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Belmont Report
Regulations
has sub items, Regulations
Regulatory Text
Annotated 2018 Requirements
Pre-2018 Requirements
2018 Requirements
Common Rule Departments and Agencies
FDA
HHS Statutory Authority
Revised Common Rule
2018 Req. Preamble
Terminology
Guidance
has sub items, Guidance
OHRP Guidance on COVID-19
OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals
OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements
Frequently Asked Questions
2018 Requirements FAQs
45 CFR 46 FAQs
Assurance Process FAQs
Children: Research with Children FAQs
Exempt Research Determination FAQs
Informed Consent FAQs
Investigator Responsibilities FAQs
IRB Registration Process FAQs
Prisoner Research FAQs
Quality Improvement Activities FAQs
Informed Consent
Institutional Issues
For Investigators
Vulnerable Populations
Protocol Review
Biological Materials & Data
Correspondence
Alphabetical List
Requests for Comments
Decision Charts
has sub items, Decision Charts
Pre-2018 Requirements Decision Charts
2018 Requirements Decision Charts
Informed Consent Posting
Single IRB Exception Determinations
has sub items, Single IRB Exception Determinations
Background
November 2019 Exception Determination
October 2020 Exception Determination
Subpart C Certification Form
Regulations & Policy Archived Materials
Alphabetical List
A
B
C
D
E
F
G
H
I
J K
L
M
N
O
P
Q
R
S
T
U
V
W
X Y Z
A
AIDS Research, Guidance for IRBs (1984)
Approval of Research with Conditions: OHRP Guidance (2010)
C
Certificates of Confidentiality - Privacy Protection for Research Subjects: OHRP Guidance (2003)
Children as Research Subjects and the HHS "407" Process
Children: Information on Special Protections for Children as Research Subjects
Clinical Data Registries - OHRP Correspondence (2015)
Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005)
Coded Private Information or Specimens Use in Research, Guidance (2008)
Compliance Oversight Procedures for Evaluating Institutions (2009)
Continuing Review Guidance (2010)
Correspondence on "Non-engaged" Scenarios
D
Determining When Institutions are Engaged in Research (January 13, 2009)
E
Effects of Disasters on Human Research Protections Programs Guidance
Emergency Medical Care and Research: OPRR Letter (1991)
Engagement of Institutions in Human Subjects Research (2008)
Engagement: When are Survey Firms Engaged in Research?; Clarification Regarding the Relationship between Institutional Engagement and the Federal Wide Assurance (FWA) (January 13, 2009 OHRP Letter)
Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language (OPRR Letter, 1996)
Exempt Research and Research That May Undergo Expedited Review
Exemptions for Public Benefit and Service Programs
Expedited Review Procedures Guidance (2003)
Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998)
Extending an FWA to Cover Collaborating Investigators (2005)
F
Fetal Tissue Transplantation Research Guidance (2003)
Financial Conflict of Interest: HHS Guidance (2004)
G
Genetic Information Nondiscrimination Act (GINA): OHRP Guidance (2009)
Guidance on Approving Research Involving Prisoners (2000)
Guidance on Reporting Incidents to OHRP (2011)
H
HIV Serostatus, Informing Those Tested, PHS Policy (1988)
HIV Serostatus, Sex-Partner Notification, PHS Policy (1990)
Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles: OHRP Guidance (2002)
Human Subject Regulations Decision Charts
Human Subject Regulations Decision Charts: 2018 Requirements
Human Subject Regulations Decision Charts: Pre-2018 Requirements
I
Indwelling Catheter QI Procedures: (July 30, 2008)
Indwelling Catheter QI Procedures: Letter, July 30, 2008
Informed Consent Checklist (1998)
Informed Consent of Subjects Who Do Not Speak English (1995)
Informed Consent Requirements for In Vitro Medical Device Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e) (OHRP Guidance, 2006)
Informed Consent Requirements in Emergency Research (OPRR Letter, 1996)
Informed Consent Tips (1993)
Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)
Institutional Review Board Written Procedures: Guidance for Institutions and IRBs (2018)
IRB Meetings Convened via Telephone Conference Call: OPRR Memorandum (2000)
IRB Review of Applications for HHS Support (2000)
IRB Review of Protocol and Informed Consent Changes for NCI/CTEP-Sponsored Clinical Trials
IRB Review of Protocol and Informed Consent Changes in Cooperative Group Protocols (OHRP Memo to the National Cancer Institute, 2008)
Issues to Consider in the Research Use of Stored Data or Tissues (1996, 1997)
M
Minutes of Institutional Review Board (IRB) Meetings Guidance for Institutions and IRBs
N
National Health Registry Activities and 45 CFR part 46 (2011)
National Health Registry Activities, OHRP August 11, 2011
National Health Registry Activities, OHRP December 29, 2011
O
OHRP’s Viewpoint on Conflicting Interests of PedCIRB Members
P
Prisoner Involvement in Research (2003)
Prisoner Research Certification (2020)
Q
Quality Improvement Activities: OHRP Correspondence Regarding Indwelling Catheter Procedures (2008)
R
Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007)
S
Secretarial Waivers
Statute on Fetal Tissue Transplantation Research (1993)
Student Subject Pools and Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)
T
Text Version of OHRP Decision Charts: Pre-2018 (2016)
U
Use of a Central Institutional Review Board (OHRP Letter, 2010)
Use of a Central IRB: Announcement (2010)
Use of a Central IRB: McDeavitt to Menikoff, April 13, 2010
Use of a Central IRB: Menikoff to McDeavitt, April 30, 2010
Use of Electronic Informed Consent: Questions and Answers
Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)
Use of Penalties for Students Who Fail to Show up: Letter to SONA SYSTEMS, (January 8, 2010)
W
Withdrawal of Subjects from Research Guidance (2010)
Related Frequently Asked Questions
45 CFR 46 (the HHS Human Research Regulations) FAQ
Assurance Process FAQs
Children: Research with Children FAQs
Exempt Research Determination FAQs
Informed Consent FAQs
Investigator Responsibilities FAQs
IRB Registration Process FAQ
Prisoner Research FAQs
Quality Improvement Activities FAQ
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This is archived HHS content.