WELCOME TO SESSION 5.
TODAY IS INFORMED CONSENT DAY.
WE'RE GOING TO START OFF WITH
DR. CHRISTINE GRADY, TWO QUICK
ANNOUNCEMENTS TODAY, THE WORD OF
THE DAY IS ASSENT, AND KATIE
TODDMAN, WHO WILL JOIN US FOR
THE CAPACITY ASSESSMENT AND
PRACTICE, CAN'T JOIN US.
HER COLLEAGUE CAROL SQUIRES IS
GOING TO JOIN US INSTEAD.
IT'S MY PLEASURE TO ONCE AGAIN
INTRODUCE DR. CHRISTINE GRADY,
CHAIR OF OUR DEPARTMENT OF
BIOETHICS AT THE CLINICAL CENTER
AT THE NIH.
HER FULL BIO I COULD NEVER COVER
TODAY IS LINKED IN THE FIRST
MODULE OF THE COURSE IF YOU'D
LIKE TO HEAR MORE.
I'M GOING TO HAND IT OVER TO
CHRISTINE.
THANK YOU.
>>GOOD MORNING.
BIG CROWDED AUDITORIUM.
I'M GOING TO TAKE MY MASK OFF SO
AT LEAST YOU GUYS CAN HEAR ME.
NICE TO BE BACK IN THE COURSE
AGAIN.
TODAY AS HOLLY SAID I'M GOING TO
TALK ABOUT INFORMED CONSENT.
SOMETHING THAT PEOPLE THINK
ABOUT ALL THE TIME WHEN THEY
THINK ABOUT ETHICS OF RESEARCH.
THE USUAL DISCLAIMER.
SO WHAT I THOUGHT I'D DO IN THE
TIME I HAVE IS A LITTLE BIT OF
SORT OF BASICS OF INFORMED
CONSENT, INCLUDING SOME OF THE
DATA ON HOW WE'RE DOING, SOME OF
THE CHALLENGES WITH RESPECT TO
INFORMED CONSENT IN THE RESEARCH
CONTEXT, AND THEN SOME OF THE
CHANGES IN RESEARCH AND IN THE
PROCESSES OF INFORMED CONSENT
THAT CREATED SORT OF NEW
CHALLENGES I GUESS, OR NEW
OPPORTUNITIES FOR CREATIVITY AND
LEARNING.
CONSENT IS A PRETTY COMMON THING
IN OUR LIVES, A POWERFUL THING.
AS PEOPLE SAY, MORAL AND LEGAL
PROTECTION FROM UNAUTHORIZED
INVASION OF ONE'S BODY AND
PROPERTY.
HAS A VERY STRONG TRANSFORMATIVE
OR FACILITATIVE MORAL POWER,
MAKING CERTAIN THINGS OKAY THAT
WITHOUT CONSENT WOULD NOT BE
OKAY.
ONE EXAMPLE, SOMEBODY ASKED TO
BORROW MY CAR, I GAVE MY
CONSENT, PERFECTLY FINE.
IF THEY TOOK MY CAR WITHOUT
ASKING, THAT WOULD NOT BE FINE,
THAT WOULD BE STEALING.
CONSENT IS WELL ENTRENCHED IN
THINGS WE DO IN LIFE, IN OUR
VALUES, JURISPRUDENCE, AND IN
OUR HEALTH CARE.
IN HEALTH CARE WE TAKE ABOUT
INFORMED CONSENT.
INFORMED CONSENT REQUIRES SOME
UNDERSTANDING OF WHAT THE
REQUEST IS.
SO THERE ARE A LOT OF
DEFINITIONS OF INFORMED CONSENT.
ONE IS AUTHORIZATION OF AN
ACTIVITY BASED ON UNDERSTANDING
WHAT THAT ACTIVITY ENTAILS.
IT IS A LEGAL AND REGULATORY AND
ETHICAL REQUIREMENT NOT ONLY IN
RESEARCH BUT IN MOST HEALTH
CARE.
INFORMED CONSENT IS REQUIRED IN
HEALTH CARE, AND MOST RESEARCH
WITH HUMAN SUBJECTS.
IT'S ALSO AND I'M SURE YOU'VE
HEARD THIS BEFORE, IT'S A
PROCESS.
IT'S A PROCESS OF REASONED
DECISION MAKING.
IT'S NOT A FORM.
IT'S NOT AN EPISODE ONE-TIME
THING.
IT'S A PROCESS OF LEARNING ABOUT
AND DECIDING ABOUT SOMETHING IN
HEALTH CARE OR RESEARCH.
AND RUTH FADEN AND TOM BEACHAM
WHO WROTE ONE OF THE MOST
IMPORTANT TREATISES,
UNFORTUNATELY NOW MORE THAN 30
YEARS OLD, CALLED IT AUTONOMOUS
AUTHORIZATION, THE IDEA THE
PERSON WHO HAS THE CAPACITY TO
BE AUTONOMOUS UNDERSTANDS WHAT
THEY ARE BEING ASKED TO DO AND
AUTHORIZES IT ON THAT BASIS.
SO,ETICALLY WE THINK ABOUT
INFORMED CONSENT AS BEING BASED
ON A PRINCIPLE OF RESPECT FOR
AUTONOMY OR PERSONS, RESPECT FOR
INDIVIDUAL'S CAPACITY AND RIGHT
TO DEFINE THEIR OWN GOALS AND
MAKE CHOICES CONSISTENT WITH
THOSE GOALS.
IN THE BELMONT REPORT WHICH
YOU'VE HEARD ABOUT ALREADY SAYS
THEY SUCCINCTLY, RESPECT FOR
PERSONS REQUIRES SUBJECTS TO THE
DEGREE THEY ARE CAPABLE BE GIVEN
THE OPPORTUNITY TO CHOOSE WHAT
SHALL OR SHALL NOT HAPPEN TO
THEM.
AND THAT OPPORTUNITY IS PROVIDED
WHEN INFORMED CONSENT IS
SATISFIED.
SO, HOLLY SAID THE WORD OF THE
DAY IS ASSENT.
THEY ARE BOTH BASED UPON AN IDEA
OF RESPECT FOR PERSONS.
A WAY WE RESPECT PERSONS WHEN WE
ASK FOR THEIR ASSENT.
A DISTINCTION BETWEEN THE TWO,
PEOPLE WHO DO NOT HAVE THE
CAPACITY OR AUTHORITY TO GIVE
CONSENT ARE ASKED FOR THEIR
ASSENT IN THE PROCESS OF
RESEARCH.
THERE'S STILL SOME ASKING THEM
FOR SOME AGREEMENT.
THERE'S GOT TO BE SOME
UNDERSTANDING, A LITTLE BIT,
ABOUT WHAT THEY ARE DOING, BUT
NOT NECESSARILY THE CAPACITY TO
UNDERSTAND WHAT THE SORT OF
TOTAL ASK IS, IN OTHER WORDS
WHAT THE STUDY IS THEY ARE BEING
ASKED TO THINK ABOUT AND DECIDE
ABOUT.
WE THINK ABOUT ASSENT PRIMARILY
WITH CHILDREN, CHILDREN WHO DO
NOT BY LAW REALLY OR REGULATION
AS WELL, BUT BY LAW, HAVE THE
AUTHORITY TO CONSENT FOR
THEMSELVES.
AND SO WHEN WE ENROLL CHILDREN
IN RESEARCH, WHENEVER POSSIBLE
WE ASK FOR THEIR ASSENT AND
THEIR PARENTS' PERMISSION OR
GUARDIAN'S PERMISSION TO ENROLL
THEM.
ASSENT IS AN IMPORTANT CONCEPT
WHEN THINKING ABOUT ADULTS WHO
DON'T HAVE THE CAPACITY TO
CONSENT FOR THEMSELVES BECAUSE,
AGAIN, IT'S A SIGN OF RESPECT
FOR WHAT CAPACITIES THEY DO
HAVE.
I UNDERSTAND SCOTT IS COMING IN
THE NEXT HOUR TO TALK ABOUT
CAPACITY.
SO, IN RESEARCH AND CLINICAL
RESEARCH, INFORMED CONSENT MAYBE
HAS A LITTLE BIT MORE WEIGHT I
GUESS IS THE WAY I WOULD SAY IT
THAN IN HEALTH CARE FOR THE
FOLLOWING REASON.
THAT THE GOAL OF RESEARCH IS TO
PRODUCE KNOWLEDGE THAT WILL
BENEFIT OTHERS, AND NOT
NECESSARILY BENEFIT THE
PARTICIPANT THEMSELVES.
THERE IS A SPECIAL ETHICAL
IMPORTANCE TO -- AGAINST USING
PEOPLE FOR THE BENEFIT OF OTHERS
WITHOUT THEIR VALID CONSENT.
AND THEREFORE, CONSENT, THE
CONTEXT OF RESEARCH, GIVES US
THE PERMISSION TO USE PEOPLE FOR
THE BENEFIT OF OTHERS BASICALLY
IS WHAT WE'RE ASKING PEOPLE TO
DO.
THE CONNOTATION OF GUINEA PIG IS
OFTEN USED IN RESEARCH, BUT ONCE
A PERSON GIVES CONSENT, THEY ARE
NO LONGER A GUINEA PIG.
THEY ARE MORE A PARTNER IN THE
PROCESS.
I THINK ALSO INFORMED CONSENT
ALTHOUGH MANY PEOPLE THINK ABOUT
IT AS A VERY ESSENTIAL PART OF
ETHICAL RESEARCH, I HOPE THAT AT
THIS POINT IN SESSION 5 YOU KNOW
IT'S ONLY ONE ASPECT OF
CONDUCTING ETHICAL CLINICAL
RESEARCH.
IN FACT, THE FRAMEWORK THAT WE
USE AND THIS COURSE IS BASED ON
IS LIKE THE SEVENTH OUT OF EIGHT
IN SEQUENTIAL ORDER.
SO YOU DON'T EVEN GO TO ASK
PEOPLE FOR THEIR INFORMED
CONSENT UNTIL ALL OF THE OTHER
THINGS ARE SATISFIED.
INFORMED CONSENT IN CLINICAL
RESEARCH IS REQUIRED BY
VIRTUALLY EVERY CODE OF RESEARCH
ETHICS, BY THE REGULATIONS, BY
THE LAWS.
THERE ARE SOME EXCEPTIONS, SOME
EXCEPTIONS IN THE COMMON RULE
AND FDA REGULATIONS, THAT ALLOW
FOR WAIVING INFORMED CONSENT OR
ALTERING INFORMED CONSENT,
IMPORTANT THOSE OF YOU IN THE
WORLD NEED TO KNOW ABOUT.
IN FDA THERE'S EXCEPTION FOR
EMERGENCY RESEARCH BUT A NUMBER
OF OTHER CONTINGENCIES THAT NEED
TO BE SATISFIED WHEN EMERGENCY
RESEARCH IS BEING CONDUCTED.
ICH-GCP PROMINENTLY REQUIRES
INFORMED CONSENT FOR ALL
RESEARCH, SO DOES DECLARATION OF
HELSINKI, CIOMS, AND A LOT OF
NATIONAL, STATE, INSTITUTIONAL
EMPHASIZE THE REQUIREMENT FOR
INFORMED CONSENT.
IN 45 CFR 46 COMMON RULE, NO
INVESTIGATOR MAY INVOLVE A HUMAN
BEING AS A SUBJECT IN RESEARCH
UNLESS THE INVESTIGATOR HAS
OBTAINED THE LEGALLY EFFECTIVE
INFORMED CONSENT OF THE SUBJECT
OR THE SUBJECT'S LEGALLY
AUTHORIZED REPRESENTATIVE.
REALLY IMPORTANT.
THERE ARE LIMITED EXCEPTIONS IN
THE REGULATIONS THAT GO ON TO
TALK ABOUT THOSE BUT I'M NOT
GOING TO TALK ABOUT THAT NOW.
REGS SAY INFORMED CONSENT HAS TO
BE SOUGHT PROSPECTIVELY AND THEN
DOCUMENTED.
THE FDA PUT OUT A GUIDANCE IN
2014 WHICH IS VERY COMPREHENSIVE
ABOUT INFORMED CONSENT, AND THIS
EXPLAINS AS MANY OF THE
LITERATURE AND MANY OF THE OTHER
REGULATIONS AND GUIDANCES DO
THAT INFORMED CONSENT HAS A
NUMBER OF PARTS TO IT.
SO IT INVOLVED PROVIDING A
POTENTIAL SUBJECT WITH
INFORMATION, ADEQUATE
INFORMATION, TO ALLOW FOR A
DECISION, FACILITATING THEIR
COMPREHENSION OF THAT
INFORMATION, PROVIDING
OPPORTUNITY FOR QUESTIONS AND
COMMENTS OR DISCUSSION, AND THEN
OBTAINING THEIR VOLUNTARY
AGREEMENT.
SO THESE ARE THE THREE PARTS OF
CONSENT THAT I'M GOING TO FOCUS
ON.
PROVIDING INFORMATION OR
DISCLOSURE, COMPREHENSION OR
UNDERSTANDING OF THAT
INFORMATION, AND VOLUNTARY
AGREEMENT.
IN ADDITION TO THOSE THREE,
THERE ARE -- THERE'S A THRESHOLD
THAT PEOPLE HAVE TO HAVE THE
CAPACITY TO CONSENT.
THERE HAS TO BE AN EVALUATION OF
WHETHER OR NOT THEY HAVE THE
CAPACITY TO UNDERSTAND AND MAKE
DECISIONS.
SCOTT WILL TALK ABOUT THAT IN
THE NEXT HOUR.
I WILL SAY THAT FOR THE MOST
PART, FOR ADULTS, WE JUST ASSUME
THEY HAVE THE CAPACITY UNLESS WE
HAVE SOME INDICATION THERE'S --
THAT THEY MIGHT, AND THEN
THERE'S A CAPACITY ASSESSMENT.
THE OTHER PART OF CONSENT, WHICH
IS IMPORTANT, BUT I'M NOT
GROWING TO TALK ABOUT, IS
AUTHORIZATION.
SO I MENTIONED ALREADY FROM THE
REGULATIONS THAT THEY REQUIRE
DOCUMENTATION OF A PROSPECTIVELY
SOUGHT CONSENT.
THAT'S USUALLY IN THE FORM OF A
SIGNATURE ON A CONSENT DOCUMENT
OR IN A CONSENT APPLICATION,
ONLINE THESE DAYS, BUT IT'S AN
INDICATION OF THE AUTHORIZATION.
SHORT OF A WRITTEN INDICATION OF
AUTHORIZATION, THERE ARE TIMES
WHEN IT'S A VERBAL OR AN ORAL
CONSENT AUTHORIZATION THAT ALSO
NEEDS TO BE DOCUMENTED.
BUT I'M NOT GOING TO TALK MORE
ABOUT THAT.
WHAT ABOUT DISCLOSURES?
THERE'S AN INTERESTING QUESTION,
WHAT INFORMATION SHOULD BE
DISCLOSED?
WHAT IS ADEQUATE INFORMATION FOR
SOMEBODY TO BE ABLE TO
UNDERSTAND WHAT YOU'RE ASKING
THEM TO DO IN THE SETTING OF A
RESEARCH STUDY, AND USE THAT
INFORMATION TO MAKE DECISIONS.
WHAT'S RELEVANT TO THEM?
IT'S A CHALLENGING QUESTION
BECAUSE ANY OF YOU INVOLVED IN
RESEARCH KNOW THERE'S A LOT OF
COMPLEXITY TO CERTAIN KINDS OF
RESEARCH STUDIES.
THE QUESTION I'LL TELL YOU ONE
STORY YEARS AGO, CALLED FOR
CONSULT ABOUT A PATIENT WHO THE
FELLOW THOUGHT DID NOT HAVE THE
CAPACITY TO CONSENT.
AND WHEN WE WENT UP TO SPEAK TO
THIS PATIENT, SHE BASICALLY
UNDERSTOOD WHAT THE STUDY WAS
ABOUT, WHAT SHE HAD TO DO, AND
WHAT THE RISKS WERE.
WHAT SHE DIDN'T KNOW WAS THE
NAME OF THE DRUG, THE MECHANISM
OF THE DRUG, SORT OF THE DETAILS
OF WHAT WAS HAPPENING.
HE THOUGHT THAT THAT WAS
INADEQUATE IN TERMS OF HER
UNDERSTANDING OR HER DISCLOSURE
AND UNDERSTANDING.
BUT THEY TOLD HER THE NAME.
THEY TOLD HER THE MECHANISM,
THAT WASN'T RELEVANT TO HER.
THERE'S ALSO A QUESTION ABOUT
HOW THE INFORMATION ONCE ONE
DETERMINES WHAT'S ADEQUATE
INFORMATION TO DISCLOSE, HOW IT
SHOULD BE PRESENTED.
SO THAT IT IS THE MOST
UNDERSTANDABLE TO THE PEOPLE
THAT YOU ARE PRESENTING IT TO,
CONSIDERING THEIR CIRCUMSTANCES,
THEIR SETTING, AND THE
POPULATION THAT YOU'RE TALKING
TO.
AND THERE ARE LOTS OF
INTERESTING QUESTIONS HERE.
YOU KNOW, WE WORK IN RESEARCH
OFTEN WITH PEOPLE WHO ARE QUITE
ILL.
WE WORK IN RESEARCH WITH PEOPLE
WHO ARE IN UNUSUAL
CIRCUMSTANCES.
WHO ARE UNDER A FAIR AMOUNT OF
DISTRESS.
CONSIDERING THOSE KINDS OF
THINGS ACTUALLY IS IMPORTANT
WHEN WE'RE THINKING ABOUT WHAT
KIND OF INFORMATION, HOW MUCH
INFORMATION, AND HOW TO PRESENT
INFORMATION.
THE REGULATIONS GO ON TO SAY
THAT THE INFORMATION GIVEN TO
THE SUBJECT SHOULD BE IN
LANGUAGE THAT'S UNDERSTANDABLE
TO THE SUBJECT, BUT IN THE MORE
RECENT REVISIONS TO THE COMMON
RULE QUALIFY THAT BY SAYING
UNDERSTANDABLE IN THE WAY THAT A
REASONABLE PERSON WOULD WANT TO
HAVE.
SO, THERE'S A SORT OF REASONABLE
PERSON STANDARD IN TERMS OF
UNDERSTANDING WHAT A PARTICULAR
INDIVIDUAL MIGHT NEED TO KNOW.
THAT REASONABLE PERSON STANDARD
GUIDES THE SORT OF SCRIPT THAT
INVESTIGATORS USE, THE CONSENT
AS IT IS WRITTEN OUT OR PROVIDED
ELECTRONICALLY.
BUT THERE MAY BE THINGS THAT A
PARTICULAR PERSON NEEDS TO KNOW
THAT ARE ABOVE AND BEYOND WHAT
THE REASONABLE PERSON WANTS TO
KNOW.
THE REGULATIONS ALSO GO ON TO
SAY THAT THE CONSENT, SINCE
AGAIN THE REVISIONS TO THE
COMMON RULE IN 2018 HAVE TO
BEGIN WITH A CONCISE AND FOCUSED
PRESENTATION OF THE KEY
INFORMATION THAT'S LIKELY TO
GIVE A PERSON REASONS WHY THEY
MIGHT OR MIGHT NOT WANT TO
PARTICIPATE.
SO, CONCISE AND FOCUSED
ORGANIZED IN A WAY THAT
FACILITATES COMPREHENSION BUT IN
SUFFICIENT DETAIL THAT THEY CAN
UNDERSTAND WHAT THE DETAILS ARE.
AND SO THIS IS A CHALLENGE, AND
I THINK WE'RE STILL WORKING ON
HOW WE DO THIS IN EACH CASE,
WITH CONSENT FORMS, FOR EXAMPLE.
ALSO THERE'S LOTS OF GUIDANCE
THAT SUGGESTS CONSENT FORMS,
WRITTEN FORMS OR, AGAIN, ONLINE
FORMS, SHOULD BE READABLE AND
UNDERSTANDABLE.
THAT INCLUDES ANYTHING THAT THE
PARTICIPANTS OR POTENTIAL
PARTICIPANTS ARE PROVIDED LIKE
ADS OR PAMPHLETS OR FLYERS THAT
MIGHT BE ACCOMPANYING OR
PRECEDING THE PROCESS OF MAKING
A DECISION.
THOSE ARE ALL IMPORTANT PARTS OF
GIVING PEOPLE INFORMATION.
AND THOSE ALL NEED TO BE
APPROVED BY THE REVIEWING IRB OR
IRBs.
REASON TO BELIEVE AND EVIDENCE
TO SHOW THAT THE LENGTH OF
CONSENT FORMS, THE FORMAT, THE
READING LEVEL AND COMPLEXITY ARE
ALL IMPORTANT IN TERMS OF
DISCLOSING INFORMATION.
SO IMAGINE JUST FOR A SECOND A
PAGE OF INFORMATION WITH NO
HEADINGS AND NO SORT OF MARGINS
OR VERY MINIMAL MARGINS, HOW
HARD THAT IS TO READ, AS OPPOSED
TO A PAGE OF INFORMATION THAT
HAS HEADINGS AND MARGINS AND
MAYBE GRAPHICS, THAT'S THE KIND
OF DISTINCTION THAT I THINK IS
IMPORTANT TO THINK ABOUT BECAUSE
IT DOES MAKE A DIFFERENCE IN HOW
PEOPLE READ IT AND UNDERSTAND
IT.
THERE'S ALSO QUESTIONS ABOUT FOR
THE CONSENT FORM ITSELF HOW
OFTEN IS IT USED IN THE
DISCUSSION?
SO CONSENT DISCUSSIONS ALWAYS
ACCOMPANY WRITTEN INFORMATION OF
ANY KIND.
AND SO DOES THE DISCUSSION
FOLLOW THE SORT OF WRITTEN
INFORMATION WORD FOR WORD?
IS IT MORE SYNTHESIS OF THAT
INFORMATION?
IS IT USING THAT INFORMATION AND
PROVIDING GRAPHICS OF SOME SORT,
VISUAL MATERIAL OF SOME SORT?
OR SOME COMBINATION.
AND THOSE ARE ALL DECISIONS THAT
NEED TO BE MADE ABOUT DISCLOSING
INFORMATION IN THE PROCESS OF
INFORMED CONSENT.
IT'S IMPORTANT TO REMEMBER THAT
UNFORTUNATELY HEALTH LITERACY IS
NOT GREAT.
THIS CAME FROM THE FDA CONSENT
GUIDANCE SHEET THAT I MENTIONED
ALREADY.
BASICALLY SAYING THAT IN THE
UNITED STATES ANYWAY, ONE-THIRD
OF ADULTS OR 77 MILLION PEOPLE
HAVE BASIC OR BELOW BASIC HEALTH
LITERACY.
AND THIS GOES ACROSS ALL RACIAL
AND ETHNIC GROUPS.
I DON'T KNOW THE DATA FROM OTHER
COUNTRIES BUT I SUSPECT IT'S
PROBABLY SIMILAR.
WORSE IS QUANTITATIVE, HALF OR
BELOW HALF HAVE QUANTITATIVE
LITERACY.
WHEN THINKING ABOUT PRESENTING
INFORMATION IN THE PROCESS OF
INFORMED CONSENT, SOME IS
PROBABILITY OR NUMERICAL DATA,
THINK ABOUT THE WAY IN WHICH
PEOPLE WHO DON'T HAVE
QUANTITATIVE LITERACY CAN
UNDERSTAND THAT.
OR CAN'T UNDERSTAND THAT.
THERE ARE SOME GUIDANCES ABOUT
HOW TO WRITE CONSENT FORMS.
THIS IS ALL PRETTY
STRAIGHTFORWARD AND ANYBODY WHO
HAS WRITTEN OR HAS LEARNED
ABOUT, YOU KNOW, HOW TO WRITE
FOR LAY AUDIENCES SHOULD THINK
ABOUT THESE KINDS OF RULES,
USING FAMILIAR AND CONSISTENT
VOICE, ACTIVE VOICE, PERSONAL
PRONOUNCE, SHORT SIMPLE
SENTENCES, SHORT PARAGRAPHS.
LOGICALLY SEQUENCED IDEAS,
AVOIDING ACRONYMS, AND FORMAT
WHICH I ALREADY MENTIONED.
SO HOW ARE WE DOING ON THIS?
WHEN WE LOOK AT CONSENT FORMS,
THESE ARE DATA THAT CAME FROM A
NUMBER OF DIFFERENT STUDIES
ACROSS TIME, I EASTBOUND --
EVEN WAS LOOKING FOR SOMETHING
RECENT.
READING LEVEL IN CONSENT FORMS
IS USUALLY HIGH EVEN THOUGH WE
KNOW THERE'S A HEALTH LITERACY
ISSUE AND THAT MANY OF THE
GUIDANCES THAT DO EXIST ABOUT
CONSENT SAY WE SHOULD BE WRITING
FORMS AT EIGHTH GRADE LEVEL.
WHEN STUDIES LOOKED AT CONSENT
FORMS OR TEMPLATES, THEY ARE
OFTEN WRITTEN MORE AT AN
ELEVENTH GRADE LEVEL OR HIGHER.
THEY ARE ALSO LONG.
THEY HAVE BEEN GETTING LONGER
OVER TIME.
IF YOU LOOK AT CONSENT FORMS
FROM 30 YEARS AGO YOU CAN FIND
SOME THAT ARE FIVE PAGES LONG.
NOW THEY ARE 25 PAGES LONG OR
SOMETIMES LONGER.
AND SOME STUDIES HAVE LOOKED AT
EVEN LONG AND COMPLEX DO THEY
INCLUDE ALL THE KINDS OF
INFORMATION THAT THE REGULATIONS
REQUIRE OR THAT MIGHT BE
RELEVANT TO PEOPLE PARTICIPATING
IN A PARTICULAR STUDY.
STUDIES ON THAT ANGLE FOUND
THERE ARE THINGS MISSING DESPITE
THE LENGTH AND COMPLEXITY; THEY
ARE MISSING IMPORTANT THINGS.
I'VE MENTIONED PRESENTATION AND
SETTING.
ONE INTERESTING CHALLENGE FOR
PEOPLE DOING RESEARCH IS NOT
ONLY PRESENTING INFORMATION AT
THE TIME TO THE PERSONS THEY ARE
SPEAKING TO BUT IS THAT IN
PERSON -- SORRY, IS THAT
INDIVIDUAL, IS THAT IN A GROUP,
IS IT BOTH, SHOULD THERE BE
WRITTEN INFORMATION FIRST,
SHOULD THERE BE VISUAL
INFORMATION FIRST?
MAYBE TIMES RESEARCH TEAMS SEND
OUT INFORMATION TO PROSPECTIVE
PARTICIPANTS BEFORE THEY COME TO
A CLINIC GIVING PEOPLE A HEADS
UP AND ALLOWED THEM TO TALK TO
PEOPLE THEY TRUST TO HELP THEM
EXPLAINING EXPLAIN THINGS.
I MENTIONED PEOPLE WHO ARE SICK,
CONFUSED, IN DISTRESSED.
I MENTIONED CHALLENGES TO
WRITING AND PRESENTING CONSENT
INFORMATION IN ACCESSIBLE
UNDERSTANDABLE WAYS THAT'S
RELEVANT TO PEOPLE WHO YOU'RE
SPEAKING TO.
NATHANIEL HAWTHORNE SAID A LONG
TIME AGO, EASYING READING IS
DAMN HARD WRITING.
IT'S EASIER TO WRITE A LONGER
PIECE THAN SHORTER PIECE, TO
REALLY FOCUS AND GET IT RIGHT IS
NOT EASY.
THE WRITTEN INFORMED CONSENT
INFORMATION NOT ONLY PROVIDES
INFORMATION TO THE PROSPECTIVE
PARTICIPANTS BUT PROTECTS THE
SPONSOR, MORE INFORMATION TO
PROTECT AGAINST LIABILITY AND
RECOGNIZING MORE INFORMATION
OFTEN MAKES THINGS HARDER TO
UNDERSTAND.
IT'S ALSO INTERESTING, IRBs
HAVE HAVE WANTED CONSENT FORMS
FOR UNDERSTANDABLE BUT THEY ARE
OFTEN REQUIRING MORE INFORMATION
MAKING FORMS LONGER AND MORE
COMPLEX.
SO, DISCLOSING INFORMATION IS
IMPORTANT PART.
NOW THE QUESTION AND THE PURPOSE
AS WE DESCRIBED IS SO PEOPLE CAN
UNDERSTAND AND MAKE A DECISION
BASED ON IT.
SO, THERE HAVE BEEN A NUMBER OF
STUDIES OTHER THE YEARS THAT
LOOKED AT HOW WELL DO PEOPLE WHO
ARE PARTICIPANTS IN RESEARCH
UNDERSTAND WHAT THEY HAVE
DON'TED TO BASICALLY, WHAT THEY
HAVE SIGNED THEIR CONSENT FOR.
AND THE STUDIES, THE ONES AT THE
TOP ALL ARE SORT OF
META-ANALYSES OR SYSTEMATIC
REVIEWS THAT LOOKED AT CONSENT
STUDIES ACROSS A WIDE SPECTRUM
AND COME UP WITH THIS PRETTY
UNSATISFACTORY CONCLUSION THAT
PEOPLE HAVE A VARIABLE
UNDERSTANDING.
BUT VARIABLE MEANING NOT AS GOOD
AS WE WOULD HOPE IN TERMS OF
WHAT WE'RE TRYING TO ACHIEVE IN
THE PROCESS OF INFORMED CONSENT.
IF YOU LOOK AT THE PARTICULAR
STUDIES YOU CAN SEE IN TERMS OF
SPECIFIC THINGS LIKE
UNDERSTANDING RESEARCH PURPOSE
AND NATURE, SOME STUDIES FIND AS
LOW AS 20% OF PEOPLE IN THE
STUDIES UNDERSTAND THE PURPOSE
AND NATURE OF THE RESEARCH THAT
THEY ARE IN.
IN OTHER STUDIES IT'S UP TO
100%.
SAME WITH RESEARCH RISK.
SOME STUDIES IN THE 20s.
AND I HAVE TO SAY THERE ARE SOME
REASONS THAT THESE DATA ARE
DIFFICULT TO PUT TOGETHER IN THE
FOLLOWING SENSE, SOME STUDIES
ASK CAN YOU RECALL RISKS THAT
THEY DISCLOSE TO YOU?
AND ASK FOR PEOPLE TO RECALL.
OTHERS, YOU KNOW, GIVE
PARTICIPANTS A LIST AND SAY
CHOOSE THE ONES YOU HEARD ABOUT.
AND OF COURSE PEOPLE DO BETTER
ON THE SECOND STYLE THAN THE
FIRST STYLE.
IT ALSO MATTERS WHEN QUESTIONS
ARE ASKED BUT THE GENERAL IDEA
IS THERE'S A REAL CHANGE IN
TERMS OF WHAT PEOPLE UNDERSTAND.
CONSISTENTLY IN EVERY STUDY
THAT'S ASKED ABOUT IT, THE KINDS
OF THINGS THAT PEOPLE HAVE THE
HARDEST TIME UNDERSTANDING ARE
THINGS LIKE RANDOMIZATION,
COMMON USED IN RESEARCH, PEOPLE
HAVE A HARD TIME UNDERSTANDING
WHAT IT MEANS AND HOW IT APPLIES
TO THEM.
THE OTHER THING THAT COMES IN
SOME STUDIES IS PLACEBO USE.
A LOT OF PEOPLE DON'T UNDERSTAND
THAT EITHER.
SO THE PERCENTAGE OF PEOPLE THAT
UNDERSTAND RANDOMIZATION AND
PLACEBO IS MUCH LOWER ACROSS THE
BOARD.
THIS IS FROM THE META-ANALYSIS
TAM AND COLLEAGUES PUBLISHED A
FEW YEARS AGO.
WHAT'S INTERESTING IS TWO
THINGS.
ONE IS THAT NOTHING IS MORE THAN
75%.
SO NO -- UNDERSTANDING OF
NOTHING, 1 OUT OF 4 PEOPLE IN
RESEARCH DON'T UNDERSTAND ANY OF
THIS.
THE OTHER THING IS TO LOOK AT
THE LIST ON THE LEFT.
I THINK THERE ARE THINGS ON THIS
LIST THAT ARE PROBABLY MORE
IMPORTANT TO UNDERSTAND THAN
OTHERS.
SO CERTAINLY YOU WANT PEOPLE TO
UNDERSTAND THE RISKS OF WHAT
THEY ARE BEING ASKED TO DO.
YOU WANT PEOPLE TO UNDERSTAND
THAT THEY CAN WITHDRAW IF THEY
DON'T WANT TO DO IT OR SAY NO IF
THEY DON'T WANT TO DO IT.
AND NONE OF THOSE THINGS
APPROACH 100%.
SO, IT'S ALSO INTERESTING TO
THINK ABOUT WHAT AFFECTS
UNDERSTANDING.
WHY DO PEOPLE HAVE A HARD TIME
UNDERSTANDING SOME DETAILS OF
THE RESEARCH THEY ARE IN?
CERTAINLY THERE ARE HOST
FACTORS.
THERE'S BEEN DATA TO SHOW, FOR
EXAMPLE, AGE MATTERS.
EDUCATION MATTERS.
PEOPLE IN PAIN OR HAVE COGNITIVE
IMPAIRMENT CAPACITY, LITERACY,
ALL OF THOSE THINGS CAN AFFECT
WHAT A PERSON ABSORBS FROM
INFORMATION, HOW WELL THEY
UNDERSTAND IT.
I THINK IMPORTANTLY AND PROBABLY
LESS WELL DOCUMENTED BUT SEEMS
TO ME ACTUALLY PROBABLY MORE
INFLUENTIAL IS THIS WHOLE
CATEGORY OF WHAT I'M CALLING
EXPECTATIONS AND FAMILIARITY.
THE PEOPLE HAVE A VARIETY OF
DIFFERENT MOTIVATIONS FOR
PARTICIPATING, IN A RESEARCH
STUDY.
IF THEY ARE DRIVEN TO
PARTICIPATE IN A RESEARCH
STUDIES BECAUSE THEY THINK THAT
THE INTERVENTION BEING TESTED IN
THIS STUDY IS GIVING THEM THE
BEST OPTION FOR TREATMENT, AND
THEY DON'T HAVE VERY MANY OTHER
OPTIONS, THEN THEY ARE LESS
INTERESTED IN UNDERSTANDING THE
DETAILS OF THE PARTICULAR STUDY
BECAUSE THEY HAVE ALREADY MADE
THAT SORT OF EXPECTATION OF
THEIR MOTIVATIONS TO BE
BENEFITED.
THERE'S BEEN -- WE DID A STUDY
WITH PARTICIPANTS IN CANCER
CLINICAL TRIALS, AND ALMOST 50%
OF THE PEOPLE IN THE TRIAL, IN
OUR STUDY, EXCUSE ME, SAID THEY
DIDN'T PAY ATTENTION TO THE
RISKS AND BENEFITS OF THE STUDY
BECAUSE THEY WANTED THE BENEFIT
AND TRUSTED IN THEIR PROVIDER
WHO TOLD THEM THIS IS YOUR BEST
OPTION.
SO THEY DIDN'T BOTHER TO READ
THE DETAILS.
THERE ARE ALSO CHALLENGES
RELATED TO CULTURAL VIEWS, HOW
PEOPLE UNDERSTAND WHAT RESEARCH
IS AND WHY RESEARCH IS BEING
DONE, OR THAT RESEARCH IS, AND
THOSE CREATE CHALLENGES TO
UNDERSTANDING.
ANOTHER EXAMPLE OF A CONSULT WE
HAD WHERE THE INTERVENTION
ITSELF WAS BASICALLY STANDARD
CARE, AND THEY WERE -- THE
RESEARCH PART OF THE STUDY WAS
TAKING PART OF THE TUMOR THAT
WAS GOING TO BE SURGICALLY
REMOVED AND STUDYING THE TISSUE
IN THE LABORATORY.
AND THE FAMILY OF THE PERSON WHO
WAS GOING TO HAVE THE SURGERY
WAS JUST LIKE, RESEARCH, NO, WE
DON'T DO RESEARCH.
AND SORT OF PARSING OUT THAT
THIS WAS THE KIND OF CARE THAT
SHE WOULD GET ANYWHERE, BUT THAT
THEY WERE JUST GOING TO LOOK AT
HER TISSUE IN THE LABORATORY
AFTERWARDS WAS VERY DIFFICULT
BECAUSE ALL THEY HEARD WAS
RESEARCH AND DIDN'T WANT HER TO
BE EXPERIMENTED ON.
PEOPLE ALSO HAVE WHAT HAS BEEN
TERMED THERAPEUTIC
MISCONCEPTION, BASICALLY JUST
MISUNDERSTANDING THAT RESEARCH
IS DONE FOR THEM.
IT CAME FROM A -- PAUL APPLEBAUM
AND COLLEAGUES STUDYING
PARTICIPANTS WITH SCHIZOPHRENIA
AND INTERVIEWED THEM AFTER
CONSENT FOR THE TRIAL.
A LARGE PERCENTAGE SAID, YES, I
UNDERSTAND THIS IS A RESEARCH.
YES, I UNDERSTAND THEY ARE
RANDOMIZING.
YES, I UNDERSTAND THERE'S
PLACEBO INVOLVED.
OH, NO, MY DOCTOR WOULD NOT LET
ME HAVE PLACEBO.
THEY ARE GOING TO GIVE ME THE
INTERVENTION.
SO, IT WAS A MISUNDERSTANDING OF
THE INTENT OF RESEARCH AS
APPLIED TO THE PERSON.
THERE ARE ALSO OF COURSE A LOT
OF PROCESS-RELATED FACTORS.
YOU CAN IMAGINE UNDERSTANDING IS
INFLUENCED BY WHAT IS DISCLOSED
AND HOW THINGS ARE DISCLOSED AND
WHO DISCLOSES IT.
AND HOW WELL THE PARTICIPANT
LISTENS.
ANOTHER EXAMPLE OF A CONSULT
MANY YEARS AGO, A YOUNG MAN WHO
WAS VERY ILL, VERY SCARED, AND
CAME FOR A PRETTY INTENSE
PROTOCOL WHICH INVOLVED LOTS OF
REALLY RISKY STUFF.
AND I'M NOT GOING TO GIVE YOU
MORE DETAILS THAN THAT.
HERE IS THE SCENARIO.
THIS IS HOW CONSENT SHOULD NOT
HAPPEN.
WE WERE IN THE CLINIC.
I WAS THERE WITH HIM.
WE WERE IN THE CLINIC, HE WAS
SITTING IN A CHAIR. THERE WERE
THREE INVESTIGATORS STANDING
OVER HIM GIVING HIM INFORMATION.
THEY GAVE HIM TONS OF
INFORMATION, REALLY CAREFULLY
DETAILED ALL OF THE PARTS OF THE
PROTOCOL AND WHAT WOULD HAPPEN
TO HIM .
IN THE MIDST OF GIVING HIM
INFORMATION, A PAGER WENT OFF,
IT WAS A CHAOTIC PRESENTATION OF
INFORMATION AS WELL BUT IT FELT
LIKE SORT OF A DUMP OF
INFORMATION ON THIS PERSON WHO
WAS SITTING DOWN UNDERNEATH
THESE THREE BIG -- NOT THAT BIG
BUT YOU KNOW WHAT I MEAN,
INVESTIGATORS.
INTIMIDATING.
AND IT JUST HAS ALWAYS STUCK IN
MY MIND AS THE WAY NOT TO GIVE
PEOPLE INFORMATION AND CERTAINLY
IT IMPACTED, AND SHOULD HAVE,
WHAT HE WAS ABLE TO ABSORB AND
UNDERSTOOD.
THERE ARE INTERESTING CHALLENGES
THAT HAVE NOT BEEN RESOLVED IN
THE RESEARCH ETHICS WORLD THAT
RELATE TO UNDERSTANDING IN THE
PROCESS OF INFORMED CONSENT.
ONE IS HOW IS OR HOW SHOULD
UNDERSTANDING BE ASSESSED.
SOMETIMES IN THE PROCESS OF
INFORMED CONSENT THE TEAM WILL
GIVE PEOPLE INFORMATION.
THEY WILL HAVE SENT INFORMATION.
THEY WILL HAVE TALKED TO FIVE
MEMBERS OF THE TEAM, HAVE READ
THE CONSENT FORM, AND THEN
SOMEBODY SAYS TO THE
PARTICIPANT, DO YOU HAVE ANY
QUESTIONS?
AND THE PERSON WHO SAYS NO, THE
ASSUMPTION IS THEY UNDERSTAND.
THAT RANGES FROM THAT MINIMAL
KIND OF ASSESSMENT TO THERE ARE
SOME STUDIES THAT HAVE,
ESPECIALLY RISKY STUDIES, THAT
HAVE BUILT-IN QUIZZES.
AFTER THE PERSON GETS
INFORMATION AND THEY HAVE TO
TAKE A QUIZ AND PASS BY 80% OR
MORE TO ENROLL IN THE STUDY.
THERE'S NO AGREEMENT ON WHAT'S
THE RIGHT WAY TO ASSESS
UNDERSTANDING.
THERE'S ALSO DISAGREEMENT ABOUT
HOW MUCH PARTICIPANTS SHOULD
UNDERSTAND.
I ALREADY TOLD YOU ABOUT THE
WOMAN WHO DIDN'T KNOW THE NAME
OF THE DRUG BUT THERE'S A LOT OF
INTERESTING LITERATURE ON IF WE
REALLY THINK PEOPLE NEED TO
UNDERSTAND XYZ WE SHOULDN'T
REALLY BE LETTING THEM IN THE
STUDY BECAUSE SO MANY PEOPLE
DON'T UNDERSTAND XYZ SO THERE'S
INTERESTING QUESTIONS ABOUT WHAT
SHOULD PEOPLE UNDERSTAND THAT
THERE'S SOME DISAGREEMENT ABOUT.
AND THEN WHAT HAPPENS OR WHAT
SHOULD HAPPEN WHEN A PARTICIPANT
DOESN'T UNDERSTAND, WHEN YOU'RE
ABLE TO SUSS OUT THAT
PARTICIPANTS DON'T.
A LOT OF PEOPLE WOULD SAY JUST
CATEGORICALLY IF THEY DON'T
UNDERSTAND ESSENTIAL ELEMENTS,
THEY SHOULDN'T BE ALLOWED TO
PARTICIPATE.
BUT, AGAIN, THAT'S A JUDGMENT
AND THAT'S CONTINGENT ON MAKING
A DECISION WHAT ARE ESSENTIAL
ELEMENTS THEY DO NEED TO
UNDERSTAND.
THERE'S BEEN WORK, A PAPER DAVE
WINDL ERICR WROTE TEN YEARS AGO,
THAT ARGUES, AND I AGREE, THE
THRESHOLD FOR WHAT SOMEBODY
UNDERSTANDS AS RISK OR NOVELTY
OF THE STUDY INCREASES.
SO THE RISKIER THE STUDY, THE
MORE WE WANT PEOPLE TO
UNDERSTAND ABOUT WHAT THEY ARE
BEING ASKED TO DO.
WHICH MAKES PERFECT SENSE.
AND HIS -- TO ME.
HIS PROPOSAL YOU ASSUME CAPACITY
FOR LOW OR MODERATE RISK BUT
NEED TO MEASURE FOR HIGH RISK,
ASSUME UNDERSTANDING FOR LOW
RISK MAYBE HAVE INFORMAL
ASSESSMENT FOR MEDIUM RISK, BUT
DO SOME KIND OF FORMAL
ASSESSMENT FOR HIGHER RISK OF
STUDIES.
AND, AGAIN, THE ASSESSMENT OF
VOLUNTARINESS WHICH I'LL GET TO
IN A MINUTE ANYWAY.
THERE ARE, I ALREADY MENTIONED,
THERAPEUTIC MISCONCEPTION, A
REALLY IMPORTANT CONCEPT IN
RESEARCH.
THERE ARE OTHER TYPES OF
MISUNDERSTANDING, IF YOU WILL,
IN TERMS OF RESEARCH.
A FELLOW AND I SORT OF DEFINED
THREE KINDS OF MISUNDERSTANDING,
ABOUT 20 YEARS AGO, WHICH HAS
GOTTEN A LOT OF ATTENTION.
MISCONCEPTION IS CERTAINLY ONE
OF THEM BUT NOT THE ONLY ONE.
SOMETIMES PEOPLE ACTUALLY DO
UNDERSTAND THEIR OWN RESEARCH
BUT HAVE A REALLY HIGH
EXPECTATION OF BENEFIT OR REALLY
UNDERESTIMATE OF RISK.
WE CALLED THAT MISESTIMATION.
AND THEN THERE ARE PEOPLE WHO
SEEM TO UNDERSTAND EVERYTHING
BUT SAY, I CAN REMEMBER A
PATIENT I TOOK CARE OF YEARS
AGO, I KNOW THIS IS RESEARCH,
YOU DON'T KNOW IF IT'S GOING TO
WORK, IT'S GOT A LOT OF RISKS
BUT I'M GOING TO BE THE ONE.
IT'S GOING TO HELP ME!
SO THAT KIND OF OPTIMISM IS
CERTAINLY UNDERSTANDABLE AND
SOME PEOPLE HAVE IT.
THERE'S A REALLY IMPORTANT
DISTINCTION AND UNDERSTANDING
BETWEEN KNOWLEDGE, PEOPLE BEING
ABLE TO SPIT BACK THE
INFORMATION THAT YOU'VE GIVEN
THEM BASICALLY, THEY UNDERSTAND
WHAT YOU'VE TOLD THEM, AND
APPRECIATING HOW IT APPLIES TO
THEM.
AND THAT'S THE SORT OF
MISUNDERSTANDING EXAMPLE I GAVE
YOU A LITTLE BIT AGO.
I'M GOING TO SKIP THIS SINCE I
ALREADY MENTIONED IT.
THERE'S BEEN A FAIR AMOUNT OF
STUDIES THAT HAVE BEEN DONE TO
TRY TO FIGURE OUT WAYS WE MIGHT
BE ABLE TO IMPROVE UNDERSTANDING
IN THE CONTEXT OF RESEARCH AND
INFORMED CONSENT.
THERE HAVE BEEN TWO, AGAIN,
SYSTEMATIC REVIEWS OF THESE
STUDIES.
ONE PUBLISHED IN 2004, ONE IN
2013, I WAS LOOKING FOR ONE MORE
RECENT.
I FOUND ONE THAT SORT OF
PARTIALLY DOES THIS, THAT WAS
PUBLISHED IN 2018, BUT IT'S NOT
QUITE AS COMPREHENSIVE AS THESE
TWO WERE.
BASICALLY THEY DIVIDED STUDIES
DONE INTO THESE CATEGORIES,
MULTIMEDIA, MEANING VIDEOTAPES
AND INTERACTIVE COMPUTERS,
ENHANCED CONSENT FORMS WHICH
MODIFIED THE LENGTH OF THE
FORMAT, EXTENDED DISCUSSION OF
THE TEAM WITH THE PARTICIPANT,
TEST FEEDBACK WHICH IS YOU GIVE
SOMEBODY A QUIZ AND IF THEY
DIDN'T GET 80% OR THE THRESHOLD
YOU EXPLAIN IT AGAIN AND SEE IF
THEY DO BETTER, AND THERE WAS
MIXED AND MISCELLANEOUS.
WHO WANTS TO GUESS WHICH WORKED
THE BEST?
ANY GUESSES?
RICH?
MIXED?
NO.
MULTIMEDIA?
NO.
HOLLY?
>>EXTENDED DISCUSSION.
IN THE STUDIES, IT WAS THE ONE
THAT WORKED THE BEST WHICH MEANT
THE MORE YOU TELL PEOPLE, THE
MORE YOU EXPLAIN, THE BETTER
THEY UNDERSTAND IT.
I THINK THERE NEEDS TO BE AN
UPDATE OF SYSTEMATIC REVIEW FOR
THE FOLLOWING REASON.
ANDREW JUST MENTIONED IT.
THERE HAVE BEEN MANY STUDIES IN
RECENT YEARS OF USING VISUALS,
COMPUTERS, APPS, VIDEOTAPES,
THINGS LIKE THAT, VIDEO, WE
DON'T USE VIDEOTAPES ANYMORE BUT
VIDEO PRESENTATIONS, AND EARLY
DATA SUGGESTED ONLY IN CERTAIN
KINDS OF POPULATIONS DID IT MAKE
A DIFFERENCE.
BUT I THINK WE SHOULD LOOK AGAIN
AT WHAT KINDS OF DIFFERENCE
THOSE KINDS OF PRESENTATIONS
MIGHT MAKE.
WE DID A SERIES OF STUDIES WHERE
WE COMPARED CONSENT FORMS, WHERE
WE RANDOMIZED PEOPLE WITHIN
OTHER CLINICAL STUDIES BOTH
HEALTHY VOLUNTEERS AND PATIENT
VOLUNTEERS TO RECEIVE THIS
STANDARD CONSENT FORM THAT OF
THE TEAM PUT TOGETHER IN A MUCH
SHORTER SIMPLER VERSION OF THE
SAME AND PEOPLE RANDOMIZED AND
WE ASSESSED THEIR UNDERSTANDING
AFTER THEY SIGNED CONSENT, AND
INTERESTINGLY, AND IN THE
PATIENT STUDY WE HAD MORE THAN
4,000 PARTICIPANTS FROM AROUND
THE WORLD, WHAT WE FOUND ACROSS
ALL OF THESE STUDIES THERE WAS
NO DIFFERENCE.
PEOPLE EITHER DID OR DIDN'T
UNDERSTAND WHAT THEY WERE DOING.
IT DIDN'T MATTER IF THEY HAD A
22-PAGE CONSENT FORM OR 10-PAGE
CONSENT FORM.
THEY DIDN'T ALWAYS READ THE
CONSENT FORMS BUT RELIED ON WHAT
THEY EXPECTED AND WHAT PEOPLE
TOLD THEM AND THEY DIDN'T RELY
THAT MUCH ON WHAT WAS WRITTEN ON
THE PAPERS.
SO, THE LAST PART OF CONSENT, SO
DISCLOSING INFORMATION,
UNDERSTANDING INFORMATION, AND
THEN MAKING A VOLUNTARY
DECISION, IS THIS VOLUNTARINESS.
AND IT BASICALLY MAKES SENSE
YOU WANT INFORMED CONSENT TO BE
REAL, YOU WANT PEOPLE TO ABSORB
WHAT IT IS YOU'RE ASKING THEM TO
DO AND DECIDE, VOLUNTARILY
DECIDE, YES, THIS IS SOMETHING I
WANT TO DO OR, NO, THIS IS
SOMETHING I DON'T WANT TO DO.
VOLUNTARINESS IS A VERY
UNDERSTUDIED CONCEPT.
IN OTHER WORDS, WHAT DOES IT
EXACTLY MEAN?
ALL OF US, ALL THE TIME, MAKE
CHOICES THAT ARE CLEARLY
INFLUENCED BY OUR EXPERIENCES,
OUR TRAINING, THE PEOPLE WE
KNOW, PEOPLE WE LOVE, ET CETERA.
SO, HOW DO WE MAKE VOLUNTARY
CHOICES?
THE REGULATIONS SUGGEST NO
DECEPTION, COERCION OR UNDUE
INFLUENCE.
DECEPTION IS CONCEALING OR
DISTORTING THE TRUTH TO MISLEAD.
COERCION IS COMPELLING BY FORCE
OR THREATENING TO MAKE THEM
WORSE OFF.
UNDUE INFLUENCE WHICH HAS THE
LEAST CLEAR DEFINITION IS AN
OFFER THAT DISTORTS JUDGMENT OR
MAKES PEOPLE MAKE DECISIONS THAT
ARE CONTRARY TO THEIR INTERESTS.
AND WE WORRY MORE ABOUT THESE
THINGS THAN WE PROBABLY SHOULD,
ESPECIALLY UNDUE INFLUENCES.
THERE ARE LOTS OF POTENTIAL
INFLUENCES INCLUDING DEPENDENT
POSITION AND POWER RELATIONSHIP
AND PRESSURE FROM OTHERS.
IF YOU ARE BEING ASKED TO
PARTICIPATE IN A STUDY BY YOUR
SUPERVISOR, YOU MAY BE LESS ABLE
TO SAY NO.
QUESTION, IS IT TRUE IF YOU'RE
BEING ASKED BY YOUR HEALTH CARE
PROVIDER.
LOTS OF QUESTIONS ABOUT THE
EXTENT TO WHICH HAVING
RESTRICTED CHOICES, BEING ILL,
OR BEING OFFERED INCENTIVES
INFLUENCES VOLUNTARINESS.
THERE'S BEEN SOME LITERATURE,
SOME STUDIES THAT HAVE LOOKED AT
THIS.
TWO THINGS ARE REALLY IMPORTANT.
ONE IS SOME STUDIES HAVE
DISTINGUISHED PRESSURE FROM
OTHERS, FROM PRESSURE FROM
HAVING A DISEASE.
AND I THINK THAT MAKES SOME
SENSE THAT THE PRESSURE FROM
OTHERS MOST PEOPLE SAY VERY
SMALL PERCENTAGE FEEL PRESSURE
FROM OTHERS.
OTHERS INCLUDED NOT ONLY
RESEARCH TEAMS BUT FAMILY.
ON THE OTHER HAND, WHEN PEOPLE
HAVE DISEASES OR IN THIS
PARTICULAR STUDY THEIR CHILD HAD
A DISEASE THEY FEEL PRESSURE TO
ENROLL BECAUSE THEY DON'T FEEL
LIKE THEY HAVE OTHER OPTIONS.
HOW MANY PEOPLE KNOW THEY WOULD
QUIT?
THERE'S A WIDE RANGE, AND A WIDE
RANGE IN TERMS OF ACTUAL
DECLINERS.
I THINK, AGAIN, POINTING OUT
THIS META-ANALYSIS FROM TAM ET
AL., THREE-QUARTERS OF PEOPLE
KNEW THEY HAD THE CHOICE TO
PARTICIPATE AND FREEDOM TO
WITHDRAW WITH MEANS AT LEAST 25%
DON'T KNOW THAT.
ALL RIGHT.
I THINK I'M GOING TO JUST END
WITH THESE NEXT TWO SLIDES.
INFORMED CONSENT IS COMPLEX,
IMPERFECT, THERE ARE ENDURING
CHALLENGES HOW WE DISCLOSE
INFORMATION, HOW PEOPLE
UNDERSTAND INFORMATION, HOW
CHOICES ARE MADE.
IT IS AFFECTED BY MOTIVATIONS
AND EXPECTATIONS.
IT'S AFFECTED BY CAPACITY.
IT'S AFFECTED BY EXPERIENCE OF
INTOLERANCE, INCONVENIENCE,
BURDEN, DIFFERENTIAL RESPONSES
TO INCENTIVES.
AND THERE ARE LOTS OF CHANGES
WHICH I THINK I'M NOT GOING TO
GET A CHANCE TO TALK ABOUT.
IS THAT RIGHT, HOLLY?
TWO MINUTES.
>>WELL, AT THE MOMENT I DON'T
HAVE ANY QUESTIONS FROM OUR
VIRTUAL AUDIENCE, AND NO
QUESTIONS HERE.
WHY DON'T YOU CONTINUE FOR
ANOTHER FIVE MINUTES?
>>OKAY, I'LL GO THROUGH SOME
CHANGES.
>>I'LL LET YOU KNOW IF SOMEONE
CHIMES IN.
>>THERE ARE TIMES OF RESEARCH
THAT ARE VERY PREVALENT RIGHT
NOW THAT CREATE CHALLENGES FOR
HOW WE THINK ABOUT AND HOW WE
IMPLEMENT A PROCESS OF INFORMED
CONSENT INCLUDING THESE THINGS
ON HERE BIOBANKS, DATA
REPOSITORIES, BIG DATA,
PRAGMATIC TRIALS, LEARNING
HEALTH CARE SYSTEMS I SHOULD
HAVE PUT. THERE THERE'S BEEN A
HUGE CHANGE IN HOW WE GET AND
EXCHANGE INFORMATION IN THE LAST
FEW YEARS.
THE IDEA OF 25-PAGE PAPER
CONSENTS WHICH WE STILL USE, BY
THE WAY, IS BECOMING OUTMODED
BECAUSE ELECTRONIC CONSENT IS
AVAILABLE, THROUGH DEVICES,
APPS, WEB INTERFACES AND
TELEHEALTH.
JUST TO GIVE YOU THE FRAME HERE,
TYPICALLY IN A TYPICAL CLINICAL
RESEARCH, SORT OF OLD-FASHIONED
CLINICAL RESEARCH, THE
RESEARCHER OR TEAM WOULD MEET
WITH THE PARTICIPANTS, HAVE A
FORM SIGNED, TO CONSENT, APPLY
THE INTERVENTION, THERE WOULD BE
DATA AND PUBLICATIONS FROM THAT
RESEARCH.
THAT'S THE CONSENT PART.
BUT WHEN WE HAVE RESEARCH WITH
DATA AND BIOSPECIMENS IT STARTS
WITH A REPOSITORY OF DATA OR
BIOSPECIMENS.
THERE'S NO INTERACTION WITH THE
RESEARCHER AND PARTICIPANT FROM
WHOM THOSE DATA OR BIOSPECIMENS
CAME, BEFORE THE RESEARCH IS
DONE AND RESEARCH IS PUBLISHED.
YET THERE IS A PERSON OR THERE
ARE PEOPLE FROM WHOM THOSE
SPECIMENS AND DATA CAME.
SO, THE QUESTION HAS BEEN HOW DO
WE DEAL WITH THIS KIND OF
CONSENT?
AND THERE'S NOT CONSENSUS AT THE
MOMENT BUT THIS WAS A STUDY WE
DID, A PAPER WE DID SOME YEARS
BACK, WHERE WE TALKED ABOUT THE
SPECTRUM FROM NO CONSENT WHICH
REGULATIONS ALLOW WHEN THERE'S
NO IDENTIFIERS, WE CAN DO
RESEARCH WITH SPECIMENS AND DATA
WITH NO CONSENT AT ALL, AND THEN
THERE'S A SPECTRUM OF INCREASING
CONTROL FROM THE PARTICIPANT
SIDE, BUT ALSO INCREASING BURDEN
FROM OF THE RESEARCH TEAM SIDE,
IN TERMS OF HOW CONSENT MIGHT BE
OBTAINED FOR THOSE KINDS OF
RESEARCH.
AND WE CAME DOWN IN THIS PAPER
ON WHAT IS CALLED BROAD CONSENT,
BASICALLY THIS IDEA THAT PEOPLE
CAN SAY, YOU CAN TAKE MY DATA,
YOU CAN TAKE MY SPECIMENS AND
USE THEM FOR FUTURE RESEARCH,
HERE ARE LIMITATIONS I PUT ON
THEM, DIFFERENT THAN BLANKET
CONSENT WHICH IS DO ANYTHING YOU
WANT.
SINCE THIS TIME BROAD CONSENT
HAS BECOME A PART OF THE
REGULATORY FRAMEWORK THAT WE
LIVE WITH, AND THERE'S A LOT
OF -- DEBATE I GUESS IS THE
RIGHT WORD WHETHER THAT'S BROAD
CONSENT OR WHETHER THERE'S
SOMETHING ELSE THAT'S BROAD
CONSENT, HOW YOU IMPLEMENT, BUT
THERE ARE REGULATORY GUIDANCE OR
RULES HOW BROAD CONSENT CAN BE
OBTAINED AND WHAT IT CAN BE USED
FOR.
SO THEN THERE'S PRAGMATIC
TRIALS, LEARNING HEALTH CARE
SYSTEMS TRIALS.
AGAIN, DIFFERENT FROM THE
PARADIGMATIC CLINICAL RESEARCH,
RESEARCH TAKES PLACE IN A HEALTH
CARE SETTING AND FACILITY WITH
PEOPLE THERE FOR HEALTH CARE
REASONS, AND SO SOMETIMES THE
INTERVENTION IS APPLIED TO THE
HEALTH CARE SYSTEM OR TO THE
PROVIDERS, AND SO NOT CONSENT
FROM THE INDIVIDUAL PARTICIPANTS
OR THE PEOPLE WHO MIGHT BE BEING
MEASURED IN SOME RESPECTS IS NOT
ALWAYS PART OF THE EQUATION.
BUT AGAIN THERE ARE PEOPLE IN
THESE SITUATIONS.
I'M NOT GOING TO BOTHER WITH
THAT.
AND THERE'S ALSO RESEARCH WITH
BIG DATA.
AND THIS IS SOMETHING THAT I
HAVE TO ADMIT I DON'T FULLY
UNDERSTAND BUT I WILL TELL YOU
THAT THERE ARE DATA OUT THERE
ABOUT ALL OF US AND THEY ARE
BEING USED FOR RESEARCH ALL THE
TIME.
AND THAT WE BY SOME PEOPLE'S
LIGHTS HAVE GIVEN CONSENT.
I WOULD SAY NOT INFORMED CONSENT
BECAUSE MANY OF US SIGNED THOSE
THINGS ON THE COMPUTER WITHOUT
READING THEM OR WITHOUT EVEN
UNDERSTANDING WHAT THEY ARE
ACTUALLY GOING TO DO WITH OUR
DATA BUT THEY ARE USING IT.
THEY ARE SELLING IT.
THEY ARE USING IT FOR RESEARCH.
AND SO THIS IS SOMETHING THAT
SOMETIMES BUBBLES TO THE SURFACE
WHEN THERE'S A SCANDAL THAT
PEOPLE DON'T LIKE.
I THINK WE'LL SEE MORE OF IT.
ELECTRONIC CONSENT, THIS WAS
GUIDANCE THAT WAS PUBLISHED IN
2016 FROM DEPARTMENT OF HEALTH
AND HUMAN SERVICES THAT COVERS
FDA AND COMMON RULE WHICH
BASICALLY SAID ELECTRONIC
PROCESSES ARE OKAY, WE CAN USE
ELECTRONIC PROCESSES.
WE DON'T HAVE TO USE PAPER
ANYMORE.
YOU CAN SEE FROM THIS QUOTE I
PULLED OUT, IT INCLUDES A BUNCH
OF STUFF.
THERE'S A LOT OF MODES OF
ELECTRONIC SYSTEMS AND PROCESSES
THAT COULD BE USED.
THIS IS WHY I SAY WE NEED MORE
DATA HOW WELL THEY ARE WORKING.
THERE'S ALSO -- THIS REALLY
BURGEONED DURING COVID, THIS
NOTION OF DECENTRALIZED TRIALS
WHICH A LOT OF PEOPLE ARE USING.
THIS IS WHERE YOU HAVE ONE
LOCATION WHERE THE STUDY TEAM OR
THE INFORMATION IS BEING
COLLECTED, BUT PEOPLE ARE
PARTICIPATING FROM ALL OVER THE
PLACE.
SO THIS IS ELECTRONIC CONSENT IS
DEFINITELY USED IN THESE TRIALS,
AND THERE'S NO REASON FOR
ANYBODY TO EVEN COME OR EVER
SOMETIMES EVER MEET THE RESEARCH
TEAM.
SO, AGAIN, ANOTHER SORT OF
DIFFERENCE IN TERMS OF HOW WE
THINK ABOUT CONSENT IN
DECENTRALIZED TRIALS.
I WOULD SAY THAT ALL OF THESE
ELECTRONIC METHODS STILL HAVE
SOME OF THESE CHALLENGES ABOUT
WHAT DO WE DISCLOSE, HOW DO WE
KNOW IF PEOPLE UNDERSTAND, WHAT
DO THEY NEED TO UNDERSTAND, HOW
DO WE KNOW IF THEY ARE MAKING A
CHOICE.
SO I'M GOING TO STOP BY THIS
SLIDE, INFORMED CONSENT IS A
PROCESS BASED ON RESPECT FOR
PERSONS, ALSO PROMOTES
PARTICIPANT WELFARE, PROMOTES
VALUES, OFFERS TRUST, HELPS
ENSURE INTEGRITY BUT CHANGES
CREATE OPPORTUNITIES FOR
INNOVATIVE EVIDENCE-BASED
STRATEGIES FOR INFORMED CONSENT.
>>BIG ROUND OF APPLAUSE FROM
THE GIANT CROWD HERE IN LIPSETT.
[APPLAUSE]
WE HAVE A QUESTION.
>>OKAY, GOOD.
>>I'M GOING TO SLIGHTLY REFRAME
THE QUESTION.
SO, YOU MENTIONED THAT A LOT OF
RESEARCH IS BEING DONE WITH
BIOBANKS.
AND DO YOU THINK IT'S ENOUGH FOR
US TO KNOW THAT WHEN WE SURVEY
PEOPLE THEY SAY, SURE, THAT
SEEMS OKAY TO ME, THAT IF YOU
USE DE-IDENTIFIED SAMPLES FOR
RESEARCH VERSUS GETTING DIRECT
CONSENT FROM AN INDIVIDUAL,
ABOUT USING THEIR BIOSPECIMEN
FOR RESEARCH.
>>SO, DO I THINK IT'S OKAY IS
THE QUESTION?
>>YEAH, IS THAT ENOUGH FOR US
TO SAY, YOU KNOW, SEEMS LIKE
PEOPLE SUPPORT THIS ENDEAVOR, IS
IT OKAY FOR US TO THEN, YOU
KNOW, PUT IT INTO REGULATIONS?
OKAY TO USE DE-IDENTIFIED
SAMPLES FOR RESEARCH?
>>IT'S A GREAT QUESTION.
AND I THINK FOR PEOPLE WHO
FOLLOWED THIS IN THE, YOU KNOW,
YEARS PRECEDING REVISIONS TO THE
COMMON RULE THIS WAS THE MAJOR
QUESTION THAT WAS DEBATED AND
FOR WHICH PUBLIC COMMENT WAS
SUBMITTED ON THE PROPOSED CHANGE
TO REGULATIONS.
AN EARLIER CHANGE WAS USE OF
DE-IDENTIFIED SPECIMENS AND DATA
WITHOUT CONSENT WOULD NOT BE
ALLOWED BECAUSE, AND WE KNOW
THIS, DE-IDENTIFICATION CANNOT
BE ABSOLUTE.
THERE'S NO WAY TO COMPLETELY
DE-IDENTIFY ANYTHING ANYMORE.
ESPECIALLY CERTAIN KINDS OF
DATA.
THERE WAS DEBATE ABOUT CAN WE DO
THIS.
VOICES THAT WERE LOUD WERE
PEOPLE THAT ARGUED THAT RESEARCH
WITH HUGE AMOUNTS OF DATA IS
VERY VALUABLE AND WE CAN LEARN
THINGS WE COULDN'T LEARN IN
OTHER WAYS.
CONSENT MAKES THAT IMPOSSIBLE TO
DO OR COULD SKEW IT BECAUSE
PEOPLE WHO SAID NO MIGHT BE
DIFFERENT THAN PEOPLE WHO SAID
YES.
THOSE ARE VOICES THAT WON THE
DAY IN TERMS OF REGULATIONS.
IN THE REGULATIONS THERE IS
INTERESTINGLY A -- I DON'T KNOW
WHAT IT IS, A PROMISE THAT THE
QUESTION OF DE-IDENTIFICATION
WILL BE REVISITED EVERY COUPLE
YEARS.
I DON'T THINK THAT THAT -- I
THINK THAT MEANS THIS COULD
CHANGE IN THE FUTURE.
I THINK THE BALANCE BETWEEN
WHAT'S GOOD FOR RESEARCH, IN
OTHER WORDS WHAT CAN WE LEARN
FROM LARGE AMOUNTS OF
DEIDENTIFIED DATA AND HOW PEOPLE
FEEL ABOUT WHETHER OR NOT THEIR
DATA CAN BE USED IS A TRICKY
ONE.
MANY PEOPLE SAY SURE, GO AHEAD.
THERE ARE PEOPLE WHO SAY NO.
>>AND RESPECTING BOTH IS THE
CHALLENGE.
ANDREW HAS A QUESTION.
>>ABOUT BIOSAMPLES AND
EQUITABLE -- AND FINANCES THAT
COME OUT OF THOSE.
SURVEILLANCE SAMPLING, PROTOCOL
FROM THE U.N. HOW DATA AND
SAMPLES ARE COLLECTED FROM
MIDDLE INCOME OR POOR INCOME
COUNTRIES AND HOW BENEFITS ARE
DISTRIBUTED BACK TO THE THOSE
COUNTRIES, SIMILAR DISCUSSIONS
OR THOUGHTS ABOUT THOSE IN
CLINICAL RESEARCH SPECIFIC LIVE
WHERE YOU COULD BE COLLECTING
SAMPLES FROM PEOPLE AND PERHAPS
MAKE DISCOVERIES FROM THOSE THAT
ARE THEN USED IN INTERVENTIONS
OR THINGS GOING ON, IS THERE
WAYS TO CONSIDER ABOUT BRINGING
THE BENEFITS OF THOSE
FINANCIALLY BACK TO THOSE
PARTICIPANTS WHO DONATED
SAMPLES?
>>THAT'S A WHOLE OTHER DAY OF
DISCUSSION.
>>AND WE WILL BE TALKING ABOUT
SPECIMENS NEXT WEEK, GENETIC IN
PARTICULAR.
>>A SHORT ANSWER I WAS TALKING
ABOUT HOW DO WE ASK PEOPLE TO
USE THEIR SPECIMENS.
THERE ARE HUGE DEBATES,
DIFFERENCES IN LAWS AND
REGULATIONS ACROSS THE WORLD IN
TERMS OF WHAT SPECIMENS CAN BE
USED AND HOW THEY CAN BE USED
AND WHO THEY CAN BE SENT TO AND
ALL THAT STUFF.
THAT'S CREATING CONSTERNATION ON
THE PART OF SOME RESEARCH TEAMS.
BUT THERE'S ALSO BEEN A
LONGSTANDING REALIZATION THAT IF
WE GET SPECIMENS FROM A CERTAIN
REGION OF THE WORLD THAT HELP
THE WHOLE WORLD THAT THE PLACE
FROM WHICH THEY COME SHOULD GET
BENEFIT FROM THAT, WHATEVER WE
DISCOVER, WHATEVER WE MAKE, A
VACCINE OR WHATEVER IT IS,
STARTED WITH INFLUENZA IN THE
EARLY 2000s AND SO, YEAH,
THERE'S A LOT OF DISCUSSION
ABOUT THAT.
>>WE'LL SHALL TALKING ABOUT
INTERNATIONAL ISSUES ON DAY 7.
ANOTHER PLACE TO REVISIT THESE
QUESTIONS.
THANK YOU AGAIN, DR. GRADY.
[APPLAUSE]
IT'S MY PLEASURE TO INTRODUCE
DR. SCOTT KIM, HE'S TRAINED AS A
PSYCHIATRIST AND PHILOSOPHER,
AND DOES EMPIRICAL WORK SO HE'S
A TRIPLE THREAT.
AREAS OF INTEREST INCLUDE
DECISION MAKING WITH ADULTS THAT
DON'T HAVE CAPACITY AND HE WILL
TALK ABOUT THAT AS WELL AS
ISSUES AROUND ASSISTED DYING.
WITHOUT FURTHER ADO.
YOU'RE NOT TALKING ABOUT THAT, I
WAS JUST SHARING THE RANGE OF
YOUR INTEREST.
HE WILL NOT TALK ABOUT ASSISTED
DYING TODAY.
TAKE IT AWAY.
>>YOU'VE SEEN THIS BEFORE.
JUST TO START WITH A LITTLE
HISTORY, BECAUSE THIS TOPIC
SEEMS RATHER ESOTERIC BECAUSE IT
ONLY APPLIES TO A SMALL
SUBSECTION OF RESEARCH WITH THE
VERY SMALL SUBGROUP OF RESEARCH
PARTICIPANTS BUT HISTORICALLY
YOU COULD ARGUE CONCERNS ABOUT
POPULATIONS OF PEOPLE WHO ARE
PARTICULARLY VULNERABLE BECAUSE
OF IMPAIRMENTS IN TERMS OF
GIVING CONSENT AND SO FORTH WAS
VERY MUCH AT THE CENTER OF WHAT
WE NOW HAVE COME TO KNOW AS THE
RESEARCH ETHICS ENTERPRISE.
SO I WANT TO QUICKLY GO THROUGH
THAT BY USING ONE OF THE PRIME
EXAMPLES OR SOURCE IN WHICH WE
TALK ABOUT THIS HISTORY AS HENRY
BEECHER'S 1966 ARTICLE WHERE HE
DESCRIBES, YOU COULD ARGUE BRIEF
BUT GORY DETAIL OF HOW SOME
VIOLATIONS TOOK PLACE.
FOR EXAMPLE, NINE OF THE 22
EXAMPLES HE USED INVOLVED AT
LEAST SOME PEOPLE WHO PROBABLY
HAD DIFFICULTY PROVIDING
INFORMED CONSENT.
FOR INSTANCE, EXAMPLE 4, THIS IS
SOMEWHAT DATED LANGUAGE SO
YOU'LL HAVE TO EXCUSE.
IT DESCRIBES MENTAL DEFECTIVE
AND DELINQUENT JUVENILES GIVEN
DRUG, BIOPSIES TAKEN,
RECHALLENGE WITH SAME DRUG, NOT
BENIGN TYPE OF RESEARCH.
ANOTHER EXPERIMENT OF 44
PATIENTS WHO HAD COGNITIVE
ABILITIES, ESTIMATED TO BE
SECOND TO TENTH GRADE.
OH, I'M SORRY, THIS IS ACTUALLY
THE -- THIS ONE IS THE CHILDREN
WHERE THEY DID ALL SORTS OF
MANEUVERS, THEY DID EXPERIMENTS
ON UNCONSCIOUS PATIENTS,
PATIENTS ABOUT TO BE IN A COMA
BECAUSE OF LIVER FAILURE AND DID
ALL SORTS OF EXPERIMENTS WITH
THEM, QUITE INVASIVE.
THERE WERE SEVERAL EXAMPLES
INVOLVING CHILDREN.
YOU CAN IMAGINE HOW MUCH
CONTROVERSY THESE KIND OF
STUDIES RAISED IN TERMS OF ALL
THE DISCUSSION THAT TOOK PLACE,
AND YOU COULD ARGUE THIS IS THE
BEGINNING OF THE SOUL SEARCHING
THAT WENT ON THAT LED TO ALL
THESE COMMISSIONS, DEVELOPMENT
OF LAWS AND SO FORTH, JUST TO
GIVE A LITTLE FLAVOR I'M GOING
TO LIST THEM.
1978 IS MOST FAMOUS, BELMONT
COMMISSION PUBLISHING RESEARCH
INVOLVING THOSE
INSTITUTIONALIZED AS MENTALLY
INFIRM.
BACK THEN, MANY, MANY PATIENTS
WERE INSTITUTIONALIZED.
THIS WAS MORE IN A CLINICAL
SETTING, A QUESTION HOW DO YOU
TREAT AND DEAL WITH THE QUESTION
OF PEOPLE WHO CAN'T GIVE THEIR
OWN CONSENT FOR TREATMENT.
AND THEN IN 1990s WE REVISITED
THAT BECAUSE OF SOME
CONTROVERSIES THAT OCCURRED.
THERE WAS A SPECIFIC MARYLAND
ATTORNEY'S WORKING GROUP MAINLY
BECAUSE NIH SITS WITHIN
MARYLAND, AND THEN THERE WAS A
NATIONAL BIOETHICS COMMISSION IN
1998 THAT ADDRESSED THE ISSUE.
THERE'S ANOTHER STATE WORKING
GROUP IN NEW YORK MAINLY BECAUSE
THERE WAS LOTS OF DISCREPANCY
WITHIN THE STATE AS TO HOW TO
CONDUCT RESEARCH WITH PEOPLE WHO
COULDN'T CONSENT.
FINALLY THE AGENCY, DEPARTMENT
OF HEALTH AND HUMAN SERVICES,
APPOINTED AN ADVISORY COMMITTEE.
THEY ISSUED TWO REPORTS IN 2009
ON THE SAME TOPIC.
AGAIN, IN 2015, WHEN PRESIDENT
OBAMA HAD A COMMISSION ON THESE
ISSUES, IT WAS, AGAIN,
REVISITED.
SO IT'S BEEN AN ONGOING ISSUE.
AND FINALLY ONE CHANGE THAT DID
TAKE PLACE IN 2018 THERE WAS --
IT DID ADDRESS ONE SPECIFIC
ISSUE AS I'LL TRY.
OKAY.
THAT'S THE HISTORY.
IF YOU ONLY TAKE AWAY ONE LESSON
FROM MY TALK, IT'S THIS.
INVOLVING THOSE LACKING
DECISION-MAKING CAPACITY OR
PEOPLE AT RISK OF LOSING THEIR
CAPACITY MUST BE SPECIFICALLY
JUSTIFIED.
THAT SEEMS LIKE AN OBVIOUS
NO-BRAINER COMMON SENSE
STATEMENT, BUT YOU'LL NOTICE
WITH THE HISTORICAL EXAMPLES I
GAVE YOU THESE FOLKS WERE TAKEN
ADVANTAGE OF, EXPLOITED, BECAUSE
THEY WERE AVAILABLE, CONVENIENT
TO EXPLOIT.
AND BECAUSE THEY WERE
VULNERABLE.
SO NOW WE HAVE CREATED A
SPECIFIC NEED FOR JUSTIFICATION,
RESEARCH, YOU HAVE TO SAY WHY
THEY CAN'T DO THIS IMPORTANT
RESEARCH WITHOUT INVOLVING THESE
FOLKS, AND IT HAS TO BE FOCUSED
ON THE DISORDER OR THE
CONSEQUENCES OF THAT DISOFFERED
SO YOU HAVE TO JUSTIFY THE
INVOLVEMENT OF THIS POPULATION.
RARELY THERE CAN BE QUESTIONS OF
EQUITY AND DISCRIMINATION THAT
ARISE IF YOU SYSTEMATICALLY
EXCLUDE THESE FOLKS FROM CERTAIN
TYPES OF RESEARCH BUT THAT'S
RARE AND WE DEAL WITH THOSE ON A
CASE-BY-CASE BASIS.
OKAY.
WHAT I'M GOING TO DO IS GIVE YOU
BACKGROUND AND DECISION MAKING
CAPACITY AND IMPAIRMENT.
GIVE YOU SOME EMPIRICAL
INFORMATION THROUGHOUT THE TALK
AS WELL ON THIS TOPIC.
ASK THE QUESTION OF IS IT
PERMISSIBLE TO DO RESEARCH WITH
THESE FOLKS?
IF SO, WHO SHOULD GIVE CONSENT
BECAUSE THE WHOLE POINT IS THEY
CAN'T GIVE CONSENT FOR
THEMSELVES, WHO SHOULD?
AND THE OTHER MOST IMPORTANT
ISSUE OF COURSE IS THAT DO WE
TREAT THIS LIKE AN INDIVIDUAL
GIVING CONSENT FOR HIM OR
HERSELF, OR GIVEN THAT SOMEBODY
ELSE IS GIVING CONSENT FOR
ANOTHER PERSON, SHOULD THERE BE
MORE RESTRICTIONS ON THE
RISK/BENEFIT CALCULUS?
I'M GOING TO GIVE EMPIRICAL
DATA, OR DATA IS ALWAYS
EMPIRICAL OF COURSE, SOME DATA
ON -- THAT'S RELEVANT TO THIS
QUESTION.
PARTLY BECAUSE A LOT OF THESE
ETHICAL ISSUES WE OFTEN TALK AS
THOUGH THERE'S SOME A PRIORI
RIGHT ANSWER BUT OFTEN IT'S A
QUESTION OF PROCEDURAL
COLLECTIVE AGREEMENT AS A
SOCIETY AS TO WHAT'S ACCEPTABLE,
EACH OF US PUTTING INTO THE POOL
OR MORAL INTUITIONS.
AND THIS IS WHY THE PUBLIC'S
VIEW CAN BE QUITE HELPFUL.
OKAY.
THEN I END WITH SOME ADDITIONAL
PROTECTIONS AND CONSIDERATIONS
THAT WE SHOULD THINK ABOUT.
I'M GOING TO TRY TO COMPLICATE
THE MATTER A LITTLE BIT BECAUSE
I JUST WANT TO REITERATE WHAT'S
REALLY IMPORTANT IS TO
UNDERSTAND AT THE CONCRETE LEVEL
WHAT KIND OF VULNERABILITIES
PEOPLE ARE FACING, NOT JUST
THEORY DID THEY HAVE OR NOT HAVE
DECISION MAKING CAPACITY.
THAT SHOULD BECOME CLEAR AS WE
GO.
ALL RIGHT.
SO WHAT TIME AM I ENDING, HOLLY?
>>YOU ARE ENDING AT 11:00
WITH -- SORRY, SORRY, SORRY.
10:10 WITH 10 MINUTES OF
DISCUSSION.
>>OKAY, 10:10.
THANK YOU.
A LITTLE BACKGROUND.
NOT EVERYBODY HAS A BACKGROUND
IN THIS.
THERE'S TERMS AND DEFINITIONS,
YOU HAVE TO TRUST ME, EVEN
THOUGH I CONSIDER MYSELF PRETTY
KNOWLEDGEABLE ABOUT THIS TOPIC,
YOU'D BE SURPRISED THAT I GIVE
TALKS AND PEOPLE CORRECT ME THAT
I DON'T UNDERSTAND THESE TERMS
AT THE TALKS I GIVE.
THAT'S PROBABLY BECAUSE WE ALL
HAVE OUR OWN FAVORITE WAYS OF
TALKING ABOUT THIS AND THINK
THAT'S THE RIGHT WAY.
BUT WHAT'S IMPORTANT FOR US IS
TO UNDERSTAND HOW I'M USING IT
TODAY AND YOU CAN TRANSLATE IT
OUTSIDE OF THIS ROOM LATER.
ALL RIGHT.
I'M GOING TO STREET THE TERMS
EQUIVALENTLY.
AND IT REFERS TO THE DICHOTOMOUS
YES/NO, HAVE IT OR DON'T HAVE IT
CONCEPT.
AND ONE OFTEN HEARS COMPETENCE A
LEGAL TERM, CAPACITY ISN'T.
IT'S NOT TRUE.
MOST MODERN LAWS ON DECISION
MAKING CAPACITY USE THE TERM
DECISION MAKING CAPACITY AND
RARELY USE THE TERM COMPETENCE.
IN THE COURTS SOMETIMES, REALLY
PREFERRED LEGAL TERM IS ACTUALLY
CAPACITY NOW.
SO, THIS IS WHAT I JUST SAID.
SO LET'S GO THROUGH SOME
DEFINITIONS.
IF WHAT YOU MEAN IS THIS
PERSON'S STATUS, THEIR DECISION
MAKING CAPACITY STATUS HAS BEEN
DETERMINED BY A JUDGE WE SHOULD
SAY THAT'S WHAT'S HAPPENED.
IT'S BEEN ADJUDICATED.
OF COURSE, MOST CASES DON'T GO
TO COURT.
IT'S DETERMINED USUALLY IN A
CLINICAL SETTING FOR TREATMENT
OR RESEARCH CONSENT, THE
CLINICIANS AAPPROXIMATION OF
WHAT A JUDGE WOULD DECIDE FIT
WENT TO COURT.
THIS HAS LEGAL BACKING IN THE
CLINICAL ARENA BECAUSE THE LAW
SPECIFICALLY SAYS THE ATTENDING
PHYSICIAN SHALL DETERMINE
DECISION-MAKING CAPACITY, ALSO
IN THE RESEARCH SETTING AS WELL,
IN THE POLICIES.
WE HAVE TO DISTINGUISH THAT
STATUS OF HAVING DECISIONAL
AUTHORITY BY VIRTUE OF HAVING
DECISION MAKING CAPACITY FROM
THE SPECIFIC ABILITIES RELEVANT
TO CAPACITY.
THESE ARE FUNCTIONAL, THAT WE
CAN MEASURE.
WE HAVE ACTUALLY INSTRUMENTS TO
DO THAT.
I'M GIVING YOU THE FOUR
ABILITIES MODEL BECAUSE THAT'S
THE MOST POPULAR IN THE U.S., IN
MANY JURISDICTIONS, BUT IN OTHER
PLACES THEY MIGHT HAVE OTHERS,
OTHER CRITERIA, THAT ARE
SLIGHTLY DIFFERENT BUT THE POINT
IS THAT YOU CAN SORT OF BREAK IT
DOWN INTO FUNCTIONAL COMPONENTS.
SO THESE ABILITIES CAN BE
MEASURED WITH INSTRUMENTS.
DID YOU THE DETERMINATION OF
YES,/NO IS A NORMATIVE AND
CLINICAL JUDGMENT.
IT IS PART OF THE INFORMED
CONSENT DOCTRINE.
INFORMED CONSENT HAS THREE
COMPONENTS.
THE PERSON HAS TO BE COMPETENT
TO GIVE INFORMED CONSENT BASED
ON ADEQUATE INFORMATION THAT'S
BEEN PROVIDED TO HIM OR HER.
AND THEY SHOULDN'T BE COERCED OR
UNDULY INFLUENCED IN MAKING THAT
DECISION.
AND CAPACITY IS JUST ONE OF
THOSE THREE ELEMENTS.
IT USED TO BE WE USED SENILEITY,
UNSOUND MIND, YOU CAN GO TO
COURT DOCUMENTS OR EARLY
LEGISLATION THAT WOULD SAY YOU
CAN COMMIT A PERSON TO AN INSANE
ASYLUM BASED ON TWO PHYSICIANS
CERTIFYING THE PERSON IS OF
UNSOUND MIND.
YOU CAN IMAGINE WHAT KIND OF
ABUSES THINGS LIKE THAT COULD
AND DID LEAD TO.
SO NOW WE DON'T DO THAT.
WE FOCUS ON THE FUNCTIONAL
ABILITIES.
THE THRESHOLD OF WHETHER A
PERSON HAS CAPACITY IS AFFECTED
BY THE CONTEXT.
MOST IMPORTANT, RISK/BENEFITS OF
THE DECISION, MOMENTOUS
SERIOUSNESS OF THE DECISION.
AND IT IS TASK OR DECISION
SPECIFIC.
I MIGHT BE INCOMPETENT TO DECIDE
ON DECISION A, BUT COMPETENT TO
DECIDE ON DECISION B.
I'M GOING TO GIVE YOU AN ASIDE.
IF YOU'RE INTERESTED TO HEAR
ABOUT THIS, I NEED TO INTRODUCE
IT AND PUT IT ASIDE.
THE U.N. COMMITTEE ON THE RIGHTS
OF PERSONS WITH DISABILITIES,
ALSO RESPONSIBLE FOR WRITING THE
CONVENTION ON THE RIGHTS OF
PERSONS WITH DISABILITIES, IN
2008, VERY IMPORTANT DOCUMENT
BECAUSE IT SETS OUT A KIND OF
GLOBAL STANDARD FOR THE KIND OF
EQUITABLE TREATMENT OF PERSONS
WITH DISABILITIES.
NOW, GENERALLY I WOULD SAY THE
FOLLOWING.
SADLY U.S. IS NOT IS A SIGNATORY
TO THIS CONVENTION, EVEN THOUGH
IT SHOULD BE SAID THAT WE WERE
AHEAD OF THE CURVE WITH
AMERICANS WITH DISABILITIES ACT,
THAT TOOK PLACE ACTUALLY DECADES
BEFORE.
WHY DO I MENTION THIS?
BECAUSE THERE'S AN ARTICLE THAT
HAS BEEN INTERPRETED BY THE
COMMITTEE ITSELF IN A SEPARATE
COMMENTARY ON THE ARTICLES THAT
WHAT THEY MEAN BY THAT ARTICLE
IS THAT LEGAL REGIMES WHICH
ALLOW SUBSTITUTE DECISION MAKING
SHOULD BE REPLACED BY SUPPORTED
DECISION MAKING BECAUSE
REGARDLESS OF FUNCTIONAL
ABILITIES EVERYBODY STILL
RETAINS LEGAL CAPACITY.
NOW, THERE ARE MOUNTAINS OF
ARTICLES WRITTEN ON THIS.
AND IF YOU'RE INTERESTED YOU CAN
LOOK AT IT.
BUT I'M GOING TO PUT THIS ASIDE
FOR MANY REASONS BECAUSE NO
SIGNIFICANT JURISDICTION HAS
REALLY TAKEN THAT UP AND IT'S
HIGHLY UNLIKELY THAT WILL EVER
HAPPEN.
AND EVEN THE COMMITTEE ITSELF
WITH CHANGES IN MEMBERSHIP HAVE
SOFTENED ITS VIEWS ON THIS.
I MENTION THAT BECAUSE YOU'LL
HEAR ABOUT IT.
OKAY.
SO LET'S JUST STEP BACK AND LOOK
AT SORT OF THE CLINICAL SIDE,
WHO ARE THE PEOPLE THAT WE'RE
TALKING ABOUT?
OBVIOUSLY IT'S PEOPLE WITH
COGNITIVE DISORDERS, THAT'S MOST
AFFECTED BY THIS ISSUE.
PEOPLE WITH NEURODEGENERATIVE
DISORDERS.
AS YOU KNOW, ALZHEIMER'S IS
VERY, VERY COMMON.
YOU HAVE A SIGNIFICANT RISK AS
YOU AGE.
THERE ARE OTHER DEMENTIAS.
ALZHEIMER'S TAKES OUT 70 TO 80%
OF ALL BUT IT'S COMMON,
NEURODEVELOPMENTAL DISORDERS,
PEOPLE WITH SIGNIFICANT
INJURIES, AS WELL AS PEOPLE WITH
MEDICAL PROBLEMS WHO ARE IN
TEMPORARY STATES OF CONFUSION IN
THE HOSPITAL.
ALSO PEOPLE WITH PSYCHOTIC
DISORDERS.
I WOULD INCLUDE IN THIS PEOPLE
WITH MOOD DISORDERS IN PSYCHOTIC
STATES LIKE, SAY, MANIA, PEOPLE
WITH BIPOLAR DISORDER.
MOOD DISORDER IS WHEN THEY ARE
SEVERE.
DEPRESSION IS WHAT I MEAN HERE
BECAUSE YOU HAVE SIGNIFICANT
COGNITIVE AND REALITY TESTING
DIFFICULTIES IF YOU'RE SEVERELY
DEPRESSED.
EATING DISORDERS WHEN SEVERE.
THERE'S SOME WRITINGS ABOUT WHAT
ABOUT EXTREME FORMS OF
PERSONALITY DISORDERS OR
SUBSTANCE ABUSE DISORDERS, SO
THERE'S A SMALL LITERATURE IN
EACH OF THOSE.
IMPORTANT THING TO TAKE AWAY
FROM THIS SLIDE IS THAT I'M NOT
SAYING THAT THESE CONSTITUTE
REASONS TO BELIEVE THE PERSON
LACKS CAPACITY BUT RATHER THEY
ARE RISK FACTORS.
IF A PERSON HAS, FOR EXAMPLE,
ALZHEIMER'S DISEASE THAT'S WELL
DIAGNOSED AND YOU'RE ASKING HIM
OR HER TO CONSENT TO A
SIGNIFICANT RISK PROCEDURE, THEN
YOU NEED TO REALLY THINK ABOUT
THE CAPACITY ISSUE, NOT ASSUME
THEY CAN'T BUT SUSPEND
PRESUMPTION PERHAPS THAT THEY
ARE CAPABLE.
OKAY.
SO WHAT IS THE PREVALENCE OF
DECISIONAL CAPACITY?
THIS IS VERY ROUGH ESTIMATES.
I'VE SORT OF SUMMARIZED LOTS OF
LITERATURE TO GIVE YOU A FEEL.
I GIVE YOU THAT CAVEAT BECAUSE
THE ACTUAL, AS YOU REMEMBER,
DECISION MAKING CAPACITY IS
DECISION SPECIFIC, CONTEXT
SPECIFIC.
THIS IS CUTTING ACROSS ALL
DIFFERENT TYPES OF DECISIONS AND
CONTEXTS.
OKAY.
SO, YOU KNOW, IF YOU WALK INTO A
GENERAL HOSPITAL, SIBLEY
HOSPITAL OR JOHNS HOPKINS
HOSPITAL, YOU WILL IMMEDIATELY
FIND SIGNIFICANT MINORITY OF
PERSONS PROBABLY CAN'T GIVE
THEIR OWN CONSENT.
IT HAS TO DO WITH HOW AGED THE
HOSPITAL POPULATION IS AND HOW
SERIOUSLY ILL MOST PEOPLE ARE
WHO ARE IN THE HOSPITAL THESE
DAYS.
NURSING HOMES, IT'S EVEN HIGHER.
IN PSYCHIATRIC HOSPITAL UNITS
THE STUDIES SHOW IT VARIES QUITE
A BIT DEPENDING ON TYPE OF UNIT.
PEOPLE WITH DIAGNOSIS OF
SCHIZOPHRENIA OR CHRONIC
SCHIZO-EFFECTIVE DISORDERS,
ACTUALLY MAJORITY HAVE CAPACITY
TO MAKE MOST DECISIONS.
THE LARGE MINORITY MIGHT HAVE
DIFFICULTY BUT YOU CAN'T ASSUME
DIAGNOSES MEANS YOU'RE
INCOMPETENT.
EVEN MODERATE DEPRESSION MAKES
VERY LITTLE IMPACT BECAUSE OF
THE WAY WE MEASURE CAPACITY
BECAUSE CAPACITY, REMEMBER, HAS
TO DO WITH WHETHER OR NOT THE
PERSON RETAINS DECISIONAL
AUTHORITY.
WE'RE NOT EAGER TO TAKE THAT
AWAY UNLESS WE'RE REALLY
CONVINCED IT'S SIGNIFICANTLY
IMPAIRED.
USING THAT STANDARD, IT DOESN'T
REALLY AFFECT THAT THAT MUCH.
INPATIENT DEPRESSION WHEN MORE
SEVERELY DEPRESSED IT DOES MAKE
A DIFFERENCE.
SOME STUDIES SHOW, MAYBE A
QUARTER OR MORE, CAN BE
AFFECTED.
I WANT TO EMPHASIZE PEOPLE WITH
ALZHEIMER'S DEMENTIA AND PEOPLE
WITH SCHIZOPHRENIA, A FLAVOR FOR
HOW MUCH PEOPLE ARE AFFECTED.
EVEN WITH MILD COGNITIVE
IMPAIRMENT, CONSIDERED A PRE---
NOT A CATEGORIZATION, YOU COULD
CALL IT PRESYMPTOMATIC
ALZHEIMER'S OH PRESYMPTOMATIC OR
PRE-ALZHEIMER'S.
A PERFECT SCORE IS 30.
THESE FOLKS ARE DOING WHAT WOULD
BE CONSIDERED NORMAL MINI
MENTAL, UP TO 40% WOULD HAVE SO
MUCH TROUBLE BASED ON EVALUATION
THEY WOULD NOT BE ABLE TO
CONSENT TO RCT.
IN OTHER STUDIES IT'S A MAJORITY
OF PEOPLE WITH MODERATE DEMENTIA
WOULD NOT BE ABLE.
ON THE OTHER HAND, PEOPLE WITH
SCHIZOPHRENIA, THE LARGEST STUDY
IN TERMS OF DECISION-MAKING
CAPACITY FOR CLINICAL TRIAL
PARTICIPATION, THIS IS ONE OF
THE MEASURES, THE UNDERSTANDING
SCORE.
YOU CAN SEE IF YOU USE A CUTOFF,
THE RED ARROW THAT A PANEL
THINKS IF THEY SCORE HIGHER THEY
SHOULD BE CONSIDERED CAPABLE,
YOU CAN SEE OVERWHELM MAG JOTTER
ARE ABLE TO UNDERSTAND THE
INFORMATION.
STILL OVERWHELMING MAJORITY FOR
APPRECIATION STANDARD TO APPLY
TO YOUR OWN SITUATION.
THAT GIVES YOU SOME FEEL FOR
CONTEXT AND POPULATIONS.
OKAY.
HERE'S THE QUESTION.
IF STUDIES WITH PEOPLE LACKING
OR AT RISK OF LACKING DMC ARE
PERMISSIBLE WHO GIVES CONSENT?
NOW, THE WAY I PUT THAT, I SAID
IF.
BUT IN THEORY FEDERAL
REGULATIONS ALLOWED.
BEFORE THE COMMON RULE REVISION,
THE TERM LEGALLY AUTHORIZED
REPRESENTATIVE, LAR, YOU'LL HEAR
THAT TERM, THOSE WHO MIGHT GO ON
CONSULTS TO DO ASSESSMENTS WE
TALK ABOUT LAR, THAT IS THE
FEDERAL RESEARCH ETHICS
REGULATIONS, THE COMMON RULE'S
TERM FOR PERSON WHO SERVE AS
SURROGATES FOR RESEARCH CONSENT.
NOW, IT WAS DEFINED AS PERSONS
AUTHORIZED UNDER APPLICABLE LAW
TO CONSENT ON BEHALF OF A
SUBJECT TO THE SUBJECT'S
PARTICIPATION AND PROCEDURES
INVOLVED IN RESEARCH.
NOW, THAT APPLICABLE LAW WAS
REFERRING TO LOCAL AND STATE
LAWS.
AND AT THE TIME, VERY FEW
JURISDICTIONS HAD CLEAR LAWS
ABOUT THIS.
IN FACT, WHEN I WROTE THIS SLIDE
WHICH IS A FEW YEARS AGO, THE
FUTURE RESTRICTIONS HAVE CLEAR
POLICIES.
NOW, WHAT'S HAPPENED, AND THEN
THERE WAS A LOT OF DISCUSSION AS
I MENTIONED, A SECRETARY'S
ADVISORY COMMITTEE TO THE
AGENCY, AND WHAT THEY NOTICED IN
THEIR REVIEW IS AT BEST THE
FIELD IS CHARACTERIZED BY A
PATCHWORK OF IRB POLICIES AN
RESEARCH PRACTICES.
SO, AFTER MUCH, MUCH DEBATE AND
MANY, MANY COMMISSIONS AND
WORKING GROUPS AND DISCUSSIONS
AND SO FORTH, THE LAW,
REGULATORY LAW, WAS CHANGED.
THE COMMON RULE WAS REVISED.
YOU SEE THE GRAY PART WHAT WE
READ EARLIER, NOW THE BLACK PART
HAS BEEN ADDED.
IF THERE IS NO APPLICABLE LAW,
SO IF YOU LIVE IN A STATE WHERE
THE LAW DOESN'T SPECIFY AND
CAN'T GUIDE YOU, WHAT YOU CAN DO
IS ASK, DOES THE INSTITUTION IN
WHICH THE RESEARCH TAKES PLACE
DEFINE WHAT IT IS?
SO, BASICALLY IT REALLY WIDENS
THE SCOPE BECAUSE THE
INSTITUTIONS, IF THEY CAN CREATE
A POLICY, THEN THAT CAN BE
RELIED UPON TO SAY THAT PERSON
CAN SERVE AS LAR.
NOW, THERE ARE VARIOUS TYPES OF
LARs, PROS AND CONS.
LAR IS JUST A PLACEHOLDER FOR A
PERSON WHO SERVES THAT FUNCTION,
THEY CAN QUALIFY THROUGH VARIOUS
WAYS DEPENNING ON POLICY OR LAW.
LEGAL GUARDIANS, LAWYERS LIKE
THIS BECAUSE IT'S CLEAR, LEGALLY
VERY CLEAR, THE JUDGE SAYS YOU,
I'M THE JUDGE, I'M TELLING YOU
TO MAKE DECISIONS ON THIS FOR
THAT PERSON.
THAT'S LEGAL GUARDIAN.
THAT LEGAL GUARDIAN AS I'LL
EXPLAIN DOESN'T HAVE TO BE THE
PERSON WHO KNOWS THE PERSON THE
PEST.
IT'S LEGAL CLARITY, DOESN'T
ALWAYS FOLLOW, SORT OF THE
COMMON SENSE ISSUES.
HEALTH CARE PROXIES ARE SECOND
MOST KIND OF LEGALLY CLEAR TYPE
OF QUALIFICATION.
THE SUBJECT GETS TO CHOOSE.
I ASK THIS PERSON TO BE MY
DECISION MAKER IF I CAN'T MAKE
THESE DECISIONS.
IN THIS CASE IT WAS FOR
HEALTHCARE DECISIONS.
HOWEVER, IT CAN BE USED
ACCORDING TO LAW FOR RESEARCH
CONSENT.
AND SINCE MANY PEOPLE DON'T HAVE
EITHER OF THE ABOVE, WE OFTEN
FALL TO THE DE FACTO FAMILY,
HEALTH CARE SURROGATE, VIRTUALLY
EVERY STATE HAS A LAW THAT SAYS
WHEN THE PERSON CAN'T GIVE
CONSENT TO TREATMENT, THESE ARE
THE ORDER IN WHICH YOU GO TO
SEEK PERMISSION.
OF COURSE, THIS IS NOT THE
PERSON THAT THE PERSON
SPECIFICALLY CHOSE.
SO IT DOESN'T HAVE THAT.
BUT IT IS DEFINED IN LAW.
WHAT WOULD BE NICE IF EVERYBODY
SAID, WELL, I MIGHT BE ASKED TO
BE IN RESEARCH WHEN I CAN'T
CONSENT SO I'LL FILL OUT A FORM
TO DESIGNATE WHO WILL DO THAT.
THAT'S NICE BUT NO ONE DOES IT.
WE HAVE STUDIES THAT SHOW EVEN
WHEN PEOPLE SAY I'M GOING TO DO
IT THEY DON'T DO IT.
IT JUST ISN'T HIGH ON PEOPLE'S
PRIORITY.
OKAY.
FOUR THROUGH EIGHT I PUT IN TO
GIVE A SENSE OF THE MOST COMMON
LEGAL HIERARCHY WHEN YOU DON'T
HAVE A PRE-SPECIFIED LEGAL
APPOINTEE.
I LEAVE THIS SLIDE IN TO LET YOU
KNOW, BECAUSE IT'S A GREAT
ARTICLE, YOU'LL BE SHOCKED BUT
ENTERTAINED BECAUSE IT'S SO WELL
WRITTEN.
I GIVE THIS EXAMPLE MAINLY TO
SHOW THAT EVEN THOUGH
GUARDIANSHIP IS LEGALLY CLEAR,
IT HAS -- IT CAN HAVE A LOT OF
PROBLEMS.
IT'S A REMINDER WE SHOULDN'T
EQUATE LEGAL CLARITY WITH
ETHICALLY OPTIMAL.
I REFER THIS ARTICLE TO YOU TO
READ.
WHAT PROPORTION OF ADULTS
PREPARE AN ADVANCE DIRECTIVE?
THIS IS IMPORTANT TO THIS TOPIC.
THERE WAS A MASSIVE AGGREGATE
REVIEW LOOKING AT DATA OVER 15
YEARS, AND IT SHOWED ONLY ABOUT
A THIRD OF THE PEOPLE HAD
COMPLETED ADVANCE DIRECTIVE, AND
PROXY DIRECTIVES, MEANING
APPOINTING SOMEBODY, WAS A
SUBSET, SIMILAR ACROSS YEARS
REVIEWED AND PATIENTS WITH
CHRONIC ILLNESS ANT HEALTHY
ADULTS.
BOTTOM LINE ONLY A SMALL
MINORITY HAVE DURABLE POWER OF
ATTORNEY OR HEALTH CARE PROXY.
ESSENTIALLY WE'RE GOING TO HAVE
TO RELY ON DE FACTO FAMILY
SURROGATES TO SERVE AS LARs.
AND SO IS THIS ACCEPTABLE?
FAMILIES DO PLAY KEY ROLE IN
CLINICAL SETTINGS REGARDING LIFE
AND DEATH DECISIONS SEE THIS
SEEMS VERY NATURAL.
SO BUT WHAT KIND OF RISK/BENEFIT
LIMIT SHOULD SUCH PERSONS HAVE
IN TERMS OF MAKING DECISIONS FOR
OTHER PEOPLE?
WE'VE STUDIED THIS TOPIC.
LET ME GIVE THE MOST COMMON
APPROACH MOST IRBs USE.
I SHOULD SAY THIS QUESTION OF
SHOULD THERE BE FURTHER
RESTRICTIONS ON RISK IS NOT PART
OF THE COMMON RULE.
IT'S NOT PART OF THE
REGULATIONS.
IT ONLY NOW CLARIFIES AND THAT
ONLY FROM A FEDERAL PERSPECTIVE
WHO CAN SERVE AS SURROGATE LAR,
IT DOESN'T SPECIFY HOW THEY DO
IT.
UNLIKE PEDIATRIC REGULATIONS
WHICH YOU'LL HEAR ABOUT, HOLLY,
THERE'S HIERARCHY OF DIFFERENT
RISK GROUPS ABOUT WHAT YOU CAN
AND CAN'T DO AND SO FORTH.
WHAT PEOPLE HAVE DONE IN IRBs
IN INSTITUTIONAL POLICIES TO
HAVE KIND OF ADOPTED THAT
PEDIATRIC FRAMEWORK, SO THERE'S
A CATEGORY CALLED PROSPECT FOR
DIRECT BENEFIT, THEY DISTINGUISH
FROM NO PROSPECT, LET'S SAY
PURELY PHYSIOLOGICAL STUDIES,
FOR EXAMPLE.
AND YOU CAN CATEGORIZE THAT AS
MINIMAL RISK OR MINOR INCREASE
OVER MINIMAL RISK WHICH I'M SURE
ALL OF OF YOU KNOW EXACTLY WHAT
IT MEANS, AND GREATER THAN MINOR
INCREASE WHICH IRBs ARE NOT
ALLOWED TO APPROVE.
AT THIS INSTITUTION, IN MANY
PLACES, AT THIS INSTITUTION YOU
CAN DO IT BUT ONLY IF THE HEAD
OF THE INTRAMURAL RESEARCH
PROGRAM APPROVES IT.
SO, IT'S A VERY -- AS FAR AS I
KNOW THERE'S ONLY BEEN ONE
INSTANCE IN OVER HOW MANY YEARS
THAT'S OCCURRED.
AND THE REASON FOR THAT IS THAT
SACHRP, THE ADVISORY COMMITTEE
ON OF I MENTIONED, POINTED OUT
IF YOU REALLY LIMIT THE RESEARCH
ONLY TO MINOR INCREASE OVER
MINIMAL RISK YOU COULD REALLY
RULE OUT IN THE FUTURE THE RARE
BUT VERY IMPORTANT RESEARCH THAT
COULD BE HIGHER RISK.
AND THIS IS BASICALLY WHAT IT'S
SAYING.
IT GIVES THE CRITERIA BY WHICH
YOU COULD TRY TO JUSTIFY DOING
THAT RESEARCH, THAT THE SPECIAL
GROUP THAT THE INSTITUTIONAL
OFFICIAL WOULD CONSTITUTE TO
REVIEW SUCH STUDIES.
OKAY.
SO LET ME JUST GO THROUGH SOME
DATA.
WHAT WE DID HERE WAS WE SURVEYED
NATIONAL REPRESENTATIVE SAMPLE
OF U.S. PUBLIC AGES 50 AND
OLDER.
AND WE ASKED THIS QUESTION.
IF PATIENTS CAN'T MAKE THEIR OWN
DECISIONS ABOUT BEING IN AND YOU
SEE THE FOUR COLUMNS, AND THESE
WERE TYPES OF PROCEDURES CLOSED
IN THE STUDY, THE VACCINE RCT IS
A LITTLE -- GENE TRANSFER WOULD
INVOLVE BRAIN SURGERY SO IT'S
HIGHLY INVASIVE.
SHOULD SOCIETY ALLOW FAMILIES TO
MAKE THE DECISION?
WE NOW THE MOST COMMENT
ONSCENARIO IS NOT HEALTH CARE
GUARDIAN, JUST FAMILIES, IS THAT
OKAY FOR PEOPLE WHO ARE AGED 50
AND OLDER?
ANDS THIS IS WHAT WE FOUND.
LUMBAR PUNCTURE, 72%.
DRUG RCT.
DRUG RCT WAS WHERE THEY WERE
TESTING ANTI-INFLAMMATORY DRUG,
FAIRLY LOW RISK.
VACCINE AND GENE TRANSFER, THIS
IS SIGNIFICANTLY PRO RESEARCH
KIND OF RESULT EVEN THOUGH THIS
IS QUITE INVASIVE.
NOW, AFTER WE DID THAT
NATIONALLY REPRESENTATIVE
SAMPLE, WHAT WE DID WAS BRING IN
173 SUCH FOLKS FROM THE PUBLIC,
THREE SEGMENTS, LARGE BANQUET
ROOM, SIX TO EIGHT PEOPLE EACH.
WE SPENT AN ENTIRE DAY
DISCUSSING THIS TOPIC.
SO THEY HEARD MUCH OF WHAT YOU
HEARD THE PROS AND CONS OF THIS
RESEARCH AND SO FORTH.
WE SURVEYED THEM BEFORE THEY
CAME IN AFTER GOING THROUGH THE
EXERCISE, YOU CAN SEE WHAT'S
STRIKING IS THAT AFTER PEOPLE
DISCUSSED A TOPIC, THEY ARE MUCH
MORE LIKELY TO SAY DEFINITELY
ALLOW FAMILY SURROGATES TO
PERMIT THIS KIND OF RESEARCH.
EVEN AT A PRETTY HIGH RISK
RESEARCH.
EVEN THOUGH THE NUMBERS MIGHT BE
SIMILAR, TRANSITION IS NOTABLE.
WHAT ACCOUNTS FOR IT?
ONCE PEOPLE TALK ABOUT THIS,
THIS IS THE KIND OF CONCLUSIONS
THEY REACH.
PARTICIPANT A, REMEMBER THESE
ARE LAYPEOPLE, PUBLIC FOLKS
BROUGHT IN AND THEY SPENT ALL
DAY TALKING ABOUT THIS WITH
EXPERTS AND PEERS.
IF THE ANSWER IS NO, YOU CAN'T
LET SURROGATES MAKE DECISIONS
FOR GENE TRANSFER STUDY, LET'S
SAY, THEN THERE'S NO HOPE FOR
EVER GETTING ANYWHERE.
PARTICIPANT B, BY VOTING NO WHAT
YOU'RE SAYING IS YOU'RE
ESSENTIALLY MAKING POLICY,
RIGHT?
THAT'S WHAT THIS PERSON IS
SAYING.
YOU'RE PUTTING YOURSELF IN A
POSITION OF IMPACTING EVERY
FAMILY WHO HAS ALZHEIMER'S.
SO, ONE OF THE THINGS THEY SEE
AND DISCUSS WHEN YOU'RE SITTING
IN THE ROOM IS THAT NOT JUST
WHAT WOULD YOU DO FOR YOUR OWN
LOVED ONE BUT AS A MEMBER OF
SOCIETY WHAT PERSPECTIVE WOULD
YOU TAKE?
THIS WAS A VERY INSIGHTFUL
COMMENT.
IT SEEMS AS THOUGH WE ALMOST
HAVE NO CHOICE BUT TO HAVE SOME
FORM OF SURROGATE SENT, THE
CHALLENGES BECOMES HOW DO WE
MAKE IT WORK AND BUILD
PROTECTIONs FOR THE
ALZHEIMER'S VICTIM, THE
PATIENTS.
ONE OF THE THINGS WE LOOKED AT
IN THIS WAS TO ASK THE LEEWAY
QUESTION, WE MEAN THE FOLLOWING.
THIS IS DIFFERENT FROM THE
POLICY QUESTION, SHOULD OUR
SOCIETY ALLOW IT.
BUT THIS QUESTION IS, DO YOU, IF
YOU BECAME INCAPACITATED, HOW
WOULD YOU WANT YOUR FAMILY TO,
WHATEVER.
THEY ANSWERED YES OR NO, ENROLL
ME, DON'T ENROLL ME.
THEN WE ALSO ASKED THEM, OKAY,
YOU SAID YOU WOULD WANT OR YOU
WOULDN'T WANT.
WHAT IF -- HOW MUCH FREEDOM OR
LEEWAY WOULD YOU GIVE YOUR
FAMILY MEMBER WHO WOULD HAVE TO
MAKE A DECISION FOR YOU WHEN YOU
CAN'T TO GO AGAINST WHAT YOU
JUST SAID?
SO YOU GAVE US A PREFERENCE.
WOULD YOU GIVE THEM THE FREEDOM
TO GO AGAINST WHAT YOU SAID?
ESSENTIALLY DOING OPPOSITE.
THIS IS WHAT WE FOUND.
ONLY A QUARTER OF PEOPLE SAY NO
LEEWAY WHATSOEVER.
OVERWHELMING MAJORITY OF PEOPLE
WOULD GIVE SOME LEEWAY OR
COMPLETE LEEWAY.
MINORITY, ONE IN SIX OR SO,
WOULD GIVE COMPLETE LEEWAY.
AND THE REST FELL IN THE MIDDLE.
NOW, AS YOU MIGHT EXPECT, PEOPLE
WHO SAID THEY DO WANT TO BE IN
IT AND YES MY FAMILY CAN
OVERTURN THAT WERE MORE LIKELY
TO GIVE LEEWAY BECAUSE THAT
SEEMS LIKE A SAFER OPTION THAT
THEY WOULD TAKE.
BUT THERE WAS A SIGNIFICANT
PROPORTION OF PEOPLE WHO SAID
I'M SAYING NO BUT I'LL LEAVE IT
TO MY FUTURE SURROGATE.
I THINK THIS IS IMPORTANT TO
THINK ABOUT BECAUSE BY THEORY WE
THINK, WELL, IF THE PERSON SAYS
A TODAY, THIS SHOULD LOCK IN THE
FUTURE FOREVER, AND THAT'S WHAT
PEOPLE INTEND.
WELL, THIS SHOWS, YOU KNOW, IT'S
MORE COMPLICATED.
AND THIS APPLIES TO NOT ONLY
RESEARCH ETHICS BUT ALSO IN
CLINICAL SITUATIONS TOO.
THERE'S INTERESTING STUDIES IN
THE CLINICAL SETTING OF THE SAME
METHODOLOGY.
OKAY.
DON'T BE ALARMED, FALL
ALLERGIES.
OKAY.
OTHER PROTECTIONS, AND I'M GOING
TO CLOSE WITH TWO EXAMPLES TO
COMPLICATE MATTERS A BIT.
TO REALLY PAY ATTENTION TO THE
FACTS ON THE GROUND AS PART OF
YOUR THINKING ABOUT THE ETHICS.
SO, THIS IS MR. A WITH
ALZHEIMER'S.
HE'S NOT ABLE TO GIVE
INDEPENDENT CONSENT.
HE'S A RETIRED PROFESSOR,
FINANCIALLY WELL OFF,
PSYCHOSOCIAL RESOURCES ARE AS
GOOD AS IT GETS FOR A PERSON IN
OUR SOCIETY.
SPOUSE, CHILDREN, SUPPORTIVE,
SAVVY AT USING THE INTERNET,
FINDING THE RIGHT KIND OF -- THE
KIND OF PEOPLE WE'RE SURROUNDED
BY IN THIS BUILDING ESSENTIALLY.
NOW, HE ENROLLS IN MINOR
INTERVENTION, MINOR EFFECT IN
THE EARLIER STUDY.
UP TO 1,000 PEOPLE RECEIVED THIS
DRUG, LET'S SAY.
THE GOAL IS TO SLOW DOWN THE
DISEASE.
HE STRONGLY WANTS TO BE IN THE
STUDY, ALTRUISTIC MOTIVE, ALSO
WANTS TO BENEFIT, IF IT
BENEFITS.
ALL RIGHT.
SO, HOW ALARMED WOULD WE BE
ABOUT THIS PERSON BEING ENROLLED
UNTIL A STUDY LIKE THIS?
HOLD THAT THOUGHT.
THE PERSON, REMEMBER, HE CAN'T
CONSENT.
IN CONTRAST THINK ABOUT MR. S,
HE MASS SCHIZOPHRENIA, MEETS
THRESHOLD FOR CAPACITY, ABLE TO
UNDERSTAND, CARRY ON A
CONVERSATION, GIVE ALL THE RIGHT
ANSWERS TO OUR QUESTIONNAIRE AND
INTERVIEW QUESTIONS.
HE CAN GIVE CONSENT FOR HIMSELF
IN .
HE'S SINGLE, SOCIAL UNEMPLOYED
AND ISOLATED, RACIAL AND ETHNIC
MINORITY, OFTEN THE CASE HERE.
RCT IS ALREADY MARKETED, NOT A
NEW PARADIGM, IN THEORY
DIFFERENT FORMULATION, COULD
OPTIMIZE BUT YOU MIGHT WONDER
THERE'S MARKETING CONSIDERATIONS
HERE, THAT DRUG COMPANY WANTS TO
EXTEND A PATENT.
OKAY.
SO THERE'S NO STRONG INCENTIVE
TO ENROLL IN THIS CASE.
HOW WOULD YOU FEEL ABOUT THIS
PERSON WHO IS COMPETENT BEING
ENROLLED IN THIS STUDY?
I WANT YOU TO THINK ABOUT
CONTRAST BETWEEN THE STUDIES
THAT CUTS ACROSS THE ISSUE OF
DECISION-MAKING CAPACITY.
SO I'M GOING TO END WITH THIS
LIST OF POTENTIAL OTHER
PROTECTIONS THAT WE SHOULD THINK
ABOUT.
IF IT'S REALLY IMPORTANT WE NEED
TO MAKE SURE THE WAY WE MEASURE
CAPACITY IS REALLY GROUNDED IN
VALID INSTRUMENTS AND CONCEPTS.
WE SHOULD TRY TO RESPECT THE
PRESERVED ABILITIES EVEN THOUGH
WE DRAW THIS LINE IN SOME SENSE
BETWEEN COMPETENT AND
INCOMPETENT.
AMONG THE PEOPLE DECLARED
INCOMPETENT THEY MIGHT HAVE WIDE
RANGE OF REMAINING ABILITIES.
THIS IS WHY WE TALK ABOUT ASSENT
DISSENT, COLLABORATIVE
DECISIONS.
THERE ARE DIFFERENT CATEGORIES
OF PEOPLE PROPOSED AND USED IN
RESEARCH SETTINGS TO PROTECT
PEOPLE WHO MAY BE VULNERABLE IN
THIS REGARD.
WE DO AT LEAST AN INFORMAL AND
SOMETIMES MORE FORMAL ASSESSMENT
OF THE SURROGATES TO SEE IF THEY
ARE IN THE RIGHT POSITION TO
PROVIDE KIND OF NOT ONLY
ACCURATE REPRESENTATION OF THE
PERSON, THE PRINCIPLE, BUT ALSO
HAVE THEIR BEST INTEREST AT
HEART.
AND THERE MAY BE OTHERS.
BUT I WANT YOU TO THINK ABOUT
THESE OTHER PROTECTIONS THAT ARE
AVAILABLE FOR IRBs TO USE IN
THE RIGHT KIND OF SETTINGS.
AND THESE SHOULD BE TAILORED TO
CONTEXT.
THE CONTEXT REALLY MATTERS, AS I
ILLUSTRATED TO YOU.
OKAY.
I'M A MINUTE AND 30 SECONDS
EARLY.
>>THANK YOU, SCOTT.
BIG ROUND OF APPLAUSE.
[APPLAUSE]
THANK YOU SO MUCH.
AND JUST AS A REMINDER WE'LL
HAVE CAROL SQUIRES JOIN US AFTER
THE BREAK.
AND TALK ABOUT AN EXAMPLE OF
THAT FIRST TYPE OF SORT OF
FORMAL CAPACITY ASSESSMENT, SO A
COUPLE QUESTIONS.
I'M NOT EXACTLY SURE ABOUT THIS
QUESTION BUT I'M GOING TO ASK IT
AND MAYBE WE CAN FIGURE IT OUT.
ON THE HEALTH CARE PROXY IS
THERE A SPECIFICATION THAT IT
CAN BE USED FOR RESEARCH
CONSENTING PURPOSES?
AND THEN THE FOLLOW-UP IS, DOES
THE PERSON IN QUESTION KNOW OR
HAVE TO OPT OUT FROM RESEARCH IF
HE OR SHE PREFERS?
I THINK WHAT THEY ARE ASKING
DOES A HEALTH CARE
PROSPECTIVELIY -- PROXY HAVE TO
HAVE THAT?
>>THERE ARE A LOT OF DETAILS IS
THE RIGHT WAY TO PUT IT.
HEALTH CARE PROXY JUST MEANS
THAT THERE'S SOME LEGAL
MECHANISM THE PERSON USED TO
APPOINT SOMEBODY FOR
HEALTH-RELATED DECISION MAKING.
THAT CAN -- DEPENDING ON THE
INSTITUTION OR THE STATE, THAT
FORM WILL VARY.
SO OUR CLINICAL CENTER FORM
ACTUALLY HAS PARTS WHERE YOU CAN
ACTUALLY APPOINT PEOPLE TO SERVE
AS RESEARCH PROXY.
SO, I DIDN'T GO INTO IT, BUT
THERE'S THIS CONCEPT OF
CONCURRENT PROXY, MEANING
REMEMBER I SAID DECISION MAKING
CAPACITY CAN BE -- YOU CAN DO A
BUT NOT B.
SUPPOSE YOU CAN'T CONSENT FOR
THE STUDY, BUT YOU'VE BEEN
DETERMINED ABLE TO APPOINT A
PROXY, THAT'S POSSIBLE, SO FOR
THOSE FOLKS YOU MIGHT ACTUALLY
HAVE THEM FILL OUT A PROXY,
APPOINT SOMEBODY AND SAY -- THEN
SAY, YES, I WANT TO BE IN
RESEARCH IN THE FUTURE OR NOT
AND SO FORTH.
THAT WILL VARY BY INSTITUTION.
THE QUESTION OF ACTUALLY
SPECIFYING I WANT TO BE IN A
NOT, THAT CONSTITUTES
INSTRUCTIONAL DIRECTIVE, OR
LIVING WILLS, THAT WILL VARY AS
WELL.
IT'S AN INTERESTING -- I COULD
GO ON.
IT DEPENDS WHAT IS THE
SIGNIFICANCE OF THAT?
WELL, THAT WOULD DEPEND ON HOW
LAWS REGULATING HEALTH CARE
PROXIES IN THAT JURISDICTION.
>>RIGHT.
IN CASE THIS IS EMBEDDED, THAT
PERSON WOULD ALWAYS HAVE THE
OPTION TO SAY NO, RIGHT?
IF YOU'RE MY PROXY, AND, YOU
KNOW, ETHAN TELLS YOU ABOUT THE
STUDY.
>>THAT'S RIGHT.
A PERSON WHO IS CAPABLE OF
DISSENTING WILL SAY NO.
AND THAT CARRIES THE DAY.
SO IN THE RESEARCH SETTING, THE
PERSON'S NO CARRIES A LOT OF
WEIGHT.
>>ANDREW?
>>A QUESTION ABOUT ASSENT.
ASSENT MAKES AT LEAST IN MY
MIND, IT'S CLEAR WHEN WE'RE
THINKING ABOUT CHILDREN.
PARENTS OR GUARDIANS CAN GIVE
CONSENT BUT YOU TALK TO CHILDREN
AND THEY CAN GIVE ASSENT.
WHAT ABOUT IN CASES YOU'RE
TALKING ABOUT, SAY, FOR
ALZHEIMER'S WHEN THE LEGAL
GUARDIANS WOULD GIVE CONSENT BUT
DEPENDING WHEN YOU'RE TALKING TO
THE SUBJECT THE ANSWER MAY
CHANGE?
IF THEY ARE IN A LUCID OR
NON-LUCID STATE.
>>WHAT WAS THE LAST SENTENCE?
WHAT DO YOU DO IN ALZHEIMER'S
PATIENTS FOR EXAMPLE WHEN THEY
MAY OR MAY NOT GIVE YOU THE SAME
ANSWER DEPENDING WHEN YOU TALK
TO THEM.
>>OH, RIGHT, OKAY.
THERE'S A COUPLE QUESTIONS IN
THERE.
ONE IS THE QUESTION OF WHEN IS
IT A TRUE DISSENT YOU HAVE TO
RESPECT, HOW SUSTAINED SHOULD IT
BE?
THE OTHER IS SORT OF
COORDINATING BETWEEN THE PERSON
WHO GIVES CONSENT AND THE
PATIENT OR THE RESEARCH
PARTICIPANT OR SUBJECT HIMSELF.
WE'LL START WITH THE SECOND ONE.
THERE'S NO ABSOLUTE GUIDANCE ON
THIS.
YOU HAVE TO USE JUDGMENT BECAUSE
A PERSON MAY SAY NO, YOU DON'T
KNOW IF THEY ARE SAYING NO TO
RESEARCH WITH THAT IN MIND OR
THEY ARE JUST EXPRESSING
SOMETHING NEGATIVE IN THE
CURRENT PRESENT CONTEXT, RIGHT?
SO, YOU CAN'T WRITE RULES TO
REGULATE THOSE KIND OF THINGS
AHEAD OF TIME.
THAT'S WHY YOU HAVE EXPERIENCED
CLINICIANS WHERE HAVE TO
EXERCISE THEIR JUDGMENT.
YOU CAN PROVIDE SOME GUIDANCE.
BUT IF IT'S A CONSISTENT NO,
OBVIOUSLY PEOPLE WOULD SAY,
YEAH, YOU CAN'T DO THAT.
SO AN EXAMPLE WOULD BE THE
FOLLOWING.
THE PERSON WHO REALLY IS
UNCOMFORTABLE DOING A CERTAIN
PROCEDURE AND EVERY TIME YOU TRY
TO DO IT THEY MOVE AND THEY SAY
NO, WELL, YOU KNOW, THAT BECOMES
PRETTY CLEAR.
ON THE OTHER HAND, THE PERSON
SAYS NO, YOU THINK, OKAY, LET'S
SEE, YOU WAIT, COME BACK NEXT
DAY, THEY ARE HAPPIER, THEY
COOPERATE, THEY DO THE THING.
THEN YOU HAVE SOME INDICATION
THAT IT'S MORE OF A TEMPORARY
THING.
DOES THAT HELP?
AND IN TERMS OF THE COORDINATION
WITH THE PATIENTS AND THEIR
SURROGATE, I THINK THE PARADIGM
REALLY IN ALZHEIMER'S RESEARCH
WHEN THE FOCUS WAS INDEED,
PEOPLE WITH SIGNIFICANT
IMPAIRMENTS, WAS REALLY TRYING
TO WORK TOGETHER WITH THE
SUBJECT AND THE PERSON WHO
PROVIDES CONSENT.
PEOPLE USE THE TERM STUDY
PARTNER, A TEAM APPROACH, BUT
LEGAL AUTHORITY ULTIMATELY OF
COURSE HAS TO FALL ON A SINGLE
PERSON.
>>WE'LL TAKE ISABELLE, IF WE
HAVE TIME ONE MORE OR WE'LL
FINISH WITH ISABELLE.
>>I JUST HAD TWO QUESTIONS
RELATED TO THE LEEWAY STUDY.
ONE, I WAS CURIOUS ABOUT REASONS
PEOPLE GAVE FOR WANTING SOME
LEEWAY.
I WANTED TO HEAR MORE AND THE
SECOND QUESTION WAS I WAS
CURIOUS WHAT WAS THE NATURE OF
THE INCAPACITY THAT YOU GAVE IN
THE EXAMPLE TO THESE
PARTICIPANTS?
WAS IT SOMETHING WHERE WE'RE
TALKING ABOUT LIKE A CONDITION
THAT'S WORSENING WHERE THEY ARE
UNLIKELY TO REGAIN CAPACITY AND
THAT'S THE SITUATION OR IT'S A
VERY TEMPORARY INCAPACITY,
BECAUSE I WOULD IMAGINE YOU
WOULD RECEIVE DIFFERENT ANSWERS.
>>IN THE SETTING OF
ALZHEIMER'S, PROGRESSIVE
IRREVERSIBLE DECLINE, AND WHAT
REASONS THEY HAD, IT WAS A
SURVEY QUESTION.
WE DIDN'T ELICIT THE QUALITATIVE
ANSWERS FOR THAT.
YOU CAN LOOK UP STUDIES AND
RELATED FIELDS IN WHICH PEOPLE
MIGHT GIVE ALL SORTS OF
DIFFERENT REASONS FOR IT.
IT'S LIKE, FOR EXAMPLE, IN THE
DISCUSSIONS PEOPLE MIGHT SAY,
WELL, LOOK, I DON'T WANT TO BE
IN IT NOW BUT, HEY, IF THEY
THINK IT'S REALLY PROMISING WHY
NOT?
BUT RIGHT NOW THIS IS HOW I
FEEL.
THINGS LIKE THAT.
>>BRIEF FOLLOW-UP, HOW DOES
THAT MAKE YOU THINK ABOUT THE
ROLE OF ADVANCE DIRECTIVES WHERE
PEOPLE ARE SPECIFYING TREATMENTS
THEY WANT IN THE FUTURE IF WE
TAKE INTO ACCOUNT PEOPLE ARE
CHANGING THEIR MINDS A LOT OR
ALSO WANT, SAY I'M
INCAPACITATED, IT MIGHT MATTER
MORE HOW MY FAMILY FEELS ABOUT
THE SITUATION OR MY LOVED ONES
FEEL THAN SOME PARTICULAR
SPECIFICATION ABOUT TREATMENT IN
ADVANCE, FOR EXAMPLE.
>>THAT'S A HUGE TOPIC.
NOT ABOUT RESEARCH ETHICS
SPECIFICALLY.
I WOULD SAY IT'S PROBABLY A FAIR
STATEMENT -- HOW CAN I SAY THIS
WITHOUT SOUNDING TOO
CONTROVERSIAL?
IT'S POSSIBLE WE COULD BE IN THE
GRIP OF A THEORY TO THINK WE CAN
PIN DOWN THE FUTURE THROUGH
PRESENT AUTONOMY FRAMEWORK, BUT
PEOPLE IN THE REAL WORLD WHEN
THEY MAKE DECISIONS HAVE MUCH
BROADER SET OF CONSIDERATIONS,
LET'S LEAVE IT AT THAT.
>>WE CAN REFER YOU TO SOME
LITERATURE.
THIS IS SLIGHTLY OFF TOPIC BUT
SOMEONE ASKED, THEY HAVE HEARD
HERE IN THE UNITED STATES THERE
ARE SOME CIRCUMSTANCES WHERE YOU
CAN DO RESEARCH ON AN INDIVIDUAL
WITHOUT CONSENT.
IN AN EMERGENCY CONTEXT.
I DON'T KNOW IF YOU WANT TO SAY
SOMETHING ABOUT THAT OR WE CAN
--
>>YEAH, IS THERE A TALK ON
THAT?
>>NO.
>>THE MOST TALKED ABOUT AND
DISCUSSED SITUATION WHERE A
PERSON WHO CAN'T GIVE CONSENT,
WOULD YOU DO THAT, WOULD BE THE
EXCEPTION FROM CONSENT --
>>I ARRIVE AT THE HOSPITAL --
>>FDA REGULATIONS, FOR EXAMPLE,
STUDIES THAT TEST OUT BLOOD
SUBSTITUTES IN THE EMERGENCY,
OUT IN THE FIELD WHEN SOMEBODY'S
BLEEDING, OBVIOUSLY YOU CAN'T
GET CONSENT, THEIR SURROGATE IS
NOT AVAILABLE, YOU HAVE TO MAKE
A DECISION RIGHT THERE.
THERE'S A SET OF GUIDELINES HOW
THIS HAS TO BE, YOU KNOW, ALL
SORTS OF CONDITIONS HAVE TO BE
MET BEFORE THEY CAN DO THAT.
YES, THAT'S TRUE, BUT THAT'S
DIFFERENT FROM THE QUESTION
OF -- SOMEWHAT DIFFERENT.
RELATED OBVIOUSLY.
>>I CAN POST THOSE FDA
GUIDELINES ONLINE.
THANK YOU AGAIN, DR. KIM.
>>OKAY.
[APPLAUSE]
JUST TO GIVE YOU ALL A SENSE OF
THE PLAN FOR THE REST OF THE
DAY, WE'RE GOING TO TAKE OUR
BREAK AT 10:20 AND THEN WE'RE
GOING TO BE JOINED BY CAROL
SQUIRES WHO IS GOING TO TALK TO
US ABOUT HOW THIS PROCESS OF
ASSESSMENT OF CAPACITY WORKS IN
THE CLINICAL CENTER.
IT'S KIND OF THE WORLD.
AND WE'RE GOING TO INCLUDE SOME
SLIDO QUESTIONS, AND SO I EAR
MAILED YOU ALL TO BE ON ALERT.
I E-MAILED YOU TO BE ON ALERT.
I'LL SAY THE NUMBER NOW AND
BEFORE CAROL'S TALK, I WILL ALSO
SEND IT OUT AS AN E-MAIL WHILE
YOU'RE ON BREAK.
IT'S 232-1871.
AND PLEASE JUST USE IT FOR THE
QUESTIONS I'M GOING TO ASK YOU.
YOU CAN USE IT TO CHITCHAT BUT
I'M NOT GOING TO PAY ATTENTION
TO THOSE QUESTIONS.
IF YOU HAVE QUESTIONS POST THEM
IN THE DISCUSSION BOARD.
WITH THAT, WE'LL TAKE OUR BREAK.
IT'S ABOUT 10:20 HERE.
LET'S COME BACK TOGETHER AT
10:35.
THANK YOU ALL.
>>WELCOME BACK, EVERYBODY.
TWO QUICK ANNOUNCEMENTS.
THE WORD OF THE DAY IS ASSENT.
WE'VE TALKED ABOUT THAT A COUPLE
TIMES.
AND THE CODE FOR SLIDO WHICH I
SENT OUT BY E-MAIL AND
ANNOUNCEMENT IS 232 1871, WE'LL
BE USING THAT ONCE CAROL JOINS
US TO GET YOUR INPUT ON TWO
CASES.
IT'S MY GREAT PLEASURE TO
INTRODUCE CAROL SQUIRES,
GRACIOUS ENOUGH TO STEP IN FOR
KATIE TODDMAN WHO CAN'T JOIN US
TODAY.
SHE AND KATIE AND OTHERS ARE
PART OF THE HUMAN SUBJECTS
PROTECTION UNIT IN NATIONAL
INSTITUTE OF MENTAL HEALTH.
YOU KNOW THAT THERE ARE
PARTICULAR ISSUES THAT COME UP
IN THAT SETTING, GIVEN WHAT YOU
HEARD FROM SCOTT, SO THEY ARE
THERE TO SERVE THE INTRAMURAL
PROGRAM.
WITH THAT, I'M GOING TO STAND IT
OVER TO CAROL.
SHE'S GOING TO TALK FOR A BIT
AND WE'RE GOING TO LAUNCH INTO
TWO CASES..
>>THANK YOU VERY MUCH, HOLLY.
THANK YOU ALL FOR BEING HERE
TODAY.
NEXT SLIDE PLEASE.
HERE IS MY DISCLAIMER.
HSPU IS COMPRISED OF CLINICAL
RESEARCH ADVOCATES, CLINICIANS
TRAINED IN BIOETHICS AND
INDEPENDENT OF THE RESEARCH
TEAM.
HSPU STAFF ARE CLINICIANS,
EXPERIENCED AS ADVOCATES FOR
RESEARCH PARTICIPANTS.
ADDITIONALLY WE ARE MEMBERS OF
THE ABILITY TO CONSENT
ASSESSMENT TEAM.
WHICH IS A COMBINATION OF THE
HSPU AND CLINICAL CENTER
BIOETHICS DEPARTMENT WHO PERFORM
CAPACITY ASSESSMENTS THROUGHOUT
THE CLINICAL CENTER.
NEXT SLIDE PLEASE.
OUR HSPU FUNCTIONS INCLUDE WE
PROVIDE PROTECTION AND ADVOCACY
FOR HUMAN SUBJECTS, WITH FOCUS
ON POTENTIALLY VULNERABLE
PARTICIPANTS AND POPULATIONS.
WE ASSESS, DEVELOP, IMPLEMENT
LEVELS OF PROTECTION IN ALL
PHASES OF RESEARCH.
WE ASSIST IN THE APPLICATION OF
FEDERAL NIH AND NIMH HUMAN
SUBJECTS RESEARCH REGULATIONS
AND POLICIES.
WE ALSO PROVIDE EDUCATION SUCH
AS THIS CLASS.
THE NIMH OFFICE OF THE CLINICAL
DIRECTOR REQUIRES CONSENT
TRAINING FOR ALL INVESTIGATORS
WHO WILL BE OBTAINING INFORMED
CONSENT FROM PARTICIPANTS IN
NIMH STUDIES AT THE CLINICAL
CENTER.
NEXT SLIDE PLEASE.
TO ADDRESS NEED FOR A SYSTEMATIC
APPROACH TO ASSESS POTENTIAL
RESEARCH PARTICIPANTS, WHOSE
ABILITY TO CONSENT MAY BE
UNCERTAIN, THE NATIONAL
INSTITUTE OF MENTAL HEALTH HAS
CREATED THE HUMAN SUBJECTS
PROTECTION UNIT, THAT EVALUATES
WHETHER PERSONS HAVE THE
CAPACITY TO CONSENT AND IF NOT,
WHETHER RETAIN ABILITIES TO
ASSIGN DECISION MAKER, WHETHER
ALSO THEY ARE APPROPRIATE TO
MAKE DECISIONS ON BEHALF OF
INCAPACITATED PARTICIPANT.
HAVING SUCH A CONSULTATION
SERVICE THAT IS INDEPENDENT OF
RESEARCH PERSONNEL CAN BE USEFUL
BECAUSE IT IS LIKELY TO BE FREER
OF CONFLICTS OF INTEREST THAN
RESEARCH TEAM AND MAY THEREFORE
BE ABLE TO PROVIDE A MORE
OBJECTIVE ASSESSMENT BY VIRTUE
OF THEIR DISTANCE FROM THE
RESEARCH.
FURTHERMORE, SUCH CONSULTANTS
HAVE SPECIAL TRAINING AND
EXPERIENCE IN PERFORMING
CAPACITY ASSESSMENTS THAT
RESEARCH TEAMS ARE UNLIKELY TO
HAVE, SUCH A CONSULTATION
SERVICE CAN PLAY A CRUCIAL ROLE
IN CONDUCT OF ETHICALLY
RESPONSIBLE CLINICAL RESEARCH
AND SERVE AS AN IMPORTANT
PROTECTIVE FUNCTION BY KEEPING
INCAPACITATED ADULTS FROM BEING
INAPPROPRIATELY ENROLLED OR
EXCLUDED.
CAPACITY AND COMPETENCE ARE
TERMS THAT ARE OFTEN USED
INTERCHANGEABLY.
FOR OUR PURPOSES, CAPACITY
REFERS TO THE ONE-TIME CLINICAL
JUDGMENT OF A POTENTIAL
SUBJECT'S ABILITY TO GIVE
INFORMED CONSENT.
IN OTHER WORDS, IT'S A SNAPSHOT
ABOUT AN INDIVIDUAL'S ABILITY TO
MAKE A DECISION ABOUT A
PARTICULAR PROTOCOL.
IT IS POSSIBLE SOMEONE COULD
HAVE CAPACITY FOR ONE PROTOCOL
AND NOT ANOTHER.
FOR EXAMPLE, ONE COULD
ADEQUATELY UNDERSTAND AND MAKE A
DECISION ABOUT AN MRI STUDY
INVOLVING ONE VISIT FOR AN MRI
VERSUS A MORE COMPLICATED
LENGTHY DOUBLE BLIND PLACEBO
CONTROLLED STUDY WITH AN
INVESTIGATIONAL MEDICATION.
THE OUTCOMES OF THESE
ASSESSMENTS HAVE NO BEARING ON
AN INDIVIDUAL'S ABILITY TO MAKE
OTHER DECISIONS OR THEIR LEGAL
AUTHORITY TO MAKE DECISIONS.
FOR EXAMPLE, WHEN WE'RE
ASSESSING SOMEONE, WE'RE NOT
LOOKING AT WHETHER THEY CAN LIVE
INDEPENDENTLY OUTSIDE OF THE
CLINICAL CENTER.
WE'RE JUST LOOKING AT THE IDEA
OF THEIR UNDERSTANDING ABOUT THE
STUDY THEY ARE ABOUT TO
PARTICIPATE IN.
NEXT SLIDE PLEASE.
CAPACITY ASSESSMENTS MAY BE
INITIATED BY RESEARCHER REQUEST,
ORGANIZATIONAL POLICY, OR AN IRB
REQUIREMENT.
NEXT SLIDE PLEASE.
THE HSPU CREATES AND ADMINISTERS
TWO TYPES OF CAPACITY
ASSESSMENT.
FIRST, THE PROTOCOL-SPECIFIC
CAPACITY ASSESSMENT USED WHEN A
PROTOCOL ROUTINELY REQUIRES SOME
OR ALL POTENTIAL PARTICIPANTS TO
BE FORMALLY ASSESSED PRIOR TO
CONSENTING BECAUSE RESEARCH TEAM
AND IRB ANTICIPATE A HIGH
PROBABILITY OF CAPACITY TO
CONSENT AMONG THE STUDY
POPULATION.
IT'S CREATED IN ADVANCE OF
PARTICIPANTS AND EXPECTED
RESPONSES TO QUESTIONS HAVE BEEN
DEVELOPED.
GENERIC CAPACITY ASSESSMENT IS
USED AS GUIDE FOR ASSESSMENT OF
INDIVIDUALS WHO ARE BEING
CONSIDERED FOR ENROLLMENT IN A
PROTOCOL THAT NORMALLY DOES NOT
ENROLL COGNITIVELY IMPAIRED
INDIVIDUALS.
IT CONSISTS OF GENERIC QUESTIONS
AND RESPONDENT ANSWERS ARE
EXPECTED TO BE APPROPRIATE TO
PROTOCOL IN QUESTION.
EXAMPLES CAN BE FOUND AT THE
WEBSITE BELOW ON THIS SLIDE IN
THE NIMH TOOLKIT FOR HUMAN
SUBJECTS PROTECTIONS.
I WILL PUT A PLUG IN FOR THE
TOOLKIT.
IT IS EXTRAORDINARILY THOROUGH
AND IT WAS A COMBINED EFFORT
WITH MY COLLEAGUE KATIE TODDMAN
REALLY TAKING A LEAD ON THIS BUT
WORTH TAKING A LOOK.
>>WE ACTUALLY POSTED IT IN THE
COURSE.
>>GREAT.
GREAT.
NEXT SLIDE PLEASE.
CAPACITY ASSESSMENT TOOLS ARE
CLINICALLY DERIVED AND HAVEN'T
BEEN VALIDATED.
BOTH PROTOCOL SPECIFIC AND
GENERIC ASSESSMENT TOOLS ASSESS
THE FOUR DOMAINS THROUGH A
SERIES OF NINE TO ELEVEN
OPEN-ENDED QUESTIONS WHICH MAY
LEAD TO FURTHER FOLLOW-UP
QUESTIONS.
THE FIRST DOMAIN IS
UNDERSTANDING.
WHEN WE'RE LOOKING AT THAT,
WE'RE TRYING TO GET A BETTER
IDEA OF THE UNDERSTANDING OF THE
POTENTIAL PARTICIPANT'S PERSONAL
SITUATION.
SOME EXAMPLES OF QUESTIONS IN
THAT REGARD WOULD BE WHAT IS THE
ILLNESS OR MEDICAL CONCERN THAT
BRINGS YOU HERE TODAY?
WHAT DO YOU HAVE THAT THE
INVESTIGATORS ARE INTERESTED IN
UNDERSTANDING BETTER?
WE ALSO WANT TO KNOW THEIR
UNDERSTANDING ABOUT
STUDY-SPECIFIC PROCEDURES OR
TASKS.
A QUESTION WOULD BE WHAT WILL
YOU BE ASKED TO DO AS PART OF
THE STUDY?
WHAT ARE THE POTENTIAL RISKS AND
POTENTIAL BENEFITS OF EITHER THE
TASKS THEMSELVES OR THE OVERALL
STUDY.
A QUESTION FOR THAT WOULD BE
WHAT ARE THE MOST IMPORTANT
RISKS TO YOU?
HOW DO YOU FEEL ABOUT
PARTICIPATING IN RESEARCH THAT
IS DESIGNED TO HELP OTHERS IN
THE FUTURE?
WE HAVE SEVERAL OF THOSE STUDIES
IN MENTAL HEALTH WITH NO DIRECT
BENEFIT BUT IT REALLY IS ABOUT
ANSWERING THE LARGER QUESTION
AND HELPING THE FUTURE.
ALTERNATIVES, WHAT ARE THE
DIFFERENCES BETWEEN BEING IN
THIS RESEARCH AND OTHER
TREATMENT OPTIONS?
THE SECOND DOMAIN THEN IS
APPRECIATION, AND I SHOULD
MENTION THESE DOMAINS BUILD ONE
ON THE OTHER AS YOU'RE TALKING
AN INDIVIDUAL.
SO WE WANT TO KNOW THAT THE
PERSON CAN APPRECIATE THE
EFFECTS OF STUDY PARTICIPATION,
ON THEMSELVES.
FOR EXAMPLE, WE HAVE TO STOP ANY
CURRENT TREATMENT -- WILL YOU
HAVE TO STOP CURRENT TREATMENT
OR MEDICATION TO COME INTO THE
STUDY?
ONE THING WE ASK BECAUSE WE'VE
GOT A LENGTH ANY STUDY THAT
COULD LAST SEVERAL MONTHS, ARE
YOU GOING TO HAVE TO TAKE TIME
OFF FROM SCHOOL OR JOB IF YOU'RE
WORKING, DO YOU HAVE A PET,
SOMEBODY TO WATCH THEM, ARE YOU
TRAVELING FROM ANOTHER PART OF
THE COUNTRY IN ORDER TO GET
HERE?
SO, HOW IS THIS GOING TO AFFECT
YOU DIRECTLY BY BEING HERE?
ALSO WE WANT TO KNOW WHY THEY
WOULD WANT TO BE -- PART OF THE
NEXT DOMAIN IS REASONING.
WHAT WOULD BE THE REASON OR
RATIONALE WHY SOMEBODY WANTS TO
PARTICIPATE IN RESEARCH?
WE SAY WE'RE NOT THE MOTIVATION
POLICE.
POLICE HAVE DIFFERENT REASONS
AND RATIONALES FOR WHY THEY WANT
TO PARTICIPATE BUT WE WANT TO
KNOW WHAT THEY ARE THINKING.
ONE QUESTION WE MIGHT ASK WHY DO
YOU THINK PARTICIPATING IS THE
BETTER OPTION FOR YOU?
AGAIN, WHAT WE'RE LOOKING AT IS
WHETHER SOMEBODY IS THINKING,
FOR EXAMPLE, BASED ON
RISK/BENEFIT LEVEL IF THEY ARE
SAYING IF I COME INTO THIS STUDY
YOU'LL BE ABLE TO CURE ME.
WELL, IT MAY NOT BE A TREATMENT
STUDY.
IT MAY BE WILL HELPING THE
FUTURE, GATHERING INFORMATION.
SOMEONE'S RATIONALE FOR DOING
THAT MIGHT BE I KNOW IT'S NOT
GOING TO HELP ME DIRECTLY BUT I
WANT TO HELP THE FUTURE.
OR I MIGHT GET MORE INFORMATION
ABOUT MY OWN INDIVIDUAL
SITUATION THAT MIGHT HELP ME
MAKE BETTER CHOICES OR
DECISIONS.
I MIGHT BE EDUCATED AND LEARN
SOME THINGS THAT WILL HELP ME AS
I GO HE FORWARD.
THOSE ARE THE KINDS OF QUESTIONS
AND CONVERSATIONS THAT WE'RE
HAVING WITH FOLKS AT THAT POINT.
THE LAST DOMAIN IS CHOICE.
WHOSE DECISION IS IT TO ENROLL
IN THIS STUDY?
WHAT WOULD HAPPEN IF YOU DIDN'T?
ONE OF THE QUESTIONS WE ALWAYS
ASK INDIVIDUALS AT THIS POINT IS
LOU -- HOW WOULD YOU LET THE
RESEARCHERS KNOW IF YOU DECIDED
YOU DIDN'T WANT TO PARTICIPATE?
SOMETIMES WE'LL FIND FOLKS ARE
CONCERNED ABOUT NOT
PARTICIPATING, THEY ARE LETTING
SOMEBODY DOWN, WHETHER IT'S
PERHAPS A FAMILY MEMBER OR
RESEARCHERS THEMSELVES.
WE WANT PEOPLE TO THINK FROM THE
BEGINNING, YOU KNOW, RESEARCH
DOESN'T WORK FOR EVERYBODY.
THERE CAN BE A LOT OF DIFFERENT
REASONS SOMEBODY CAN'T
PARTICIPATE.
SO WE WANT THEM TO BE THINKING
HOW WOULD THEY TALK TO THE TEAM
ABOUT THIS.
WE WANT THEM TO FEEL COMFORTABLE
ENOUGH TO HAVE THAT
CONVERSATION.
THE THRESHOLDS ON SUFFICIENCY
FOR EACH OF THESE DOMAINS ARE
WITH RARE EXCEPTION BASED ON THE
JUDGMENTS BY TWO EVALUATORS WHO
MUST REACH AND AGREEMENT
REGARDING THEIR RECOMMENDATIONS,
EACH EVALUATOR RATES POTENTIAL
PARTICIPANT'S ANSWER TO
QUESTIONS PERTAINING TO THE FOUR
DOMAINS.
WE WANT TO SEE DO THEY
UNDERSTAND, DO THEY HAVE PARTIAL
UNDERSTANDING, ARE THEY NOT
UNDERSTANDING AT ALL WHAT THE
STUDY IS ABOUT?
AND TWO EVALUATORS MAKE OVERALL
ASSESSMENT MUCH INDIVIDUAL'S
CAPACITY FOR CONSENT.
NEXT SLIDE PLEASE.
THIS IS A PAGE FROM ONE OF OUR
CAPACITY ASSESSMENT TOOLS.
SO, THE NUMBERS FOLLOWING THE
QUESTIONS LIKE THE NUMBER 1 THAT
REFERS TO THE IDEA THAT SOMEONE
IS ABLE, THAT THEY ARE
UNDERSTANDING WHAT YOU'RE ASKING
AND ABLE TO UNDERSTAND THAT
QUESTION.
2, IT'S QUESTIONABLE ABILITY,
MAYBE THEY ARE GETTING PART BUT
NOT THE FULL UNDERSTANDING OF
WHAT YOU'RE ASKING THEM TO TALK
TO YOU ABOUT IN TERMS OF WHAT'S
INVOLVED IN THE STUDY.
OR 3, THEY ARE UNABLE TO
UNDERSTAND THAT PARTICULAR
QUESTION.
THEY ARE RATINGS, BUT THEY ARE
NOT A SCORE.
THEY ARE USED AS INDICATORS OF
AREAS OF CONCERN FOR RATERS TO
DISCUSS AFTER THE INTERVIEW IS
COMPLETE.
THE INTERVIEW MAY BE STOPPED IF
IT'S CLEAR THAT AN INDIVIDUAL
DOESN'T HAVE CAPACITY PRIOR TO
ALL THE QUESTIONS BEING
ADMINISTERED.
WE DON'T FEEL LIKE YOU HAVE TO
FORCE SOMEONE TO CONTINUE TO NOT
BE ABLE TO ANSWER QUESTIONS IF
IT'S CLEAR THAT THEY ARE NOT
UNDERSTANDING.
ONE IMPORTANT PIECE IS A
PARTICIPANT MUST BE EDUCATED
ABOUT THE STUDY BEFORE HAVING
THEIR CAPACITY TO CONSENT
ASSESSED.
US ASKING INDIVIDUALS QUESTIONS
ABOUT THE TASKS THEY WILL BE
ASKED TO DO IF SOMEONE HAS NOT
DISCUSSED AHEAD OF TIME IT'S NOT
FAIR TO ASK THAT QUESTION.
WE ENSURE THAT INVESTIGATORS HAD
AN OPPORTUNITY TO EDUCATE THE
INDIVIDUAL BEFORE THE ASSESSMENT
TAKES PLACE.
NEXT SLIDE PLEASE.
AGAIN, I GIVE ALL THANKS TO MY
CO-WORKERS KATHERINE TODDMAN WHO
DEVELOPED THIS ASSESSMENT
ALGORITHM TRYING TO DISTILL IT
DOWN SO IF AN INVESTIGATOR IS
TAKING IT LOOK IT WALKS THEM
THROUGH THE BEGINNINGS OF
EDUCATING A PARTICIPANT ABOUT
THE STUDY THEIR CAPACITY IS
BEING ASSESSED FOR THROUGH
ASSESSING THEIR CAPACITY AND
THEN ULTIMATELY AN OUTCOME.
THIS IS TO HELP WALK THEM
THROUGH THE PROCESS AHEAD OF
TIME.
NOW WE GO TO VIGNETTE 1.
THANK YOU.
INVESTIGATORS SUBMIT A PROTOCOL
TO THE IRB TO STUDY ADULTING
DIAGNOSED WITH SCHIZOPHRENIA
THROUGH IMAGING, PET AND MRI
SCANS, ON AND OFF ANTIPSYCHOTIC
MEDICATIONS.
THE PROTOCOL IS A DOUBLE BLIND
PLACEBO CONTROLLED CROSS-OVER
DESIGN, LASTS FOR 10 WEEKS,
REQUIRES AN INPATIENT STAY, IT
DOES NOT ALLOW PRN OR ADDITIONAL
MEDICATIONS, FOR EXAMPLE
ANTIDEPRESSANTS.
IT DOES NOT ALLOW FOR INDIVIDUAL
THERAPY DURING THIS STUDY.
THERE CAN BE GROUPS AND OTHER
ACTIVITIES OFFERED BUT NO
STRUCTURED INDIVIDUAL THERAPY.
IT PROVIDES STANDARD TREATMENT
AFTER STUDY PROCEDURES AND/OR
WHEN A PARTICIPANT HAPPENS TO
WITHDRAW.
THE IRB HAS DETERMINED THAT THE
PROTOCOL IS MORE THAN MINIMAL
RISK, HAS NO PROSPECT OF DIRECT
BENEFIT, DOES NOT ALLOW FOR
SURROGATE CONSENT, AND REQUIRES
AN INDEPENDENT CAPACITY
ASSESSMENT FOR ALL PARTICIPANTS.
>>SO, HERE IS THE PERSON WHO
WE'RE TALKING ABOUT.
THEY ARE 21 AND DIAGNOSED WITH
SCHIZOPHRENIA.
THEY ARE TREATMENT NAIVE,
CURRENTLY EXPERIENCING AUDITORY
HALLUCINATIONS AND ANXIETY.
DURING CAPACITY ASSESSMENT,
IMAGINE CAROL IS THERE DOING THE
CAPACITY ASSESSMENT.
M STATES SHE'S AT THE NIMH
BECAUSE SHE'S HEARING VOICES AND
THE DOCTORS WOULD LIKE TO TAKE
PICTURES OF HER BRAIN OFF AND ON
MEDICATIONS.
SHE'S WILLING TO STAY ON THE
INPATIENT UNIT BUT IS NOT ABLE
TO DISTINGUISH THAT THIS IS FOR
RESEARCH PURPOSES.
AND THAT OTHERWISE AN INPATIENT
STAY IS NOT CLINICAL INDICATED.
SHE IS NOT AWARE OF ALTERNATIVE
TREATMENTS AVAILABLE TO HER IN
THE COMMUNITY, AND THE ADVOCATE
DISCUSSES DIFFERENCE BETWEEN
RESEARCH AND CLINICAL CARE WITH
THEM.
M CONTINUES TO HAVE DIFFICULTY
APPRECIATING DIFFERENCE BETWEEN
THE TWO BUT IS WILLING TO
ENROLL.
HERE IS WHERE SLIDO COMES IN,
EVERYBODY.
THE QUESTION IS, DO YOU THINK
THAT M HAS THE CAPACITY TO
PROVIDE INFORMED CONSENT AT THIS
TIME?
SO, QUICK YES/NO.
LET US KNOW WHAT YOU THINK.
WE'LL TAKE IT FROM THERE.
WE'LL SEE HOW GOOD YOU ARE AT
BEING A CONSENT ASSESSOR.
SEND YOUR C.V.s, IF YOU ANSWER
CORRECTLY, WHICH WE'LL FIND OUT
IN A MOMENT.
SO WE'LL GIVE A COUPLE MINUTES
TO JOIN.
AND THEN WE'RE GOING TO SORT OF
TALK THROUGH THE THINGS TO
CONSIDER.
SO, TURNS OUT EVERYBODY,
EVERYBODY WHO RESPONDED, THINKS
SHE DOESN'T HAVE THE CAPACITY TO
PROVIDE CONSENT AT THIS TIME,
WHICH IS THE CORRECT ANSWER.
WE'RE GOING TO TALK ABOUT WHY
THAT'S THE CASE.
NEXT SLIDE, CONOR.
SO, WHY DON'T YOU START WITH THE
SORTS OF THINGS WE SHOULD BE
THINKING ABOUT.
>>THE POINTS TO CONSIDER WOULD
BE ALTERNATIVE STANDARD
TREATMENTS ARE AVAILABLE IN THE
COMMUNITY.
THAT'S REALLY IMPORTANT TO LET
SOMEONE KNOW THAT THEY HAVE A
CHOICE, THAT THIS IS NOT THE
ONLY AVAILABLE OPTION FOR THEM.
THEY CAN HELP WITH RESEARCH,
HELP THE FUTURE, BUT IN ORDER TO
GET TREATMENT THEY DO NOT HAVE
TO COME HERE TO PARTICIPATE IN
THE STUDY SO WE WOULD WANT TO
MAKE SURE THIS PERSON WAS VERY
AWARE OF THAT.
AND THAT LEADS US TO THINK ABOUT
THE THERAPEUTIC MISCONCEPTION,
ENSURING SHE WOULD KNOW THE
DIFFERENCE BETWEEN THAT.
THE LEVEL OF RISK AND DELAY OF
TREATMENT MAKING SURE SHE'S
AWARE, IN THIS CASE COMING OFF
OF HER MEDS, THEN DELAYING IN
HAVING TREATMENT OFFERED TO HER
DEPENDING ON LENGTH OF STUDY WE
DO HAVE ONE SIMILAR, IT COULD BE
SEVERAL MONTHS BEFORE THEY GO
BACK ON MEDICATION, HELPFUL TO
THEM FROM THE COMMUNITY.
THAT'S PART OF THE REASONING
PIECE, APPRECIATING HOW LONG
THEY ARE GOING TO BE OFF THEIR
MEDICATIONS, MAKING SURE SHE'S
CLEAR ABOUT THAT.
THERE'S NO DIRECT BENEFIT,
AGAIN, THIS IS ABOUT HELPING THE
FUTURE.
ONE OF THE THINGS THAT I
FREQUENTLY SAY IN THIS SORT OF
CAPACITY ASSESSMENT IS THAT
YOU'RE UNDERGOING SCANS, TALKED
ABOUT PET AND MRI, UNDERGOING A
PET OR MRI SCAN HELPS RESEARCH
IN THE FUTURE, IT'S NOT GROWING
TO TREAT YOUR SCHIZOPHRENIA.
YOU'RE HELPING SOMEONE ELSE, NOT
GETTING MEDICATION.
SO THAT SOMETIMES IS MAKING IT
CONCRETE LIKE THAT, IT CAN BE
HELPFUL TO INDIVIDUALS.
DIFFERENCE BETWEEN RESEARCH AND
CLINICAL CARE, THE THERAPEUTIC
MISCONCEPTION, SOME PEOPLE MAY
VERY WELL WANT TO COME HERE
FULLY UNDERSTANDING THEY ARE NOT
GOING TO GET ANY DIRECT BENEFIT
BUT THEY SAY I CAN GET MORE
INFORMATION ABOUT MY OWN
PERSONAL MEDICAL PROFILE FROM
PEOPLE THAT HAVE DONE THIS THAT
ARE EXPERT.
ONE OF THE QUESTIONS THAT I
WOULD ALSO BE TALKING WITH HER
ABOUT, WHY DOES SHE WANT TO DO
THIS?
FLESHING THAT OUT MORE, AND AT
THIS POINT ONE OF THE THINGS
THAT WOULD HAPPEN IS WE WOULD
SAY, YES, THAT SHE DOESN'T
POSSESS ENOUGH CAPACITY REALLY
TO GIVE HER OWN PERSONAL CONSENT
AND THEN IT WOULD BE A
CONVERSATION WITH THE
INVESTIGATOR AT THAT POINT, DO
YOU WANT TO PROVIDE MORE
EDUCATION FOR THIS INDIVIDUAL,
HELP THEM UNDERSTAND MORE ABOUT
THIS STUDY?
AND WE CERTAINLY HAVE SEEN THAT
HAPPEN SIGNIFICANTLY, ABSOLUTELY
HAVE SEEN, AGAIN, THIS
PARTICULAR STUDY, THESE FOLKS,
THIS INDIVIDUAL WOULD BE STAYING
ON THE INPATIENT UNIT SO THERE
WOULD BE A LOT OF TIME TO DO
MORE EDUCATION WITH THEM,
NURSING STAFF WOULD BE HELPFUL
WITH THAT.
WE WOULD NOT PERSONALLY DO THAT
KIND OF EDUCATION BECAUSE THAT
WOULD BE CONSIDERED A CONFLICT,
BUT THE NURSING STAFF WOULD DO A
VERY GOOD JOB.
WE CERTAINLY HAVE HAD MANY
PEOPLE WHERE THAT'S HAPPENED.
THEY JUST DID NOT HAVE ENOUGH
GOOD UNDERSTANDING FOR US TO
FEEL CONFIDENT THEY HAD CAPACITY
TO GIVE THEIR OWN CONSENT BUT
AFTER SEVERAL WEEKS OF FURTHER
EDUCATION, TALKING WITH THEM, BY
THAT POINT THEY HAD A MUCH
CLEARER AND BETTER UNDERSTANDING
AND CLEARLY HAD CAPACITY, IF
THEY WANTED TO DO IT AT THAT
POINT.
>>I'LL ADD THE BIOETHICS
FACULTY ALSO DULLS CAPACITY
ASSESSMENTS MORE LIKE THE
GENERIC ONES THAT CAROL
MENTIONED.
THE ONES THAT WE'RE TALKING
ABOUT NOW, THAT ARE OFTEN IN THE
RESPONSIBILITY OF NIMH, IT'S
LIKE EVERYBODY GETS THIS
ASSESSMENT.
ALL THE PATIENTS WHO MIGHT BE
ELIGIBLE FOR THAT TRIAL WOULD
HAVE THIS ASSESSMENT DONE.
ANOTHER-- THE RESEARCHERS KNOW
THAT, RIGHT?
LIKE THEY KNOW HSPU IS GOING TO
BE INVOLVED.
WHEN WE DO IT SOMETIMES IT'S
ALWAYS UP TO THE INVESTIGATOR TO
DECIDE WHETHER OR NOT A CAPACITY
ASSESSMENT IS NEEDED.
SO, FOR US, WHAT SOMETIMES
HAPPENS IS INVESTIGATOR WILL
CALL US, AND THEY WILL SAY,
SO-AND-SO IS COMING TO THE
CLINIC, WE'VE TALKED TO THEM ON
THE PHONE, AND WE'RE NOT SURE
ABOUT THEIR CAPACITY.
CAN YOU COME AND ASSESS THEIR
CAPACITY?
IF THEY CALLED AND SAID I KNOW
THEY WILL BE ABLE TO CONSENT, I
WOULD SAY, WELL, YOU DON'T NEED
US BECAUSE YOU MAKE THAT CALL.
YOU, THE INVESTIGATOR, HAVE THAT
RESPONSIBILITY.
IF YOU'RE UNSURE, WE'RE ALWAYS
AVAILABLE.
IF YOU'RE SURE THEY DON'T HAVE
THE CAPACITY, YOU DON'T NEED US
BECAUSE IF THAT'S CLEAR, THERE'S
REALLY NO ROLE FOR ASSESSING
CAPACITY.
SO, WE STRONGLY ENCOURAGE
INVESTIGATORS WHENEVER THERE'S A
QUESTION ABOUT THE CAPACITY THAT
WE ARE A RESOURCE, HSPU IS A
RESOURCE, AND THEY SHOULD FEEL
FREE TO REACH OUT TO US TO HELP
THEM WITH THAT ASSESSMENT.
AND THEN, YEAH, ANOTHER POSSIBLE
OUTCOME, I JUST WANTED TO PICK
UP ON, IS THAT WE SAY NO, I'M
SORRY, M, YOU CAN'T BE IN THE
STUDY.
RIGHT?
BECAUSE EVEN IF WE DID THAT
ADDITIONAL EDUCATION, SHE STILL
MAY NOT UNDERSTAND THESE KEY
POINTS, RIGHT?
AND SO SHE WOULD THEN BE TOLD
SHE'S NOT ELIGIBLE TO ENROLL
BECAUSE SHE CAN'T PROVIDE
INFORMED CONSENT.
THIS IS SOMETIMES TRICKY WHEN
SOMEONE MIGHT BE COMING HERE TO
THE CLINICAL CENTER BECAUSE IF
YOU ENROLL IN A CLINICAL TRIAL
HERE AT THE CLINICAL CENTER,
IT'S FREE.
YOUR CARE IS AT NO COST TO YOU.
SO, IN MY TIME, I'VE ONLY ONCE
HAD THE EXPERIENCE OF SOMEONE
BEING QUITE UPSET THAT THEY
WOULDN'T BE ABLE TO ENROLL
BECAUSE IN THIS CASE THE
PARTICULAR PATIENT DIDN'T HAVE
CAPACITY, THE PARTNER OF THE
PERSON WAS UPSET THAT THE PERSON
COULDN'T BE ENROLLED IN THE
STUDY BECAUSE THEY KNEW THAT IT
WOULD BE FREE HERE SO JUST A
LAYER OF COMPLICATION WHEN IN
THE UNITED STATES NOT EVERYBODY
HAS ACCESS TO HEALTH CARE AND
HEALTH INSURANCE.
>>ANOTHER POINT TOO, THAT'S
WHERE IT'S IMPORTANT TO KNOW
WHAT YOUR PROTOCOL ALLOWS.
THIS PARTICULAR PROTOCOL DID NOT
ALLOW FOR SURROGATE CONSENT.
YOU HAVE TO KNOW WHAT IS ALLOWED
WITHIN YOUR PROTOCOL, WHETHER
IT'S ALREADY BEEN PUT INTO THE
PROTOCOL, IT'S ALREADY BEEN
APPROVED BY THE IRB, OR
DEPENDING ON THE HIERARCHY OF
POTENTIAL SURROGATES WHAT THE
RISK/BENEFIT LEVEL IS, WHETHER
YOU WOULD BE ALLOWED TO HAVE A
SURROGATE.
THERE WOULD NOT BE AN OPTION
BEYOND THEM HAVING CAPACITY TO
GIVE THEIR CONSENT.
THEY COULD NOT STAY IN THAT
PROTOCOL.
>>WHY DON'T WE -- WE HAVE
PLENTY OF TIME.
WE HAVE LOTS OF FLEXIBILITY.
SO LET'S SAY THIS STUDY DID
ALLOW A SURROGATE.
WHAT WOULD BE THE NEXT STEP FOR
YOU IN HELPING THE RESEARCH TEAM
DECIDE WHETHER THAT CAN HAPPEN,
WHETHER THAT SURROGATE CAN BE
DESIGNATED.
>>WE HAVE TO TO SEE IF THE
PERSON HAS ALREADY SIGNED AN
ADVANCE DIRECTIVE OR A
GUARDIANSHIP OR SOMEONE WITH
THEM.
>>THEIR SPOUSE, FOR EXAMPLE.
>>FOR EXAMPLE THEY HAD BROUGHT
THE PAPERWORK WITH THEM FROM THE
OUTSIDE AND IT HAD BEEN
REVIEWED.
YES, THEY HAD SPECIFICALLY NAMED
THEIR SPOUSE, THEN WE WOULD MAKE
SURE THAT RESEARCH WAS COVERED
UNDER THAT AND THEN WE WOULD
WANT TO TALK WITH THE SURROGATE,
WITH THE SPOUSE, TO MAKE SURE
THAT -- WE'RE NOT DOING A
CAPACITY ASSESSMENT PER SE BUT
WE WANT TO MAKE SURE THEY KNOW
THEIR ROLE AND RESPONSIBILITIES
IN TERMS OF ADVOCATING AND
SPEAKING ON BEHALF OF THIS
PERSON.
ONE OF THE THINGS THAT WE TALK
TO THEM ABOUT WHAT IS YOUR
UNDERSTANDING OF TASKS AND
WHAT'S GOING TO HAPPEN, THIS IS
NOT A DIRECT BENEFIT TYPE OF
STUDY, BECAUSE THEY ARE
REPRESENTING THEIR WISHES WE
WANT TO MAKE SURE THEY KNOW THE
THRESHOLD FOR SAYING NO TO
THINGS.
WE WANT TO MAKE SURE THEY ARE
COMFORTABLE SPEAKING UP ON THE
PERSON'S BEHALF.
YOU KNOW THIS PERSON BETTER THAN
ANYONE.
THE TEAM IS GOING TO RELY ON YOU
TO SPEAK UP AND SAY, YOU KNOW,
FOR EXAMPLE LIKE AN MRI, THEY
ARE CLAUSTROPHOBIC, I NEED TO BE
CLOSE BY, NOT SURE THIS IS GOING
TO WORK, CAN WE PRACTICE, THOSE
SORTS OF THINGS, THEY ARE
ADVOCATING.
WE WANT TO MAKE SURE THEY ARE
COMFORTABLE SPEAKING ON THEIR
BEE BEHALF AND SPEAKING UP IF
SOMETHING NEEDS TO BE STOPPED AT
THAT POINT.
>>IN AN INPATIENT SETTING THAT
MAY MEAN BEING AVAILABLE BEFORE
PARTICULAR PROCEDURES, ON AN
OUTWAISHT -- IN AN OUTPATIENT
TRIAL YOU MAY BE RESPONSIBLE FOR
BRINGING THEM BACK AND FORTH TO
THE CLINIC OR KNOWING WHEN THEY
ARE NOT WILLING TO COME BACK AND
FORTH, SO I LIKE YOUR TERM OF
ADVOCATE.
THEY REALLY ARE THE ADVOCATE OF
THE SUBJECT.
>>IT DOESN'T END AT SIGNING THE
PAPER, THEY HAVE TO BE WILLING
TO BE WITH THEM TO ADVOCATE FOR
HOWEVER SHORT OR LONG THAT MAY
BE.
>>WHY DON'T WE GO TO THE NEXT
ONE, CONOR.
SO, HOW ABOUT YOU READ THIS
PART, I'LL READ THE NEXT PART.
>>OKAY.
INVESTIGATORS SUBMIT A PROTOCOL
TO THE IRB TO STUDY THE SIGNS,
SYMPTOMS, COURSE OF ALZHEIMER'S
DISEASE, A LONGITUDINAL NATURAL
HISTORY DESIGN INVOLVING PET
SCANS WITH INVESTIGATIONAL
LIGAND AND MEMORY ASSESSMENTS.
CURRENT TREATMENT AND
MEDICATIONS WILL NOT BE CHANGED.
STUDY REQUIRES TWO OUTPATIENT
VISITS A YEAR FOR FIVE YEARS.
THE IRB HAS DETERMINED THAT THE
PROTOCOL ONE IS MORE THE MINIMAL
RISK, HAS NO PROSPECT OF DIRECT
BENEFIT, ALLOWS FOR SURROGATE
CONSENT, AND REQUIRES AN
INDEPENDENT CAPACITY ASSESSMENT
AND IF NEEDED, ABILITY TO ASSIGN
SURROGATE ASSESSMENT AND
APPROPRIATENESS OF SURROGATE
ASSESSMENT.
>>HERE IS VIGNETTE 2.
NEXT SLIDE, CON HE WERE.
T IS A 70-YEAR-OLD DIAGNOSED
WITH ALZHEIMER'S, ELIGIBLE TO
ENROLL IN THE STUDY.
DURING THE CAPACITY ASSESSMENT,
HE STATES HE UNDERSTANDS THE
RESEARCHERS ARE STUDYING
DEMENTIA AND WILL ASK HIM TO
PARTICIPATE IN A PET SCAN WITH
AN EXPERIMENTAL LIGAND.
AND SOME MRIs AND
NEUROPSYCHOLOGICAL TESTING, HE
WILL BE RELYING ON HIS SPOUSE TO
GET HIM TO OUTPATIENT
APPOINTMENTS, STATES HE KNOWS
PARTICIPATING WILL NOT CURE HIS
DEMENTIA, CONCERN FOR CHILDREN'S
RISK OF INHERITING IT MOTIVATES
HIM TO CONTRIBUTE TO POSSIBLE
FUTURE TREATMENT FOR OTHERS.
THE QUESTION, ARM YOUR SLIDO, IS
DO YOU THINK T HAS THE CAPACITY
TO PROVIDE INFORMED CONSENT AT
THIS TIME? LET US KNOW WHAT YOU
THINK.
I THINK WE HAVE TO NEIGHBORING
-- MAKE THESE HARDER IN THE
FUTURE, CAROL.
WE HAVE DISSENT OR DIFFERENCE IN
OPINION.
WE'LL GIVE FOLKS A COUPLE MORE
MINUTES, OR ANOTHER MINUTE I
WOULD SAY.
OKAY, GREAT.
PRETTY OVERWHELMING PEOPLE SAID
YES BUT A FEW PEOPLE SAID NO.
THEY DIDN'T THINK HE HAS
CAPACITY TO MAKE THE INFORMED
CONSENT DECISION.
NEXT SLIDE, CONOR.
WHY DON'T YOU TALK ABOUT THE
POINTS TO CONSIDER.
>>DOESN'T INVOLVE CHANGE IN
CURRENT TREATMENT, I THINK
THAT'S REALLY HELPFUL.
THIS PERSON COULD COME AND
PARTICIPATE IN RESEARCH ABOUT
ALZHEIMER'S DISEASE, WOULD NOT
HAVE TO STOP ALZHEIMER'S DISEASE
MEDICATION OR BEHAVIORAL HEALTH
MEDICATIONS, BECAUSE THIS IS A
LONG STUDY, FIVE YEARS.
THAT'S REALLY HELPFUL THEY CAN
STAY ON.
IT APPEARED HE UNDERSTOOD THAT.
HOW FAR APART ARE THE RESEARCH
PROCEDURES?
IT'S A LONG TIME.
ONE OF THE THINGS THAT YOU HAVE
TO TAKE INTO CONSIDERATION IS
THE VERY NATURE OF THE DISEASE,
ALZHEIMER'S DISEASE, IT'S
DEMENTIA, IT'S PROGRESSIVE.
COGNITIVE ABILITIES ARE GOING TO
BE DETERIORATING OVER TIME.
WE KNOW THAT THERE ARE SOME
PROGRESSIONS ARE FASTER THAN
OTHERS, THERE'S DIFFERENT PHASES
AND STAGES OF THE DISEASE BUT
ONE OF THE THINGS RESEARCHERS
WANT TO TAKE INTO ACCOUNT IS
THIS PERSON HAS CAPACITY NOW,
PERHAPS WE WANT TO GO AHEAD AND
FORMALIZE AND ADVANCE DIRECTIVE
KNOWING THINGS WILL CHANGE IN
THE FUTURE AND THEY COULD DO
THIS WHILE THEY'VE GOT CAPACITY
TO GIVE CONSENT.
YOU CAN ASSESS THEM FOR ABILITY,
AT THAT POINT THE MERE FACT THEY
HAVE CAPACITY TO GIVE CONSENT
YOU COULD AUTOMATICALLY HAVE
THEM FILL OUT THE ADVANCE
DIRECTIVE, NAMING WHOEVER IT IS,
I ASSUME THEIR SPOUSE, NAMING
THEM SPECIFICALLY THAT GOES INTO
THE MEDICAL RECORD SO PEOPLE
WOULD HAVE THAT ON HAND.
THEY WOULDN'T HAVE TO GO THROUGH
THAT TYPE OF ASSESSMENT AGAIN IN
TERMS OF WHO COULD GIVE CONSENT
FOR THEM.
AND AGAIN WHAT IF HIS CAPACITY
CHANGES?
THEN AS HE COMES IN, EACH TIME,
WE HAD A STUDY LIKE THIS BEFORE
WITH ALZHEIMER'S FOLKS, THERE
WAS SIX MONTHS IN BETWEEN
DIFFERENT VISITS.
INVESTIGATOR WOULD HAVE US
ASSESS CAPACITY EVERY TIME AND
AT SOME POINT PEOPLE DID NOT
HAVE CAPACITY TO GIVE CONSENT
AND YOU WOULD ALREADY HAVE IT IN
PLACE FOR THE SPOUSE TO
OFFICIALLY BE ABLE TO GIVE
SURROGATE CONSENT.
>>I JUMPED THE GUN.
SO, JUST TO SORT OF HIGHLIGHT,
RIGHT?
THOSE KEY POINTS THAT THERE WERE
KEY POINTS, THAT T UNDERSTOOD
EVEN THOUGH HE HAS ALZHEIMER'S,
THAT M COULDN'T.
AND I JUST WANT TO POINT OUT
THAT IT MAY HAVE NOTHING TO DO
WITH THEIR DIAGNOSIS, THAT T
MIGHT BE EARLY IN HIS
ALZHEIMER'S, AND HAS THE SORT OF
MOMENTARY CLARITY OR NOT
MOMENTARY BUT LIKE LET'S SAY ON
THIS DAY, HE CLEARLY HAS
CAPACITY, CLEARLY UNDERSTANDS
WHAT'S BEING ASKED OF HIM.
AND IN THIS CASE THEN THAT HIS
SPOUSE, RIGHT, AND THE RESEARCH
TEAM WILL BE SORT OF, YOU KNOW,
KEEPING TRACK, KNOWING THAT HIS
ALZHEIMER'S MAY PROGRESS.
I STILL DON'T THINK WE KNOW HOW
DEMENTIA PROGRESSES IN EVERY
SINGLE PERSON, SO IT'S ALSO A
SORT OF REMINDER TO THE TEAM
THAT IT'S SOMETHING THAT THEY
ARE GOING TO BE MONITORING OVER
TIME.
TO PREPARE THE SPOUSE IN THIS
CASE THAT WE MAY NEED TO CALL ON
HIM OR HER TO PROVIDE.
>>WE HAD ONE SITUATION WHEN WE
WERE DOING ALZHEIMER'S WORK,
JUST AS A COUNTER TO THAT.
>>YEAH, PLEASE.
>>IT WAS A GENTLEMAN WHO
BROUGHT HIS WIFE IN.
SHE WAS MUCH MORE IMPAIRED, DID
NOT HAVE CAPACITY.
THEY DID ALLOW FOR SURROGATE
CONSENT BUT SHE DID NOT WANT TO
PARTICIPATE AND SHE DIDN'T
UNDERSTAND EXACTLY WHAT WAS
INVOLVED IN THIS STUDY, HOW LONG
IT WAS GOING TO BE, SHE KNEW SHE
WAS IMPAIRED BUT SHE WAS VERY
CLEAR.
SHE WAS AFRAID.
SHE DID NOT WANT TO DO IT.
IT WAS DIFFICULT BECAUSE THE
HUSBAND VERY MUCH WANTED HER TO
BE HERE.
IT WAS NOT FOR DIRECT BENEFIT
BUT I THINK WHAT HE WAS LOOKING
FOR WAS CLARIFICATION OF
DIAGNOSIS TO SOME DEGREE.
IT WAS A LONG CONVERSATION WITH
THE INVESTIGATOR, THE
INVESTIGATOR SAID WE CAN'T GO
FORWARD, EVEN THOUGH SHE DOESN'T
HAVE CAPACITY TO GIVE CONSENT
SHE'S MAKING IT CLEAR HER CHOICE
IS NO NOT PARTICIPATE.
SHE'S CLEARLY DISSENTING.
WE HONORED THAT.
IT WAS IMPORTANT AT THAT POINT
TO GIVE HIM SOME INFORMATION
WHERE HE COULD GO IN THE
COMMUNITY POTENTIALLY, DIFFERENT
SERVICES AND RESOURCES FOR WHAT
HE WAS LOOKING FOR.
>>AND THAT QUESTION CAME UP
EARLIER ABOUT, YOU KNOW,
RESPECTING DISSENT, RIGHT IN
THE.
>>ABSOLUTELY.
>>IN THIS CASE IT'S VERY CLEAR
THAT THE PERSON, DESPITE THE
OPTION OF HAVING A SURROGATE, IT
PUTS EVERYBODY IN A VERY
CHALLENGING POSITION, RIGHT?
YOU CAN'T SORT OF DISCOUNT HER
CLEAR SORT OF HEARTFELT IN THIS
CASE BECAUSE SHE WAS AFRAID
CHOICE OR CONSIDERATION.
I THINK WE'RE AT THE END.
YES, DISCUSSION.
SO, I DIDN'T KNOW -- GREAT.
KIKO HAS A QUESTION.
I'M THE LAST SPEAKER, JUST AS AN
FYI.
MY PRESENTATION IS RELATIVELY
BRIEF.
SO WE'LL TAKE THIS QUESTION AND
IF FOLKS OUT THERE IN THE
VIRTUAL LAND HAVE QUESTIONS,
FEEL FREE TO SEND THEM ALONG.
>>THANK YOU.
I HAVE TWO QUESTIONS.
SO FIRST ONE, DO YOU HEAR ME
OKAY?
THE FIRST QUESTION IS ABOUT THE
LAST CASE OF ALZHEIMER'S
DISEASE.
SO, I THINK TYPICAL SURROGATE
DECISION MAKERS ARE SPOUSE, AND
SPOUSE THEMSELVES ARE ABOUT THE
SAME AGE.
AND IT'S A LONG STUDY.
SO, IF YOU HAVE SOME EXPERIENCE,
I START TO WONDER ABOUT THE
SPOUSE'S CAPACITY, BECAUSE IT
GOES AROUND, AROUND.
SO THAT'S ONE QUESTION.
THE OTHER IS MORE FOR HOLLY THAT
REGULAR IRB CASE.
>>GENERIC.
>>GENERIC CONSULT.
YOU SAID IF RESEARCHERS ARE SURE
THAT NONE OF THIS POTENTIAL
PARTICIPANT COULD CONSENTV
CAPACITY, DON'T COME TO US, IF
YOU'RE SURE THEY CAN NOT, DON'T
COME TO US, JUST ONLY THE CASE
THAT YOU'RE NOT SURE, WE ARE
HERE FOR YOU.
BUT ISN'T IT A LITTLE BIT
RELYING ON THE VIRTUE OF THE
INVESTIGATORS.
>>YES.
>>BECAUSE INVESTIGATORS HAVE
INTEREST TO ENROLL.
AND THEN THEY WANT TO HAVE THE
STUDY PARTICIPANTS QUICKLY, A
LOT, AS MANY AS THEY WANT.
IS THERE ANY ISSUE THERE THAT
THERE'S NO THIRD PARTY
ASSESSMENT RELYING ON THE GOOD
PART OF THE INVESTIGATORS?
>>YEAH, SO I'LL START THERE.
IT'S A REALLY GREAT POINT, AND
WE SELDOM -- I CAN'T THINK OF
ANY SITUATION WHERE I HAVE SAID
DON'T -- I'M NOT COMING, RIGHT?
I ALWAYS ERR, IF A RESEARCHER
CALLS US THAT BASICALLY MEANS
THEY ARE NOT SURE, RIGHT, SO AND
THEN WE TALK THROUGH AND THEN
DETERMINE, RIGHT?
BUT THERE ARE, AS YOU SAY, THERE
ARE LOTS OF CASES WHERE THE
RESEARCHER MAY NOT BE PICKING UP
THAT PHONE.
IN MY EXPERIENCE, THE RESEARCH
ASSISTANTS OR RESEARCH
ASSOCIATES ARE THE MOST LIKELY
PERSON TO HAVE SORT OF HAD A
PERSONAL CONVERSATION WITH THE
PATIENT OR SOMETIMES WITH THE
SPOUSE AND THE PATIENT, AND THEY
TOO CAN CALL US AND/OR RECOMMEND
TO THE INVESTIGATOR TO CALL US.
SO, I'M NOT -- MAYBE I SHOULD
BE BUT I'M NOT CONCERNED ABOUT
THE ABILITY TO MAKE THE YES/NO
QUESTION AND I HOPE THEY SEE US
AS AN ASSET AND COME TO US.
THE ALTERNATIVE HSP MOD WHERE
WILL WE SAY EVERY PARTICIPANT
NEEDS A CAPACITY ASSESSMENT
AFTER THE RESEARCH IS EXPLAINED
TO THEM, AND WE WOULD HAVE TO BE
DOING THAT 24/7 WHICH WOULD BE
REALLY HARD TO DO.
BUT IT'S A REALLY GREAT POINT,
RIGHT? WE ARE RELYING ON THE
INVESTIGATORS AND THE STUDY TEAM
TO SAY THIS IS NOT CLEAR, WE
NEED TO CALL BIOETHICS.
>>TERMS.
OTHER POINT ABOUT THE
ALZHEIMER'S INDIVIDUAL, I WILL
SAY JUST AS AN ASIDE WE DO SEE
VARIOUS -- I SAW VARIOUS
SCENARIOS, I WORKED FOR THE
AGING INSTITUTE BEFORE I CAME TO
MENTAL HEALTH AND WAS INVOLVED
WITH ALZHEIMER'S THERE, ADULT
CHILDREN WOULD BRING A FAMILY
MEMBER IN, ALSO A SPOUSE.
ONE OF THE THINGS WE HAVE TALKED
ABOUT IS THE IDEA THAT UNLIKE
OTHER TYPES OF ILLNESSES SOMEONE
WITH ALZHEIMER'S DISEASE MOST
LIKELY HAD CAPACITY, MOST OF
THEIR LIFE.
>>YES.
>>SO A SPOUSE WHO WOULD HAVE
KNOWN THEM FOR A NUMBER OF YEARS
TYPICALLY, THEY WOULD HAVE SEEN
WHAT THEIR PREFERENCES WERE,
WHAT THEIR WISHES WERE ABOUT
THIS SORT OF THING, WOULD HAVE
POTENTIALLY HAD CONVERSATIONS
ABOUT IT.
THEY COULD REALLY FILL IN SOME
OF THAT INFORMATION FOR US.
WHAT WOULD THEY HAVE WANTED TO
DO, AS YOU'VE KNOWN THEM FOR THE
LAST 40 OR SO YEARS.
IN TERMS OF POTENTIAL SURROGATE,
HAVING CONCERNS ABOUT, YOU KNOW,
THEIR CAPACITY, I THINK WHAT
THAT WOULD CALL IN TO -- IT
WOULD HAVE US STOP, TAKE A
BREATH, START TALKING WITH THE
INVESTIGATOR BECAUSE IT COULD BE
SOMETHING WHERE THE INVESTIGATOR
BEFORE WE EVEN COME IN MIGHT BE
SAYING TO US, YOU KNOW, YOU'RE
GOING TO BE ASSESSING THIS
PERSON BUT I'VE GOT CONCERN
CLINICALLY THEY BE PICKING UP
THINGS WITH THE PERSON THAT
BROUGHT THEM ABOUT, WHAT ARE
THEY CONCERNED ABOUT, WE COULD
SIT DOWN AND DOING THE SURROGATE
ASSESSMENT AT THAT POINT IN TIME
WHILE IT'S NOT LIKE A FULL BLOWN
CAPACITY ASSESSMENT LIKE WHAT WE
DO WITH PARTICIPANT WE WOULD BE
ASKING THEM ABOUT WHAT'S YOUR
UNDERSTANDING ABOUT WHAT THIS
STUDY IS ABOUT.
WHAT ARE SOME THINGS THEY ARE
GOING TO ASK YOUR LOVED ONE,
YOUR PERSON TO DO THAT YOU'RE
GOING TO REPRESENT?
AND WE COULD HAVE THAT KIND OF
CONVERSATION WITH THEM.
I THINK THAT'S ONE OF THE
IMPORTANT THINGS IS EVEN THOUGH
WE'VE GOT THESE QUESTIONS HERE,
WE'RE WRITING DOWN ANSWERS, WE
DON'T WANT TO MAKE IT A CHECK A
CHECKLIST.
IT'S IMPORTANT TO FLOW AS A
CONVERSATION.
THE MORE COMFORTABLE SOMEBODY
IS, THAT'S HELPFUL TO US IN
GETTING MORE INFORMATION ABOUT
WHAT'S HAPPENING WITH THEM.
I'VE NOT COME ACROSS A SURROGATE
THAT DID NOT HAVE THAT ABILITY
IN AN ALZHEIMER'S STUDY.
THERE WAS ANOTHER ONE WITH
PEOPLE WITH PSYCHOTIC DISORDERS,
AND THERE WAS A PERSON THAT HAD
COME IN WITH PARTICIPANT, IT WAS
REALLY CLEAR THAT THAT PERSON
WAS NOT GOING TO SERVE WELL AS A
SURROGATE.
SO THAT WAS VERY, VERY CLEAR,
IT'S MORE KIND OF THE SUBTLE
DIFFERENCES TO MAKE SURE YOU
WERE AS CLEAR AS YOU COULD BE,
IF YOU WERE SAYING THIS PERSON
COULD NOT PROVIDE SURROGATE
CONSENT YOU WOULD HAVE TO
CLINICALLY MAKE SURE YOU WERE
VERY THOROUGH IN QUESTIONS YOU
WERE ASKING AND KIND OF
RESPONSES YOU WERE GETTING AND
EXPLAINING TO THAT PERSON IT
COULD BE IF THERE WERE CONCERNS
ABOUT THAT INDIVIDUAL, THERE MAY
BE AN ADULT CHILD THEY HAD OR
SOMEONE ELSE THE POTENTIAL
PARTICIPANT COULD ACTUALLY HAVE
THEM SERVE IN THAT STEAD
INSTEAD.
IT'S NOT A CLEAR BACK AND
WHITENS.
IT'S THAT GRAY AREA THAT'S
HARDER BECAUSE YOU HAVE TO ASK
QUESTIONS, GET FEEDBACK AND
SPEND TIME WITH IT AND HAVE
CONSULTATION WITH YOUR TEAM.
>>GREAT.
THANK YOU FOR JOINING US, CAROL.
>>THANK YOU.
>>I'M GOING TO FINISH WITH JUST
A COUPLE THOUGHTS ABOUT INFORMED
CONSENT, REALLY DRAWING OR WHAT
DR. GRADY ALREADY SHARED.
THANK YOU, CONOR.
SO, I'M CALLING THIS NUTS AND
BOLTS BECAUSE I REALLY JUST WANT
TO GIVE YOU A RESOURCE THAT YOU
CAN, YOU KNOW, TAKE AND HAVE IN
HAND WHEN THINKING ABOUT CONSENT
FORMS.
MY DISCLAIMER, YOU'VE ALL SEEN
THAT.
SO, QUICK, CONSENT IS A PROCESS,
NOT A FORM.
AND THE INFORMED CONSENT PROCESS
IS ONLY ONE OPPORTUNITY AMONG
MANY TO CONVEY RESPECT TO
POTENTIAL SUBJECTS.
KEEP THAT IN MIND.
WHAT I'M GOING TO DO, VERY
QUICKLY, YOU'LL HAVE THIS AS
SOMETHING YOU CAN PUT IN YOUR
POCKET, IT'S A POWERPOINT, SO
MAYBE NOT, BUT I'LL SEND IT AS A
DOCUMENT.
WE'LL TALK ABOUT FORM AND
UNDERSTANDING.
AND AS I SAID, DR. GRADY ALREADY
HIGHLIGHTED A NUMBER OF THESE
THINGS.
BUT THESE ARE REALLY KEY THINGS
THAT AS POTENTIAL INVESTIGATORS
AND STUDY TEAM MEMBERS SHOULD
KEEP IN MIND WHEN YOU ARE
DRAFTING YOUR CONSENT FORMS.
SO, SHORT SENTENCES.
SHORT WORDS.
SIMPLIFYING TEXT.
STATING THE MAIN IDEAS, ONE IDEA
PER PARAGRAPH, CLEARLY STATE THE
PURPOSE.
WHEN I SAT ON AN -- THIS WAS
MANY YEARS AGO, I WAS STILL AT
JOHNS HOPKINS, I SAT ON THE
NHGRI INTRAMURAL IRB HERE AT THE
CLINICAL CENTER, AND ONE OF THE
MEMBERS OF THE IRB WHO WAS AN
UNAFFILIATED MEMBER, SHE ON THE
SIDE OR AS PART OF HER LIFE DID
A LOT OF ADULT LITERACY
TRAINING.
WHEN WE HAD CONSENT FORMS SHE
WOULD TAKE THOSE FORMS TO HER
ADULT LITERACY CLIENTS AND HAVE
THEM CIRCLE ALL THE WORDS THEY
DIDN'T UNDERSTAND.
SHE WOULD BRING THAT FORM TO THE
IRB MEETING AND SAY THESE ARE
THE WORDS THAT MY STUDENTS DON'T
UNDERSTAND.
WE'VE GOT TO DO A BETTER JOB
EXPLAINING THESE PARTICULAR
ITEMS.
SO, PRESENT CLEAR SEQUENCE OF
EVENTS.
AVOID IRRELEVANT INFORMATION,
THIS IS REALLY IMPORTANT, RIGHT?
WE'VE TALKED ABOUT THE FACT THAT
THESE FORMS ARE 20 PAGES LONG.
DOES THE INFORMATION BELONG IN
THE CONSENT FORM?
AVOID LEGAL JARGON, TRY TO WRITE
IN A CONVERSATIONAL STYLE AND IN
ACTIVE VOICE.
AND AS CHRISTINE MENTIONED, I
WILL REITERATE, THERE IS NO
CLASS IN MEDICAL SCHOOL OR PhD
school for how to write a good
consent form.
AND SO, WE, THE ROYAL WE, ARE
ALL TRAINED TO WRITE ARTICLES
THAT WILL BE PUBLISHED IN THE
NEW ENGLAND JOURNAL OF MEDICINE.
THIS IS NOT THAT, RIGHT?
OFTEN I HAVE SEEN CONSENT FORMS
THAT ARE BASICALLY WRITTEN FOR
THE NEGM AUDIENCE, NOT THE
POTENTIAL SUBJECT COMING IN FOR
THE TRIAL.
BE CONSISTENT.
THIS IS ANOTHER THING, SO WHEN
WE ALL LEARNED TO WRITE WE'RE
ENCOURAGED TO USE DIFFERENT
WORDS TO CONVEY SIMILAR
SENTIMENTS OR TERMS.
THAT'S NOT A GOOD THING TO DO IN
A CONSENT FORM.
PICK A WORD AND STICK WITH IT.
USE THAT WORD TO DESCRIBE THE
THING YOU WANT TO CONVEY BECAUSE
IF YOU START USING OTHER WORDS
LIKE MEDICATION, THERAPEUTIC,
TREATMENT, DRUG, MEDICINE, WHEN
YOU'RE REFERRING EACH TIME TO
THE STUDY DRUG, THAT CAN BE VERY
CONFUSING TO THE SUBJECT.
THIS ONE, KNOW YOUR AUDIENCE, IS
A REALLY IMPORTANT ONE, RIGHT?
IF YOU'RE DOING A STUDY WHERE
YOU'RE ENROLLING MD/PHDs AT
THE CLINICAL CENTER MAYBE YOU
DON'T HAVE TO WORRY ABOUT WHAT
I'M TELLING US BECAUSE THEY READ
NEW ENGLAND JOURNAL OF MEDICINE,
THEY WILL UNDERSTAND WHAT YOU'RE
SAYING.
BUT IF YOUR GROUP OF SUBJECTS
ARE LIKELY TO NOT BE LITERATE IN
HEALTH AND/OR IN RESEARCH, IT'S
REALLY IMPORTANT TO TAKE MANY OF
THESE MESSAGES TO HEART.
AS I MENTIONED EARLIER, HAVE THE
FORMS REVIEWED BY A PATIENT.
IF YOU HAVE DRAFTED IT AND DON'T
KNOW IF IT'S GOING TO BE
UNDERSTANDABLE, YOU CAN ALWAYS
ASK SOMEONE LIKE THE PERSON
YOU'RE PLANNING TO RECRUIT OR
FAMILY MEMBER OR GRANDMOTHER.
THAT'S A FAMILY MEMBER.
BUT YOU COULD ASK SOMEONE TO
READ IT.
IN TERMS OF FORMAT, WHAT YOU
IMAGINE IN YOUR HEAD, THE
AVERAGE CONSENT FORM TO LOOK
LIKE, IS PROBABLY THE SAME AS
MINE.
A SINGLE PAGE, SINGLE SPACED,
LOTS OF WORDS.
AND WE KNOW FROM ADULT LEARNING
THOSE AREN'T CONDUCIVE TO
UNDERSTANDING.
SO WE WANT TO USE A READABLE
TYPE STYLE, MAYBE NOT "NEW YORK
TIMES," WHATEVER THAT ONE IS.
USE BIG LETTERS.
20 PAGES IS TOO LONG BUT IT
MIGHT BE PERFECTLY RIGHT IF
YOU'RE USING A BIG-SIZE TEXT SO
IT'S EASY TO READ, YOU'RE USING
A READABLE TYPE STYLE, USE UPPER
AND LOWER CASE.
IT CAN BE CONFUSING, SOMEONE
MIGHT THINK YOU'RE YELLING IF
IT'S IN ALL CAPS.
DOUBLE SPACE, SPACE BETWEEN
SECTIONS.
WE TALK ABOUT 20 PAGES IS TOO
MANY, 20 PAGES OF SINGLE-SPACE
NARRATIVE, GENERALLY THAT'S VERY
BAD.
YOU CAN DO SIMPLE THINGS TO
INCREASE READABILITY.
USING HEADERS, QUESTION/ANSWER
FORMAT.
USE LISTS, BOXES, TABLES, RIGHT?
WE ALL KNOW RDA, IF YOU LOOK AT
A BOX OF CEREAL, THERE'S THE RDA
MESSAGE ON THERE.
WE ALREADY KNOW PUTTING THINGS
IN BOXES LIKE THAT IS A GOOD WAY
TO CONVEY IMPORTANT INFORMATION.
SO WE CAN USE THOSE SORTS OF
THINGS AS EXAMPLES.
SO, AS DR. GRADY MENTIONED,
UNDERSTANDING IS IMPROVED SO
YOU'VE GOT THIS AWESOME FORM,
THE FORM I THINK, I'VE DECIDED
IT'S AWESOME.
WE KNOW THAT ONCE YOU HAVE THAT
FORM, THAT THE CONSENT FORM IS
JUST ONE PART.
AND WE KNOW THAT UNDERSTANDING
IS IMPROVED WHEN PATIENTS OR
SUBJECTS MUST VERBALIZE
INFORMATION.
DR. GRADY MENTIONED A
DISCUSSION, RIGHT?
IMAGINE, RIGHT, IT'S NOT ME
STANDING HERE TALKING AT YOU.
THIS ISN'T A DISCUSSION.
I'M LECTURING AT YOU.
A DISCUSSION HAS BACK AND FORTH,
RIGHT?
AND WE'LL GET TO HOW I THINK TO
ENCOURAGE THAT IN A MOMENT.
AND UNDERSTANDING IS IMPROVED BY
ADMINISTRATION QUIZZES AND
CORRECTING INACCURATE RESPONSES,
BUT YOU'RE BASICALLY TEACHING TO
THE TEST.
IF I GIVE YOU A 10-QUESTION
TRUE/FALSE QUIZ AND FIVE OF THEM
ARE TRUE, FIVE ARE FALSE, GET
THREE OR FOUR WRONG, IF I TEACH
TO THAT TEST AND GIVE YOU THE
SAME TEST HIGHLY LIKELY YOU'RE
GOING TO GET 100%.
RIGHT?
SO, I WOULD SAY, YES, IT MIGHT
BE IMPROVED BUT I'M NOT SURE I
LIKE THAT ARE TYPE MUCH
IMPROVEMENT BECAUSE I'M NOT
REALLY SURE HOW SUSTAINABLE THAT
IS.
IF I WAS THE KING OF THE WORLD,
QUEEN OF THE WORLD, HERE IS WHAT
I WANT ALL OF YOU TO DO.
YOU'VE GONE THROUGH THE CONSENT
FORM.
NOW YOU'RE GOING TO START A
CONVERSATION WITH THE POTENTIAL
SUBJECT.
FIRST, THESE ARE QUESTIONS YOU
COULD ASK.
OF COURSE YOU CAN CHANGE THEM IF
YOU WOULD LIKE BUT THESE ARE THE
ONES I THINK ARE REALLY
IMPORTANT.
IF YOU'RE GOING TO TELL A FRIEND
WHAT THE STUDY IS ABOUT, WHAT
WOULD YOU SAY?
AND IN ADVANCE, KNOW WHAT A GOOD
ANSWER IS.
RIGHT?
IF YOU DON'T DO THAT, YOU'RE
GOING TO BE LIKE, YEAH, THAT'S
CLOSE ENOUGH, NEXT QUESTION.
SO PREPARE.
MAYBE WITH YOUR STUDY TEAM.
WHAT DO WE THINK A GOOD ANSWER
TO THIS QUESTION IS?
AND IF THEY SAY SOMETHING THAT'S
NOT QUITE RIGHT YOU HAVE AN
OPPORTUNITY TO ENGAGE THEM IN
CONVERSATION ABOUT WHAT'S REALLY
GOING TO HAPPEN.
PROCEDURES, WHAT ARE MAIN THINGS
YOU'LL DO OR WILL HAPPEN TO YOU
WHILE YOU'RE IN THE STUDY.
IF RANDOMIZATION IS INVOLVED, A
COUPLE QUESTIONS ABOUT THAT.
WHAT ARE THE BAD THINGS THAT
MIGHT HAPPEN TO YOU?
WHAT ARE THE GOOD THINGS THAT
MIGHT HAPPEN TO YOU?
WHAT WILL HAPPEN IF YOU DECIDE
NOT TO BE IN THE STUDY ANYMORE.
WHAT HAPPENS IF YOU CHANGE YOUR
MIND, RIGHT?
AND YOU KNOW IN ADVANCE THAT THE
ANSWER TO THE LAST ONE ISN'T THE
DOCTOR IS GOING TO BE REALLY MAD
AT ME.
THE ANSWER IS, I CAN ALWAYS
CHANGE MY MIND.
I'LL LET YOU KNOW.
SO, PLEASE THINK ABOUT USING
THAT IN YOUR ENGAGEMENT AROUND
INFORMED CONSENT.
AND I'M JUST ENDING WHERE I
STARTED, CONSENT IS A PROCESS,
NOT A FORM.
A REMINDER THAT IT'S NOT THE
ONLY WAY TO CONVEY RESPECT TO
YOUR SUBJECTS.
IT'S ONE OF THE FIRST WAYS.
BUT YOU SHOULD BE RESPECTFUL IN
YOUR RECRUITMENT, RESPECTFUL IN
HOW YOU REACH OUT TO REMIND THEM
OF FOLLOW-UP APPOINTMENTS,
GIVING THEM THE RESULTS OF THE
STUDY IN THE LONG RUN.
SO, I'VE EXHAUSTED OUR TIME
TOGETHER TODAY.
I HOPE YOU'RE LEAVING WITH A LOT
MORE INFORMATION IN YOUR BRAINS
AROUND INFORMED CONSENT.
AND WE WILL RETURN NEXT WEEK
WHERE OUR TOPIC IS GENETICS, AND
WE WILL HAVE THREE GUESTS, LEILA
JAMAL, BEN BERKMAN, AND KATRINA
CLAW, UNIVERSITY OF COLORADO AND
MEMBER OF THE NAVAJO TRIBE WHO
WILL TALK ABOUT ENROLLMENT OF
NATIVE POPULATIONS IN RESEARCH,
GENETICS RESEARCH IN PARTICULAR.
THANK YOU ALL.
THAT'S IT FOR TODAY.