Mini-Tutorials

Reporting to OHRP (1): Unanticipated Problems (18:05)

This video reviews the regulatory requirements for reporting unanticipated problems to OHRP, including how to determine when an unanticipated problem or adverse event must be reported. (November 10, 2020)

Watch: Reporting to OHRP (1): Unanticipated Problems

Reporting to OHRP (2): Non-compliance, Suspensions, and Terminations (9:24)

This video reviews the regulatory requirements for reporting non-compliance, suspensions, and termination of research to OHRP, including how to determine when incidents of non-compliance must be reported. (January 15, 2021)

Watch: Reporting to OHRP (2): Non-compliance, Suspensions, and Terminations

Relevant OHRP Guidance: Guidance on Reporting Incidents to OHRP

This webinar from the Office for Human Research Protections (OHRP) discusses the concept of institutional engagement in human subjects research. It explains how to determine whether an institution is considered engaged in human subjects research for the purpose of applying the Common Rule. (October 7, 2019)

Watch: Institutional Engagement in Human Subjects Research

Relevant OHRP guidance: 2008 Engagement Guidance, Determining When Institutions are Engaged Guidance, Correspondence on "Non-engaged" Scenarios (2011)

This video, produced in 1986 by the National Library of Medicine, depicts an Institutional Review Board (IRB) in action and explains the IRB review criteria. (October 25, 2017)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Watch: IRB Review Criteria

This webinar from the Office for Human Research Protections (OHRP) discusses the regulatory requirements for quorum and voting in convened IRB meetings. It explains the requirements and provides examples to help viewers think through applying the regulations. (October 18, 2019)

Watch: Quorum and Voting in IRB Meetings

This webinar from the Office for Human Research Protections (OHRP) discusses the HHS regulations and policies related to IRB membership requirements. It explains the requirements and provides examples to help viewers think through applying the regulations. (April 28, 2017)

Watch: Membership Requirements for Institutional Review Boards (IRB)

Prisoner Research 1: 45 CFR 46 Subpart C-Basics (16:23)

OHRP's Julia Gorey discusses the history and requirements of subpart C for research with prisoners, including who is considered a prisoner, IRB review of research with prisoners, allowable categories of prisoner research, and subpart C certification. (Feb 13, 2017)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Watch: Prisoner Research 1: 45 CFR 46 Subpart C-Basics

Prisoner Research 2: Considerations When a Subject Becomes a Prisoner (18:16)

OHRP's Julia Gorey discusses the ways prisoners may become involved in research and trigger subpart C protections, the relevant areas of regulatory concern, and IRB review of subpart C research. (Feb 13, 2017)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Watch: Prisoner Research 2: Considerations When a Subject Becomes a Prisoner

Relevant OHRP guidance: Prisoner FAQs, Prisoner research certification, and Prisoner Involvement in Research.