NIH Policy and Guidelines

The NIH Amended 2001 Policy incorporate for points on: 1. Definition of clinical research 2. Definition of racial and ethnic categories based on the NIH Office of Management and Budget (OMB) 3. Clarifying language on NIH-defined Phase III clinical trials 4. Clarifying language on roles and responsibilities of NIH staff and the extramural community

"The NIH is mandated by law (Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2) to ensure the inclusion of women and minority groups in clinical research. The goal is to ensure that individuals are included in clinical research in a manner that is appropriate to the scientific question under study." It includes:

• Updated News
• Policy Documents, Contacts, and Forms
• NIH Forms and Applications
• Narrated slide deck
• New FAQs on Reporting Race and Ethnicity to the NIH
• Updated FAQs on Inclusion on the Basis of Sex/Gender, Race, and Ethnicity

Megan Columbus from NIH's Office of Extramural Research with Dr. Meredith Temple-O'Connor talk about how grant applicants should be reporting race and ethnicity to the NIH in their clinical research grants. Recorded on July 13th, 2013.

Megan Columbus, NIH Office of Extramural Research talks about requirements for inclusion of women, minority individuals and children in clinical research with Dr. Della Hann from the NIH Office of Extramural Research. Recorded on April 11th, 2011.

Interview with Dr. John Ruffin, Director of the NIH National Institute on Minority Health and Health Disparities (NIMHD) - Conducted December 28, 2012.  The following clips explore the multifaceted nature of racial-ethnic minority involvement in clinical trial research.

• Clip 1: Researchers and Recruitment of Minorities
• Clip 2: Inclusion and Heterogeneity of Ethnic Populations
• Clip 3: Reasons Why Minorities Don’t Want to Participate in Research Studies
• Clip 4: Community-Based Research
• Clip 5: The Importance of Community Involvement

Guidelines for the Review of Inclusion on the Basis of Sex/Gender, Race, Ethnicity, and Age in Clinical Research