Short Videos

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.

Watch: Overview of Changes to Exemptions in the Revised Common Rule (Focusing on Exemptions 1, 2, 3, and 5) (26:06)

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.

Regulatory Options for Secondary Research with Private Information and Biospecimens Part 1 (Including Discussion of Exemptions 4,7, 8) (24:59)

This video explains options for investigators planning to do secondary research with private information or biospecimens under the revised Common Rule.

Watch: Regulatory Options for Secondary Research with Private Information and Biospecimens Part 2 (16:02)

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.

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

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)

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.

Watch: Revised Common Rule Transition Provision and Research Initiated Before January 21, 2019 (1:20)