General Regulatory Information
Short presentation by OHRP staff on WebEx platform, followed by moderated Q&A session. (April 28, 2020)
Watch: The recorded videocast on OHRP’s COVID-19 Guidance (52:46)
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 (21:58)
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. (July 12, 2018)
Watch: What's New in Informed Consent: Revisions to the Common Rule (26:50)
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. (July 11, 2018)
These timelines help to explain the transition provision.
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. (June 22, 2018)
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. (June 22, 2018)
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. (June 22, 2018)
This video explains options for investigators planning to do secondary research with private information or biospecimens under the revised Common Rule. (June 22, 2018)
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)
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)
