OUR SPEAKER TODAY IS DAVE WHO
IS TRAINED IN THE PHILOSOPHY OF
SCIENCE AND BEEN AT THE NIH FOR
30 YEARS AS A FELLOW AND
CURRENTLY SENIOR INVESTIGATOR AND.
TOPICS ASSESSING RISK
SYSTEMATICALLY AND AUTONOMY AND
PEDIATRIC RESEARCH AND RESEARCH
STORED BY LOGICAL SAMPLES.
TODAY'S PRESENTATION WILL BE
ARCHIVED IN THE NIH VIDEO SITE
AND LINK TO THE VIDEO CAST AND
SLIETDS FROM THE SESSION ON THE
WEBSITE AND SESSION AND
PRESENTATION ARCHIVE SESSION
FOLLOWING EDUCATION TRAINING
WEBPAGE AND ENCOURAGE YOU
THROUGHOUT THE SESSION TO SUBMIT
QUESTIONS CLICKING ON THE BOX
ENTITLED LIVE FEEDBACK AND WILL
ADDRESS THE QUESTIONS IN THE Q &
A AFTER THE PRESENTATION AND
THANKS FOR JOINING US AND LET'S
GET STARTED.
>> THANK YOU, PAT TY.
>> INFORMED CONSENT IS IMPORTANT
AND AS A RESULT OF THAT AND
RELIANCE ON INFORMED CONSENT THE
PARTICIPATION OF ADULTS WHO
CAN'T CONSENT RAISES ETHICAL
CONCERN AND THERE IS A WORRY
BECAUSE THEY CAN'T CONSENT FOR
THEMSELVES THAT THEY MIGHT BE
ENROLLED OR PARTICIPATE IN
RESEARCH INAPPROPRIATELY.
SO TO ADDRESS THIS CONCERN, WHAT
SOME PEOPLE DO IS FEWER THAN IN
THE PAST AND STILL SOME
GUIDELINES AND COMMENTATORS
ARGUE THAT WE SHOULDN'T DO
RESEARCH WITH ADULTS WHO CAN'T
CONSENT AND FAMOUSLY A LOT OF
PEOPLE PROBABLY KNOW THIS. THE
NUREMBERG CODE SAYS SUBJECTS
CONSENT AND NOT LA CONSENT AND
SUBJECTS THEMSELVES CONSENT THAT
IS ABSOLUTELY ESSENTIAL TO
ETHICAL RESEARCH AND THAT
APPROACH OBVIOUSLY IN TERMS OF
PROTECTIONS HAS A LOT GOING FOR
IT IF WE CAN'T ENROLL ADULTS WHO
ARE NOT ABLE TO CONSENT INTO
RESEARCH AND WE CAN'T EXPLOIT
THEM IN THE RESEARCH PROCESS.
IN TERMS OF PROTECTION, IT DOES
A LOT. OBVIOUSLY, AT THE SAME
TIME IT HAS SIGNIFICANT
PROBLEMS.
ONE, IT JUST BLOCKS VALUABLE
RESOURCES.
THERE IS AT LEAST SOME CASES IN
WHICH ENROLLING ADULTS WHO CAN'T
CONSENT IS IMPORTANT FOR
SCIENTIFIC PURPOSES DEPENDING
UPON THE CONDITION AND THE
CIRCUMSTANCES THAT ARE BEING
STUDIED AND ALSO WHILE IT
PROTECTS INDIVIDUALS FROM BEING
EXPLOITED IT PRECLUDES THEM FROM
PARTICIPATING IN RESEARCH THAT
MAY BENEFIT THEM CLINICALLY AND
ARE SIGNIFICANT LIMITATIONS .
SINCE NUREMBERG CODE PEOPLE HAVE
BEEN STRUGGLING WITH WAYS TO TRY
TO PROTECT ADULTS THAT CAN'T
CONSENT AND ALLOWING VALUABLE
RESEARCH ON CONDITIONS THAT
EFFECT THEM AND SOME PEOPLE
MIGHT KNOW THAT DECLARATION OF
HELSINKI AND MOTIVATING IDEAS
BEHIND DECLARATION OF HELSINKI
AND GO AROUND THIS AND
PARTICIPATE IN RESEARCH WHEN
APPROPRIATE TO DO SO
YOU HAVE TO GET CONSENT OF
PARTICIPANT THEMSELVES OR
LEGALLY AUTHORIZED
REPRESENTATIVE AND COMING TO
ADULTS INLIKE PEDIATRIC RESEARCH
THAT IS IT AS FAR AS US
REGULATIONS ARE CONCERNED AND IS
NOT CONDITIONAL CONDITIONS WITH
RESEARCH ADULTS AS THERE ARE IN
PEDIATRIC RESEARCH AND IMPORTANT
IMPLICATION FOR TODAY'S TALK OF
THAT IS THERE IS NO REGULATORY
MANDATE AT LEAST ACCORDING TO US
FEDERAL REGS TO OBTAIN ASSETS
FROM ADULTS THAT CAN'T CONSENT
OR LATER TO RESPECT THEIR
DISSENT AND SOME PEOPLE ACTUALLY
SUPPORT THAT APPROACH AND
BASICALLY ARE USING SOMETHING
ALONG THE LINES OF IF AN ADULT
CAN'T GIVE INFORMED CONSENT AND
IF THEY CAN'T CONSENT FOR
THEMSELVES, IT FOLLOWS THEY ARE
NOT ABLE TO UNDERSTAND OR ABLE
TO MAKE THEIR OWN DECISIONS AND
IN THAT CASE IT DOESN'T MAKE
SENSE TO TRY TO OBTAIN CONSENT
AND DOESN'T MAKE SENSE TO
EXPLAIN THE STUDY TO THEM AND
SOLICIT THEIR AFFIRMATIVE
AGREEMENT TO PARTICIPATE OR NOT.
THAT IS AN ASSUMPTION THAT LOTS
OF PEOPLE MAKE AND DON'T KNOW IF
SOME PEOPLE ARE FAMILIAR WITH
THIS AND THAT IS A PROMINENT
LEGAL CASE AND DISTRICT COURT OF
APPEALS IN TARL OE DC AND WON'T
GO INTO DETAILS OF THIS AND
MENTIONING PROMINENT SUPPORT OF
THIS VIEW AND SUIT BY THREE DC
RESIDENT DEPARTMENTS WITH
INTELLECTUAL DISABILITIES THAT
WERE SUBJECTED TO ELECTIVE
SURGERY WITHOUT THEIR INPUT THAT
WASN'T SOLICITED AND AGREEMENT
WASN'T OBTAINED.
THERE WAS A STRING OF SUITS AND
APPEALS THAT ENDED UP AT COU CO
OF APPEALS AND DOESN'T MAKE
LOGICAL SENSE TO SOLICIT VIEWS
OF PATIENTS WHO LACK DECISIONAL
CAPACITY AND THOUGHT THERE WAS
AT THE POINT THAT SOMEBODY LACKS
DECISIONAL CAPACITY THERE IS NO
POINT IN INVITING THEM AND
INVOLVING THEM IN DECISION
MAKING AT ALL.
WHAT IS WRONG WITH THIS VIEW?
IT IS WRONG AND WHAT IS WRONG
WITH IT AND BASIC PROBLEM IS IT
ASSUMES DECISIONAL CAPACITY IS
ALL OR NOTHING AND ASSUMES THAT
YOU HAVE GOT DECISIONAL CAPACITY
OR DON'T HAVE DECISIONAL
CAPACITY AT ALL.
IF THAT WERE RIGHT, THEN I THINK
THAT THE COURT WOULD HAVE BEEN
RIGHT AND SEEKING INPUT OF
PEOPLE WITH DECISIONAL CAPACITY
DOESN'T MAKE SENSE FOR HOW THEY
ARE TREATED AND INSTEAD WE
SHOULD FOCUS ON MAKING TREATMENT
DECISIONS BASED ON WHAT IS IN
THE INDIVIDUAL'S BEST INTEREST
AND THAT WOULD RAISE COMPLICATED
INTERESTING QUESTIONS ABOUT WHAT
THE IMPLICATIONS WOULD BE FOR
RESEARCH ESPECIALLY AND RESEARCH
THAT DOESN'T OFFER PROSPECT OF
DIRECT BENEFIT.
BUT IF IT IS NOT RIGHT IT IS NOT
RIGHT BECAUSE IT IGNORES FACT
THAT CAPACITY TO CONSENT IS A
MATTER OF DEGREE AND WHY IS IT A
MATTER OF DEGREE?
A COUPLE REASONS I WILL GO
THROUGH QUICKLY THAT ARE
FAMILIAR TO MOST PEOPLE ON THE
CALL.
ONE IS JUST THAT THE CAPACITY TO
CONCEPT IS NOT UNITARY AND
DEPENDS UPON A NUMBER OF
UNDERLYING CAPACITIES AND IS
SOME DEBATE ABOUT THIS AND THIS
IS A STANDARD VIEW AND TO HAVE
CAPACITY CONSENT YOU NEED
CAPACITIES TO UNDERSTAND, TO
APPRECIATE THE INFORMATION, TO
REASON ABOUT IT IN LIGHT OF
PREFERENCES AND VALUES AND TO
MAKE A VOLUNTARY DECISION
WHETHER OR NOT TO PARTICIPATE IN
RESEARCH IN OUR CASE.
AND THEN COMMUNICATE THAT
DECISION AFTER THINKING ABOUT IT
AND POINT IS NOT ONLY IS THERE A
NUMBER OF CAPACITIES HERE BUT
CAPACITIES THEMSELVES ARE
COMPLICATED AND ONE CHALLENGE
FOR THIS TALK WAS TO SEE CAN I
GET ALL OF THE ITEMS THAT THE US
REGULATIONS LIST AS IMPORTANT IN
TERMS OF UNDERSTANDING
REQUIREMENT ON TO ONE'S SLIDE?
I THINK I DID.
AS YOU WILL SEE, IT IS A LOT.
UNDERSTANDING ITSELF IS
COMPLICATED AND THERE IS A LOT
OF THINGS YOU NEED TO UNDERSTAND
AND NOT ONLY DO YOU NEED FIVE
DIFFERENT CAPACITIES AND EACH OF
THE CAPACITIES HERE
UNDERSTANDING ITSELF IS
COMPLICATED THAT IS A NUMBER OF
SUB ELEMENTS AND FINALLY, THOSE
ELEMENTS THEMSELVES ARE
COMPLICATED.
SO ONE OF THE ELEMENTS
PREVIOUSLY YOU NEED TO
UNDERSTAND IS IN THE WORDS OF
THE REGULATIONS AND REASONABLY
FORESEEABLE RISKS.
OF COURSE, IT IS RARE THAT
THERE IS NEVER, I GUESS, A
PROTOCOL WITH ONE FORESEEABLE
RISKS AND LOTS OF THEM AND COULD
BE 5 OR 10 OR 20 AND THEY COULD
INCLUDE DIFFERENT KINDS OF SHORT
TERM RISKS LONG TERM RISKS AND
LIKELY AND UNLIKELY RISKS AND
THE POINT HERE IS THAT THERE IS
A LOT GOING ON AND LOTS THAT
NEEDS TO BE IN PLACE FOR
SOMEBODY TO HAVE DECISIONAL
CAPACITY AND POINT IS THAT IF
SOMEBODY DOESN'T HAVE ONE OF
THOSE CAPACITIES OR ONE OF THOSE
SUB-ELEMENTS.
I WILL CALL THEM HERE ESSENTIAL
ELEMENTS AND LET'S IMAGINE WE
HAVE A PROTOCOL FOR LONG TERM
RISKS THAT ARE ESSENTIAL
ELEMENTS IN A SENSE THAT TO
CONSENT TO THE STUDY YOU NEED TO
LEARN OR KNOW AND UNDERSTAND OR
APPRECIATE LONG TERM RISK AND
IMAGINE LONG TERM RISK IS RISK
OF DEATH AND PEOPLE HAVE TO
UNDERSTAND THAT IF THEY ARE
GOING TO HAVE CAPACITY TO ENROLL
IN THIS STUDY AND WHETHER IT IS
SOMEBODY THAT DOESN'T UNDERSTAND
THAT SPECIFIC ELEMENT THEN WILL
HAVE DECISIONAL INCAPACITY AND
WON'T BE ABLE TO CONSENT FOR
THEMSELVES WITH RESPECT TO THIS
SPECIFIC PROTOCOL. OF COURSE,
NOT UNDERSTANDING THE LONG-TERM
RISKS IS COMPATIBLE WITH
SOMEBODY THAT IS UNDERSTANDING A
LOT OF OTHER THINGS THAT ARE
RELEVANT TO THE PROTOCOL. FOR
INSTANCE, THEY MIGHT UNDERSTAND
ITS RESEARCH OR THAT THEY ARE IN
THE CLINICAL CENTER AND THEY
MIGHT HAVE VERY GOOD SENSE FOR
THEIR OWN VALUES AND PREFERENCES
WITH RESPECT TO RESEARCH AND
MIGHT KNOW THAT THERE IS
SOMEBODY THAT SUPPORTS RESEARCH
AND IS INTERESTED IN
CONTRIBUTING TO IT AND ON THE
OTHER HAND SOMEBODY WHO DOESN'T
AND IS NOT INTERESTED IN
CONTRIBUTING TO IT AND THAT IS
THE FIRST POINT THAT DECISION
MAKING CAPACITIES IS COMPLICATED
AND MULTI-FACETED AND DON'T HAVE
ONE ELEMENT IN PLACE DOESN'T
MEAN YOU HAVE NOTHING IN PLACE
THAT IS THE ASSUMPTION THAT THE
ALL OR NOTHING VIEW ASSUMED.
THAT VIEW IS MISTAKEN.
NOW SOME PEOPLE REALLY RUN WITH
THIS CONCLUSION.
THEY WILL SAY, YEAH. THAT IS
RIGHT. NOT ONLY IS IT A MATTER
OF DEGREE, BUT NOBODY'S
DECISIONAL CAPACITY IS PERFECT
AND NOBODY UNDERSTANDS
EVERYTHING AND NOBODY IS ABLE TO
REASON PERFECTLY.
SO WHAT IS NOW HAS BEEN CALLED
PEOPLE MIGHT BE FAMILIAR WITH
THIS AND WE CAN TALK MORE IN THE
Q & A PEOPLE INTERESTED AND WHAT
IS SUPPORTIVE DECISION MAKING
AND PEOPLE IN EFFECT GOT OTHER
WAY FROM ALL OR NOTHING VIEW.
WHAT THEY WILL SAY IS, LOOK. IT
IS A MATTER OF DEGREE.
DAVE JUST SAID THAT AND NOBODY
IS PERFECT AND HAS ZERO AND
PEOPLE UNDERSTAND SOME THINGS.
THAT IS THE FIRST POINT.
WHAT SOME PEOPLE ARGUE THEN IS
DRAWING A THRESHOLD ANYWHERE ON
THE CONTINUUM WILL BE ARBITRARY
AND WHAT WE DO. WE HAVE TO SAY
HOW MUCH UNDERSTANDING IS
SUFFICIENT OR ENOUGH.
SOME PEOPLE CONCLUDE THAT
WHEREVER YOU PLACE THE THRESHOLD
IT IS ARBITRARY.
THEY CONCLUDE FROM THAT FACT
THAT YOU SHOULDN'T DRAW THE
THRESHOLD AT ALL.
INSTEAD, YOU SHOULD TAKE THE
VIEW.
THIS IS THE EXTREME SUPPORTIVE
DECISION MAKING VIEW THAT
EVERYBODY, NO MATTER WHAT
COGNITIVE CAPACITY RETAINS THE
RIGHT OR CLAIM TO MAKE DECISIONS
FOR THEMSELVES AND MY VIEW IS
BOTH OF THE VIEWS ARE WRONG.
WE HAVE TO FIGURE OUT HOW TO
LIVE IN THE MIDDLE.
SO WHY IS THAT VIEW WRONG?
I THINK THAT VIEW IS WRONG.
WHAT THAT VIEW DOES IS IT JUST
ASSUMES THAT NOT ONLY IMPORTANT
BUT THE OVERRIDING IMPORTANCE IS
JUST LETTING PEOPLE MAKE THEIR
OWN DECISIONS AND LETTING PEOPLE
GUIDE DECISIONS FOR THEMSELVES.
THAT IS IMPORTANT BUT NOT ONLY
THING WE CARE ABOUT AND NOT ONLY
THANG IS PART OF RESPECT FOR
OTHERS.
THERE IS ALSO AN IMPORTANT
COMPONENT OF RESPECTING AND
PROTECTING THE VALUES AND
INTERESTS OF OTHERS.
WHEN SOMEBODY HAS LESS
DECISIONAL CAPACITY, THEY
THEMSELVES ARE LESS IN A
POSITION TO PROTECT AND PROMOTE
VALUES AND INTEREST AND
THEREFORE WE HAVE REASON WHY WE
SHOULD CHANGE WHAT WE DO AND
MAKE SURE THAT THEIR VALUES AND
INTERESTS ARE PROTECTED IN THE
PROCESS HERE OF ENROLLING THEM
AND THEY ARE PARTICIPATING IN
RESEARCH.
SO THIS LEAVES US WITH A
CHALLENGE OF TRYING TO FIGURE
OUT A WAY TO RECOGNIZE BOTH THAT
PEOPLE HAVE DECISIONAL
CAPACITIES AND THEY HAVE
DECISIONAL LIMITATIONS.
SO THE QUESTION IS CAN WE
INVOLVE INDIVIDUALS IN THE
DECISION MAKING PROCESS, ADULTS
WHO CAN'T GIVE INFORMED CONSENT
AFRND CAN WE INVOLVE THEM IN
DECISION MAKING PROCESS ABOUT
YOU DO IT IN A WAY THAT ALSO
ADEQUATELY PROTECTS VALUES AND
INTERESTS.
SO TO SHOW US HOW LONG I HAVE
BEEN AT THIS, THIS IS A PAPER
THAT IS ALMOST 25 YEARS OLD.
NOW THAT I WROTE WITH A FELLOW
AT THE TIME KIERAN PRES AD AND I
WENT BACK AND LOOKED AT THIS
LAST WEEK AND PAPER HOLDS UP
WELL THANKFULLY AND THAT PAPER
WHAT WE DID IS WE ARGUED WAY YOU
DO THIS WHAT I WAS CALLING
LIVING IN THE MIDDLE HERE AND
WAY YOU CONTINUE TO INVOLVE
INDIVIDUALS WITH DECISIONAL
IMPAIRMENTS IN THE DECISION
PROCESS ABOUT YOU STILL PROTECT
THEM IS WITH FIVE SAFEGUARDS AND
I THINK THAT THE SAFEGUARDS WE
SHOULD BE THINKING ABOUT WHEN WE
ARE THINKING ABOUT RESEARCH WITH
ADULTS THAT CAN'T CONSENT AND
WON'T GO THROUGH FIRST FOUR AND
TODAY WILL TALK ABOUT THE LAST
ONE. IMPORTANCE OF SOLICITEE
ASSENT AND RESPECTING DESCENT
AND GIVING PART ON THIS
LITERATURE AND LOTS OF PEOPLE
OPINED ON THIS. THIS IS A
SAMPLING OF THEM AND PEG HAS A
LOT MORE FOR PEOPLE THAT ARE
INTERESTED.
THE POINT OF THIS IS GOING TO BE
IN THE END THAT THERE IS JUST
ALMOST UNANIMOUS, EXTREMELY WIDE
AGREEMENT ABOUT THIS, THAT
RESPECTING DECENT AND SOLICITING
ASSENT ARE IMPORTANT AND THIS IS
ADVISORY COMMITTEE TO OHAP AND
THEY THINK YOU NEED TO GET
ASSENT AS WELL THROUGHOUT COURSE
OF RESEARCH INVOLVEMENT THEY
EMPHASIZE THAT YOU COME BACK AND
DECLARATION OF HELSINKI SAYS
SIMILAR THING AND NO ET IN HERE
THAT SUBJECT'S DECENT SHOULD BE
RESPECTED AS WELL AND PEOPLE ARE
NOT FAMILIAR WITH THIS COUNCIL
OF ORGANIZATIONAL MEDICAL
SCIENCES THAT IS A VERY
PROMINENT SET OF GUIDELINES FOR
RESEARCH AND LOW AND MIDDLE
INCOME COUNTRIES AND DON'T KNOW
AS MUCH ABOUT IT AND IS NOT AS
POPULAR OR FAMILIAR IN THE US.
AGAIN, SAME THING CONSENT OF
EACH SUBJECT SHOULD BE OBTAINED
TO EXTENT OF PERSON'S
CAPABILITIES AND REFUSE ALE TO
PARTICIPATE IN RESEARCH AND
ALWAYS BE RESPECTED AND THERE IS
A CAVEAT THAT SOME PEOPLE PUT ON
IT AND WE CAN COME BACK IN Q & A
WHEN PEOPLE ARE INTERESTED AND
WHAT ABOUT DECENT IN SETTING OF
RESEARCH STUDY THAT OFFERS
REALLY IMPORTANT POTENTIAL
BENEFITS NOT AVAILABLE OUTSIDE
OF THE RESEARCH SETTING AND
REMAINING IMPORTANT QUESTION IN
THIS CONTEXT AND OTHERS IN NEW
YORK STATE ADVISORY GROUP ABOUT
20 YEARS AGO AND WENT THROUGH
THIS DECENT AS WELL AS MARYLAND
ATTORNEYS AND GROUP DID THE SAME
THING AND CANADIAN TRICOUNSEL
STATEMENT AND POLICY THAT REGS
MIGHT BE FAMILIAR WITH AND LOOKS
LIKE WE MAY HAVE THIS IS PART OF
POLICY 403 AND IRBS SHOULD BE
HEARING MORE ABOUT THAT IN THE
NEAR TERM THAT ASSENT AROUND
DECENT WILL BE PART OF POLICY
AND PROCESSES AS WELL.
THAT WAS TO SAY EVERYBODY AGREES
ON THIS AND SHOULD BE SOLICITING
ASSENT AND WHERE CHALLENGE AND
WORK NEEDS TO BE DONE IS
FIGURING OUT WHO HAS CAPACITY TO
ASSENT AND THINGS SAY THAT IF
SOMEBODY HAS CAPACITY TO CONCEPT
YOU SHOULD OBTAIN IT AND DON'T
SAY WHO HAS THAT CAPACITY AND IS
THE REAL CHALLENGE THEN AND HOW
DO WE FIGURE THAT OUT?
THIS IS WAY THAT PHILOSOPHER
THINKS AND WE NEED TO FIGURE
THIS OUT AND WHAT IS THE POINT
AND WHY ARE WE SOLICITING ASSENT
IN THE FIRST PLACE?
PRESUMABLY THE GOAL IS TO ENSURE
PROPER RESPECT AS I MENTIONED
FOR INDIVIDUALS THAT HAVE
INTELLECTUAL OR COGNITIVE
DISABILITIES.
IF THAT IS RIGHT, THE WAY TO
POSE THE QUESTION IS AS FOLLOWS
WHEN DOES OBTAINING AFFIRMATIVE
AGREEMENT OR ASSET AND WHEN DOES
OBTAINING AFFIRMATIVE AGREEMENT
OF ADULTS THAT CAN'T CONCEPT FOR
THEMSELVES AND WHEN DOES THAT
PROMOTE THIS GOAL OF RESPECTING
THESE INDIVIDUALS?
WHAT IS CURRENT GUIDANCE SAY?
LARGELY IT SAYS IT DEPENDS AND
ALSO SAYS THAT LOTS OF PEOPLE
TAKE THIS SIMILAR WORDING AND
PEOPLE MIGHT BE FAMILIAR WITH IN
PEDIATRIC REGS TALKING ABOUT
WHICH CHILDREN ARE ABLE TO
DECENT YOU LOOK AT INDIVIDUAL'S
ABILITIES AND PSYCHOLOGICAL AND
EMOTIONAL STATE AND CONDITIONS
AND CIRCUMSTANCES AND ALL THAT
OBVIOUSLY MAKES SENSE.
WE NEED TO KNOW MORE
SPECIFICALLY WHAT ABOUT THEIR
DECISIONAL ABILITIES AND WHAT
DECISIONAL ABILITIES DO THEY
NEED TO HAVE IN M PARTICULAR TO
HAVE CAPACITY TO ASSENT? MY
THOUGHT ABOUT THIS AND I
ACTUALLY THINK SOME PEOPLE
DISAGREE WITH THIS AND THINK IT
IS RIGHT AND WOULD BE INTERESTED
IN PEOPLE DOING THE Q & A AND
SEEMS WE ARE TALKING ABOUT
RESPECT HERE AND DON'T THINK IT
IS RESPECTFUL TO ASK SOMEBODY TO
AGREE TO SOMETHING THEY DON'T OR
CAN'T UNDERSTAND.
I DON'T SEE HOW THAT IS A MATTER
OF RESPECTING THE PERSON.
IF THAT IS RIGHT, TO JUST
SOMETHING THAT IS A FOLLOWING
PRINCIPLE WHICH IS WHETHER AN
ADULT THAT CAN'T CONSENT HAS THE
CAPACITY TO ASSENT IT DEPENDS
WHETHER THEY CAN UNDERSTAND AT
LEAST WHAT I'M CALLING THE BASIC
ELEMENTS OF THE STUDY AND CAN
THEY UNDERSTAND THE STUDY AT
LEAST AT SOME BASIC ELEMENTARY
LEVEL AND IF THEY CAN, MY VIEW
IS THAT THEY HAVE THE CAPACITY
TO ASSENT. IF THEY CAN'T, I
DON'T THINK THEY HAVE CAPACITY
TO ASSET AND NOW THAT RAISES
QUESTION OF WHICH ARE AND WHAT
ARE BASIC ELEMENTS THAT ARE
IMPORTANT TO ASSENT. I DON'T
KNOW IF PEG FOUND MORE I
COULDN'T FIND MORE ON THIS.
MAYBE THIS IS A GAP IN THE
LITERATURE.
I FOUND A LITTLE BIT AND WHAT I
FOUND. THIS IS FROM STANFORD
WHO SAYS THAT IN ORDER TO BE
ABLE TO ASSENT, AN INDIVIDUAL
HAS TO UNDERSTAND THESE BULLETED
ITEMS AND SHOULD SAY THIS IS
PULLED OFF THE INTERNET AND
WHETHER IT IS UP TO DATE I DON'T
REALLY KNOW AND LATEST
INFORMATION TO FIND BUT MIGHT
NOT BE UP TO DATE FOR ALL I
KNOW.
THIS IS TAKEN FROM THE FEDERAL
REGS AND IT IS PROBABLY TAKEN A
LITTLE TOO STRICTLY FROM THE
FEDERAL REGULATIONS AND
INSTANCE, I'M NOT SURE TO BE
ABLE TO ASSENT THAT YOU HAVE TO
UNDERSTAND THE PLAN FOR
COMPENSATION FOR RESEARCH
INJURIES AND IS IMPORTANT THAT
THERE IS A PLAN AND I'M NOT SURE
IT HAS TO BE UNDERSTOOD BY AN
ADULT WHO CAN'T GIVE INFORMED
CONCEPT AND I'M ALSO NOT SURE OR
NOT CONVINCED AT LEAST THAT
SOMEBODY TO GET ASSENT THAT THEY
HAVE TO UNDERSTAND THAT THERE IS
CERTAIN INFORMATION YOU MIGHT
HAVE TO GET TO THE SPONSOR OF
THE TRIAL AND SEEMS TO ME IS ON
THE RIGHT TRACK WITH SOME OF IT
AND SEEMS A LITTLE BIT TOO MUCH
OR A LITTLE BIT TOO BROAD OR
DEMANDING AND THIS IS FROM CHOP
AND THIS CHILDREN'S HOSPITAL IN
PENNSYLVANIA MOSTLY DOES
PEDIATRICS AND TEENAGERS THAT
TURN INTO ADULTS AND THEY KEEP
TREATING THEM AND THEY HAVE A
POLICY IN THIS REGARD AND THEY
SAY SOMETHING VERY TRIMMED DOWN
FROM STANFORD. YOU MUST BE ABLE
TO UNDERSTAND THE GENERAL
PURPOSE OF ROOT HE SEARCH AND
NATURE OF PROCEDURES AND MUST BE
ABLE TO UNDERSTAND CONCEPT OF
VOLUME UNTARINESS AND DON'T
UNDERSTAND WHAT IT MEANS CONCEPT
OF VOLUNTEERS AND SEEMS ON RIGHT
TRACK TO ME AND MAYBE SEEMS A
LITTLE TOO MINIMAL AND IS MY
TENTATIVE PROPOSAL AND WOULD BE
VERY INTERESTED IN WHAT PEOPLE
THINK ABOUT THIS.
YOU NEED TO UNDERSTAND SOMETHING
ABOUT RESEARCH.
WHAT IS THAT?
FOR ME, IT IS BASICALLY
UNDERSTANDING THAT PART OF THE
RESEARCH PROCESS INVOLVES TRYING
TO LEARN THINGS IN THE
INTERACTIONS WITH THIS
INDIVIDUAL TO GAIN INFORMATION
THAT MIGHT HELP OTHERS.
THEN YOU HAVE TO ASK WHAT THEY
WILL BE ASKED TO DO AND STAY
HERE FOR A DAY AND GO THROUGH
SOME TESTS AND WE WILL ASK YOU
QUESTIONS AND GIVE YOU A DRUG OR
WHOEVER IT IS. IF THERE IS A
CHANCE OR NOT OF PERSONAL
BENEFIT THEY SHOULD UNDERSTAND
THAT.
I DON'T THINK YOU NEED TO
UNDERSTAND THE SPECIFIC HARMS IT
WILL HURT MY KIDNEY VERSUS MY
LIVER BUT THEY NEED TO
UNDERSTAND SOMETHING ABOUT THE
MAGNITUDE OF THE POTENTIAL HARMS
AND THERE ARE SMALL HARMS AND
THERE ARE SIGNIFICANT ONES.
AT LEAST SOMETHING IN THE
BALLPARK OF THEIR PROBABILITY
AND THEY ARE UNLIKELY AND
POSSIBLE AND THEY ARE LIKELY AND
OBVIOUSLY THE PERSON AND THEY
DON'T NEED TO UNDERSTAND THE
CONCEPT OF VOLTAIRINESS AS CHOPS
IS BUT THEY CERTAINLY NEED TO BE
ABLE TO AND BE WILLING TO SAY
NO.
ONE THING ABOUT THAT THAT IS
INTERESTING IS THAT I THINK
PEOPLE AND I HAVE TO DO THIS AND
GET TRIPPED UP WHEN YOU TALK
ABOUT THIS AND HAVE AN ADULT
THAT CAN'T CONSENT AND YOU HAVE
AN LAR AND SOME PEOPLE DESCRIBE
THAT AS IT IS NOT UP TO THE
PARTICIPANT ANYMORE BUT UP TO
THE LAR.
WELL, IF YOU ARE GETTING ASSENT,
THAT IS NOT TRUE.
INSTEAD TO HAVE A PARTICIPATION,
YOU NEED TWO YESES.
RIGHT?
THIS IS A JOINT DECISION.
YOU NEED TWO YESES.
IN THAT CASE, EITHER NO, NO FROM
EITHER PARTY IS A NO.
RIGHT?
IF LAR DOESN'T GET PERMISSION
YOU CAN'T ENROLL THEM AND IF THE
INDIVIDUAL THEMSELVES DESCENT,
YOU ENROLL THEM.
ALL RIGHT. THIS IS WHAT I
MENTIONED IS -- THOSE WERE
INTENDED PROPOSALS AND BASIC
ELEMENTS ARE AND THOUGHT IS IF
SOMEBODY CAN UNDERSTAND THEM,
THEY CAN UNDERSTAND WHAT IS
BEING ASKED OF THEM AT LEAST AT
A VERY BASIC LEVEL.
YOU SHOULD SOLICIT THAT
INDIVIDUAL ASSET.
IF THEY CAN'T UNDERSTAND ONE OR
MORE OF THOSE THINGS, THEY DON'T
HAVE THE CAPACITY TO ASSENT.
YOU SHOULDN'T SOLICIT THEIR
ASSENT.
SO HOW DO YOU DO THAT?
OBVIOUSLY EXPLAIN THE BASIC
ELEMENTS TO THE EXTENT AND IN A
WAY THAT THE INDIVIDUAL
HOPEFULLY CAN UNDERSTAND THEM
AND HERE IS SOMETHING FROM AHARP
THE ACCREDITATION PROCESS ABOUT
MAKING SURE THAT THE INFORMING
PROCESS IS KEEPING IN MIND
ABILITIES AND PROCLIVITIES OF
THIS SPECIFIC INDIVIDUAL.
I THINK WE DID THIS STUDY AND
HAVEN'T SEEN EMPIRICAL DATA ON
THIS.
WE DID AN EMPIRICAL STUDY A
COUPLE YEARS AGO AND ASKED
TEENA
TEENAGER WHAT THEY THOUGHT ABOUT
ASSENT AND ASKED THEM WHETHER OR
NOT THEY WANTED TO SIGN A FORM
AND GOING INTO IT NO THAT IS
POINTLESS OR JUST DOCUMENTATION
AND I DON'T CARE.
WE WERE SURPRISED TO FIND THAT A
VAST MAJORITY OF THEM WANTED TO
SIGN A FORM AND FELT IT
MEANINGFUL AND FELT IT SHOWED
THAT RESEARCHERS WERE REALLY
TAKING VIEWS AND OPINIONS
SERIOUSLY AND IF WE ASSUME THAT
THOSE VIEWS EXTRAPOLATE OUT TO
ADULTS AS WELL, IT SUGGESTS THAT
AT LEAST IN A LOT OF CASES IF
THE PROCESS IS MEANINGFUL TO THE
PERSON IF THEY CAN UNDERSTAND
WHAT IT INVOLVES THEN HAVING
THIS AND INFORMING THE
INDIVIDUAL TO SIGN IT MAKES
SENSE AND ONE THING THAT IS MY
ACCESS AND TRY TO GRIND ON THE
IRB AND SAT ON NIGHT IRB FOR 20
YEARS AND ALWAYS FOUGHT WITH
INVESTIGATORS OVER CONSENT FORMS
AND THOUGHT NO OTHER HUMAN BEING
EXCEPT FOR THEM COULD POSSIBLY
UNDERSTAND.
AT ONE POINT ONE OF THE
INVESTIGATORS STARTED TO DO
RESEARCH WITH TEENS AND CREATED
ASSET IN FORUMS AND THOUGHT
THERE IT IS AND WHAT A CONSENT
FORM SHOULD LOOK LIKE AND THINK
NOT ONLY ASSENT FORMS ARE GOOD
FOR ADULTS THAT CAN'T CONSENT
AND FOR TEENAGERS BUT MIGHT BE
RIGHT WAY TO START WITH CREATING
CONSENT FORMS. THEY SEEM MUCH
CLEARER AND TO THE POINT TO ME
THAN CONSENT FORMS AND GOES BACK
TO WHAT I HIGHLIGHTED BEFORE
FROM DECLARATION OF HELSINKI AND
FOR MOST PART I'M FOCUSED ON
INITIAL ENROLLMENT INTO A STUDY
AND OBVIOUSLY IF A LONGITUDINAL
STUDY THAT GOES ON FOR A WHILE
THEY SHOULD BE SOLICITING THE
ONGOING ASSET AT RECENT
INTERVALS THAT IS DEPENDENT UPON
THE NATURE OF THE STUDY AND
INDIVIDUAL AND LAR AS I
MENTIONED IF THEY AGREE AND GIVE
AFFIRMATIVE AGREEMENT INDIVIDUAL
CAN PARTICIPATE AND IF
INDIVIDUAL DECLINES OR DISSCENTS
THEY ARE NOT ENROLLED OR IF IN
THE PROTOCOL ALREADY THEY SHOULD
BE WITHDRAWN.
THAT IS ASSET.
PEDIATRIC REGULATIONS DO THIS
THEY HAVE THIS THOUGHT DISSENT
IS LACK OF ASSENT AND IF THEY
DISSENT THEY ARE NOT GIVING
ASSENT AND ASSUME FROM THAT AND
THIS IS A MISTAKE THAT NATIONAL
COMMISSION MADE THAT
RECOMMENDATIONS FORM BASIS OF
PEDIATRIC REGULATIONS IF THAT IS
TRUE YOU DON'T NEED SEPARATE
DISSENT REQUIREMENT ANYBODY THAT
DISSCENTS IS NOT BY FORCE
ASSENTING SO YOU TAKE THEM OUT
AND PROBLEM WITH THAT IS AS WE
NOTED THERE WILL BE AT LEAST
SOME PEOPLE THAT NOT ONLY CAN'T
CONSENT BUT DON'T HAVE CAPACITY
TO ASSENT.
SO IF THERE IS NOT A SEPARATE
DISSENT REQUIREMENT OR DEMAND
THAT YOU RESPECT THE DISSENT OF
INDIVIDUALS, THEN YOU ARE NOT
GOING TO HAVE ANY REQUIREMENT
FOR RESPECTING THE DISSENTIVE
INDIVIDUALS THAT ARE NOT ABLE TO
ASSENT.
IT IS IMPORTANT TO HAVE SEPARATE
CONSIDERATION OF DISSENT FOR
THOSE INDIVIDUALS.
SO IMPORTANT THING IS AS ASSENT,
I KNOW IT IS -- YOU DON'T
UNDERSTAND EVERYTHING BUT HAVE
TO UNDERSTAND SOME THINGS TO BE
MAKING A DECISION ABOUT WHETHER
ENROLL IN THE STUDY AND WHAT IS
IMPORTANT ABOUT ASSENT SORRY
ABOUT DISSENT IS IT IS NOT LIKE
THAT.
DISSENT DOESN'T REQUIRE
UNDERSTANDING.
IN FACT, IN PRACTICE A LOT OF
TIMES, DISSENT MAY BE GENERATED
BY A FAILURE TO UNDERSTAND AND
SOMEBODY DOESN'T UNDERSTAND AND
WHEN WE DON'T UNDERSTAND THINGS,
WE TEND NOT TO LIKE THEM.
THEREFORE, DISSENT MAY JUST BE A
FUNCTION OF NOT UNDERSTANDING
ANYTHING ABOUT THE STUDY AND NOT
LIKING IT.
SO, WHY DO WE WANT TO RESPECT
PEOPLES DISSENT IF THEY CAN'T
ASSENT?
TWO REASONS. ONE, IT GIVES
INDIVIDUALS SOME CONTINUED
CONTROL OVER THEIR LIVES.
AND THE OTHER THING IS THAT EVEN
IF THEY CAN'T CONSENT AND CAN'T
ASSENT, WE WANT TO BE VERY SURE
WE ARE NOT EXPOSING THEM TO
EXCESSIVE RISKS AND BURDENS OR
EXCESSIVE STRESSES AND DISSENT
IS A GOOD SIGNAL THAT MIGHT BE
OCCURRING AND THIS MIGHT BE TOO
MUCH AND MIGHT BE OVERWHELMING
FOR THIS INDIVIDUAL.
IT IS NOT JUST A MATTER OF
GIVING THEM SOME CONTROL OVER
THEIR LIVES ABOUT YOU IS ALSO
MAKING SURE WE HAVE APPROPRIATE
PROTECTIONS IN PLACE FOR THEIR
WELLBEING AND THEIR INTERESTS.
HERE IS ONE OF THE WORRIES THAT
I TALK ABOUT THIS WITH CONSENT
TO THE WAY THAT WE THINK OFTEN
ABOUT INFORMING PEOPLE ABOUT
CLINICAL TRIALS IS THROUGH
CONSENT FORMS AND SOMETIMES
ASSENT FORMS AND DESCRIBE STUDY
IN CONSENT FORM AND ASSENT FORM
AND HOW PEOPLE GET INFORMATION
ABOUT STUDIES AND MY WORRY WITH
THAT PRACTICE AND MAKES SENSE IS
WHEN YOU START TO TALK ABOUT
ADULTS THAT CAN'T CONSENT OR
ASSENT AND THERE IS A WORRY IF
ONLY INFORMING PROCESS OCCURS
THROUGH CONSENT OR ASSENT FORM
THAN THESE INDIVIDUALS WON'T BE
PROVIDED WITH ANY INFORMATION AT
ALL REGARDING PARTICIPATION AND
HOPE THAT EVERYBODY AGREES WITH
ME THAT IS A MISTAKE PROVIDING
INFORMATION IS IMPORTANT AS A
MEANS TO PUT PEOPLE IN A
POSITION TO MAKE DECISIONS FOR
THEMSELVES AND NOT THE ONLY
REASON WHY WE PROVIDE PEOPLE
WITH INFORMATION.
THERE ARE OTHER REASONS. FOR
INSTANCE, TO GIVE THEM A SENSE
FOR WHAT TO EXPECT AND WHAT IS
COMING AND WHAT THEY WILL BE
DOING AND ALSO AT LEAST IN SOME
CASES DOING THAT CAN REDUCE OR
MINIMIZE DISTRESS WHEN PEOPLE
KNOW WHAT IS GOING ON AND HOW
LONG THEY WILL BE HERE FOR
INSTANCE AND THAT CAN REDUCE THE
STRESS OF BEING HERE.
EEFSH FOR SOMEBODY WHO CAN'T
CONSENT OR ASSENT STILL I THINK
IT IS IMPORTANT TO HAVE A
MECHANISM THAT THE INVESTIGATORS
DESCRIBE FOR PROVIDING AT LEAST
BASIC INFORMATION THAT PEOPLE
CAN UNDERSTAND AND ALSO
ASSESSING WHETHER OR NOT THEY
HAVE ANY QUESTIONS EVEN IF THEY
ARE NOT BEING ASKED FOR ASSENT.
WE WANT TO ADDRESS THEIR
QUESTIONS TO THE EXTENT THAT WE
ARE ABLE TO DO SO.
THIS CAN OBVIOUSLY GET REALLY
HARD.
A LOT OF TIMES WHETHER OR NOT
SOMEBODY IS DISSENTING IS JUST
NOT CLEAR.
RIGHT?
SOMETIMES IT IS. SOMETIMES
SOMEBODY SAYS, NO. I DON'T WANT
TO DO THIS ANYMORE.
GET ME OUT OF HERE. THAT CAN BE
RELATIVELY CLEAR AND OTHER CASES
PARTICULARLY FOR PEOPLE WHO HAVE
PROBLEMS WITH COMMUNICATION,
PEOPLE WHO HAVE EXPRESSIVE
PROBLEMS, IT CAN BE HARD.
SO IF THEY ARE NOT ABLE TO
COMMUNICATE CLEARLY WITH YOU BY
LANGUAGE, THEY MIGHT BE PULLING
AWAY AND ARE FROWNING AND DON'T
LOOK LIKE THEY LIKE WHAT IS
GOING ON AND IT CAN BE HARD AT
LEAST IN SOME CASES TO FIGURE
OUT WHETHER OR NOT THOSE ACTIONS
OR EXPRESSIONS CONSTITUTE
DISSENT.
THIS WAS A CONSULT WE HAD A LONG
TIME AGO NOW WHEN THERE WAS
INPATIENT ALZHEIMER'S STUDY AND
WAS A WOMAN HERE FOR A
THREE-WEEK INPATIENT STUDY.
AFTER ABOUT DAY 10, SHE STARTED
TO SAY TO THE NURSES I WANT TO
GO HOME.
AND WE DID A CONSULT AND DID A
NUMBER OF ASSESSMENTS AND HER
HUSBAND GOT INVOLVED.
WE COULDN'T FIGURE OUT EXACTLY
WHAT WAS GOING ON OR WHETHER OR
NOT THIS WAS AN EXPRESSION OF
DISSENT.
HOW DO YOU FIGURE THAT OUT?
THERE IS TWO QUESTIONS YOU CAN
ASK, WHETHER OR NOT
COMMUNICATION OR EXPRESSION OR
ACTION, WHETHER OR NOT IT IS
FOCUSED ON THE STUDY ITSELF.
I CAN TELL NEW THIS WOMAN'S CASE
IT TURNED OUT NO THE TO BE
WHENEVER SHE WAS HOME SHE SAID
SHE WANTED TO GO HOME AS WELL
AND JUST THAT SHE WASN'T
COMFORTABLE WHEREVER SHE WAS.
FOR HER, THOSE STATEMENTS
WEREN'T AN EXPRESSION OF
OBJECTIONS OR CONCERNS ABOUT THE
STUDY BUT WAS CONCERNS ABOUT HER
VERY UNFORTUNATE SITUATION.
BUT SO WHAT WE WANT TO ASK IS,
IS THE COMMUNICATION OR
EXPRESSION OR ACTION INDICATING
SOMETHING ABOUT THEY DON'T WANT
TO BE IN THE STUDY?
IT IS ABOUT THE STUDY OR JUST
THEY ARE EXPERIENCING DISTRESS
OR ANXIETY OR SOME OTHER
AVERSIVE EMOTIONS AS A RESULT OF
BEING IN A STUDY AND THINK THOSE
ARE THE QUESTIONS TO ASK IN
TRYING TO DO THESE
INTERPRETATIONS.
HERE IS A SUMMARY OF THAT.
OBVIOUSLY WHAT WE FOUND IS TRUE
IN LOTS OF CASES AND WHAT WE DID
IN THAT CASE AS I MENTIONED WE
CALLED IN THE HUSBAND AND AT
LEAST PEOPLE WHO HAVE EXPERIENCE
WITH THESE INDIVIDUALS SOMETIMES
CAN TELL YOU WHAT ARE THEY
TRYING TO EXPRESS? IS THIS A
BASELINE FROWN THEY HAVE OR IS
IT SOMETHING THAT IS PARTICULAR
TO WHAT IS GOING ON WITH THEM
NOW?
ONE THING THAT I THINK IS
IMPORTANT IS THAT WE WANT TO
SOLICIT ASSENT AND WE ALSO WANT
TO RESPECT DISSENT. LIKE I
SAID, IF SOMEBODY SAYS, YEAH,
MAN. YOU DON'T TAKE THAT
FOREVER AS A DECISION AND YOU
DISCUSS IT WITH THEM AND IF THEY
CHANGE THEIR MIND THEY GET TO
CHANGE THEIR MIND.
SIMILARLY WITH DISSENT, WHILE WE
WANT TO RESPECT DISSENT AND
OBVIOUSLY DON'T WANT TO BULLY
PEOPLE OR TRY TO NUDGE THEM INTO
STAYING IN A STUDY, IT IS ALSO
TRUE THAT I DON'T THINK
RESPECTING DISSENT REQUIRES THAT
THE INSTANT THAT YOU GET A CLEAR
EXPRESSION OF DISSENT YOU NEED
TO REMOVE THE PERSON FROM THE
STUDY OR NOT ENROLL THEM IF A
QUESTION OF INITIAL ENROLLMENT
AND INSTEAD I THINK YOU GO
THROUGH A PROCESS OF STOPPING,
ASSESSING OR TRYING TO ADDRESS
IT AND STOP WHAT IS GOING ON AND
SEE IF YOU CAN FIGURE OUT WHAT
THE -- IF THERE IS A CONCERN AND
IF THERE IS A CONCERN WHAT THE
CONCERN IS WITH RESPECT TO.
THEN IF IT CAN BE IDENTIFIED,
FIGURE OUT IF THERE ARE WAYS TO
ADDRESS IT AND PUT OFF THE MRI
SCAN FOR AN HOUR OR GIVE THEM
MORE TIME TO THINK ABOUT IT OR
GIVE THEM MORE EXPLANATION OR
WHATEVER IT MIGHT BE.
AND I THINK THAT IF THAT CAN BE
DONE SUCCESSFULLY WHERE IT IS NO
THE JUST A MATTER OF PUSHING
THEM OR FORCING THEM TO GO AHEAD
AND INSTEAD ACTUALLY ADDRESSING
AND REMOVING THE CONCERN THEN
THE INDIVIDUAL CAN CONTINUE TO
PARTICIPATE.
NOW IF AN INDIVIDUAL OBVIOUSLY
CONTINUES TO DISSENT THEY SHOULD
BE WITHDRAWN AND ONE EXCEPTION
IS AT LEAST IN SOME CASES NO THE
EVERY ASPECT OF OUR PROTOCOL IS
ABSOLUTELY NECESSARY AND MIGHT
BE AN MRI FOR SOME SECONDARY
OUTCOME THAT INVESTIGATORS ARE
LOOKING AT BUT MAYBE DOESN'T
HAVE TO BE DONE IN EVERY SINGLE
SUBJECT.
MAYBE IN SOME CASES YOU CAN ASK
OKAY. WE UNDERSTAND THEY DON'T
LIKE THE MRI AND DO WE NEED THE
MRI IN THIS PERSON AND CAN WE
SKIP IT OR DROP IT AND IF SO
CONTINUE IN PROTOCOL AND IF NOT
PERSON IS GOING TO NEED TO BE
WITHDRAWN.
ALL RIGHT. THAT IS ALL I HAVE
FOR TODAY. JUST IN SUMMARY
IMPORTANT POINTS I THINK
DECISIONAL CAPACITY IS A MATTER
OF DEGREE AND OBTAINING ASSENT
OF ADULTS THAT HAVE CAPACITY TO
ASSENT IN TERMS OF GIVING
AFFIRMATIVE AGREEMENT SHOWS
RESPECT FOR THEIR REMAINING
CAPACITIES AND WHAT I WAS
ARGUING IS THAT WHETHER OR NOT
SOMEBODY HAS THE CAPACITY TO
ASSENT DEPENDS UPON THE FACT
THAT EVEN THOUGH THEY CAN'T
CONSENT CAN THEY NONETHELESS
UNDERSTAND WHAT I'M CALLING
BASIC ELEMENTS OF THE STUDY IN
QUESTION.
THEY CAN UNDERSTAND THE STUDY AT
A BASIC LEVEL. IF THEY CAN, IN
MY VIEW, THEY ARE ABLE TO
ASSENT.
IF THEY CAN'T UNDERSTAND EVEN
THOSE THINGS, THEN THEY ARE NOT
CAPABLE OF ASSENT AND PROVIDING
INFORMATION NOT JUST TO PEOPLE
THAT ARE CAPABLE OF ASSENT TO
EVERYBODY IN A WAY THAT THEY CAN
UNDERSTAND AND ALSO RESPECTING
DISSENT OF ALL INDIVIDUALS HELPS
TO PROTECT THEM FROM SIGNIFICANT
DISTRESS AND HELPS TO ENSURE
THAT WE ARE NOT DOING RESEARCH
THAT GOES OVER ACCEPTABLE RISK
LEVELS WITH ADULTS THAT ARE
UNABLE TO CONSENT OR EVEN UNABLE
TO ASSENT.
ALL RIGHT. SO THANK YOU. I
LOOK FORWARD TO ANY QUESTIONS
YOU HAVE. I WILL -- I THINK I
WILL STOP SHARING HERE.
>> OKAY.
PLEASE IF YOU HAVE QUESTIONS GO
AHEAD AND SUBMIT THEM CLICKING
ON BOX IN VIDEO SAYING LIVE
FEEDBACK LINK AND WE WILL BRING
THEM UP AND I HAVE ONE GENERAL
QUESTION IN TERMS OF -- I KNOW
YOU SERVED ON A NUMBER OF IRBS
AND WHEN THINGS COME UP WITH
REGARD TO MENTAL HEALTH RESEARCH
WHERE THERE IS EVEN AN
ANTICIPATION OF WAXING AND
WANING CAPACITY DUE TO CHANGES
IN MEDICATIONS.
>> YEAH.
>> HOW SHOULD THAT BE APPROACHED
AND WOULD YOU ADVISE?
>> YEAH. I THINK THAT IS REALLY
HARD.
SO I DON'T KNOW IF PEOPLE ARE
FAMILIAR.
SO I THINK THERE MIGHT BE
CHANGES TO THIS PROGRAM
INTRAMURAL MENTAL HEALTH FOR A
LONG TIME GOING BACK TO DAYS OF
[INDISCERNIBLE] PEOPLE MIGHT
REMEMBER HAVE HUMAN SUBJECTS
PROTECTION UNIT AND ONE THING
THAT UNIT DOES IS IT IS ASSIGNED
TO INDIVIDUALS AND INDIVIDUALS
THAT WOULD BE IN THIS CATEGORY
AND THEY MONITOR THEM OVER TIME
AND ADVANTAGE IS THERE AND YOU
GET SOMEBODY WHO REALLY KNOWS
THE PERSON AND STAYS WITH THE
PERSON OVER TIME AND THEN ON A
REGULAR BASIS CAN ASSESS THEIR
CAPACITY AND HOW THEY ARE DOG
AND WHETHER THEY ARE OKAY NOW
AND WHETHER THEY ARE NOT OKAY
NOW.
AND SO THAT IS IN REAL-TIME.
IF YOU CAN ANTICIPATE THAT I
THINK IT IS REALLY IMPORTANT TO
TRY TO HAVE IN PLACE A
SURROGATE.
FOR INSTANCE, IDEALLY TALKING TO
THESE PEOPLE AHEAD OF TIME AND
IT IS EXPECTED AND YOU WILL GET
HIGH DOSE STEROIDS AND THERE IS
LIKELY A CHANCE THAT YOU WILL
HAVE COGNITIVE EFFECTS FOR A
COUPLE OF DAYS AND WE ARE
WORRIED YOU MIGHT NOT BE IN A
POSITION TO MAKE DECISIONS FOR
YOURSELF AND TALK TO THAT PERSON
THROUGH THE PROCESS OF FILLING
OUT AN ADVANCED DIRECTIVE NAMING
SOMEBODY THAT WOULD BE THEIR
SURROGATE FOR THE TIME WHERE
THEY ARE NOT ABLE TO CONSENT
UNTIL THAT CAPACITY COMES BACK.
HOPEFULLY PEOPLE KNOW THAT WE
RESPECT ADVANCED DIRECTIVES THAT
PEOPLE BRING WITH THEM FROM
OTHER STATES.
WE ALSO HAVE OUR OWN ADVANCED
DIRECTIVES AND YOU COULD ALSO
ALWAYS HAVE SOMEBODY FILL OUT
ONE OF OURS AND ONE ADVANTAGE OF
FORM UNLIKE MOST STATE FORMS IS
WE HAVE AN EXPLICIT SECTION
DEVOTED TO RESEARCH PREFERENCES
AND NOT ONLY CAN A PERSON
IDENTIFY A SURROGATE BUT THERE
IS A SECOND BOX THEY CAN DO AN
ALTERNATE OR SECOND SURRO GATE
AND IS A SECTION ALSO IF THEY
HAVE SPECIFIC VIEWS ABOUT
RESEARCH PARTICIPATION AND
THINGS THEY WOULD BE WILLING OR
NOT WILLING TO DO AND IF THEY
COULDN'T CONCEPT THEY COULD
DESCRIBE THOSE PREFERENCES AS
WELL AND THINK IT IS A
COMBINATION OF TRYING TO
ANTICIPATE AND GET A POTENTIAL
SURROGATE IN PLACE AHEAD OF TIME
AND REASONABLE REGULAR
MONITORING OF THE INDIVIDUAL
OVER THE COURSE OF THE STUDY TO
SEE WHETHER OR NOT THEY REALLY
DO LOSE CAPACITY.
IF THEY DO, HOPEFULLY THERE IS
SOME RELIABLE PROCESS IN PLACE
FOR GETTING THAT SURROGATE
INVOLVED EITHER VIRTUALLY OR
GETTING THEM HERE IN PERSON.
>> OKAY. WE HAVE A QUESTION
HERE.
IF A [INDISCERNIBLE] BOTH
CHILDREN AND ADULTS THAT CAN'T
CONSENT THEMSELVES, DO YOU THINK
IT IS APPROPRIATE TO USE THE
SAME ASSENT FORM FOR BOTH
COHORTS AND SHOULD THEY BE
WRITTEN FOR CHILDREN AND
SEPARATE ONE FOR ADULTS AND IF
THE LATTER, WHAT DO YOU THINK
SHOULD DIFFER BETWEEN THEM?
>> SO IT IS A GOOD QUESTION.
THE FIRST THING I WILL SAY IS I
WILL GIVE THE TYPICAL
PHILOSOPHICAL ANSWER WHICH IS
THAT IT DEPENDS.
I THINK IT DEPENDS ON -- SO WE
WERE JUST TALKING ABOUT WHICH
ADULTS ARE CAPABLE OF GIVING
ASSENT AND NOT SURPRISINGLY
PEOPLE MIGHT KNOW ABOUT THIS.
THERE IS A LOT OF DEBATE OVER
WHICH MINORS ARE CAPABLE OF
GIVING ASSENT.
HERE, THERE IS JUST
EXTRAORDINARILY BROAD RANGE. I
KNOW PEOPLE THAT WORK IN
PEDIATRIC RESEARCH ETHICS AND
PEOPLE I RESPECT AND WHO ARE
SMART AND HAVE DONE IT A LONG
TIME AND THINK 3 AND FOUR YEAR
OLDS ARE CAPABLE OF ASSENT TO
RESEARCH PARTICIPATION.
I ALSO KNOW PEOPLE WHO ARE
REALLY SMART AND DONE THIS A
LONG TIME AND DON'T THINK 17
YEAR OLDS CAN GIVE ASSENT TO
RESEARCH PARTICIPATION.
SO MY ANSWER TO THE QUESTION IS
IT DEPENDS WHERE YOU FALL WITHIN
THAT RANGE AND WILL GIVE YOU MY
PERSONAL VIEW THAT WE CAN TALK
ABOUT MAYBE SOME OTHER TIME IF
PEOPLE ARE INTERESTED.
I THINK THAT FOR THE MOST PART
THAT MOST PEOPLE BECOME CAPABLE
OF ASSENT SOMETIME AROUND 13 OR
SOMETHING LIKE THAT AND BETWEEN
12 AND 14 AND UP TO 14.
SO ON THAT VIEW, THEN I THINK
THAT YOU SHOULD BASICALLY USE
THE SAME FORM.
I THINK THAT YOU ARE AT THE
POINT WHERE FOR MOST KIDS THEY
WILL BE ABLE TO UNDERSTAND SAME
THING ADULTS CAN UNDERSTAND AND
LOTS OF CASES CAN YOU USE THE
SAME FORP.
I THINK IF YOU HAVE A VIEW THAT
FOUR YEAR OLDS CAN GIVE ASSENT,
I THINK YOU HAVE TO HAVE IT
POSSIBLY A DIFFERENT VIEW AND
DON'T KNOW WHAT AN ASSENT FORM
WOULD LOOK LIKE FOR A 3 OR 4
YEAR OLD AND NOT SURE EVEN AND
DON'T THINK THEY COULD GIVE
ASSENT. I WOULDN'T DO IT IF YOU
HAVE THAT VIEW YOU WOULD HAVE A
DIFFERENT ONE AND IF TAKING MY
VIEW THAT SOMETHING LIKE 13 OR
14 IS AGE AT WHICH MOST KIDS ARE
ABLE TO ASSENT IT IS REASONABLE
TO THINK THAT THAT FORM SHOULD
INCLUDE WHAT I'M DESCRIBING AS
BASIC ELEMENTS BOTH FOR 14 YEAR
OLD AND ADULTS AND DON'T SEE
REASON YOU COULDN'T USE SAME
FORM AND INTERESTED IF QUESTION
OR ANYBODY ELSE HAD A DIFFERENT
THOUGHT ON THAT.
>> OKAY. ANOTHER QUESTION HERE.
DO AGREE IN SITUATIONS WHERE
DISSENT OR WITHDRAWAL OF ASSENT
MAY EMERGE AND SHOULD BE MORE
THAN ONE INDIVIDUAL INVOLVED IN
NEGOTIATING TO UNDERSTAND AND
ASSESS AND ADDRESS AND PROTECT
PARTICIPANTS FROM UNDUE PRESSURE
TO STAY ON AND WITHDRAWAL FROM
CONSENT AS WELL AND EQUALLY
PARTICIPANT SHOULD BE ABLE TO
HAVE SOMEONE ELSE INDEPENDENT
THAT IS VOFRED FOR THE SAME
REASON.
>> YES. ABSOLUTELY.
PARTICULARLY. SO ONE WORD I
HAVE WHEN I GIVE TALKS LIKE THIS
AND RESPONSE I WILL GET IS WHAT
I SAY AS I SAID IS THAT YOU
DON'T NEED TO WITHDRAW SOMEBODY
AT THE FIRST SIGN OF DISSENT.
YOU SHOULD STOP AND SHOULD
ASSESS IT AND TRY TO ADDRESS IT.
WORRY I THINK IS THIS PERSON IS
RIGHTLY POINTING OUT IS IN
IMPLEMENTATION THAT MIGHT TURN
INTO A PROCESS OF TRYING TO
PRESSURE OR BULLY THE PERSON
INTO RATHER THAN ADDRESSING
THEIR CONCERNS JUST SIMPLY
BULLYING THEM INTO STAYING IN
THE STUDY AND WITHDRAWING THEIR
DISSENT AND THAT IS REALLY BAD
AND TO ADDRESS THAT WE NEED TO
MAKE SURE THAT WE HAVE IN PLACE
PROTECTIONS FOR THE INDIVIDUAL.
I THINK FOR THE MOST PART IT IS
HARD FOR ME TO SEE WHY THAT
ASSESSMENT IN ALL OF THOSE
DISCUSSIONS SHOULD BE CONDUCTED
AND MAYBE THEY ARE EXCEPTIONAL
CIRCUMSTANCES.
FOR THE MOST PART, IT IS REALLY
HARD TO SEE WHY IT WOULD MAKE
SENSE FOR JUST ONE PERSON TO BE
DOING THAT AND THINK YOU NEED TO
HAVE MORE THAN ONE PERSON
INVOLVED.
WHEN I HAVE DISCUSSIONS LIKE
THIS, WHAT I WILL OFTEN DO IS WE
-- WELL, I TYPICALLY TAKE A
FELLOW WITH ME AND I WILL ALSO
ASK ONE OF THE CARE TEAMS.
FOR INSTANCE A FLOOR NURSE OR
SOCIAL WORKER WHO IS NOT
INVOLVED IN THE PROTOCOL AND ARE
INDEPENDENT OF THE PROTOCOL AND
HOPEFULLY THEY HAVE A
RELATIONSHIP WITH THE PERSON TO
GO INTO THE ROOM WITH ME.
>> OKAY. SO THE PEDIATRIC
REGULATIONS GIVEN EXCEPTION FOR
REQUIREMENT FOR ASSENT WHEN
POTENTIAL DIRECT BENEFIT AND
INTERVENTION IS ONLY AVAILABLE
IN A RESEARCH SETTING.
>> RIGHT.
>> HOW DO YOU FEEL WITH ADULTS
AND LACK OF CAPACITY TO CONSENT?
>> SO I THINK THAT -- I THINK IN
EXTRAORDINARY CIRCUMSTANCES THAT
MAKES SENSE WHEN IT COMES TO
MINORS.
I THINK THAT IT COULD MAKE SENSE
WHEN IT COMES TO SOME ADULTS
THAT CAN'T CONSENT AND WHO
DISSENT.
I'M MORE AT LEAST I'M MORE
HESITANT ABOUT IT OR MORE
WORRIED ABOUT IT.
REASON IS BECAUSE IT IS -- WHEN
YOU TALK ABOUT A 6 OR 7 OR 8 OR
9 YEAR OLD AND SOMETIMES I THINK
THAT THEY JUST DON'T UNDERSTAND
OBVIOUSLY THEIR MEDICAL
INTERESTS AND SECTLY THEY MIGHT
NOT HAVE DEVELOPED STRONG VALUES
WITH RESPECT TO RESEARCH
PARTICIPATION OFTEN OTHER HANDS
ADULTS SAY SOMEBODY THAT IS 70
OR HAD A STROKE OR IS DEVELOPING
MODERATE DEMENTIA MAY STILL HAVE
A REALLY GOOD SENSE FOR THEIR
OWN PREFERENCES AND VALUES AND
JUST THEIR VIEW MAY BE THAT
PARTICIPATING IN RESEARCH IS
JUST INCONSISTENT WITH THEM.
IN A CASE LIKE THAT, I WOULD BE
REALLY RELUCTANT AND SAY WOULD
BE JUST TO NEVER OVERRIDE
DISSENT ON THAT BASIS EVEN IF IT
IS IN A STUDY THAT REALLY OFFERS
THEM POTENTIAL FOR SIGNIFICANT
BENEFIT.
ONLY EXCEPTIONS I COULD IMAGINE
WOULD BE ONES WHERE THERE REALLY
IS THAT CIRCUMSTANCE OR NOTHING
ELSE FOR THIS PERSON AND THERE
IS REALLY GOOD REASON TO THINK
THIS COULD HELP THEM IN
SIGNIFICANT WAYS AND THERE IS
ALSO A GOOD REASON TO BELIEVE
THAT THEIR DISSENT IS BASED ON
CONFUSION. IF THEY REALLY
UNDERSTOOD THEY THEMSELVES WOULD
WANT TO BE IN THE STUDY.
AND SO I MEAN I WOULD BE WILLING
TO -- I'M SURE THERE MUST BE
SOME CASES LIKE THAT AND THEY
ARE PROBABLY EXTRAORDINARILY
RARE AND MY SUGGESTION WOULD BE
THIS IS SORT OF LIKE I HAVE A
CONFLICT OF INTEREST HERE AND
WOULD SAY IF YOU GET A CASE LIKE
THAT CALL A BIOETHICS
CONSULTATION AND TALK WITH
PEOPLE BEFORE YOU DO ANYTHING.
>> OKAY. ALL RIGHT. IF ANYBODY
HAS ANY QUESTIONS, GO AHEAD AND
SUBMIT THOSE NOW SO WE CAN
ADDRESS THEM BEFOREHAND OR
BEFORE WE LEAVE.
OKAY. I DON'T SEE ANYTHING ELSE
AND THANKS VERY MUCH.
>> ALL RIGHT.
>> FOR THIS INTERESTING
DISCUSSION WE GREATLY APPRECIATE
ESPECIALLY WITH CHANGE COMING
DOWN THE PIKE.
SURE. EXCITING CHANGES AND
THANKS FOR INVITING ME.
OKAY. TAKE CARE.
BYE,