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Frequently Asked Questions About Human Research

These FAQs provide guidance that represents OHRP's current thinking on these topics and should be viewed as recommendations, unless specific regulatory requirements are cited. The use of the word "must" in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word "should" in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777.

Categories:

45 CFR 46 (the Human Research Regulations) FAQs (PDF - 38 KB)

Assurance Process FAQs (PDF - 68 KB)

Children: Research with Children FAQs (PDF - 69 KB)

Exempt Research Determination FAQs (PDF - 26 KB)

Informed Consent FAQs (PDF - 135 KB)

Investigator Responsibilities FAQs (PDF - 44 KB)

IRB Registration Process FAQs (PDF - 34 KB)

Prisoner Research FAQs (PDF - 64 KB)

Quality Improvement Activities FAQs (PDF - 37 KB)

Commonly Used Abbreviations

CFR — Code of Federal Regulations
FDA — Food and Drug Administration
FWA — Federalwide Assurance
HHS — Department of Health and Human Services
IEC — Independent Ethics Committee
IRB — Institutional Review Board
OHRP — Office for Human Research Protections


Search OHRP FAQs by questions or key words:

Feedback for OHRP FAQs can be sent to: ohrp@hhs.gov