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

Disclosures

I get paid to do research…

Research funding NIH PCORI Greenwall Foundation

No industry relationships to disclose

What is the worry?

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

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

People do treat it differently

Largent et al. IRB. 2012

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

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

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.

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)

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

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

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

Commodification

Payment for physical risk

Not paying for labor or talent

Treats “bodies” as fungible

Hardly unique

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

Compromises understanding

Conceptually problematic- Improve the consent process before removing something people want.

Not supported by data

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.

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

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

Lying or concealing data

Devine et al. Clin Trials. 2013

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.

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

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”