Revisions to the Common Rule

Effective January 1, 2019:

All Studies approved after January 21, 2019 are required to comply with the new Revised Common Rule. All studies approved prior to January 21, 2019 continue under the previous version of the Common Rule.

What are the revisions?

Exempt Research
The Revised Common Rule broadens the types of research that qualify for exemption. Exemption is defined as requiring IRB approval but not continuing review. Several exempt categories have been revised, and there are new categories of exemptions. City U policy requires all student and faculty researcher to submit their research protocols for review and approval. The Chair or Chair-designate determines whether the research is exempt, expedited or requires a full board review.

Continuing Review
The Revised Common Rule removes the requirement for continuing review for minimal risk research and for full-board research that is in long-term follow-up or data analysis only, unless the research is FDA-regulated. When the new rules go into effect, new minimal risk research will still require IRB approval but will not automatically undergo continuing review by the IRB unless it is FDA-regulated. The IRB may require continuing review for special circumstances such as studies involving conflict of interest, IRB reliance or prior compliance concern.Even when continuing review is not required,investigators remain responsible for updating the IRB about adverse and other unanticipated problems, seeking IRB approval for changes to personnel, protocol amendments, recruitment materials, etc., and informing the IRB when the research is complete.

Informed Consent
When the new regulations go into effect, changes will be required to the structure and content of informed consent documents. Consent forms will begin with a concise summary of “key information” that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to join the research.