The Common Rule was revised in 2017 and is officially referred to as the 2018 Requirements.
- Visit OHRP’s Regulations page for regulatory text and associated details.
- Find decision charts and associated guidance documents and policy FAQs at https://www.hhs.gov/ohrp/regulations-and-policy/index.html.
Common Questions and Answers:
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.
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.
Overview of Changes to Exemptions in the Revised Common Rule (Focusing on Exemptions 1, 2, 3, and 5) [June 22, 2018]
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.
Regulatory Options for Secondary Research with Private Information and Biospecimens Part 1 (Including Discussion of Exemptions 4,7, 8) [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.
Regulatory Options for Secondary Research with Private Information and Biospecimens Part 2 [June 22, 2018]
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.
Revised Common Rule Transition Provision and Research Initiated Before January 21, 2019 [July 11, 2018]
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.
Draft guidance documents
- The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))
- Activities Deemed Not to be Research: Public Health Surveillance, 2018 Requirements
- Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements
- When Continuing Review Is Not Required During the 6-Month Delay Period
- Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements