The Duke Health Research Community was treated to a lively presentation on “Changes to the Common Rule and NIH Certificates of Confidentiality” by David Matesanz and June Walker, both of the DUHS IRB. Today’s presentation was the first of three Research Wednesdays sessions that will discuss in detail changes to the Common Rule scheduled to go into effect January 19, 2018.
The major changes include:
- New definition of human subject
- Changes to informed consent
- Adds waiver requirement
- Changes continuing review requirements
- Changes exemption categories
- Concept of broad consent
- Single IRB requirement
Today’s presentation elaborated changes 1 – 4. The December 13th Research Wednesdays session will provide additional details on changes 5 – 7.
Some highlights from the presentation include:
The new definition of human subject was broadened in scope, especially in regard to biospecimen. NIH also implemented a “reasonable person” standard which is a new comparative standard not previously in use in the context of consent.
Another major change to the Common Rule includes the requirement of a Concise Summary at the start of informed consent documents:
45 CFR 46.116(a)(5)(i): 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. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
Continuing review requirements were changed for Minimal Risk studies reviewed via the expedited procedure. These studies will no longer require annual continuing review under the new rule and will instead require a brief institutional check-in with the IRB every two years.
Finally, NIH recently announced that as of October 1 2017, NIH- funded human subjects research automatically comes with a Certificate of Confidentiality. These certificates protect participant privacy by limiting the disclosure of identifiable information. This policy change is retroactive to studies that were ongoing as of 12/13/2016.
NIH awardees no longer have to apply for a CoC.
View the entire presentation
https://dukemed.mediasite.com/Mediasite/Play/d5627ca8731f491884efafb6e3b463de1d
Presentation slides
https://duke.app.box.com/file/247746560959