Direct and enhanced disclosure of researcher financial conflicts of interest: the role of trust.

Abstract

In earlier writing, I recommended direct disclosure of major researcher financial conflicts of interest in per capita funding arrangements--the practice of providing researchers with a fixed sum for each subject recruited and enrolled in a study. This Article adds a recommendation for enhanced direct disclosure. The enhancement in the disclosure is a summary of why per capita and excess payments are being discussed and further includes whether the sponsors of the research and the researchers have claimed that there are no excess payments. The reason per capita payments are being discussed is because of the risk--with special caution when sponsors and researchers are not willing to claim that there are no excess payments--of introducing bias into researchers' decisions regarding study design, implementation, and interpretation, as well as concerning whom to enroll or keep in studies. Researchers' claims that there are no excess payments do not vitiate the risk of such payments. Nevertheless, a special admonition when sponsors and researchers do not claim the absence of excess payments would hopefully encourage them to eschew excess payments. My recommendations are required by the rights to bodily integrity and autonomy embedded in informed consent. Several arguments have been made against my recommendations, many of which relate to supposed effects on trust. My rights-based recommendations should not be rejected because of objections based on propositions that (1) are conceptually unclear because of a failure to unbundle different kinds and degrees of trust and (2) have not been empirically proven even where concepts are clarified. In some instances, the required strong empirical confirmation cannot be made because of practical or ethical restraints, including the fact that some of the necessary studies would require invasion of the right to informed consent. Finally, I suggest and partially apply an organizational method to generate empirical questions and guidance for future research in this area. Even the few hypothetical scenarios addressed demonstrate how complex--and sometimes practically or ethically impossible--the empirical studies must be to adduce proofs sufficient to overcome the imperative of informed consent.