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Policies & Guidance
- U-M Operations Manual
- U-M Human Research SPG (pdf)
- Authorization Agreements
- Certificates of Confidentiality
- When is IRB Oversight Necessary? (pdf)
- Activities Subject to the HRPP (Operations Manual, Part 4)
- Determining Regulated vs. Not Regulated Human Research (Operations Manual, Part 4, pp. 4-6)
- Class Activities
- Research Using Publicly Available Data Sets
- IRBMED Guidance Page
- IRB-HSBS Guidance Page
- International Human Subjects Research Resources
- Tools & Tips for Protecting Your Computer and Data
- Department of Defense FWA Addendum (pdf)
- U-M HRPP Guide to Department of Defense Research (pdf)
- Investigator Guide to Department of Defense Research (pdf)
- Guidance for IRB Staff
Ethical Guidance
- Belmont Report
- Declaration of Helsinki
- International Ethical Guidelines for Biomedical Research Involving Human Subjects, Council for International Organizations of Medical Sciences (CIOMS), 2002 (pdf)
Regulations
U.S. Department of Health and Human Services
- Basic HHS Regulation on Protection of Human Subjects -- 45 CRF part 46
- Federal Register Notice -- Waiver of the Applicability of Certain Provisions of 45 CFR 46 for Dept. of Homeland Security Conducted or Supported Epidemiologic Research Involving Prisoners as Subjects (pdf)
- Health Insurance Portability and Accountability Act (HIPAA) Regulations for Standards for Privacy of Individually Identifiable Health Information -- 45 CFR parts 160 and 164 (pdf)
- Subpart F HHS Regulations for Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought -- 42 CFR part 50
Food and Drug Administration
- Regulations for the Protection of Human Subjects -- 21 CFR part 50
- Regulations for Institutional Review Boards -- 21 CFR part 56
- Investigational New Drugs (INDs)
- Is An Investigational New Drug (IND) Application Required? (pdf)
- Bioavailability or Bioequivalence Studies (pdf)
- Investigational Device Exemptions (IDEs)
- UM Electronic Signature Certification (pdf)
- Self-Assessment of eResearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures (pdf)