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

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.

Scientific misconduct and liability for the acts of others.

We argue that two ambiguities in [U.S.] Public Health Service ("PHS") misconduct regulations make them so vague that they are unconstitutional and unfair: (1) they provide no guidance concerning when one can be held responsible for others' actions; and (2) they simultaneously are intended to allow misconduct findings only when there are "significant departure[s] from established practices of the relevant research community" but even if one complied with customary standards of practice in her research community, thus providing confusion rather than guidance. The effect of these ambiguities is not only to leave researchers without notice as to proscribed or prescribed conduct but also to give officials discretion to apply the regulations arbitrarily and discriminatorily. The regulations' effect is illustrated by applying them, hypothetically, to facts relating to the central charge in the misconduct case pressed by the University of Arizona in 1997 through 2003 against then Arizona Regents' Professor Marguerite Kay.

What is scientific misconduct, who has to (dis)prove it, and to what level of certainty?

This article traces the regulation of [U.S.] Public Health Service ("PHS")-funded research from changes begun with the proposal (1999) and then adoption (2000) of a basic, Uniform Federal ("research misconduct") Policy. It argues that the PHS misconduct regulations deny due process of law and are fundamentally unfair because they fail to specify the level of culpability for guilt, force accused researchers to prove that they are innocent, and, although admittedly quasi-criminal, adopt a standard of proof that tolerates nearly a 50 percent probability of false convictions. The regulations' infirmities will be demonstrated by applying them to facts relating to the central charge in the misconduct case pressed by the University of Arizona in 1997 through 2003 against then Arizona Regents' Professor Marguerite Kay, which facts are set forth in our companion piece in this theme issue.