>> WELCOME, EVERYBODY TO SESSION
2 OF OUR ETHICAL ASPECTS OF
CLINICAL RESEARCH AND I'M HOLLY
HERE AT THE DEPARTMENT OF
BIOETHICS AND HAVE A COUPLE
REALLY QUICK REMINDERS.
THAT'S MY DISCLAIMER.
IF YOU JUST ENROLLED I KNOW SOME
OUT IN VIDEO LAND HAVE JUST
ENROLLED IN THE COURSE.
THE RECORDING OF SESSION 1 IS IN
THE SESSION 1 MODULE SO PLEASE
GO AND REVIEW THAT.
PLEASE ALSO REVIEW THE WELCOME
MESSAGE AND THE COURSE BASICS IN
THE KEY DOCUMENTS MODULE.
THOSE SHOULD COVER ANY BURNING
QUESTIONS YOU MIGHT HAVE ABOUT
THE COURSE.
IF YOU DON'T FIND AN ANSWER
THERE, YOU CAN REACH OUT TO ME
OR TO ALEX.
AND TODAY AND TODAY AND MOVING
FORWARD TO ASK QUESTIONS AND
THERE'S TWO WAYS TO DO THAT.
ONE IS TO GO TO THE DISCUSSION
SESSION SECTION THAT I'VE
CREATED ON THE DISCUSSION BOARD.
YOU CAN POST QUESTIONS THERE.
YOU CAN ALSO E-MAIL TO BIOETHICS
INQUIRIES AT MAIL AT NIH
DOT-GOV.
THEY'LL GO TO ALEX AND HE'LL
FORWARD THEM TO ME DURING THE
COURSE.
AND THREE OTHER QUICK THINGS.
FIRST, IF YOU SELF ENROLL YOU
NEED TO SELF REGISTER TO GET THE
CERTIFICATE OF COMPLETION.
YOU HAVE TO GO TO CANVAS TO DO
THAT.
WE DON'T SEND THAT OUT TO YOU.
IT'S POSTED IN CANVAS.
THE SESSION QUIZZES ARE ALSO ON
CAMPUS.
WE DON'T SEND THAT OUT TO YOU.
YOU JUST HAVE TO GO INTO THE
MODULE.
IT'S POSTED AT THE BOTTOM.
AND THEN YOU'LL ALSO GET SESSION
EVALUATIONS AND THOSE COME BY
E-MAIL AND THEY'RE A SURVEY
MONKEY QUIZ.
THE QUIZZES ARE THE ONES THAT
YOU NEED TO COMPLETE TO GET THE
CERTIFICATE.
AND WITH THAT, I'M GOING TO HAND
IT OVER.
TODAY IS INFORMED CONSENT DAY
AND WE'RE GOING TO START OFF AS
WE DID LAST WEEK WITH DR. GRADY
WHO IS GOING TO GIVE US AN
INTRODUCTION TO INFORMED
CONSENT.
DR. GRADY IS THE CHAIR OF THE
DEPARTMENT HERE AT THE CLINICAL
CENTER AND SHE WILL BE FOLLOWED
BY SCOTT KIM, WE'LL HAVE A BREAK
AND THEN CAROL SQUIRE'S FROM
NIHM WILL JOIN US.
WITH THAT I'LL HAND IT OVER TO
CHRISTINE.
>> THANK YOU, HOLLY.
GOOD MORNING TO EVERYBODY.
HANDFUL OF PEOPLE IN THE ROOM.
EVERYBODY WHO'S OUT THERE IN
CYBER SPACE.
I'LL TALK ABOUT INFORMED CONSENT
TODAY.
THIS IS MY DISCLAIMER AND I HAVE
FROM CONFLICTS.
WHAT I THOUGHT I WOULD DO IN THE
TIME I HAVE IS A LITTLE BIT
ABOUT THE BASICS.
FOR SOME IT WILL BE A LITTLE BIT
ABOUT REVIEW AND CHALLENGES AND
A LITTLE BIT ABOUT CHANGES WE'RE
DEALING WITH, I GUESS, IS THE
RIGHT WORD NOW.
AND THOSE ARE BOTH CHANGES IN
RESEARCH AND CHANGES IN HOW WE
GET INFORMED CONSENT.
SO TO START WITH AS A BASIC
IDEA, CONSENT IS SOMETHING
THAT'S VERY FAMILIAR TO ALL OF
US.
IT'S A MORAL AND LEGAL
PROTECTION FROM UNAUTHORIZED
INVASIONS OF ONE'S BODY OR ONE'S
PROPERTY.
IT HAS A VERY STRONG
FACILITATIVE MORAL POWER.
IT MAKES THINGS PERMISSIBLE THAT
OTHERWISE WOULD NOT BE.
FOR EXAMPLE, I COULD BORROW YOUR
CAR AND CAN AGREE TO HAVE MY
BLOOD DRAWN, ALL THOSE THINGS
WITHOUT MY CONSENT WOULD BE
ROBBERY, RAPE AND BODILY
ASSAULT.
AND IT'S A VERY WELL ENTRENCHED
CONCEPT IN OUR SOCIETY AND MANY
SOCIETIES AROUND THE WORLD.
AND IN OUR VALUES AND
JURISPRUDENCE AND IN HEALTH
CARE.
IT'S A COMMON CONCEPT.
INTERESTINGLY IN HEALTH CARE IN
MEDICAL CARE AND RESEARCH, WE
DON'T JUST TALK ABOUT CONSENT
BUT WE TALK ABOUT INFORMED
CONSENT.
THAT MEANS BASICALLY THE
AUTHORIZATION, THE CONSENT WE
GIVE IS BASED ON UNDERSTANDING
WHAT THE ACTIVITY ENTAILS.
YOU MIGHT WISH THAT WAS TRUE FOR
ALL CONSENT AND MAYBE IT IS TRUE
FOR MOST KINDS OF CONSENT BUT IN
HEALTH CARE WITH DON'T TALK
ABOUT CONSENT WE TALK ABOUT
INFORMED CONSENT.
YOU PROBABLY KNOW IT IS A LEGAL
REGULATORY AND ETHICAL
REQUIREMENT IN BOTH HEALTH CARE
AND IN MOST RESEARCH WITH HUMAN
SUBJECTS.
IT'S ALSO AND YOU'VE HEARD THIS
I'M SURE BEFORE, A PROCESS.
A PROCESS OF REASONED DECISION
MAKING.
IT'S NOT A FORM OR A SINGLE
EPISODE IN THE TRAJECTORY OF
DELIVERY OF HEALTH CARE OR
RESEARCH.
IN A CLASSIC TEXTBOOK TODD
BEACHAM WROTE 30 YEARS AGO IT'S
CALLED THE HISTORY AND THEORY OF
INFORMED CONSENT.
THEY DESCRIBE IT AS AUTONOMOUS
AUTHORIZATION.
THAT'S AN IMPORTANT CONCEPT TO
KEEP IN MIND.
ETHICALLY IT'S BASED ON THE
NOTION OF AUTONOMY.
FOR PEOPLE'S CAPACITY AND RIGHT
TO DEFINE THEIR OWN GOALS AND
MAKE CHOICES CONSISTENT WITH
THOSE GOALS.
IN A LOT OF THE LITERATURE THE
SECOND QUOTE IS FROM THE BELMONT
REPORT, THIS SORT OF IDEA IS
REITERATED IN ONE WAY OR ANOTHER
BUT TIED TO INFORMED CONSENT AND
THE BELMONT REPORT EXPLICITLY
AND SUBJECTS BE GIVEN THE
OPPORTUNITY TO DECIDE WHAT SHALL
OR SHALL NOT HAPPEN TO THEM
THROUGH INFORMED CONSENT.
THERE'S A SPECIAL INJUNCTION
WITH USING PEOPLE FOR THE
BENEFIT OF CONSENT.
SOMEBODY YOU CAN DO SOMETHING
FOR SOMEBODY FOR THEIR BENEFIT
BUT SOMETIMES IT'S FOR THE
BENEFIT OF OTHERS SO YOU NEED
THEIR CONSENT TO DO SO.
AND INFORMED CONSENT THOUGH
CRITICALLY IMPORTANT FOR ETHICAL
RESEARCH IS ONLY ONE ASPECT OF
CONDUCTING ETHICAL RESEARCH AND
IF YOU REMEMBER MY EIGHT
PRINCIPLES IS THE SEVEN OUT OF
EIGHT IN ORDER.
IT IS REQUIRED BY VIRTUALLY ALL
CODES OF RESEARCH ETHICS AND
REGULATIONS AND LAWS THOUGH
THERE ARE SOME SOME EXCEPTIONS.
I WON'T TALK MUCH ABOUT THE
EXCEPTIONS BUT HAPPY TO ANSWER
QUESTIONS ABOUT THOSE AND I'M
SURE HOLLY WILL TOO LATER.
THAT INCLUDES THE U.S. FEDERAL
REGULATIONS, THE ICHDP, HELSINKI
AND MOST NATIONAL, STATE AND
INSTITUTIONAL REQUIREMENTS TALK
ABOUT CONSENT IN RESEARCH.
IT'S INTERESTING TO LOOK AT THE
LANGUAGE OF THE U.S. FEDERAL
REGULATIONS BECAUSE IT HELPS US
UNDERSTAND WHAT CERTAIN
EXPECTATIONS OF THE REQUIREMENT.
THIS BASICALLY SAYS YOU CAN'T
ENROLL SOMEBODY IN RESEARCH
UNLESS YOU OBTAIN THEY'RE
LEGALLY VALID INFORMED CONSENT.
THAT HAS TO BE PROSPECTIVE AND
HAS TO BE DOCUMENTED.
SO THOSE ARE IMPORTANT THINGS.
THIS IS A STATEMENT FROM AN FDA
GUIDANCE THAT CAME OUT A FEW
YEARS AGO, I GUESS LAST YEAR --
IT WAS REVISED LAST YEAR.
AND I LIKE IT BECAUSE IT GIVES
YOU THE SORT OF FULL FLAVOR OF
WHAT'S INVOLVED IN THE PROCESS.
IT'S PROVIDING A PROSPECTIVE
SUBJECT OR LEGALLY AUTHORIZED
REPRESENTATIVE WITH ADEQUATE
INFORMATION TO MAKE A DECISION.
FACILITATING THEIR
UNDERSTANDING, GIVING THEM AN
OPPORTUNITY TO ASK QUESTIONS AND
TO CONSIDER WHETHER TO
PARTICIPATE, OBTAINING THEIR
VOLUNTARY AGREEMENT AND
CONTINUED TO PROVIDE INFORMATION
AS INDICATED AS THINGS CHANGE
ONE WAY OR ANOTHER.
SO IF YOU FAKE THE PARAGRAPH, IT
BOILS DOWN TO THE THREE THINGS
IN THE MIDDLE.
AND THAT IS INFORMATION DISC
DISCLOSURE AND VOLUNTARY
INFORMATION.
I PUT MORE DOWN MORE AND YOU
HAVE TO MAKE SURE THE PERSONS
YOU'RE TALKING TO HAVE CAPACITY
TO GIVE CONSENT AND YOU'LL HEAR
FROM SCOTT AFTER ME SO I WON'T
TALK ABOUT THAT AT ALL.
AS THE YOU SAW IN THE REGULATORY
LANGUAGE, THERE NEEDS TO BE
DOCUMENTATION.
THERE NEEDS TO BE SOME
AUTHORIZATION OF CONSENT,
USUALLY IT'S A WRITTEN
SIGNATURE.
THERE'S DEBATE ABOUT THAT AND
OTHER OPTIONS BUT IT'S AN
IMPORTANT THING THERE NEEDS TO
BE SOME DOCUMENTATION.
I'LL TALK ABOUT THE THREE IN THE
MIDDLE.
START STARTING WITH INFORMATION
DISCLOSURE.
THERE'S AN INTERESTING CHALLENGE
IN TRYING TO DECIDE WHAT
INFORMATION SHOULD BE DISCLOSED.
WHAT IS IMPORTANT -- WHAT'S
ADEQUATE FOR THE PERSON TO MAKE
A DECISION, WHAT'S
UNDERSTANDABLE AND RELEVANT TO
THEM AND WHAT'S ACCESSIBLE TO
THEM AND THIS IS AN
INTERESTINGLY DIFFICULT
CHALLENGE IN THE CONTEXT OF
RESEARCH WHICH IS OFTEN QUITE
COMPLEX.
THEN THERE'S A SECOND PART OF
DISCLOSURE AND HOW SHOULD THAT
INFORMATION BE PRESENTED?
OFTEN WE SEE WRITTEN CONSENT
DOCUMENTS.
THAT'S ONE WAY OF PRESENTING
INFORMATION.
ALMOST ALWAYS ACCOMPANIED BY
SOMEBODY TALKING TO THE
PARTICIPANT, SOMETIMES OTHER
KINDS OF INFORMATIONAL,
EDUCATIONAL MATERIALS, VIDEOS,
WHATEVER.
IT COULD BE ONE-ON-ONE OR GROUPS
OR ALL KINDS OF THINGS AND THOSE
ALL MATTER IN TERMS OF HOW
INFORMATION IS DISCLOSED AND HOW
A PERSON MIGHT RECEIVE IT.
THE REGULATORY LANGUAGE AGAIN
GOES BACK FOR TWO REASONS.
ONE, IT SAYS IT SHOULD BE IN
LANGUAGE UNDERSTANDABLE TO THE
SUBJECT OR THE LAR AND HOW DO
YOU FIGURE THAT OUT?
YOU HAVE TO FIGURE WHAT A
REASONABLE PERSON THAT'S LIKE
THE PEOPLE YOU'RE INVITING TO
PARTICIPATE IN RESEARCH MIGHT
WANT TO KNOW AND MIGHT BE ABLE
TO UNDERSTAND AND PRESENT IT IN
THAT WAY.
THE REGULATIONS ALSO REVISED IN
2018 ADDED AN ADDITIONAL
REQUIREMENT FOR INFORMED CONSENT
AND HAS TO BEGIN WITH A CONCISE
AND FOCUSSED PRESENTATION OF THE
KEY INFORMATION ORGANIZATION --
ORGANIZED IN A WAY PEOPLE CAN
COMPREHEND BUT IN SUFFICIENT
DETAIL THEY GET THE WHOLE LIST.
IT'S NOT JUST A LIST.
IT'S A DETAILED LIST OF FACTS.
SO THIS IS AN INTERESTING SORT
OF A LITTLE BIT OF A CONFLICTUAL
CHALLENGE.
YOU WANT MANY SUFFICIENT DETAIL
AND CONCISE AND THIS WAS
PUBLISHED BY THE WORLD HEALTH
ORGANIZATION RECENTLY THAT
BASICALLY SAYS AND A LOT OF
PEOPLE AGREE IT'S ESSENTIAL
THEY'RE INFORMED BUT EXHAUSTIVE
DETAIL CAN WORK AGAINST THIS
OBJECTIVE BY OVERWHELMING,
CONFUSING OR DISCONCERTING
PARTICIPANTS.
THAT'S THE SORT OF CHALLENGE IN
TERMS OF DISCLOSURE.
SO, HOW ARE WE DOING?
AS THE BEEN RESEARCH IN HOW WE
ARE DOING IN RESEARCH INFORMED
CONSENT.
I PUT SOME REFERENCES BUT THE
OVER ALL CONCLUSION ABOUT
CONSENT IS THAT UP CONSENT FORMS
THE READING LEVEL IS USUALLY
HIGH.
AND HIGHER THAN WHAT PEOPLE
BELIEVE IS THE HIGHER READING
LEVEL THAN THE U.S. POPULATION
AND HIGHER THAN 8th GRADE WHICH
IS WHAT THE GUIDANCE RECOMMENDS
WE WRITE AT THAT LEVEL.
SO READING LEVEL IS HIGH.
CONSENT FORMS ARE LONG AND
THEY'VE INCREASED IN LENGTH OVER
TIME.
IF YOU LOOK AT CONSENT FORMS
FROM YEARS AGO NOW THEY'RE 25 OR
SOMETIMES HIGHER.
THEY'RE QUITE LONG AND TAKE A
WHILE TO READ AND ABSORB.
AND THEN THERE'S BEEN A FEW
STUDIES THAT HAVE LOOKED AT
BEING LONG AND COMPLEX DO THEY
DO THEY HAVE TO HAVE AND THE
ANSWER IS, NO.
THEY'RE SOMETIMES MISSING
INFORMATION REQUIRED BY
REGULATIONS.
WE'RE NOT DOING SO GREAT ON THE
CONSENT FORMS.
THERE'S INTERESTING AND
UNANSWERED QUESTIONS ABOUT THE
EFFECT OF HOW INFORMATION IS
DISCLOSED ON HOW PEOPLE
UNDERSTAND OR RECEIVE IT.
YOU MIGHT TO THE IDEAL IS
SOMEONE SITTING DOWN ONE-ON-ONE
AND DISCUSSING AND GIVING
INFORMATION AND THAT DOES HAPPEN
BUT NOT ALWAYS.
I LOVE TO TELL A STORY THAT
HAPPENED TO ME ON A CONSULT.
A YOUNG MAN HAD COME FROM FAR
AWAY FOR A COMPLICATED PROTOCOL
TO TREAT HIS CANCER AND REQUIRE
HIM TO BE HOSPITALIZED FOR WEEKS
AND RECEIVE INFUSIONS OF THIS
NOVEL SUBSTANCE BUT THE IDEA IS
IT MIGHT SPARE HIS ARM AND HE
WAS AN ARTIST AND DIDN'T CARE
ANYTHING ABOUT PRESERVING HIS
ARM FOR HIS ART.
THE SCENARIO WAS HE WAS SITTING
IN A ROOM.
I WAS THERE WITH HIM.
THERE WERE THREE INVESTIGATORS
WHO CAME IN.
THEY ALL STOOD, HE SAT.
THEY ARE DAVE HIM LOTS OF
INFORMATION.
THEY BOMBARDED HIM WITH
INFORMATION IN A CERTAIN WAY AND
IN THE MIDDLE OF THIS
CONVERSATION THEY EACH HAD
PAGERS ON AND THEY WOULD GO OUT
AND ANSWER THE PAGER AND COME
BACK AND IN AND OUT.
IT FELT LIKE DUMPING INFORMATION
ON THIS GUY WHO WAS SITTING
DOWN.
THEN WHEN THEY WERE FINISHED
THEY SAID DO YOU WANT TO DO IT?
I REMEMBER FEELING LIKE WHOA,
TOO MUCH INFORMATION, TOO MUCH
AGGRESSIVE INFORMATION.
HE NEEDS TIME AND SPACE TO JUST
SIT WITH IT, ASK QUESTIONS,
THINK ABOUT IT, ETCETERA.
THAT WASN'T THE PLAN AT THAT
MOMENT.
THE REALITY OF HOW INFORMATION
IS PRESENTED IS VERY CRITICAL.
THEN THE OTHER THING IS OF
COURSE WE HAVE PEOPLE, MANY
PEOPLE PARTICIPATING IN RESEARCH
WHO ARE IN DIRE STRAITS.
THEY'RE IN DISTRESS, THEY'RE IN
PAIN.
THEY HAVE HEADACHES, THEY'RE
CONFUSED.
THESE ARE ALL REALITIES OF THE
CLINICAL SITUATIONS IN WHICH
WE'RE OFTEN PRESENTING
INFORMATION TO PEOPLE AND HOPING
THEY CAN THEN USE IT TO MAKE A
DECISION.
THESE ARE REALLY CRITICAL
QUESTIONS ABOUT WHO DOES IT,
WHEN, WHERE AND HOW.
UP RECENT YEARS THIS CAME OUT OF
A FEDERAL REGISTER GUIDANCE
ABOUT EIGHT YEARS AGO THAT
BASICALLY SAID INFORMED CONSENT
DOESN'T HAVE TO BE ON A PIECE OF
PAPER.
DOESN'T HAVE STO START WITH A
PIECE OF PAPER YOU TALK TO
SOMEBODY ABOUT.
IT CAN BE ELECTRONIC, PODCASTS,
INTERACTIVE SITES, ETCETERA.
THIS IS ANOTHER WAY TO DISCLOSE
INFORMATION AND THE QUESTION IS
HOW DOES THIS HELP PEOPLE
UNDERSTAND BETTER OR NOT SO MUCH
BETTER?
WHAT ARE SOME CHALLENGES WITH
DISCLOSURE?
I MENTIONED DETERMINING WHAT IS
THE RELEVANT INFORMATION IN
CONTEXT TO DISCLOSE UNDERSTOOD
TO FACILITATE DECISION MAKING IS
A CHALLENGE.
RESEARCH INFORMATION IS
SOMETIMES QUITE COMPLICATED.
ANOTHER THING IS WRITTEN CONSENT
DOCUMENTS SERVE MULTIPLE
PURPOSES.
THEY NOT ONLY ARE DESIGN TO HELP
SOMEBODY GET INFORMATION THEY
NEED, BUT THEY ALSO PROTECT THE
INSTITUTION AND INVESTIGATORS.
SO THAT'S A REALLY IMPORTANT
THING TO KEEP IN MIND.
SOMEONE SAID BASICALLY EASY
READING IS DAMN HARD WRITING.
I DON'T KNOW IF SOMEONE TRIED
WRITING ONE PARAGRAPH WHAT YOU
HAVE IN FOUR PAGES IT'S HARD TO
MAKE IT UNDERSTANDABLE.
AND NOT SURPRISINGLY,
INSTITUTION, SPONSORS AND
INVESTIGATORS AND EVEN IRBs
OFTEN WANT MORE INFORMATION AND
THEREFORE CONCEPT FORMS GET
LONGER AND MORE COMPLEX BASED ON
THOSE INPUTS.
THE SECOND INFORMATION IS
DISCLOSED.
THE SECOND IMPORTANT PART OF
INFORMED CONSENT IS
UNDERSTANDING.
AND WE ALL KNOW THAT WHEN YOU
HEAR INFORMATION EVEN WHEN
YOU'RE LISTENING THERE'S ONLY A
SORT OF A LITTLE BIT, I GUESS IS
THE RIGHT WORD WHERE YOU REALLY
UNDERSTAND.
AND IT CAN'T BE EXPECTED
EVERYTHING YOU'RE TOLD IS
SOMETHING YOU UNDERSTAND.
THE QUESTIONS THAT REALLY PLAGUE
THE PROCESS OF INFORMED CONSENT
IS HOW MUCH IS NEEDED FOR
CONSENT.
JOE MILLON WHO USED TO BE IN OUR
GROUP WITH DANIEL BRUM SUGGESTED
A MINIMAL UNDERSTANDING
CONSISTENT WITH VALID INFORMED
CONSENT.
THERE'S ALSO A QUESTION ABOUT
HOW SHOULD WE AND HOW DO WE
ASSESS WHETHER PEOPLE DO
UNDERSTAND.
I'VE SEEN THE FULL GAMUT OF THE
EXAMPLE, ARE YOU COME, DO YOU
WANT TO DO OUT WITHOUT
QUESTIONS.
SOMETIMES PEOPLE SAY DO YOU HAVE
ANY QUESTIONS.
SOMETIMES INVESTIGATORS AND
RESEARCH TEAMS USE QUIZZES.
THEY HAVE WRITTEN QUIZZES AND
PEOPLE HAVE TO GET A CERTAIN
PERCENTAGE RIGHT TO DEMONSTRATE
UNDERSTANDING.
THERE'S A WIDE RANGE OF WHY AND
HOW SHOULD WE DO IT AND A
QUESTION ON WHAT HAPPENS OR WHAT
SHOULD HAPPEN WHEN PARTICIPANTS
DON'T UNDERSTAND AND WHAT IF
THEY DON'T UNDERSTAND WHAT?
THEY DON'T UNDERSTAND ANYTHING?
THEY ARE UNDERSTAND CERTAIN
THINGS BUT NOT OTHER THINGS AND
SHOULD THEY BE ABLE TO
PARTICIPATE OR NOT AND DOES IT
DEPEND ON THE STUDY?
THESE ARE HARD QUESTIONS TO
ANSWER.
AGAIN, THERE'S BEEN A FAIR
AMOUNT OF RESEARCH ON INFORMED
CONSENT WHICH IS BASICALLY
CONCLUDED OVER ALL THAT RESEARCH
PATIENTS HAVE VARIABLE
UNDERSTANDING OF THE STUDIES
THEY CONSENTED TO.
THEY CONSENTED, THEY'RE IN THE
STUDY, SOMEBODY INTERVIEWS OR
SURVEYS THEM TO FIGURE OUT WHAT
THEY'VE UNDERSTAND AND
UNDERSTAND SOME THINGS AND NOT
OTHER THINGS AND THAT'S
BASICALLY ALL THE DATA SUGGESTED
THAT'S THE CASE.
AND THE RANGE IS QUITE STRIKING
IF YOU LOOK AT SOME OF THESE
DOWN HERE.
RESEARCH PURPOSE AND NATURE
SOMETIMES AS LOW AS 27%
UNDERSTAND AND SOMETIMES 100%
UNDERSTAND IT.
OF RISKS, THE SAME KIND OF
RANGE.
OF RANDOMIZATION AND PLACEBO USE
IS OFTEN LOWER.
PEOPLE UNDERSTAND THAT LESS WELL
IN GENERAL THAN OTHER THINGS BUT
STILL QUITE A RANGE.
THERE'S ALSO BEEN A COUPLE OF
META-ANALYSES OF THE INFORMED
CONSENT STUDIES TO TRY TO SHOW
WHAT PEOPLE DO OR DO NOT
UNDERSTAND.
THIS IS A BUSY SLIDE AND I'M
GOING TO SHOW YOU ANOTHER BUSY
SLIDE.
TWO TAKEAWAYS, NOTHING REALLY
APPROACHES 100%.
THAT'S ONE THING TO NOTICE AND
SEE THERE ARE SEVERAL THINGS
LIKE PLACEBO RANDOMIZATION AND
ALTERNATIVE TREATMENTS CLOSER TO
50%.
THAT'S A LITTLE BIT DISCONCERT
ARING.
THIS WAS A META-ANALYSIS
PUBLISHED IN 2015 BASED ON DATA
THAT HAD BEEN COLLECTED TO DATE.
THERE WAS A SECOND ONE PUBLISHED
JUST THIS YEAR WHICH USED SOME
OF THE SAME METHODOLOGY AND
BASICALLY SEE THE NUMBERS.
THERE'S NOT MUCH DIFFERENT THAN
THE OTHER META-ANALYSES.
AND THE RESULTS SHOW MOST
PARTICIPANTS UNDERSTAND THE
FUNDAMENTAL COMPONENTS OF
INFORMED CONSENT.
MEANING STUDY NATURE,
VOLUNTARINESS AND FREEDOM TO
WITHDRAW MOST AS A QUESTION MARK
AND OTHER THINGS LIKE PLACEBO
AND THE ABILITY TO NAME AT LEAST
ONE RISK WAS MUCH LOWER.
WHAT AFFECTS UNDERSTANDING?
THERE'S PROCESS RELATED FACTORS
AND WHAT INFORMATION THEY'RE
GIVEN AFFECTS HOW THEY
UNDERSTAND AND AS WELL BY HOW
WELL THEY PROCESS AND LEARN AND
LISTEN AND THERE'S FACTORS THAT
INFLUENCE THE UNDERSTANDING OF
RESEARCH PARTICIPANTING INCLUDE
SOME OF THOSE WON'T SURPRISE YOU
AT ALL, AGE, OLDER PEOPLE
UNDERSTAND LESS AND LESS
EDUCATED PEOPLE UNDERSTAND LESS.
PEOPLE IN PAIN.
PEOPLE WHO HAVE COGNITIVE
IMPAIRMENT.
PEOPLE UNDER STRESS.
THOSE HOST FACTORS ARE
ASSOCIATED WITH LOWER LEVELS OF
UNDERSTANDING.
THERE'S UNEXPLORED ASPECTS OF
WHAT IMPACTS UNDERSTANDING
RESEARCH PARTICIPANTS AND
EXPECTATIONS AND WHAT DO PEOPLE
THINK WILL HAPPEN BEFORE THEY
GET ANY INFORMATION.
WHY DO THEY DO IT?
THAT INFLUENCES WHAT THEY LISTEN
TO AND END UP UNDERSTANDING.
THERE'S CULTURAL VIEWS.
THERAPEUTIC MISCONCEPTIONS AND
OTHER RELATED UNDERSTANDINGS.
IMPORTANTLY THINKING ABOUT
DISCLOSURE AND UNDERSTANDING
IT'S IMPORTANT TO THINK ABOUT
HEALTH LITERACY.
THIS IS U.S. DATA COMING FROM
BOTH THE NATIONAL LIBRARY OF
MEDICINE AND THE OTHER
ORGANIZATION I CAN'T THINK OF
THE NAME OF, CHCS.
THEY GRADE ON THE NUMBERS SO I
PUT THEM BOTH DOWN THERE.
BASICALLY THEY SAY NINE OUT OF
TEN ADULTS STRUGGLE WITH HEALTH
LITERACY.
EVEN PEOPLE WITH OTHERWISE GOOD
LITERACY SKILLS, PEOPLE WHO CAN
READ AND WRITE AND CALCULATE
PLAY HAVE LOW HEALTH LITERACY.
I FIND THAT REALLY INTERESTING.
I EXPECT YOU ALL KNOW PEOPLE
LIKE I DO, SMART PEOPLE WHO ARE
MASTER'S IN THEIR DOMAIN OF THE
WORLD WHO DON'T UNDERSTAND MUCH
ABOUT HEALTH.
IT'S QUITE INTERESTING BUT THIS
HAS TO INFLUENCE HOW PEOPLE
UNDERSTAND THE KINDS OF
INFORMATION WE'RE PROVIDING IN
THE CONTEXT OF MAKING DECISIONS
ABOUT RESEARCH PARTICIPATION.
HOW MUCH PEOPLE UNDERSTAND AND
HOW WE ASSESS UNDERSTANDING
SHOULD VARY BY THE LEVEL OF RISK
TO THE PARTICIPANT.
IF YOU LOOK AT THE ROW, THE
RECOMMENDED IF IT'S LOW RISK YOU
CAN ASSUME PEOPLE UNDERSTAND IT
AND COMPETENT TO UNDERSTAND IT.
IF IT'S MODERATE OR HIGH RISK
WITH POTENTIAL BENEFIT YOU MAY
DO A BRIEF OR INFORMAL
ASSESSMENT OF HOW MUCH THEY
UNDERSTAND BUT HIGHER THE RISK
OR HIGH RISK WITH LITTLE OR NO
POTENTIAL BENEFIT YOU NEED A
HIGHER THRESHOLD OF KNOWING THE
PERSON UNDERSTAND THE DETAILS OF
THE STUDY DATA PRESENTED TO
THEM.
I AGREE WITH THAT, BY THE WAY.
AS THE DIFFERENT KINDS OF
MISUNDERSTANDING AND THAT'S
HELPFUL TO THINK THROUGH.
PEOPLE FOCUS ON THERAPEUTIC
MISCONCEPTION WHICH IS BASICALLY
NOT RECOGNIZING PEOPLE IS
DIFFERENT THAN REGULAR CLINICAL
CARE AND GIVE A DEFINITION IN A
MINUTE.
THERE'S OTHER KIND OF
MISUNDERSTANDINGS.
SOME PEOPLE UNDERSTAND RESEARCH
IS RESEARCH BUT MISS ESTIMATE
THE LEVEL OF BENEFIT OR RISK OR
BOTH.
THE EXPECTATION IS IT WILL BE 5%
BENEFICIAL OR WHATEVER.
UNDERSTANDING THAT
MISUNDERSTANDING IS IMPORTANT
TOO.
THEN THERE'S BEEN A WHOLE BUNCH
OF LITERATURE ON THE INFLUENCE
OF OPTIMISM.
THERE ARE PEOPLE WHO BECAUSE OF
EXPECTATIONS A GUY SAID I GET
IT.
IT'S BRAND NEW, FIRST IN HUMAN.
DON'T KNOW IF IT WILL HELP ME AT
ALL OR WORK IN ANYBODY BUT I'LL
BE THE ONE.
SO THAT KIND OF OPTIMISM CAN BE
NATURE FOR CERTAIN PEOPLE AND
ALSO CAN ACCOMPANY
MISUNDERSTANDING OF THE DETAILS.
SEPARATING WHAT IS HOPE THAT'S
OKAY WITH HOPE THAT'S
UNREALISTIC.
THERE'S ALSO BEEN AN IMPORTANT
DISTINCTION WHICH IS HELPFUL TO
TO THE WHEN KNOWLEDGE OF
RELATIVE INFORMATION WHICH CAN
BE SEEN AS UNDERSTANDING AND
APPRECIATION OF HOW IT APPLIES.
THE CLASSIC EXAMPLE IS A STUDY
THAT LED TO THE TERMINOLOGY OF
THERAPEUTIC MISCONCEPTION.
A GROUP OF PEOPLE WITH
SCHIZOPHRENIA JOINING A PLACEBO
TRIAL INTERVENTION AND THE
INTERVIEWS DONE WITH THE
INDIVIDUALS AFTER THE CONSENT
PROCESS WAS FINISHED, THEY HAD A
PRETTY GOOD UNDERSTANDING OF THE
FACTS.
THIS IS A RANDOMIZED TRIAL.
HALF THE PEOPLE WILL GET THE
EXPERIMENTAL DRUG AND HALF WILL
GET PLACEBO.
I FORGET THE OTHER FACTS BUT
THEY HAD A PRETTY GOOD
UNDERSTANDING OF THE FACTS AND
COULD RECITE THEM BACK THEN THEY
SAID, OH, BUT MY DOCTOR WILL
MAKE SURE I GET THE DRUG.
THAT'S THE DIFFERENCE BETWEEN
KNOWLEDGE AND FACTS OR THE
ABILITY TO RECITE THE FACTS AND
APPRECIATION OF HOW THE FACTS
MIGHT APPLY TO AN INDIVIDUAL
THEMSELVES.
AND PAUL APPLEBAUM COINED THE
TERM THERAPEUTIC MISCONCEPTION
AND SAID WHEN A RECENT
PARTICIPANT FAILS TO RECOGNIZE
HOW INDIVIDUALIZED MEDICAL CARE,
THAT IS THE PHYSICIAN'S
OBLIGATION TO MAKE MEDICAL
DECISIONS IN THE PATIENT'S BEST
INTEREST, MAY BE COMPROMISED BY
RESEARCH PROCEDURES BECAUSE
RESEARCH OFTEN HAS A PROTOCOL
WHICH DICTATES WHO GETS WHAT AND
WHAT DOSES.
ETCETERA.
IT'S NOT DECIDED BY THE
INDIVIDUAL PHYSICIAN BASED ON
THE INDIVIDUAL PERSON'S NEEDS.
AND APPLEBAUM AND COLLEAGUES GO
ON TO MAKE THE POINT IN MANY
PAPERS FAILURE TO RECOGNIZE
THESE DIFFERENCES NEGATES THE
ABILITY TO PROVIDE MEANINGFUL
INFORMED CONSENT.
THIS IS A TYPE OF
MISUNDERSTANDING THAT MAKES IT
IMPOSSIBLE TO REPRESENT.
AND STUDIES THAT LOOKED AT
IMPROVING THE UNDERSTANDING OF
INFORMED CONSENT.
THERE'S TWO SYSTEMATIC REVIEWS
THAT CATEGORIZED THE TYPES OF
STUDIES INTO THESE GROUPS.
I THINK THEY'RE QUITE TELLING
EVEN TODAY THOUGH THESE ARE BOTH
OLD STUDIES SO WE NEED A NEW
ONE.
BUT THEY COMPARED STUDIES THAT
TESTED MULTI-MEDIA INTERVENTION
TO TRY TO IMPROVE UNDERSTANDING
WITH ENHANCED CONSENT FORMS
MEETING DIFFERENT STYLES OR
SHORTER, EXTENDED DISCUSSION,
TEST FEEDBACK AND A BUNCH OF
OTHER MISCELLANEOUS ITEMS.
WHAT DO YOU THINK WORKED THE
BEST?
EXTENDED DISCUSSION.
SHOCKING, RIGHT?
THE MORE YOU TALK TO SOMEBODY
ABOUT WHAT'S HAPPENING THE MORE
THEY UNDERSTAND.
THERE WERE ONLY A FEW STUDY IN
THAT CATEGORY.
THERE WAS CLEARLY BETTER
UNDERSTANDING FROM THAT THAN
ANYTHING ELSE.
THERE ARE WAYS IN WHICH THAT
MAKES SENSE.
THERE'S RESOURCE QUESTIONS THAT
LIMIT HOW MUCH TIME WE CAN SPEND
TALKING TO PEOPLE IT'S NOT LIKE
NOW WE KNOW WHAT TO DO, LET'S DO
IT.
ONE INTERESTING THING IS BOTH
THESE META-ANALYSES SAID
ENHANCED CONSENT FORMS MIGHT
WORK BUT WE NEED A RANDOMIZED
TRIAL.
SO OUR GROUP DID A NUMBER OF
RANDOMIZED STUDIES WHERE WE TOOK
AND DID THREE VERSIONS OF IT
WITH HEALTHY VOLUNTEERS IN PHASE
1 DRUG STUDIES WITH HEALTHY
VOLUNTEERS IN FLU STUDIES AND
PEOPLE WITH HIV AND
MULTI-NATIONAL TREATMENT STUDY.
ALTOGETHER THE HEALTHY VOLUNTEER
STUDIES WERE 130 IN EACH ONE IN
THE HIV STUDY WAS ABOUT 4,000
PEOPLE.
WE RANDOMIZED THEM TO GET THE
STANDARD CONCEPT FORM OR A
SHORTER SIM POLICE OFFICER LOWER
READING LEVEL CONCEPT FORM AND
THE AMAZING THING IS DIDN'T MAKE
A DIFFERENCE.
MOST PEOPLE UNDERSTAND CERTAIN
THINGS BETTER THAN OTHER THINGS
BUT THE SHORTER FORMS DIDN'T
HELP THEM UNDERSTAND MORE WHICH
IS QUITE INTERESTING.
THERE'S ALSO BEEN STUDIES DONE
MORE RECENTLY.
HOLLY WAS INVOLVED WITH ONE
WHERE THEY RANDOM I'VEED PEOPLE
TO THREE FORMATS AND PEOPLE
EXPOSED TO VIDEO HAD MORE SATS
SATISFACTION.
OTHER STUDIES SIMILARLY SHOWED
THOUGH DATA DOESN'T ALWAYS
IMPROVE UNDERSTANDING AS THE
TESTS THAT MEASURE THEM BUT
IMPROVES SATS FAC AND ENGAGEMENT
WITH THE INFORMATION.
THAT'S INTERESTING TOO AND
PEOPLE LOOK AT THE WEB BASED AND
INTERACTIVE METHODS AND HOW MUCH
THEY INCREASE UNDERSTANDING.
THE THIRD PILLAR IS VOLUNTARY
CHOICE.
DISCLOSE INFORMATION.
PEOPLE UNDERSTAND HOPEFULLY
ENOUGH TO MAKE AN INFORMED
DECISION AND THIS HAS GOTTEN THE
LEAST ATTENTION AND IT'S
INTERESTING TO THINK OF WHAT A
VOLUNTARY CHOICE.
WE MAKE CHOICES EVERY DAY.
WE MAKE CHOICES HOPEFULLY
VOLUNTARILY BUT THEY'RE BASED ON
OUR EXPERIENCES OUR
EXPECTATIONS, THE KINDS OF
THINGS THAT OUR NETWORK OF
SUPPORTERS PUSH FOR.
THERE'S A LOT OF THINGS THAT
INFLUENCE HOW WE MAKE DECISIONS
EVERY DAY AND YET I WOULDN'T
CALL THEM NOT VOLUNTARY.
THINKING ABOUT HOW DO YOU THINK
OF A VOLUNTARY CHOICE WITHIN THE
CONTEXT OF RESEARCH IS NOT
COMPLETELY STRAIGHTFORWARD.
THE REGULATORY LANGUAGE AND THE
LITERATURE SUGGEST THERE'S THREE
THINGS WE HAVE TO AVOID IN ORDER
FOR CHOICE TO BE VOLUNTARY.
THERE SHOULD BE NO DECEPTION, NO
COERCION, THERE SHOULD BE NO
UNDUE INFLUENCE.
UNDERSTANDING WHAT THOSE TERMS
MEAN HELP UNDERSTAND WHAT IS
VOLUNTARY.
CONCEPTION IS DISTORTING THE
TRUTH IN ORDER TO MISLEAD AND
THERE'S SOMETHING CALLED
FRAUDULENT DISCLOSURE
WITHHOLDING INFORMATION OR
PRESENTING IN A WAY THAT IS NOT
FACTUALLY INCORRECT BUT
MISLEADING.
THAT'S DECEPTION.
COERCION IS COMPELLING SOMEBODY
TO DO SOMETHING AGAINST THEIR
WILL BY THREATENING THEM.
THREATENING TO MAKE THEM WORSE
OFF.
THERE'S EXAMPLES OF COERCION IN
RESEARCH BUT PROBABLY NOT THAT
MANY WITH COULD IDENTIFY.
AND THIS IS UNDUE INFLUENCE
PEOPLE DEFINE AS AN OFFER.
NOT A THREAT.
IT'S NOT COERCIVE.
IT'S AN OFFER THAT DISTORTS
SOMEBODY'S JUDGMENT OR ENTICES
THEM TO DO SOMETHING THAT IS
AGAINST THEIR INTEREST SO THEY
DON'T WANT TO DO IT.
AND THIS IS TRICKY TOO BECAUSE
IF YOU THINK ABOUT IF YOU GIVE
SOMEBODY AN INNOCCENTIVE TO DO
SOMETHING IT'S NOT AN UNDUE
INCENTIVE, IF YOU GET PAID TO
WORK YOU'RE NOT BEING UNDULY
INFLUENCED.
THERE'S A LINE BETWEEN WHAT'S
OKAY AND WHAT IS EXCESSIVE OR
INAPPROPRIATE OR MAKES PEOPLE DO
THINGS AGAINST THEIR OWN
INTEREST OR DISTORTS THEIR
JUDGMENT.
WHAT COULD INFLUENCE VOL --
VOLUNTARINESS MAYBE YOUR BOSS OR
DOCTOR ASKS YOU TO PARTICIPATE
IN A STUDY OR SOMEBODY YOU FEEL
SUB SERVANT TO IN SOME WAY.
PRESSURE.
THAT COULD BE FROM A NUMBER OF
SOURCES.
IT COULD BE FROM A RESEARCH TEAM
AND FROM FAMILY AND FRIENDS AND
THE FACT YOU HAVE NO MONEY.
THERE ARE WAYS IN WHICH PRESSURE
COMES FROM LOTS OF THINGS.
TRUST IN HEALTH CARE PROVIDERS
IS SOMETHING PEOPLE WORRY ABOUT.
THERE'S SEVERAL STUDIES TO
SUGGEST PEOPLE WHO MAKE
DECISIONS ABOUT PARTICIPATING IN
RESEARCH MAKE THEM BASED ON MY
DOCTOR TOLD ME TO DO IT AND
WITHOUT REALLY PAYING ATTENTION
TO WHAT'S BEING ASKED OF THEM OR
WHAT THE RISKS AND BENEFITS
MIGHT ENTAIL.
AND THIS IS -- THERE'S AGAIN A
SMALL AMOUNT OF LITERATURE ON
THE DUAL ROLE OF A PHYSICIAN
ALSO PART OF A STUDY INVITING
THEIR PATIENTS TO BE PART OF THE
STUDY PRECARIOUSLY INFLUENCED
VOLUNTARINESS AND THERE'S LESS
DIRECT WORTHINESS ON
VOLUNTARINESS AND THERE'S
RESTRICTED VOICES.
IF YOU DON'T HAVE A LOT OF
ALTERNATIVES FOR DOING SOMETHING
AND DECIDE THIS IS WHAT I WANT
TO DO, DOES THAT MAKE IT LESS
VOLUNTARY THAN WITH A BUNCH OF
CHOICES?
I DON'T THINK SO BUT SOME PEOPLE
DO.
YOU HAVE TO SORT OF PUT THE
CONTEXT UP THERE AND SAME WITH
ILLNESS.
IF YOU'RE SICK, YOU MAY HAVE
LESS CHOICES.
YOU MAY HAVE LESS INTEREST IN
MAKING CHOICES.
YOU MAY PUT MORE TRUST IN YOUR
PROVIDERS.
THERE COULD BE LOTS OF THINGS
THAT WOULD INFLUENCE YOUR
ABILITY TO MAKE A VOLUNTARY
CHOICE.
IN ADDITION TO NOT CONFUSION BUT
LESS CLARITY ON THE CONCEPTS
IT'S LESS CLEAR HOW YOU MEASURE
VOLUNTARINESS.
THERE'S SOME STUDIES USEFUL FOR
A COUPLE THINGS TO THINK ABOUT
TO EVEN FIND IN STUDIES.
ONE IS DO PEOPLE REPORT FEELING
PRESSURE FROM OTHERS.
AND FOR THE MOST PART THE NUMBER
OF PEOPLE REPORT PRESSURE FROM
OTHERS INCLUDING FAMILY MEMBERS
AND DOCTORS IS PRETTY LOW.
AND THEY PEEL THEY HAVE DO DO
SOMETHING AND THAT FEELS LIKE
PRESSURE.
THERE'S A QUESTION DO PEOPLE
KNOW THEY CAN QUIT OR IT'S A
VOLUNTARY CHOICE.
THE RANGE IS ALL OVER THE PLACE.
AND YOU CAN LOOK AT NUMBER OF
WHO DECLINES OR DOESN'T
PARTICIPATE.
AND THERE WAS AN INTERESTING
PAPER IN THE JOURNAL OF
EMPIRICAL PAPER WHERE THEY
MEASURED VOLUNTARINESS AND THEY
SAID THERE'S SOME INDICATION BUT
WE DON'T HAVE CONSENSUS ON HOW
WE UNDERSTAND WHETHER SOMETHING
IS VOLUNTARY OR NOT.
AND IF YOU LOOK AT THE TWO
INSIDE THAT CIRCLE, VOLUNTARY
NATURE OF PARTICIPATION AND
FREEDOM TO WITHDRAW AT ANY TIME,
25% DON'T KNOW IT'S TRUE.
IS THAT GOOD ENOUGH OR SHOULD WE
BE DOING BETTER ON THAT?
SO INFORMED CONSENT IS COMPLEX.
THERE'S ENDURING CHALLENGES AND
IT'S AFFECTED BY A NUMBER OF
DIFFERENT THINGS.
SOME OF WHICH I MENTIONED AND
YOU'LL HEAR ABOUT MORE.
I JUST WANT TO SPEND FIVE
MINUTES TO TALK ABOUT THE FIVE
CHANGES.
WE'VE HAD LOTS OF KINDS OF
RESEARCH THAT HAVE GROWN IN
RECENT YEARS LIKE BIO BANKS AND
DATA REPOSITORY AND PRAGMATIC
TRIALS AND DECENTRALIZED TRIALS.
ALL THESE POSE WE HAVE TO THINK
CAREFULLY HOW WE GET CONSENT IN
THE CONTEXT WHICH IS DIFFERENT
THAN THE TRADITIONAL SIT DOWN
WITH SOMEBODY IN A CLINIC TO ASK
THEM TO JOIN A CLINICAL TRIAL
AND THERE'S WAYS TO EXCHANGE
INFORMATION AND GET VERIFICATION
AND AUTHORIZATION OF CONSENT
INCLUDING ELECTRONIC DEVICES,
APPS, WEB INTERFACES, ETCETERA.
ALL THESE ARE OFFER ADVANTAGES
IN CERTAIN WAYS BUT ALSO OFFER
CHALLENGES IN CERTAIN WAYS.
I THINK I'LL SKIP THE REST AND
GO TO THE LAST SLIDE WHICH IS
DESPITE THE WAY CONSENT IS
OBTAINED ON THE OLD FASHIONED
PAPER SITTING WITH A PARTICIPANT
UP A ROOM OR THROUGH A
DECENTRALIZED TRIAL AND AN APP
AND REMOTE INTERACTION.
YOU STILL HAVE TO THINK THROUGH
WHAT HES THE INFORMATION WE'LL
BE GIVING AND DISCLOSURE ELEMENT
S AND HOW MUCH PEOPLE HAVE TO
UNDERSTAND AND HOW TO ASSESS
WHETHER THEY ARE UNDERSTANDING
AND HOW DO WE KNOW IF IT IS
VOLUNTARY.
AND SOME OFFER CONVENIENCE AND
OPPORTUNITIES THEY MAY NOT
OTHERWISE HAVE AND OFFERS
CHALLENGES IN THESE DOMAINS
BECAUSE YOU CAN'T SEE THE PERSON
OR READ THEIR BODY LANGUAGE.
YOU HAVE TO VERIFY THEIR
IDENTITY.
HOW DO YOU KNOW SOMETHING IS
VOLUNTARY WHEN YOU CAN'T EVEN
SEE THE PERSON?
THAT'S THE END.
I'M GOING TO STOP.
I'LL LET YOU READ THESE TWO.
>> A REMINDER IF YOU HAVE A
QUESTION HERE IN THE AUDITORIUM,
PLEASE TWO TO A MIKE SO THE FOKZ
OUT IN VIDEO LAND CAN HEAR YOU.
FOLKS IN VIDEO LAND CAN HEAR
YOU.
I HAVE A QUESTION FROM VIDEO
LAND.
KIM ASKS AND SAYS FIRST THANKS
FOR THE LECTURE, IS THERE SPACE
FOR GROUP EDUCATION SESSIONS
PRIOR TO THE INDIVIDUAL INFORMED
CONSENT PROCESS.
PROTECT PARTICULARLY IF THE
LENGTH AND DETAIL OF THE STUDY
AND THE CONSENT FORM ITSELF IS
PROHIBITIVE.
IF YES, CAN THE GROUP AWARENESS
SESSION BE SEEN AS A RECRUITMENT
VERSUS EDUCATION TOOL AND DOES
IT NEED IRB APPROVAL.
THERE'S A LOT PACKED IN THERE.
>> CERTAINLY THERE ARE
SITUATIONS, TYPES OF TRIALS AND
POPULATIONS IN WHICH TRIALS ARE
BEING DONE WHERE GROUP EDUCATION
ABOUT WHAT THE STUDY IS ABOUT IS
CRITICAL AND HELPFUL.
IT'S BOTH EDUCATION FOR THE
INDIVIDUALS WHO ARE PART OF THE
GROUP BUT ALSO SOMETIMES ONE
PERSON WILL ASK A QUESTION
ANOTHER QUESTION WOULDN'T HAVE
THOUGHT OF SO IT'S A GOOD WAY TO
GET PEOPLE TO ENGAGE.
MY OWN VIEW IN MOST CASES MRAB
ALL BUT MOST -- MAYBE ALL BUT
MOST SHOULD HAVE OF MEET WITH
THE INDIVIDUAL BECAUSE SOMETIMES
PEOPLE FEEL PRESSURE FROM THE
GROUP BUT THAT'S NOT WHAT YOU
WANT.
YOU WANT EACH INDIVIDUAL TO MAKE
THEIR OWN DECISION.
AND THERE'S PARTS THE IRB DOES
REVIEW BUT DON'T KNOW IF IT'S
ALWAYS REQUIRED.
>> I'M WONDER IF AN EDUCATION
MODULE IS SOMETHING THE
INVESTIGATORS WILL DIRECTLY
ENGAGE THE PARTICIPANT WITH I
WOULD THINK IT NEED TO BE AND IT
BEGS THE QUESTION OF SOME MIGHT
NEED IRB APPROVAL BUT MAYBE AN
INTRODUCTION TO THE TYPES OF
RESEARCH GOING ON OR EDUCATION
ABOUT THE INTERVENTION THINGS
THAT ARE LESS AFTER THIS I'M
GOING TO ASK YOU A QUESTION
ABOUT YOUR ENROLLMENT.
AND COGNITIVE OF THE POTENTIAL.
>> IT HAS TO DO WITH THE PEOPLE
THAT GET THROUGH THE DOOR.
I WAS WORKING ON A PROJECT A
NUMBER OF YEARS AGO AT PENN
WHERE AT THE ALZHEIMER'S CENTER
THEY HAD SORT OF OPEN HOUSES FOR
INDIVIDUALS WHO HAD ALZHEIMER'S
AND OR THEIR PARTNERS COME AND
LEARN ABOUT THE CENTER, LEARN
ABOUT THEIR RESEARCH AND I
REMEMBER THINKING THIS IS A VERY
PARTICULAR GROUP OF PEOPLE
COMING.
THEY KNOW ABOUT IT.
THEY CAN AFFORD TO GET
THEMSELVES HERE AND HAVE A
PARTNER WHO CAN BRING THEM.
NOT TO SAY IT'S BAD BUT DOES
SORT OF ONLY SOME PEOPLE WILL
MAKE THAT MOVE.
HI, DANIEL, THANKS.
>> THANKS FOR THE LECTURE.
SO I WAS WONDERING IF THERE'S NO
DECEPTION OR COERCION OR UNDUE
INFLUENCE AND SEEMS THE PRESSURE
CAN BE NOT DECEPTIVE OR COERCIVE
OR LIKE GUILT TRIPPING OR
MANIPULATION.
I'M WONDERING HOW THEY FIGURE
INTO DECIDING IF THE CHOICE IS
VOLUNTARY.
>> GREAT QUESTION.
THE UNDUE INFLUENCE IS LANGUAGE
THAT COMES IN REGULATION.
THERE'S A WAY IN WHICH SOME
PEOPLE SAY IT'S VOLUNTARY IF
THERE'S NO COERCION OR UNDUE
INFLUENCE.
I PERSONALLY AND SOME HAVE SAID
I DON'T WANT DO BUT MY SPOUSE IS
MAKING ME OR MY PARENTS EXPECT
ME TO.
THAT PRESSURE NEEDS TO BE
RECOGNIZED AND DEALT WITH.
AND SOME SAY I FEEL PRESSURE
FROM LIFE AND ONE STORY, ONE GUY
AN ADOLESCENT WHO SAID HE
DOESN'T WANT TO PARTICIPATE AND
WAS FEELING LIKE HIS PARENTS
WERE FORCING HIM AND WE TALKED
TO HIM FOR HOURS ABOUT YOU DON'T
HAVE TO DO THIS.
WE CAN FIND A WAY TO GET YOU TO
SAY NO AND IT WILL BE OKAY.
IN THE END HE SAID I'LL DO IT
AND WE SAID WHY DID YOU CHANGE
YOUR MIND AND HE SAID I HAVE TO
LIVE WITH THEM.
I DON'T KNOW HOW YOU PUT THAT IN
THE RUBRIC OF WAS THAT VOLUNTARY
OR NOT.
I THINK IT WAS BUT IT WAS A
COMPLICATED CHOICE.
PRESSURE MATTERS.
>> I'M WONDERING IF ALTERNATIVE
DECISIONS MATTER.
IN THE CASE WHERE HE HAS TO LIVE
WITH HIS PARENTS AND THEN HAS TO
LIVE WITH THE DECISION TO NOT
ENROLL IN THE STUDY AND THERE'S
ALTERNATIVES THAT DOESN'T SEEM
THAT GREAT SO I'LL CHOOSE IT
HAVE A JOB AND MAYBE
VOLUNTARINESS DEALS WITH LIFE
OUTCOMES AND WHAT WE'RE GIVEN
AND MAKING A CHOICE IN THAT TYPE
OF CONTEXT.
I NEED A JOB TO HAVE MONEY, TO
LIVE WITH MY PARENT SO I NEED TO
ALSO RESPECT MAYBE WHAT THEY
WANT.
OR IN THE CASE OF OTHER
PATIENTS, THE RESEARCH PROGRAM
IS A WAY TO GET NEW TREATMENTS
OR ONLY WAY WHERE I CAN GET
MONEY.
AND IT MATTERS FOR VOLUNTARY
DECISION MAKING AND WONDERING IF
IT'S RELEVANT IN THE FIELD OR A
CORRECT INTERPRETATION.
>> I THINK IT'S CORRECT.
AND VEEP THE PRESSURE AND
INFLUENCE THAT IS NOT COMPLETELY
EVER GONE BUT IN THE CASE I JUST
DESCRIBED, I FEEL LIKE THIS
PARTICULAR INDIVIDUAL WAS
FEELING PRESSURE.
WE ADDRESSED IT DIRECTLY, GAVE
HIM PERMISSION TO NOT
PARTICIPATE AND THEN DECIDED I'M
GOING TO DO IT ANYWAY BECAUSE I
HAVE TO LIVE WITH THESE PEOPLE
THEY'RE MY PARENTS.
WHAT WE NEED TO FIGURE OUT IS
WHAT'S ADEQUATELY VOLUNTARY SO
WE'RE NOT FINDING SOMEBODY
FEELING PRESSURE THEY CANNOT
RESIST.
THERE ARE TYPES OF PRESSURE THAT
ARE OVER BEARING AND PEOPLE
SHOULD BE ABLE TO DECIDE
THEMSELVES.
>> IF YOU DON'T LET HIM ENROLL
IS ALSO A FORM OF COERCION AND
NOT RESPECTING THE POSITION.
THANK YOU.
>> THIS IS A MINOR EXAMPLE BUT
PEOPLE SCORE HIGH ON I KNOW I
CAN LEAVE AND KNOW NO BAD THINGS
WILL HAPPEN IF I DO BUT SAY I'LL
NEVER LEAVE.
THEY WENT TO BE A GOOD RESEARCH
SUBJECT BIT WE DON'T KNOW WHAT
THE PRESSURES ARE.
PEOPLE WILL SAY I KNOW IT'S MY
CHOICE BUT WHAT OTHER CHOICE DO
I HAVE.
IT'S COMMON PRACTICE TO GET
UNDERGRADS TO ENROLL BY
INCLUDING THAT AS PART OF YOUR
GRADE AND TEAR USUALLY MINIMAL
RISK BUT BENEFITS THE PROFESSOR
IN THAT DEPARTMENT TO HAVE MORE
PEOPLE ENROLL.
WHAT MAKES THAT OKAY IN TERMS
OF -- THEIR GRADES ARE BEING
INFLUENCED.
THEY HAVE A PROFESSOR TELLING
THEM TO DO IT.
>> CORRECT ME IF I'M WRONG, MY
UNDERSTANDING WHEN A PROFESSOR
HAS THAT AS A POSSIBLE WAY TO
GET A GRADE, THERE NEEDS TO BE
AN ALTERNATIVE FOR PEOPLE WHO
DON'T WANT TO PARTICIPATE.
DO YOU HAVE AN OPTION NOT TO
TAKE THE COURSE?
>> WHEN I WAS AN UNDERGRAD MANY
YEARS AGO THE EXPECTATION WAS
EVERYBODY PARTICIPATE IN A
TRIAL.
THERE WAS NO OPTION.
MY ASSUMPTION IS THAT THAT'S
CHANGED.
THE EXPECTATION IS IT'S
RECOMMENDED.
THERE'S AN ALTERNATIVE YOU COULD
WRITE A PAPER.
PERHAPS WE HAVE TO LOOK INTO
THAT AGAIN.
IN RESEARCH THERE'S SOMETIMES A
LEGITIMATE CASE FOR SOME KINDS
OF DECEPTION.
THAT'S VERY DIFFICULT THAN
MISLEADING SOMEBODY AND GIVING
THEM INFORMATION.
>> THANK YOU.
THANKS AGAIN.
SO, IT'S ME AGAIN AND IT'S MY
PLEASURE TO INTRODUCE DR. SCOTT
KIM.
HE'S A SENIOR INVESTIGATOR IN
THE DEPARTMENT OF BIOETHICS AND
HE DOES BOTH PHILOSOPHICAL AND
EMPIRICAL RESEARCH IN A WHOLE
VARIETY OF ISSUES AND LUCKY FOR
US IS AN EXPERT IN DECISION
MAKING CAPACITY AND WILL TELL US
WHAT WE NEED TO KEEP IN MIND
WHEN WE'RE THINKING ABOUT
CONDUCTING RESEARCH WITH THOSE
WHO HAVE IMPAIRED DECISION
MAKING CAPACITY.
>> ALL RIGHT.
CAN YOU HEAR ME?
OKAY.
ME WIFE SAYS MY VOICE IS SOFT.
I DON'T TALK LOUD ENOUGH SO I'LL
TRY MY BEST SO YOU CAN HEAR ME.
THANK YOU, HOLLY AND LET'S START
IN 1966.
HOW MANY PEOPLE HERE HAVE HEARD
OF THIS ARTICLE.
I'M SURE MANY ONLINE MAY HAVE
HEARD OF THIS ARTICLE BECAUSE
IT'S HISTORICALLY QUITE
SIGNIFICANT.
ONE OF THOSE THINGS WE MENTION
WHEN WE TALK ABOUT THE HISTORY
OF RESEARCH ETHICS REGULATION.
MAYBE A LITTLE OVER A THIRD OF
EXAMPLES INVOLVE SOME WHO HAD
DIFFICULTY GIVING CONCEPT.
THOSE GIVEN TOXIC DRUG OR
BIOPSIES TAKEN.
ANOTHER STUDY IN WHICH THEY ARE
INDUCED CONFUSION AND MANY
PEOPLE IT'S NOT CLEAR IF THEY
ARE WERE ABLE DURING THE STUDY
TO SAY LOOK, I DON'T WANT TO DO
THIS ANYMORE.
EXPERIMENTS ON UNCONSCIOUS
PATIENTS WAS COMMON AND STUDY OF
COMA IN SICK PEOPLE WITH FAILING
LIVER.
THEY WERE QUITE INVASIVE
PROCEDURES AU CAN SEE.
AS YOU CAN SEE.
AND DR. BEECHER FOUND THOSE
STUDIES.
THERE'S SEVERAL EXAMPLES
INVOLVING CHILDREN AND INFANTS.
AND LED TO ISSUES AS WHAT WE
ACCEPT AS LAWS THAT REGULATE THE
ETHICAL PRINCIPLES OF HUMAN
SUBJECT RESEARCH.
AND THERE WERE ISSUES THAT
WEREN'T RESOLVED IN THE
BEGINNING.
LET ME GO THROUGH SOME HISTORY
QUICKLY.
THE NATIONAL COMMISSION IS THE
BELMONT COMMISSION THAT'S
ANOTHER TERM PEOPLE USE.
THEY PUBLISH BOOKS OR MONOGRAPHS
REGARDING DIFFERENT TOPICS AND
IT'S INTERESTING, ALL OF THEM
BECAME THE FOUNDATION FOR THE
REGULATIONS THAT WE HAVE NOW.
AND IF YOU READ THOSE AND READ
THE REGULATIONS YOU'LL SEE THAT
EXCEPT FOR ONE WHERE RESEARCH
INVOLVING THOSE
INSTITUTIONALIZED AS MENTALLY
INFIRMED REALLY THAT QUESTION
REMAINED OPEN.
IT WAS AGAIN DEBATED IN 1982 IN
THE BROADER CONTEXT OF MAKING
HEALTH CARE AND RESEARCH
DECISIONS IN AMONG PEOPLE WHO
HAVE TROUBLE GETTING THEIR OWN
CONSENT.
199 8 WAS AN ACTIVE YEAR WITH
SCANDALS, CONTROVERSIES EAST AND
WEST COAST AROUND THE TIME I WAS
GETTING INTO DOING WORK IN THIS
AREA.
THERE WAS ONE BY THE MARYLAND
ATTORNEY'S WORKING GROUP.
A FAMOUS ONE WAS THE NATIONAL
BIOETHICS ADVISORY COMMISSION.
NEW YORK DEPARTMENT OF HEALTH
ALSO HAD A WORKING GROUP AND
ISSUED A REPORT THE YEAR AFTER
THAT.
AND THERE'S DEBATES AND STUDIES
I HELPED CONTRIBUTE TO DURING
THE INTERVENING YEARS AND IN
2009 THERE WAS RECOMMENDATIONS
MADE BUT SACHRP MEANING ADVISING
THE DHHS SECRETARY.
IN 2005 DURING PRESIDENT OBAMA'S
YEARS, THERE WAS A NOTICE FOR
PUBLIC -- I WORK FOR THE
GOVERNMENT.
I KNEW HOLLY WOULD KNOW BECAUSE
SHE KNOWS ALL THESE TECHNICAL
TERMS.
SO THE COMMON RULE HAD BEEN IN
PLACE FOR DECADES.
AND IT RECEIVED A REVISION AND
ONE OF THE THINGS THAT IT
ADDRESSED WAS THIS TOPIC.
AND I'LL TELL YOU SOMETHING
ABOUT THE CHANGE THAT TOOK
PLACE.
SO THROUGHOUT ALL THIS, I WOULD
SAY THE MOST SIGNIFICANT INSIGHT
OR AGREEMENT THAT THE FIELD
AMONG RESEARCHERS, REGULATORS
AND ETHICISTS IS THIS AGREEMENT
WHICH IS THAT IF YOU'RE GOING TO
INVOLVE THOSE LACKING OR AT RISK
FOR LACKING DECISION MAKING
CAPACITY YOU NEED TO
SPECIFICALLY JUSTIFY WHAT IT IS
YOU ARE DOING BY MEETING THESE
CONDITIONS.
THAT RESEARCH CAN'T BE DONE
WITHOUT THE POPULATION.
IF YOU CAN DO IT WITH OTHER
OPTIONS EVEN LESS CONVENIENTLY,
THERE'S NO INTRINSIC
JUSTIFICATION FOR HAVING TO USE
THE POPULATION.
THAT'S RELATED TO THE SECOND
POINT, RESEARCH MUST BE FOCUSSED
ON THE DISORDER CAUSING THE
INCAPACITY AND IF THAT
POPULATION WILL BENEFIT IN SOME
BROAD SENSE.
IT BENEFITS PEOPLE IN OUR
CURRENT GENERATION AND PEOPLE
WHO HAVE THE FEATURE.
NOW, I WANT TO SAY IT'S
IMPORTANT TO INVOLVE PERSONS
WITH DIFFICULTIES FOR OTHER
DISORDERS.
THESE WILL BE SITUATIONS WHERE
IF YOU EXCLUDE THEM BASED ON THE
FIRST TWO BULLET POINTS, IT CAN
ACTUALLY AMOUNT TO A KIND OF
DISCRIMINATION.
THIS IMPLIES THERE ARE SOME TYPE
OF RESEARCH THAT HAS MORE OR
LESS POTENTIAL FOR BENEFIT.
AND WE ALL RECOGNIZE THAT.
SO FOR EXAMPLE IF THEY'RE
TESTING A PROMISE PROMISING SA
MONOCLONAL TREATMENT FOR
MELANOMA AND A PERSON WITH
DISABILITY MAY NOT BE ABLE TO
GIVE CONSENT OR BE AT RISK FOR
GIVING CONSENT HAS THE SAME
CANCER TO EXCLUDE THEM MERELY
BASED ON DISABILITY IN THAT CASE
COULD BE DISCRIMINATION.
THIS THINKING BECOMING MORE
PROMINENT IN RESEARCH ETHICS IS
A SIGN OF TREMENDOUS PROGRESS IN
THIS AREA.
WE NOW THE FIRST TWO BULLET
POINTS IS WIDELY ACCEPTED.
AS ANY POLICY SHOULD WE SHOULD
BE SENSITIVE TO DEVELOPMENT AND
UNINTENDED CONSEQUENCES.
AND I'M GOING TO TALK ABOUT
DECISION MAKING CAPACITY
IMPAIRMENT AS A TOPIC.
AND THEN TALK ABOUT TALK ABOUT
THE NOTION THAT IN THEORY,
STUDIES INVOLVING PEOPLE WHO
CAN'T CONSENT IS PERMISSIBLE.
NOW, THE QUESTION IS HOW DO YOU
DO IT.
WHO SHOULD GIVE CONSENT AND
SHOULD THERE BE LIMITS TO RISK?
THOSE ARE THE TWO FUNDAMENTAL
QUESTIONS WHEN YOU SAY, I SHOULD
BE OKAY BUT -- SO BUT HAS AT
LEAST TWO MAJOR BULLET POINTS.
I'M GOING TO GIVE YOU EVIDENCE
THAT WE'VE GATHERED BEFORE I
CAME TO NIH AT MICHIGAN WE DID A
LOT OF STUDIES ON THIS TOPIC
THAT REALLY INFORMS HOW WE MIGHT
MAKE POLICY AND THE MORAL
PERSPECTIVES OF THE PUBLIC THAT
THESE KINDS OF DECISION MAKING.
THEN I'LL CLOSE WITH ADDITIONAL
PROTECTS OR SAFEGUARDS IRB AND
INVESTIGATORS MIGHT CONSIDER
DEPENDING ON THE CONTEXT.
AND WHAT IS THE DECISION
CAPACITY AND IMPAIRMENT?
HAVING GONE TO COURSE MAKING
DECISION WHETHER THE PERSON HAS
CAPACITY OR NOT.
WE OFTEN USE THE TERMS CAPACITY
AND COMPETENCE INTERCHANGEABLY.
THE MEANING IS DO THEY HAVE THE
ABILITY SUFFICIENT TO MAKE A
DECISION AND IT'S THE JUDGE WHO
MAKES THE DECISION.
IT HAS A SPECIAL LEGAL FORCE.
NOTICE I DON'T DISTINGUISH
BETWEEN CAPACITY AND COMPETENCE
AS LYING BETWEEN CLINICAL AND
LEGAL.
I JUST WANT TO WARN YOU, MANY
PEOPLE WILL TELL YOU THAT'S HOW
THE WORLD IS AND HOW YOU'RE
SUPPOSED TO USE IT.
THAT IS OUT RIGHT NOT TRUE.
WE CAN TALK ABOUT THAT IF YOU
WANT BUT DON'T GET MISLED BY
THAT DISTINCTION.
WHEN WE ORDINARILY TALK ABOUT
THE TERMS IN A CLINICAL SETTING
IT'S AN APPROXIMATION OF WHAT
THE COURTS MIGHT OR WOULD SAY.
USUALLY THE CARRIES THE DAY.
WHY?
IT GIVES THE PERSONS THE
DECISION UNLESS THERE'S A
CHALLENGE WHEN IT GO GOES TO
COURT AND IF YOU HAVE A
SUFFICIENT AMOUNT YOU COULD BE
DEEMED COMPETENT OR HAVE
SUFFICIENT CAPACITY TO MAKE YOUR
OWN DECISIONS.
NOW, THE ABILITIES COME
UNDEGREES.
THEY GO BY THE NAME OF THINGS
LIKE UNDERSTANDING,
APPRECIATING, REASONING AND
COMMUNICATING A SAFE CHOICE.
THESE ARE PSYCHO METRIC
CONCEPTS.
YOU CAN HAVE WELL TRAINED PEOPLE
WHO CAN OPERATIONALIZE THESE SO
YOU CAN ACTUALLY DEVELOP TOOLS
TO MEASURE THEM.
OF COURSE THE CAVEAT IS BECAUSE
AS YOU'LL SEE THE CONCEPT IS
DECISION SPECIFIC.
YOU HAVE TO MODIFY THEM FOR EACH
CONTEXT WHICH KIND OF PUTS SOME
PRESSURE ON WHAT DOES IT MEAN TO
HAVE A VALIDATED INSTRUMENT AND
SUCH BECAUSE YOU HAVE TO
CUSTOMIZE TO EACH SITUATION.
YOU CAN DECIDE TO BRING THE
ASTRONAUTS BACK USING THEIR
VEHICLE OR NOT SURE HOW SAFE IT
IS SO YOU HAVE TO MAKE ANOTHER
DECISION.
YOU CAN'T JUST SORT OF DO IT OR
NOT DO IT AT THE PSALM TIME.
-- SAME TIME.
SAME THING.
YOU HAVE TO USE ALL THAT
INFORMATION AND REDUCE IT TO
YES, NO.
IT'S PART OF THE DOCTRINE OF
INFORMED CONSENT.
THE ABILITY OR CAPACITY TO MAKE
THE DECISION.
HAVING RECEIVED RELEVANT
INFORMATION AND TO MAKE THE
DECISION WITHOUT DURESS,
COERCION, UNDUE INFLUENCE.
THE MODEL OF DECISION-MAKING
CAPACITY HAS SEVERAL COMPONENTS.
ONE IS THE DECISION OF CAPACITY.
WE USUALLY SAY ADULTS ARE
PRESUMED TO BE CAPABLE UNLESS
HAVE YOU A REASON TO SUSPEND
THAT PRESUMPTION.
IT DOESN'T MEAN THEY'RE NOT
CAPABILITY IT JUST MEANS YOU
HAVE A REASON TO INVESTIGATE
WHETHER OR NOT WE NEED MAKE A
DECISION WHETHER THIS PERSON HAS
CAPACITY OR NOT.
WE NO LONGER USE TERMS LIKE
SENILE, UNSOUND MIND.
IF YOU GO BACK TO THE WRITINGS
OF THE EARLY 20th CENTURY
DOCTORS USE TERMS LIKE THIS TO
SAY THAT PERSON CAN'T MAKE THEIR
OWN DECISION BECAUSE THEIR MIND
IS UNSOUND.
THE THRESHOLD AND IF A PERSON
EVEN WITH MILD DEMENTIA IS IN
THE HOSPITAL BECAUSE THEY HAVE
AN IN SECTION AND SOMEBODY COMES
IN AND SAYS, MR. JONES, WE'RE
GOING TO DRAW BLOOD FOR LABS AND
HE PUTS HIS ARM OUT.
ARE YOU GOING TO USE A FULL
COMPLICATED ASSESSMENT TO MAKE
SURE HE'S GIVEN CONSENT?
PROBABLY NOT BECAUSE IT MAY BE
APPROPRIATE.
AND IF THE SAME PERSON IS ASKED
TO PARTICIPATE IN A CLINICAL
TRIAL OF NEURAL SURGICAL IMPLANT
OF GENE THERAPY AND SAYS DOC,
YOU KNOW BEST AND ARTICULATES IT
CLEARLY I WOULD THINK WE HOLD
THAT PERSON TO A HIGHER
STANDARD.
AND IS THE TASK DECISION
SPECIFIC.
I WANT TO SPEND A COUPLE MINUTES
ON THIS SLIDE BECAUSE DEPENDING
ON WHERE YOU'RE LISTENING TO ME
AT THIS MOMENT YOU'RE MORE OR
LESS FAMILIAR WITH THIS CON
SENSE.
2008 WAS A CONVENTION THAT
OUTLINED THE HUMAN RIGHTS BASED
RIGHTS OF PERSONS WITH
DISABILITIES.
VERY IMPORTANT.
THERE WAS A PROBLEM WITH IT IN
THAT THERE WAS AN ARTICLE AMONG
IN THE CONVENTION THAT BASICALLY
STRONGLY IMPLIED THAT REGARDLESS
OF YOUR ABILITYIES WHAT I LAID
OUT AT THE FUNCTIONAL ABILITIES,
YOU HAVE LEGAL CAPACITY.
IT WAS CHALLENGING FUNCTIONAL
CAPACITY.
CONSEQUENTLY SAYING WE HAVE TO
GET RID OF ALL SURROGATE
DECISION MAKING REGIMES.
I'M NOT GOING INTO THE
COMPLICATED, POLITICAL AND
HISTORY OF WHY THIS CAME TO BE
IN THE CONVENTION.
THERE WAS A GENERAL COMMENT
EXPLAINING IT IN THIS SENSE I
JUST TALKED TO YOU ABOUT.
EVEN COMPANIES THAT ACCEPTED
THIS CONVENTION ALMOST ALWAYS
INSERT WHAT IN MEMORIAL WE CALL
SIGNING STATEMENTS.
WE THINK IT'S A GREAT CONVENTION
AND AS IT IMPLIES SUCH AND SUCH
WE REFER THE RIGHT TO X, Y, Z.
IT'S A VERY IMPORTANT TOPIC BUT
I'M GOING TO PUT IT ASIDE.
BECAUSE WE'RE USING THE CONCEPT
THAT THE GENERAL COMMENT NUMBER
ONE OF THE CONVENTION SAYS WE
SHOULD BE USING WE ARE AND
VIRTUALLY EVERY JURISDICTION I
KNOW DOES.
SOME DISORDERS ELEVATE THE RISK
FOR INCAPACITY AND SOME AFFECT
NEURAL DEGENERATIVE DISORDERS,
ALZHEIMER'S FROM THE TEMPORAL
DEMENTIAS.
NEURAL -- NEURODEVELOPMENT
DISORDERS AND INTELLECTUAL
DISABILITIES DISORDERS AND
STROKES, TRAUMATIC BRAIN INJURY.
PEOPLE WHO SUFFER TRAUMA FROM
WAR ACCIDENTS, WAR OR
INFECTIONS.
PEOPLE WHO COME IN WITH ACUTE
SITUATIONS WHO HAVE TEMPORARY
LOSS OF COGNITIVE FUNCTION.
WHAT WE CALL DELIRIUM AND
PSYCHOTIC DISORDERS I CONSIDER
MANIC STATES OF BIPOLAR DISORDER
AS FALLING UNDER PSYCHOTIC
SITUATIONS.
MOOD DISORDERS WHEN SEVERE.
EATING DISORDERS WHEN SEVERE
DOES AFFECT DECISION MAKING
CAPACITY.
THERE'S OTHER AREAS OF
CONTROVERSY.
FOR INSTANCE, PEOPLE WHO HAVE
PERSONALITY DISORDERS UNDER
DISTRESS OR DECOMPENSATING
THOUGH THEY DON'T HAVE A MAJOR
SEVERE PSYCHOTIC DISORDER.
THERE'S RISK FACTORS NOT
DEFINING AND IT'S COMMON IN
HOSPITAL AND PATIENTS DOING A
SURVEY ROOM TO ROOM, RESEARCHERS
FIND ABOUT 30% TO 40% CAN'T QUIV
THEIR OWN CONSENT.
IT'S PROBABLY HIGHER BECAUSE A
LOT OF THE STUDIES ARE BASED ON
INTERVIEWS OF PEOPLE WHO ARE
ABLE TO BE INTERVIEWED.
IF YOU COUNT PEOPLE WHO CAN'T DO
INTERVIEWS IS HIGHER AND IT
DEPENDS ON THE KIND OF UNIT
YOU'RE RUNNING WHETHER IT'S A
DIFFERENT SEVERITY OF ILLNESS,
DISTRESSING BUT DIFFERENT TIME
VERSUS A STATE-RUN HOSPITAL
WHERE YOU HOSPITALIZE PEOPLE WHO
HAVE NO OTHER RESOURCES PUTTING
THEMSELVES OR OTHERS IN DANGER.
IT WILL VARY.
IF YOU JUST LOOK AT PEOPLE WITH
CHRONIC PSYCHOSIS IT VARIES
QUITE A BIT BUT ONLY ABOUT HALF
AT MAXIMUM.
CHRONIC PSYCHOSIS DON'T CREATE
SEVERE ZAMENT EXCEPT UNDER
SUBSET MILD DEPRESSION DOESN'T
REALLY AFFECT CAPACITY GIVEN THE
TYPES OF ASSESSMENTS WE NOW
STANDARDLY DO.
WE GENERALLY -- THESE
ASSESSMENTS AREN'T SO
DEMANDING -- WE KIND OF BUILD IN
AND LIVE IN A SOCIETY THAT
VALUES AUTONOMY AND IT'S WRONG
IF IN A CERTAIN RAGE BUT IF
YOU'RE VERY DEPRESSED CERTAIN
PEOPLE WILL HAVE INCAPACITY.
LET ME TALK ABOUT TWO DISORDERS
BECAUSE THEY HAVE -- THEY'RE
VERY COMMON BOTH AND THERE'S
BEEN A LOT OF RESEARCH SO THIS
ISSUE COMES UP A LOT IN RESEARCH
ETHICS.
SO ALZHEIMER'S DISEASE AND SOME
WITH MILD COGNITIVE IMPAIRMENT
WHERE TECHNICALLY THEY MIGHT
FALL ON THE BORDER WITHIN RANGE
OF CERTAIN COGNITIVE TESTS ARE
FOUND TO LACK CAPACITY TO GIVE
CONSENT TO LIKE A DRUG OR CT.
IN OUR STUDY TWO-THIRDS TO
THREE-QUARTERS OF PATIENTS WITH
MANY MENTAL SKILLS.
IT'S A COGNITIVE TEST 0 TO 30.
30 IS PERFECT, 0 IS -- 22-23 IS
ON THE BORDER.
YOU WOULD SAY A PERSON HAS
MODERATE DEMENTIA BUT YOU GET
MODERATE DEMENTIA AND MOST WILL
LACK THE ABILITY TO CONSENT TO A
CLINICAL TRIAL.
WHERE I DID THE CLINICAL TRIAL
CALLED CATTIE ON THE
UNDERSTANDING SCORE ON THE TOOL
USED THE VAST MAJORITY ARE ABOVE
THE CUT OFF AT LEAST THE EXPERTS
WHO CAME WITH THIS THOUGHT THE
PERSON DIDN'T UNDERSTAND
SUFFICIENT AMOUNT AND THIS IS A
LITTLE BIT LESS.
THAT'S JUST TO GIVE YOU AN IDEA.
A CONTRAST.
IF STUDIES WITH PEOPLE LACKING
ARE PERMISSIBLE, WHO GIVES
CONSENT?
IF YOU CAN'T GIVE CONSENT HOI
ARE THEY GOING TO PARTICIPATE?
SOMEBODY HAS TO GIVE PERMISSION.
AND A COMMON RULE SAID YOU WILL
OFTEN HERE LAR, LEGALLY
AUTHORIZED REPRESENTATIVE.
THIS IS A SPECIFIC REGULATORY
TERM WHERE THEY'RE REFERRING TO
PEOPLE TO BE AUTHORIZED WITHIN
THE REGULATIONS TO GIVE CONSENT
FOR SOMEBODY ELSE TO BE IN
RESEARCH.
HOW DO THEY DEFINE IT?
THEY ARE DEFINE IT AS PEOPLE
AUTHORIZED UNDER APPLICABLE LAW
AND THERE'S STATE AND LOCAL LAWS
THAT PLAY BE RELEVANT ON THE
PARTICIPANT INVOLVED IN
RESEARCH.
YOU MIGHT ASK WHAT DOES
APPLICABLE LAW LOOK LIKE?
BEFORE 2018, EVEN NOW FEW HAVE
ADDRESSED THIS IN THEIR STATE
LAWS.
IT'S NOT HIGH ON THE AGENDA OF
LEGISLATORS BECAUSE IT'S A NICHE
TOPIC.
CALIFORNIA, NEW JERSEY, VIRGINIA
HAVE HAD ENACTMENT OF WHAT I
CALL MODERN LAWS.
YOU CAN WHOEVER WROTE THIS
UNDERSTOOD FEDERAL ETHICS AND
WROTE THAT IN THEIR KNOWLEDGE
BASE.
AND THEY WERE GENERALLY WRITTEN
GENERALLY OR INDEPENDENT OF
RESEARCH ETHICS.
THE REVISED COMMON RULE WHICH
REALLY SORT OF FOR MOST
SITUATIONS HELP RESOLVE THE
UNCERTAIN TIP BECAUSE THE
QUESTION WAS IF YOU DON'T LIVE
IN NEW JERSEY, VIRGINIA OR OTHER
PLACES WHERE THE ATTORNEY
GENERAL HAS ISSUED A STATEMENT
OR THINGS LIKE THIS, WHO IS LAR?
THAT WAS A DEBATABLE QUESTION
UNTIL THE REVISED COMMON RULE
SAYS THIS, IF THERE'S NO
APPLICABLE LAW THEN IT MEANS AN
INDIVIDUAL RECOGNIZED BY
INSTITUTIONAL POLICY.
IT ACTUALLY GIVES AUTHORITIES TO
ACADEMIC AND RESEARCH
INSTITUTIONS AND OTHER SETTINGS
IN WHICH A PERSON IS INVOLVED IN
RESEARCH.
PUTTING ASIDE THAT SPECIAL --
NOT PUTTING ASIDE AND I HAVE TO
GO THROUGH POSSIBILITIES.
ONE IS LEGAL GUARDIANS.
THEY'RE PEOPLE APPOINTED BY
JUDGES.
THERE'S REAL LEGAL CLARITY AND
SOMETIMES IT'S PEOPLE WHO ARE
STRANGERS TO THE PERSON WHO LOST
CAPACITY.
AND SECOND TYPE IS HEALTH CARE
PROXIES OR POWER OF ATTORNEYS
WHERE THE SUBJECT PICKS OUT WHO
PLAYS THAT ROLE.
AND THE FACT OF FAMILY IS THE
MOST COMMON.
AND RESEARCH PROXIES ARE A GREAT
IDEA.
EVERYBODY FILLED OUT IF I GET
INCAPACITATED AND COULD BE
ELIGIBLE FOR RESEARCH I WOULD
LIKE THIS TO BE DONE.
VIRTUALLY NO ONE FILLS THAT OUT
UNLESS THEY'RE ASKED TO AFTER
DIAGNOSIS IN A SPECIAL SETTING.
IF YOU'RE DIAGNOSED WITH AN
ILLNESS LIKE ALZHEIMER'S BUT
STILL ABLE TO MAKE OTHER TYPES
OF DECISIONS, ONE OF THOSE
DECISIONS WOULD BE TO APPOINT
SOMEBODY.
YOU KNOW, THAT PERSON MIGHT BE
FULLY CAPABLE OF THINKING
FOLLOWING.
I CAN SEE THAT.
AND YOU CAN CONSULT OR SOMETHING
LIKE THAT.
THIS IS A LIST FROM SACHRP
PROPOSED WHICH I THINK IS A GOOD
ONE.
SO YOU GO WITH THE STATE LAW AND
EXTRAPOLATE TO THE RESEARCH
CONTEXT.
YOU'RE HOPING THE HEALTH CARE
ZIG -- DECISIONS EXTENDS TO
RESEARCH.
NOT UNREASONABLE GIVEN THAT
PERSON IS SUPPOSED TO REPRESENT
YOUR VALUES OR VIEWS OR
INTEREST.
THE LEGAL GUARDIAN NOTICE IS
THIRD NOT IN THE TOP.
AND THEN THE REST IS HIERARCHY
FOR DE FACTO FAMILY MEMBERS
THOUGH EIGHT -- IF YOU DON'T
HAVE FAMILY MEMBERS IT'S SIMILAR
TO WHAT WE HAVE IN THE CLINICAL
CENTER AT THE NIH.
I SUSPECT THIS IS VIRTUALLY
IDENTICAL CROSS STATES.
VIRTUALLY EVERY STATE HAS A DE
FACTO FAMILY SURROGATE LAW FOR
CLINICAL SITUATIONS.
MOST RECAPITULATE THE ORDER.
YOU SHOULD READ IT.
IT'S A HORRIFYING EXPOSÉ OF HOW
GUARDIAN LOSS COULD BE
EXPLOITED.
I'LL MENTION THIS BECAUSE IT'S
IMPORTANT TO REALIZE GUARDIAN
LAWS ARE SUPPOSED TO PROTECT
PEOPLE BUT IF YOU READ THIS
YOU'LL VALUE THE IMPORTANCE OF
UNDERSTANDING HOW IT WILL PLAY
OUT AND HOW TO MONITOR AND KEEP
PEOPLE SAFE.
IT'S WRITTEN BY RACHEL AVIVE AND
HER WORK HAS AFFECTED HEALTH
CARE POLICIES IN MANY WAYS.
SO WHAT PROPORTION OF ADULTS
PREPARE AN ADVANCED DIRECTIVE?
THIS IS A SYSTEMATIC REVIEW AND
THE BOTTOM LINE IS ABOUT A
THIRD.
IT DOESN'T MATTER HOW CHRONIC
YOUR ILLNESS IS OR WHETHER
YOU'RE HEALTHY.
IT'S NOT SOMETHING PEOPLE DO.
YOU'LL HAVE TO FALL BACK TOWARD
MOST SITUATIONS THE FACT OF
SURROGATE FAMILY DECISION
MAKING.
I'M GOING TO SPEED UP A LITTLE
BIT.
DE FACTO SURROGATES WILL HAVE TO
BE LARs.
IT USUALLY MEANS FAMILY MEMBERS
BUT IT'S ACCEPTABLE.
WE DID RESEARCH ON THE QUESTION
COMBINING IT WITH THE RISK
BENEFIT LIMITS.
MOST COMMON APPROACH IS BY THIS.
PROSPECT FOR DIRECT BENEFIT?
HOW MUCH RISK?
MINIMAL AND THIS SHOULD BE
FAMILIAR IF YOU HAVE OR WILL
HAVE SOME OVERVIEW OF THE
PEDIATRIC RESEARCH REGULATIONS.
THIS DOESN'T APPLY TO ADULTS
ACTUALLY.
BUT PEOPLE HAVE IMPORTED THIS
FROM THE PEDIATRIC AND TO HOW TO
THINK ABOUT THIS INCAPACITATED
PERSON'S PARTICIPATION IN
RESEARCH.
NOW, SO HOW DOES THE PUBLIC VIEW
RESEARCH AND WHAT LEVEL OF RISK
IS ACCEPTABLE?
WE DO THE SURVEY.
THIS IS A NATIONALLY
REPRESENTATIVE SAMPLE OF
U.S. PUBLIC 50 AND OLDER AND WE
FOUND THAT IF YOU ASK THE
QUESTION, IF PATIENTS CAN'T MAKE
THEIR OWN DECISIONS ABOUT BEING
IN A STUDY AND SEE THE SCENARIOS
AND THE FOUR COLUMNS, SHOULD
SOCIETY ALLOW FAMILIES TO MAKE
THE DECISION IN THEIR PLACE, YES
OR NO?
I'M ONLY GIVING THE YES.
DEFINITELY PROBABLY YES.
IT'S INTERESTING THE MAJORITY
SAY YES.
LUMBAR PUNCTURE, A PHYSIOLOGICAL
STUDY.
DRUG RCT.
WE USED SOMETHING FOR
ALZHEIMER'S SIMILAR TO SOMETHING
AS RISKY AS TAKING MOTRIN,
NSAID, ASPIRIN.
VACCINE RCT, THERE WAS AN
ATTEMPT TO DEVELOP ANTIBODIES TO
TO YOUR OWN PATH LOGIC MATERIALS
IN THE BRAIN.
AND THEN GENE THERAPY.
THIS WAS A NATIONAL SAMPLE YOUR
TYPICAL CROSS-SECTIONAL NOT VERY
WE'RE NOT ASKING THEM TO THINK
ABOUT IT OR DON'T DO ANY OF
THAT.
HOWEVER WE HAVE DONE A STUDY A
WEDDING BANQUET RESEARCH AND WE
HAVE IT IN WEDDING BANQUET ROOMS
WITH SIX TO EIGHT, NINE, PEOPLE
A ROOM FULL OF 60 PEOPLE, MAYBE
EIGHT, NINE TABLE AND SPEND THE
DAY WITH EXPERTS TALKING ON
EITHER SIDE.
THIS IS UNDER THE DEMOCRATIC
DELIBERATE RESEARCH AND I DID A
LOT OF THIS IN MICHIGAN.
IT'S INTERESTING.
WHEN HAVE YOU PEOPLE DEBATE
THIS, HEAR PEOPLE TALK BIT AT
THE TABLE PEOPLE DON'T KNOW
THERE'S REGULATORY COMPONENTS
AND YOU HEAR THINGS THE HISTORY
OF THE REGULATIONS AND THE NEED
FOR THE RESEARCH.
YOU'LL SEE IN EVERY CASE PRE,
POST THERE'S A SHIFT TO GREATER
ACCEPTANCE OF FAMILY SURROGATE
CONSENT FOR THOSE TYPES OF
RESEARCH.
JUST NOTICE THE TREND.
AND COMMON DELIBERATIONS WERE
FASCINATING.
.
THE RESEARCH ETHICS TOPICS WE
THINK WE NEED EXPERTS TO GET
THEIR INTUITION AND SO FORTH.
HONESTLY A LOT OF THESE
QUESTIONS MOST PEOPLE CAN
READILY UNDERSTAND AND PEOPLE
ARE QUICK TO SEE THE DILEMMA AND
THAT'S IMPRESSIVE WHEN YOU
ENGAGE THE PUBLIC IN THIS KIND
OF RESEARCH.
FOR EXAMPLE, PARTICIPANT A SAYS
IF THE ANSWER NO, YOU CAN'T LET
FAMILIES DO THIS AND THAT
SURROGATES CAN'T GET CONSENT
THERE'S NO HOPE FOR GETTING
ANYWHERE AND SEEN THE DATA AND
LIKELY NEED.
THE ANSWER HAS BEEN NO IN MY
MIND -- YES, MEANING THEY HAVE
TO BE ALLOWED.
PARTICIPANT B SAYS BY VOTING NO
AGAINST SURROGATE IMPARTMENT
YOU'RE VOTING NO TO EVERY OTHER
FAMILY.
YOU'RE PUTTING YOURSELF IN UP A
POSITION OF EVERYBODY WITH ABLE
ALZHEIMER'S PATIENT.
I FOUND THAT AN INTERESTING WAY
TO ARTICULATE WHAT A POLICY
DOES.
HE'S SAYING IT'S A POLICY AND
POLICY WORKS THIS WAY.
AND WE HAVE NO HOPE BUT
SURROGATE CONCEPT BUT HOW DO WE
MAKE IT WORK AND BUILD PROTECTS
FOR PEOPLE WITH ALZHEIMER'S AND
THEIR FAMILIES?
ONE OF THE INTERESTING THINGS
WAS WHEN WE ASKED PEOPLE SHOULD
THERE BE LEEWAY, A PERSON SAYS
TO YOU, YEAH, I WANT TO BE IN
RESEARCH OR NOT.
AFTER YOU SAY THAT TO THEM IF
YOU LATER BECAME INCAPACITATED
HOW MUCH LEEWAY SHOULD YOUR
FAMILY MEMBERS HAVE IN GOING TO
WITH WHAT YOU SAID NOW OR VEEP
GOING AGAINST IT BASED ON WHAT
THEY KNOW THEN VERSUS NOW?
MOST PEOPLE UNDERSTAND THE
COMPLEXITY AND LIMITATIONS OF
CURRENT KNOWLEDGE WHEN YOU TRY
TO PIN DOWN THE FUTURE OF I WANT
THIS, I DON'T WANT THAT.
WE OFTEN UNDERESTIMATE THE
WISDOM OF THE PUBLIC IN THESE
ISSUES.
I'LL RUN DOWN THE LIST OF OTHER
POTENTIAL SITUATIONS.
PATIENT A IS FINANCIALLY STABLE
AND FAMILY ARE SUPPORTIVE AND
INVOLVED AND IS A PROFESSOR AND
ENROLLS IN A MINOR INTERVENTION
AND MINOR EFFECTS SEEN AND HAS A
GOAL OF SLOWING DOWN THE
DISEASE.
HE WANTS TO BE IN THE STUDY.
HE HAS AN ALTRUISTIC MOTIVE AND
DESIRED BENEFIT IS PERCEIVED TO
BE WORTH THE GAMBLE.
THIS PERSON IS VULNERABLE BUT
IT'S VERY DIFFERENT FROM THE
FOLLOWING PERSON.
THIS PERSON DOES HAVE --
REMEMBER, THIS PERSON IS DEEMED
NOT TO HAVE CONSENT BECAUSE HE'S
QUITE IMPAIRED.
THIS PERSON MEETS THE THRESHOLD
FOR CAPACITY AND IN THEORY CAN
CONSENT FOR HIM OR HERSELF BUT
UNEMPLOYED AND ISOLATED IN A
MINORITY GROUP, RCT OF A
COMPOUND ALREADY MARKETED BEING
STUDIED AND IT'S NOT A NEW
PARADIGM.
I WOULD SAY THIS PERSON IS MORE
VULNERABLE THOUGH THEY HAVE
CAPACITY.
IT'S IMPORTANT TO REMEMBER.
HOW WE SPELL OUT THE CAPACITY
AND IS THERE WAY TO WORK WITH
THE PRESERVED ABILITY?
WE HAVE MONITORS AND ASSESSMENT
OF APPROPRIATE SURROGATES.
SOMETIMES SURROGATES MAY ALSO BE
95 YEARS OLD.
THERE MAY BE A NEED TO ASSESS
INCREASED RISK.
IT SHOULD BE TAILORED TO
CONTEXT.
I'M THREE MINUTES EARLY.
THANK YOU, SCOTT.
I HAVE A QUESTION FROM VIDEO
LAND AND THOSE IN THE ROOM HEAD
TO THE MICROPHONES IF YOU HAVE A
QUESTION.
THIS ONE REFLECTS SOME COMMENTS
YOU MADE EARLIER.
ESTER SAID CAN YOU SAY MORE ON
THE DISTINCTION BETWEEN
COMPETENCE AND CAPACITY?
I'VE FINANCE TAUGHT THAT
COMPETENCE IS A LEGAL
DETERMINATION OF BROAD
INCAPACITY WHERE CAPACITY IS A
CLINICAL DETERMINATION.
>> YES.
I'VE GIVEN TALKS AND PEOPLE HAVE
COME UP AND TOLD ME I'M WRONG
AND I HAVE A SLIDE DOCUMENTS
WHERE I SAY THE FOLLOWING.
AND DECISIONAL CAPACITY, MENTAL
CAPACITY, COMPETENCE, ALL THOSE
TERMS REFER TO AUTHORITY TO SEEK
FUNCTIONAL ABILITIES.
THEY ARE MEAN THE SAME THING.
THE DISTINCTION BETWEEN LEGAL
AND CLINICAL BEFORE ADJUDICATED
OR DEEMED TO HAVE CAPACITY OR
NOT BASED ON LAWS DECISIONS ARE
ALLOWED TO MAKE AND THAT SHOULD
BE DETERMINED IF IT'S DETERMINED
BY COURT.
ADJUDICATED OR A CLINICAL
DETERMINATION.
TO SAY IT'S A LEGAL TERM IS
CONTRADICTORY TO LAWS THAT USE
CAPACITY, MENTAL CAPACITY,
DECISION MAKING CAPACITIES IN
THE LAWS THEMSELVES.
>> GREAT.
>> YOU HAD A SLIDE OF TERMS
RELEVANT TO CAPACITY AND ONE IS
COMMUNICATING A STABLE
PREFERENCE OR DECISION OR
CHOICE.
[NO AUDIO]
>> AND YOU SAY CAN YOU DO THE
PROCEDURE AND YOU TAKE HIM TO
THE O.R. THE NEXT MORNING AND HE
SAID I DON'T WANT TO DO THAT AND
THE ATTENDING SHOWS UP AND HE
SAYS I WANT THE PROCEDURE AND
THE NEXT MORNING YOU TRY TO DO
IT AGAIN AND HE SAYS NO.
THIS IS AN EXAMPLE THAT NEEDS
MORE CONTEXT TO UNDERSTAND
BECAUSE OF HIS BACKGROUND OF HIS
ILLNESS PUT SO THE DEFINITION IS
STABLE ENOUGH SO YOU CAN CARRY
OUT THE PROCEDURE THAT HE
EXPRESSED PREFERENCES FOR.
IF YOU CAN'T DO THAT, YOU CAN'T
REALLY SAY YOU'VE MET THE
CRITERION.
>> SO THE STABILITY HAS TO DO
WITH THE SPECIFIC PROCEDURE?
>> YEAH.
AND IT DOES VARY.
DEPENDING THE EXAMPLE.
A RECENT CASE IN GERMANY A DOCK
TO
-- THE DOCTOR WAS CONVICTED
BECAUSE HE ASSISTED SUICIDE AND
THE COURT WANTED EVIDENCE THE
PERSON HAD A STABLE PREFERENCE
FOR AN EXTENDED PERIOD AND THEY
DISAGREED WITH THE DOCTOR'S
ATTESTATION WAS THE CASE.
SO IT VARIES.
>> I THINK MY QUESTION IS
RELATED TO A NUMBER OF THINGS IN
YOUR TALK.
AT SOME POINT AREN'T OF
CAPACITORS AND PSYCHO METRICS OF
CAPACITY.
>> TO A SUFFICIENT DEGREE TO
HAVE CAPACITY.
>> RIGHT.
SOMEONE FOR INSTANCE WHO HAS
REALLY HAS WHACKY BELIEFS ABOUT
A CERTAIN STANDARD PROCEDURE
THIS PREVENTS THAT PERSON FROM
UNDERSTANDING WHAT THE ACTUAL
TREATMENT WILL ENTAIL OR FROM
RAISING WITH WHAT IMPLICATIONS
ARE.
HOW DO WE NAVIGATE IN THOSE
TYPES OF CASES.
>> IT'S A QUESTION OF SOMETHING
LIKE HOW DO YOU KNOW THIS ISN'T
A PERSON WHO IS A JEHOVAH'S
WITNESSES HAS AN ESTABLISHED
UNDERSTANDING OF DIVERSE VIEWS
VERSUS SOMEBODY UNDER A
RELIGIOUS DILUT ILLUSION AND THE
DEFINITIONS AND PROCEDURES AND
JUDGMENTS THAT YOU HAVE TO MAKE
TO DISTINGUISH BETWEEN THE TWO.
YES.
I HAVE A QUESTION ABOUT CONCEPT
FORTUNE CAL PROCEDURES AND
THINGS LIKE THEY'RE BLEEDING OUT
AND EMTs TAKE THEM TO THE
EMERGENCY ROOM AND THEY ARE
DON'T WANT ANYTHING THAT WOULD
PREVENT ME FROM BLEEDING OUT BUT
IF YOU DON'T DO THAT THEY'LL DIE
IN THAT SITUATION WOULD YOU BE
ABLE TO OVERRIDE THEIR CLEAR
LACK OF CONSENT?
>> THAT'S A GREAT QUESTION.
>> THIS WILL TAKE LONGER TO
ANSWER IT FULLY BECAUSE THERE'S
A VARIETY OF SITUATIONS LIKE
THIS.
AND ONE SOMETIMES THE LACK OF
CONSENT SEEMS OBVIOUS BUT MAY
NOT BE.
THERE COULD BE UNDERLYING -- FOR
EXAMPLE, I HAD AN EXPERIENCE
WITH THE PERSON SEEMED LIKE THEY
WERE MAKING A CLEAR PREFERENCE
AND THREE DAYS LATER SHE SAID
ARE YOU KIDDING, I WAS ON
ANOTHER PLANET AND OTHER TIMES
THEY PLAY HAVE A PARTICULAR VIEW
IN WHICH THAT MAKES SENSE AND
YOU MAY NOT BE ABLE TO OVERRIDE.
IT'S FACT SENSITIVE.
>> OKAY.
>> AND IT WOULD BE DIFFERENT IN
A CLINICAL SETTING VERSUS A
RESEARCH SETTING.
>> RIGHT.
THOUGH AS HOLLY KNOWS VERY WELL
THERE ARE RESEARCH THAT'S DONE
IN EMERGENCY SETTINGS AND THIS
ISSUE -- THERE'S A COMPLICATED
SET OF ISSUES THAT COME UP.
BECAUSE EMERGENCY MEANS A BROAD
SET OF THINGS A PERSON BLEEDING
OUT IS A SUPER EMERGENCY BUT A
PERSON COMING IN WITH A HEART
ATTACK.
IT'S ACUTE BUT NOT TWO MINUTES.
UNLESS THEY GET AN ARRHYTHMIA
IT'S MORE OF AN EVOLVING THING
IN WHICH YOU CAN GET CONCEPT.
THE QUESTION IS HOW DO YOU
ASSESS.
>> DANIEL.
>> MY QUESTION IS HIERARCHY FOR
DECISION MAKERS AND THE ANSWER
MAY BE IT VARIES STATE TO STATE
BUT WONDER IF THERE'S A PATTERN
OR IF WE HAVE REASON TO SKIP
OVER SOMEONE ON THE HIERARCHY
THAT WOULD BE A PERFECTLY
CAPABLE DECISION MAKER.
NOT EXTREMELY OLD OR KNOWS THE
PATIENT'S WISHES BUT MAY HAVE
OTHER REASONS TO SKIM OVER THEM
LIKE THEY MAY NOT HAVE THE
PATIENT'S BEST INTEREST.
IS THAT A REASON TO SKIP OVER
THEM LIKE IF A SPOUSE OR MRAB
THEY'RE MARRIAGE SON THE ROCKS
OR HEADING TOWARDS A MESSY
DIVORCE YOU MAY SKIP OVER THEM
AND TAKE AN ADULT CHILD WHO
SIMILARLY KNOWS THE WISHES OF
THE PATIENT.
>> THAT'S A GOOD QUESTION.
IT VARE YES ON CONTEXT AND WHAT
KERPZ YOU HAVE.
-- WHAT CONCERNS YOU HAVE.
AND YOUR OVER ALL POINT HOW DO
APPLY THE HIERARCHY IS WHAT YOUR
QUESTION IS.
AND YOU DON'T JUST BLINDLY
FOLLOW IT.
IF YOU HAVE REASON TO SUSPECT
THE SPOUSE WHO IS 95 AND SHE
HERSELF SEEMS IMPAIRED WHEN YOU
TALK TO HER TO GET CONSENT THEN
YOU NEED TO PURSUE THAT.
EVEN IN THIS HOSPITAL AND HIS
COMES FOR CLINICAL THAN RESEARCH
CONCEPT IS AVAILABILITY IS A BIG
FACTOR.
YOU'RE NOT REQUIRED TO HIRE A
PRIVATE SINGLE DIGIT ER BEING -
PRIVATE INVESTIGATOR.
SO YOU HAVE TO EXERCISE SOME
GENERAL RULES OF APPLICATION.
OTHER COMMENTS, QUESTIONS HERE
OR IN CYBER SPACE.
>> NONE APPARENTLY HERE OR IN
CYBER SPACE SO WE'RE GOING TO
SEND YOU ON YOUR WAY WITH A
GREAT ROUND OF PLAUS.
THANK YOU, SCOTT.
SO WE'RE TAKING OUR 15-MINUTE
BREAK NOW SO IF FOLKS CAN GO GET
A CUP OF COFFEE OR WHATEVER YOU
NEED, WE'LL RECONVENE AT 10:35 AND CAROL SQUIRES WILL BE JOINING US.
>> WELCOME BACK.
IT'S MY PLEASURE TO INTRODUCE
CARE -- CAROL SQUIRES AND SHE'S
DEVELOPED INTEREST AND EXPERTISE
IN FACILITATING, ASSESSING AND
UNDERSTANDING INFORMED CONSENT
OF FOLKS SIMILAR TO THE ONES
SCOTT WAS TALKING ABOUT AS WELL
AS THOSE WITH OTHER MENTAL
HEALTH ISSUES.
SO I'M GOING TO HAND IT OVER TO
CAROL.
>> THANK YOU VERY MUCH I'M WITH
THE NATIONAL INSTITUTE OF MENTAL
HEALTH, CAROL SQUIRES, HUMAN
SUBJECTS PROTECTION UNIT.
I'LL GO AHEAD AND MAKE SURE I
CAN GET THE SLIDES GOING.
UME WITH HSPU HUMAN SUBJECTS
PROTECTION UNIT WORKING UNDER
DR. POWE.
THE OFFICE OF THE CLINICAL.
SHE IS THE CLINICAL DIRECTOR OF
NIMH AND OUR DIRECTOR
SUPERVISOR.
THERE'S THREE OF US.
MYSELF, KATHERINE TODDMAN AND
BRITTANY HERE FOR MORAL SUPPORT
AND YEAR SOCIAL WORKERS AND
LICENSED IN THE AREA.
WE'RE CLINICIANS INDEPENDENT OF
THE RESEARCHERS.
BASICALLY BEING INDEPENDENT OF
THE RESEARCH TEAM DOES ALLOW US
A LEVEL OF NEUTRALITY AND
OBJECTIVITY BECAUSE WE'RE NOT
INTERESTED WHETHER SOMEONE
PARTICIPATES BUT ENSURE THEY GET
THE INFORMATION THEY NEED TO
MAKE AN INFORMED DECISION AND WE
ARE IN COMBINATION WITH THE
BIOETHICS DEPARTMENT AND WORK
COLLABORATIVELY WITH THEM AND
WORK ON ISSUES AROUND
INDIVIDUALS, RESEARCHERS, GET IN
TOUCH WITH US WHEN THEY HAVE
CONCERN ABOUT ABILITY TO GIVE
CONSENT AT THE CLINICAL CENTER.
OUR OVERARCHING FUNCTION IN HBSU
IS WE PROVIDE PROTECTION AND
ADVOCACY.
WE FOCUS ON WHAT WE REFER TO AS
INDIVIDUALS WHO ARE POTENTIALLY
VULNERABLE PARTICIPANTS.
A LITTLE BIT OF BACKGROUND,
WE'LL HAVE CASE STUDIES LATER
AND TALK ABOUT THIS A BIT MORE
BUT THE FOLKS THAT COME INTO OUR
STUDIES, WE SEE CHILDREN AS WELL
AS ADULTS.
THEY CAN HAVE MOOD AND ANXIETY
DISORDERS, MAJOR DEPRESSION, WE
HAVE A STUDY THAT LOOKS AT FOLKS
WITH SCHIZOPHRENIA, PSYCHOTIC
DISORDERS AND CHILDREN WITH AN
ARRAY OF DIFFERENT MOOD
DISORDERS AS WELL.
I THINK ONE OF THE THINGS THAT
WE HAVE ALL COME TO RECOGNIZE IS
THAT THE TERM VULNERABILITY CAN
APPLY TO ALL OF US.
IT DOESN'T MEAN YOU HAVE TO HAVE
A BEHAVIORAL HEALTH DIAGNOSIS IN
ORDER TO BE VULNERABLE.
ONE EXAMPLE LIKE I IF WERE TO
FALL DOWN THE STAIRS AND END UP
IN THE E.D. ACROSS THE STRESS,
PEOPLE WOULD PUT PAPERWORK IN
FRONT OF MY FACE, I'LL SIGN
EVERYTHING AND I MAY NOT NEED MY
HUSBAND TO HELP OUT BUT IT'S
IMPORTANT TO BEAR IN MIND THE
TERM VULNERABLE CAN BE APPLIED
TO ALL OF US AT ANY POTENTIAL
TIME.
WE ASSESS, DEVELOP AND INTIMATE
PROTECTION.
THE THINGS WE DO AS CLINICAL
RESEARCH ADVOCATES WE PROVIDER
CONSENT MONITORING FOR ALL THE
NIMHD STUDIES WE'RE SITTING
THERE WHEN THE CONSENT IS BEING
DISCUSSED WITH THEM AND BEING
INFORMED ON WHAT WILL BE DONE
BEFORE THEY SIGN IT.
WE DO PARTICIPATE MONITORING
WHICH MEANS WE GO SEE THE PEOPLE
IN PATIENTS AT NIMHD STUDIES ON
A REGULAR BASIS AND DO ROUNDS
AND TALK TO THE CLINICAL STAFF
AND HAVE A RELATIONSHIP WITH ALL
OF THEM TO MAKE SURE PEOPLE ARE
CONTINUING TO BE INFORMED IN
WHAT THEY ARE DOING AND DO THEY
STILL WANT TO PARTICIPATE AND
HELP IN ASSIST IN APLAYING THE
DIFFERENT REGULATIONS AND
POLICIES LIKE CLINICAL CENTER
POLICY AND FEDERAL POLICIES,
THAT SORT OF THING.
AND WE PROVIDE A CONSENT SORT OF
TRAINING IT'S CALLED ELEMENTS OF
A SUCCESSFUL INFORMED MANDATORY
FOR ALL NIMHD INVESTIGATORS
OBTAINING CONSENT AND ANYONE CAN
TAKE IT ANY TIME.
IT'S ONLY PLANNED TRY FOR NIMHD.
HOPEFULLY TODAY OBJECTIVE WISE
WE'LL TALK ABOUT KNOWING WHAT
THE CONSENT CAPACITY IS AND WHAT
WE DO WITHIN HSPU.
AGAIN, MORE DETAIL HOW WE ASSESS
FOR CAPACITY, CONSENT CAPACITY
AND WHAT CONTRIBUTES TO A GOOD
CAPACITY ASSESSMENT IN TERMS OF
IT GOING WELL AND WHAT THE
PITFALLS CAN BE.
IT CAN BE AN ANXIETY PRODUCING
MOMENTS AND I'LL TALK WHAT ABOUT
WHAT OUR EXPERIENCES ARE AND
TALK ABOUT THINGS TO CONSIDER
WHEN ENROLLING POTENTIALLY
VULNERABLE POPULATIONS.
ALSO ONE OF THE THINGS I WANT TO
GIVE A SHOUT OUT TO AS WELL I
MENTIONED TO HOLLY BEFORE HAND
SHE SAID SHE HAS UPLOADED THE
LINK AND YOU HAVE ACCESS TO THE
POWER POINT AND WE ENCOURAGE
PEOPLE TO TAKE A LOOK IF SOMEONE
IS THINKING OF DEVELOPING
RESEARCH PROCESS AND WHERE ANY
INDIVIDUAL PARTICIPATING IT
TALKS YOU THROUGH AND THINGS TO
CONSIDER IN THE CONCEPT PROCESS
AND I THINK IT'S REALLY IF.
REAR PROUD OF THAT.
-- WE'RE PROUD OF THAT.
THIS IS OUR NIMHD CONCEPT
PROCESS.
I'LL GIVE A SHOUT OUT TO
KATHERINE TODDMAN SHE PUT THIS
TOGETHER AND WHEN YOU'RE
THINKING ABOUT INCLUDING PEOPLE
WHO MAY NOT HAVE CONSENT PROCESS
AND DOES THE PROTOCOL ALLOW WHAT
YOU DO AN IF IT DOESN'T WHAT CAN
YOU DO AT THAT POINT.
I WON'T GO THROUGH THIS AT THIS
POINT IN TIME BUT IT'S THERE AND
IT'S A GOOD REASON TO TAKE A
LOOK AT THE POWER POINT.
THIS IS A CAPACITY ASSESSMENT
ALGORITHM WHICH IS HELPFUL AS
WELL.
AT THE TOP IT TALKS ABOUT BEFORE
GOING IN TO ASSESS SOMEBODY'S
CONSENT CAPACITY WE WANT TO MAKE
SURE THE RESEARCHER HE'S
EDUCATED THE PARTICIPANT ABOUT
THE PROTOCOL.
WE ALWAYS SAY IT'S NOT FAIR TO
ASK QUESTIONS OF A PERSON ABOUT
A STUDY IF THEY HAVEN'T REALLY
HAD AN OPPORTUNITY TO TALK WITH
THE RESEARCHER OR SOMEBODY FROM
THE STUDY TEAM, ENLIGHTENING
THEM, EDUCATING THEM ABOUT WHAT
THE STUDY ENTAILS.
WE'RE INTERESTED IN YOU BECAUSE
YOU HAVE THIS CONDITION THAT'S
GOING ON.
THESE ARE THE TASKS OR THE
PROCEDURES WE'RE GOING TO ASK
YOU TO DO.
WHAT THE POTENTIAL RISKS ARE OF
EACH OF THOSE PROCEDURES.
GOING OVER THAT.
THEY NEED TO HAVE THAT EDUCATION
BEFORE WE CAN GO IN AND REALLY
PROPERLY ASSESS THEM.
THE NEXT CATEGORY DOWN IS HSPU
ADMINISTERS THE CAPACITY
ASSESSMENT.
WHAT WE ALWAYS DO IS WE MAKE IT
A CONVERSATION.
I'LL GO THROUGH THE DIFFERENT
DOMAINS THAT WE USE AND HOW WE
STRUCTURE OUR CAPACITY
ASSESSMENT.
THE ACTUAL TOOL ITSELF.
BUT AGAIN WE'RE INTERESTED IN
WHAT PEOPLE KNOW AND UNDERSTAND
ABOUT THE STUDY AND WE ALWAYS
ENCOURAGE OR CLARIFY WITH PEOPLE
BECAUSE WE'RE ASKING THEM A LOT
OF QUESTIONS.
IT'S JUST SPECIFICALLY ABOUT THE
STUDY.
WHAT WE'RE DETERMINING AND
ASKING ABOUT.
WE'RE NOT CONCERNED WHETHER THEY
LIVE ALONE IN THE COMMUNITY OR
IF THEY CAN MANAGE THEIR OWN
FINANCE OR HAVE A JOB.
WE WANT TO KNOW AND IT'S A
SNAPSHOT OF WHAT THEIR
UNDERSTANDING IS ABOUT THE
STUDY.
AGAIN, I'LL TALK MORE ABOUT THIS
ACTUAL QUESTIONS AND HOW WE SET
THIS UP BUT AFTER WE'VE HAD TIME
TO TALK WITH THEM, AND DEPENDING
ON TE -- THE PERSON IT COULD BE
10 OR 15 MINUTES AND IF I THAT
WANT TO TALK MORE THAT'S FINE.
TYPICALLY THERE'S TWO OF US THAT
DO THE ASSESSMENT.
ONE IS THE INTERVIEWER AND ONE
IS THE PERSON WHO IS TAKING
NOTES AND WATCHING AND ADDING
WHAT THEY NEED TO AT THE TIME
BUT THEY'RE ALSO TAKING IN WHAT
THE PERSON IS SAYING.
TYPICALLY WE'LL HAVE A FEW
MINUTES OUTSIDE THE ROOM AFTER
WE'RE FINISHED WITH THE PERSON
AND CAN HAVE A DISCUSSION.
DO WE HAVE CONCERNS ABOUT THIS
PERSON.
A LOT OF TIMES THERE'S NOT EVEN
A QUESTION AND WE CAN GO
STRAIGHT INTO THE CONSENT
PROCESS.
AND WITHIN NIMHD WE'RE PROVIDING
CONSENT MONITORING FOR THOSE
PEOPLE.
AND WHAT WE'RE LOOKING AT AND IT
TALKS ABOUT THE THREE CATEGORIES
WE HAVE AFTER WE'VE DONE THE
ASSESSMENT.
IS THE PERSON ABLE TO GIVE THEIR
OWN CONSENT?
NO QUESTION.
ARE WE CONCERNED THERE'S A
QUESTIONABLE ABILITY.
MAYBE THEY GET THE OVER ARCHING
UNDERSTANDING BUT THERE MAY BE
SPECIFICS ABOUT IT.
IT'S A LITTLE BIT QUESTIONABLE
AND WE THEN ARE GOING TO TAKE
THAT TO THE RESEARCHER AND TALK
TO THEM ABOUT IS WHAT WE FOUND
AT THIS POINT IN TIME.
WE DO FEEL LIKE, YES, CLINICALLY
THESE PEOPLE GET MOST OF IT BUT
MAY NEED SOME HELP, SOME
GUIDANCE, SOME REMINDERS FROM
FOLKS AS WELL OR DO WE FIND THE
PERSON ABSOLUTELY DOES NOT HAVE
CAPACITY AT THIS TIME AND AGAIN
IT SAYS THE RESEARCHER DECIDES
AND THE DIFFERENT OPTIONS UNDER
THAT THEN DO THEY WANT TO SPEND
MORE TIME EDUCATING THE
PARTICIPANT?
IT COULD BE GIVEN MORE TIME,
MORE INFORMATION THEY MIGHT
ACTUALLY HAVE CAPACITY TO GIVE
THEIR OWN CONSENT.
IF THE PROTOCOL ALLOWS IT AT
THIS POINT, DO WE WANT TO PURSUE
AND MAKE SURE IT'S A LEGALLY
AUTHORIZED REPRESENTATIVE OR
SURROGATE GIVING CONSENT ON
THEIR BEHAVE.
SOMETIMES IT'S YES, THEY HAVE
CAPACITY BUT THEY COULD BENEFIT
FROM REMINDERS AND THIS PERSON
HELPING THEM BUT STILL HAVE THE
ABILITY TO GIVE THEIR OWN
CONSENT OR THEY'RE NOT GOING TO
BE ENROLLED AT ALL.
SO AGAIN IT'S A CONVERSATION
WITH THE INVESTIGATORS, WE'RE
TALKING AMONGST OURSELVES ABOUT
THAT AND WE ALWAYS WANT TO MAKE
SURE THAT PEOPLE ARE AWARE.
WE WANT TO NORMALIZE THE PROCESS
AND MAKE SURE THAT PARTICIPANTS
KNOW THIS IS PART OF THE STUDY.
IN OUR CASES A LOT OF TIMES IT'S
PROTOCOL MANDATED.
THEY HAVE WRITTEN IT TO THE
PROTOCOL WE'LL BE ASSESSING
PEOPLE.
WE DON'T WANT SURPRISES.
WE WANT PEOPLE TO KNOW THIS IS
GOING TO HAPPEN AND THESE ARE
THE POTENTIAL OUTCOMES.
SO, THIS IS JUST MORE
INFORMATION ABOUT TYPICALLY WHAT
HAPPENS HERE AT THE CLINICAL
CENTER AND SPECIFICALLY TALKING
AT LENGTH AT WHAT DO AT NIMHD.
ADULT PARTICIPANTS HAVE TO HAVE
CAPACITY TO GIVE CONSENT.
OFTEN WHAT HAPPENS IN THE
CLINICAL CENTER IS THE
INVESTIGATORS OBTAINING CONCEPT
ARE USING THEIR OWN CLINICAL
JUDGMENT.
THEY DON'T NECESSARILY HAVE A
SEPARATE ASSESSMENT TOOL THEY
USE.
THEY'RE USING THEIR OWN CLINICAL
JUDGMENT AND ACUMEN.
THAT'S BEEN APPROVED BY THE IRB,
THAT'S FINE.
A MORE FORMAL PROCESS CAN
INCLUDE OURSELVES OR THE TEAM
AND JUST AS A REMINDER WE HAVE
AN OUT PATIENT AND IN PATIENT
STUDY WHERE HSBU IS WRITTEN INTO
THE PROTOCOL TO ASSESS
INDEPENDENTLY SOMEONE'S CONCEPT
CAPACITY.
FOR A PROTOCOL SPECIFIC CAPACITY
ASSESSMENT IS USED WHEN THE
PROTOCOL REQUIRES THEY NEED TO
BE NORMALLY AND INDEPENDENTLY
ASSESSED.
WE CREATE THE TOOL IN ADVANCE.
WHAT WE DO IS CREATE THE
QUESTIONS, WE DEVELOP THE
EXPECTED ANSWERS FOR THOSE
QUESTIONS AND SHARE THAT WITH
THE INVESTIGATOR, THE P.I. OF
THE PROTOCOL AHEAD OF TIME.
THIS IS WHAT WE'RE GOING TO ASK.
ARE THESE THE ANSWERS WE WOULD
EXPECT.
THESE ARE THE MINIMUM
REQUIREMENTS WE'RE LOOKING AT TO
THINK ABOUT SO WE CAN ENSURE
SOMEBODY DOES HAVE CONSENT
CAPACITY.
AND AS I SAID WE HAVE EXPECTED
RESPONSES TO THE QUESTIONS WE
DEVELOPED AND WE ALSO CAN USE
PROMPTS.
ESPECIALLY WITH SOME FOLKS FOR
EXAMPLE WE HAVE AN OUT PATIENT
STUDY AND MAY MIGHT HAVE MEMORY
PROBLEMS AND GIVING THEM A
PROMPT LIKE ARE YOU GOING TO
HAVE SCANS AND THEY PLAY NOT SAY
IT'S A PET SCAN OR TOMOGRAPHY
BUT THEY CAN SAY IT'S A SCAN
WHERE I LAY DOWN FLAT.
WE KNOW THEY DO GET THAT.
THOSE ARE THE KINDS OF THINGS WE
FEEL LIKE IS PERFECTLY
ACCEPTABLE TO TALK TO THEM
ABOUT.
THE DIFFERENCE THEN IS GENERIC
CAPACITY ASSESSMENTS.
AS IT SAID, IT USES A GUIDE FOR
THE UNEXPECTED ENROLLMENT OF
PEOPLE WHO MAY NOT HAVE CONCEPT
CAPACITY AND IT CAN OCCUR IN A
SITUATION WHERE THE RESEARCHERS
HAVE SOMEBODY WHO COMES IN AND
THIS ISN'T A REGULAR PART OF
WHAT THEY SEE WITH THE ILLNESS
AND THEY'RE NOT EXPECTING
SOMEBODY TO HAVE DIFFICULTY BUT
MAYBE THEY WANT ADDED HELP.
THEIR OWN CLINICAL ASSESSMENT.
THEY KIND OF WANT AN OUTSIDE
OPINION AND CAN CONTACT THE TEAM
AND BIOETHICS DEPARTMENT AND ONE
OF US MAY GO OR IT MAY BE
BIOETHICS DEPARTMENT THAT GOES
OR IT MAY BE US.
THAT SORT OF THING.
SO THEY'RE GENERIC QUESTIONS.
NOT SPECIFIC TO THE PROTOCOL BUT
LOOKING TO SEE IF THE PERSON HAS
INFORMATION ABOUT THE STUDY
ITSELF THAT LENDS ITSELF TO YOUR
UNDERSTANDING.
YES, THEY'VE BEEN EDUCATED ABOUT
THIS AND UNDERSTAND WHAT'S GOING
TO HAPPEN.
SO, THESE ARE THE TOOLS IN
TALKING ABOUT THE CAPACITY
ASSESSMENT WITH HSPU.
THEY'RE CLINICALLY DERIVED AND
HAVE NOT BEEN VALIDATED.
THEY DO USE FOUR DIFFERENT
DOMAINS AND WE HAVE
APPROXIMATELY NINE TO 11
QUESTIONS.
THEY'RE OPEN-ENDED BECAUSE WE
WANT THIS TO BE MORE OF A
CONVERSATION RATHER THAN A
CHECKLIST.
WE WANT TO BE ABLE TO TALK TO
SOMEBODY.
SOMETIMES DEPENDING ON WHETHER
IT'S OUT PATIENT OR COMING BACK
OVER TIME YOU MAY NOT HAVE --
THEY HAVEN'T HAD A LOT OF TIME
TO HAVE THE EDUCATION PIECE.
AND YOU WANT THEM -- THEY'VE
GONE THROUGH AND DRIVEN HERE
WITH A FAMILY MEMBER PERHAPS OR
MAYBE ON THEIR OWN.
THEY'VE ALSO VOLUNTEERED
ADMISSIONS AND TRYING TO MAKE
SURE THEY'RE IN THE RIGHT SPOT,
RIGHT LOCATION.
IF THERE'S A LITTLE
UNDERSTANDABLE ANXIETY AND
GETTING SETTLED YOU WANT TO GIVE
THAT PERSON TIME TO GET SETTLED
ENOUGH AND GET COMFORTABLE
ENOUGH WITH YOU TO HAVE THE
CONVERSATION AND NOT FEEL LIKE
THEY'RE BEING QUIZZED.
USUALLY WE HAVE TWO EVALUATORS.
WE CAN DO IT WITH ONE.
IT DOES WORK WELL WITH TWO
BECAUSE THEN CLINICALLY
AFTERWARDS PEOPLE CAN TALK WITH
EACH OTHER AND SHARE THEIR
THOUGHTS AND OPINIONS ABOUT WHAT
THEY'VE SEEN AND MAKE SURE THAT
WE'RE BOTH COMFORTABLE WITH
MOVING AHEAD.
IT CONSISTS OF TAILORED
QUESTIONS TO EACH DOMAIN.
I THINK THIS IS REALLY HELPFUL.
WE DEVELOPED A SHORTER VERSION
OF THE MACARTHUR COMPETENCE
ASSESSMENT TOOL DEVELOPED BY TWO
DOCTORS AND THEY CREATED THE
DOMAINS AND INDIVIDUALS WITH
SCHIZOPHRENIA AND WE TAILORED IT
DOWN TO FEWER QUESTIONS BUT
STILL USE THE DOMAIN CONCEPT
WHICH I THINK IS REALLY
VALUABLE.
UNDERSTANDING IS THE FIRST
DOMAIN.
AS IT SAYS HERE UNDERSTANDING OF
THE POTENTIAL PARTICIPANT'S
PERSON SITUATION AND STUDY
SPECIFIC PROCEDURE.
THE QUESTIONS THAT WE ASK
UNDERNEATH THAT DOMAIN TYPICALLY
ARE WHAT DO YOU HAVE THE
RESEARCHERS ARE INTERESTED IN
STUDYING?
FOR EXAMPLE SOMEBODY COMES IN
WITH ALZHEIMER'S DISEASE THEY
DON'T HAVE TO SAY ALZHEIMER'S
DISEASE BUT IF THEY CAN CONVEY
THEY'RE HAVING MEMORY
DIFFICULTIES.
I'M WORRIED ABOUT THIS AND
SOMETIMES SAY IT'S IN THEIR
FAMILY.
YOU'RE ASKING QUESTIONS ON WHAT
BRINGS YOU HERE AND WHAT THEY'LL
ASK YOU TO DO AS PART OF THE
STUDY HERE AT NIH YOU'LL BE
INVOLVED IN?
THEN IF THAT SEEMS CLEAR THEY
HAVE A GOOD UNDERSTANDING OF WHY
THEY'RE HERE AND WHAT THEY'LL BE
ASKED TO DO AND THE APPRECIATION
OF THE EFFECTS OF STUDY
PARTICIPATION ON THE POTENTIAL
PARTICIPANT.
WHAT THAT TRANSLATES TO THEN IN
QUESTIONS IS WHAT ARE YOU GOING
TO HAVE TO DO IN WHY YOU ARE
LIFE TO BE HERE?
FOR EXAMPLE, WE HAVE A STUDY ON
THE 7th FLOOR WITH PEOPLE WHO
HAVE PSYCHOTIC DISORDERS.
THEY HAVE TO COME AND STAY FOR
MANY MONTHS AT A TIME.
ARE YOU GOING TO COME OFF YOUR
MEDICATIONS?
DID YOU HAVE TO TRAVEL HERE?
IF YOU'RE AN OUT PATIENT, ARE
YOU GOING TO BE DRIVING YOURSELF
HERE?
HOW ARE YOU GOING TO GET BACK
AND FORM AND HOW WILL IT AFFECT
YOUR LIFE AND WE TALK TO PEOPLE
ABOUT THEIR PETS PAUSE THAT'S A
CONCERN FOR PEOPLE IF THEY'LL BE
HERE A LONG TIME.
DO THEY HAVE SOMEBODY TO TAKE
CARE OF THEIR ANIMALS FOR THEM.
IT'S APPRECIATING WHAT IT MEANS
TO BE HERE AT THE CLINICAL
CENTER AND HOW THAT MAY IMPACT
YOUR LIFE.
THE NEXT DOMAIN THEN IS
REASONING.
IT SAYS THE REASONING OF WHY
POTENTIAL PARTICIPANTS WANT TO
BE IN RESEARCH.
ONE OF THE THINGS WE ALWAYS SAY
TO PEOPLE IS WE'RE NOT THE
MOTIVATION POLICE.
THERE'S A LOT OF DIFFERENT
REASONS WHY PEOPLE WANT TO COME
TO THE NIH TO PARTICIPATE IN A
STUDY.
WHAT WE WANT TO MAKE SURE ABOUT
IS ENSURING PEOPLE ARE USING THE
INFORMATION TO MAKE A DECISION
AND THEY MAY NOT GET A
MEDICATION TO TREAT THEIR
CONDITION YOU WANT TO MAKE SURE
THEY'RE NOT COMING HERE THINKING
YOU'RE GOING TO CURE THEM.
THE LAST DOMAIN IS CHOICE.
HOW MANY -- IF YOU'RE DECIDING
YES I WANT TO DO THIS WE'RE LIKE
THAT'S FINE BUT WE ALSO WANT YOU
TO TAKE SERIOUSLY WHEN PEOPLE
DON'T WANT TO PARTICIPATE AND
HOW WOULD YOU LET THE
RESEARCHERS KNOW IF YOU CHANGED
YOUR MIND ABOUT BEING IN THE
STUDY.
THESE ARE THIS DIFFERENT
HIERARCHIES.
I BELIEVE DR. KIM SPOKE ABOUT
THIS A LITTLE BIT SO I WON'T GO
IN GREAT DETAIL BUT WE HAVE
LEGAL GUARDIANS AND INDIVIDUALS
COME WITH A LEGAL GUARDIANSHIP.
THAT HAS TO BE REVIEWED BY THE
OFFICE OF GENERAL COUNCIL AT
NIH.
I'M A SOCIAL WORKER, THE
RESEARCHERS -- WE NEED TO MAKE
SURE IT COVERS RESEARCHERS AND
SOME COME FROM OUTSIDE DURABLE
POWERS OF ATTORNEY, IF NOT THEY
CAN FILL OUT AN NIH FORM 200
ADVANCED DIRECTIVE OR NEXT OF
KIN DEPENDING ON THE RISK
BENEFIT LEVEL OF A STUDY.
BEING ABLE TO ASSIGN AN NIH
ADVANCE DIRECTIVE OBLIGATED TO
COME IN IF SOMEBODY DOESN'T HAVE
CONCEPT CAPACITY AND HAVEN'T AND
IT'S A PROTOCOL THAT ALLOWS FOR
SURROGATE CONSENT BUT DON'T HAVE
SOMEBODY THEY'VE NAMED THEY NEED
TO ASSESS TO MAKE SURE THOUGH
ASSIGNING SOMEBODY TO MAKE
DECISIONS ON YOUR BEHALF IS KIND
OF A LOWER BAR THAN HAVING
CONSENT CAPACITY.
YOU WANT TO MAKE SURE THIS
PERSON IS CLEAR ABOUT WHAT THIS
INDIVIDUAL'S GOING TO DO FOR
THEM.
YOU WANT TO MAKE SURE THEY'RE
AWARE THEY'RE GIVING THE
AUTHORITY TO SOMEBODY ELSE.
SO THE TEAM CAN COME IN AND
ASSESS FOR THAT.
THE VALIDITY OF THE LAR.
YOU WANT TO MAKE SURE THOSE
INDIVIDUALS -- YOU WANT TO
CONFIRM THIS IS THE INDIVIDUAL
THE PERSON WANTS AND ALLOWED
UNDER THE DIFFERENT CATEGORIES.
THEY THEMSELVES HAVE CAPACITY TO
GIVE CONSENT ON BEHALF OF
SOMEBODY ELSE ON RESEARCH AND
REPRESENTING THE BEST WISHES OF
THE INDIVIDUAL.
ONE OF THE THINGS WE WILL ASK
PEOPLE IS ARE YOU COMFORTABLE
SPECKING UP ON BEHALF OF THIS
PERSON?
YOU MAY VERY WELL HAVE TO SAY TO
THE RESEARCH TEAM, WE CAN'T DO
THIS ANYMORE.
IT'S TOO DIFFICULT FOR THE
PERSON AND ARE YOU COMFORTABLE
DOING THAT AND ASKING QUESTIONS
ON THEIR BEHALF.
ONE OF THE THINGS WE'VE ASKED
PEOPLE IS HOW WOULD YOU KNOW IF
THIS INDIVIDUAL DIDN'T WANT TO
DO SOMETHING AND THAT SEEMS TO
BE A HELPFUL QUESTION FOR THE
TEAM.
ARE THEY GOING TO -- A LOT OF
TIMES YOU'LL GET AN ANSWER RIGHT
AWAY AND THEY MAY SPEAK UP AND
SOME MAY BEHAVIORALLY DISSENT
AND STOMP OFF BUT YOU WANT TO BE
SURE THEY KNOW THEIR OBLIGATIONS
IN DOING SO.
THIS IS A BIT MORE INFORMATION
WHEN CAPACITY ASSESSMENTS GO
WELL.
WHEN PEOPLE KNOW IT'S GOING TO
HAPPEN, WHEN THE PAPERWORK HAS
BEEN LOOKED AT AHEAD OF TIME.
YOU MAKE SURE YOU'VE ARRANGED
PLENTY OF TIME TO MAKE ANY AND
ALL ASSESSMENTS BEFORE THE
CONSENT IS SIGNED AND MAKING
SURE THE INVESTIGATOR HOW THEY
GET ALONG AND HOW THEY'VE MADE
DECISIONS IN THE PAST AND
DOCUMENTING WHAT THE DECISIONS
ARE AND WHO THE PERSON IS GOING
TO BE.
THESE ARE SOME OF THE PITFALLS.
IT CAN BE VERY ANXIETY
PROVOKING.
OUR GROUP IS LESS SO BECAUSE
WE'RE WRITTEN INTO PROTOCOLS AND
THEY KNOW THEY HAVE TO SCHEDULE
US AHEAD OF TIME AND KNOW THE
TEAMS WELL AND HAVE GOTTEN TO
KNOW THE PARTICIPANTS WE'RE
FOLLOWING AS WELL BUT IF
SOMEBODY DOESN'T FLOW -- KNOW A
CAPACITY ASSESSMENT IS REQUIRED
AND NOT TALKING ABOUT IT AHEAD
OF TIME AND NOT NORMALIZED AND
SOMETHING WE DO FOR EVERYBODY
DEPENDING ON THE PROTOCOL, THE
ASSESSMENT GETS DONE AFTER THE
CONSENT IS SIGNED, NOT EDUCATING
THE PARTICIPANT AHEAD OF TIME.
WE'VE HAD THAT HAPPEN.
IT'S NOT FAIR TO ASK QUESTIONS
IF THEY HAVEN'T LAD AN
OPPORTUNITY TO -- HAD AN
OPPORTUNITY TO UNDERSTAND AND
THERE'S POOR COMMUNICATION AND
PEOPLE CAN GET VERY ANXIOUS, THE
TEAM AS WELL AS THE PARTICIPANT.
THESE ARE CONSIDERATIONS IF
YOU'RE WRITING A PROTOCOL.
ARE YOU GOING TO ALLOW PEOPLE
WHO HAVE LEGAL GUARDIANS, ARE
YOU GOING TO ALLOW SURROGATES.
WHEN MINORS AGE OUT MAYBE THEY
ARE HAVE CAPACITY ISSUES AND ANY
ADDITIONAL PROTECTS, DETERMINES
WHO ADMINISTERS THE ASSESSMENT,
POLICY VERSUS PROTOCOL, ONGOING
CONSENT AS WELL.
I THINK WE'RE UP TO CASE
EXAMPLES NOW.
>> THANK YOU FOR THAT.
>> WE'LL TALK ABOUT THE CASES.
>> AN ADULT THAT PRESENTS AT THE
CLINICAL CENTER TO PARTS OPERATE
AND HIS MEANS MINOR INCREMENT
OVER MINIMAL RISK NOT FOR DIRECT
BENEFIT AND THE DAY BEFORE THE
INVESTIGATOR CALLED THE
PARTICIPANT TO MAKE SURE WHEN
THEY COME IN THEY HAVE MORE
INFORMATION AND HAVE HAD AN
OPPORTUNITY TO ASK HIM
QUESTIONS.
THE STUDY DOES ALLOW FOR LAR
CONSENT AND BRINGS HER ADULT
DAUGHTER WITH HER AS SHE ALREADY
ASSIGNS A DURABLE POWER OF
ATTORNEY.
IF SHE DOESN'T HAVE CAPACITY WE
CAN GO TO THE ADULT DAUGHTER.
THE STUDY REQUIRES TO COME IN
AND DO THE CAPACITY ASSESSMENT.
WE DETERMINED SHE DOESN'T HAVE
CAPACITY WHICH MEANS WE CAN GO
TO SURROGATE BUT THE DAUGHTER
ALSO INDICATES SHE IS ELIGIBLE
TO ENROLL IN AN MRI STUDY OF
MINIMAL RISK, LONGITUDINAL STUDY
WITH ANOTHER NIH INSTITUTE.
SO WHAT ARE SOME OF THE THINGS
PEOPLE THINK ABOUT HOW WE WOULD
PROCEED AT THIS POINT?
I GAVE ONE AWAY.
>> AND DON'T FEEL LIKE YOU HAVE
TO RUN OVER TO THE MIKE FOR
THIS.
IMAGINE THIS IS A SITUATION
YOU'RE FACED WITH.
SHOULD WE ENROLL HER?
RAISE YOUR LAND IF YOU WANT TO
GO AHEAD AND ENROLL HER?
ANYONE?
ALEX, YOU WANT TO GO AHEAD AND
YEP ROLL HER.
-- ENROLL HER.
BE BEING -- IN THIS CASE WE GO
TO THE DAUGHTER AND THE STUDY
ALLOWS FOR AN LAR CONSENT.
TELL ME, CAROL, SO THE LAST
BULLET HERE ABOUT SHE'S ALSO
ELIGIBLE TO ENROLL IN ANOTHER
STUDY HOW WOULD THAT COME IN TO
YOUR CONSIDERATION?
>> THE DAUGHTER DISCOVERED SHE
DIDN'T HAVE CAPACITY AT THAT
MOMENT.
AS YOU MENTIONED THE DAUGHTER
HAS BPA AND THE PARTICIPANT WAS
FINE WITH THE DAUGHTER GIVE
SURROGATE CONCEPT FOR THE NIMHD
STUDY, HOWEVER, THE DAUGHTER WAS
CONCERNED ABOUT THE OTHER STUDY.
COULD SHE PARTICIPATE AND WE
DON'T HAVE DECISIONS OR SWAY OR
ASSESSMENT ONE THING WE TALK
ABOUT IS IT'S A MINIMAL RISK
STUDY.
SOMEBODY COULD HAVE CAPACITY FOR
ONE AND NOT FOR THE OTHER AND
MAKE A DETERMINATION WHETHER SHE
HAD CAPACITY TO MAKE HER OWN
CONCEPT OR NOT.
WE WOULD BE DOCUMENTING AND OUR
RESEARCHER WOULD BE DOCUMENTING
OUR FINDING AND WE USED A
SURROGATE AND THAT WOULD BE
AVAILABLE AND COULD SEE THAT BUT
AGAIN IT SHOULDN'T HAVE AN
AFFECT ON THE OTHER STUDY.
THEY NEED TO MAKE THEIR OWN
DETERMINATION BECAUSE IT'S A
DIFFERENT STUDY AND SHE PLAY
VERY WE WILL HAVE A BACK SEAT.
>> MAYBE ANOTHER WAY OF SAYING
THAT IS THE FIRST ONE TO REMIND
FOLKS IT'S A MINIMAL INCREASE
OVER MINOR RISK AND NO DIRECT
BENEFIT TO THE PARTICIPANT.
I DON'T MEAN TO PUT WORDS IN
YOUR MOUTH BUT THAT STUDY IS
RISKIER AND THE DAUGHTER MAY BE
UNCOMFORTABLE PUT HER MOTHER AT
RISK BUT MAY BE MORE COMFORTABLE
WITH THE LOWER RISK IN THE SENSE
THAT HUR BURDEN MAY BE LESS IF
SOMETHING WENT WRONG.
ARE YOU SAYING THE CAPACITY IS
DIFFERENT BECAUSE IT'S RISKIER
OR SAYING THE GROUP WHO IS
ASSESSING IN THE SECOND STUDY
PLAY HAVE A DIFFERENT WAY OF
ASSESSING CAPACITY?
>> I THINK BOTH.
THE RISKIER STUDY THAT WOULD BE
OURS DOES HAVE LIKE A PET SCAN
AND CAN STAY ON MEDICATIONS BUT
IT'S MORE INVOLVED.
THERE CAN BE A HIGHER RISK AND
NOT FOR DIRECT BENEFIT OR GIVING
HER MEDICATION OR A PROCEDURE
WHERE HER MEMORY MIGHT IMPROVE.
IT'S FOR CLINICAL RESEARCH AND A
LOT OF TIMES WHAT WE HEAR FROM
FOLKS IS THEY HAVE AN
UNDERSTANDING THIS ISN'T GOING
TO HELP THEM.
WE DON'T JUST SAY NOT FOR DIRECT
BENEFIT.
THEY'RE VERY GOOD ABOUT
EXPLAINING WHAT THAT MEANS.
YOU'RE HELPING THE FUTURE AND A
LOT OF THESE FOLKS WILL COME IN
SEVERAL IN THE LAST COUPLE
WEEKS.
I KNOW THIS ISN'T GOING TO HELP
ME BUT MY MOTHER HAD THIS AND
ANOTHER HAD IT AND THEY PASSED
AND WERE WORRIED ABOUT THEIR
CHILDREN AND GRANDCHILDREN AND A
BIG PART OF THEIR MOTIVATION WAS
CONTRIBUTING TO THE FUTURE AND
HOPEFULLY HELP THEIR FAMILY
MEMBERS AND THE OTHER MINIMAL
RISK, LONGITUDINAL STUDY MAY BE
SOMETHING ELSE ENTIRELY.
IT WOULD BE IMPORTANT FOR THE
TEAM TO DO THEIR OWN ASSESSMENT
AND FOR THE DAUGHTER.
SHE CAN STILL WEIGH IN EVEN IF
HER MOTHER HAS CAPACITY BUT IT
WOULD BE -- THEY WOULD COME TO
THEIR OWN DECISION SEPARATELY
ABOUT THAT.
>> GREAT.
AND SOMETIMES SINCE CAROL AND
HER GROUP AND I'M JUST GETTING
TO THE NEXT CASE WE MIGHT BE THE
FOLKS ASKED TO COME IN, THE
DEPARTMENT OF BIOETHICS ASKED TO
COME IN AND ONE DIFFERENCE
BETWEEN OUR APPROACHES IS THAT
FOR THE NIMHD STUDY WHERE THAT'S
AN ASSESSMENT SPECIFIC TO A
PROTOCOL.
WE ASK A SERIES OF QUESTIONS BUT
THEY'RE GENERIC IN THE SENSE OF
TELL ME ABOUT THE PURPOSE.
DON'T QUOTE ME, TELL ME ABOUT
THE PURPOSE OF THE STUDY OR WHAT
RISKS YOU MIGHT BE EXPOSED TO
AND YOU'VE ALREADY PREPARED TO
GET PARTICULAR ANSWERS TO THOSE
QUESTIONS.
IT COULD BE THAT WHEN WE DO THE
ASSESSMENT FOR THE MINIMAL RISK
STUDY, THEY DO HAVE THE CAPACITY
TO UNDERSTAND THE RELATIVELY
MINIMAL PROCEDURES THAT ARE
INVOLVED IN THE MRI STUDY.
SO WE'RE GOING TO GO TO CASE 2.
TELL US ABOUT THIS ONE.
>> YES.
C HAS SKITS FCHIZOPHRENIA AND ED
IN A MINIMAL RISK PROTOCOL TO
DETERMINE THEIR ELIGIBILITY FOR
MORE THAN MINIMAL RISK, NOT FOR
DIRECT BENEFIT DOUBLE PLACEBO
STUDY THE NURSING POINT WITH
THESE CASES THEY ARE COME IN AND
ARE THERE FOR SEVERAL WEEKS
SOMETIMES LONGER BEFORE WE'RE
GOING A CAPACITY ASSESSMENT AND
IN THIS STUDY AN LAR IS NOT
ALLOWED TO PROVIDE CONCEPT.
THEY HAVE TO HAVE CAPACITY IN
ORDER TO PARTICIPATE IN THE
STUDY.
SO AT THIS TIME WE DETERMINED
THAT C DID NOT HAVE CAPACITY AND
C HAD INDICATED RESERVATION
ABOUT PARTICIPATING AND THAT'S
NOT AN UNUSUAL SCENARIO WE HAVE
AS WELL.
SO WHAT DO PEOPLE THINK OUR NEXT
STEPS ARE.
>> SO ONE OPTION MIGHT JUST BE
OKAY, C DIDN'T HAVE CAPACITY HE
IS THEREFORE NOT ELIGIBLE FOR
THE STUDY AND THAT'S IT.
SEND HIM ON HIS WAY.
IS THERE ANY IDEAS ABOUT AN
ALTERNATIVE TO THAT?
>> WE HAVE A CONVERSATION AND
WHAT'S THAT ABOUT AND WE TALK
WITH THE RESEARCHERS TOO.
ONE OPTION IS WE WOULD -- IF THE
PERSON IS GIVEN THE CHOICE.
WE'RE ALWAYS VERY CLEAR
ESPECIALLY WITH THIS POPULATION
IT'S THEIR DECISION TO
PARTICIPATE IN THE STUDY AND
IT'S NOT ATYPICAL YOU GET REALLY
WELL MEANING FAMILY AND FRIENDS
WHO FEEL LIKE THEY'RE HERE AT
THE NIH.
THIS IS THE GOLD STANDARD.
IF ANYBODY CAN HELP MY LOVED
ONE, YOU CAN.
WE ALWAYS REMIND THEM, IT'S THE
PARTICIPANT'S DECISION.
WE CAN SAY THERE'S SEVERAL
OPTIONS.
YOU CAN BE DISCHARGED.
THAT'S FINE.
YOU CAN GO BACK HOME WHEREVER
THAT IS WHATEVER THAT SCENARIO
IS.
WE CAN REMIND THEM AGAIN, YOU
DON'T HAVE TO DO THIS.
DO YOU WANT TO SPEND MORE TIME
LEARNING ABOUT THE STUDY AND
WE'LL TALK ABOUT THE AREAS THEY
HAD DIFFICULTY WITH AND TALK
WITH THE RESEARCHERS.
THE RESEARCHERS DON'T WANT TO
PRESSURE SOMEBODY TO STAY AT
THAT POINT BUT SOMETIMES AT THAT
POINT THE PERSON HAS A CLEAR
UNDERSTANDING THOUGH MY PARENTS
ARE SAYING AND THIS IS SOMEBODY
ABLE 18 OR OLDER AND THIS IS NOT
AN UNUSUAL SCENARIO THEY'LL SAY
SO YOU MEAN MY PARENTS CAN'T
MAKE ME STAY.
NO, WE CAN'T.
MAYBE WE WILL STAY THEN.
THEY'VE GOTTEN USED TO THE UNIT
AND THEY'VE DEVELOPED RAPPORT
WITH THE STAFF AND EVERYONE IS
REMINDING THEM THIS IS YOUR
DECISION ABOUT GETTING HERE AND
EVEN IF YOU GET IN THE MORE
RISKY STUDY, HIGHER RISK STUDY
YOU CAN STILL CHANGE YOUR MIND.
SO SOMETIMES WHAT A PERSON WILL
SAY IS OKAY, ALL RIGHT, I WILL
SAY I KNOW I CAN'T.
I CAN CHANGE MY MIND AND WE
WOULD DO MORE EDUCATION AND THEN
REASSESS AND SEE WHERE WE ARE AT
THAT POINT.
IF THEY STILL DON'T HAVE
CAPACITY, THEN WE'RE TALKING
WITH THE RESEARCHERS AND IT
COULD BE THIS PERSON IS NEVER
GOING TO HAVE CAPACITY TO GIVE
THEIR OWN CONSENT AND NEED TO
START PLANNING FOR DISCHARGE.
SOME PEOPLE DECIDE THEY WANT TO
GO BACK HOME AND A LOT OF TIMES
THEY TALK ABOUT THIS MORE AND
WE'VE HAD PEOPLE COME BACK.
I'VE ALSO HAD PEOPLE WHO HAD
CAPACITY AND SELF-SABOTAGE
BECAUSE THEY THOUGHT THEY WERE
BEING MADE TO STAY THEIR PARENTS
PUTTING PRESSURE ON THEM AND
WENT HOME AND COME BACK.
IT'S NOT TYPICAL PEOPLE DON'T
HAVE CAPACITY.
WE'VE HAD THAT A HANDFUL OF
TIMES AND GAVE THEM SEVERAL
OPPORTUNITIES AND STABILIZED
THEM AND MAYBE MADE TREATMENT
RECOMMENDATIONS DIFFERENCES AND
THEY'LL SEND THEM BACK HOME AND
WON'T GO THROUGH THE HIGHER RISK
PROTOCOL.
>> DOES ANYBODY HAVE QUESTIONS
FOR CAROL?
>> CAPACITY?
THE STUDY WAS FOR DIRECT BENEFIT
AND SOMETHING WE HAVE TO BE
CLEAR WITH FOLKS ABOUT.
UNDERGOING A PET SCAN OR MRI
COMING OFF YOUR MEDICATION IS
ABOUT HELPING THE FUTURE.
IT'S NOT GOING TO CHANGE YOUR
PSYCHOTIC DISORDER.
AND THEY REALLY HAD THAT
CONFUSED AND ALSO AT THE SAME
TIME THEY WERE FEELING SOME
PRESSURE FROM AGAIN WELL MEANING
FAMILY MEMBERS BUT WE HAVE TO BE
CLEAR IT'S NOT LIKE WHEN YOU
BREAK YOUR LEG AND GO TO THE
E.R.
YOU HAVE THE RIGHT TO MAKE THE
DECISION AND THEY WERE FEELING
PRESSURE FROM THEIR FAMILY AND
WEREN'T 100% SURE THEY COULDN'T
INFLUENCE THE RESEARCH TEAMS TO
MAKE THEM STAY AND WE WERE THERE
TO CLARIFY THAT WASN'T TRUE.
ULTIMATELY, AS I RECALL, THIS
PARTICULAR PERSON HAD CAPACITY
AFTER THEY HAD MORE TIME AND THE
IDEA, THE PRESSURE OF HAVING TO
STAY WAS LIFTED.
>> WHY WOULD STUDIES
[OFF-MIC]
>> IT DEPENDS ON WHAT
RESEARCHERS WANT TO DO.
THERE ARE RESEARCHERS WHO WANT
TO MAKE SURE THEY HAVE A PERSON
WHO COMPLETELY UNDERSTANDS WHAT
IT IS THEY'RE AGREEING TO.
THEY DON'T REALLY WANT TO LEAVE
THAT TO A SURROGATE AND IT
REALLY IS UP TO THE INDIVIDUAL
RESEARCHERS BUT THEY SPEND A LOT
OF TIME TALKING WITH THEIR TEAMS
AND IRB BEFORE THEY MAKE THAT
DECISION AS WELL AND IN THIS
CASE THIS WAS A STUDY FROM 1989
AND THEY MADE THE DECISION A
LONG TIME AGO THEY WANTED TO
MAKE SURE THE PARTICIPANTS HAD
THEIR OWN CONSENT CAPACITY.
>> AND AS A GENERAL RULE,
STUDIES THAT ARE NO MORE THAN
MINIMAL RISK OR WHAT I'LL CALL A
NATURAL HISTORY STUDY.
OFTEN FOLKS WITH RARE DISORDERS
FOR WHICH THERE ARE NO
TREATMENTS MIGHT ENROLL IN A
STUDY HERE AT THE CLINICAL
CENTER AND ALL, QUOTE, UNQUOTE
THE TEAM WANTS IT DO IS COLLECT
BLOOD SAMPLES.
MAYBE DO SOME GENETIC ANALYSIS.
THERE'S VERY LITTLE PHYSICAL
RISK SO THE IDEA IS THAT IN THAT
CASE IT'S RELATIVELY COMMON FOR
THERE FOR BE AN LAR DESIGNATION.
WHEN THE RISK STARTS TO RISE
THERE ARE CONCERNS ABOUT IS IT
OKAY TO ENROLL SOMEONE WHO
DOESN'T HAVE CAPACITY IN A TRIAL
THAT HAS SOME RISK AND NO DIRECT
BENEFIT?
IT'S JUST A RESPECT FOR AND THE
ABILITY OF THE PERSON TO MAKE A
DECISION ON THEIR OWN BEHALF.
AND THERE'S A LITTLE SPACE IN
THE MIDDLE OF THERE'S MORE THAN
MINIMAL RISK BUT POTENTIAL FOR
DIRECT BENEFIT AND THAT'S WHERE
THERE'S MAYBE LESS COMMON -- I
GUESS TO SAY SOMETIMES THERE'S
AN LAR SOMETIMES THERE ISN'T.
THAT'S WHEN IT COMES TO THE TEAM
AND HOW THEY WANT TO MOVE
FORWARD AND THEIR CONSIDERATIONS
ABOUT THE DISEASE AS CHRISTINE
AND SCOTT MENTIONED.
SOME RESEARCH SO LET'S IMAGINE
SOMEONE WHO HAS ALZHEIMER'S IN A
LATER STAGE.
THEY MAY NOT HAVE CAPACITY BUT
THIS STUDY MAY HAVE SOME DIRECT
BENEFIT FOR THEM AND SO WE HAVE
TO ENROLL PEOPLE WHO HAVE
ALZHEIMER'S NRPDIN ORDER TO FIN
THAT OUT AND THAT'S A CLEAR CASE
WHERE THE INVESTIGATORS WANT TO
MAKE SURE AN LAR IS ALLOWED TO
MAKE THAT DECISION.
>> ON THE HEELS OF THAT IT'S
IMPORTANT TO REMEMBER ASSENT AND
DISSENT AND A WOMAN WITH
ALZHEIMER'S DISEASE AND HER
HUSBAND BROUGHT HER AND SHE
DIDN'T HAVE CAPACITY AND DIDN'T
UNDERSTAND WHAT WAS GOING TO BE
DONE EVEN AFTER WE TALKED ABOUT
THE TASK AND THE ACTIVITIES
WE'RE GOING TO BE AS PART OF THE
STUDY AND HER HUSBAND
DESPERATELY WANTED HER IN THE
STUDY AND IT WAS EDUCATING HIM
IT WOULD NOT PROVIDE TREATMENT
BUT IT WAS A THOROUGH OVERVIEW
TO IDENTIFY WHAT WAS GOING ON
AND WAS DESPERATE TO GET IT DONE
AND WE SAID SHE DOESN'T HAVE
CAPACITY AND THEY LAD DPAs AND
EVERYTHING BUT SHE WAS CLEAR SHE
DIDN'T WANT TO BE HERE AND
DIDN'T UNDERSTAND NIH BUT
EQUATED HER WITH MEDICAL CARE
AND SCARED HER TERRIBLY AND WE
SAID YOU CAN'T ENROLL HER
BECAUSE IT WAS VERY
DISAPPOINTING FOR THE PERSON.
I THINK WHAT WAS HELPFUL WAS THE
INVESTIGATOR THEN WAS WORKING
WITH HIM TO MAKE SURE THEY WOULD
BE REFERRED ON THE OUTSIDE TO A
FACILITY THAT COULD HELP THEM A
BIT MORE.
>> GREAT.
THANKS, CAROL.
>> THANK YOU, ALL.
SO YOU'LL GET A LITTLE MORE FROM
ME BEFORE WE FINISH UP FOR
TODAY.
I CALL THIS LECTURE NUTS AND
BOLTS AND THE BOTTOM LINE HERE
IS THAT WE'VE TALKED A LITTLE
ABOUT THE THEORETICAL ISSUES AND
SOME CONCERNS ABOUT CAPACITY.
MANY OF YOU MIGHT JUST BE
WRITING CONSENT FORMS FOR
AVERAGE CLINICAL TRIAL.
I JUST WANTED TO SHARE A COUPLE
OF THINGS TO KEEP IN MIND AND
THIS IS IN FACT REALLY MORE FOR
YOU TO HAVE ON HAND AS A FUTURE
REFERENCE THAN SOMETHING WE NEED
TO GO INTO MUCH DETAIL ABOUT BUT
AS A REMINDER, CONSENT IS A
PROCESS NOT A FORM.
I'M GOING TO TALK A LOT ABOUT
THE FORM AS I MOVE FORWARD BUT I
WANT TO REITERATE THAT INFORMED
CONSENT PROCESS IS ONLY ONE WAY
TO CONVEY RESPECT TO THE
POTENTIAL PARTICIPANTS.
YOU NEED TO MAKE SURE YOU
RESPECT THEM IN ALL SORTS OF
WAYS EVEN AFTER INFORMED
CONSENT.
I'LL TALK ABOUT BEST PRACTICES
AND FORM AND PROMOTING.
AGAIN, STYLE.
I WON'T READ ALL THESE TO YOU
AND SOME SHOULD BE I WOULD
IMAGINE PRETTY STRAIGHTFORWARD.
THE LAST TIME I READ A BOOK BY
FAULKNER IT WAS HARD TO READ ONE
LONG SENTENCE, VERY COMPLICATED
WORDS AND TEXT.
YOU'RE LOOKING FOR SOMETHING
WITH SHORT SENTENCES, SHORT
WORDS AND IMPORTANTLY LIKE
STATES ONE MAIN IDEA CLEARLY IN
EACH PARAGRAPH.
YOU'LL BE MAYBE NOT SURPRISED TO
LEARN THAT PUTTING SPACE BETWEEN
PARAGRAPHS IS REALLY HELPFUL
WHEN SOMEONE IS GIVEN A FORM
THAT IS 25 PAGES LONG.
YES, ADDING SPACE MAY MAKE IT
LONGER BUT IT'S A MESSAGE TO THE
INDIVIDUAL THAT HERE IS ONE
IDEA.
PRESENT A CLEAR SEQUENCE OF
EVENTS.
I WAS REVIEWING A PROTOCOL.
WE HAD A CONSULT THE OTHER DAY
WHERE AN INDIVIDUAL CLINICIAN
HAD A CONCERN ABOUT A CHANGE IN
THE PROTOCOL AND THAT MEANS THE
CONSENT FORM CHANGE IN THIS CASE
AND EVERYBODY HAS TO BE
RE-CONSENTED.
ONE OF THE WAYS THEY ORGANIZED
THEIR DATA WAS THEY HAD THIS
REALLY LOVELY TABLE THERE WAS AN
ICON OR EMOTHER THAT WAS LIKE A
BLOOD DRAW.
THEY HAD A PICTURE OF A NEEDLE
AND TALKED ABOUT THE BLOOD DRAW.
THERE WAS A PICTURE OF A LIVER
TO SAY YOU CAN USE THINGS AND IS
SOMETHING I ENCOUNTER WHEN FOLKS
ARE STARTING TO RIGHT A CONSENT
FORM.
USE DIFFERENT WORDS TO CONVEY
THE SAME POINT.
IT GETS BORING IF YOU USE THE
SAME WORD OVER AND OVER.
IN THIS CASE YOU WANT TO MAKE
SURE YOU'RE USING THE SAME WORDS
TO DESCRIBE THE THING ON PAGE 1
AS YOU'RE USING TO DESCRIBE IT
ON PAGE 2 BECAUSE THE PERSON
DESCRIBING ITS DIFFERENT LIE
LI --
DIFFERENTLY LIKE IS THIS WHAT
THEY TOLD ME ABOUT OR A
DIFFERENT THING?
KNOW YOUR AUDIENCE.
WE DON'T SPEND ENOUGH TIME AS
INVESTIGATORS PLANNING YOUR
PROTOCOL YOU LIKELY HAVE IN MIND
YOUR SAMPLE POPULATION AND WHO
IS THE AVERAGE PERSON IN THAT
SAMPLE POPULATION.
IF THE AVERAGE PERSON IS NOT
LITERATE, THAT'S VERY DIFFERENT
THAN THE AVERAGE PERSON IN YOUR
SAMPLE IS A CLINICAL
INVESTIGATOR AT THE NIH.
YOU'LL HAVE A VERY DIFFERENT
APPROACH WRITE AND CONVEY THAT
INFORMATION.
AND IT'S ALWAYS GOOD REGARDLESS
OF WHETHER THEY'RE NOT LITERAL
OR AN NIH INVESTIGATOR BUT
KNOWING YOUR AUDIENCE IS REALLY
IMPORTANT.
NO OFFENSE TO THE Ph.D.s IN THE
CLINICAL CENTER OR AUDIENCE BUT
YOU NEVER TOOK A CLASS CALLED
HOW TO WRITE A CONSENT FORM.
YOU TOOK CLASS TO PREPARE YOU TO
WRITE GRANT PROPOSALS, ARTICLES
PUBLISHED IN NIMHD,
PRESENTATIONS TO A WORLD WIDE
AUDIENCE.
YOU MAY NOT HAVE THE ABILITY AND
BE HUMBLE ABOUT NOT HAVING THE
ABILITY TO HAVE SOMEONE HELP YOU
OUT IN WRITING YOUR FORM.
SOMETIMES YOU CAN HAVE IT
REVIEWED BY A PATIENT OR I OFTEN
SAY I HAVE MY GRANDMOTHER REVIEW
IT OR SOMEONE IN YOUR LIFE WHO
IS PERHAPS MORE AVERAGE THAN YOU
BECAUSE YOU'RE AN NIMHD REVIEW
THE FORM AND CIRCLE THE WORDS
THEY DON'T UNDERSTAND.
IN TERMS OF FER -- FORMAT,
READABLE, USE LARGE POINTS AND
DOUBLE SPACE AND BLEND OF WHITE
SPACE AND TEXT.
I APPRECIATE THIS MAY MAKE
THINGS LONGER BUT IT'S ALSO
GOING TO MAKE IT MORE READABLE
AND NOT THE CASE CONSENT FORMS
INVEST RECENT PAST HAVE GONE
FROM 10 PAGES TO 20 PAGES
BECAUSE THEY'RE DOUBLE SPACING
THEM.
THEY'RE STILL SINGLE SPACED 10
PAGES NOW SINGLE SPACED 20 PLUS
PAGES.
I WANT TO GO TO UNDERSTAND.
I HAVE A GOAL OF MAKING ALL OF
YOU BELIEVERS IN WHAT I'M ABOUT
TO SHARE BECAUSE IT'S A REALLY
GOOD THOUGHTFUL WAY TO ASSESS
UNDERSTANDING.
AND UNDERSTANDING IS IMPROVED
WHEN PATIENTS OR SUBJECTS
VERBALIZE INFORMATION.
SO IF YOU ASK THEM AN OPEN-ENDED
QUESTION AND ASK THEM TO
VERBALIZE WHAT THE UNDERSTAND,
BECAUSE YOU CAN THEN INTERVENE
AND TALK FURTHER IT ACTUALLY
IMPROVES UNDERSTANDING.
AND UNDERSTANDING IS IMPROVED BY
ADMINISTERING QUIZZES AND
CORRECTING INCORRECT RESPONSES
BUT FRANKLY I THINK IT'S A BIT
OF TEACHING TO THE TEST.
LET'S SAY I GIVE ALEX THE WITH
QUIZ AND THE FIRST TIME HE GETS
IT RIGHT AND MY CUT OFF IS
SEVEN.
I COULD SAY SORRY, ALEX, YOU
CAN'T BE IN MY STUDY BUT A LOT
OF STUDIES SAY LET'S REVIEW WHAT
YOU GOT WRONG.
YOU SAID TRUE ON THESE AND THEY
ARE WERE FALSE.
LET'S GIVE YOU THE QUIZ AGAIN.
IF HE DOESN'T GET IT RIGHT THAT
TIME WE'LL BE CONCERNED.
I DON'T THINK IT'S A ROBUST WAY
OF ASSESSING UNDERSTANDING.
HERE'S WHAT I WANT YOU ALL TO
DO.
SO YOU'VE WRITTEN YOUR CONSENT
FORM AND READY TO OPEN YOUR
STUDY AND BRING FOLKS IN.
YOU'VE RECRUITED THEM AND NOW
SCHEDULING THEM.
I WANT YOU TO THINK ABOUT WHAT
FOR YOUR STUDY ARE THE MOST
IMPORTANT THINGS YOU WANT THIS
PERSON TO KNOW.
THESE ARE LIKELY SOME OF THE
THINGS YOU'LL WANT TO KNOW AND
WANT YOU TO PREPARE ANSWERS TO
THOSE QUESTIONS IF YOU ARE
ANSWERING THE QUESTION OR HAVING
REVIEWED THE FORM, HOW DO YOU
THINK YOU WOULD ANSWER THOSE
QUESTIONS SO YOU HAVE IN YOUR
MIND THIS IS THE MAYBE NOT THE
RIGHT ANSWER BUT AN ADEQUATE
RESPONSE TO MY QUESTION.
AND NOW YOU'RE READY TO ASK THE
PARTICIPANT AFTER YOU'VE GONE
THROUGH THE CONSENT FORM A
SERIES OF QUESTIONS LIKE THIS.
THEY'RE OPEN ENDED.
FOR EXAMPLE, IF YOU'RE GOING TO
GO HOME AND TELL A FRIEND ABOUT
THE STUDY WHAT THE STUDY'S
ABOUT, WHAT WOULD YOU SAY?
IT'S NOT SAYING TELLING ME ME
THE PURPOSE OF THE STUDY.
I WANT FOR THEIR WORDS FOR THEM
TO TELL ME WHAT THEY THINK
THEY'RE GETTING THEMSELVES INTO.
NOW, IF THEY SAY OH, GOSH, THIS
STUDY'S GOING TO CURE MY CANCER,
THAT MAY NOT BE TRUE.
THAT CREATES AN OPPORTUNITY FOR
YOU TO SAY, OH, THAT'S
INTERESTING YOU HEARD THAT.
LET ME TELL YOU -- IT'S ACTUALLY
NOT GOING TO CURE YOUR CANCER.
IT'S GOING TO DO X, Y OR Z AND
WE'LL SET ASIDE FOR A MOMENT THE
FOLKS WHO INSIST IT WILL CURE
THEIR CANCER AND ASSUME IT
HIGHLIGHTS SOMETHING THEY MAY
NOT UNDERSTAND.
BLAZE GOING TO HAPPEN TO YOU?
ARE YOU GOING TO GET MRI, PET
SCANS, BLOOD DRAW, ETCETERA.
IF THERE ARE PARTICULAR THINGS
ABOUT YOUR STUDY IT'S IMPORTANT
TO KNOW.
FOR EXAMPLE, LET'S SAY I'M DOING
A LONGITUDINAL STUDY AND NEED
PEOPLE TO COME IN AND THIS IS A
STUDY WE ALSO GOT A CONSULT
ABOUT THE OTHER DAY.
I'M GOING IT TAKE YOUR BLOOD
TODAY AND HAVE YOU COME BACK
EVERY WEEK AND I'M GOING TO
MEASURE A SUBSTANCE IN YOUR
BLOOD EVERY WEEK AND YOU'RE
GOING TO HAVE TO COME BACK EVERY
WEEK ANYTHING I CAN'T SEE THE
SUBSTANCE ANYMORE.
THE AVERAGE PERSON IS 10 WEEKS
BUT I HAD SOMEONE FOR WHOM IT'S
TAKEN 20 WEEKS.
ARE YOU READY AND DO YOU IS THIS
GOING TO WORK FOR YOU?
IF SOMEONE SAYS I'M GOING ON
VACATION FOR THREE WEEKS OR
GOSH, NO, IN A MONTH THEY'RE
SWITCHING JOBS AND WON'T BE AS
FLEXIBLE.
THEY MAY BE IMPORTANT.
IF THERE'S RANDOMIZATION THAT
PLAY BE SOMETHING MAKE SURE THEY
UNDERSTAND.
I WANT YOU TO ALL GO OUT AND USE
THIS APPROACH AND TELL ALL YOUR
FRIENDS ABOUT IT SO WE JUST
DIFFUSE THIS ACROSS THIS GLOBE.
THAT'S MY PLAN.
THAT'S IT FOR ME TODAY.
AND WE'LL BE BACK NEXT WEEK.
WE'LL TALK ABOUT STUDY DESIGN,
RISK BENEFITS AND SOCIAL VALUE
AND THEN DAVE WENDLER WILL TALK
ABOUT THAT AND SHIMA WILL JOIN
US FROM NORTHWESTERN AND HAVE A
LECTURE ABOUT THIS ENROLLMENT OF
KIDS SCOTT REFERENCED IN HIS
LECTURE IN THINKING ABOUT
MINIMAL RISK, MORE THAN MINIMAL
RISK, ETCETERA.
THANK YOU ALL.