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Office for Human Research Protections (OHRP)

Policy Guidance [by topics]

Guidance Topics

Archive of Guidance Documents No Longer In Effect

OHRP welcomes comments on any of its policy guidances. Comments may be submitted to OHRP by email at: (please insert the title of the specific guidance document in the subject field), or by mail to:

Division of Policy and Assurances
Office for Human Research Protections
1101 Wootton Parkway
Suite 200
Rockville, MD 20852

All relevant comments will be considered in OHRP decisions on timing and content of revisions to guidance documents, or development of new guidance documents. Comments generally will not result in direct responses from OHRP.

OHRP Correspondence

Related Resources

Guidance Topics

407 Review Process

Adverse Events (see also Unanticipated Problems)


Assurance FAQs

Biological Specimens (see also Coded Private Information)


Certificate of Confidentiality

Clinical Trial Websites (see also IRBs)

Coded Private Information (see also Biological Specimens)

Common Rule

Compliance Oversight

  • Compliance Oversight Procedures [PDF | HTML]

Conflict of Interest

Consent - See Informed Consent

Continuing Review [PDF - 52KB]

Databases and Data Storage

Decision Charts

Emergency Research

Engagement in Research

Exculpatory Language

Exempt Research/Exemptions

Expedited Review

Fetal Tissue

Frequently Asked Questions

  • OHRP Frequently Asked Questions
    (Links to sets of FAQs for use on-line.
    Sets of all questions by category are available in pdf format for printing from this page.)
    Topics addressed include:
    • Assurances [PDF - 119KB]
    • IRB Registration Process [PDF - 73KB]
    • 45 CFR 46 [PDF - 67KB]
    • Research with Children [PDF - 125KB]
    • Investigator Responsibilities [PDF - 76KB]
    • Prisoner Research [PDF - 118KB]
    • Informed Consent [PDF - 253KB]


HHS Funding Support


Human Subjects

Incident Reporting

Individual Investigator Agreement

Informed Consent

Informed Consent FAQ's

Investigator Responsibilities FAQs

In Vitro Medical Devices

IRB (Institutional Review Board )

IRB Registration FAQs

Multicenter Clinical Trials

Pharmaceutical Companies


Quality Improvement Activities

Repositories (see also Tissue Storage/Repositories)


Stem Cells

Tissue Storage/Repositories

Unanticipated Problems (see also Adverse Events)

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Last revised: December 29, 2008


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