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Part 1 – Evolving Concern: Protection for Human Subjects

This video is part of a series produced in 1986 by the National Library of Medicine. This segment traces the development of the current regulations and policies to protect human subjects in research. It presents historical events and the resulting societal concerns that led to the protections we have today. (Oct 25, 2017)

Watch: Part 1 – Evolving Concern: Protection for Human Subjects

Part 2 – Balancing Society’s Mandates: I.R.B. Review Criteria

This video is part of a series produced in 1986 by the National Library of Medicine. It depicts an Institutional Review Board (IRB) in action. Narrated by Dr. Edmund Pellegrino of the Kennedy Institute of Ethics, it explains the IRB review process and criteria, and why IRBs sometimes seek clarification and information from researchers. (Oct 25, 2017)

Watch: Part 2 – Balancing Society’s Mandates: I.R.B. Review Criteria

Part 3 – The Belmont Report: Basic Ethical Principles and their Application

This video is part of a series produced in 1986 by the National Library of Medicine. This segment describes the basic ethical principles that underlie research involving human subjects, illustrates their application in case studies, and shows the principles at work in the resolution of ethical conflicts. (Oct 25, 2017)

Watch: Part 3 – The Belmont Report: Basic Ethical Principles and their Application

IRB meeting

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. (Oct 18, 2017)

Watch: Quorum and Voting in IRB Meetings

Membership Requirements for Institutional Review Boards (IRB)

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)

Reporting to OHRP: What’s Necessary, What’s Not - Part 1 of 2

OHRP staff member Lisa Buchanan explains what constitutes unanticipated problems, adverse events, serious non-compliance, and continuing non-compliance, in addition to discussing IRB suspensions and terminations. She also explains requirements for written procedures for reporting to OHRP. (Mar 3, 2017)

Watch: Reporting to OHRP 2: What’s Necessary, What’s Not

Reporting to OHRP - Part 2 of 2

OHRP staff member Lisa Buchanan discusses what investigators should do when a reportable incident occurs, actions that IRBs need to take, when to report an incident to OHRP, and how OHRP will process incident reports. (Mar 3 , 2017)

Watch: Reporting to OHRP 2

Prisoner Research 1: 45 CFR 46 Subpart C - Basics

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)

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

Prisoner Research 2: Considerations When a Subject Becomes a Prisoner

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)

 

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

Back to Basics: Does My Project Fall within the Scope of Regulations?

OHRP's Misti Ault Anderson provides an overview of OHRP, the Common Rule, and how the HHS regulations on human research protections are applied. This video is for investigators or IRB professionals seeking basic training or a refresher on the HHS regulations for the protection of human subjects. (Jul 12, 2016)

Watch: Back to Basics: Does My Project Fall within the Scope of Regulations?