Everything about the Final Rule and CITI Program
This article provides information on the Final Rule and CITI Program’s planned response, including revisions to our current content and development of new content, how these changes will affect organizations and learners, and how we will keep organizations and learners updated.
Final 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
Because the Final Rule changes affect many areas of research (including biomedical and social and behavioral), institutional officials and staff, IRB administrators and members, researchers, and sponsors all need to understand and prepare to implement the changes.
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.
The effective and compliance date is now 19 July 2018 for all changes except cooperative research (45 CFR 46.114). Changes to cooperative research requirements were not delayed and will be effective on 20 January 2020.
NPRM Proposes Additional 6-Month Delay to Compliance Date
On 20 April 2018, HHS and 16 other agencies published a NPRM to delay the effective compliance date until 21 January 2019, but allow for three provisions from the revised Common Rule to be available during the delay period.
This proposed rule is intended to provide additional time to prepare for the revised rule. This NPRM would allow regulated parties to implement three specific provisions from the revised Common Rule, including:
- New definition of “research”
- Elimination of continuing review requirement for no more than minimal risk research
- Elimination of IRB requirement to review grant applications
CITI Program's Plan
We have developed a new course, resources, and plan to update all of our content by the Final Rule’s compliance and effective date.
Revised Common Rule Course
This new course provides training on the revisions to the Common Rule. It can be used by organizations and learners to address their current needs as they prepare for the Final Rule going into effect. Visit CITI Program's Revised Common Rule course.
Final Rule Resources
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.
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). If elements proposed but the most recent NPRM are made effective, then modules will be updated accordingly to reflect the current regulations during the delay period.
Modules numbers will not change, nor will any aspect of course requirements (for example, module status such as "Required" or "Optional" or passing score requirements).
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.