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revised common rule video 5

This video explains the concept of broad consent as described in the revised Common Rule. It describes what it is, what it is not, and how it is anticipated to be used. (June 22, 2018)

Watch: Broad Consent in the Revised Common Rule (17:30)

revised common rule video 6

This video provides an overview of the changes in the revised Common Rule on IRB reviews including: limited IRB review, expedited review, continuing review, elimination of the requirement to waive informed consent for certain early research activities, single IRB requirement, and the removal of IRB review of grant applications. (June 22, 2018)

Watch: What's New in IRB Review Under the Revised Common Rule (8:22)

IRB Review Criteria

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)

Watch: IRB Review Criteria

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