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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.

Frequently Asked Questions (FAQs)

Frequently Asked Questions (FAQs)

Access FAQs about human research protections and OHRP’s answers

Informed Consent

Informed Consent

Find OHRP guidance on informed consent

For Investigators

For Investigators

Find guidance documents for investigators

Institutional Issues

Institutional Issues

Find guidance on institutional issues

Vulnerable Populations

Vulnerable Populations

Find guidance on human subjects research with vulnerable populations

Protocol Review

Protocol Review

Find guidance on the protocol review process

Biological Materials and Data tile

Biological Materials and Data

Find guidance on research with biological materials and data

Correspondence

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

Alphabetical List

Access all OHRP guidance materials, listed in alphabetical order
Content created by Office for Human Research Protections (OHRP)
Content last reviewed on February 16, 2016