GOOD AFTERNOON, THANK YOU
FOR JOINING US FOR OUR FIRST
OHSRP EDUCATION SERIES SESSION
OF 2024 ENTITLED, TO PAY OR NOT
TO PAY, IS THAT THE QUESTION?
OUR PRESENTER ABOUT PARTICIPANT
COMPENSATION IS DR. CHRISTINE
GRADY, CHIEF OF THE DEPARTMENT
OF BIOETHICS, A NURSE BUY-ET
CYST AND SENIOR INVESTIGATOR
WHOSE RESEARCH CONTRIBUTIONS ARE
IN ETHICS OF CLINICAL RESEARCH
INCLUDING INFORMED CONSENT,
VULNERABILITY, STUDY DESIGN,
RECRUITMENT, INTERNATIONAL
RESEARCH ETHICS AS WELL AS
ETHICAL ISSUES FACED BY NURSES
AND OTHER HEALTH CARE
PROFESSIONALS. FROM 2010-2017
DR. GRADY SERVED ON THE
PRESIDENT'S COMMISSION FOR
ISSUES, A FELLOW OF THE HASTINGS
CENTER AND FELLOW OF ACADEMY OF
NURSING, KENNEDY INSTITUTE OF
ETHICS AND ELECTED MEMBER OF
NATIONAL ACADEMY OF MEDICINE.
DR. GRADY HOLDS A B. S. FROM
GEORGETOWN AND MSN FROM BOSTON
COLLEGE AND PH.D. FROM
GEORGETOWN UNIVERSITY. A FEW
DETAILS. TODAY'S PRESENTATION
WILL BE ARCHIVED IN THE PAST
EVENTS SECTION OF THE NIH VIDEO
CAST SITE. A LINK TO THE CAST AS
WELL AS SLIDES WILL BE POSTED ON
THE OHSRP WEBSITE APPROXIMATELY
ONE TO TWO WEEKS AFTER THE
SESSION. THAT WILL BE IN THE
PRESENTATION ARCHIVE SECTION OF
THE OHSRP EDUCATION PAGE.
FINALLY WE ENCOURAGE VIEWERS TO
SUBMIT QUESTIONS THROUGHOUT THE
SESSION BY CLICKING ON THE BOX
BELOW THE VIDEO TITLED LIVE
FEEDBACK LINK. WE WILL GET TO
THOSE QUESTIONS AFTER THE
PRESENTATION. THANK YOU FOR
JOINING US, DR. GRADY. YOU CAN
GO AHEAD AND GET STARTED.
>> THANK YOU, PEG, VERY MUCH
FOR INVITING ME. I CAN'T SEE WHO
IS OUT THERE BUT HELLO TO
EVERYBODY OUT THERE. I'M GOING
TO START WITH MY DISCLAIMER.
THESE ARE MY VIEWS AND NOBODY
ELSE'S. I HAVE NO OTHER
CONFLICTS TO DISCLOSE. THESE ARE
OBJECTIVES I PROVIDED TO PEG. I
WILL TALK ABOUT REASONS WE PAY,
RESEARCH AND COMMON ETHICAL
CONCERNS, FAMILIARIZE YOU WITH
EMPIRICAL DATA THAT WILL HELP
YOU UNDERSTAND REASONS AND
ETHICAL CONCERNS. THEN TALK A
LITTLE ABOUT POSSIBLE MODELS FOR
PAYMENT AND CHALLENGES IN
DETERMINING HOW MUCH TO PAY. I
JUST MENTIONED THIS TO PEG A FEW
MINUTES AGO. I WAS REMINDED THAT
IN 2005 -- ALMOST 20 YEARS AGO
-- GAVE A TALK AT GRAND ROUNDS
AT THE CLINICAL CENTER ON
PAYMENT RESEARCH PARTICIPANTS. I
ACTUALLY ENTITLED IT ALMOST THE
SAME, WITHOUT REMEMBERING THAT I
HAD, TO PAY OR NOT TO PAY. SO I
STARTED THINKING ABOUT WHAT'S
CHANGED IN THOSE ALMOST 20
YEARS. INTERGLY SOME THINGS
HAVEN'T CHANGED AT ALL. I THINK
IT IS STILL TRUE THAT PAYMENT
EVEN THOUGH IT IS PRETTY COMMON
IS CONTROVERSIAL, REMAINS
CONTROVERSIAL. WHAT HAS CHANGED
-- FIRST OF ALL, I HAVE GOTTEN A
LOT OLDER, ONE THING. THE OTHER
THING IS THERE IS A LOT MORE
EMPIRICAL DATA AND COMMENTARIES
ON PAYMENT. A LOT OF ACCEPTANCE
OF THE IDEA THAT WE SHOULD BE
PAYING PEOPLE IN MANY
CIRCUMSTANCES. SOME OF THE
CONTROVERSY STILL EXISTS, SO
THAT IS WHAT WE WILL TALK ABOUT
TODAY. SO PAYMENT IS WIDESPREAD
AND COMMON. WE DID A STUDY IN
2002, SO MORE THAN 20 YEARS AGO,
THAT SHOWED THAT 80% OF RESEARCH
INSTITUTES PAY PARTICIPANTS IN
AT LEAST SOME OF THE STUDIES. IT
IS THE CASE AT THE CLINICAL
CENTER WE HAVE BEEN PAYING
PEOPLE IN RESEARCH ALMOST SINCE
THE DOORS OPENED OF THE CLINICAL
CENTER. IT IS A LONG-STANDING
PRACTICE HERE AND IN THE WORLD.
ONE OF HIS TOR K -- HISTORICAL
EXAMPLES IS THAT OF WALTER REED.
HE DID HIS YELLOW FEVER
EXPERIMENTS AROUND 1900. AT THAT
TIME PAID $100 IN GOLD TO
PARTICIPANTS IN STUDY, ANOTHER
$100 IF THEY GOT INFECTED AND IF
DIED $100 TO THEIR FAMILY THERE
ARE LOTS OF ADVERTISEMENTS
EVERYWHERE YOU LOOK ABOUT
GETTING PAID TO BE PART OF
RESEARCH. MANY OF THEM HAVE
NUMBER, SOME DON'T. I THINK THIS
WAS INTERESTING IN IT SAID THESE
LEGITIMATE CLINICAL TRIALS.
THERE ARE PHONE NUMBERS OR
PLACES TO FIND OUT A VARIETY OF
STUDIES THAT OFFER PAYMENT TO
PEOPLE. SOME OF THE WEBSITES ARE
VERY EXPLICIT. THEY TELL YOU
WHAT THE AMOUNTS ARE AND DETAILS
OF WHAT YOU HAVE TO DO FOR
DIFFERENT STUDIES. THERE'S EVEN
A WEBSITE THAT HAS THE 15 BEST
PAID WEBSITES -- NO, SORRY. 15
WEBSITES FOR BEST PAID RESEARCH
STUDIES IN THE COUNTRY THAT YOU
CAN GO TO AND FIND OUT ABOUT
DIFFERENT STUDIES. OUR CLINICAL
CENTER WEBSITE THAT FOCUSES ON
PATIENT RECRUITMENT SAYS WE AT
THE CLINICAL CENTER PROCESS OVER
20,000 PAYMENT TRANSACTIONS A
YEAR TO BOTH PATIENTS AND
HEALTHY VOLUNTEERS. SO YOU CAN
SEE IT IS VERY COMMON AND VERY
WIDESPREAD. IT IS ALSO ALLOWED
BY REGULATIONS, I'M GOING TO
TALK ABOUT SOME OF THAT BRIEFLY,
IT IS ETHICALLY ACCEPTABLE TO
PAY RESEARCH PARTICIPANTS. IT IS
SURPRISINGLY PERENNIALLY
FRAUGHT. PEOPLE REALLY WORRY
ABOUT IT. SO WHAT ARE THE
REGULATIONS SAY? FDA HAS SOME
GUIDANCE ON PAYMENT, WHICH
EXPLICITLY SAYS PAYING
PARTICIPANTS IS ACCEPTABLE AND
SHOULD BE JUST AND FAIR. THE IRB
HAS A ROLE IN REVIEWING BOTH THE
AMOUNT AND THE METHODS OF
PAYING. THE METHOD AND THE
TIMING TO ASSURE NEITHER ARE
UNDULY INFLUENTIAL, PAYMENT
SHOULD PROGRESS AND SHOULD BE
PRORATED AND COMPLETION BONUSES
ARE ACCEPTABLE AS LONG AS THEY
ARE NOT COERCIVE OR UNDUE
INDUCEMENT. IN THE COMMON RULE
THERE IS NOTHING SPECIFIC TO
PAYMENT OTHER THAN AVOIDING
COERCION AND UNDUE INFLUENCE AS
A GENERAL RULE. BUT OHRP HAS
THIS INFORMED CONSENT FAQs ON
THEIR WEBSITE, ONE OF WHICH IS
ABOUT COMPENSATING RESEARCH
PARTICIPANTS AND WHETHER
UNDERMINED INFORMED CONSENT. IF
YOU READ THAT SECTION, BASICALLY
REITERATES A LOT OF THINGS I
JUST SAID WERE ON THE FDA
GUIDANCE. THAT IT IS ACCEPTABLE,
COMMON. HOWEVER, WE HAVE TO PAY
ATTENTION TO THE AMOUNT, THE
TIMING AND THE METHOD OF PAYMENT
TO MAKE SURE IT IS NOT UNDULY
INFLUENTIAL OR COERCIVE. OF NOTE
ON THIS FAQ PAGE, IF YOU LOOK
BELOW WHAT I HAVE HIEMEGHLIGHTE
CAN NON-FINANCIAL INCENTIVES
CONSTITUTE THIS. WITHOUT OPENING
I WOULD SAY THE ANSWER THEY HAVE
IS YES, THEY CAN. ABSOLUTELY
THEY CAN. IN THE INTRA MURAL
PROGRAM WE HAVE A POLICY OF
3014302 SUBJECT RECRUITMENT AND
COMPENSATION, WHICH YOU CAN FIND
IN THE POLICY MANUAL, WHICH
TALKS ABOUT RECRUITMENT IN
GENERAL BUT COMPENSATION IN
SPECIFIC. GIVES GUIDANCE FOR
BOTH IRBs AND INVESTIGATORS AND
ALSO A GUIDELINE FOR
INVESTIGATORS ON PAYING RESEARCH
PARTICIPANTS, WHICH HAS MORE
DETAIL IN IT. ETHICALLY
ACCEPTABLE, JUST ONE EXAMPLE,
THE CEOMS GUIDELINES EXPLICITLY
SAY THAT PARTICIPANTS SHOULD BE
-- NOT ONLY CAN BE BUT SHOULD BE
REASONABLY REIMBURSED FOR COSTS
INCURRED AND COMPENSATED
REASONABLY FOR INCONVENIENCE AND
THE TIME SPENT DOING RESEARCH.
THEN, OF COURSE, THEY ALSO
CAUTION THAT COMPENSATION
SHOULDN'T BE SO LARGE AS TO
INDUCE POTENTIAL PARTICIPANTS TO
CONSENT AGAINST THEIR BETTER
JUDGMENT, WHICH THEY CALL UNDUE
INDUCEMENT, WHICH I WILL COME
BACK TO THAT IN A MINUTE. SOME
OF THE LITERATURE IN RECENT
YEARS HAS GONE A LITTLE FURTHER
AND SAID THE PROBLEM IS NOT THAT
RESEARCH PARTICIPANTS ARE BEING
PAID BUT THAT THEY ARE NOT BEING
PAID ENOUGH AND THAT WE OUGHT TO
CHANGE THE DEFAULT TO FAVOR
RATHER THAN ENCOURAGE SUSPICION
OF OFFERS TO PAYMENT TO RESEARCH
PARTICIPANTS. THIS IS JUST ONE
ARTICLE BY EMILY LARGEEN AND
EMILY FERNANDEZ LYNCH WHO HAVE
WRITTEN A NUMBER OF PAPERS ABOUT
PAYMENT TO RESEARCH
PARTICIPANTS. SO EVEN THOUGH IT
IS ALLOWED, EVEN THOUGH IT IS
COMMON AND WIDESPREAD, ALLOWED
AND ETHICALLY ACCEPTABLE IT
CONTINUES TO BE -- THIS ALWAYS
SURPRISES ME, I HAVE TO SAY --
PERLY FRAUGHT. I HAVE DONE THIS
SOME YEARS BECAUSE I ENCOUNTERED
IN CLINICAL STUDIES WITH
INVESTIGATORS ON VARIOUS
VIEWPOINTS ON WHETHER OR NOT TO
PAY PEOPLE. WHETHER OR NOT IT
WAS OKAY. NOT JUST WHETHER OR
NOT TO DO IT BUT WHETHER OR NOT
IT WAS OKAY TO. SO I THINK WHEN
I THOUGHT ABOUT THIS FROM AN
ETHICAL PERSPECTIVE FOR MANY,
MANY YEARS, I LIKE TO THINK
ABOUT IN MORE DETAIL THE REASONS
WE PAY PEOPLE. WHAT ARE THE
REASONS WE OFFER PAYMENT AND
WHAT ARE THE CONCERNS AND HOW TO
PUT THOSE TOGETHER AND LOOK AT
SOME OF THE EMPIRICAL DATA
THAT'S ADDRESSED BOTH OF THEM.
SO WHY DO WE OFFER PAYMENT? I
THINK THE MOST COMMON REASON
CITED IS IT WILL HELP
RECRUITMENT AND ENROLLMENT. THAT
IS AN IMPORTANT THING. WE ALL
KNOW THAT RECRUITMENT AND
ENROLLMENT OF PARTICIPANTS IN A
TIMELY MANNER IS CRITICAL TO THE
COMPLETION OF CHRISTLINICAL TRIO
SATISFY THE SOCIAL AND
SCIENTIFIC VALUE OF RESEARCH,
THE STUDY HAS TO BE DONE AND IN
A WAY THAT -- AS IT WAS PLANNED,
AS IT MAKES SENSE. WE KNOW THAT
RECRUITING AND RETAINING
PARTICIPANTS IN RESEARCH IS A
FREQUENT CHALLENGE. IN FACT,
SOME OF THE DATA THAT EXISTS
SUGGESTS UP TO 40% OF TRIALS ARE
NOT FINISHED IN TIME BECAUSE
THEY CAN'T ENROLL ENOUGH
PARTICIPANTS. SOME CLOSE WITH
UNDERPOWERED TRIALS BECAUSE THEY
CAN'T GET THE RECRUITMENT
TARGETS THAT THEY HAVE. THIS
INDUSTRY -- SORRY, INDUSTRY
STANDARD REPORT IN 2014 IS A
REPORT THAT HAS -- IS
SPECIFICALLY ABOUT RECRUITMENT.
BASICALLY TALKS ABOUT THE
PROBLEMS WITH DELAYING IN
FINISHING CLINICAL TRIALS, THE
COSTS TO INDUSTRY OF NOT
COMPLETING A CLINICAL TRIAL IN
TIME AND SAYS WE SHOULD USE ANY
AND ALL MEANS TO INCREASE
ENROLLMENT AND RETENTION. SO ONE
OF THOSE MEANS THAT PEOPLE HAVE
TALKED ABOUT IS OFFERING PAYMENT
TO RESEARCH PARTICIPANTS. SO THE
QUESTION I WANT US TO THINK
THROUGH IS HOW WELL DOES
OFFERING INCREASE RATES OF
ENROLLMENT? UNLIKE 2005 WE
ACTUALLY HAVE DATA, WHICH IS
VERY USEFUL. STARTING WITH THREE
DIFFERENT KINDS OF RESEARCH. IN
SURVEYS THERE HAVE BEEN A NUMBER
OF STUDIES THAT HAVE SHOWN THAT
EVEN A VERY SMALL AMOUNT OF
MONEY, SOMETIMES $5 IN THE
ENVELOPE OR PROMISE TO SOMEBODY,
INCREASES THE RESPONSE RATES FOR
SURVEYS. THAT MONEY IS MORE
EFFECTIVE THAN VOUCHERS OR
LOTTERIES OR OTHER MEANS OF
PERHAPS INCENTIVISING PEOPLE TO
FINNISH A SURVEY. THE CITATION I
HAVE HERE IS A SYSTEMATIC REVIEW
AND META ANALYSIS JUST PUBLISHED
THIS YEAR IN PLUS ONE THAT
REVIEWS 46 DIFFERENT STUDIES.
THAT LOOKED AT WHETHER OR NOT
PAYMENT INCREASED SURVEY
RESPONSE RATES. THE ANSWER IS
YES, IT DOES. WHAT ABOUT HEALTHY
VOLUNTEER S? WE WERE ABLE TO DO
A STUDY A FEW YEARS AGO
FOLLOWING 1200 HEALTHY VOLUNTEER
WHO'S PARTICIPATED IN PFIZER
PHASE 1 DRUG DEVELOPMENT
STUDIES. SO THESE ARE SURVEY
DATA FROM THOSE 1200 PEOPLE.
WHAT YOU'LL SEE IS A COUPLE
THINGS. THIS IS A SLIDE, EXCUSE
ME, SHOWING MOTIVATIONS FOR
PARTICIPATION. THE BLUE BEING
MAIN MOTIVATION, RED BEING ANY
MOTIVATION. YOU WILL SEE MONEY
FAR EXCEEDS ANY OF THE OTHER
MOTIVATIONS PEOPLE DESCRIBE IN
THIS HEALTHY VOLUNTEER GROUP. WE
ALSO ASKED THEM TO TELL US WHICH
WAS MORE IMPORTANT IN SERIES OF
TRADE-OFF QUESTIONS. TO THEIR
DECISION TO ENROLL IN STUDIES AT
PFIZER. YOU CAN SEE IN ALMOST
EVERY CASE MONEY BEATS OUT
ANYTHING ELSE. ANY OTHER
CONSIDERATIONS. EXCEPT -- THIS
IS REALLY IMPORTANT. EXCEPT FOR
RISK. THIS COHORT TOLD US THAT
RISKS AND SIDE EFFECTS WERE MORE
IMPORTANT TO THEIR ENROLLMENT
DECISION THAN THE MONEY BEING
OFFERED. WE ALSO FOUND IN A
DIFFERENT STUDY WHERE WE DID A
SYSTEMATIC REVIEW HEALTHY
VOLUNTEERS ALTHOUGH ALMOST
ALWAYS MOTIVATED BY MONEY ALSO
REPORT A NUMBER OF THERMO TIFS,
INCLUDING THINGS LIKE CURIOSITY,
SEEKING KNOWLEDGE, ALTRUISTIC
AND SENSATION-SEEKING. THIS WAS
A COCKERING REVIEW, LOOKING AT
IMPROVED METHODS TO RECRUITMENT
TRIALS. FINANCIAL INCENTIVES,
THIS IS A -- I DON'T KNOW IF YOU
CAN SEE THIS IS THE INCREASED
COLUMNS. FINANCIAL INCENTIVES
INCREASED RECRUITMENT. INTERGLY
IN THIS META ANALYSIS THEY ONLY
HAD THREE INCLUDED, TWO WERE
HYPOTHETICAL. BUT THEY WERE --
IN ALL THREE THEY WERE ABLE TO
SHOW OFFERING MONEY INCREASED
THE CHANCES OF ENROLLMENT. THIS
IS A MORE RECENT STUDY DONE BY
SCOTT HALPERN AND HIS COLLEAGUES
AT THE UNIVERSITY OF
PENNSYLVANIA. IT IS A REALLY
INTERESTING STUDY. WHAT THEY
WERE ABLE TO DO WAS TAKE TWO
CLINICAL TRIALS AND IN THEM
EMBED RANDOMIZATION TO DIFFERENT
LEVELS OF OFFERS OF PAYMENT. SO
THIS WAS A SMOKING CESSATION
TRIAL DONE IN A NUMBER OF
CLINICS. RANDOMIZED THE GROUP IN
THOSE WHO WERE TOLD THEY
RECEIVED NO MONEY, THOSE THAT
RECEIVED $200, THOSE THAT
RECEIVED $500. THE OTHER TRIAL
WAS AN AMBULATION TRIAL DONE IN
THE IN-PATIENT UNIT OF HOP.
AGAIN, PERSONS WERE RANDOMIZED
TO RECEIVE NO MONEY, $100 OR
$300. WHAT IS INTERESTING IS IN
THE SMOKING TRIAL THE AMOUNT OF
MONEY BEING OFFERED HAD A
SIGNIFICANT EFFECT ON
ENROLLMENT. MORE THAN TWICE AS
MANY PEOPLE OFFERED $500
ENROLLED IN THOSE THAN OFFERED
NOTHING. IN THE AMBULATION TRIAL
DIDN'T MAKE A DIFFERENCE AT ALL.
DIDN'T INCREASE ENROLLMENT AT
ALL. THIS IS A BUSY SLIDE BUT IF
YOU LOOK RIGHT BUT LOW THE ONE I
HAVE HIGHLIGHTED, ANOTHER
INTERESTING THING TO NOTE IS IN
THE SMOKING TRIAL ABOUT HALF THE
PEOPLE IN ALL OF THE
COMPENSATION GROUPS THOUGHT
THERE WAS SOME RISK ASSOCIATED
WITH THE TRIAL. WHEREAS IN THE
AMBULATION TRIAL ALMOST NOBODY
THOUGHT THERE WAS SOME RISK.
THOUGH THERE WAS A LITTLE BIT OF
A HIGHER RISK IN THE $300 GROUP
THAN THE REST. SO ANOTHER THING
PEOPLE THINK IS OFFERING PAYMENT
MIGHT HELP WITH RECRUITING
UNDERREPRESENTED GROUPS. SO
THERE HAVE BEEN A NUMBER OF
STUDIES THAT HAVE LOOKED AT
THIS. ONE STUDY BY JENNINGS ET
AL. IN 2015 FOUND ALTHOUGH
PAYMENTS MARGINALLY IMPROVE
RECRUITMENT RATES INTO SOME
TRIALS, IT DID NOT BROAD EN
THEIR DEMOGRAPHICS. THEY LOOKED
SPECIFICALLY AT SOCIALLY
DEPRIVED INDIVIDUALS AND ELDERLY
PATIENTS. IN ANOTHER STUDY THEY
FOUND THAT LOW INCOME
INDIVIDUALS, WHEN ASKED FOR A
HYPOTHETICAL SCENARIO, REQUESTED
SIMILAR AMOUNTS OF PAYMENT FOR
PARTICIPATION AS THEIR
HIGH-INCOME PEERS BUT THAT
HIGHER PAYMENT MIGHT BE
NECESSARY TO INCREASE OVERALL
PARTICIPATION IN SOME STUDIES.
BARBARA BAYER AND COLLEAGUES
HAVE WRITTEN STUDIES TRYING TO
MAKE THE CASE WHEN WE ARE
ENROLLING PEOPLE IN RESEARCH, WE
WANT TO BE SURE THAT THEY ARE
NOT MADE WORSE OFF. THAT IS A
GENERAL SORT OF NORMAL OF
RESEARCH. THAT INCLUDES
FINANCIALLY WORSE OFF. SO
THEY'VE ARGUED FOR PAYING
ACTUALLY MORE MONEY TO TRY TO
NOT MAKE PEOPLE OF LOWER
SOCIOECONOMIC STATUS FINANCIALLY
WORSE OFF.
THIS RAISES THE ISSUE OF
WHICH WE KNOW MORE ABOUT THAN WE
DID 20 YEARS AGO THAT ACTUALLY
COSTS OF RESEARCH PARTICIPATION
CAN BE A DETERRENT. CLINICAL
TRIALS CAN POSE SUBSTANTIAL
COSTS, BOTH FROM HEALTH-RELATED
COSTS, NOT COVERED BY THE TRIAL
OR THE INSURANCE OF THE
PARTICIPANT. OF COURSE THIS IS
LESS RELEVANT FOR THE CLINICAL
CENTER, THAT KIND OF COST, BUT
ALSO INDIRECT COST, LIKE TRAVEL
AND LOST WAGES AND LODGING,
THINGS LIKE THAT. IT IS ALSO
TRUE THAT PEOPLE WHO ARE AT
HIGHEST RISK FOR FINANCIAL
TOXICITY, IN OTHER WORDS, THOSE
WHO CAN'T AFFORD SOME OF THESE
COSTS, ARE EXACTLY THOSE WHO ARE
LESS LIKELY TO PARTICIPATE IN
CLINICAL TRIALS. WE ALL KNOW
SKEWED PARTICIPATION CAN SKEW
THE VALIDITY SO WE NEED A
BALANCED PATIENT POPULATION TO
HAVE GENERAL IZABLE RESULTS.
SOME OF THIS WAS TAKEN FROM AN
ASKO EDUCATIONAL BOOK
SPECIFICALLY FOCUSED ON
FINANCIAL TOXICITY AND ACCESS.
THIS WAS A BLOG SITE THAT LOOKED
SPECIFICALLY AND WAS JUST
PUBLISHED A YEAR AGO THAT LOOKED
SPECIFICALLY AT POVERTY AND
PARTICIPATION IN RESEARCH. OF
COURSE WE KNOW FROM RESEARCH
THAT PATIENTS FROM
UNDERREPRESENTED AND
UNDERRESOURCED COMMUNITIES ARE
MORE LIKELY TO EXPERIENCE
POVERTY AND HAVE POOR HEALTH
OUTCOMES. WHAT THIS GROUP DID
WAS FIND DATA THAT SUGGESTED
THAT RESEARCH ALSO CAN LEAVE
THESE POPULATIONS BEHIND. ONE OF
THE MAJOR BARRIERS TO
PARTICIPATION ARE THE COSTS,
TIME AND RESOURCE CONSTRAINTS
ASSOCIATED WITH PARTICIPATION.
SO THESE KIND OF DATA SUGGESTS
MORE REASONS TO PAY PEOPLE
BEYOND INCREASING RECRUITMENT
AND ENROLLMENT. THESE ARE
REASONS WHICH I THINK ETHICALLY
MAKE A LOT OF SENSE. CERTAINLY
SOMETIMES PAYMENT CAN ENABLE
PEOPLE TO PARTICIPATE WHO CAN'T
AFFORD SOME OF THOSE DAYS AWAY
FROM WORK OR COSTS ASSOCIATED
WITH TRAVEL, ET CETERA.
REIMBURSEMENT CAN ALSO MAKE
PARTICIPATION MORE OR LESS
REVENUE-NEUTRAL FOR PARTICIPANTS
SO THEY DON'T END UP HAVING --
BEING S WERE OFF FINANCIALLY
THAN PARTICIPATING IN THE STUDY.
PAYING PEOPLE CAN ALSO
COMPENSATE THEM FOR TIME,
CONTRIBUTION AND RISK, OUT OF
RESPECT OF APPRECIATION FOR WHAT
THEIR TIME CONTRIBUTION IS. IT
CAN ALSO MINIMIZE THE
POSSIBILITY OF EXPLOITING PEOPLE
BY GIVING THEM MORE BENEFITS AND
CAN DEMONSTRATE RESPECT AND
GRATITUDE FOR THEIR
PARTICIPATION. THESE ARE ALL OF
COURSE NOT MUTUALLY EXCLUSIVE
AND MAYBE ANY OF THESE REASONS
COULD ALSO FACILITATE
RECRUITMENT. IN OTHER WORDS,
PEOPLE ARE MORE LIKELY TO ENROLL
IF PARTICIPATION IS
REVENUE-NEUTRAL FOR THEM. WHAT
ARE THE CONCERNS? WHAT ARE THE
ETHICAL CONCERNS THAT
CONTINUALLY POP UP IN THE
DISCUSSION OF PAYING RESEARCH
PARTICIPANTS? COERCION, UNDUE
INFLUENCE OR INDUCEMENT, UNJUST
-- WHAT PEOPLE CALL UNJUST
INDUCEMENT, EXPLOITATION AND
DECEPTION ARE THE ONES MOST
COMMONLY DESCRIBED. SO WHAT
ABOUT COERCION? COERCION BY
DEFINITION IS A THREAT. A THREAT
TO MAKE SOMEBODY WORSE OFF BY
EITHER VIOLATING THEIR RIGHTS OR
DEPRIVING THEM OF SOMETHING THEY
ARE ENTITLED TO. LEAVING THEM IN
A SITUATION WHERE THEY HAVE NO
REASONABLE ALTERNATIVE BUT TO
COMPLY WITH THE THREAT. THE SORT
OF CLASSIC EXAMPLE, OF COURSE,
IS YOUR MONEY OR YOUR LIFE. YOU
KNOW, YOU HAVE NO RESPECTABLE
ALTERNATIVE BUT TO GIVE UP YOUR
MONEY, UNLESS YOU HAVE A DEATH
WISH OF SOME SORT. MANY AUTHOR S
HAVE ARGUED THAT THE OFFER OF
PAYMENT MAKES SOMEONE -- OR CAN
MAKE SOMEONE BETTER OFF, NOT
WORSE OFF. THEREFORE PAYMENT IS
NOT COERCIVE. ALL THE TIMES WE
TALK ABOUT COERCION FROM
PAYMENT, WE'RE MISSPEAKING.
COERCION IS NOT THE RIGHT LABEL
FOR WHAT WE MIGHT WORRY ABOUT
WITH PAYMENT. WHAT MANY PEOPLE
DO WORRY ABOUT IS UNDUE
INFLUENCE OR UNDUE INDUCEMENT.
THIS IS A LITTLE -- THE
DEFINITION OF UNDUE INFLUENCE IS
A LITTLE LESS UNIVERSALLY AGREED
TO THAN THAT OF COERCION BUT WE
ARE GETTING CLOSE, BETTER.
BASICALLY UNDUE ARE OFFERS WHOSE
ATTRACTIVENESS DISTORT JUDGMENT
INDUCING THEM TO DO SOMETHING
THAT IS UNREASONABLE OR
SOMETHING AGAINST THEIR OWN
INTERESTS. IT IS THE IDEA OF
BEING BLINDED BY THE MONEY. SO
YOU ARE NOT PAYING ATTENTION OR
DON'T CARE ABOUT WHAT YOU ARE
BEING ASKED TO DO. IMPORTANTLY,
INDUCEMENTS ARE PART OF EVERYDAY
LIFE. WE ALL DO THINGS -- WE ARE
ALL INDUCED BY MONEY IN MANY
CASES TO DO THINGS WE MIGHT NOT
OTHERWISE DO IF WE WEREN'T BEING
PAID. YET THOSE ARE REASONABLE
THINGS. THOSE ARE NORMAL
INDUCEMENTS. THEY ARE NOT UNDUE.
THEY DON'T BLIND US TO WHAT WE
ARE BEING ASKED TO DO. WE MAKE
VOLUNTARY DECISIONS TO GO TO
WORK. BUT WE MIGHT NOT DO THAT
IF WE WEREN'T PAID FOR WORK. THE
CHALLENGE HERE IS DISCERNING
WHAT IS AN INDUCEMENT, WHICH
GIVES SOMEBODY THE INCENTIVE TO
DO SOMETHING THEY MIGHT NOT
OTHERWISE DO FROM AN UNDUE
INDUCEMENT WHICH INDUCES THEM TO
DO SOMETHING THAT IS AGAINST
THEIR INTERESTS. SACARP, OR
SECRETARY'S ADVISORY COMMITTEE
ON HUMAN RESEARCH PROTECTION,
SECRETARY OF HSS THAT IS
PUBLISHED RECOMMENDATIONS IN
2019 PATIENT TO RESEARCH
PARTICIPANTS. THEY DEFINE UNDUE
INFLUENCE IN THE FOLLOWING WAY.
IT OCCURS WHEN THERE IS AN
EXCESSIVE OFFER OF SOMETHING
VALUABLE OR DESIRABLE THAT LEADS
TO POOR JUDGMENT OR A
COMPROMISED DECISION MAKING
PROGRESS WHICH IN TURN LEADS TO
DECISION TO ENGAGE IN A HARMFUL
ACTIVITY THAT SERIOUSLY
CONTRAVENES DECISION MAKER'S
INTERESTS OR OBLIGATIONS. THEY
GO ON TO DESCRIBE -- OTHER
COMMENTATOR S HAVE DONE THIS IN
THE LITERATURE-E THAT IN THE
CONTEXT OF RESEARCH THAT IS ALL
REVIEWED IN ADVANCE BY AN I R
B , THE LIKELIHOOD OF THERE
BEING UNREASONABLY HARMFUL
ACTIVITY WITH RISKS AND BENEFITS
THAT ARE NOT JUSTIFIED IS VERY
LOW -- AT LEAST MITIGATED. THAT
DOESN'T REMOVE THE POSSIBILITY
THAT AN INDIVIDUAL EITHER
BECAUSE OF INDIVIDUAL
SUSCEPTIBILITIES OR SOME KIND OF
SOMETHING ABOUT THE INDIVIDUAL
CIRCUMSTANCES COULD BE INDUCED
TO PARTICIPATE IN A STUDY THAT
IS HARMFUL TO THEM OR THAT
CONTRAVENES THEIR INTEREST IN A
CERTAIN WAY. BUT BECAUSE
RESEARCH IS REVIEWED BY AN IRB,
THIS CONCERN IS MUCH LESS THAN
IT MIGHT BE IN OTHER PARTS OF
THE WORLD, WHERE THINGS ARE NOT
REVIEWED. SACARP GOES ON TO SAY,
UNDUE INFLUENCE OCCURS WHEN
APPEARS LIKELY TO PROHIBIT
ADEQUATE CONSIDERATION OR/AND
REFLECTION ABOUT IMPORTANT STUDY
FEATURES SUCH AS RISK, BURDEN,
DISCOMFORTS AND COMPARE
UNDERSTANDING OF RESEARCH AND
PARTICIPATION IN IT. SO THERE
HAVE BEEN A NUMBER OF STUDIES
HAVE HAVE TRIED TO LOOK AT THIS.
THERE WAS A STUDY CRITER AND ALL
PUBLISHED IN SOCIAL SERVICE
MEDICINE AND HALPERNS
INTERNATIONAL MEDICINE FOUND
HIGH PARTICIPATION PAYMENTS --
IN OTHER WORDS, THE MORE MONEY
YOU GAVE PEOPLE, THE MORE LIKELY
THEY WERE TO PERCEIVE STUDY HAD
RISK AND THE MORE TIME THEY WERE
-- THE MORE TIME THEY WERE
LIKELY TO SPEND REVIEWING THE
RISK INFORMATION. SO IT IS NOT
-- AT LEAST THOSE DATA SUGGEST
IT IS NOT THE PEOPLE IGNORE THE
RISK. THEY ACTUALLY PAY MORE
ATTENTION TO THEM. WE DID A
STUDY ABOUT COMPREHENSION AFTER
INFORMED CONTENT. HAD NOTHING TO
DO WITH -- IT WASN'T
SPECIFICALLY ABOUT MONEY. BUT
WHAT WE FOUND IN THAT STUDY WAS
-- AND THESE WERE HEALTHY
VOLUNTEERS -- THAT THOSE WHO
SAID THEIR MAIN MOTIVATION FOR
PARTICIPATING WAS FINANCIAL HAD
HIGHER COMPREHENSION SCORE. IN
OTHER WORDS, UNDERSTOOD MORE
ABOUT THE STUDY THAN THOSE WHO
REPORTED OTHER MOTIVATIONS FOR
PARTICIPATING. WHAT ABOUT STUDY
RISKS? AGAIN, THERE HAVE BEEN A
NUMBER OF STUDIES. THIS STUDY BY
BENTLEY AND THACKER THAT MONEY
INCREASED RESPONDENT'S
WILLGLINESS -- HYPOTHETICAL
STUDIES -- REGARDLESS OF RISK.
IN OTHER WORDS, GIVE THEM MORE
MONEY THEY WERE MORE WILLING TO
TAR TIS PATE BUT WILLINGNESS
DECREASED AS RISK INCREASED.
THAT WAS NOT AT TEN YOU WAITED
BY HIGHER PAYMENT. ANOTHER
STUDY, SIMILAR, THOUGH
INCREASING PAYMENTS MOTIVATED
GREATER WILLGLY TO PARTICIPATE,
PARTICIPATION RATES DROPPED
EQUIVALENTLY WITH INCREASING
RISKS ACROSS ALL PAYMENT LEVELS
SO FOUND ALMOST THE SAME THING
BENTLEY AND THACKER DID. IN THE
STUDY I DESCRIBED WITH HEALTHY
VOLUNTEER WHO'S VOLUNTEERED FOR
PHASE I DRUG STUDIES WITH PFIZER
THEY RATED RISK AS MORE
IMPORTANT TO ENROLLMENT DECISION
THAN MONEY WAS. SO THEY PAID
ATTENTION TO RISK. IN FACT,
ANOTHER THING THEY CARED ABOUT A
LOT WAS THE AMOUNT OF TIME THEY
HAD TO SPEND THERE AND DEGREE OF
SORREN
SORT OF DISCOMFORT OR THINGS
THEY HAD TO DO. JILL FISCHER WHO
HAS DONE A LOT OF STUDIES WITH
HEALTHY VOLUNTEERS HAS IN THIS
ONE PAPER SHE PUBLISHED IN 2018
FOUND HEALTHY VOLUNTEERS ARE
GENERALLY QUITE AWARE OF AND
REFLECTIVE ABOUT PHASE I TRIAL
RISKS. THE MAJORITY THOUGHT
TRIALS WERE OF MEDIUM-HIGH OR
EXTREMELY HIGH RISK. NONETHELESS
FELT THEY WERE PERSONALLY SAFE
FROM HARM AND THEREFORE WILLING
TO PARTICIPATE. WHAT ABOUT
UNJUST INDUCEMENT? UNJUST
INDUCEMENT MEANS IF WE ARE
PAYING PEOPLE, IT WILL INCREASE
THE EXTENT TO WHICH RESEARCH
RELIES ON THE POOR, WHICH BOTH
IS PROBLEMATIC FOR
GENERAL IZABILITY BUT ALSO FOR
DISPROPORTIONATELY PUTTING THE
BURDEN OF RESEARCH ON PEOPLE WHO
ARE LESS WELL-RESOURCED. THERE
HAVE BEEN A COUPLE STUDIES, NOT
AS MANY, BUT THE TWO I'M CITING
BASICALLY TRY TO DEBUNK THIS AND
SAY -- THE HALPERIN STUDY IN
2004 FOUND POSITIVE CONNECTION
BETWEEN INCOME AND MONEY ON
WILLGLY TO PARTICIPATE. BUT WHAT
THEY FOUND WAS PAYMENT HAD A
STRONGER INFLUENCE AMONG PEOPLE
WHO MADE MORE MONEY, WHO WERE
WEALTHIER RATHER THAN THE
OPPOSITE. THIS OTHER STUDY DONE
LOOKING AT COVID STUDY SAID IT
HAD LITTLE IMPACT ON POORER
INDIVIDUALS. IN OTHER WORDS, IT
HAD -- PEOPLE WHO WERE LESS WELL
RESOURCED WERE NOT LIKELY TO
PARTICIPATE WITH SMALL
INCENTIVES BECAUSE THEY WERE
HESITANT ABOUT THE STUDY MORE
THAN BECAUSE THE MONEY WASN'T
THAT GREAT. ONCE THE INCENTIVES
GOT LARGER, MORE PEOPLE WERE
WILLING TO PARTICIPATE ACROSS
INCOME LEVELS, SORRY. WHAT ABOUT
EXPLOITATION? SO EXPLOITATION IS
THOUGHT OF AS TAKING UNFAIR
ADVANTAGE OF PEOPLE. MEANING IN
RESEARCH WHEN THE PARTICIPANTS
DO NOT RECEIVE BENEFITS THAT ARE
FAIR, GIVEN THE RISKS OR BURDENS
THAT THEY ASSUME AND THE EXTENT
TO WHICH OTHERS ARE BENEFIT ING
FROM THEIR INVOLVEMENT, THAT IS
THE DEFINITION OF EXPLOITATION
THAT'S BEEN AROUND FOR SOME
TIME. MANY HAVE ARGUED THAT
PAYMENT MIGHT ACTUALLY INCREASE
THE EXTENT TO WHICH PARTICIPANTS
BENEFIT. THEREFORE REDUCING THE
CHANCES OF EXPLOITATION, NOT
INCREASING IT. PEOPLE WHO ARGUE
THIS SAY WE SHOULD BE PAYING
PEOPLE MORE. THAT IF WE ARE NOT
PAYING THEM AT ALL OR IF WE ARE
PAYING THEM TOO LOW THAT, IS
MORE EXPLOITIVE. LAST ON MY
POSSIBLE LIST OF CONCERNS IS
DECEPTION. THIS IS SOMETHING
THAT -- THERE WAS A STUDY IN
2013 IN CLINICAL TRIALS THAT
FOUND OUT OF 100 PARTICIPANTS IN
AT LEAST TWO TRIALS, ALMOST A
THIRD CONCEALED THEIR HEALTH
PROBLEMS. 28% CONCEALED
MEDICATIONS. 14% PRETENDED TO
HAVE A CONDITION THEY DIDN'T
HAVE. THIS WAS -- THIS TENDENCY
TO CONCEAL WAS CORRELATED WITH A
GREATER INTEREST IN MONETARY
AWARDS. THIS IS PROBLEMATIC.
NEIL DICKERT WHO WORKED WITH ME
A LONG TIME AGO ON ISSUES
RELATED TO PAYMENT IN A
COMMENTARY SAID INCENTIVE
PAYMENTS MAY LEAD PARTICIPANTS
TO LIE ABOUT THEIR HISTORY IN
ORDER TO BE ELIGIBLE OR DENY
SIDE EFFECTS TO AVOID BEING
DROPPED. THIS IS SOMETHING WE DO
NEED TO PAY ATTENTION TO. IT WAS
AN INTERESTING PEOPLE IN THE DMJ
JUST ABOUT A MONTH AGO ACTUALLY.
BASICALLY YOU CAN SEE THE TITLE,
WHEN SCIENCE GOES WRONG,
MISREPRESENTATION, COERCION,
UNDUE INFLUENCE IN PAYING
RESEARCH PARTICIPANTS. THIS IS
INTERESTING .
THE PREVIOUS WORK HAD SHOWN
ELEVATED MERCURY LEVELS IN URINE
OF MINORS FROM A MINE IN
ZIMBABWE. THIS TIME HOWEVER IN
THIS STUDY SHE IS REPORTING ON
DESPITE INCREASE IN MINING
ACTIVITY IN THE COUNTRY THE
AVERAGE MERCURY LEVELS WERE
LOWER. WHEN THE INVESTIGATIVE
TEAM WERE CONFUSED. HOW CAN THAT
POSSIBLY BE? WELL, WHEN THEY
LOOKED THEY REALIZED WHAT
HAPPENED. THEY WERE PAYING A
COMPENSATION PAYMENT OF $5. NOT
VERY MUCH, RIGHT. BUT THAT
AMOUNT OF MONEY ATTRACTED PEOPLE
FROM OFFICES. SALARIED WORKERS
FROM THE DOWNTOWN OFFICES. NOT
JUST MINORS, SO THEREFORE
DISTORTED THE POPULATION THAT
THEY WERE STUDYING. THOSE PEOPLE
HAD MISREPRESENTED THEMSELVES AS
MINORS IN ORDER TO ACCESS THE
PAYMENT. SOMETHING THAT DIDN'T
HAPPEN THE PREVIOUS TIME WHEN
THEY HAD DONE THE STUDY AT THE
MINE AND NOT IN THE TOWN. VERY
INTERESTING LESSON IN THE
DETAILS OF WHERE THE STUDY IS
DONE, WHAT THE STUDY IS ABOUT,
WHO THE PARTICIPANTS MIGHT BE
ARE IMPORTANT. WE NEED TO PAY
ATTENTION TO THOSE THINGS TO
MINIMIZE THE POSSIBILITY OF
REPRESENTATION. ERIC DEVINE AND
COLLEAGUES, WHO DID THAT PRIOR
STUDY ON MISREPRESENTATION, HAVE
A PAPER IN CONTEMPORARY CLINICAL
TRIALS IN 2017 WHERE THEY HAVE A
SERIES OF SUGGESTIONS ABOUT
STRATEGIES TO REDUCE THIS
POSSIBILITY OR THIS PROBLEM OF
MISREPRESENTATION. BASICALLY
THEY SAY TO EXCLUDE SUBJECTS WHO
CONCEAL AND FABRICATE
INFORMATION. THEIR STRATEGIES
INCLUDE HOW YOU WRITE THE
ADVERTISEMENTS, HOW MUCH MONEY
YOU ACTUALLY OFFER, THE
SCREENING PROCESS AND WHAT
QUESTIONS YOU ASK PEOPLE, HOW
YOU ASSESS PARTICIPANT'S
MOTIVATIONS. PAYING ATTENTION TO
INCONSISTENCIES IN
HISTORY-TAKING OR REPORTS. ALSO
USING SUBJECT REGISTRIES TO SEE
IF PEOPLE ARE PARTICIPATING IN
MULTIPLE TRIALS AT THE SAME
TIME. I THINK ONE OF THE THINGS
WE DON'T KNOW ABOUT -- THIS IS
SOMETHING THAT WOULD BE REALLY
INTERESTING TO STUDY, IF THERE
WAS A WAY TO STUDY IT, IS
WHETHER AND TO WHAT EXTENT
PEOPLE MISREPRESENT THEMSELVES
IN OTHER TRIALS. WHAT I MEAN BY
THAT IS I THINK SOMETIMES THERE
IS A VERY STRONG DESIRE TO
PARTICIPATE IN A SPECIFIC KIND
OF TRIAL. ESPECIALLY TRIALS OF
CERTAIN NEW THERAPIES FOR
DEVASTATING DISEASES. I THINK IT
IS POSSIBLE THAT PEOPLE WHO WANT
TO PARTICIPATE IN THOSE TRIALS
MIGHT NOT TELL THE WHOLE STORY
ABOUT THE MEDICATIONS THEY ARE
ON, CO MORBIDITIES OR WHATEVER,
BECAUSE THEY WANT TO BE IN THE
TRIAL SO BADLY. SO THIS IS A --
I DON'T HAVE DA TO SUPPORT THAT,
BUT I THINK IT IS -- INTUITIVELY
IT MAKES SENSE. IT IS HOW MUCH
YOU WANT SOMETHING. YOU ARE
WILLING SOMETIMES TO
MISREPRESENT YOU'RE TO GET IT.
THE ZIMBABWE STORY WAS, YOU
KNOW, $5, VERY EASY STUDY. ALL
YOU HAVE TO DO IS GIVE URINE.
EASY TO SAY, OH SURE. I'M A
MINOR. I WANT TO PARTICIPATE IN
THAT STUDY. SO HAVING SUMMARIZED
SOME OF THE ETHICAL CONCERNS I
THINK HERE ARE THE THINGS I
WOULD CONCLUDE. MONEY IS NOT
COERCIVE. WE PROBABLY WORRY TOO
MUCH ABOUT UNDUE INFLUENCE.
OFTEN PEOPLE OFTEN MAKE RATIONAL
DECISIONS TO ACCEPT MORE RISK
FOR MORE MONEY BUT THAT DOESN'T
NECESSARILY BLIND THEM TO THE
RISK. WE STILL HAVE TO REMEMBER
THAT OTHERS HAVE DIFFERENT
MOTIVATIONS FOR PARTICIPATING IN
RESEARCH. IN OTHER WORDS, SOME
PEOPLE WHO WANT THE EXPERIMENTAL
DRUG THAT IS PROMISING FOR THEIR
CONDITION, THEY MAY NOT CARE
THAT MUCH ABOUT THE MONEY THAT
IS BEING OFFERED, IF MONEY IS
BEING OFFERED, OTHER THAN IT
MIGHT ENABLE THEM TO PARTICIPATE
IN A STUDY. I THINK WE SHOULD
WORRY LESS THAN WE DO ABOUT
UNDUE INFLUENCE. I THINK THE
VARIATION IN THE POPULATION
DISTRIBUTION OF RESEARCH RISK
AND BENEFIT, WHAT SOME CALL
UNJUST INDUCEMENT, IS DRIVEN BY
A LOT OF FACTORS. MONEY DOESN'T
APPEAR TO BE THE MAIN THING THAT
MAKES DIFFERENCES IN
SOCIOECONOMIC CHARACTERISTICS IN
POPULATIONS. WHAT I MEAN BY THAT
IS, IF YOU LOOK AT CANCER TRIALS
AND SOCIAL OWE DEMOGRAPHICS OF
PEOPLE WHO PARTICIPATE IN CANCER
TRIAL, THEY ARE PREDOMINANTLY
WHITE, MIDDLE CLASS, INSURED
INDIVIDUALS. IF YOU LOOK AT
POPULATIONS THAT PARTICIPATE --
THEY ARE NOT BEING OFFERED
PAYMENT. IF YOU LOOK AT
POPULATIONS THAT PARTICIPATE IN
OTHER KINDS OF TRIALS, THEY ARE
SIMILAR TO WHAT I HAVE JUST
DESCRIBED. IF YOU LOOK AT
HEALTHY VOLUNTEERS PRIMARILY
DRIVEN BY -- MOTIVATED, EXCUSE
ME, BY MONEY, WE SEE MUCH MORE
REPRESENTATION OF DIFFERENT
RACIAL AND ETHNIC GROUPS THAN WE
DO IN SOME CLINICAL TRIALS. BUT
THEY ALSO HAVE NO OTHER
MOTIVATION TO PARTICIPATE IN A
TRIAL OTHER THAN PERHAPS MAKING
MONEY OR PERHAPS CURIOSITY,
KNOWLEDGE OR AL TRUISM. I THINK
WE NEED TO TAKE TAKES TO
MINIMIZE POSSIBILITY OF
MISREPRESENTATION IN CLINICAL
TRIALS. AS I JUST ALLUDED TO
MAYBE ACROSS THE BOARD. NOT JUST
IN TRIALS THAT OFFER MONEY. WE
ALSO ALWAYS SHOULD DO OUR BEST
TO MAXIMIZE PARTICIPANT
UNDERSTANDING ACROSS STUDIES.
AGAIN, REGARDLESS OF WHETHER
PAYMENT IS BEING OFFERED OR NOT.
TO THE LAST PART I WANT TO TURN
TO, HOW MUCH DO WE FIGURE OUT
HOW MUCH TO PAY PARTICIPANTS.
THIS IS SOMETHING THAT IF WE
LOOK AT STUDIES THAT DO PAY,
THERE'S A WIDE VARIETY IN TERMS
OF AMOUNTS. THERE ARE
DIFFERENCES FROM INSTITUTION TO
INSTITUTION. SOMETIMES
DIFFERENCES WITHIN A
MULTI CENTER STUDY ON THE SAME
STUDY. O THERE ARE VARIATIONS IN
HOW MUCH PAYMENT IS OFFERED TO
PEOPLE AND NOT ENTIRELY CLEAR
ALWAYS HOW THE NUMBERS ARE COME
UP WITH. YEARS AGO NEIL DICKERT
AND I PROPOSED THERE WERE MAYBE
THREE MODELS OF PAYING RESEARCH
PARTICIPANTS THAT COULD HELP US
FIGURE HOW MUCH TO PAY. ONE WAS
A MARKET MODEL, LIKE AN
INCENTIVE PAYMENT. THAT WOULD BE
DRIVEN BY THE MARKET, SUPPLY AND
DEMAND AND HOW MUCH -- HOW
QUICKLY YOU WANTED TO ENROLL.
THE WAGE PAYMENT MODEL WAS MORE
LIKE A WORKING WAGE RECRUITING
PEOPLE -- SORRY, PAYING PEOPLE
BASED ON THE SORT OF UNSKILL AID
LOR THAT CONTRIBUTE TO
PARTICIPATION IN RESEARCH. THAT
WOULD BE PROBABLY TIME AND
INCONVENIENCE , THE WAY WE HAVE
OFTEN THOUGHT ABOUT PAYING
PEOPLE THROUGH THIS MODEL.
REIMBURSEMENT IS BASICALLY
REIMBURSING PEOPLE FOR EXPENSES.
THIS IS SOMETHING THAT PEOPLE DO
DEBATE BECAUSE THEY COULD BE
JUST EXPENSES YOU HAVE RECEIVES
FOR OR TRAVEL AND FOOD AND
LODGING OR CAN BE LOST WAGES AND
CHILD CARE AND ALL KINDS OF
THINGS. SO THERE IS STILL SOME
DISCREPANCY ABOUT HOW PEOPLE
THINK ABOUT REIMBURSEMENT. IF WE
LOOK AT THE GUIDELINES AT THE
NIH YOU CAN SEE THEY USE ALL
THREE OF THESE, REIMBURSEMENT,
COMPENSATION AND INCENTIVE AND
DESCRIBE THEM, AS I DID, FOR
DIFFERENT REASONS. WE PAY PEOPLE
FOR DIFFERENT REASONS AND HELP
YOU TO FIGURE OUT AMOUNTS. IT IS
INTERESTING THAT SOME PEOPLE
HAVE RECOMMEND ED A FOURTH MODEL
CALLED THE APPRECIATION MODEL.
BASICALLY I DON'T THINK IT
REALLY SERVES AS A SEPARATE
MODEL FOR DETERMINING EITHER
REASONS TO PAY OR AMOUNTS TO
PAY. IT IS A REASON TO PAY, TO
APPRECIATE PEOPLE. BUT IT
DOESN'T HELP NECESSARILY WITH
AMOUNTS. YOU CAN SHOW
APPRECIATION TO A GROUP FOR
PARTICIPATING IN YOUR STUDY BY
GIVING THEM A $20 STARBUCKS GIFT
CARD, THAT IS APPRECIATION, BUT
NOT DRIVEN BY EXPENSES THEY
INCURRED OR INCENTIVES THAT
WOULD INCENTIVISE THEM TO
PARTICIPATE OR COMPENSATE THEM
FOR TIME AND INCONVENIENCE.
INTERGLY A STUDY WE DID SOME
YEARS AGO LOOKING AT IRB MEMBERS
ACROSS THE COUNTRY -- THERE WERE
ABOUT 600 IN OUR STUDY, THE
MAJORITY SAID THEY WERE SOMEWHAT
MODERATELY OR VERY CONCERNED BY
PAYING PARTICIPANTS IN ANY
AMOUNT. I DON'T KNOW -- THIS IS
TEN YEARS AGO. I DON'T KNOW IF
IT IS DIFFERENT TODAY BUT I
THINK IT WAS SURPRISING IN THAT
ERA THAT MANY PEOPLE WERE
CONCERNED AT ANY AMOUNT AND MUCH
HIGHER NUMBER OR PERCENTAGE,
EXCUSE ME, WERE CONCERNED IF THE
AMOUNT OF PAYMENT WAS
SUBSTANTIAL. THE MAJORITY IN
THIS SAMPLE ALSO HAD SUBSTANTIAL
MISCONCEPTIONS ABOUT INDUCEMENT
AND BASICALLY THOUGHT EITHER ONE
OF THEM WAS EXPLAINED BY
SOMEBODY DECIDING TO DO
SOMETHING THAT THEY OTHERWISE
PROBABLY WOULDN'T DO. I THINK, I
HOPE I CONVINCE YOU THAT IS NOT
THE DEFINITION OF EITHER CO. WER
SHUN OR UNDUE INDUCEMENT.
INTERGLY THE SAME COHORT OF IRB
MEMBERS ACROSS THE COUNTRY, WHEN
WE ASKED THEM, IS IT OKAY TO
REIMBURSE PARTICIPANTS FOR
EXPENSES ALMOST ALL SAID YES.
REGARDLESS WHETHER THEY WERE
HEALTHY OR PATIENTS IN STUDIES
WITH NO PROSPECT OF BENEFIT OR
PROSPECT OF BENEFIT. ALMOST ALL
THOUGHT IT WAS FINE TO
COMPENSATE PEOPLE FOR TIME AND
INCONVENIENCE. FEWER THOUGHT
OKAY TO OFFER MONEY AS
INCENTIVE. FEWER STILL OFFER
MONEY AS A COME P COMPENSATION
FOR RISK. THERE ARE THESE
INTERESTING -- I FOUND THIS
WEBSITE THAT HAS A TOOL YOU CAN
PLUG IN DETAILS OF YOUR STUDY.
THEY WILL CALCULATE FOR YOU HOW
MUCH YOU SHOULD PAY PEOPLE. IT
IS ENTERING. WHAT THEY SAY HERE
IS DECIDING ON THE RIGHT
INCENTIVE AMOUNT IS A DELICATE
PROBLEM. PAY TOO LITTLE, YOU
WON'T GET ENOUGH PARTICIPANTS.
PAY TOO MUCH, YOU BLOW UP YOUR
BUDGET. THEY DID RESEARCH AND
ARE USING THAT FOR THE ALGORITHM
THEY PROVIDE FOR FIGURING HOW
MUCH YOU SHOULD PAY. I DON'T
KNOW HOW GOOD IT IS. THOUGHT I
WOULD PUT IT OUT AS SOMETHING TO
LOOK AT. IT WAS UPDATED PRETTY
RECENTLY. SO HOW DO WE DECIDE
HOW MUCH TO OFFER RESEARCH
PARTICIPANTS? YOU MIGHT THINK
THERE ARE BENCHMARKS. WE DID A
STUD DAY FEW YEARS AGO WHERE WE
LOOKED AT THE INCONVENIENCED
UNITS USED BY RESEARCHERS IN THE
CLINICAL CENTER QUITE A WHOLING
A OVER THE PERIOD OF 2004-2008
TO SEE HOW CON VER GENETIC THEY
WERE IN TERMS OF THE AMOUNT THEY
PAID BUT ALSO THE NUMBER OF
INCONVENIENCE UNITS THEY
ASSIGNED. LET ME POINT OUT A
COUPLE THINGS. HERE IF YOU LOOK
HERE AT LUMBAR PUNCTURE THE
RANGE WAS FROM ONE INCONVENIENCE
UNIT TO 57 INCONVENIENCE UNITS.
THAT IS HUGE. MRIs WERE NOT MUCH
BETTER, 0-40. UP HERE, THINGS
LIKE BLOOD DRAW, THERE WAS LOTS
OF CONVERGENCE. MOST PEOPLE
THOUGHT HAVING A BLOOD DRAW WAS
TOO MANY UNITS. MANY OF YOU
MIGHT KNOW WE HAD A SYSTEM WHERE
THERE WAS A NUMBER PREDICTING --
SORRY, RECOMMENDED FOR THE
AMOUNT OF TIME A PERSON SPENT BY
HOUR OR BY DAY AND BY THE NUMBER
OF INCONVENIENCE UNITS.
INCONVENIENCE UNIT IN THESE DATA
IS $10. SO $20 FOR BLOOD
DRAWING. THOSE KINDS OF
BENCHMARKS DON'T EXIST VERY
WIDELY. THEY ARE VERY HARD TO
FIND. THERE IS A COLLEAGUE IN
NIDCD WHO SAID I COULD TELL YOU
HER NAME, DEANA LYON COLLECTING
DATA ON INTRA MURAL COMPENSATION
SO SHE MAY HAVE MORE RECENT
BENCHMARKS THAN OTHERS I JUST
SHOWED YOU FROM THE OTHER SLIDE.
OTHER WAYS TO SORT OF THINK
ABOUT HOW TO PAY SOMEBODY ARE
REASONS WE ARE PAYING THEM?
PAYING THEM TO INCENTIVISE THEM
OR REIMBURSING THEM OR
COMPENSATING THEM FOR THEIR TIME
AND INCON CONVENIENCE /*
INCONVENIENCE? THE DESIGN
MATTERS. THOSE THINGS MATTER.
THIS IS SIMILAR TO THEIR
CONTRIBUTIONS, MAYBE
VULNERABILITIES. BUDGET. IN THE
STUDY I JUST SHOWED YOU WHERE WE
LOOKED AT INTERMURAL PAYMENT,
MOST OF THE TIME INVESTIGATORS
GAVE A NUMBER. THEY DIDN'T USE
THE TIME AND CONVENIENCE UNITS,
JUST GAVE A NUMBER. I'M GOING TO
PAY PEOPLE X NUMBER OF DOLLARS.
IF YOU LOOK THOSE ARE DICTATED
ABOUT HOW MUCH MONEY THE
RESEARCHER HAS. BUDGETS ARE CON
TRAINED. IF YOU THINK ABOUT A
THOUSAND PARTICIPANTS YOU ARE
GOING TO HAVE TO PAY LESS THAN
IF YOU ARE -- AND YOU HAVE THE
SAME BUDGET THAN IF YOU HAVE
MUCH LOWER NUMBER. IT IS
IMPORTANT AS YOU SAW THE
GUIDELINES THAT PAYMENT BE FAIR
AND JUST. THOSE ARE THINGS WE
NEED TO THINK THROUGH IN TERMS
OF IF WE ARE PAYING PEOPLE FOR
THEIR TIME AND INCONVENIENCE,
EVERYBODY WHO'S GIVING US TIME
AND INCONVENIENCE SHOULD BE PAID
FAIRLY AND JUSTLY. IF WE ARE
PAYING $50 FOR AN MRI, EVERYBODY
WHO IS GETTING THE MRI SHOULD BE
GETTING THE $50. WE NEED TO
CONSIDER INSTITUTIONAL
GUIDELINES, LOCAL, SOCIETAL,
LEGAL, CULTURAL NORMALS THERE
ARE SOME PLACES WHERE PAYMENT IS
LOOKED UPON SUSPICIOUS, TRUE IF
YOU HAVE INTERNATIONAL SITES OR
DOING RESEARCH BE EARLY. WHEN
AND HOW THERE ARE MECHANISMS FOR
PAYING PEOPLE NOT SIMPLY CASH.
IN FACT, CASH IS HARDEST. THERE
ARE GIFT CARDS AND VOUCHERS AND
OTHER THINGS. SOME PEOPLE LIKE
THOSE LESS THAN THEY LIKE CASH.
SOME PLACES PAY IN-KIND WITH,
YOU KNOW, FOOD OR DIAPERS OR
OTHER THINGS THAT PEOPLE MIGHT
NEED THEN A LOT OF DISCUSSION
ABOUT WHEN. I THINK SOME THINK
PRO RATING IS A FAIR WAY TO PAY
FOR THINGS THEY HAVE CONTRIBUTED
THUS FAR. COMPLETION BONUSES AT
SOME LEVEL ARE ETHICALLY
ACCEPTABLE. LOOP CHALLENGEES AND
COLLEAGUES PUT A FRAMEWORK FOR
PAYING PARTICIPANTS IN THE NEW
ENGLAND JOURNAL A COUPLE YEARS
AGO, THERE ARE A COUPLE OF
POINTS ON THE BOX FOR
CONSIDERATION FOR INVESTIGATORS.
THEY HAVE IN PAPER CONSIDERATION
FOR IRB MEMBERS SO IF YOU ARE
INTERESTED IN LOOKING AT THOSE.
FIRST AND FOREMOST THEY SAY IT
IS IMPORTANT TO COMMUNE KAPT THE
RATIONALE FOR WHY YOU DECIDED ON
A SPECIFIC AMOUNT. THAT IS FOR
THE IRB. TO UNDERSTAND WHETHER
IT IS REIMBURSEMENT,
COMPENSATION, INCENTIVE OR ALL
THE ABOVE. THEY ALSO TALK ABOUT
FAIRLY REIMBURSING AND
COMPENSATING PEOPLE. GO ON TO
SAY WE SHOULD BE REIMBURSING
PEOPLE UNLESS THERE IS A STRONG
REASON NOT TO. WE SHOULD ALSO BE
COMPENSATING PARTICIPANTS FOR
THEIR TIME, COMMITMENT AND
BURDENS THEY ASSUME. THEN
PROVIDE JUSTIFICATION FOR WHY
THE RATES PROPOSED FOR
COMPENSATING PEOPLE ARE FAIR.
INCENTIVES ONLY WHEN PROPOSING
TO OFFER MORE THAN WOULD BE
JUSTIFIED BY REIMBURSEMENT OR
COMPENSATION. THEN TALK ABOUT
OTHER THINGS I THINK REALLY
IMPORTANT, WE DON'T HAVE
INSURANCE COVERAGE FOR PEOPLE
WHO MIGHT SUFFER
RESEARCH-RELATED INJURIES AS A
SEPARATE ISSUE BUT ONE THEY
INCLUDED IN THIS PAPER. AND THEY
TALK ABOUT INCREASING SAFEGUARDS
FOR UNDERSTANDING, COMPREHENSION
AND INFORMED CONSENT. THEY
DIDN'T TALK ABOUT SAFEGUARDS FOR
MISREPRESENTATION BUT I THINK
THEY MIGHT IF THEY WERE ASKED
TODAY. SO, IN SUM, REIMBURSING
EXPENSES SHOULD BE STANDARD.
COMPENSATION FOR TIME AND
INCONVENIENCE IS FAIR AND
RESPECTFUL AND SHOULD BE DONEN
MOST CASES. INCENTIVES MAY BE
USEFUL IN SOME CASES. THAT IS ON
TOP OF THE OTHER TWO. PAYMENT IS
ACCEPTABLE BY REGULATION AND BY
ETHICAL ANALYSIS. OFFERING MONEY
IS NOT COERCIVE. IS UNLIKE TLOI
RESULT IN UNJUST INDUCEMENT. MAY
PROMOTE UNDERSTANDING NOT
INTERFERE WITH IT. LIKELY
REDUCES THE CHANCE OF
EXPLOITATION. WE NEED TO TAKE
STEPS TO REDUCE THE CHANCES IN
RARE CASE IT MIGHT OCCUR AND
MISREPRESENTATION OR DECEPTION
THAT COMES WITH PAYING PEOPLE
AND OTHER MOTIVATIONS
PARTICIPATING IN RESEARCH. THANK
YOU, I THINK THERE IS SOME TIME
FOR QUESTIONS.
>> OKAY THAT, IS GREAT. THAT
WAS A FANTASTIC PRESENTATION. WE
DO HAVE SOME QUESTIONS AND/OR
COMMENTS. IF YOU STILL HAVE
QUESTIONS YOU'D LIKE TO SUBMIT,
PLEASE GO AHEAD AND DO SO. CLICK
ON THE BOX THAT SAYS LIVE
FEEDBACK LINK. LET ME GO AHEAD
AND GET TO QUESTIONS WE HAVE.
OKAY. HERE'S ONE. SHOULD WE
CONSIDER THE PROVISION OF FREE
MEDICAL CARE ASSOCIATED WITH THE
TRIAL AT THE NIH CLINICAL CENTER
AS FORM OF COMPENSATION TO OUR
PARTICIPANTS?
>> SO HERE IS WHERE WE KNOW
LANGUAGE PROBABLY MATTERS. I
DON'T KNOW IF IT IS
COMPENSATION. I THINK IT IS AN
INCENTIVE. I THINK PEOPLE DO
SOMETIMES COME TO THE CLINICAL
CENTER BECAUSE THEY GET FREE
MEDICAL CARE. IT IS CERTAINLY A
BENEFIT FOR THEM. WHETHER IT IS
COMPENSATION IN TRUE SENSE OF
WHAT COMPENSATION IS ABOUT, I'M
NOT SO SURE ABOUT THAT. I MEAN,
IT IS DEFINITELY A BENEFIT AND
DEFINITELY AN INCENTIVE. I DON'T
KNOW IF THAT ANSWERS THE
QUESTIONER'S QUESTION.
>> OKAY. THERE WAS A COUPLE
QUESTIONS REGARDING MY MINORS.
ARE THERE SPECIFICS WHEN PARENT
IS ENROLLING IN RESEARCH AND A
SIMILAR QUESTION, CAN YOU A
DRESS PAYMENT TO MINORS FOR
RESEARCH PARTICIPATION THERE
HAVE BEEN SITUATIONS WHERE THE
PARENT MAY PRESSURE THE CHILD TO
PARTICIPATE FOR THE FINANCIAL
BENEFITS AND CONCERNS ABOUT THE
CHILD'S ABILITY TO CONSENT OR
PROVIDE ASCENT.
>> YAH. SO THAT IS A TRICKY
AREA. ONE THAT WE HAVE WORKED ON
A LITTLE BIT IN THE PAST. I
THINK WE DON'T HAVE A LOT OF
DATA ON THIS. HERE IS THE WAY I
THINK ABOUT IT. I THINK, YOU
KNOWF WE ARE GIVING PEOPLE MONEY
FOR THEIR CONTRIBUTION, THEN
CHILDREN SHOULD BE COME PPENSAT
FOR THEIR CONTRIBUTION TOO. FOR
SMALL CHILDREN MONEY DOESN'T
MEAN THAT MUCH. WE SHOULD BE
CREATIVE IN THINKING ABOUT WHAT
WOULD BE A BETTER COMPENSATION
FOR THE BURDEN AND INCONVENIENCE
THAT THE CHILD IS UNDERTAKING OR
ASSUMING TO BE PART OF RESEARCH.
THAT COULD BE, YOU KNOW, TOYS OR
COULD BE A COLLEGE -- DONATION
TO A COLLEGE FUND OR SOMETHING,
I DON'T KNOW. COULD BE OTHER
KINDS OF WAYS TO GIVE CHILDREN
RECOGNITION OR COMPENSATION FOR
THEIR CONTRIBUTION. I THINK THE
THING ABOUT PARENTS IS REALLY
HARD BECAUSE IT IS TRUE, I'M
AWARE THAT IT IS TRUE SOME
PARENTS WOULD OR DO PRESSURE
THEIR CHILDREN TO PARTICIPATE IN
ORDER TO GET MONEY OFFERED FOR
THAT STUDY. THAT IS PROBLEMATIC,
FOR ME. I THINK WE NEED TO BE
REALLY DILIGENT ABOUT HOW WE GET
ASCENT FROM CHILDREN WHEN
STUDIES WITH MONEY INVOLVED SO
THEY ARE NOT DOING IT BECAUSE
THEIR PARENTS ARE PRESSURING
THEM IN A VERY SIGNIFICANT WAY.
ON THE OTHER HAND, PARENTS WHO
BRING THEIR CHILDREN IN TO THE
CLINICAL CENTER OR ANY CLINIC
FOR RESEARCH PARTICIPATION INCUR
COSTS, RIGHT. THEY HAVE TO TAKE
TIME OFF FROM WORK, PRESUMEGLY
BLI, OR OTHER THINGS THEY ARE
DOING. THEY HAVE TRANSPORTATION
COSTS, FOOD COSTS, LODGING
COSTS. WE SHOULD AT LEAST BE
REIMBURSING THEIR COSTS SO THAT
THEY DON'T HAVE FINANCIAL COSTS
FROM HELPING THEIR CHILD BE A
PARTICIPANT IN RESEARCH. I DON'T
KNOW IF YOU GOT THE TWO SIDES OF
MY WORRY. I THINK WE SHOULD BE
REIMBURSING PEOPLE. I THINK
PARENTS, EXCUSE ME. I THINK WE
SHOULD BE THINKING OF CREATIVE
WAYS TO COMPENSATE CHILDREN.
DON'T THINK WE WANT TO PROVIDE
INCENTIVES FOR PARENTS TO
PRESSURE THEIR CHILDREN.
>> OKAY. I HAVE A
CLARIFICATION ON THE EARLIER
QUESTION ABOUT PROVISION OF FREE
MEDICAL CARE THAT YOU GET AT THE
CLINICAL CENTER. IS THIS AN
INCENTIVE THAT COULD POTENTIALLY
BE UNDUE INDUCEMENT?
>> I THINK IN MOST CASES THE
ANSWER IS NO. I THINK PEOPLE --
I HAVE BEEN HERE A LONG TIME. I
HAVE SEEN A LOT OF STUDIES OVER
THE YEARS. MY STRONG IMPRESSION
FROM BOTH ASKING PEOPLE BUT ALSO
OBSERVING IS THAT PEOPLE COME
HERE THINK FEEL ARE IMPORTANT
FOR THEIR DISEASE. MOST THE
PEOPLE WE HAVE AT THE CLINICAL
CENTER ARE NOT HEALTHY
VOLUNTEERS; THEY ARE PATIENTS.
THEY HAVE CONDITIONS THAT ARE
RARE, THAT ARE HARD TO TREAT,
THAT, YOU KNOW, HAVE EXPERTS
HERE THAT KNOW THINGS ABOUT
THEIR DISEASE THAT OTHER PEOPLE
DON'T KNOW. THEY DO GET
TREATMENT HERE THEY MIGHT NOT BE
ABLE TO GET ON THE OUTSIDE. THE
FACT IT IS FREE IS A REALLY
WONDERFUL BENEFIT BUT I DON'T
THINK IT IS AN UNDUE INDUCEMENT
THAT THEY WILL COME HERE AND NOT
CARE ABOUT DETAILS AND RISKS
BECAUSE IT IS FREE. THEY ARE NOT
GOING TO COME FOR REASONS. IT IS
A DIFFERENT STORY WITH
VOLUNTEERS. WE ARE TO BE
COGNIZANT. WE HAVE SEEN OVER THE
YEARS, AND THIS GOES BACK TO
MISREPRESENTATION WORRY, WE HAVE
SEEN, NOT COMMON BUT HAPPEN,
HEALTHY VOLUNTEERS WHO VOLUNTEER
THREE, FOUR STUDIES AT THE SAME
TIME, SOMETIMES STUDIES THAT
CONTRADICT EACH OTHER. I
REMEMBER ONE CASE YEARS A WHEN
DISCOVERED AN INDIVIDUAL
VOLUNTEER FOR THREE WEIGHT LOSS
STUDIES BUT SIMULTANEOUSLY. THAT
SCREWS UP THE DATA. IF YOU ARE
TRYING INTERVENTION FOR WEIGHT
LOSS AND DOING THREE AT THE SAME
TIME YOU ARE NOT GOING TO KNOW
IF ANY WORK. WE NEED TO BE
VIGILANT ABOUT WHAT KINDS OF
STUDIES PEOPLE ARE PARTICIPATING
IN. OFTEN BECAUSE THEY WANT THE
COMPENSATION. MANY YEARS AGO
THERE WAS INTERNAL REGISTRY SO
YOU COULD FIND OUT WHAT KIND OF
STUDIES THEY WERE IN AND AVOID
THAT PROBLEM WITH MULTIPLE
STUDIES MAY BE ATTRACTIVE
BECAUSE THEY WERE OFFERING
PAYMENT. WE DON'T HAVE A
REGISTRY, TO MY KNOWLEDGE. ONE
OTHER THING OF INTEREST IN THIS
REGARD IS ONE OF THE STUDIES
WHICH I DIDN'T PUT UP THAT JILL
FISCHER DID, SHE WAS LOOKING AT
HEALTHY VOLUNTEERS IN DRUG
DEVELOPMENT STUDIES AND TRYING
TO GET A SENSE OF -- SOMETIMES
PEOPLE SAY THAT IS HOW THEY --
THAT IS THEIR INCOME, HOW THEY
MAKE MONEY AND LIVE ON IT. THE
AVERAGE AMOUNT OF MONEY -- I'M
GOING TO FORGET NOW. THE AVERAGE
AMOUNT PEOPLE MADE IN A YEAR OF
THE COHORT SHE STUDIED WAS LIKE
LESS THAN $10,000. SO CERTAINLY
AN ADJUNCT TO PEOPLE'S INCOME
BUT NOT TOO MANY CAN LIVE ON
LESS THAN $10,000 TODAY.
>> OKAY. WE ARE ABOUT OUT OF
TIME BUT I HAVE ONE OR TWO MORE
THINGS. WOULD YOU COMMENT ON
COMPETITION BY PHARMA HAVING
MUCH HIGHER REMUNERATION?
>> YAH. I MEAN THIS WAS ONE
OF THE REASONS THAT, YOU KNOW,
20 YEARS AGO WE PROPOSED MAYBE
THINKING THE WAGE PAYMENT MODEL
IS THE BEST FOR THINKING ABOUT
HOW TO COME UP WITH AMOUNTS FOR
COMPENSATION BECAUSE INDUSTRIES
DO HAVE BIGGER BUDGETS THAN
ACADEMICS GENERALLY. THEY CAN
THEREFORE PAY MORE FOR RESEARCH
PARTICIPANTS. THAT CREATES A
MARKET THAT IS UNFAIR TO
RESEARCHERS WHO HAVE SMALLER
BUDGETS. A LOT OF TIME THE
STUDIES ARE DIFFERENT. I
MENTIONED THE PHASE I, THEY PAY
PRETTY WELL FOR THOSE BUT THOSE
ARE PEOPLE WHO HAVE NO OTHER
REASON TO PARTICIPATE AND GO
INTO THESE CLINICAL RESEARCH
UNITS AND OFTEN REQUIRED TO STAY
THERE THREE, FOUR WEEKS
SOMETIMES. THEY HAVE A WHOLE
BUNCH OF THINGS DONE TO THEM.
THEY ARE ON RESTRICTED DIETS,
CAN'T SMOKE, LOTS OF THINGS
HAPPEN TO THEM. IN THOSE KINDS
YOU THINK THEY SHOULD PAY
BECAUSE THAT IS A LOT TO THE
ASK. I THINK THE PROBLEMATIC
ONES ARE THIS IS A STUDY OF A
DRUG A LOT OF PEOPLE WOULD
BENEFIT FROM. A DRUG COMPANY
MIGHT WANT TO EXPEDITE AND PAY
MORE IN CRO THAN INSTITUTIONN.
THOSE CASES I THINK IT IS HARD
FOR ACADEMICS TO COMPETE.
>> OKAY. I THINK WE WILL STOP
THERE IN INTEREST OF TIME. THERE
WERE A COUPLE I MAY SEND TO YOU
OFF-LINE, IF THAT IS OKAY.
>> OKAY.
>> WE ARE VERY APPRECIATIVE
OF YOUR TIME AND FANTASTIC
PRESENTATION. JUST AN
ANNOUNCEMENT, OUR NEXT EDUCATION
SESSION WILL BE THURSDAY
FEBRUARY 1ST AT 3:00 VIA NIH
VIDEO CAST TITLED OVERVIEW OF
IRB EXPECTATIONS WHEN
NON-ENGLISH SPEAKING PERSONS
ENROLL IN RESEARCH. IMPORTANCE
OF ENSURING COMPREHENSION. WE
HOPE YOU WILL ALL BE ABLE TO
JOIN US FOR THAT AS WELL, SO THANK YOU, EVERYBODY.
THANKS, PEG.