Freedom of Information Act Office
IC Directors' Meeting Highlights
October 26, 2011
| To: | IC Directors |
| Subject: | IC Directors' Meeting Highlights — April 7, 2011 |
Inclusion Task Force Findings and Recommendations: Steve Katz and Sally Rockey
The task force was created in 2009 by the NIH Deputy Director to advise on the most effective ways for NIH to respond to PL 103-42 which related to the inclusion of women and minorities as subjects in clinical research, including Phase 3 clinical trials. In particular, they were tasked to look at NIH’s current policy for including children in clinical research. The NIH Revitalization Act of 1993 (PL 103-43) includes a section entitled Women and Minorities as Subjects in Clinical Research to help reinforce the existing NIH inclusion policy.
The task force undertook a formal review of inclusion both intramurally and extramurally with a focus on how the agency can improve and broaden its understanding of the inclusion policies for women, minorities, and children. Recommendation include the consideration these populations during initial protocol review, tracking each population, and the development of an electronic tracking mechanism to support the monitoring and tracking of these populations.
Under the governance model, a subcommittee of the EAWG is recommended and is charged with monitoring the NIH’s success in meeting the inclusion policies, providing operating procedures and compliance monitoring, and identifying training needs for NIH staff to promote the inclusion policy.
Clinical Center Governing Board Report: Steve Katz
The Clinical Center Governing Board is chaired by Dr. Katz and is comprised of eight Institute and Center Directors charged with making recommendations to the NIH Director on the scope of CC programs and budgetary issues. This board is in response to the SMRB’s objective of maintaining the CC as a state-of-the-art national resource for clinical and translational research.
The CC budget is a part of Central Services and plans are to place the line item in the OD Appropriation beginning in FY 2013. For FY12, there are numerous programs competing for Central Service funding dollars that are just as worthy as the needs of the CC. Funding approaches and their implications are being reviewed.
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