The U.S. Department of Health and Human Services, Office of Human Research Protections has issued updated guidelines for research involving human subjects. These new guidelines, referred to as the Revised Common Rule, sometimes referred to as the Final Rule, went into effect on Jan. 21.
The Revised Common Rule updates terminology and reduces some of the regulatory burden on Institutional Review Boards (IRB) and researchers by changing some criteria and procedures for exempt and expedited reviews. It also adds a new category of review, titled “limited review,” and changes the required elements of informed consent documents to better protect human research subjects. Other changes relate to continuing review, clinical trials and collaborative research. Southeast’s IRB has been fully trained in, and implementing these changes since January.
While additional training was previously suggested for researchers, Revised Common Rule training will now be required for any Southeast researcher submitting a proposal for a new research project on or after Jan. 1, 2020.
This means different things for different researchers, including:
- Researchers who have already completed the CITI “Revised Common Rule” course DO NOT need to complete additional training.
- Researchers who have completed CITI “IRB for Social and Behavioral,” “IRB for Biomedical,” or a refresher course on or after Jan.21, 2019, DO NOT need to complete additional training.
- Researchers who last completed CITI “IRB for Social and Behavioral,” “IRB for Biomedical,” or a refresher course before Jan. 21, 2019, DO need to complete additional training — the CITI Revised Common Rule course or the appropriate refresher course — if they plan to submit a proposal for a new research project on or after Jan. 1, 2020.
Those who are nearing the three-year expiration of their training certification may elect to take the appropriate refresher course instead of the Revised Common Rule course.
Instructions for adding the Revised Common Rule training modules can be found under “Forms” on Southeast’s IRB website or at https://semo.edu/provost/pdf/IRB-Revised-Common-Rule-Course-Addition.pdf.
Additionally, please be aware that the application for exempt review and informed consent templates on the IRB website have been extensively updated to reflect Revised Common Rule Changes. Other forms are in the process of being updated for minor changes, such as new definitions and editorial issues. Please be sure to use the most current forms and templates available on the IRB website under “Forms.”
For more information or questions, including those on completing additional training or determining which course is appropriate for certain situations, should contact Dr. Jennifer Bengtson, IRB chairperson, at email@example.com or (573) 651-2354.