May 2025

The Organization authorizes the JHM IRBs to request the assistance of consultants in preparing for discussion of a research protocol in accordance with DHHS regulations at 45 CFR 46.107 and FDA regulations at 21 CFR 56.107. If no member of the IRB has the appropriate expertise, the IRB may refer the protocol review to another IRB committee or determine that a consultation is required.  Consultations may be formal requests for written comments or email requests. For protocols requiring convened IRB review where a consult is sought, the inclusion of a consult will be documented in the IRB’s meeting minutes. Consultants may not vote with the IRB members. The IRB may not request the opinion from a consultant who has a conflict of interest, as defined consistent with policies on member or investigator conflicts of interest (See University Policy on Conflict of Interest and Organization Policies Organization Policy on IRB Composition and OHSR Staff Qualifications andOrganization Policy on Convened Meeting Primary Reviewer System). Prior to receiving any study-related information or documents, the consultant must confirm to the IRB member or Compliance Team member requesting the consultation that he or she has no conflicts of interest and will maintain confidentiality with respect to all information provided. When an application is submitted for JHM IRB review that involves research populations outside of the United States, the IRB will require documentation of review and approval by a local IRB or Ethics Board (EB) to satisfy the local context review requirement. However, where no local IRB/EB exists or is available to provide this review, the IRB will obtain a consult from an individual familiar with the cultural background, local context, and community attitudes of the country in which the research will be conducted. A consultant for this purpose must make the same confirmations with respect to conflict of interest and the maintenance of confidentiality.