Holly Fernandez Lynch , J.D., M.Bioethics Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School Faculty, Center for Bioethics, Harvard Medical School Emily Largent, J.D., Ph.D., R.N. Research Associate, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School December 9, 2016 PAYING RESEARCH PARTICIPANTS: CONSIDERATIONS AT BOTH ENDS OF THE SPECTRUM
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Holly Fernandez Lynch and Emily Largent, "Paying Research Participants: Considerations at Both Ends of the Spectrum"
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H o l l y F e r n a n d e z L y n c h , J . D . , M . B i o e t h i c s E x e c u t i v e D i r e c t o r , P e t r i e - F l o m C e n t e r f o r H e a l t h L a w P o l i c y ,
B i o t e c h n o l o g y , a n d B i o e t h i c s , H a r v a r d L a w S c h o o l F a c u l t y , C e n t e r f o r B i o e t h i c s , H a r v a r d M e d i c a l S c h o o l
E m i l y L a r g e n t , J . D . , P h . D . , R . N .
R e s e a r c h A s s o c i a t e , P e t r i e - F l o m C e n t e r f o r H e a l t h L a w P o l i c y , B i o t e c h n o l o g y , a n d B i o e t h i c s , H a r v a r d L a w S c h o o l
D e c e m b e r 9 , 2 0 1 6
PAYING RESEARCH PARTICIPANTS: CONSIDERATIONS AT BOTH ENDS
OF THE SPECTRUM
Disclaimer This work was conducted with support from Harvard Catalyst, the Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic healthcare centers. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Catalyst, Harvard University and its affiliated academic healthcare centers, or the National Institutes of Health.
Recap: What Do We Know?
• Paying participants is common • US regulations focus on coercion
and undue influence • Confusion around those terms • Most attention to high payment
• Several different ways to conceptualize paying participants – what are we paying for?
Overview
• Assessing high payment • Assessing low payment • How to balance both ends of the
spectrum – what should we really worry about?
• Spoiler alert: Low payment is an ethical concern, too.
Concerns about high payment: COERCION
• Proposed definitions: B has no reasonable alternative but to accept
A’s proposal A threatens to make B worse off (i.e., physical,
psychological, or social harm) in order to obtain compliance
A threatens to violate B’s rights or not fulfill an obligation to B in order to obtain compliance AND B has no reasonable alternative
Concerns about high payment: COERCION
• Coercion requires a threat • Payment is an offer, not a threat • So, payment cannot coerce Coercion is possible in research, but not due to
payment
Concerns about high payment: UNDUE INFLUENCE
Distinct from mere inducement, which is not an ethical concern Doing something you would not do but for the
payment is not per se problematic Must be undue Proposed definitions: A makes B a “coercive offer” A offers B an excessive or improper reward A offers B an excessive reward that produces bad
judgment and entails risk of harm (inducing decision unreasonably against B’s interests)
Concerns about high payment: UNDUE INFLUENCE
Payment could cause undue influence But IRB review should generally protect
against it IRB risk/benefit determination occurs
independent of payment offers IRB approval means that participation is a
reasonable choice for the target population Doesn’t have to be best interests – just not
unreasonably against interests NB: Concern about payment may be proxy for concern about risk-
benefit ratio of study
Concerns about high payment: UNDUE INFLUENCE
Caveat: IRB review is not complete protection Reviewing for target population as a whole,
rather than for individuals Participation might still be unreasonable for
certain individuals: some characteristic that they are aware of that the IRB didn’t or couldn’t consider that makes participation an unreasonable choice
Concerns about high payment: UNDUE INFLUENCE
Distinguishing unreasonable v. rational but unfortunate choices?
Protect few by limiting payment for all? Not necessarily a “safe” choice… And no clear threshold applicable for all
participants
Concerns about high payment: DECEPTIVE PARTICIPANTS
High payment may cause subjects to lie or conceal info that might disqualify them from enrollment Might be unduly influenced Might be damaging to scientific integrity/value of
the study Is limiting payment the only solution? Is deception more likely in certain types of studies?
Concerns about low payment: RECRUITMENT ISSUES
Low recruitment is an ethical problem Assuming research is important and/or any
subjects are already exposed to risks/burdens Higher payment may: Enroll more diverse participant population Increase likelihood of study completion
(enrollment and continuation) Although higher payment won’t be a panacea Other reasons for not participating Budget issues
Concerns about low payment: EXPLOITATION
Exploitation = taking unfair advantage One party insufficiently benefits or assumes
unfair share of burdens relative to other party May be consensual and mutually beneficial Not a “deal breaker” – but should be avoided
Takeaways Offers of payment are never coercive IRB approval protects most participants against undue
influence BUT not all Choice 1: Should we level-down, just in case?
High payment may lead to deception in some cases Choice 2: Is reducing payment the only lever?
Payment can help with recruitment Not always, or completely – so does this outweigh concerns
about undue inducement or deception? Low payment risks exploitation of participants who have few
alternatives Is exploitation an equivalent concern to undue inducement?
Balance concern about high and low payment by asking what is FAIR
New Approach: Fair Payment
Possible considerations: Risks, burdens, and benefits of research Opportunity costs/alternatives Social value Non-research contexts – relevant? Others?
Thank You
Case Study
2016: 6 subjects hospitalized—one pronounced brain-dead—after a “serious accident” in French Phase I trial
BIA 10-2474, novel compound designed to treat “anxiety and motor disorders associated with Parkinson’s disease, and chronic pain in people with cancer and other conditions”
Each participant paid €1,900 (about $2,060) “including travel expenses; in return, they agreed to stay at [the testing] facility in Rennes [France] for 2 weeks, swallow a drug on 10 consecutive days, undergo extensive medical tests, and provide at least 40 blood samples”
Was the payment unduly influential/ethically problematic?