107.2 Organization Policy on Consultants

April 2016

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 the IRB does not include a member familiar with participants vulnerable to coercion or undue influence, they may request a consultation.

Consultations may be formal requests for written comments or email requests and 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 Organization Policies 107.1 and 111.11).  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.