Decatur Memorial Hospiotal

Institutional Review Board

Resources for Human Subject Protection

Regulations:

45 CFR 46 (Common Rule):
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

21 CFR 50 (FDA Informed Consent Regulations):
http://www.fda.gov/oc/gcp/default.htm

21 CFR 56 (FDA IRB Regulations):
http://www.fda.gov/oc/gcp/default.htm

Comparison of FDA and HHS Human Subject Protection Regulations:
http://www.fda.gov/oc/gcp/comparison.html

U.S. Food and Drug Administration:
www.fda.gov

Office for Human Research Protections (OHRP):
http://www.hhs.gov/ohrp/


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