Motives and protection

Motives and protection

R. Douglas Bruce

This case discussion revolves around a Phase I pharmacokinetic study designed to examine the effects of Kaletra, a medication for the treatment of HIV, upon the pharmacokinetic disposition of buprenorphine, a treatment for heroin dependence.  As a Phase I study, this study offers no benefit to the subjects enrolled, but will provide important information to medical providers who treat heroin dependent patients receiving buprenorphine therapy and Kaletra.

Several issues were raised in the IRB discussion of this protocol regarding the remuneration to subjects.  One question was, “Is it ethical to remunerate substance abusers with a large, lump sum payment for participation in research?”  The better question is, “What is reasonable compensation for the work received?”  The subjects in this study must go daily to the hospital unit to receive their treatment and must spend a total of 4 nights in the hospital.  In other words, the subjects expend a lot of time and effort for the completion of the study.  As such, the remuneration of $1000 was deemed reasonable given the effort involved.  The general concern with such remuneration was the following: “Does the size of the remuneration create sufficient incentive for someone to participate in the study solely for financial gain?  Does this financial incentive have a negative impact on the ability to obtain proper informed consent?”  The inner motivations of a person are always difficult to know and it is certainly possible that an individual’s entire motivation to participate may be financial gain.  A general desire for the betterment of humanity, however, is not required to consent to a protocol and to participate in research.  The proper question, then, is the latter: Does such financial motivation compromise consent?  Again, we are trying to delve into the heart of the individual and ascertain motives.  There is no actual assessment that would insure “proper” consent, so we must address the true concern regarding financial compensation: will the provided finances result in ongoing drug use or a relapse to drug use?  The investigators in the protocol take great pains to insure that the patient entering into the study is drug free and stable in treatment.  Those individuals engaging in ongoing drug use are excluded entirely from participation.  Those with a history of sobriety are less at risk of relapse once remunerated for the study.  Of course, the question of autonomy is raised.  Doesn’t the drug user have a right to use any wages as s/he sees fit?  What if a study participant in another study – a study about sexual risk for example – utilizes the study payments to purchase sex?  What is to stop any individual who participates in research from using that money to purchase tobacco, alcohol, or other drugs that result in harm to self or others?  Are the investigator and the IRB responsible for the actions of an individual?

Several individuals wish to challenge the timing of the payments.  Specifically, they ask, “Is it acceptable to delay full payment for study participation until the subject completes all study interventions?  When does the timing or the size of the remuneration become coercive?”  One critical reason to defer payment is that the observation of the subject over the course of the study, with the routine urine toxicology screens and examinations of ongoing behavior, are crucial to ascertaining safety.  If a subject were to exhibit aberrant behavior or, in the midst of the study produce a urine toxicology demonstrating a relapse to drug use (which has happened), that subject would be discharged from the study.  In such an instance, payment would likely result in greater harm given the possibility that the subject would use that money on drugs.  A second reason to consider delay of payment is that often the worker receives his/her wages upon completion of the work.  While in some studies, any participation can produce useful information, in this study, for the information to be useful, the subject must complete the entire protocol.  Otherwise, the information is not meaningful and is discarded.  So on the part of the investigator, there is a serious desire for the subjects to complete all of the pieces of the study prior to being paid. The obvious concern is that many individuals would leave after a partial payment, and, as a consequence, the study may not be able to afford partially paying multiple subjects who produce no meaningful data.   Finally, the remuneration schedule is clearly discussed with subjects prior to consent.  In fact, all of that information is also contained in the informed consent.  A subject who believes the remuneration schedule is not to his/her liking is free not to participate in the study.

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