Background
The revised Common Rule (2018 Requirements) requires at 45 CFR 46.114(b) that all institutions located in the United States that are engaged in cooperative human subjects research that involves more than one institution, conducted or supported by a Federal department or agency, rely upon approval by a single IRB for the portion of the research that is conducted in the United States.
Follow the NIH sIRB Mandate Procedures for proposals to NIH.
Determine if Sponsor is a 2018 Common Rule Signatory
Follow the NIH sIRB Mandate Procedures for proposals to NIH.
For all other (non-NIH) Federal agencies, check the list of signatory Federal agencies to identify if the sponsor is a 2018 Common Rule signatory. If the answer is yes, proceed to "Determine if a Single IRB is Required".
Determine if Single IRB is Required
Follow the NIH sIRB Mandate Procedures for proposals to NIH.
If the (non-NIH) Federal agency, does the proposal involve conducting non-exempt human subject research?
If the answer is “Yes,” or you are unsure, complete the sIRB consultation request form to [email protected]. Consultation is necessary prior to proposal development because the proposal budget may need to include the cost of additional personnel and/or IRB fees depending on the outcome of the consultation.
Start planning at least 90 days prior to the application submission due date.