January 25, 2005 PRAC Meeting 1

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2

2005 Biennial Advisory Council Report on Inclusion of Women and

Minorities in Clinical Research

Walter T. Schaffer, Ph.D.Office of Extramural Research, NIH

January 25, 2005

January 25, 2005 PRAC Meeting 3

NIH Policy on Inclusion of Women & Minorities in Clinical Research

Section 131 of the PHS Act (PL 103-43, 42 USC 287) of 1993 directs the NIH to ensure that women and

minorities are included as subjects in clinical research

Directs NIH to prepare guidelines related to the inclusion of women and minorities

Those guidelines (published in 1994 at 59 FR 14508) direct the advisory council for each institute/center to prepare a biennial report on how the institute has complied with this requirement.

January 25, 2005 PRAC Meeting 4

NIH Policy on Inclusion

NIH staff must appropriately train peer reviewers to evaluate the proposed plan for inclusion, and

initial review groups must evaluate the inclusion plan in each application for appropriate representation.

January 25, 2005 PRAC Meeting 5

NIH Policy on Inclusion

We will ask PRAC to asses our adherence to the requirements established by law.

Within the next two weeks we will provide an email package that includes

A description of procedures for training NIH review staff and reviewers about the assessment of inclusion information in grant applications.

Information related to the outcomes of those reviews. If this committee has concerns about NIH adherence to

the statutory requirements, we will include those in the report being prepared for Congress.