Office for Human Research Protections (OHRP)

Policy Guidance [by topics]

Guidance Topics

OHRP welcomes comments on any of its policy guidances. Comments may be submitted to OHRP by email at: ohrp@osophs.dhhs.gov (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

• Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") Review Process [PDF - 37.5K]

Adverse Events (see also Unanticipated Problems)

• Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events [PDF - 180KB]

AIDS

• AIDS Research, Guidance for IRBs
• HIV Serostatus, Informing Those Tested, PHS Policy
• HIV Serostatus, Sex-Partner Notification, PHS Policy

Assurance FAQs

• Assurance FAQs

Biological Specimens (see also Coded Private Information)

• Guidance on Research Involving Coded Private Information or Biological Specimens [PDF - 41KB] [NEW]

Children

• OHRP Children's Special Issues Page
• Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") Review Process [PDF - 37.5K]
• FAQs on Research with Children

Certificate of Confidentiality

• Certificate of Confidentiality: Privacy Protection for Research Subjects [PDF - 18.9KB]

Clinical Trial Websites (see also IRBs)

• Clinical Trial Websites [PDF - 33.5KB]

Coded Private Information (see also Biological Specimens)

• Guidance on Research Involving Coded Private Information or Biological Specimens [PDF - 41KB] [NEW]

Common Rule

• Federal Policy for the Protection of Human Subjects
• 45 CFR 46
• 45 CFR 46 FAQs
• Federal Register Notice announcing the final rule
• Portions of the Federal Register Notice announcing the final rule:
  • Common Rule 1
  • Common Rule 2
  • Common Rule 3
  • Common Rule 4

Compliance Oversight

• Compliance Oversight Procedures [PDF | HTML]

Conflict of Interest

Consent - See Informed Consent

Continuing Review [PDF - 52KB]

Databases and Data Storage

• Repositories, Tissue Storage Activities, Data Banks

Decision Charts

• Human Subject Regulations Decision Charts

Emergency Research

• Emergency Research Informed Consent Requirements
• Emergency Medical Care

Engagement in Research

• Guidance on Engagement of Institutions in Human Subjects Research [PDF - 66KB] [NEW]

Exculpatory Language

• Exculpatory Language in Informed Consent Documents

Exempt Research/Exemptions

• Exemptions for Public Benefit and Service Programs
• Exempt Research and Research That May Undergo Expedited Review

Expedited Review

• Guidance on the Use of Expedited Review Procedures [PDF - 207KB]
• Expedited IRB Review - Categories

Fetal Tissue

• Fetal Tissue Transplantation [PDF - 14.7KB]
• Fetal Tissue Transplantation Research, Public Law 103-43, Section 498A

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]

FWA

• Individual Investigator Agreement [PDF - 43.9KB]

HHS Funding Support

• IRB Review of Applications for HHS Support

HIV/AIDS

• AIDS Research, Guidance for IRBs
• HIV Serostatus, Informing Those Tested, PHS Policy
• HIV Serostatus, Sex-Partner Notification, PHS Policy

Human Subjects

• Basic Protections for Human Subjects
• Human Subject Research Decision Charts

Incident Reporting

• Reporting Incidents to OHRP [PDF - 51.6KB]

Individual Investigator Agreement

• Individual Investigator Agreement [PDF - 43.9KB]

Informed Consent

• Emergency Research Informed Consent Requirements
• Exculpatory Language in Informed Consent Documents
• Informed Consent Tips
• Informed Consent Checklist
• Informed Consent, Legally Effective and Prospectively Obtained
• Informed Consent, Non-English Speakers
• Informed Consent Requirements for In Vitro Medical Device Clinical Investigations Conducted Under FDA�s Interim Final Rule at 21 CFR 50.23(e) [PDF - 45K]

Informed Consent FAQ's

Investigator Responsibilities FAQs

In Vitro Medical Devices

• Informed Consent Requirements for In Vitro Medical Device Clinical Investigations Conducted Under FDA�s Interim Final Rule at 21 CFR 50.23(e) [PDF - 45K]

IRB (Institutional Review Board )

• AIDS Research, Guidance for IRBs
• Clinical Trial Websites [PDF - 33.5KB]
• Expedited Review--1998 Revised Categories
• Knowledge of Local Research Context
• Meetings Convened via Telephone Conference Call
• Multicenter Clinical Trials, Local IRB Review
• Multicenter Clinical Trials, Local IRB Review, DAIDS, NIAID
• Review of Applications for HHS Support
• Written Institutional Review Board (IRB) Procedures [PDF - 58KB]

IRB Registration FAQs

• IRB Registration FAQs

Multicenter Clinical Trials

• Multicenter Clinical Trials, Local IRB Review
• Multicenter Clinical Trials, Local IRB Review, DAIDS/NIAID

Pharmaceutical Companies

• Engagement of Pharmaceutical Companies in HHS-Supported Research

Prisoners

• Prisoner Research [PDF - 21.6KB]
• FAQs on Prisoner Research

Quality Improvement Activities

• OHRP Quality Improvement Activities Frequently Asked Questions

Repositories (see also Tissue Storage/Repositories)

• Repositories, Tissue Storage Activities, Data Banks

Research

• Guidance on Engagement of Institutions in Human Subjects Research [PDF - 66KB] [NEW]

Stem Cells

• Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles: OHRP Guidance for Investigators and Institutional Review Boards

Tissue Storage/Repositories

• Repositories, Tissue Storage Activities, Data Banks (11/97)

Unanticipated Problems (see also Adverse Events)

• Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events [PDF - 180KB]

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