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: 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 o protections. Research involving severe or unusual intrusions, either physical or psychological, on o human participants such as consciousness‐altering drugs or mind control techniques. Prisoners. o Potentially or inherently controversial topics (such as those likely to attract significant o 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: 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 o will take place. To access the Department of Defense Directive for human research protections, visit:
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:
document_118_-_irbmember_handbook.docx