Direct and Enhanced Disclosure of Researcher Financial Conflicts of Interest: The Role of Trust
Roy G. Spece Jr.
University of Arizona - James E. Rogers College of Law
May 1, 2012
Health Matrix, (2013 Forthcoming)
Arizona Legal Studies Discussion Paper No. 12-21
In earlier writing I recommended direct disclosure of a major researcher financial conflict of interest, per capita funding — i.e., providing a fixed sum per subject recruited and enrolled in a study. In this article I add a recommendation for enhanced direct disclosure, i.e., the disclosure must explain that per capita payments risk introducing bias into researchers’ decisions regarding study design, implementation, and interpretation as well as concerning whom to enroll or keep in studies. The core justification of my recommendations is a nonconsequentialist moral framework concerning each subject’s — indeed, all persons’ — presumptive individual rights. But, being a moral pluralist of sorts, I believe that consequences are morally material. I agree that strong empirical proof demonstrating the high likelihood of significant harm and little good resulting from enhanced direct disclosure might overcome a presumption in favor of subjects’ individual rights. I identify several arguments that have been made against my recommendations, many of them based on supposed effects on subjects’ trust. I address these trust-based objections and show that the current studies do not supply the proof necessary to overcome the moral imperative of informed consent. The current studies: (a) are conceptually unclear because of a failure to unbundle different kinds and degrees of trust; and (b) do not have sufficient power even where concepts are clarified. In some instances, empirical confirmation cannot be made because of practical or ethical restraints. These restraints include 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. Even the few hypothetical scenarios addressed demonstrate how complex — and sometimes practically or ethically impossible — would be the empirical studies necessary to adduce proofs sufficient to overcome the imperative of informed consent.
Number of Pages in PDF File: 14
Keywords: clinical research, financial conflicts of interest, disclosure, per capita payments, trust, ethics, informed consent, right to bodily integrity, autonomy in decision making
Date posted: June 20, 2012 ; Last revised: February 24, 2014