Conflicts of Interest: Single IRB requirements when the Reviewing IRB cannot rely upon the COI assurances from NIH

If the Reviewing IRB concludes it cannot rely upon the conflict of interest assurances from NIH and the Research is withdrawn from Ceded Review with respect to NIH, can the Reviewing IRB continue to provide review of the Research for other Relying Institutions? In this situation, how will NIH’s Policy on Use of a Single IRB for Multi-Site Research (NIH sIRB Policy) and the Revised Common Rule’s single IRB requirement apply?

In this situation, the NIH Intramural Research Program can work with the funding applicant institution to seek an exception from NIH to the NIH sIRB Policy and an exception from the cooperative research provision of the Revised Common Rule. Note that with respect to an exception under the Revised Common Rule, there is currently (as of the date of these FAQs) no existing exception that would apply to this situation, and OHRP will need to be involved in consideration of the request. Alternatively, the NIH Intramural Research Program can choose not to participate in the Research. If exceptions are obtained or if the NIH Intramural Research Program chooses not to participate in the Research, the Reviewing IRB can continue as the Reviewing IRB for the other Relying Institutions involved in the Research. Note that the NIH Intramural Research Program may withdraw from the Research while an exception is sought, so as not to delay the review and approval of the Research for the other Relying Institutions.