Legislative Process Framework : NIH Requirements for Use of Human Subjects
NIH clinical studies are subject to HHS requirements for use of human subjects, including the informed consent regulations. In addition, NIH-funded research must observe NIH regulations formulated to fulfill the mandate of the NIH Revitalization Act of 1993.
"It is the policy of NIH that women and members of minority groups … must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification establishes…that inclusion is inappropriate with respect to the health of the subjects or the purposes of the research…"11
Visit the Office of Research on Women's HealthWeb site on Inclusion of Women at http://orwh.od.nih.gov/inclusion.html
The NIH stance on the inclusion of women and minorities as human subjects in clinical research progressed from one in the 1980s, of encouraging inclusion, to one taken in 1994, requiring inclusion. An overview of the historical documents that reflect this development can be accessed at http://orwh.od.nih.gov/inclusion/inclpolicy.html.
This section of the lesson highlights the current NIH requirements on inclusion of women and minorities.
1993 NIH Revitalization Act: Requires, by law, strengthening of inclusion guidelines.
1994 NIH Revised Guidelines: Specifically addresses the inclusion of women and minorities in clinical research.
2000: Strengthens guidelines related to sex/gender analyses and publication of results.
2000-2003: Increases attention to training, a new system for data collection, data analyses, and compliance.
