Final Revisions to the Common Rule Guidance

Final Revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the Common Rule) were issued by the Department of Health & Human Services (HHS) January 18, 2017. The majority of changes were scheduled to go into effect January 2018, but were then delayed for six months and have been delayed again. The compliance date for the revised Common Rule is now scheduled for January 21, 2019. 

Institutions may begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule; as such, Ferris IRB will allow for consent rule changes to take effect should investigators wish to implement the changes.

Major Regulation Changes 

Exemptions: New categories and clarification of existing categories. Some exemptions may require "limited IRB review" (similar to an expedited review process). 

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. Under the new regulations: 

  • 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 authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. 
  • Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented ina way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized reprsentative's understanding of the reasons why one might or might not want to participate.
  • All elements of consent must be provided. See revised consent templates and consent guidance document to ensure consent forms meet the requirements of the revised Common Rule.

Continuting Review: Will no longer be required for some minimal risk research. 

Single IRB-of-Record (sIRB): IRB oversight for most federally-funded collaborative research projects located in the U.S. are required to use a single IRB (commercial, academic, or hospital-based) as of January 20, 2020. As such, reliance agreements would be implemented; investigators should allow additional time in the approval process for legal reviews.

Broad Consent: Ferris IRB will not implement the new regluatory "Broad Consent" option as an informed consent process at this time. Exemptions 7 & 8, which rely on Broad Consent, also will not be implemented. 

 

The Ferris IRB is working to interpret the new Common Rule elements and update our policies, procedures and application process. Your patience with reviews during this time are appreciated.