Protecting subjects, preserving trust, promoting progress I: policy and guidelines for the oversight of individual financial interests in human subjects research.

Abstract

In December 2001, the AAMC Task Force on Financial Conflicts of Interest in Clinical Research released this report, the first of two (both published in this issue of Academic Medicine). This report focuses on gaps in existing federal financial disclosure regulations of individual conflicts of interests, finding that additional scrutiny is recommended in two areas: human subjects research and privately sponsored research. The task force suggests that when potential conflicts exist, a conflicts of interest committee should apply a rebuttable presumption against engaging in human subjects research. The task force recommends that the circumstances giving rise to the presumption against the proposed activity be balanced against compelling circumstances in favor of the conduct of the research. The AAMC task force delineates core principles to guide institutional policy development. First, an institution should regard all significant financial interests in human subjects research as requiring close scrutiny. Second, in the event of compelling circumstances, an individual holding a significant financial interest may be permitted to conduct the research. Whether circumstances are deemed compelling will depend in each case upon the nature of the science, the nature of the interest, how closely the interest is related to the research, and the degree to which the interest may be affected by the research. Four other core principles for development of institutional policies are identified in the report, pertaining to reporting, monitoring, management of conflicts, and accountability.