Guidance

OHRP has published a variety of guidance documents to assist the research community in conducting ethical research that is in compliance with the HHS regulations. On this page, OHRP guidance documents are organized in categories that should be intuitive for members of the research community. In addition, all guidance documents can be accessed through an alphabetical list.

OHRP Guidance on COVID-19

Access guidance for the application of the 45 CFR 46 regulations to actions taken in response to the COVID-19 pandemic

OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals

Access guidance on elimination of IRB review of grant applications and protocols

OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements

Options for How New Sites Added to Ongoing Cooperative Research Can Follow the Same Version of the Common Rule.

Frequently Asked Questions (FAQs)

Access FAQs about human research protections and OHRP’s answers

Informed Consent

Find OHRP guidance on informed consent

For Investigators

Find guidance documents for investigators

Institutional Issues

Find guidance on institutional issues

Vulnerable Populations

Find guidance on human subjects research with vulnerable populations

Protocol Review

Find guidance on the protocol review process

Biological Materials and Data

Find guidance on research with biological materials and data

Correspondence

Find correspondence with IRBs, researchers, institutions, or federal agencies that OHRP occasionally posts that may assist in understanding the applicability and interpretation of 45 CFR part 46

Alphabetical List

Access all OHRP guidance materials, listed in alphabetical order

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