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 was published in 1974 and later revised in 1991. The changes also aim to reduce the administrative and regulatory burden of the previous rule (known as the pre-2018 requirements), as well as better protect human subjects in research. The revised Common Rule was delayed several times, but the general compliance date is 21 January 2019 (following a six-month delay from the effective date of 19 July 2018).
During the extended delay period (19 July 2018 – 20 January 2019), the pre-2018 requirements remained in effect. However, the 19 June 2018 Final Rule allowed institutions to employ three burden-reducing provisions during the delay.
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
CITI Program's Plan
We have developed a new course, released free resources, created legacy versions of HSR courses, and updated all of our content to reflect the 2018 Requirements.
Revised Common Rule
This new course provides training on the revisions to the Common Rule. It can be used by organizations and learners to provide specific training on the regulatory changes.
Final Rule Resources
CITI Program has created resources to help the research community understand the revisions to the Common Rule. These resources were developed with the assistance of expert authors and peer reviewers.
Revisions to Current Content
Prior to the general compliance date, CITI Program modules reflected the previous Common Rule (pre-2018 requirements).
On 20 January 2019, we updated current CITI Program modules to reflect the revisions (2018 Requirements).
Module ID numbers did not change, nor did any aspect of an organization's course requirements (for example, module or passing score requirements).
How does this affect organizations?
- Organizations will not have to request the updated content. The revised content replaced the current content automatically. We notified organizations when the update occurred.
How does 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 revised modules in their courses after the update on 20 January 2019. Credit for any modules completed prior to the update are preserved.
- All learners who completed modules prior to the 20 January 2019 update may return after the modules are updated and review the revised Common Rule content (integrated into the modules).
How do our training options address the new regulatory requirements?
- Administrators can refer to our support center article on options for revised Common Rule training - What are the Options for Common Rule Training?
What if I want learners to receive training that is not updated to the 2018 Requirements (does not contain any changes from the revised Common Rule)?
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’s pre-2018 requirements. There are two legacy track offerings – Biomed and SBE, with each having one Basic and one Refresher course. Legacy versions of content must be requested through CITI Program Support and require new gradebooks.
- Federal Register: 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 (06/19/2018)
- 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."
- Office for Human Research Protections (OHRP). “Revised Common Rule.”
- PRIM&R's Revised Common Rule Information