January 21, 2019

Revised Common Rule and Its Impact on Researchers

The U.S. Department of Health and Human Services (HHS) and other federal departments and agencies have implemented a revised rule on the Federal Policy for the Protection of Human Subjects (also known as the Common Rule). While implementation of this rule has been delayed several times, the revised rule became effective January 21, 2019.

Impact on New and Existing Studies

New Studies. The revised Common Rule applies to research, with limited exceptions, initially approved by the MSU IRB or determined exempt by the MSU HRPP on or after January 21, 2019. New study submissions that were submitted to the MSU HRPP before January 21, 2019 may be subject to the revised Common Rule requirements; this determination will be made by the IRB on a study by study basis.

Ongoing Studies. Research initially approved by the MSU IRB or determined exempt by the MSU HRPP before January 21, 2019 are NOT required to comply with the revised Common Rule requirements and remain subject to the previous Common Rule. However, a study may be transitioned to the revised Common Rule by the IRB. If transitioned, the study must comply with the revised Common Rule. MSU plans to consider whether to transition studies on a study by study basis at the time of annual continuing review.

Studies subject to U.S. Department of Justice requirements are required to comply with the previous Common Rule requirements. Studies regulated by the U.S. Food and Drug Administration also must comply with the FDA requirements.

Overview of the Revised Common Rule’s Impact on Researchers

Exemptions. More studies may qualify for exemption. Changes include:

  • New and revised exemption categories (when specific criteria are met), e.g.:
    • Use of identifiable health information regulated under the Health Insurance Portability and Accountability Act (HIPAA)
    • Benign behavioral interventions with collection of information from an adult subject (certain types of data collection require a limited IRB review of privacy and confidentiality provisions)
    • Educational tests, survey, interview, or observation of public behavior involving adults where the data is identifiable and disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation, which also requires a limited IRB review of privacy and confidentiality provisions
  • Certain categories of exemption that require a limited IRB review by an IRB member in addition to the exempt determination review by the HRPP

TIP: If you are submitting a new study, carefully review the updated exemption categories in the updated HRP-503 – Template – Protocol to see if your study qualifies for a new exemption or if the study is impacted by changes to an existing exempt category.

Expedited or full board studies. The most significant changes include:

  • Elimination of annual renewal for studies reviewed under the expedited procedure unless otherwise required by the IRB
  • New requirements for the informed consent form, including that the informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research
  • New requirement to post clinical trial consent forms for each clinical trial conducted or supported by a Federal department or agency

TIP: Visit the MSU HRPP Informed Consent Templates webpage: https://hrpp.msu.edu/templates/consent.html for updated consent templates that incorporate the revised Common Rule requirements and to view guidance on the new informed consent requirement for a concise and focused presentation of key information.

Resources

Webinars. Webinars on the changes to human research protection regulations and how the changes impact researchers are being offered this January.

Upcoming sessions are scheduled for:

  • Wednesday, January 23, 2019 from 10:00 A.M. – 11:00 A.M.
  • Tuesday, January 29, 2019 from 3:00 P.M. – 4:00 P.M.

Registration is required. Please register through the MSU ORA Ability Learning Management System at 

https://abilitylms.msu.edu/MSU/LearnerWeb_PTM.asp?ActionID=ListEvents&CourseID=HRPP-6329-ILT

Updated Documents. Updated protocol templates and informed consent templates that include the revised Common Rule requirements are available in the Click™ Research Compliance System and on the MSU HRPP website: https://hrpp.msu.edu/templates/index.html

More Information. More detailed information about the revised Common Rule is also available at https://hrpp.msu.edu/help/revisedrule/index.html

Questions?

Contact the MSU HRPP with any questions: by email at irb@msu.edu or by phone at 517-355-2180.