/ Department of Defense

1PURPOSE

1.1The purpose of this document is to describe the policies and procedures for human subjects research that involves any component of the Department of Defense (DOD).

2POLICY

2.1It is University of Washington (UW) policy to comply with all applicable regulations governing human subjects research that involves the DOD.

2.2Per guidance from DOD, research is considered to involve the Department of Defense when:

2.2.1The research is funded by a component of DOD.

Example: A grant from the Office of Naval Research

2.2.2The research involves cooperation, collaboration, or other type of agreement with a component of DOD.

Example: An Army Medical Laboratory will conduct malaria antigen detection tests for study

2.2.3The research uses property, facilities, or assets of a component of DOD.

2.2.4The subject population will intentionally include personnel (military and/or civilian) from a component of DOD.

2.3The UW maintains an active Addendum to its Federalwide Assurance (FWA), confirming that the UW will apply all applicable DOD human subjects regulations and policies when conducting, reviewing, approving, overseeing, supporting, or managing human subjects research involving the DOD.

2.3.1The Addendum:

2.3.2In the past several years, DOD components have significantly enhanced their human subjects protection requirements, including the application of those requirements to researchers who are not employees of the DOD.

2.3.3The UW complies with the basic DOD regulations that apply to all research involving DOD, as well as the regulations that are specific to each major component of the DOD (for example, the Navy).

2.4DOD policies and requirements do not apply when DOD personnel incidentally participate as subjects in research that is not supported by DOD, and DOD personnel are not an intended population of the research.

3DEFINITIONS

3.1Department of Defense: This term is used to refer to any component of the federal Department of Defense. The Department of Defense components include, but may not be limited to:

  • Navy
  • Office of Naval Research
  • Naval Academy
  • U.S. Naval Observatory
  • Army
  • U.S. Army Corps of Engineers
  • Military Academy (West Point)
  • Air Force
  • Air Force Academy
  • Marines
  • Coast Guard
  • Coast Guard Academy
  • National Guard
  • Missile Defense Agency
  • Defense Advanced Research Projects Agency (DARPA)
  • Pentagon Force Protection Agency
  • Defense Intelligence Agency
  • National Geospatial-Intelligence Agency
  • National Security Agency
  • National War College
  • Tricare Health System

3.2Minimal risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

4RESPONSIBILITIES

4.1Researchers have many additional human subjects responsibilities when conducting research involving the DOD. See section 5.

4.2IRB and HSD responsibilities are described in section 6.

5PROCEDURES: Researchers

5.1Planning. DOD related research typically requires additional compliance activities, documentation, and subject protections. Researchers should anticipate and plan for these requirements, which may require significant coordination of timing and activities among offices and institutions.

5.2Budgeting. Meeting DOD requirements may increase the costs of conducting the research.

5.2.1DOD has provided the following guidance:

“Most costs associated with Human Research Protections are expected to be included in an Institution’s indirect overhead rates. However, if an Institution has identified a specific cost directly associated with performance of a particular effort and thinks the cost should be direct [sic] charged to an award, they should approach the awarding agency contracting Officer for further consideration. The awarding agency Contracting Officer would normally make a determination as to whether this type of cost is reasonable as a direct cost to their award”.

Guidance provided to the UCLA Office for the Protection of Research Subjects, as posted in the 5/31/2007 version of the document, “Guidance: Department of the Navy Human Subject Protections”.

5.2.2Example: for DOD projects involving greater-than-minimal-risk, a Research Monitor is required by DOD policy. The costs associated with the monitor might qualify as direct costs. For assistance in identifying such costs and dealing with the funding agency, researchers should consult with the UW Office of Sponsored Programs.

5.3DOD funding. Researchers are not allowed to expend DOD funds for human subjects research until all of the following requirements have been met:

5.3.1The IRB has reviewed and approved the research (or HSD has granted Exempt Status).

5.3.2The UW Office of Sponsored Programs has furnished the Human Research Protection Program at the DOD component that is funding the research with:

  • A copy of the UW DOD Addendum to its Federalwide Assurance.
  • Documentation of the IRB approval.
  • If the research qualifies for exempt status: documentation of the exempt determination, including citation of the exempt category and a rationale statement.

5.3.3The UW Office of Sponsored Programs has received notice from the Contracting Officer at the DOD component that the DOD Human Research Protection Program has reviewed the research protocol and accepted the IRB approval or exempt determination for compliance with the DOD component policies.

5.4DOD Supplement form. This UW IRB form is a supplement to the UW IRB application forms. It must be completed and submitted with the appropriate IRB application form for all DOD related research involving human subjects.

5.5DOD approval of surveys and interviews. See Question 4.1 on the DOD Supplement form. Research involving the administration of surveys to, or interviews of, DOD personnel (military or civilian) may require DOD approval of the survey or interview questions. For example, see the Navy Survey Policy entitled OPNAV Instruction 5300.8D.

5.6Waiver of consent. See Section 3 of the DOD Supplement form.

5.6.1The requirement to obtain consent cannot be waived for any research involving the DOD, and 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, except under one or more of the following conditions.

5.6.1.1The research is intended to be beneficial to the subject, the subject lacks the capacity to provide consent, and a legally authorized representative will provide consent. Examples: young minors, cognitively impaired individuals.
5.6.1.2The Head of the DOD component involved in the research may waive the requirement for consent in order to advance the development of a medical product necessary to the Armed Forces, but only if the research may directly benefit the subject and the research is carried out in accord with all other applicable laws and regulations (such as 21 CFR 50.24).

5.6.2This prohibition does not apply to screening (sometimes called “pre” screening) of records to identify possible subjects.

5.7Research in which legally authorized representatives (LARs) provide consent. See Question 4.2 on the DOD Supplement form. Per military law and DOD directive, informed consent may be provided by a legally authorized representative of subjects if: (1) the subject lacks capacity (due to age, condition, or other reason) to make a decision regarding consent to participate in the research; AND (2) the IRB has determined that the research is intended to be beneficial to the individual subjects.

5.8Monitor for greater-than-minimal risk research. An independent research monitor is required for research involving greater-than-minimal risk to subjects. See Questions 5.1 and 5.2 on the DOD Supplement form. The IRB is responsible for making the risk determination, using the definition of minimal risk provided above in section 3.2

5.8.1The monitor: a medical monitor or a non-medical monitor? DOD has advised other institutions that if a medical monitor would not be appropriate for the research, then a non-medical monitor may be appointed.

Advice provided to the UCLA Office for the Protection of Research Subjects, as posted in the 8/27/2007 version of the document, “Guide to Completing the Form HS-1 Navy Supplement”.

5.8.2DOD guidance about the monitor, from Department of Defense Directive 3216.2 (section 4.4.3):

5.8.2.1The monitor must be appointed by name.
5.8.2.2Medical monitors may be physicians, dentists, psychologists, nurses, or other healthcare providers capable of overseeing the research and its progress, especially issues of individual subject/patient management and safety.
5.8.2.3Monitors shall be independent of the investigative team and shall possess sufficient educational and professional experience to serve as the subject/patient advocate.
5.8.2.4Depending on the nature of the study, the monitor may be assigned to assess one or more of the following phases of the research: subject recruitment; subject enrollment; data collection; or data analysis and storage.
5.8.2.5At the discretion of the IRB, the monitor may be assigned to discuss progress with the lead researcher; interview subjects; consult on individual cases; or evaluate adverse events.
5.8.2.6Monitors shall promptly report discrepancies or problems to the IRB.
5.8.2.7Monitors shall have the authority to stop a research study; remove subjects from a study; and take whatever steps are necessary to protect the safety and well-being of subjects until the IRB can assess the monitor’s reports.

5.9Protections for subjects who are military personnel. See Question 5.4.1 on the DOD Supplement form. DOD requires certain protections for military personnel being recruited for research that involves greater-than-minimal risk.

5.10Independent scientific review prior to IRB review. See Questions 7.1.2 and 8.1.2 on the DOD Supplement form. The Navy and the Army require independent scientific review and approval prior to IRB review of new applications and substantive modifications.

5.10.1Who conducts the review? A scientific review conducted by a funding agency (including DOD) or by an established internal review mechanism in the researcher’s school or department will satisfy this requirement. In the absence of such a review, an ad hoc scientific review may be provided by the researcher’s chair or dean.

5.10.2What topics should the review cover? Researchers may wish to look at the National Naval Medical Center scientific review template and at the Army’s description of scientific review criteria in its Human Research Protections Office Policies and Procedures. These are essentially the same as the scientific review conducted by any federal funding agency. An internal or ad hoc review should cover the same topics including:

5.10.2.1Significance
5.10.2.2Approach (conceptual framework, design, methods, analysis)
5.10.2.3Researcher
5.10.2.4Research environment

5.10.3Documentation of the review. The IRB must be provided with written documentation of the scientific review that summarizes the scientific issues raised and addressed during the review, together with a statement that names and describes the reviewers.

Examples of appropriate documentation include: copy of a review summary from a federal agency; or a memo from the researcher’s department chair.

5.11Education and training requirements. The DOD education and training requirements exceed the requirements of the UW. See section 3.2 of the DOD Supplement form, and the training section of the HSD website. Researchers should contact the human research protection office of the DOD component to identify any human subjects training requirements and how to fulfill them.

5.12International research. See question 8.1.3 on the DOD Supplement form about Navy-involved research with human subjects who are not U.S. citizens or Department of Defense personnel.

5.13Documentation responsibilities. See question 3.3 on the DOD supplement form.

5.13.1Researcher files. Researchers are required by DOD policy to maintain an extensive number of research-related and compliance-related documents in their files.

5.13.2DOD Documentation requirements.It is the responsibility of the researcher to provide DOD with documents required by DOD.

5.14Post-IRB approval responsibilities.

5.14.1Continuing review.

5.14.1.1Continuing education. It is the researcher’s responsibility to provide the IRB with documentation that any DOD-required continuing education about human subjects has been fulfilled, with the regular Status Report.
5.14.1.2Research results. DOD requires that the researcher provide the IRB with copies of publications, presentations, and reports resulting from the research. These should be provided to the IRB with the Status Report form.

5.14.2Modifications to the research. When preparing a Modification form for IRB review, the researcher is responsible for reviewing the DOD Supplement form that he/she has already provided to the IRB, to ensure that it still accurately reflects the research.

5.14.2.1If it does not, a revised Supplement (and any additional documentation) should be provided to the IRB with the Modification form.

5.14.2.2If a Modification involves substantive changes (e.g., new procedures, a new subject population, a new aim), the researcher should attach documentation of scientific review and approval of the changes to the Modification form.

5.14.2.3If the research was not previously DOD-related but the Modification will make it DOD-related, the researcher submits the completed DOD Supplement form and all required attachments, with the Modification form.

5.14.3Reporting obligations. The researcher is responsible for notifying DOD and the IRB of any audits, investigations or inspections of DOD-related research.

6IRB and HSD RESPONSIBILITIES

6.1Pre-review. During the standard pre-review process, HSD staff screen IRB application materials to identify DOD-related research. DOD research is tagged in the HSD database.

6.1.1If the research is DOD-related but the researcher has not provided a DOD Supplement form, HSD staff inform the researcher about the need to fulfill this requirement before IRB review can begin.

6.1.2HSD staff screen the DOD Supplement form for completeness, including the required attachments, before IRB review. Missing information or clarification is obtained from the researcher.

6.2Initial review.

6.2.1Regulatory checklist. The IRB and HSD staff use the CHECKLIST:Department of Defense (DOD)during the review process to ensure and document compliance with DOD human subjects regulations.

6.2.1.1The completed checklist is placed in the IRB file. It is also considered part of the IRB meeting minutes.

6.2.2Mandatory IRB determinations. The CHECKLIST describes, and is used to document, the DOD-related determinations the IRB is required to make, including:

6.2.2.1Air Force Research focus area.

6.2.2.2Level of research risk.

6.2.2.3Research monitor.

6.2.2.4Benefits to individual subjects if a legally authorized representative may provide the research consent.

6.3Modification review.

6.3.1Research that is already DOD-related (i.e., prior to the Modification request) and that has already been reviewed by the UW IRB as DOD-related.

6.3.1.1The HSD staff screen the Modification form, within the context of the existing DOD Supplement form in the IRB file.

6.3.1.1.1If the Supplement no longer accurately reflects the research, HSD staff ask the researcher for a revised Supplement (and any additional documentation).
6.3.1.1.2If the Modification involves substantive changes, HSD staff ensure that the researcher provides documentation of scientific review and approval of the modifications.

6.3.1.2The criteria for level for IRB review (i.e., expedited versus full IRB) are the same for DOD-related research as for other types of research.

6.3.2Research that has not been DOD-related, but that becomes DOD-related because of the requested Modification.

6.3.2.1If the initial application was reviewed by the full IRB, then the Modification must also be reviewed by the full IRB because a new set of regulations is involved.

6.3.2.2HSD staff ensure that the researcher has provided the DOD supplement form and all required attachments, which should address all procedures and populations which are DOD-related. HSD staff screen the supplement form as described above.

6.4Continuing review.

6.4.1Screening. HSD staff screen the Status Report form to ensure that the following two DOD requirements have been fulfilled. If not, the staff contact the researcher so that the requirements can be met before the continuing review.

6.4.1.1Continuing education about human subjects.Research.

6.4.1.2Research results: copies of publications, presentations, and reports resulting from the research.

6.5Reporting obligations.

6.5.1HSD and the IRB are required to report to the involved DOD component any of the following events or situations that occur for DOD-related research:

6.5.1.1Serious or continuing non-compliance

6.5.1.2Suspension or termination of research

6.5.1.3Unanticipated problems involving risks to subjects or others

6.5.1.4Significant communication between the UW and other federal departments and agencies, regarding compliance and oversight.

6.5.2This reporting obligation is fulfilled by using the standard UW federal reporting letter template. The DOD FWA number must be provided in the letter.

6.5.2.1When a specific situation involves reporting to more than one federal agency, then the letter is addressed to the primary federal agency (typically OHRP or FDA), and a “carbon copy” is sent to DOD.

7REGULATORY CITATIONS

7.132 CFR 219, “Protection of Human Subjects”

7.2Department of Defense (DOD) Directive 3216.2, “Protection of Human Subjects and Adherence to Ethical Standards in DOD Supported Research”

7.3Department of Defense Directive 5500.7-R, Joint Ethics Regulation, “Standards of Conduct”.

7.4Department of Defense (DOD) Instruction 6200.02, “Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs, February 27, 2008.

7.5Under Secretary of Defense Memorandum, HA Policy 05-003, March 28, 2005, “Policy for Protection of Human Subjects in Department of Defense Sponsored Research”

7.6Department of Defense Instruction 1100.13, November 21, 1996, “Surveys of DOD Personnel”

7.7Section 980 of Title 10, United States Code

7.8Section 209 of Title 18, United States Code

7.948 CFR 207, “Acquisition Planning” part of Defense Federal Acquisition Regulations Supplement (DFARS). Specifically: 48 CFR 207.172

7.1048 CFR 235, “Research and Development Contracting” part of Defense Federal Acquisition Regulations Supplement (DFARS). Specifically: 48 CFR 235.072

7.1148 CFR 252, “Solicitation Provisions and Contract Clauses” part of Defense Federal Acquisition Regulations Supplement (DFARS). Specifically: 48 CFR 252.235-7004

7.12Secretary of the Navy, SECNAV INSTRUCTION 3900.39D, “Human Research Protection Program”.

7.13National Naval Medical Center Scientific Review Template, revision 12-15-06.

7.14Naval Operations, OPNAV INSTRUCTION 5300.8B

7.15Army Human Research Protections Office Institutional Policies and Procedures, Version 1, April 2005, Section V.A., “Scientific Peer Review of Research”

7.16Army Regulation 70-25, January 25, 1990, “Use of Volunteers as Subjects of Research”.

7.17Air Force Instruction 40-402, “Protection of Human Subjects in Biomedical and Behavioral Research”, May 5, 2005.

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