Managing the science in the presence of financial conflict of interest.

We consider the question of why (primarily) and how (secondarily) to perform scientific oversight of research performed by investigators with a financial conflict of interest (COI). One way to frame the trade-off of having investigators with financial COI participate in research is through a decision rule: "Our institution is willing for financially conflicted investigators to participate in research around their intellectual property if (a) the science is likely to be significantly better with their participation (or if other significant benefits accrue); and (b) the COI can be adequately managed". A key component of COI management is the demonstration that the underlying science is sufficiently rigorous and transparent, and in turn, a scientific oversight plan is a key element of that demonstration. Scientific oversight plans should be proactively generated, by individuals (i.e., scientific reviewers) who are independent and expert, and they should assess the rigor and transparency of the research, in a fashion which is fair and efficient. Abbreviations: COI: conflict of interest; SOP: scientific oversight plan.

Duke Scholars

Author Gregory P. Samsa Biostatistics & Bioinformatics, Division of Biostatistics