Major Regulation Changes
“The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators” (OHRP, 2018).
Highlights to the New Common Rule
- The definition of “research” has also been expanded to list activities that are specifically deemed not to be research
- (e.g., oral history, journalism, public health surveillance, criminal justice or criminal investigative activities, and activities in support of intelligence, homeland security, defense, or other national security missions).
- New Exemption Categories
- Broad consent is now permitted and is geared toward repositories for which the primary purpose is secondary research use, with the understanding that later use is not exactly known; broad consent is permitted as an “alternative” to the standard informed consent requirements.
- Annual continuing review requests are no longer required in the following circumstances:
- Research eligible for exempt review
- Studies that have completed study interventions and are merely analyzing study data
- In an effort to streamline the process and prevent duplication of effort, the use of one IRB for cooperative research will be required for all non-federally funded research. On January 20, 2020, this will extend to federally funded research.
- Revision to Informed Consent requirements
What to Expect
For new studies, expect to see:
- iMedris & IRB application changes
- Informed consent template revisions
- IRB Policy Manual updates
TCNJ IRB accepted the new Common Rule elements and updated the College’s policies and iMedris system to accommodate the changes while maintaining a high-level of subject protection.
Exemptions – There are now new categories and clarification of existing categories of research exemption. Some exemptions may require “limited IRB review” (similar to an expedited review process), while others may qualify for “self-determination.” TCNJ plans to pursue options for self-determination for some exemption categories. As this is a big change to current College practice, a post-approval audit period will be implemented to evaluate the effectiveness and limit potential risk. By adopting this modified optional element of the Common Rule, the IRB believes that TCNJ can demonstrate administrative flexibility. If this self-determination element rolls-out with audits shows effective use, the IRB will consider shifting to a post-approval audit. Click for a decision tree on the Common Rule Decision Tree.
Multi-Site Research – TCNJs IRB will either serve as the single IRB-of-Record for inter-institutional multi-site research, or cede review to another institution or a commercial IRB that has Federalwide Assurance (FWA) for the protection of human subjects. TCNJ researchers using another institution’s IRB for research must complete the iMedris process for notifying the IRB of the research and provide evidence of the IRB approval.
Informed Consent – A new “Key Elements” section and a rearrangement of content is designed to facilitate a potential subject’s decision to participate or not. New Common Rule compliant consent form templates are available under the template tab on the IRB homepage.
Continuing Review – No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
Broad Consent – TCNJ will implement the new regulatory “Broad Consent” option as an informed consent process. Exemptions 7 & 8, which rely on Broad Consent, will also be implemented.
Office of Human Research Protections Guidance on the new Common Rule
For your viewing pleasure OHRP has also developed a series of VIDEOS to further explain the changes with the new Common Rule.
What Does the Revised Common Rule Mean for Human Research
For your reading pleasure….