THE DAUGHTER.

3164
02:20:14,338 --> 02:20:16,574
SHE CAN STILL WEIGH IN EVEN IF 

3165
02:20:16,574 --> 02:20:19,110
HER MOTHER HAS CAPACITY BUT IT 

3166
02:20:19,110 --> 02:20:21,012
WOULD BE -- THEY WOULD COME TO 

3167
02:20:21,012 --> 02:20:24,482
THEIR OWN DECISION SEPARATELY 

3168
02:20:24,482 --> 02:20:25,116
ABOUT THAT.

3169
02:20:25,116 --> 02:20:26,250
>> GREAT.

3170
02:20:26,250 --> 02:20:30,121
AND SOMETIMES SINCE CAROL AND 

3171
02:20:30,121 --> 02:20:32,990
HER GROUP AND I'M JUST GETTING 

3172
02:20:32,990 --> 02:20:35,560
TO THE NEXT CASE WE MIGHT BE THE

3173
02:20:35,560 --> 02:20:41,265
FOLKS ASKED TO COME IN, THE 

3174
02:20:41,265 --> 02:20:42,567
DEPARTMENT OF BIOETHICS ASKED TO

3175
02:20:42,567 --> 02:20:44,101
COME IN AND ONE DIFFERENCE 

3176
02:20:44,101 --> 02:20:53,945
BETWEEN OUR APPROACHES IS THAT 

3177
02:20:53,945 --> 02:20:57,982
FOR THE NIMHD STUDY WHERE THAT'S

3178
02:20:57,982 --> 02:21:00,284
AN ASSESSMENT SPECIFIC TO A 

3179
02:21:00,284 --> 02:21:03,654
PROTOCOL.

3180
02:21:03,654 --> 02:21:05,456
WE ASK A SERIES OF QUESTIONS BUT

3181
02:21:05,456 --> 02:21:07,124
THEY'RE GENERIC IN THE SENSE OF 

3182
02:21:07,124 --> 02:21:10,728
TELL ME ABOUT THE PURPOSE.

3183
02:21:10,728 --> 02:21:12,096
DON'T QUOTE ME, TELL ME ABOUT 

3184
02:21:12,096 --> 02:21:14,999
THE PURPOSE OF THE STUDY OR WHAT

3185
02:21:14,999 --> 02:21:16,634
RISKS YOU MIGHT BE EXPOSED TO 

3186
02:21:16,634 --> 02:21:19,537
AND YOU'VE ALREADY PREPARED TO 

3187
02:21:19,537 --> 02:21:21,539
GET PARTICULAR ANSWERS TO THOSE 

3188
02:21:21,539 --> 02:21:21,806
QUESTIONS.

3189
02:21:21,806 --> 02:21:23,341
IT COULD BE THAT WHEN WE DO THE 

3190
02:21:23,341 --> 02:21:26,010
ASSESSMENT FOR THE MINIMAL RISK 

3191
02:21:26,010 --> 02:21:31,082
STUDY, THEY DO HAVE THE CAPACITY

3192
02:21:31,082 --> 02:21:33,551
TO UNDERSTAND THE RELATIVELY 

3193
02:21:33,551 --> 02:21:34,352
MINIMAL PROCEDURES THAT ARE 

3194
02:21:34,352 --> 02:21:35,519
INVOLVED IN THE MRI STUDY.

3195
02:21:35,519 --> 02:21:37,822
SO WE'RE GOING TO GO TO CASE 2.

3196
02:21:37,822 --> 02:21:40,758
TELL US ABOUT THIS ONE.

3197
02:21:40,758 --> 02:21:41,826
>> YES.

3198
02:21:41,826 --> 02:21:47,031
C HAS SKITS FCHIZOPHRENIA AND ED

3199
02:21:47,031 --> 02:21:50,301
IN A MINIMAL RISK PROTOCOL TO 

3200
02:21:50,301 --> 02:21:51,736
DETERMINE THEIR ELIGIBILITY FOR 

3201
02:21:51,736 --> 02:21:56,641
MORE THAN MINIMAL RISK, NOT FOR 

3202
02:21:56,641 --> 02:21:59,910
DIRECT BENEFIT DOUBLE PLACEBO 

3203
02:21:59,910 --> 02:22:02,213
STUDY THE NURSING POINT WITH 

3204
02:22:02,213 --> 02:22:05,483
THESE CASES THEY ARE COME IN AND

3205
02:22:05,483 --> 02:22:06,751
ARE THERE FOR SEVERAL WEEKS 

3206
02:22:06,751 --> 02:22:11,689
SOMETIMES LONGER BEFORE WE'RE 

3207
02:22:11,689 --> 02:22:22,233
GOING A CAPACITY ASSESSMENT AND 

3208
02:22:22,233 --> 02:22:24,802
IN THIS STUDY AN LAR IS NOT 

3209
02:22:24,802 --> 02:22:28,272
ALLOWED TO PROVIDE CONCEPT.

3210
02:22:28,272 --> 02:22:29,373
THEY HAVE TO HAVE CAPACITY IN 

3211
02:22:29,373 --> 02:22:31,142
ORDER TO PARTICIPATE IN THE 

3212
02:22:31,142 --> 02:22:31,709
STUDY.

3213
02:22:31,709 --> 02:22:34,645
SO AT THIS TIME WE DETERMINED 

3214
02:22:34,645 --> 02:22:37,148
THAT C DID NOT HAVE CAPACITY AND

3215
02:22:37,148 --> 02:22:38,716
C HAD INDICATED RESERVATION 

3216
02:22:38,716 --> 02:22:41,152
ABOUT PARTICIPATING AND THAT'S 

3217
02:22:41,152 --> 02:22:44,288
NOT AN UNUSUAL SCENARIO WE HAVE 

3218
02:22:44,288 --> 02:22:44,889
AS WELL.

3219
02:22:44,889 --> 02:22:49,694
SO WHAT DO PEOPLE THINK OUR NEXT

3220
02:22:49,694 --> 02:22:52,263
STEPS ARE.

3221
02:22:52,263 --> 02:22:55,733
>> SO ONE OPTION MIGHT
JUST BE 

3222
02:22:55,733 --> 02:22:57,401
OKAY, C DIDN'T HAVE CAPACITY HE 

3223
02:22:57,401 --> 02:22:58,869
IS THEREFORE NOT ELIGIBLE FOR 

3224
02:22:58,869 --> 02:23:01,539
THE STUDY AND THAT'S IT.

3225
02:23:01,539 --> 02:23:03,974
SEND HIM ON HIS WAY.

3226
02:23:03,974 --> 02:23:09,613
IS THERE ANY IDEAS ABOUT AN 

3227
02:23:09,613 --> 02:23:19,957
ALTERNATIVE TO THAT?

3228
02:23:25,463 --> 02:23:27,198
>> WE HAVE A CONVERSATION
AND 

3229
02:23:27,198 --> 02:23:29,033
WHAT'S THAT ABOUT AND WE TALK 

3230
02:23:29,033 --> 02:23:31,102
WITH THE RESEARCHERS TOO.

3231
02:23:31,102 --> 02:23:34,238
ONE OPTION IS WE WOULD -- IF THE

3232
02:23:34,238 --> 02:23:36,140
PERSON IS GIVEN THE CHOICE.

3233
02:23:36,140 --> 02:23:37,842
WE'RE ALWAYS VERY CLEAR 

3234
02:23:37,842 --> 02:23:38,576
ESPECIALLY WITH THIS POPULATION 

3235
02:23:38,576 --> 02:23:39,677
IT'S THEIR DECISION TO 

3236
02:23:39,677 --> 02:23:41,112
PARTICIPATE IN THE STUDY AND 

3237
02:23:41,112 --> 02:23:43,981
IT'S NOT ATYPICAL YOU GET REALLY

3238
02:23:43,981 --> 02:23:46,884
WELL MEANING FAMILY AND FRIENDS 

3239
02:23:46,884 --> 02:23:48,185
WHO FEEL LIKE THEY'RE HERE AT 

3240
02:23:48,185 --> 02:23:48,719
THE NIH.

3241
02:23:48,719 --> 02:23:51,322
THIS IS THE GOLD STANDARD.

3242
02:23:51,322 --> 02:23:53,290
IF ANYBODY CAN HELP MY LOVED 

3243
02:23:53,290 --> 02:23:54,291
ONE, YOU CAN.

3244
02:23:54,291 --> 02:23:56,427
WE ALWAYS REMIND THEM, IT'S THE 

3245
02:23:56,427 --> 02:23:57,661
PARTICIPANT'S DECISION.

3246
02:23:57,661 --> 02:24:00,264
WE CAN SAY THERE'S SEVERAL 

3247
02:24:00,264 --> 02:24:00,498
OPTIONS.

3248
02:24:00,498 --> 02:24:01,565
YOU CAN BE DISCHARGED.

3249
02:24:01,565 --> 02:24:04,201
THAT'S FINE.

3250
02:24:04,201 --> 02:24:06,103
YOU CAN GO BACK HOME WHEREVER 

3251
02:24:06,103 --> 02:24:08,038
THAT IS WHATEVER THAT SCENARIO 

3252
02:24:08,038 --> 02:24:08,205
IS.

3253
02:24:08,205 --> 02:24:10,007
WE CAN REMIND THEM AGAIN, YOU 

3254
02:24:10,007 --> 02:24:15,012
DON'T HAVE TO DO THIS.

3255
02:24:15,012 --> 02:24:15,713
DO YOU WANT TO SPEND MORE TIME 

3256
02:24:15,713 --> 02:24:16,714
LEARNING ABOUT THE STUDY AND 

3257
02:24:16,714 --> 02:24:18,816
WE'LL TALK ABOUT THE AREAS THEY 

3258
02:24:18,816 --> 02:24:19,784
HAD DIFFICULTY WITH AND TALK 

3259
02:24:19,784 --> 02:24:21,452
WITH THE RESEARCHERS.

3260
02:24:21,452 --> 02:24:23,053
THE RESEARCHERS DON'T WANT TO 

3261
02:24:23,053 --> 02:24:23,888
PRESSURE SOMEBODY TO STAY AT 

3262
02:24:23,888 --> 02:24:28,259
THAT POINT BUT SOMETIMES AT THAT

3263
02:24:28,259 --> 02:24:30,194
POINT THE PERSON HAS A CLEAR 

3264
02:24:30,194 --> 02:24:30,861
UNDERSTANDING THOUGH MY PARENTS 

3265
02:24:30,861 --> 02:24:33,330
ARE SAYING AND THIS IS SOMEBODY 

3266
02:24:33,330 --> 02:24:37,134
ABLE 18 OR OLDER AND THIS IS NOT

3267
02:24:37,134 --> 02:24:38,469
AN UNUSUAL SCENARIO THEY'LL SAY 

3268
02:24:38,469 --> 02:24:40,438
SO YOU MEAN MY PARENTS CAN'T 

3269
02:24:40,438 --> 02:24:43,007
MAKE ME STAY.

3270
02:24:43,007 --> 02:24:44,508
NO, WE CAN'T.

3271
02:24:44,508 --> 02:24:47,178
MAYBE WE WILL STAY THEN.

3272
02:24:47,178 --> 02:24:50,948
THEY'VE GOTTEN USED TO THE UNIT 

3273
02:24:50,948 --> 02:24:53,484
AND THEY'VE DEVELOPED RAPPORT 

3274
02:24:53,484 --> 02:24:55,286
WITH THE STAFF AND EVERYONE IS 

3275
02:24:55,286 --> 02:24:56,520
REMINDING THEM THIS IS YOUR 

3276
02:24:56,520 --> 02:24:57,855
DECISION ABOUT GETTING HERE AND 

3277
02:24:57,855 --> 02:25:00,891
EVEN IF YOU GET IN THE MORE 

3278
02:25:00,891 --> 02:25:02,827
RISKY STUDY, HIGHER RISK STUDY 

3279
02:25:02,827 --> 02:25:04,295
YOU CAN STILL CHANGE YOUR MIND.

3280
02:25:04,295 --> 02:25:06,197
SO SOMETIMES WHAT A PERSON WILL 

3281
02:25:06,197 --> 02:25:07,932
SAY IS OKAY, ALL RIGHT, I WILL 

3282
02:25:07,932 --> 02:25:10,234
SAY I KNOW I CAN'T.

3283
02:25:10,234 --> 02:25:12,269
I CAN CHANGE MY MIND AND WE 

3284
02:25:12,269 --> 02:25:14,572
WOULD DO MORE EDUCATION AND THEN

3285
02:25:14,572 --> 02:25:15,873
REASSESS AND SEE WHERE WE ARE AT

3286
02:25:15,873 --> 02:25:16,207
THAT POINT.

3287
02:25:16,207 --> 02:25:17,942
IF THEY STILL DON'T HAVE 

3288
02:25:17,942 --> 02:25:19,009
CAPACITY, THEN WE'RE TALKING 

3289
02:25:19,009 --> 02:25:21,178
WITH THE RESEARCHERS AND IT 

3290
02:25:21,178 --> 02:25:22,513
COULD BE THIS PERSON IS NEVER 

3291
02:25:22,513 --> 02:25:23,647
GOING TO HAVE CAPACITY TO GIVE 

3292
02:25:23,647 --> 02:25:26,784
THEIR OWN CONSENT AND NEED TO 

3293
02:25:26,784 --> 02:25:29,553
START PLANNING FOR DISCHARGE.

3294
02:25:29,553 --> 02:25:31,956
SOME PEOPLE DECIDE THEY WANT TO 

3295
02:25:31,956 --> 02:25:32,857
GO BACK HOME AND A LOT OF TIMES 

3296
02:25:32,857 --> 02:25:34,391
THEY TALK ABOUT THIS MORE AND 

3297
02:25:34,391 --> 02:25:37,161
WE'VE HAD PEOPLE COME BACK.

3298
02:25:37,161 --> 02:25:39,864
I'VE ALSO HAD PEOPLE WHO HAD 

3299
02:25:39,864 --> 02:25:42,132
CAPACITY AND SELF-SABOTAGE 

3300
02:25:42,132 --> 02:25:43,734
BECAUSE THEY THOUGHT THEY WERE 

3301
02:25:43,734 --> 02:25:46,070
BEING MADE TO STAY THEIR PARENTS

3302
02:25:46,070 --> 02:25:47,238
PUTTING PRESSURE ON THEM AND 

3303
02:25:47,238 --> 02:25:49,707
WENT HOME AND COME BACK.

3304
02:25:49,707 --> 02:25:52,276
IT'S NOT TYPICAL PEOPLE DON'T 

3305
02:25:52,276 --> 02:25:53,244
HAVE CAPACITY.

3306
02:25:53,244 --> 02:25:56,280
WE'VE HAD THAT A HANDFUL OF 

3307
02:25:56,280 --> 02:25:58,048
TIMES AND GAVE THEM SEVERAL 

3308
02:25:58,048 --> 02:25:59,817
OPPORTUNITIES AND STABILIZED 

3309
02:25:59,817 --> 02:26:02,019
THEM AND MAYBE MADE TREATMENT 

3310
02:26:02,019 --> 02:26:02,953
RECOMMENDATIONS DIFFERENCES AND 

3311
02:26:02,953 --> 02:26:04,288
THEY'LL SEND THEM BACK HOME AND 

3312
02:26:04,288 --> 02:26:07,091
WON'T GO THROUGH THE HIGHER RISK

3313
02:26:07,091 --> 02:26:07,358
PROTOCOL.

3314
02:26:07,358 --> 02:26:08,492
>> DOES ANYBODY HAVE
QUESTIONS 

3315
02:26:08,492 --> 02:26:18,669
FOR CAROL?

3316
02:26:26,777 --> 02:26:27,578
>> CAPACITY?

3317
02:26:27,578 --> 02:26:29,413
THE STUDY WAS FOR DIRECT BENEFIT

3318
02:26:29,413 --> 02:26:31,181
AND SOMETHING WE HAVE TO BE 

3319
02:26:31,181 --> 02:26:33,884
CLEAR WITH FOLKS ABOUT.

3320
02:26:33,884 --> 02:26:35,653
UNDERGOING A PET SCAN OR MRI 

3321
02:26:35,653 --> 02:26:37,354
COMING OFF YOUR MEDICATION IS 

3322
02:26:37,354 --> 02:26:39,390
ABOUT HELPING THE FUTURE.

3323
02:26:39,390 --> 02:26:40,090
IT'S NOT GOING TO CHANGE YOUR 

3324
02:26:40,090 --> 02:26:41,659
PSYCHOTIC DISORDER.

3325
02:26:41,659 --> 02:26:45,429
AND THEY REALLY HAD THAT 

3326
02:26:45,429 --> 02:26:47,364
CONFUSED AND ALSO AT THE SAME 

3327
02:26:47,364 --> 02:26:50,634
TIME THEY WERE FEELING SOME 

3328
02:26:50,634 --> 02:26:52,269
PRESSURE FROM AGAIN WELL MEANING

3329
02:26:52,269 --> 02:26:55,139
FAMILY MEMBERS BUT WE HAVE TO BE

3330
02:26:55,139 --> 02:26:57,908
CLEAR IT'S NOT LIKE WHEN YOU 

3331
02:26:57,908 --> 02:27:00,978
BREAK YOUR LEG AND GO TO THE 

3332
02:27:00,978 --> 02:27:01,178
E.R.

3333
02:27:01,178 --> 02:27:02,780
YOU HAVE THE RIGHT TO MAKE THE 

3334
02:27:02,780 --> 02:27:03,781
DECISION AND THEY WERE FEELING 

3335
02:27:03,781 --> 02:27:06,116
PRESSURE FROM THEIR FAMILY AND 

3336
02:27:06,116 --> 02:27:08,452
WEREN'T 100% SURE THEY COULDN'T 

3337
02:27:08,452 --> 02:27:09,720
INFLUENCE THE RESEARCH TEAMS TO 

3338
02:27:09,720 --> 02:27:11,655
MAKE THEM STAY AND WE WERE THERE

3339
02:27:11,655 --> 02:27:14,391
TO CLARIFY THAT WASN'T TRUE.

3340
02:27:14,391 --> 02:27:17,595
ULTIMATELY, AS I RECALL, THIS 

3341
02:27:17,595 --> 02:27:18,362
PARTICULAR PERSON HAD CAPACITY 

3342
02:27:18,362 --> 02:27:20,097
AFTER THEY HAD MORE TIME AND THE

3343
02:27:20,097 --> 02:27:22,900
IDEA, THE PRESSURE OF HAVING TO 

3344
02:27:22,900 --> 02:27:29,940
STAY WAS LIFTED.

3345
02:27:29,940 --> 02:27:32,843
>> WHY WOULD STUDIES 

3346
02:27:32,843 --> 02:27:33,110
[OFF-MIC]

3347
02:27:33,110 --> 02:27:34,945
>> IT DEPENDS ON WHAT 

3348
02:27:34,945 --> 02:27:36,280
RESEARCHERS WANT TO DO.

3349
02:27:36,280 --> 02:27:37,548
THERE ARE RESEARCHERS WHO WANT 

3350
02:27:37,548 --> 02:27:39,817
TO MAKE SURE THEY HAVE A PERSON 

3351
02:27:39,817 --> 02:27:40,951
WHO COMPLETELY UNDERSTANDS WHAT 

3352
02:27:40,951 --> 02:27:42,786
IT IS THEY'RE AGREEING TO.

3353
02:27:42,786 --> 02:27:44,355
THEY DON'T REALLY WANT TO LEAVE 

3354
02:27:44,355 --> 02:27:47,224
THAT TO A SURROGATE AND IT 

3355
02:27:47,224 --> 02:27:49,059
REALLY IS UP TO THE INDIVIDUAL 

3356
02:27:49,059 --> 02:27:49,927
RESEARCHERS BUT THEY SPEND A LOT

3357
02:27:49,927 --> 02:27:52,296
OF TIME TALKING WITH THEIR TEAMS

3358
02:27:52,296 --> 02:27:54,264
AND IRB BEFORE THEY MAKE THAT 

3359
02:27:54,264 --> 02:27:55,232
DECISION AS WELL AND IN THIS 

3360
02:27:55,232 --> 02:27:58,402
CASE THIS WAS A STUDY FROM 1989 

3361
02:27:58,402 --> 02:28:00,204
AND THEY MADE THE DECISION A 

3362
02:28:00,204 --> 02:28:01,238
LONG TIME AGO THEY WANTED TO 

3363
02:28:01,238 --> 02:28:02,473
MAKE SURE THE PARTICIPANTS HAD 

3364
02:28:02,473 --> 02:28:04,441
THEIR OWN CONSENT CAPACITY.

3365
02:28:04,441 --> 02:28:09,046
>> AND AS A GENERAL RULE, 

3366
02:28:09,046 --> 02:28:11,849
STUDIES THAT ARE NO MORE THAN 

3367
02:28:11,849 --> 02:28:14,251
MINIMAL RISK OR WHAT I'LL CALL A

3368
02:28:14,251 --> 02:28:16,520
NATURAL HISTORY STUDY.

3369
02:28:16,520 --> 02:28:17,855
OFTEN FOLKS WITH RARE DISORDERS 

3370
02:28:17,855 --> 02:28:20,591
FOR WHICH THERE ARE NO 

3371
02:28:20,591 --> 02:28:22,826
TREATMENTS MIGHT ENROLL IN A 

3372
02:28:22,826 --> 02:28:23,827
STUDY HERE AT THE CLINICAL 

3373
02:28:23,827 --> 02:28:26,296
CENTER AND ALL, QUOTE, UNQUOTE 

3374
02:28:26,296 --> 02:28:28,298
THE TEAM WANTS IT DO IS COLLECT 

3375
02:28:28,298 --> 02:28:30,100
BLOOD SAMPLES.

3376
02:28:30,100 --> 02:28:32,302
MAYBE DO SOME GENETIC ANALYSIS.

3377
02:28:32,302 --> 02:28:33,904
THERE'S VERY LITTLE PHYSICAL 

3378
02:28:33,904 --> 02:28:38,108
RISK SO THE IDEA IS THAT IN THAT

3379
02:28:38,108 --> 02:28:41,345
CASE IT'S RELATIVELY COMMON FOR 

3380
02:28:41,345 --> 02:28:45,315
THERE FOR BE AN LAR DESIGNATION.

3381
02:28:45,315 --> 02:28:48,452
WHEN THE RISK STARTS TO RISE 

3382
02:28:48,452 --> 02:28:49,620
THERE ARE CONCERNS ABOUT IS IT 

3383
02:28:49,620 --> 02:28:52,322
OKAY TO ENROLL SOMEONE WHO 

3384
02:28:52,322 --> 02:28:55,693
DOESN'T HAVE CAPACITY IN A TRIAL

3385
02:28:55,693 --> 02:29:01,231
THAT HAS SOME RISK AND NO DIRECT

3386
02:29:01,231 --> 02:29:01,598
BENEFIT?

3387
02:29:01,598 --> 02:29:03,133
IT'S JUST A RESPECT FOR AND THE 

3388
02:29:03,133 --> 02:29:05,035
ABILITY OF THE PERSON TO MAKE A 

3389
02:29:05,035 --> 02:29:07,237
DECISION ON THEIR OWN BEHALF.

3390
02:29:07,237 --> 02:29:09,373
AND THERE'S A LITTLE SPACE IN 

3391
02:29:09,373 --> 02:29:12,209
THE MIDDLE OF THERE'S MORE THAN 

3392
02:29:12,209 --> 02:29:13,077
MINIMAL RISK BUT POTENTIAL FOR 

3393
02:29:13,077 --> 02:29:19,249
DIRECT BENEFIT AND THAT'S WHERE 

3394
02:29:19,249 --> 02:29:21,418
THERE'S MAYBE LESS COMMON -- I 

3395
02:29:21,418 --> 02:29:24,888
GUESS TO SAY SOMETIMES THERE'S 

3396
02:29:24,888 --> 02:29:26,090
AN LAR SOMETIMES THERE ISN'T.

3397
02:29:26,090 --> 02:29:28,358
THAT'S WHEN IT COMES TO THE TEAM

3398
02:29:28,358 --> 02:29:31,595
AND HOW THEY WANT TO MOVE 

3399
02:29:31,595 --> 02:29:35,532
FORWARD AND THEIR CONSIDERATIONS

3400
02:29:35,532 --> 02:29:37,234
ABOUT THE DISEASE AS CHRISTINE 

3401
02:29:37,234 --> 02:29:40,304
AND SCOTT MENTIONED.

3402
02:29:40,304 --> 02:29:41,905
SOME RESEARCH SO LET'S IMAGINE 

3403
02:29:41,905 --> 02:29:44,308
SOMEONE WHO HAS ALZHEIMER'S IN A

3404
02:29:44,308 --> 02:29:46,744
LATER STAGE.

3405
02:29:46,744 --> 02:29:49,246
THEY MAY NOT HAVE CAPACITY BUT 

3406
02:29:49,246 --> 02:29:53,417
THIS STUDY MAY HAVE SOME DIRECT 

3407
02:29:53,417 --> 02:29:54,718
BENEFIT FOR THEM AND SO WE HAVE 

3408
02:29:54,718 --> 02:30:01,692
TO ENROLL PEOPLE WHO HAVE 

3409
02:30:01,692 --> 02:30:02,726
ALZHEIMER'S NRPDIN ORDER TO FIN 

3410
02:30:02,726 --> 02:30:06,830
THAT OUT AND THAT'S A CLEAR CASE

3411
02:30:06,830 --> 02:30:08,198
WHERE THE INVESTIGATORS WANT TO 

3412
02:30:08,198 --> 02:30:10,734
MAKE SURE AN LAR IS ALLOWED TO 

3413
02:30:10,734 --> 02:30:13,670
MAKE THAT DECISION.

3414
02:30:13,670 --> 02:30:17,040
>> ON THE HEELS OF THAT
IT'S 

3415
02:30:17,040 --> 02:30:20,744
IMPORTANT TO REMEMBER ASSENT AND

3416
02:30:20,744 --> 02:30:22,780
DISSENT AND A WOMAN WITH 

3417
02:30:22,780 --> 02:30:24,181
ALZHEIMER'S DISEASE AND HER 

3418
02:30:24,181 --> 02:30:26,283
HUSBAND BROUGHT HER AND SHE 

3419
02:30:26,283 --> 02:30:27,084
DIDN'T HAVE CAPACITY AND DIDN'T 

3420
02:30:27,084 --> 02:30:28,786
UNDERSTAND WHAT WAS GOING TO BE 

3421
02:30:28,786 --> 02:30:30,020
DONE EVEN AFTER WE TALKED ABOUT 

3422
02:30:30,020 --> 02:30:31,955
THE TASK AND THE ACTIVITIES 

3423
02:30:31,955 --> 02:30:34,224
WE'RE GOING TO BE AS PART OF THE

3424
02:30:34,224 --> 02:30:36,727
STUDY AND HER HUSBAND 

3425
02:30:36,727 --> 02:30:37,828
DESPERATELY WANTED HER IN THE 

3426
02:30:37,828 --> 02:30:41,298
STUDY AND IT WAS EDUCATING HIM 

3427
02:30:41,298 --> 02:30:42,733
IT WOULD NOT PROVIDE TREATMENT 

3428
02:30:42,733 --> 02:30:46,370
BUT IT WAS A THOROUGH OVERVIEW 

3429
02:30:46,370 --> 02:30:47,404
TO IDENTIFY WHAT WAS GOING ON 

3430
02:30:47,404 --> 02:30:50,941
AND WAS DESPERATE TO GET IT DONE

3431
02:30:50,941 --> 02:30:52,776
AND WE SAID SHE DOESN'T HAVE 

3432
02:30:52,776 --> 02:30:56,346
CAPACITY AND THEY LAD DPAs AND 

3433
02:30:56,346 --> 02:30:58,549
EVERYTHING BUT SHE WAS CLEAR SHE

3434
02:30:58,549 --> 02:30:59,917
DIDN'T WANT TO BE HERE AND 

3435
02:30:59,917 --> 02:31:01,251
DIDN'T UNDERSTAND NIH BUT 

3436
02:31:01,251 --> 02:31:05,122
EQUATED HER WITH MEDICAL CARE 

3437
02:31:05,122 --> 02:31:07,257
AND SCARED HER TERRIBLY AND WE 

3438
02:31:07,257 --> 02:31:08,592
SAID YOU CAN'T ENROLL HER 

3439
02:31:08,592 --> 02:31:09,860
BECAUSE IT WAS VERY 

3440
02:31:09,860 --> 02:31:10,928
DISAPPOINTING FOR THE PERSON.

3441
02:31:10,928 --> 02:31:12,696
I THINK WHAT WAS HELPFUL WAS THE

3442
02:31:12,696 --> 02:31:14,398
INVESTIGATOR THEN WAS WORKING 

3443
02:31:14,398 --> 02:31:17,634
WITH HIM TO MAKE SURE THEY WOULD

3444
02:31:17,634 --> 02:31:19,937
BE REFERRED ON THE OUTSIDE TO A 

3445
02:31:19,937 --> 02:31:20,571
FACILITY THAT COULD HELP THEM A 

3446
02:31:20,571 --> 02:31:22,906
BIT MORE.

3447
02:31:22,906 --> 02:31:24,308
>> GREAT.

3448
02:31:24,308 --> 02:31:25,242
THANKS, CAROL.

3449
02:31:25,242 --> 02:31:31,248
>> THANK YOU, ALL.

3450
02:31:31,248 --> 02:31:32,649
SO YOU'LL GET A LITTLE MORE FROM

3451
02:31:32,649 --> 02:31:35,319
ME BEFORE WE FINISH UP FOR 

3452
02:31:35,319 --> 02:31:35,519
TODAY.

3453
02:31:35,519 --> 02:31:39,156
I CALL THIS LECTURE NUTS AND 

3454
02:31:39,156 --> 02:31:41,859
BOLTS AND THE BOTTOM LINE HERE 

3455
02:31:41,859 --> 02:31:43,660
IS THAT WE'VE TALKED A LITTLE 

3456
02:31:43,660 --> 02:31:46,063
ABOUT THE THEORETICAL ISSUES AND

3457
02:31:46,063 --> 02:31:48,298
SOME CONCERNS ABOUT CAPACITY.

3458
02:31:48,298 --> 02:31:51,902
MANY OF YOU MIGHT JUST BE 

3459
02:31:51,902 --> 02:31:55,105
WRITING CONSENT FORMS FOR 

3460
02:31:55,105 --> 02:31:55,739
AVERAGE CLINICAL TRIAL.

3461
02:31:55,739 --> 02:31:57,107
I JUST WANTED TO SHARE A COUPLE 

3462
02:31:57,107 --> 02:32:00,310
OF THINGS TO KEEP IN MIND AND 

3463
02:32:00,310 --> 02:32:03,380
THIS IS IN FACT REALLY MORE FOR 

3464
02:32:03,380 --> 02:32:07,150
YOU TO HAVE ON HAND AS A FUTURE 

3465
02:32:07,150 --> 02:32:10,153
REFERENCE THAN SOMETHING WE NEED

3466
02:32:10,153 --> 02:32:11,321
TO GO INTO MUCH DETAIL ABOUT BUT

3467
02:32:11,321 --> 02:32:12,956
AS A REMINDER, CONSENT IS A 

3468
02:32:12,956 --> 02:32:15,659
PROCESS NOT A FORM.

3469
02:32:15,659 --> 02:32:16,627
I'M GOING TO TALK A LOT ABOUT 

3470
02:32:16,627 --> 02:32:19,196
THE FORM AS I MOVE FORWARD BUT I

3471
02:32:19,196 --> 02:32:24,468
WANT TO REITERATE THAT INFORMED 

3472
02:32:24,468 --> 02:32:26,203
CONSENT PROCESS IS ONLY ONE WAY 

3473
02:32:26,203 --> 02:32:30,107
TO CONVEY RESPECT TO THE 

3474
02:32:30,107 --> 02:32:30,908
POTENTIAL PARTICIPANTS.

3475
02:32:30,908 --> 02:32:36,713
YOU NEED TO MAKE SURE YOU 

3476
02:32:36,713 --> 02:32:40,284
RESPECT THEM IN ALL SORTS OF 

3477
02:32:40,284 --> 02:32:41,385
WAYS EVEN AFTER INFORMED 

3478
02:32:41,385 --> 02:32:43,253
CONSENT.

3479
02:32:43,253 --> 02:32:44,488
I'LL TALK ABOUT BEST PRACTICES 

3480
02:32:44,488 --> 02:32:46,857
AND FORM AND PROMOTING.

3481
02:32:46,857 --> 02:32:47,858
AGAIN, STYLE.

3482
02:32:47,858 --> 02:32:48,992
I WON'T READ ALL THESE TO YOU 

3483
02:32:48,992 --> 02:32:52,329
AND SOME SHOULD BE I WOULD 

3484
02:32:52,329 --> 02:32:56,400
IMAGINE PRETTY STRAIGHTFORWARD.

3485
02:32:56,400 --> 02:33:02,539
THE LAST TIME I READ A BOOK BY 

3486
02:33:02,539 --> 02:33:06,510
FAULKNER IT WAS HARD TO READ ONE

3487
02:33:06,510 --> 02:33:08,011
LONG SENTENCE, VERY COMPLICATED 

3488
02:33:08,011 --> 02:33:10,781
WORDS AND TEXT.

3489
02:33:10,781 --> 02:33:11,415
YOU'RE LOOKING FOR SOMETHING 

3490
02:33:11,415 --> 02:33:15,786
WITH SHORT SENTENCES, SHORT 

3491
02:33:15,786 --> 02:33:17,854
WORDS AND IMPORTANTLY LIKE 

3492
02:33:17,854 --> 02:33:20,324
STATES ONE MAIN IDEA CLEARLY IN 

3493
02:33:20,324 --> 02:33:21,858
EACH PARAGRAPH.

3494
02:33:21,858 --> 02:33:24,394
YOU'LL BE MAYBE NOT SURPRISED TO

3495
02:33:24,394 --> 02:33:27,597
LEARN THAT PUTTING SPACE BETWEEN

3496
02:33:27,597 --> 02:33:28,865
PARAGRAPHS IS REALLY HELPFUL 

3497
02:33:28,865 --> 02:33:32,302
WHEN SOMEONE IS GIVEN A FORM 

3498
02:33:32,302 --> 02:33:34,104
THAT IS 25 PAGES LONG.

3499
02:33:34,104 --> 02:33:40,310
YES, ADDING SPACE MAY MAKE IT 

3500
02:33:40,310 --> 02:33:45,515
LONGER BUT IT'S A MESSAGE TO THE

3501
02:33:45,515 --> 02:33:47,884
INDIVIDUAL THAT HERE IS ONE 

3502
02:33:47,884 --> 02:33:48,085
IDEA.

3503
02:33:48,085 --> 02:33:49,252
PRESENT A CLEAR SEQUENCE OF 

3504
02:33:49,252 --> 02:33:49,720
EVENTS.

3505
02:33:49,720 --> 02:33:52,823
I WAS REVIEWING A PROTOCOL.

3506
02:33:52,823 --> 02:34:03,266
WE HAD A CONSULT THE OTHER DAY 

3507
02:34:03,266 --> 02:34:05,902
WHERE AN INDIVIDUAL CLINICIAN 

3508
02:34:05,902 --> 02:34:07,304
HAD A CONCERN ABOUT A CHANGE IN 

3509
02:34:07,304 --> 02:34:10,007
THE PROTOCOL AND THAT MEANS THE 

3510
02:34:10,007 --> 02:34:11,908
CONSENT FORM CHANGE IN THIS CASE

3511
02:34:11,908 --> 02:34:12,442
AND EVERYBODY HAS TO BE 

3512
02:34:12,442 --> 02:34:18,015
RE-CONSENTED.

3513
02:34:18,015 --> 02:34:20,117
ONE OF THE WAYS THEY ORGANIZED 

3514
02:34:20,117 --> 02:34:25,055
THEIR DATA WAS THEY HAD THIS 

3515
02:34:25,055 --> 02:34:28,458
REALLY LOVELY TABLE THERE WAS AN

3516
02:34:28,458 --> 02:34:30,293
ICON OR EMOTHER THAT WAS LIKE A 

3517
02:34:30,293 --> 02:34:30,927
BLOOD DRAW.

3518
02:34:30,927 --> 02:34:33,163
THEY HAD A PICTURE OF A NEEDLE 

3519
02:34:33,163 --> 02:34:42,039
AND TALKED ABOUT THE BLOOD DRAW.

3520
02:34:42,039 --> 02:34:47,878
THERE WAS A PICTURE OF A LIVER 

3521
02:34:47,878 --> 02:34:58,422
TO SAY YOU CAN USE THINGS AND IS

3522
02:35:10,434 --> 02:35:12,269
SOMETHING I ENCOUNTER WHEN FOLKS

3523
02:35:12,269 --> 02:35:13,470
ARE STARTING TO RIGHT A CONSENT 

3524
02:35:13,470 --> 02:35:23,580
FORM.

3525
02:35:25,215 --> 02:35:26,817
USE DIFFERENT WORDS TO CONVEY 

3526
02:35:26,817 --> 02:35:28,318
THE SAME POINT.

3527
02:35:28,318 --> 02:35:31,154
IT GETS BORING IF YOU USE THE 

3528
02:35:31,154 --> 02:35:32,823
SAME WORD OVER AND OVER.

3529
02:35:32,823 --> 02:35:34,791
IN THIS CASE YOU WANT TO MAKE 

3530
02:35:34,791 --> 02:35:36,326
SURE YOU'RE USING THE SAME WORDS

3531
02:35:36,326 --> 02:35:38,628
TO DESCRIBE THE THING ON PAGE 1 

3532
02:35:38,628 --> 02:35:42,866
AS YOU'RE USING TO DESCRIBE IT 

3533
02:35:42,866 --> 02:35:44,534
ON PAGE 2 BECAUSE THE PERSON 

3534
02:35:44,534 --> 02:35:49,573
DESCRIBING ITS DIFFERENT LIE 

3535
02:35:49,573 --> 02:35:50,240
LI --

3536
02:35:50,240 --> 02:35:51,074
DIFFERENTLY LIKE IS THIS WHAT 

3537
02:35:51,074 --> 02:35:52,676
THEY TOLD ME ABOUT OR A 

3538
02:35:52,676 --> 02:35:56,313
DIFFERENT THING?

3539
02:35:56,313 --> 02:35:59,216
KNOW YOUR AUDIENCE.

3540
02:35:59,216 --> 02:36:01,184
WE DON'T SPEND ENOUGH TIME AS 

3541
02:36:01,184 --> 02:36:01,818
INVESTIGATORS PLANNING YOUR 

3542
02:36:01,818 --> 02:36:04,287
PROTOCOL YOU LIKELY HAVE IN MIND

3543
02:36:04,287 --> 02:36:05,655
YOUR SAMPLE POPULATION AND WHO 

3544
02:36:05,655 --> 02:36:10,627
IS THE AVERAGE PERSON IN THAT 

3545
02:36:10,627 --> 02:36:11,862
SAMPLE POPULATION.

3546
02:36:11,862 --> 02:36:13,563
IF THE AVERAGE PERSON IS NOT 

3547
02:36:13,563 --> 02:36:15,265
LITERATE, THAT'S VERY DIFFERENT 

3548
02:36:15,265 --> 02:36:18,468
THAN THE AVERAGE PERSON IN YOUR 

3549
02:36:18,468 --> 02:36:20,070
SAMPLE IS A CLINICAL 

3550
02:36:20,070 --> 02:36:21,271
INVESTIGATOR AT THE NIH.

3551
02:36:21,271 --> 02:36:27,277
YOU'LL HAVE A VERY DIFFERENT 

3552
02:36:27,277 --> 02:36:28,545
APPROACH WRITE AND CONVEY THAT 

3553
02:36:28,545 --> 02:36:33,850
INFORMATION.

3554
02:36:33,850 --> 02:36:35,318
AND IT'S ALWAYS GOOD REGARDLESS 

3555
02:36:35,318 --> 02:36:40,290
OF WHETHER THEY'RE NOT LITERAL 

3556
02:36:40,290 --> 02:36:42,259
OR AN NIH INVESTIGATOR BUT 

3557
02:36:42,259 --> 02:36:43,460
KNOWING YOUR AUDIENCE IS REALLY 

3558
02:36:43,460 --> 02:36:49,399
IMPORTANT.

3559
02:36:49,399 --> 02:36:51,168
NO OFFENSE TO THE Ph.D.s IN THE 

3560
02:36:51,168 --> 02:36:52,335
CLINICAL CENTER OR AUDIENCE BUT 

3561
02:36:52,335 --> 02:36:55,272
YOU NEVER TOOK A CLASS CALLED 

3562
02:36:55,272 --> 02:36:57,007
HOW TO WRITE A CONSENT FORM.

3563
02:36:57,007 --> 02:37:00,310
YOU TOOK CLASS TO PREPARE YOU TO

3564
02:37:00,310 --> 02:37:03,613
WRITE GRANT PROPOSALS, ARTICLES 

3565
02:37:03,613 --> 02:37:05,115
PUBLISHED IN NIMHD, 

3566
02:37:05,115 --> 02:37:07,250
PRESENTATIONS TO A WORLD WIDE 

3567
02:37:07,250 --> 02:37:11,021
AUDIENCE.

3568
02:37:11,021 --> 02:37:12,722
YOU MAY NOT HAVE THE ABILITY AND

3569
02:37:12,722 --> 02:37:15,825
BE HUMBLE ABOUT NOT HAVING THE 

3570
02:37:15,825 --> 02:37:18,361
ABILITY TO HAVE SOMEONE HELP YOU

3571
02:37:18,361 --> 02:37:20,964
OUT IN WRITING YOUR FORM.

3572
02:37:20,964 --> 02:37:23,767
SOMETIMES YOU CAN HAVE IT 

3573
02:37:23,767 --> 02:37:25,835
REVIEWED BY A PATIENT OR I OFTEN

3574
02:37:25,835 --> 02:37:27,304
SAY I HAVE MY GRANDMOTHER REVIEW

3575
02:37:27,304 --> 02:37:31,274
IT OR SOMEONE IN YOUR LIFE WHO 

3576
02:37:31,274 --> 02:37:33,944
IS PERHAPS MORE AVERAGE THAN YOU

3577
02:37:33,944 --> 02:37:36,313
BECAUSE YOU'RE AN NIMHD REVIEW 

3578
02:37:36,313 --> 02:37:37,480
THE FORM AND CIRCLE THE WORDS 

3579
02:37:37,480 --> 02:37:43,253
THEY DON'T UNDERSTAND.

3580
02:37:43,253 --> 02:37:53,730
IN TERMS OF FER  -- FORMAT, 

3581
02:37:54,698 --> 02:37:56,032
READABLE, USE LARGE POINTS AND 

3582
02:37:56,032 --> 02:37:57,701
DOUBLE SPACE AND BLEND OF WHITE 

3583
02:37:57,701 --> 02:37:59,769
SPACE AND TEXT.

3584
02:37:59,769 --> 02:38:01,671
I APPRECIATE THIS MAY MAKE 

3585
02:38:01,671 --> 02:38:04,541
THINGS LONGER BUT IT'S ALSO 

3586
02:38:04,541 --> 02:38:06,176
GOING TO MAKE IT MORE READABLE 

3587
02:38:06,176 --> 02:38:07,544
AND NOT THE CASE CONSENT FORMS 

3588
02:38:07,544 --> 02:38:09,613
INVEST RECENT PAST HAVE GONE 

3589
02:38:09,613 --> 02:38:11,881
FROM 10 PAGES TO 20 PAGES 

3590
02:38:11,881 --> 02:38:14,584
BECAUSE THEY'RE DOUBLE SPACING 

3591
02:38:14,584 --> 02:38:14,884
THEM.

3592
02:38:14,884 --> 02:38:16,720
THEY'RE STILL SINGLE SPACED 10 

3593
02:38:16,720 --> 02:38:19,256
PAGES NOW SINGLE SPACED 20 PLUS 

3594
02:38:19,256 --> 02:38:28,298
PAGES.

3595
02:38:28,298 --> 02:38:29,499
I WANT TO GO TO UNDERSTAND.

3596
02:38:29,499 --> 02:38:34,904
I HAVE A GOAL OF MAKING ALL OF 

3597
02:38:34,904 --> 02:38:36,740
YOU BELIEVERS IN WHAT I'M ABOUT 

3598
02:38:36,740 --> 02:38:38,475
TO SHARE BECAUSE IT'S A REALLY 

3599
02:38:38,475 --> 02:38:40,510
GOOD THOUGHTFUL WAY TO ASSESS 

3600
02:38:40,510 --> 02:38:46,850
UNDERSTANDING.

3601
02:38:46,850 --> 02:38:48,051
AND UNDERSTANDING IS IMPROVED 

3602
02:38:48,051 --> 02:38:50,020
WHEN PATIENTS OR SUBJECTS 

3603
02:38:50,020 --> 02:38:51,588
VERBALIZE INFORMATION.

3604
02:38:51,588 --> 02:38:53,957
SO IF YOU ASK THEM AN OPEN-ENDED

3605
02:38:53,957 --> 02:38:57,427
QUESTION AND ASK THEM TO 

3606
02:38:57,427 --> 02:38:58,528
VERBALIZE WHAT THE UNDERSTAND, 

3607
02:38:58,528 --> 02:39:00,897
BECAUSE YOU CAN THEN INTERVENE 

3608
02:39:00,897 --> 02:39:05,702
AND TALK FURTHER IT ACTUALLY 

3609
02:39:05,702 --> 02:39:06,536
IMPROVES UNDERSTANDING.

3610
02:39:06,536 --> 02:39:10,540
AND UNDERSTANDING IS IMPROVED BY

3611
02:39:10,540 --> 02:39:12,309
ADMINISTERING QUIZZES AND 

3612
02:39:12,309 --> 02:39:13,276
CORRECTING INCORRECT RESPONSES 

3613
02:39:13,276 --> 02:39:15,478
BUT FRANKLY I THINK IT'S A BIT 

3614
02:39:15,478 --> 02:39:20,250
OF TEACHING TO THE TEST.

3615
02:39:20,250 --> 02:39:23,353
LET'S SAY I GIVE ALEX THE WITH 

3616
02:39:23,353 --> 02:39:25,121
QUIZ AND THE FIRST TIME HE GETS 

3617
02:39:25,121 --> 02:39:27,057
IT RIGHT AND MY CUT OFF IS 

3618
02:39:27,057 --> 02:39:27,791
SEVEN.

3619
02:39:27,791 --> 02:39:31,261
I COULD SAY SORRY, ALEX, YOU 

3620
02:39:31,261 --> 02:39:34,764
CAN'T BE IN MY STUDY BUT A LOT 

3621
02:39:34,764 --> 02:39:35,865
OF STUDIES SAY LET'S REVIEW WHAT

3622
02:39:35,865 --> 02:39:37,133
YOU GOT WRONG.

3623
02:39:37,133 --> 02:39:39,402
YOU SAID TRUE ON THESE AND THEY 

3624
02:39:39,402 --> 02:39:41,938
ARE WERE FALSE.

3625
02:39:41,938 --> 02:39:44,307
LET'S GIVE YOU THE QUIZ AGAIN.

3626
02:39:44,307 --> 02:39:47,243
IF HE DOESN'T GET IT RIGHT THAT 

3627
02:39:47,243 --> 02:39:49,245
TIME WE'LL BE CONCERNED.

3628
02:39:49,245 --> 02:39:52,315
I DON'T THINK IT'S A ROBUST WAY 

3629
02:39:52,315 --> 02:39:53,450
OF ASSESSING UNDERSTANDING.

3630
02:39:53,450 --> 02:39:55,452
HERE'S WHAT I WANT YOU ALL TO 

3631
02:39:55,452 --> 02:39:59,055
DO.

3632
02:39:59,055 --> 02:40:00,490
SO YOU'VE WRITTEN YOUR CONSENT 

3633
02:40:00,490 --> 02:40:02,559
FORM AND READY TO OPEN YOUR 

3634
02:40:02,559 --> 02:40:03,626
STUDY AND BRING FOLKS IN.

3635
02:40:03,626 --> 02:40:06,496
YOU'VE RECRUITED THEM AND NOW 

3636
02:40:06,496 --> 02:40:07,263
SCHEDULING THEM.

3637
02:40:07,263 --> 02:40:10,233
I WANT YOU TO THINK ABOUT WHAT 

3638
02:40:10,233 --> 02:40:12,802
FOR YOUR STUDY ARE THE MOST 

3639
02:40:12,802 --> 02:40:17,841
IMPORTANT THINGS YOU WANT THIS 

3640
02:40:17,841 --> 02:40:24,047
PERSON TO KNOW.

3641
02:40:24,047 --> 02:40:26,249
THESE ARE LIKELY SOME OF THE 

3642
02:40:26,249 --> 02:40:27,484
THINGS YOU'LL WANT TO KNOW AND 

3643
02:40:27,484 --> 02:40:30,720
WANT YOU TO PREPARE ANSWERS TO 

3644
02:40:30,720 --> 02:40:32,288
THOSE QUESTIONS IF YOU ARE 

3645
02:40:32,288 --> 02:40:33,356
ANSWERING THE QUESTION OR HAVING

3646
02:40:33,356 --> 02:40:34,524
REVIEWED THE FORM, HOW DO YOU 

3647
02:40:34,524 --> 02:40:36,393
THINK YOU WOULD ANSWER THOSE 

3648
02:40:36,393 --> 02:40:39,229
QUESTIONS SO YOU HAVE IN YOUR 

3649
02:40:39,229 --> 02:40:42,165
MIND THIS IS THE MAYBE NOT THE 

3650
02:40:42,165 --> 02:40:43,266
RIGHT ANSWER BUT AN ADEQUATE 

3651
02:40:43,266 --> 02:40:46,603
RESPONSE TO MY QUESTION.

3652
02:40:46,603 --> 02:40:48,471
AND NOW YOU'RE READY TO ASK THE 

3653
02:40:48,471 --> 02:40:50,206
PARTICIPANT AFTER YOU'VE GONE 

3654
02:40:50,206 --> 02:40:51,608
THROUGH THE CONSENT FORM A 

3655
02:40:51,608 --> 02:40:54,277
SERIES OF QUESTIONS LIKE THIS.

3656
02:40:54,277 --> 02:40:55,945
THEY'RE OPEN ENDED.

3657
02:40:55,945 --> 02:40:57,947
FOR EXAMPLE, IF YOU'RE GOING TO 

3658
02:40:57,947 --> 02:40:59,616
GO HOME AND TELL A FRIEND ABOUT 

3659
02:40:59,616 --> 02:41:01,751
THE STUDY WHAT THE STUDY'S 

3660
02:41:01,751 --> 02:41:03,386
ABOUT, WHAT WOULD YOU SAY?

3661
02:41:03,386 --> 02:41:04,654
IT'S NOT SAYING TELLING ME ME 

3662
02:41:04,654 --> 02:41:06,222
THE PURPOSE OF THE STUDY.

3663
02:41:06,222 --> 02:41:07,724
I WANT FOR THEIR WORDS FOR THEM 

3664
02:41:07,724 --> 02:41:11,795
TO TELL ME WHAT THEY THINK 

3665
02:41:11,795 --> 02:41:12,429
THEY'RE GETTING THEMSELVES INTO.

3666
02:41:12,429 --> 02:41:13,897
NOW, IF THEY SAY OH, GOSH, THIS 

3667
02:41:13,897 --> 02:41:16,299
STUDY'S GOING TO CURE MY CANCER,

3668
02:41:16,299 --> 02:41:17,901
THAT MAY NOT BE TRUE.

3669
02:41:17,901 --> 02:41:20,036
THAT CREATES AN OPPORTUNITY FOR 

3670
02:41:20,036 --> 02:41:21,971
YOU TO SAY, OH, THAT'S 

3671
02:41:21,971 --> 02:41:24,307
INTERESTING YOU HEARD THAT.

3672
02:41:24,307 --> 02:41:26,810
LET ME TELL YOU -- IT'S ACTUALLY

3673
02:41:26,810 --> 02:41:28,311
NOT GOING TO CURE YOUR CANCER.

3674
02:41:28,311 --> 02:41:30,713
IT'S GOING TO DO X, Y OR Z AND 

3675
02:41:30,713 --> 02:41:35,652
WE'LL SET ASIDE FOR A MOMENT THE

3676
02:41:35,652 --> 02:41:38,388
FOLKS WHO INSIST IT WILL CURE 

3677
02:41:38,388 --> 02:41:40,123
THEIR CANCER AND ASSUME IT 

3678
02:41:40,123 --> 02:41:40,723
HIGHLIGHTS SOMETHING THEY MAY 

3679
02:41:40,723 --> 02:41:42,592
NOT UNDERSTAND.

3680
02:41:42,592 --> 02:41:47,897
BLAZE GOING TO HAPPEN TO YOU?

3681
02:41:47,897 --> 02:41:50,834
ARE YOU GOING TO GET MRI, PET 

3682
02:41:50,834 --> 02:41:52,569
SCANS, BLOOD DRAW, ETCETERA.

3683
02:41:52,569 --> 02:41:57,607
IF THERE ARE PARTICULAR THINGS 

3684
02:41:57,607 --> 02:41:58,975
ABOUT YOUR STUDY IT'S IMPORTANT 

3685
02:41:58,975 --> 02:41:59,609
TO KNOW.

3686
02:41:59,609 --> 02:42:02,812
FOR EXAMPLE, LET'S SAY I'M DOING

3687
02:42:02,812 --> 02:42:04,113
A LONGITUDINAL STUDY AND NEED 

3688
02:42:04,113 --> 02:42:06,382
PEOPLE TO COME IN AND THIS IS A 

3689
02:42:06,382 --> 02:42:07,784
STUDY WE ALSO GOT A CONSULT 

3690
02:42:07,784 --> 02:42:08,718
ABOUT THE OTHER DAY.

3691
02:42:08,718 --> 02:42:09,786
I'M GOING IT TAKE YOUR BLOOD 

3692
02:42:09,786 --> 02:42:12,889
TODAY AND HAVE YOU COME BACK 

3693
02:42:12,889 --> 02:42:15,558
EVERY WEEK AND I'M GOING TO 

3694
02:42:15,558 --> 02:42:16,860
MEASURE A SUBSTANCE IN YOUR 

3695
02:42:16,860 --> 02:42:17,827
BLOOD EVERY WEEK AND YOU'RE 

3696
02:42:17,827 --> 02:42:20,296
GOING TO HAVE TO COME BACK EVERY

3697
02:42:20,296 --> 02:42:23,766
WEEK ANYTHING I CAN'T SEE THE 

3698
02:42:23,766 --> 02:42:24,868
SUBSTANCE ANYMORE.

3699
02:42:24,868 --> 02:42:26,603
THE AVERAGE PERSON IS 10 WEEKS 

3700
02:42:26,603 --> 02:42:29,572
BUT I HAD SOMEONE FOR WHOM IT'S 

3701
02:42:29,572 --> 02:42:34,210
TAKEN 20 WEEKS.

3702
02:42:34,210 --> 02:42:36,312
ARE YOU READY AND DO YOU IS THIS

3703
02:42:36,312 --> 02:42:40,650
GOING TO WORK FOR YOU?

3704
02:42:40,650 --> 02:42:43,520
IF SOMEONE SAYS I'M GOING ON 

3705
02:42:43,520 --> 02:42:45,455
VACATION FOR THREE WEEKS OR 

3706
02:42:45,455 --> 02:42:47,924
GOSH, NO, IN A MONTH THEY'RE 

3707
02:42:47,924 --> 02:42:51,995
SWITCHING JOBS AND WON'T BE AS 

3708
02:42:51,995 --> 02:42:52,262
FLEXIBLE.

3709
02:42:52,262 --> 02:43:02,639
THEY MAY BE IMPORTANT.

3710
02:43:10,213 --> 02:43:12,515
IF THERE'S RANDOMIZATION THAT 

3711
02:43:12,515 --> 02:43:14,217
PLAY BE SOMETHING MAKE SURE THEY

3712
02:43:14,217 --> 02:43:14,517
UNDERSTAND.

3713
02:43:14,517 --> 02:43:17,053
I WANT YOU TO ALL GO OUT AND USE

3714
02:43:17,053 --> 02:43:19,255
THIS APPROACH AND TELL ALL YOUR 

3715
02:43:19,255 --> 02:43:22,025
FRIENDS ABOUT IT SO WE JUST 

3716
02:43:22,025 --> 02:43:23,192
DIFFUSE THIS ACROSS THIS GLOBE.

3717
02:43:23,192 --> 02:43:24,160
THAT'S MY PLAN.

3718
02:43:24,160 --> 02:43:26,162
THAT'S IT FOR ME TODAY.

3719
02:43:26,162 --> 02:43:28,298
AND WE'LL BE BACK NEXT WEEK.

3720
02:43:28,298 --> 02:43:31,134
WE'LL TALK ABOUT STUDY DESIGN, 

3721
02:43:31,134 --> 02:43:34,070
RISK BENEFITS AND SOCIAL VALUE 

3722
02:43:34,070 --> 02:43:36,673
AND THEN DAVE WENDLER WILL TALK 

3723
02:43:36,673 --> 02:43:38,775
ABOUT THAT AND SHIMA WILL JOIN 

3724
02:43:38,775 --> 02:43:40,810
US FROM NORTHWESTERN AND HAVE A 

3725
02:43:40,810 --> 02:43:43,947
LECTURE ABOUT THIS ENROLLMENT OF

3726
02:43:43,947 --> 02:43:45,048
KIDS SCOTT REFERENCED IN HIS 

3727
02:43:45,048 --> 02:43:46,749
LECTURE IN THINKING ABOUT 

3728
02:43:46,749 --> 02:43:48,718
MINIMAL RISK, MORE THAN MINIMAL 

3729
02:43:48,718 --> 02:43:49,252
RISK, ETCETERA.

3730
02:43:49,252 --> 02:43:59,495
THANK YOU ALL.