Paying Research Participants: Ethical and Regulatory Parameters

Session 2

Research Exceptionalism: Is Payment in Research Special?

Alexander M. Capron University Professor

Scott H. Bice Chair in Healthcare Law, Policy and Ethics University of Southern California

FOR: Paying Research Subjects Raises

Unique Ethical Issues

“Unique” Issues Compared to What?

• Is it the status of the subject compared with other people who are paid: workers?

• Is it the relationship of the subject to the enterprise: biomedical research?

• Is it payment in money—rather than in other rewards (e.g., access to innovative intervention; partnership in research)?

Contrasting Foci • Orientation of the Symposium: to explore

relationship of payment and recruitment • Figure out what is “appropriate payment”

– Helping IRBs navigate between “exploitation” and “undue inducement”

– Perhaps even removing concerns about payment from IRB’s tasks

• Not part of “risk/benefit” calculation • Only concern would be transparency of terms

Contrasting Foci • My orientation begins a step back

– The world didn’t get it wrong at Nuremberg – Not limited to Nazis: applies to “normal” research

• Research is different – Researchers are not ordinary employers – Subjects are not ordinary workers

• Special rules are needed (the three pillars): risk/benefit; informed consent; prior review

Premise (Agreeable to all?)

• Analysis should be limited to situations in which A (researcher) conducts research in which B agrees to participate

• Excludes situations of frank coercion, e.g.: – B is forced or threatened with force – A threatens not to meet an obligation A owes

to B, which could result in harm to B

To Deny that Research is Exceptional Means That . . .

• Researchers could set any terms to which subjects would agree, short of fraud – e.g., may impose penalties for “quitting”

• Market sets “fair” payment – Nothing inherently exploitative about benefitting

from subjects’ physical/financial vulnerability – Competitive price = no special advantage taken

of party’s defects in capacity or vulnerabilities (vs background circumstances of health & $)

To Claim that Research is Exceptional Arises From…

1. Identification as basis for legitimacy

2. Social role of research (public good)

3. Professional duties

4. Broader understanding of exploitation

5. Soft paternalism – These factors are interrelated

1. Identification

• Hans Jonas’ argument that research should use investigators as subjects – Not simply to make research more difficult – Not simply to enhance comprehension

• Researchers identify with the goal • Extrapolating: person needing to be paid

to participate, least identified with goal

2. Social Role

• Research produces “public goods” • Benefits shared beyond those who

contributed to their creation – Market & scarcity prevent perfect public good

• Respect for & deference to investigators – Especially true in biomedical research

• Ethical requirements [Belmont]

3. Professional Duties

• In most biomedical research, being a “patient” slides into & out of being a “subject” – Extends into non-biomedical research

• Arise from MD’s duties but also social role • Protective duties (not to harm; to benefit),

duties of respect (autonomy), and relational duties (justice/fairness)

4. Added Types of Exploitation • “Fair benefit” (Wertheimer) – mutually

advantageous agreement, even if one party benefits disproportionately – To overcome, merely set the payment high enough

• “Fair process” – not respect subjects – Violates “fair play” (duty to protect) [R.E. Goodin] – “degrading to have your weaknesses taken

advantage of” [A.W.Wood] • Researchers’ privileged position: use to resist

injustice & not make subjects complicit in it

5. Soft Paternalism

• Institute restrictions on a practice, when substantial number of persons involved will lack truly voluntary & informed consent

• Especially arises when subjects are in dependent relationship with investigator, or where reasons for not consenting are strong (riskiness; burden; unusual aspects of research)

Conclusions

• Have suggested reasons for long tradition (pre- as well as post-Nuremberg) of treating research differently than other contracts

• Thus, appropriate that IRB review critically • Have not proven that research is “unique” • Have not proven that payment raises “unique”

problems in research – Other motivations can be greater & more problematic

Thank You

acapron@law.usc.edu