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OHRP Guidance Documents

Policy & Guidance Index


Policy and Guidance documents are listed alphabetically in the linked chart.  (Click on the Policy & Guidance Index title to see the chart.)  The columns to the right of the document titles indicate the topic categories in which the documents are grouped.

Please note that all documents in the Policy and Guidance section of the OHRP website reflect current regulatory guidance and findings, including older materials published by OHRP's predecessor organization, the Office for Protection from Research Risks (OPRR).

Informed Consent


Institutional Issues


For Investigators


Vulnerable Populations


Protocol Review


Biological Materials & Data


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.


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

Assurance Process FAQs [PDF 68KB]

Children: Research with Children FAQs [PDF 69KB]

Exempt Research Determination FAQs [PDF 26KB]

Informed Consent FAQs [PDF 135KB]

Investigator Responsibilities FAQs [PDF 44KB]

IRB Registration Process FAQs [PDF 34KB]

Prisoner Research FAQs [PDF 64KB]

Quality Improvement Activities FAQs [PDF 37KB]


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