The U.S. Department of Health and Human Services (HHS) issued an Interim Final Rule delaying the implementation of the revised Common Rule (45 CFR 46) until July 19, 2018. NIH policy changes (e.g., single IRB of Record) remain scheduled to go into effect on Jan. 25, 2018.
Although most provisions in the revised Common Rule have been delayed, the NEIU IRB has decided to start applying new exempt categories to non-federally funded studies. The requirement for annual continuing review for expedited studies and full review studies in which only remaining activities are data analysis and assessment of follow-up clinical data will continue until July 19, 2018.
The revised Federal Policy for the Protection of Human Subjects (45 CFR 46. Subpart A) known as the "Common Rule” is scheduled to go into effect on Jan. 19 of 2018. The NEIU IRB is making updates in its policies and procedures in accordance with the requirements of the revised rule.
Please read the information below to familiarize yourself with new regulatory requirements and changes in the NEIU IRB review process.
Summary of Major Changes in the Revised Common Rule
Continuing Review - No longer required for most expedited studies. Furthermore, full board studies, where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data, will no longer require continuing review.
Exemptions - The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (board). The revised Common Rule broadens the types of research that can be reviewed at the exempt level, which is the level requiring the least oversight.
Informed Consent - The revised Common Rule requires a new "Key Elements" section and a rearrangement of the content of consent forms to facilitate a potential subject's decision to participate or not. A "broad consent" option has been added for unspecified future use of identifiable data/biospecimens.
Single IRB-of-Record (sIRB) - Most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB starting Jan. 20, 2020. NIH funded research projects will be required to use a single IRB starting Jan. 25, 2018. See the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research for information about the NIH sIRB policy implementation.
What to Expect
Previously approved studies:
The new regulations will not apply retroactively to existing studies. For approved expedited studies and full review studies, the IRB will evaluate the need for continuing review at the time of the next scheduled continuing review submission.
The IRB will begin applying some of the provisions of the revised rule to new studies submitted after Jan. 1, 2018.
Expect to see the following changes in the near future:
- Changes in IRB applications and approval documentation
- Revisions in the informed consent template
- Assignment of new exempt categories
- Changes in the continuing review policy
- New guidances, decision trees and tips sheets
More information will be forthcoming. Feel free to contact us with any questions you may have at email@example.com or (773) 442-4675.