As I have discussed before in this space (January and May 2008 Nexus issues), ensuring that research is conducted objectively and without bias is of paramount importance to maintaining the public’s trust in our activities. This necessitates an ongoing and robust collaboration with you the investigators and your institutions. In February 2008, I appointed a task force to conduct a comprehensive review of the regulations governing extramural Financial Conflicts of Interest (FCOI) and the policies and procedures that have been put in place to comply with those regulations, both at the NIH and in the wider community. As a result of the task force’s activities, we have identified and are reviewing several areas for oversight enhancement. These include consistency of Institutional FCOI policies with the regulation; full implementation of those policies by the Institutions; reporting of all identified FCOIs to the NIH; complete disclosure of relevant financial interests by Investigators to their Institutions; and development of additional guidance and training for NIH staff on how to handle Institutional reports of FCOI.
We are instituting a variety of measures to address these issues quickly and carefully. First, we are embarking on an enhanced outreach and education campaign to raise the awareness of the importance of proper identification and management of FCOI in the extramural community. We have posted an expanded FAQ document about the relevant regulations on the OER Web site (http://grants.nih.gov/grants/policy/coifaq.htm) and will soon publish a Web-based Tutorial that will thoroughly review the roles and responsibilities of the NIH, the awardee Institutions and the Investigators. I encourage you to consult regularly these resources and additional information on the OER Conflict of Interest Web site (http://grants.nih.gov/grants/policy/coi/index.htm) and to contact FCOICompliance@mail.nih.gov with any questions. Second, to improve our ability to monitor FCOI reports, we have developed a Web-based reporting and tracking tool that provides a central place for collection of all FCOI reports received across the NIH. This tool has been in use by NIH staff since March and will be rolled out to the extramural community later in the year. Third, we are developing detailed internal procedures and training modules to ensure that all NIH staff is able provide appropriate oversight of FCOI issues. Finally, we are considering gathering public comment on whether to modify the FCOI regulation (42 CFR Part 50, Subpart F).
As we develop these measures, I will continue to update you about our progress on these activities.
— Norka Ruiz Bravo, Ph.D.
OER Director and NIH Deputy Director for Extramural Research
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