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) and other Common Rule departments and agencies 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 requirements), 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.
Six-month Extended Delay to Compliance Date and Use of Three Burden-Reducing Provisions
The Final Rule on 19 June 2018 (“Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions during the Delay Period
”) delayed the Revised Common Rule’s compliance date for an additional six months. The compliance date is now 21 January 2019 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.
During this extended delay period (19 July 2018 – 20 January 2019), the current (pre-2018 requirements) regulation remains in effect. However, the 19 June 2018 Final Rule also allows institutions to employ three burden-reducing provisions during the delay.
The three provisions include:
- The definition of “research”
- Elimination of continuing review for no more than minimal risk research
- Elimination of the requirement for Institutional Review Boards (IRBs) to review grant applications
While the current (also referred to as the pre-2018 requirements) Common Rule is in effect, CITI Program modules will reflect the pre-2018 requirements.
CITI Program's Plan
We have developed a new course, resources, and plan to update all of our content by the Final Rule's general compliance date (21 January 2019).
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.
Note: This course reflects the 19 June 2018 Final Rule (Six-Month Delay).
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.
Note: These resources reflect the 19 June 2018 Final Rule (Six-Month Delay).
Revisions to Current Content
Prior to the general compliance date, CITI Program modules will reflect the current (pre-2018 requirements) Common Rule. We will update current CITI Program modules to reflect the revisions by the compliance date (21 January 2019). Current modules will also be updated to reflect the Final Rule as published on 19 June 2018.
Module ID numbers will not change, nor will any aspect of an organization's 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?
What if I want learners to receive training that is not updated to the 2018 requirements (that does not contain any changes from the revised Common Rule)?
- 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.
CITI Program is offering a “Legacy” content option. Legacy versions of courses reflect the core modules that focus on/or relate to elements of the Common Rule. There are two legacy track offerings – Biomed and SBE, with each having one Basic and one Refresher level versions of the courses. Legacy versions of content must be requested through CITI Program Support.