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Human Subjects Division (HSD)

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Federal Regulations

A number of federal regulations govern the conduct and oversight of human subjects research at the UW Human Subjects Division. "These federal regulations point out issues to which IRBs should pay attention and presents, wherever possible, areas where ethicists and others concerned with these issues have arrived at a consensus on the ethical acceptability of a particular activity or method." - Penslar, R.L. & Porter, J.P. Office of Human Research Protections IRB Guidebook.

Primary amongst these regulations are:

  • 45 CFR 46: Federal Policy, Department of Health & Human Services (DHHS)

The Federal Policy or "Common Rule," as it is sometimes called, is designed to make uniform the human subjects protection system in all relevant federal agencies and departments.

- Subpart A - Basic HHS Policy for Protection of Human Research Subjects
- Subpart B - Pregnant Women, Human Fetuses and Neonates Involved in Research
- Subpart C - Biomedical and Behavioral Research Involving Prisoners as Subjects
- Subpart D - Children Involved as Subjects in Research

  • 21 CFR 50 & 56: Food & Drug Administration

Additional FDA regulations that are relevant to IRB review of research are:

- Part 312 - Investigational New Drug Application
- Part 812 - Investigational Device Exemptions
- Part 860 - Medical Device Classification Procedures

  • Health Insurance Portability & Accountability Act (HIPAA)
  • Environmental Protection Agency
  • Occupational Safety & Health Administration