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Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

NIH ACD Discusses PSW Recommendations, Clinical Trials, Among Other Items

December 19, 2014—The National Institutes of Health (NIH)’s Advisory Committee to the Director (ACD) met Dec. 11-12 to discuss the implementation of the Physician Scientist Working Group (PSW) recommendations, clinical trials, and data sharing, among other items.

The PSW implementation plan of recommendations, first proposed in June 2014, were presented by Deputy Director of the Office of Extramural Research Sally Rockey, Ph.D., and Director of the Office of Extramural Programs Sherry Mills, M.D., M.P.H. [see Washington Highlights, June 13]. Dr. Mills grouped the PSW implementation recommendations into three main categories: collecting more data on and tracking physician scientists, strengthening support for physician scientists’ training and career development, and enhancing diversity among physician and other clinician scientists.

Dr. Mills reported that NIH received more than 200 responses, including from the AAMC, to the NIH’s request for information on enhancing career development for physician scientists [see Washington Highlights, Nov. 7]. Many responses stressed the need for a bridge between career development and receipt of an R01. 

Based on the community’s input, NIH is considering enhancing and providing additional support of K08 and K23 awards to be more optimal than pursuing a modified type of K99/R00 mechanism, which integrates career development with a research project grant. Such modifications may include an increase to the current salary cap on K08/K23 to $120,000 and provide unspecified bridge support to research projects. 

The NIH is also reviewing innovative ways to integrate research training into residency. Dr. Mills noted consideration to expand loan repayment programs (LRP) authorized by Congress, and to establish a sixth LRP for veterinarian scientists.

Other PSW recommendations include: linking the American Board of Medical Specialties (ABMS) and NIH databases to examine the physician scientist workforce; capturing investigators’ information and career trajectories in newly developed Biomedical Workforce (BMW) Dashboard; and, in coordination with NIH Chief Officer for Scientific Workforce Diversity, establish a national network of mentors to support unique needs of underrepresented physician-scientists.

NIH Deputy Director Kathy Hudson, Ph.D., discussed clinical trials and data sharing, and reviewed the recent draft policy to require the use of a single Institutional Review Board (IRB) for all multi-site clinical trials, stating that this would reduce costs and review time and increase consistency [see Washington Highlights, Dec. 5].

In order to collect evidence to inform its policies, NIH has awarded multiple bioethics grants to the community to study single IRBs, as well as other areas of interest, such as standard of care research. Dr. Hudson also noted the Notice of Proposed Rulemaking (NPRM) from the Department of Health and Human Services (HHS) on clinicaltrials.gov, and said this would be considered in tandem with the draft policy released by NIH to expand the scope of clinical trials registration and reporting [see Washington Highlights, Nov. 21].

Philip Pizzo, M.D., professor and former dean of Stanford University School of Medicine, led a discussion on the NIH’s assessment of the feasibility for proceeding with the National Children’s Study (NCS). The review committee concluded that while the goals and intent of the study should be a priority for future scientific support, the NCS as currently outlined is not feasible. The panel passed a motion, which NIH Director Francis Collins, M.D., Ph.D., accepted, to dismantle the current pilot study, which has been collecting data since 2009, and suspend plans for the main study which was to begin in 2015.

Finally, the ACD discussed initiatives of broad concern to scientists, including unconscious bias in peer review and rigor/transparency in research. These are ongoing priorities at the NIH to ensure that research funding is distributed equitably and that the community derives the broadest possible benefit and use from research investment.

Contact:

Irena Tartakovsky, M.D.
Director, Constituent Engagement
Telephone: 202-862-6134
Email: itartakovsky@aamc.org

Anurupa Dev, Ph.D.
Senior Science Policy Analyst
Telephone: 202-862-6048
Email: adev@aamc.org

Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488
Email: sheinig@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org