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
