June 11, 2009
The Association of American Universities (AAU) and the Association of American Medical Colleges (AAMC) have submitted joint comments (link below) to the National Institutes of Health (NIH) on strengthening the regulatory framework governing conflicts of interest in federally funded research.
The letter responds to a May 8 Advance Notice of Proposed Rule Making (ANPRM) issued by NIH on behalf of the Department of Health and Human Services and the Public Health Service.
The comment deadline for the NIH notice is July 7. Institutions are strongly encouraged to submit comments on the ANPRM and to consider using the AAU/AAMC comments in fashioning their responses.
The AAMC/AAU comment letter is consistent with the recommendations contained in the February 2008 AAMC and AAU report, “Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research.”
Here are the key elements of the AAU/AAMC response:
The letter supports requiring covered investigators to report to institutions all of their external financial interests directly or indirectly related to their research responsibilities, regardless of amount. It also supports NIH lowering the threshold to $5,000 for requiring institutions to disclose to the awarding agency related external financial interests of investigators.
The letter indicates that the associations would not be opposed to a zero disclosure threshold, except for the enormous amount of “noise” generated by such a requirement. Receiving and reviewing such a huge volume of information would also have a trivial impact, if any, on research integrity.
The letter also supports requiring institutions to submit information on managed conflicts of interest that goes beyond current regulatory requirements, but it opposes routine disclosure to NIH of full management plans themselves, unless requested by NIH.
The letter also opposes required standards for management plans, in favor of case-by-case evaluation. It opposes ceilings on outside earnings and indicates that institutions are in a far better position to monitor and address such earnings than research agency personnel. AAMC and AAU oppose mandatory accreditation of conflict of interest programs but support efforts by the Association for the Accreditation of Human Research Protection Programs to enhance its standards relating to conflicts of interest with respect to existing regulatory requirements governing research on human subjects.
The comment letter may attract press attention, as may comments filed by individual institutions.
The AAU/AAMC comments on the regulation of financial conflicts of interest are only the latest step in our community’s effort to address public concerns about patient safety and scientific objectivity. Much has been done by our institutions and by NIH to improve the management of these issues, and much more needs to be done.
Your response to the ANPRM—and ongoing institutional efforts on conflict of interest—will enable us to engage constructively in the rulemaking process.