On 19 January 2017, the U.S. Department of Health and Human Services (HHS) issued a Final Rule to update the current regulations at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" (the Common Rule). The revisions are intended to reflect changes in the types of human subjects research being conducted and the landscape of research since the original rule published in 1974 and last revised in 1991. The changes also aim to reduce the administrative and regulatory burden of the current rule (known as the pre-2018 rule), as well as better protect human subjects in research.
What are the changes?
The HHS press release encompasses the most significant changes adopted in the Final Revisions to the Common Rule. The Federal Register includes an executive summary outlining the changes and the final regulatory text.
Final rule changes include:
- Improving the informed consent document and process to increase subject understanding
- Requiring that consent forms for certain federally funded clinical trials be posted on a publicly available federal website
- Requiring single Institutional Review Board (sIRB) review for cooperative research for some studies
- Allowing the use of broad consent for future research for secondary studies on stored identifiable data or identifiable biospecimens
- Eliminating continuing review for certain minimal risk research
- Establishing new exempt categories of research based on level of risk posed to subjects
- Adopting the definition of “clinical trial” that includes behavioral health-related outcomes
The effective date is on 19 January 2018 for all changes except cooperative research (45 CFR 46.114). Changes to cooperative research requirements will be effective on 20 January 2020.
CITI Program's Plan
CITI Program has created resources to help the research community understand the revisions to the Common Rule issued by HHS in its Final Rule published on 19 January 2017. These resources were developed with the assistance of expert authors and peer reviewers.
CITI Program organizational subscribers are encouraged to use these trainings at their organizations and to share with their learners.
Note: These resources are based on the Final Rule as published in the Federal Register on 19 January 2017. The Final Rule is still under review. In addition, there is a proposed one-year delay (while allowing the use of three burden-reducing provisions during the delay year) and another Final Rule that would delay the implementation date. If there are any changes, the CITI Program will update these resources as applicable.
Visit CITI Program's Final Rule Resources page to download the materials.
Revisions to Current Content
We will update CITI Program courses to reflect the revisions by January 2018 (if the Final Rule changes go into effect as outlined in the 19 January 2017 Federal Register.)
How will this affect organizations?
- Organizations will not have to request the updated content. The revised content will replace the current content automatically. We will notify organizations when the update occurs.
How will this affect learners?
- For learners who already completed a human subjects research course, they will not have to re-complete the revised content unless required by their organization.
- They will have access to the revised modules in their gradebooks.
- For learners in the process of completing a human subjects research course, they will receive credit for the completed modules, and be presented the revised modules for modules they still need to complete in their gradebook. They will be able to see updated modules within their gradebooks at any time.
How do we update learners on the new regulatory requirements?
- For updating learners, we recommend organizations use our complimentary Final Rule resources. We encourage disseminating the resources in a manner that best meets the organization’s needs.
- Additional options for updating learners within the CITI Program are available. Please contact our support staff to learn more.
- Federal Register: Federal Policy for the Protection of Human Subjects (01/19/2017)
- HHS Press Release About the Final Rule
- HRP Consulting Group "New Final Common Rule - Summary of Changes."
- PRIM&R's Revised Common Rule Information