Scientific Reviewers  If you are the primary or secondary reviewer, feel free to contact the PI in advance to clarify questions or to request materials.  Always contact the RCA for the committee if you receive new documents from the PI.  Any revisions made by the PI prior to the meeting should be either sent to the committee in advance (via yourself or the RCA) or brought to the meeting for all members to review.  Complete the reviewer form in entirety and sign it. This becomes a part of the official record and is our documentation that regulations were met in the review process. You may alternatively complete the reviewer form on line (go to the For IRB Members link).  Assign a of risk for the protocol and provide justification of that level of risk on the reviewer form.  If you have any questions, please contact the RCA for your committee, the Chair, or the Education Coordinator.  E‐mail (with signature page hardcopy) and/or give the completed and signed reviewer form to the RCA at the IRB meeting.  Speak up at the meeting on any issues. Non‐Scientific Reviewers (“Community Members”)  The non‐scientific members are a key and valuable component of each IRB committee. Indeed, the IRB committee is not properly constituted without a non‐scientific member present and voting cannot take place.  Your expertise is your layperson’s review and impressions of the studies that come to the IRB committee. We invite all members to consider and speak‐up on local cultural aspects to consider in the conducting of research, also.  If you are the 2nd Reviewer on a protocol, the focus of your review will be on the consent form from a layperson’s perspective (please see the section on consent form issues).  Complete the reviewer form in entirety and sign it. You may indicate that you do not feel qualified to answer certain questions that require a scientific background. This becomes a part of the official record and is our documentation that regulations were met in the review process.  You may choose to complete the reviewer form on line (go to the For IRB Members link).  E‐mail (with signed hardcopy) and/or give the completed and signed reviewer form to the RCA at the IRB meeting.  If you have any questions completing the reviewer form, please contact the RCA for your committee, the Chair, or the Education Coordinator.  Speak up at the meeting on any issues.
Additional Criteria for Department of the Navy  For research involving more than minimal risk to participants, the protocol must include an arrangement for emergency treatment and necessary follow‐up of any research.  If research involves any of the following, the Secretary of the Navy must approve the research: o Waiver or alteration of the consent process. o Exceptions to the requirement for the consent process under 21 CFR 50.24. o Request for waiver of requirements of Department of Navy Policy regarding research protections. o Research involving severe or unusual intrusions, either physical or psychological, on human participants such as consciousness‐altering drugs or mind control techniques. o Prisoners. o Potentially or inherently controversial topics (such as those likely to attract significant media coverage or that might invite challenge by interest groups).  If the research involves human participants who are not US citizens or Department of Defense personnel, and is conducted outside the US, and its territories and possessions: o The permission of host company has been obtained. o The law, customs and practices of the host country and the US will be followed. o An ethics review by the host country, or Navy IRB with host country representation will take place. To access the Department of Defense Directive for human research protections, visit: