Yes, for DoD-supported multi-site research, the DoD requires that any institution located in the U.S. that is engaged in multi-site cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the U.S. This requirement applies to all research, to include studies subject to the U.S. Food and Drug Administration's regulations. The primary awardee (lead institution) of a USAMRDC-managed research proposal that includes a multi-site, cooperative effort must develop a plan for coordinating all collaborating sites' reliance on a single IRB for DoD-supported multi-site cooperative research.

In addition to seeking local guidance from your human research protection program officials and reviewing Institutional Review Board (IRB), notify the OHRO in the following circumstances:

1. Amendments: Per the terms of your OHRO approval, substantive amendments require OHRO review and approval prior to implementation. The OHRO will not require pre-approval of amendments intended to minimize risk of COVID-19 exposure for research volunteers or study team members. You must follow your institution's guidance or requirements for IRB review and approval for amendments and must provide documentation to the OHRO of all such actions in a prompt manner via email to the following address: usarmy.detrick.medcom-usamrmc.mbx.COVID-19@health.mil.
2. Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs): Per the terms of your OHRO approval and the Common Rule, UPIRTSOs must be promptly reported. This includes any UPIRTSOs related to the COVID-19 pandemic, such as inadvertent exposure of research subjects and/or study personnel, missed or delayed safety assessments due to the pandemic, inability to provide study product or conduct key research interventions, etc. UPIRTSOs related to the COVID-19 pandemic must be promptly reported to the reviewing IRB and the following OHRO mailbox: usarmy.detrick.medcom-usamrmc.mbx.COVID-19@health.mil
3. Halting research: Promptly report any actions taken to halt the conduct of ongoing human subjects research (e.g. pausing new enrollment, canceling follow-up procedures with previously enrolled subjects, etc.) due to the COVID-19 pandemic to the reviewing IRB and the following OHRO mailbox: usarmy.detrick.medcom-usamrmc.mbx.COVID-19@health.mil
4. Note: You must adhere to all other reporting and submission requirements specified in your OHRO approval memorandum.

If notification by electronic mail is not feasible, notifications can be made telephonically to 301-619-2165. If you have questions, you can contact 301-619-2165 or the OHRO mailbox at usarmy.detrick.medcom-usamrmc.mbx.COVID-19@health.mil.

If your research will involve the participation of human subjects or use of human anatomical substances, human data or human cadavers, it will require review and acceptance/approval by our office before your research may be initiated. View a description of the DOD and Army-unique issues and requirements (32 KB) that should be considered during preparation of your research protocol and informed consent document.

The following list taken from 45 CFR 46.104 (163 KB) details the exemption categories.

1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § __.111(a)(7).
3. 1. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
      1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
      2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
      3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § __.111(a)(7).
   2. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
   3. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
   1. The identifiable private information or identifiable biospecimens are publicly available;
   2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
   3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of "health care operations" or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b); or
   4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
   1. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
   2. [Reserved]
6. Taste and food quality evaluation and consumer acceptance studies:
   1. If wholesome foods without additives are consumed, or
   2. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
7. Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by § __.111(a)(8).
8. Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
   1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with § __.116(a)(1) through (4), (a)(6), and (d);
   2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with § __.117;
   3. An IRB conducts a limited IRB review and makes the determination required by § __.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Investigators who believe that their protocol is exempt from review should submit

1. a completed OHRO Submission Form - Secondary Research Involving the Use of Data/Specimens and
2. documentation from the local IRB stating that the protocol has been determined to be exempt.

If human anatomical substances are being used, a copy of the consent form that was used with subjects when the anatomical substances were initially obtained for use in research should be provided. This consent form should demonstrate that subjects consented to the use of their donated samples in the type of research being conducted. Additional information may be requested (e.g. survey tools, etc.) depending upon the category of exemption requested.

You may simply click on the MS Word or MS Excel file links to view them in your browser. Alternatively, you may download the files to your computer by clicking the right mouse button on the file links. You will see a pop-up menu. If you are using Netscape Navigator, select "Save Link As," or if you are using Internet Explorer, select "Save Target As." A dialog box will appear enabling you to save the files on your computer. Please note that in order to use the MS Word/MS Excel applications, you will need a PC running Word, and/or Excel (both for Windows 95 version 7.0 or higher).

No