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IRB Cases: Comment

Large Academic Medical Center

David H. Smith

I’ve always envied theater and music critics who can unleash the arrows of criticism unworried about effects of their rhetoric on authors, performers or directors. For when I am asked to play the role of critic all my insecurities click in, and the Golden Rule stifles invective. Luckily this case commentary doesn’t put me in a cleft stick; it’s a record of a responsible IRB deliberation, coming to a reasonable conclusion. And the players whose actions are recorded are established players, unshakable by a voice from the rear of the hall. I report a contrasting perspective that could have led to a somewhat different conclusion.

I begin with the observation that this protocol is for a procedure that is pure research; there is not a whiff of therapy in it. The subjects are being tested for their reaction to Kaletra, an anti-viral drug for AIDS, when they do not have AIDS. Rationale for choice of these subjects is explicitly discussed in Point 5 of the rationale: Kaletra alone would be an insufficient treatment for potential AIDS+ subjects. I do not challenge that reasoning, only mention that any chance of the subjects medically benefiting from their involvement is remote.

A second striking feature of this protocol is that all payment is to be withheld until the end of the two week period. Insofar as money is an incentive or in any way relevant, the financial benefit is all or nothing. The subject who drops out after ten days gets the same reward as one who withdraws after 48 hours – nothing. The rationale for this is that the statistical significance of the study will be destroyed if subjects don’t stay involved for the full two week period. The researchers can imagine too many people checking out after a week or ten days, collecting their pay, and contributing nothing to the research study. The researchers would have been ripped off.

How powerful is this defense? A really staunch moralist might argue that it’s not too good. For at the end of the day there is no fundamental moral obligation to do this research, while there is a basic duty to respect the personhood of the subjects. If we have to choose between getting knowledge that may be helpful OR being fair to the subjects, being fair must win. Of course the researchers want to do the research, primarily for good reasons, but if the end justifies the means the entire IRB network could be dismantled.

I think a reasonable compromise exists, however. (To some of my colleagues I am insufficiently staunch.) To play fair with the subjects a strategy that correlates investment of time with payment must be found; otherwise their freedom to withdraw is compromised. I suggest prorating payment but deferring any payments until the end of the two week cycle. That increases incentive to stay in the study, but does not over-penalize someone who must withdraw early for whatever reason. Some ripping off will doubtless go on, but if the subjects are competent they will see the advantages of sticking things through to the end. And their right to change their minds is treated more fairly.

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