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Advisory Panel on Research

May 21, 2008
Fairmont Washington Hotel

Agenda

8:30 a.m. - Introductions and Welcome

Larry J. Shapiro, M.D. - APR Chair
David Korn, M.D. - AAMC Chief Scientific Officer, Biomedical and Health Sciences Research

8:35 a.m. - Legislative and Regulatory Report (PDF, 42 pages)

David Moore - AAMC Sr. Associate Vice President, Office of Government Relations

9 a.m. - Conflicts of Interest in Research and Medical Education: Implementing the Recommendations of the AAMC-AAU Advisory Committee (PDF, 37 pages)

David Korn, M.D.
Susan Ehringhaus, J.D. - AAMC Associate General Counsel for Regulatory Affairs

The AAMC-AAU report released Feb. 28 calls on all medical schools and major research universities to develop and implement institutional financial conflict of interest (COI) policies in clinical research within the next two years, and to refine standards for addressing individual COIs. Further, the AAMC's Task Force on Conflicts of Interest in Medical Education released its final report on April 28. Dr. Korn and Ms. Ehringhaus will briefly present on the deliberations and the major recommendations of the two separate bodies. The APR is asked in particular to advise AAMC on next steps to promote and implement the recommendations relating to management of COI in Clinical Research. APR member Robert Rich, M.D., was co-chair of the AAMC-AAU advisory committee, and has been asked to open the panel's discussion of this topic.

11 a.m. - AAMC Initiatives for Translating Validated Research Findings into Medical Practice (PDF, 49 pages)

David Davis, M.D. - AAMC Vice President, Continuing Health Care Education and Improvement

The Panel last examined the topic of research on the "second translational block" in Oct. 2006 in the context of the CTSA awards. Dr. Davis will present on other aspects of this research involving dissemination of knowledge and the role of physicians as life-long learners. Dr. Davis will review the wide scope of new initiatives within AAMC for use of continuing medical education and other mechanisms to overcome the T2 Translational block.

12 p.m. - Working Lunch

12:15 p.m. - Clinical Trials Registration (PDF, 40 pages)

Deborah A. Zarin, M.D. - NIH National Library of Medicine

Dr. Zarin, who presented to the panel in October, has been asked to provide a progress report on the enhanced clinical trials registration program and on the array of decisions that the NLM has made in interpreting the FDAAA that will lead to a forthcoming request for comment in the Federal Register. Many decisions have focused on information required in reporting results from clinical trials. [NB: the "open access" requirements is also an issue at NLM that the panel will be interested in revisiting.]

1:15 p.m. - Static Funding Environment

Dr. David Korn

The session will report on steps AAMC has taken following two previous APR meetings on institutional and community response to persisting flat NIH budgets and eroding purchasing power of the Federal component for financing biomedical research. Dr. Korn and staff will report on a recent presentation to the Clinical Research Forum on recommendations following from the APR, and a session of the recent GRAND (Research Deans) meeting on institutional collaboration and on our recent recommendations on the CTSA program.

2 p.m. - Concluding Discussions, Next Steps, and Future Topics

2:30 p.m. - Adjourn


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