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Human Research Protection Program

 

 

 

 

 

 

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Office Hours:
Monday - Friday
8am - 5pm

 

Mailing Address:
Michigan State University

207 Olds Hall
East Lansing, MI 48824

Phone: (517) 355-2180
Fax: (517) 432-4503
Email: irb@msu.edu

 

Office Location:
207 Olds Hall.
Olds Hall is located between the Administration Building and MSU Main Library. Campus Map

 

Federal Regulations

 

Please click on the links below to view various Federal Regulations documents and other related information

 

Department of Health and Human Services (DHHS)

Food and Drug Administration (FDA)

Other Federal Departments and Agencies

Health Insurance Portability and Accountability Act (HIPAA)

Federal Register

 

 

Department of Health and Human Services (DHHS)

  • 45 CFR 46 - DHHS regulations on the protection of human subjects. Subpart A of the HHS regulations incorporates the Federal Policy for the Protection of Human Subjects.

Food and Drug Administration (FDA)

  • 21 CFR 50 - FDA regulations on the protection of human subjects.
  • 21 CFR 56 - FDA regulations on institutional review boards.
  • 21 CFR 312 – FDA regulations on investigational new drug application.
  • 21 CFR 812 – FDA regulations on investigational device exemptions.

Other Federal Departments/Agencies that have codified the Federal Policy for Protection of Human Subjects

  • 7 CFR 1c: Department of Agriculture (Subpart A)
  • 10 CFR 745: Department of Energy (Subpart A)
  • 14 CFR 1230: National Aeronautics and Space Administration (Subpart A)
  • 15 CFR 27: Department of Commerce (Subpart A)
  • 16 CFR 1028: Consumer Product Safety Commission (Subpart A)
  • 22 CFR 225: International Development Cooperation Agency, Agency for International Development (Subpart A)
  • 24 CFR 60: Department of Housing and Urban Development (Subpart A)
  • 28 CFR 46: Department of Justice (Subpart A)
  • 32 CFR 219: Department of Defense (Subpart A)
  • 34 CFR 97: Department of Education (Subpart A, D)
  • 38 CFR 16: Department of Veterans Affairs (Subpart A)
  • 40 CFR 26: Environmental Protection Agency (Subpart A – Q)
  • 45 CFR 690: National Science Foundation (Subpart A)
  • 49 CFR 11: Department of Transportation (Subpart A)

Health Insurance Portability and Accountability Act (HIPAA)

Federal Register proposed, interim or final regulations not yet published in the Code of Federal Regulations

  • 71 FR 32827 – Interim Final Rule. FDA Medical Devices; Exception from General Requirements for Informed Consent (21 CFR 50.23(e)). Published June 7, 2006.
  • 71 FR 6137 – Final Rule. Environmental Protection Agency Protections for Subjects in Human Research (40 CFR 9, 26). Published February 6, 2006.

 

 

Quick Links

 

Biomedical and Health Institutional Review Board (BIRB)

 

Community Research Institutional Review Board (CRIRB)

 

Social Science/Behavioral/Education Institutional Review Board (SIRB)

 

MSU Privacy Board