Emory IRB Review Checklist for Department of Defense (Dod) Research

Emory IRB Review Checklist for Department of Defense (DoD) Research Instructions: PI/study staff complete this worksheet and upload in the eIRB study record. The Emory IRB will rely on the information provided here to conduct a review compliant with DoD regulations. Other special agency requirements may also apply1. If you have questions, please contact the IRB Director at [email protected]. Date: Click here to enter a date. IRB File # PI: Funding source:

Researchers who are receiving DoD support for a study must provide the Emory IRB with the following information at the time of their submission of an initial IRB application to the Emory IRB:

1. Describe how the study has met the DoD’s scientific review requirement prior to IRB submission. a) Was your study scientifically reviewed by a central site? Choose an item. If no, go to question 1.b. If yes, please provide the IRB with the central scientific review report. The report should include information on the merit of the proposal, i.e., does it make sense to conduct this research? Does the research avoid unnecessary duplication of the literature? Is it is an area worthy of research and the associated resources? Does the research have a reasonable likelihood of success? b) In the absence of another formal mechanism (e.g. scientific review by the central site in a multisite study), Emory has interpreted this requirement as being satisfied by convening an ad hoc committee of a least three uninvolved faculty with expertise in the study’s subject matter. Ideally, members should be appointed by the Department/Division Chair to be sure that there are not conflicts of interest. The committee should keep notes of the discussion and should prepare a short report. The notes and a copy of the report should be kept on file in the department, in case the DoD requests to review it. b.i. If no review by a central site: b.i.a) Has your department set up an ad hoc committee? Choose an item. I Are the members free of any conflict of interest? Choose an item. b. Requirement has not been completed; please explain: 2. Does this study involve multiple sites? Choose an item. If no, go to question (3). If yes, a) list the roles and responsibilities of each party at each site participating in the research: b) A written agreement must be in place among Emory and the other sites. Do you have an agreement with each site? Choose an item. If not, please explain: 3. Does this study involve any surveys or questionnaires that will be given to DoD personnel and/or U.S. military personnel? Choose an item. If no, go to question (4). If yes, a) Please indicate if the survey has been approved by the appropriate DoD unit: Choose an item. b) Please list the units who have provided approval or explain: 4. Does this study involve more than minimal risk?i Choose an item. If no, go to question (5). If yes, a. You are required to appoint an independent research monitor by name. Please add the name of the person you have selected as independent monitor:. b. Please also attach the monitor’s CV with this completed checklist. (Note: The IRB, in its discretion, also may require a medical monitor for minimal risk studies.) 5. Will the study, or any part of the study, be conducted outside of the United States or its territories and involve participants who are not U.S. citizens or DoD personnel? Choose an item. If no, go to question (6). If yes: a) Have you obtained written permission from the host country? Choose an item.

1 Source: Chapter 18, Emory IRB Policies and Procedures.

Emory IRB DOD Checklist version 9/16/2015 b) Are you in compliance with the country’s laws, regulations and customs? Choose an item. Please attach documentation of approval and certification of such compliance with this completed checklist. 6. Does this research include DoD personnel or U.S. Military personnel as participants? Choose an item. If no, go to question (7). If yes: a) The IRB application must specify how the additional requirements set forth in IRB Policy and Procedure 78 – Recruitment of Subjects will be met.ii Has this information been included in the protocol or detailed in the submission? Choose an item. b) In addition, certification must be provided that all requirements set forth in IRB Policy and Procedure 79 – Payment of Subjects will be followed.iii Has this information been included in the protocol or detailed in the submission? Choose an item. 7. Are you requesting a waiver of informed consent? Choose an item. If no, go to question (8). If yes, a) Do participants fall within the definition of Research Involving a Human Being as an Experimental Subject?iv Choose an item. (See Emory Policies & Procedures, definitions). b) Has the Secretary of Defense granted a waiver of consent? Choose an item. If no, explain: 8. Does this research involve prisoners of war? Choose an item. 9. Does this research involve testing of chemical or biological agents? Choose an item. 10. Is this research’s subject population one for which it is likely that surrogate consent may have to be obtained? Choose an item. (The IRB must then determine that the study offers direct benefit to the subject). 11. Please state what initial and continuing research ethics education requirements are required by the DoD division supporting the study, both for researchers, and for those who review/oversee the research (e.g. IRB members): Attach documentation with this completed worksheet that the initial requirements have been met by all research team members. NOTE FOR STUDY TEAM AND IRB: Reporting Requirements: DoD supported research requires notification to DoD units of serious and/or continuing non-compliance, as well as other events. See Emory IRB Policy & Procedure – Reporting to Governmental Regulatory Authorities for additional information regarding these requirements Research Related Injury: DoD supported research requires the research site to make arrangements for the provision of treatment for research related injuries and some DoD components require that participants not bear any costs related to such treatment. Researchers should contact their DoD funding unit’s liaison to determine specific requirements. See IRB Policy and Procedure – Informed Consent Policy for additional information regarding research related injury requirements. Please see Emory Policies and Procedures Chapter 18, and your DoD grant, for further requirements. FOR IRB USE ONLY: The IRB Director must review the responses in this worksheet prior to full committee or expedited review.

Emory IRB DOD Checklist version 9/16/2015 i Minimal Risk: In Research funded or conducted by the Department of Defense, the definition of Minimal Risk based on the phrase “ordinarily encountered in daily life or during the performance of routing physical or physiological examinations or tests” is not interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For example, the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain). ii Research Subject to a DOD Addendum: When more than minimal risk Research enrolls Department of Defense or U.S. military personnel as human subjects then the following additional requirements must be included in the IRB application and followed: a. Non-commissioned officers shall not be permitted to influence the decisions of their subordinates as to whether or not to participate in the Research. b. Unit officers and senior non-commissioned officers in the chain of command shall not be permitted to be present at the time of research subject solicitation and consent during any research recruitment sessions in which members of units under their command are offered the opportunity to participate in the Research. However, these officers and non-commissioned officers who are excluded shall separately be offered the opportunity to participate as research subjects. c. During recruitment sessions where a percentage of a unit is being recruited to participate in research as a group, an ombudsman not connected to the research or the unit will be present to monitor that the voluntary nature of participation is adequately stresses and that information provided about the research is complete and accurate. iii Research Subject to a DOD Addendum: If Research subject to a DOD Addendum involves DOD personnel, including U.S. military personnel, then the following limitations regarding participant compensation apply: a. An individual cannot receive pay from more than one position for more than 40 hours of work in a calendar week. This limit on dual- compensation includes temporary, part-time and intermittent positions. b. Individuals may receive compensation for research activities if they do not take place during scheduled work hours. c. Federal employees while on duty and non-federal persons may be compensated for blood draws for research up to $50 for each blood draw. d. Non-federal persons may be compensated for research participating other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the research. iv Research Involving a Human Being as an Experimental Subject: For projects subject to a United States Department of Defense (DOD) Addendum, this term means an activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Examples of interventions or interactions include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject’s environment, the withholding of an intervention that would have been undertaken if not for the research purpose. This term does not include:  Activities carried out for the purposes of diagnosis, treatment or prevention of injury and disease in members of the Armed Forces and other mission essential personnel under Force Health Protection programs of the DOD. Authorized health and medical activities as part of the reasonable practice of medicine or other health professions.  Monitoring for compliance of individuals and organizations with requirements applicable to military, civilian or contractor personnel or to organizational units. This includes activities such as drug testing, occupational health and safety monitoring and security clearance reviews.