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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
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eProst User Guide
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Western IRB (WIRB)
About the HSRO


Basic Folder Information

Women and Minorities in Research


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

February 8, 2005



Women and Minorities in Research

As stated in its guidelines, the NIH Outreach Notebook of the Inclusion of Women and Minorities in Biomedical and Behavioral Research (1994), the NIH has concluded that the inclusion of women in research is sufficiently important that the only justifiable reason to exclude non-pregnant women of child-bearing potential from research is a compelling rationale that the proposed project would be inappropriate with respect to the health of the subject or the purpose of the research.

The policy statement referenced above pertains primarily to the inclusion of women as subjects in clinical trials. However, investigators should also aspire to the inclusion of women in behavioral and other forms of research unless there is a compelling rationale that the inclusion is inappropriate regarding the health of the subject or the purpose of the research.

In addition to requiring the equitable selection of women as research subjects, federal regulations require the equitable selection of minorities as research subjects [45 CFR 46. 111(a)(3)]. The equitable selection of minorities in research is important both to ensure that they receive an equal share of the benefits of research and to ensure that they do not bear a disproportionate burden of the risks.



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