Final Rule Revisions to the Common Rule
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
Interim Final Rule Delays Effective and Compliance Date
The effective and compliance date of the revised Common Rule was delayed for six months by the Interim Final Rule as published on 22 January 2018 (“Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects”).
The current (also referred to as the pre-2018 rule) Common Rule will remain in effect. Prior to the effective and compliance date, CITI Program modules will reflect the current (pre-2018) Common Rule.
Further interim rules and delays are possible. The Interim Final Rule states that it is meant to provide additional time to prepare for implementing the Final Rule, as well as time for potential further regulatory delays.
CITI Program's Plan
Final Rule Resources
We have created resources, are developing a new course, and plan to update all of our content by the Final Rule's compliance and effective date.
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 share with their learners.
Note: These resources are based on the Final Rule and Interim Final Rule issued by HHS at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" (the Common Rule) on 19 January 2017 and 22 January 2018, respectively. Further delays and/or interim rules are possible. If there are any changes, CITI Program will update these resources as applicable.
Visit CITI Program's Final Rule Resources page to download the materials.
Final Rule Course
A new course covering Final Rule revisions is also in development to assist organizations in addressing their learner needs. Look for more information on this upcoming course in the next few weeks.
Revisions to Current Content
Prior to the compliance and effective date, CITI Program modules will reflect the current (pre-2018) Common Rule. We will update CITI Program courses to reflect the revisions by the effective and compliance date (by 19 July 2018 if there are no further delays or interim final rules).
Modules numbers will not change, nor will any aspect of course requirements (for example, minimum course average score or minimum per module score).
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?
- Learners who already completed an affected course, 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.
- Learners in the process of completing an affected course, will receive credit for the completed modules and automatically be presented the revised modules for modules they still need to complete in their course.
- All learners will be presented with all updated modules in their courses after the compliance and effective date. Credit for any modules completed prior to the update are preserved.
- All learners who complete modules prior to the effective and compliance date may return after the modules are updated, and re-complete modules to receive Final Rule training.
How do we update learners on the new regulatory requirements?
- All affected modules will have an alert message posted to notify learners that the module was revised based on the Final Rule.
- 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: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects (01/22/2018)
- 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