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NIH Policy and Guidelines

NIMICT's Resource Collection

NIH Policy 1993

  • Source: NIH
  • Condition: All
  • Format: Website
NIH Guidelines on then inclusion of women and minorities as subjects in clinical research - NIH GUIDE, Volume 23, Number 11, March 18, 1994.

NIH Amended 2001 Policy

  • Source: NIH
  • Condition: All
  • Format: Website
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

Policy Implementation of Inclusion of Women and Minorities

  • Source: NIH
  • Format: Website
"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:

Interview with Dr. Meredith Temple-O'Connor, NIH Inclusion Policy Officer

  • Source: NIH
  • Condition: All
  • Format: Podcast
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.

Interview with Dr. Della Hann, NIH Office of Extramural Research

  • Source: NIH
  • Condition: All
  • Format: Podcast
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. Ruffin, Director of NIMHD [SERIES]

  • Source: Maryland Center for Health Equity
  • Format: Podcast
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.

NIH Policy Guidelines

  • Source: NIH
  • Condition: All
  • Format: PDF
Guidelines for the Review of Inclusion on the Basis of Sex/Gender, Race, Ethnicity, and Age in Clinical Research 

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

  • Source: NIH
  • Format: Website

Office of Extramural Research (OER) at NIH

  • Source: NIH
  • Format: Website
 Budget and Trial Mechanics