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02/23/2018

Reviewing the ethics of paying human research subjects

Sometimes it is both necessary and proper to pay a person to participate in a clinical trial, of a drug or some other medical intervention, or a data-collection study, or something else that involves people.  An article in this week’s New England Journal of Medicine reviews many of the relevant ethical issues.

A link to the article is here.  Correction to initial post:  subscription or purchase does appear required.

Why pay somebody to be in a trial?  The main reasons are to reimburse them for unavoidable expenses, to compensate them for time that would not otherwise be required in the course of standard medical care or normal life, and, indeed, to get them to participate in the first place.  In cancer medicine, where I’ve worked, the subjects are cancer patients who are generally not paid to participate; they usually are willing to do so in the hope of possible benefit, plus, often, a sense of altruism.  But most drugs have their first human testing in healthy volunteers, to begin to identify potential safety concerns and understand how, and how rapidly, the drug is eliminated from the body.  In those cases, the research subjects are almost always paid, sometimes substantially.

Such payments are not necessarily unethical, as long as they are not too big.  If they are, then they could create an undue influence to participate.  That would upset the balance of benefits and risks and compromise true informed consent.  By well-accepted ethical standards for research on human subjects—many of which are codified in regulation—the risks to human subjects must not be excessive, must be avoided or mitigated to the extent reasonably possible and commensurate with the goals of the research, and must not exceed the foreseeable benefits of the research, either to the individual subject or to society overall (e.g., in the form of important medical knowledge), or both.

Payment to a subject is not considered a benefit in and of itself, but should be “neutral” to the benefit/risk assessment.

There’s no hard and fast rule about paying subjects—no single standard “fee schedule,” so to speak.  Rather, each ethics board reviewing a study must also review and approve the amount and timing of payments to subjects.  Again, such payments should be high enough to respect the subject’s contribution to the research, but not too high so as to give them incentive to participate when maybe they should not.  Also, it’s a general principle that payment should be in installments; generally, no more than 10-15% of the total should be held back to the very end of the study.  Why this last point?  Because it’s also a principle that subjects can opt out of a study at any time, but if they think “I have to stay in to the bitter end to get paid,” that could pressure them too much.

Note, BTW, that such pressure is not the same as coercion, which by definition involves a threat, and does not apply to this payment question.

Also, payments must be appropriate so that subjects don’t get a wrong idea about the potential value or efficacy of an experimental drug, or that they might be induced to try to be in more than one study at once.  You might be surprised how significant that last risk is.  In my past IRB work, we just to worry about “professional subjects” who make some level of living by going from one research study to another.  More than one at once means getting two or more drugs at once that probably ought not to be combined, willy-nilly.

And of course, the potential for economic exploitation of low-income individuals must also be considered and respected.

The NEJM article really doesn’t break new ground but is a helpful review for those interested in essential research ethics.  The FDA has also provided guidance, which can be reviewed here.

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