December 9, 2016 This symposium brought together a variety of experts to discuss key ethical and legal questions regarding offers of payment to research participants. Panels covered: - Why payment is offered to research participants - Regulatory parameters governing payment - Whether payment to research participants should be considered exceptional, compared to payment in other contexts - How offers of payment affect participants - How to define coercion and undue influence with regard to paying research participants - Which factors should be considered when evaluating proposed payments - The problem of low payment This event was free and open to the public. This event was part of the collaboration between the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School. Cosponsored by the MRCT Center of Brigham and Women's Hospital and Harvard. Learn more on our website: http://petrieflom.law.harvard.edu/events/details/paying-research-participants

1. PAYING RESEARCH SUBJECTS
IS NOTHING (REALLY) SPECIAL
NEAL DICKERT, MD, PHD
DEPARTMENT OF MEDICINE, CARDIOLOGY
EMORY UNIVERSITY SCHOOL OF MEDICINE
DEPARTMENT OF EPIDEMIOLOGY
EMORY ROLLINS SCHOOL OF PUBLIC HEALTH
EMORY CENTER FOR ETHICS
December 9, 2016

2. Disclosures
 I get paid to do research…
 Research funding
 NIH
 PCORI
 Greenwall Foundation
 No industry relationships to disclose

3. What is the worry?
“What’s the matter, honey? Are they
not paying people enough?”
Neal’s grandmother, 1997

4. What is the worry?
 Nothing intrinsically problematic about paying
people for services
 In almost all other contexts, ethical worries center
around not paying people enough
 Human subjects research is one of the only
contexts in which the worry tends to go the other
way

5. People do treat it differently
Largent et al. IRB. 2012

6. The Common Rule
“An investigator shall seek such consent only
under circumstances that provide the
prospective subject or the representative
sufficient opportunity to consider whether or
not to participate and that minimize the
possibility of coercion or undue influence.”
45 CFR 46.116

7. Why payment exceptionalism?
 Conceptual reasons
 Compromises voluntariness
 Wrong reasons
 Contaminates judgment
 Exposes people to risks
 Commodification (passivity concern)
 Exploits people
 More practical reasons
 Compromises understanding
 Distributive justice
 Promotes concealment and fabrication

8. Why payment exceptionalism?
 Conceptual reasons
 Compromises voluntariness
 Wrong reasons
 Contaminates judgment
 Exposes people to risks
 Commodification (passivity concern)
 Exploits people
 Failure of respect (rare and not really special)
 More practical reasons
 Compromises understanding
 Distributive justice
 Promotes concealment and fabrication (?)
Lynch HF. Yale Journal of Health Policy, Law, and Ethics. 2014.

9. Compromises voluntariness
 This is just backwards.
 People induced to participate because of money
want the money and accept participation in
exchange
 We don’t raise this concern in any other context
(job offers, sales/discounts, rewards)

10. Wrong reasons
 Payment leads people to participate because of a
desire for money rather than identification with the
ends of the research, altruism, or other reasons
 No reason to believe any specific motivation is
needed for enrollment to be ethical (clarified by
OHRP)
 Common view about motivations is, at best, over-
protective and, at worst, promotes problematic role
confusion

11. Contaminates judgment
 Payment influences
willingness
 Relative influence stable as
risk increases
 May level off some
 No suggestion that
judgment is impaired
 No reason to think money
affects judgment uniquely
in research Halpern, S. D. et al. Arch Intern Med. 2004

12. Exposes people to risks
 Concern misdirected if there is no risk.
 Research is tightly regulated
 If enrollment is poor judgment because of serious
risk, the study shouldn’t be approved.
Emanuel, J Law Med Ethics. 2004. Emanuel, AJOB. 2005.
 Many jobs have greater risks

13. Commodification
 Payment for physical risk
 Not paying for labor or talent
 Treats “bodies” as fungible
 Hardly unique

14. Exploitation
 “An exploitative transaction is one in which A
takes unfair advantage of B.”
Wertheimer, Exploitation. 1999.
 Solution is to offer more…
 “Using each other” is a 2-way street
Slomka et al. JGIM 2007

15. Compromises understanding
 Conceptually problematic- Improve the consent
process before removing something people want.
 Not supported by data

16. Payment and understanding
When told payment based on risk, perceived risk increases
Cryder CE, London AJ, Volpp KG, and Loewenstein G. Soc Sci Med 2010.

17. Distributive Justice
 Concern= Disproportionate research burden borne
by disadvantaged individuals
 Not clear why this matters differently in research
compared to other areas of work
 Enrollment = valuable opportunity & communal good
 All solutions generate other concerns
 Very low payment- increases problem, risks exploitation.
 Prohibit enrollment- inappropriately paternalistic

18. Concealment and fabrication
 Multiple ways this might happen
 Simultaneous enrollment, concealment to gain entry,
over/under reporting events or outcomes.
 Biggest concern with patient-reported data without
biomarkers or methods of verification
 Two concerns, different wrongs:
 Scientific integrity- big deal if true but a practical
consideration
 Subject safety- whose responsibility?
 Big question how often this occurs

19. Lying or concealing data
Devine et al. Clin Trials. 2013

20. Any residual concerns?
 Risks are not the same to all people.
Risk tolerance lies on a spectrum
As studies get riskier (and payment goes up),
more likely to induce people to take risks that
really push their boundaries.
 Non-risk factors- participation may impact
values or important preferences.
 Jehovah’s witness asked to participate in a
highly paid blood product study.

21. Potential Failure of Respect
 Not about consent
 More to respect than simply honoring
decisions made by capacitated adults.
 Concern = institutionalizing practices that
don’t consider variations in acceptability of
risk or properly regard values and
preferences.
 Practically meaningful only at the upper limits
of approvable risk

22. Summary
 Payment for research is not fundamentally different
than in other contexts
 Rare considerations related to respect that may be more
salient in research but are not truly unique
 The ways it ought to be treated differently are
primarily practical
 Concerns about concealment and fabrication have real
potential scientific implications
 Reasons to believe that research is not well understood
 Highly heterogeneous form of “work”