OHRP has produced a set of videos to help IRB personnel, researchers, and others in the research community learn about and understand the revised Common Rule. These videos are for educational purposes. Please refer to the text of the revised Common Rule for a complete and accurate description of the regulatory requirements.
Access companion material Revised Common Rule Q&As.
OHRP's materials are intended for public use and distribution, and we invite you to share or link to them from your website.
In this presentation from the SACHRP meeting on July 11, 2018, OHRP staff member Lauren Hartsmith discusses the transition provision for the revised Common Rule. The presentation focuses on the six month “delay” period from July 19, 2018 through January 20, 2018, and addresses the rules that apply for institutions that choose to transition research to the revised Common Rule during that time period.
These timelines help to explain the transition provision.
In this video, OHRP Director, Jerry Menikoff, explains the changes and requirements for informed consent in the revised Common Rule including a brief discussion on broad consent.
Watch: What's New in Informed Consent: Revisions to the Common Rule (26:50)
This video reviews the revised Common Rule and how to determine when a research study is considered nonexempt human subjects research under the revised Rule. The presentation also includes a brief introduction of the exemptions.
Watch: When Does the Common Rule Apply? Review of the Basics Under the Revised Rule (18:14)
This video explains the eight exemptions in the revised Common Rule, focusing specifically on exemptions 1, 2, 3, and 5. It also discusses the requirement for limited IRB review for the new provisions in exemptions 2 and 3, and how the exemptions work with the subparts.
This video discusses the concept of secondary research and how secondary research can be done under the revised Common Rule and covers exemptions 4, 7, and 8 in detail.
This video explains options for investigators planning to do secondary research with private information or biospecimens under the revised Common Rule.
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.
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.
Watch: What's New in IRB Review Under the Revised Common Rule (8:22)
