April 2008 The Organization authorizes a JHM IRB to request the assistance of a consultant 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 consult. Consults may be formal requests for written comments or email requests and will be documented in the protocol file. Consultants may not vote with the JHM IRB members. The JHM 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 JHM IRB Policies 107.1 and 111.11). The consultant must confirm for the IRB member or Regulatory Team member requesting the consult that that no conflict exists. The consultant then will be forwarded the applicable study information. When an application is submitted for JHM IRB review that involves research populations outside the U.S., the JHM IRB will accept the review by the local IRB or Ethics Board to satisfy the local context review requirement. The JHM IRB will request from the JHM investigator a copy of the local approval document. The JHM 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 if there is no local entity to review the study or if the entity cannot provide an approval document. The consultant must confirm for the IRB member or Regulatory Team member requesting the consult that that no conflict of interest exists. | 
