MSU HRPP Manual Section 2-2-A

U.S. Department of Defense

This policy applies to all research involving human subjects conducted or supported by the U.S. Department of Defense (DoD), or otherwise subject to DoD requirements. While the DoD abides by Part 219 of Title 32, Code of Federal Regulation (CFR) (the Common Rule), including subparts B-D (protections for vulnerable populations of pregnant women, prisoners, and children), additional requirements are provided in the DoD Instruction 3216.02, Protection of Human Subjects and Adherences to Ethical Standards in DoD-Conducted and -Supported Research (effective April 15, 2020).

In addition, some components have unique policies and procedures that reflect the characteristics of the agency (e.g., leadership, culture, risk tolerance, mission). The following entities are referred to collectively in the DoD Instruction 3216.02 as DoD Components:

Office of the Secretary of Defense
Military Departments (e.g., Army, Navy, Air Force, including the Army National Guard and Air National Guard)
Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff
Combatant Commands
Office of the Inspector General of the Department of Defense
Defense Agencies (e.g., Defense Advanced Research Projects Agency)
DoD Field Activities
All other organizational entities within the DoD

The DoD also typically requires DoD review and approval for surveys. See DoD Instruction 1100.13 (January 15, 2015, Incorporating Change 1, Effective March 31, 2017). When appropriate, the research protocol is reviewed and approved by the IRB prior to DoD approval. Surveys performed on DoD personnel must be submitted, reviewed, and approved by the DoD after the research protocol is reviewed and approved by the IRB. When a survey crosses DoD Components, additional review is required.

Research involving human subjects, regardless of source of funding, must be conducted in accordance with applicable Federal, DoD-specific, DoD Component specific, sponsor-specific, and other applicable requirements, including relevant international requirements when conducted or supported by the DoD, or otherwise subject to DoD requirements.

When a Michigan State University (IRB) submission is received where DoD requirements may be applicable, an MSU Institutional Review Board (IRB) administrator is assigned to obtain information from the MSU Principal Investigator (PI) of the study regarding the DoD requirements, to identify which DoD Component(s) are conducting or supporting the study, and to determine whether there are any additional DoD Component specific requirements. The MSU IRB Administrator will work with the MSU PI to identify additional DoD Component specific requirements and to assure the DoD Component specific requirements are met. The MSU Human Research Protection Program (HRPP) may require that the MSU PI consult with the DoD if uncertainty arises regarding DoD-conducted or DoD-supported research.

Relevant sections of the DoD Instruction 3216.02 are included below; however, see DoD Instruction 3216.02 for full requirements.

Applicability

DoD Instruction 3216.02 applies to:

DoD Components
DoD Components and other organizational entities that issue, implement, update, and monitor a component human research protection program management plan in order to conduct or support DoD research involving human subjects
Human subject research conducted or supported by the DoD (note that assistance is a subset of support)
Activities conducted or supported by the DoD, such as research, development, testing, and evaluation that involve humans, human data, human biospecimens, or activities regulated by the Food and Drug Administration (FDA)

See DoD Instruction 3216.02 for exclusions.

DoD Instruction 3216.02 applicability is not dependent upon the budget activities funding the research, the security classification of the research, the location of the research in the United States or a foreign country, or whether the research is conducted or supported by a program that is not considered research for other purposes.

DoD support means funds or assistance that are provided by the DoD to non-DoD institutions for human subject research through a grant, contract, or similar arrangement subject to the Defense Federal Acquisition Regulation Supplement (DFARS) or other applicable DoD regulations, such as the DoD Grant and Agreement Regulations.

DoD support includes the DoD’s provision of assistance to non-DoD institutions, whether or not through collaboration between DoD and non-DoD institutions, such as facilities, equipment, personnel (investigators or other personnel performing tasks identified in the research protocol), access to or information about DoD-affiliated personnel for recruitment, or data or specimens.
DoD support does not include DoD-conducted human subject research, whether or not conducted in collaboration between a DoD institution and non-DoD institution.

DoD-supported research should comply with the whole of the DoD Instruction 3216.02 when applicable.

Determination of Human Subject Research

The following activities conducted or supported by the DoD are not considered human subject research:

Activities carried out solely for purposes of diagnosis, treatment, or prevention of injury and disease under force health protection programs of DoD, including health surveillance pursuant to Section 1074f of Title 10, United States Code (U.S.C.), and the use of medical products consistent with DoD Instruction 6200.02.
Health and medical activities as part of the reasonable practice of medicine or other health professions undertaken for the sole purpose of diagnosis, cure, mitigation, treatment, or prevention of disease in a patient.
Activities performed for the sole purpose of medical quality assurance (see Section 1102 of Title 10, U.S.C., and DoD Instruction 6025.13).
Activities that meet the definition of operational test and evaluation as defined in Section 139(a)(2)(A) of Title 10, U.S.C.
Activities performed solely for assessing compliance, including occupational drug testing, occupational health and safety reviews, network monitoring, and monitoring for compliance with requirements for protection of classified information.
Activities, including program evaluation and surveys, user surveys, outcome reviews, and other methods, designed solely to assess the performance of DoD programs where the results are only for the use of government officials responsible for the operation or oversight of the program being evaluated.

See MSU HRPP Manual 4-3, Determination of Human Subject Research, for the not human subject research determination process.

DoD Component Level Review for Non-Exempt Human Subject Research

For DoD-conducted or DoD-supported research, the DoD Component must conduct a component-level administrative review of all non-exempt human subject research when any of the following conditions occur:

Research is conducted in a foreign country, unless it is conducted by a DoD overseas institution, or involves subjects who are DoD-affiliated personnel that are U.S. citizens.
The research requires a waiver of informed consent pursuant to Paragraph (b) of Section 980 of Title 10, U.S.C.
The research is fetal research as described in Sections 289g–289g-2 of Title 42, U.S.C.
Large scale genomic data is collected from DoD-affiliated personnel.
The research constitutes classified human subject research as defined by DoD Instruction 3216.02.
Research is required to be approved by the DoD Office for Human Research Protections.

DoD administrative and DoD Component security reviews must be conducted before research involving large scale genomic data collected from DoD-affiliated personnel may begin. Large scale genomic data is data derived from genome-wide association studies; single nucleotide polymorphisms arrays; genome sequencing; transcriptomic, metagenomic, epigenomic analyses; and gene expression data; etc. Research involving large scale genomic data may or may not also constitute human subject research. Examples of research involving large scale genomic data includes, but is not limited to, projects that involve generating the whole genome sequence data for more than one gene from more than 1,000 individuals, or analyzing 100 or more genetic variants in more than 1,000 individuals.

The MSU PI is responsible to assure the DoD Component review occurs when necessary.

DoD-Conducted Research

DoD institutions conducting human subject research in collaboration with non-DoD institutions, with or without DoD support, must comply with all requirements in the DoD Instruction 3216.02 pertaining to DoD-conducted research.

For DoD-conducted non-exempt human subject research where MSU is engaged and Single IRB requirements apply, an MSU IRB Administrator will work with the MSU PI to identify the IRB of record. Consultation with the MSU HRPP Director will occur if MSU is asked to serve as the IRB of record for DoD-conducted research.

DoD institutions collaborating in human subject research with non-DoD institutions may rely on the collaborating non-DoD institution’s IRB if all of the following conditions are met:

The DoD institution determines the non-DoD institution has an appropriate federal assurance or that a federal assurance is not required.
The non-DoD institution’s IRB is registered in accordance with Subpart E of Part 46 of Title 45, CFR.
The DoD institution reviews the protocol to ensure all applicable local and DoD requirements are addressed in the protocol.
The DoD institution and the non-DoD institution (including if the non-DoD institution uses an independent IRB) enter into an institutional agreement for IRB review specifying that the non-DoD IRB will apply the DoD requirements specified in this issuance.
If the research constitutes classified human subject research, the component office of human research protections, on behalf of the DoD senior designated official, approves the agreement to rely on the non-DoD institution’s IRB.

If MSU agrees to act as IRB of record on a DoD-conducted research study, all requirements for DoD-conducted research must be met. These include:

IRB must comply with Section 219.107 of Title 32, CFR.
IRB will document their consideration of scientific merit; within the consideration of scientific merit, feasibility of study completion should be considered.

For MSU IRB submissions that are DoD-conducted that may be exempt human subject research or are requesting a determination of not human subject research, the MSU IRB Administrator will work with the MSU PI to obtain the DoD determination. For DoD-conducted human subject research, only designated federal DoD HRPP personnel are authorized to make determinations regarding whether or not an activity is human subject research or is exempt human subject research.

DoD-Supported Research

The DoD human research protection official (HRPO) is a federal employee designated by a DoD Component or institution to conduct administrative review of DoD-supported research in accordance with the requirements of the DFARS, or comparable requirement, and whose review of DoD-supported research is intended to ensure compliance with DoD human subject requirements. This review is required for both exempt and non-exempt research.

For non-exempt human subject research, the non-DoD institution must submit to DoD HRPO:

Documentation that the DoD-supported human subject research has been reviewed and approved by an IRB, including scientific merit, amendments, and additional reviews.
Documentation of key investigators’ human research protection training.
IRB-approved protocol documents.
Current FWA and IRB registration number (the non-DoD institution must rely on a federal-wide assurance (FWA), or a comparable federal assurance).

However, when a DoD IRB serves as the reviewing IRB pursuant to Part 219 of Title 32, CFR, the DoD IRB approval will constitute the DoD HRPO review; an additional DoD HRPO review is not required.

For research that is exempt or does not involve human subjects, the non-DoD institution must submit to DoD HRPO:

Institutional documentation of the determination that the research is either not human subject research, exempt human subject research, or limited IRB review.
All protocol documents.

The non-DoD institution must promptly (no longer than within 30 days) notify the DoD HRPO of the following:

When significant changes to the research protocol are approved by the IRB. Significant changes, in this context, include changes to investigators or institutions; decreased benefit or increased risk to subjects in greater than minimal risk research as defined in Part 219 of Title 32, CFR; addition of vulnerable populations as subjects, or addition of DoD-affiliated personnel as subjects.
Transfer of human subject research oversight to a different IRB.
Notification by any federal body, State agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government that the non-DoD institution’s DoD-supported human subject research is under investigation.
Any problems involving risks to subjects or others, suspension or termination of IRB approval, or any serious or continuing noncompliance pertaining to DoD-supported human subject research.
The results of the IRB’s continuing review, if required.
Change in status when a previously enrolled human subject becomes pregnant, or when the researcher learns that a previously enrolled human subject is pregnant, and the protocol was not reviewed and approved by the IRB in accordance with Subpart B, Subpart 46 of Title 45, CFR.
Change in status when a previously enrolled human subject becomes a prisoner, and the protocol was not reviewed and approved by the IRB in accordance with Subpart C, Subpart 46 of Title 45, CFR.
A DoD-supported study’s closure.

The following must be promptly reported to the DoD Office for Human Research Protections:

Allegations of serious or continuing noncompliance related to human subject research that are substantiated by investigation, and subsequent actions taken based on the findings, within five business days of completion of the report
Any unanticipated problems involving risks to subjects or others for any DoD-supported research must be promptly (no longer than within five days) reported
Any suspension or termination of DoD-supported research must be promptly reported (no longer than five days)

The MSU PI is typically responsible for providing the required documentation and notification to DoD HRPO. However, the non-DoD institution must also comply with all reporting requirements that may otherwise be applicable, in addition to the DoD HRPO reporting and submission requirements. See the following sections from the MSU HRPP Manual: 8-10, Site Visits; 9-1, Unanticipated Problems Involving Risks to Subjects or Others; 9-2, Noncompliance; 9-3, Termination or Suspension of IRB Approval; and 4-8, Reporting Policy.

Failure to comply with applicable DoD requirements may result in the DoD:

Wholly or partially terminating or suspending the award;
Temporarily withholding payment under the award pending correction of the deficiency;
Disallowing all or part of the cost of the activity or action that is not in compliance; and/or
Contacting publishers of articles that reference the noncompliant human subject research.

Selection of Human Subjects

The selection of human subjects in DoD-conducted or DoD-supported human subject research must comply with Section 252 of the National Defense Authorization Act for Fiscal Year 1994 (Public Law 103-160), with respect to gender, minority participation, and membership in the Armed Services. The statute requires that the Secretary of Defense ensure that women who are members of the armed forces and members of minority groups who are members of the armed forces are to be included as subjects of the research. The authority to waive the requirements of this statute may be delegated in the component human research protection program management plan.

In the case of a project of clinical research in which women or members of minority groups will be included as subjects of the research, the statute requires that the Secretary of Defense ensure that the project is designed and carried out so as to provide for a valid analysis of whether the variables being tested in the research affect women or members of minority groups, as the case may be, differently than other persons who are subjects of the research.

If an MSU IRB submission proposes to exclude women who are members of the armed forces or members of minority groups who are members of the armed forces, the MSU PI is responsible for working with the DoD to assure that the appropriate waiver is in place.

Minimal Risk

The definition of minimal risk in 32 CFR 219 does not include the inherent occupational risks that certain subjects face in their everyday life, such as those:

Encountered by Service members, law enforcement, or first responders while on duty.
Resulting from or associated with high-risk behaviors or pursuits.
Experienced by individuals whose medical conditions involve frequent tests or constant pain.

DoD-Affiliated Personnel as Subjects

There are additional requirements when human subject research involves DoD affiliated personnel as subjects. DoD-affiliated personnel means service members, Reserve Service members, National Guard members, DoD civilians, and DoD contractors. Service members are individuals appointed, enlisted, or inducted for military service under the authority of the DoD. The Military Services are the Army; the Navy, including the Coast Guard under circumstances involving the declaration of war; the Air Force; the Marine Corps; and the Reserve Components. Members of the Reserve Components are included when in a duty status.

Human subject research that involves DoD-affiliated personnel as subjects must comply with the following requirements:

The key investigator must receive command or Component approval to execute the research.
Military and civilian supervisors, officers, and others in the chain of command:
- Are prohibited from influencing their subordinates to participate in human subject research.
- Must not be present at any human subject research participant recruitment sessions or during the human subject research consent process for DoD-affiliated personnel. Excluded supervisors or those in the chain of command may participate in separate human subject research recruitment sessions, if applicable.
Service members and all Reserve Component and National Guard members in a federal duty status are considered for purposes of this DoD Instruction, to be adults. If a Service member, Reserve Component or National Guard member in federal duty status, student at a Service Academy, or trainee is under 18 years of age, the IRB must carefully consider the human subject research recruitment process and the necessity of including such member as a human subject.
Compensation to DoD-affiliated personnel for participation in research while on duty is prohibited in accordance with Title 5, U.S.C., with particular reference to Subparts G and H, with some exceptions for purposes consistent with Section 30 of Title 24, U.S.C.
If the human subject research includes any risks to the DoD-affiliated personnel’s fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document must inform DoD-affiliated personnel about these risks and that they should seek command or Component guidance before participating.

In order to approve research involving DoD-affiliated personnel as human subjects, the IRB or DoD HRPO must determine whether the following requirements have been satisfied:

The consent documentation must include, if applicable, potential risks for the revocation of clearance, credentials, or other privileged access or duty.
For research involving recruitment of DoD-affiliated personnel in human subject research determined greater than minimal risk, as defined by Part 219 of Title 32, CFR, and when human subject research recruitment occurs in a group setting, the IRB must appoint an ombudsperson. An ombudsperson is a person who acts as an impartial and objective advocate for human subjects participating in research. The ombudsperson:
- Must not have a conflict of interest with the research or be a part of the research team
- Must be present during the human subject research recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials
- Should be available to address DoD-affiliated personnel’s concerns about participation

Consent

Consent documents for all DoD-conducted and DoD-supported research must include:

A statement that the DoD or a DoD organization is funding the study.
A statement that representatives of the DoD are authorized to review research records.

DoD Facility

If the human subject research takes place on a DoD facility, the key investigator must also receive approval from the command or DoD Component responsible for the facility. The MSU PI is responsible for confirming appropriate approvals are in place.

Restrictions on Use of Human Subjects for Testing of Chemical or Biological Agents

Human subject research involving the testing of chemical or biological agents is prohibited, pursuant to Section 1520a of Title 50, United States Code (U.S.C.). Some exceptions for research for prophylactic, protective, or other peaceful purposes apply. Before any excepted testing of chemical or biological agents involving HSR can begin, explicit written approval must be obtained from the DoD Office for Human Research Protections (DOHRP). See Section 1520a of Title 50, U.S.C. for requirements.

Compensation

When the research involves U.S. military personnel, there are limitations on dual compensation:

S. military personnel may be compensated for research if the subject is involved in the research when not on duty.
Federal employees while on duty and non-federal persons may be compensated for blood draws for research up to $50 for each blood draw.

Research Involving Large Scale Genomic Data Collected on DoD-Affiliated Personnel

DoD-conducted or DoD-supported research involving large scale genomic data collected on DoD-affiliated personnel, or for which research the DoD provides assistance, is subject to additional requirements.

When research involves large scale genomic data collected from DoD-affiliated personnel, the following requirements apply:

Requires administrative, technical, and physical safeguards commensurate with risk, including the secondary use or sharing of de-identified data or specimens, as the disclosure of DoD-affiliated personnel’s genomic data may pose a risk to national security.
Is subject to DoD Component security review to ensure the adequacy of the proposed administrative, technical, and physical safeguards, including the secondary use or sharing of de-identified data or specimen.
Requires application for a U.S. Health and Human Services Certificate of Confidentiality pursuant to Title 42, U.S.C., and Public Law 114-255.

Provisions for Research-Related Injury

For DoD-supported research involving human subjects, all non-exempt human subject research must meet the requirement in Section 219.116 of Title 32, CFR.

For DoD-conducted research involving human subjects, all human subject research that is determined to be greater than minimal risk must meet the requirement of Section 219.116 of Title 32, CFR, to provide subjects with an explanation as to whether any compensation and any medical treatments are available for research–related injuries.

Explanations must include a statement that subjects may, for the duration of the study, be eligible for health care services for research-related injuries at a military treatment facility, in accordance with Part 108 of Title 32, CFR. This eligibility for health care services extends beyond subjects’ participation in the study to such time after the study has ended, in accordance with Section 219.108 of Title 32, CFR.
Component human research protection program management plans and institutional HRPPs must document how institutions will care for subjects with research-related injuries, including injuries that are the direct result of activities performed by DoD-affiliated personnel in studies that are collaborative with a non-DoD institution.
Subjects injured in DoD-conducted research may obtain care for such injuries at a DoD medical treatment facility on a space-available basis during the pendency of the research study in accordance with DoD Instruction 6025.23

The MSU PI is responsible for informing the IRB if there are any requirements from DoD Component’s related to the provision of care in the case of a research-related injury. If the DoD Component has stricter requirements than the Common Rule or MSU HRPP policies, this will need to be discussed and agreed upon by MSU’s General Counsel and Institutional Official. These requirements will also need to be disclosed in the informed consent document.

Unique DoD Limitations on Waiver of Consent

Section 980 of Title 10, U.S.C imposes limitations on waiving informed consent when DoD appropriated funds are used to finance the research. The limitation is:

Applicable only to DoD-conducted and DoD-supported research when involving a human being as an experimental subject, who are a subset of research involving human subjects.
Not applicable to exempt human subject research.

Research involving a human being as an experimental subject is an activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving a human being as an experimental subject is a subset of research involving human subjects. This definition relates only to the application of Section 980 of Title 10, U.S.C.; it does not affect the application of Part 219 of Title 32, CFR.

When Section 980 of Title 10, U.S.C. applies:

Informed consent must be obtained in advance from the experimental subject or the subject’s legal representative (consistent with Part 219 of Title 32, CFR, if the subject cannot consent).
If consent is obtained from the subject’s legal representative, the intention of the key investigator must be for the research to be beneficial to the subject.
For research that involves no more than minimal risk, an IRB may alter or waive other required elements of informed consent pursuant to Part 219 of Title 32, CFR, so long as it still preserves informed consent of the subject (i.e., the consent indicates the subject’s participation in the research is completely voluntary and includes the requirement that the subject is informed of research risks).

The advance informed consent requirement pursuant to Section 980 of Title 10, U.S.C. may be waived by DoD Office for Human Research Protections or its delegate when the following conditions are met:

The research is to advance the development of a medical product necessary to the DoD.
The research may directly benefit the individual experimental subject.
The research is conducted in compliance with all other applicable laws and regulations.

Certificate of Confidentiality

A DoD institution conducting human subject research or a non-DoD institution conducting human subject research with DoD support may request a Certificate of Confidentiality (CoC) pursuant to Section 241 of Title 42, U.S.C. All studies involving large scale genomic data collected on DoD-affiliated personnel will apply for an U.S. Health and Human Services CoC.

Pregnant Women

For purposes of applying Subpart B, the phrase “biomedical knowledge” is replaced with “generalizable knowledge.” However, the applicability of Subpart B is limited to research involving pregnant women as human subjects involved in human subject research that is more than minimal risk, and includes interventions, as defined in Part 219 of Title 32, CFR, or invasive procedures involving: the woman or the fetus; or fetuses or neonates as human subjects.

Human subject research using fetal tissue must comply with Sections 289g–289g-2 of Title 42, U.S.C.

For human subject research that would not otherwise be approved but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates, DoD institutions must demonstrate to the DoD senior designated official that the IRB has fulfilled its duties in accordance with Subpart B of Part 46, Title 45, CFR. Before human subject research activities may begin, the DoD senior designated official must receive explicit written approval from the DoD Office for Human Research Protections.

Prisoners

In addition to the categories of permissible human subject research involving prisoners identified in Subpart C of Part 46 of Title 45, CFR, two additional categories are permissible:

Epidemiological research that meets the waiver criteria in accordance with Pages 36929-36931 of Volume 68, Federal Register, may be approved in accordance with the applicable requirements of Subpart C of Part 46 of Title 45, CFR, this issuance, and other applicable requirements.
Human subject research that would otherwise meet exemption criteria may be conducted, but must first be approved by an IRB and must meet the requirements in Subpart C of Part 46 of Title 45, CFR, this issuance, and other applicable requirements.

DoD institutions conducting research involving prisoners must demonstrate to the DoD senior designated official that the IRB has fulfilled its duties in accordance with Subpart C of Part 46 of Title 45, CFR.

When a previously enrolled human subject becomes a prisoner, and the protocol has not been reviewed and approved by the IRB in accordance with Subpart C of Part 46 of Title 45, CFR, the key investigator must promptly notify the IRB. For DoD-conducted research, the DoD Human Protections Director must notify the DoD component office of human research protections. For DoD-supported research, the non-DoD institution must notify the DoD HRPO and other federal agencies, if required.

Detainees or Prisoners of War

Research involving a detainee or prisoner of war as a human subject is prohibited.

Detainee is defined in DoD Directive 2310.01E as any individual captured by, or transferred to the custody or control of, DoD personnel pursuant to the law of war. This does not include persons being held solely for law enforcement purposes, except where the United States is the occupying power. Detainees who are U.S. citizens or U.S. resident aliens will continue to enjoy all applicable rights and privileges under U.S. law and DoD regulations. (August 19, 2014; Incorporating Change 2, Effective September 18, 2020)

A prisoner of war is defined as a detained person as defined in Articles 4 and 5 of the Geneva Convention Relative to the Treatment of Prisoners of War of August 12, 1949. In particular, one who, while engaged in combat under orders of his or her government, is captured by the armed forces of the enemy. As such, they are entitled to the combatant's privilege of immunity from the municipal law of the capturing state for warlike acts which do not amount to breaches of the law of armed conflict. For example, a prisoner of war may be, but is not limited to, any person belonging to one of the following categories who has fallen into the power of the enemy: a member of the armed forces, organized militia or volunteer corps; a person who accompanies the armed forces without actually being a member thereof; a member of a merchant marine or civilian aircraft crew not qualifying for more favorable treatment; or individuals who, on the approach of the enemy, spontaneously take up arms to resist the invading forces. Also called POW or PW.

This prohibition does not apply to activities covered by investigational new drug or investigational device provisions of Title 21, CFR when the purpose is for diagnosis or treatment of a medical condition in a patient. Such treatment may be offered to detainees or prisoners of war with their informed consent when the medical products are subject to Title 21, CFR, and only when the same product may be available to DoD-affiliated personnel consistent with established medical practices.

Children

Human subject research involving children as human subjects must comply with Subpart D of Part 46 of Title 45, CFR. DoD institutions must demonstrate to the DoD senior designated official that the IRB has fulfilled its duties in accordance with Part 407 of Subpart D of Part 46 of Title 45, CFR, and Section 50.54 of Title 21, CFR.

Noncompliance

For noncompliance allegations involving a non-DoD institution, the non-DoD institution must conduct an investigation in accordance with the applicable support agreement, to be furnished to the supporting DoD organization via the DoD HRPO. The DoD institution supporting the human subject research must ensure in its agreements with the non-DoD institution that allegations are promptly and properly investigated. The DoD institution will then promptly report substantiated serious and/or continuing non-compliance findings to the DoD component office of human research protections.

Records

Records maintained that document compliance or non-compliance with DoD regulations must be made accessible for inspection and copying by representatives of the DoD at reasonable times and in a reasonable manner as determined by the supporting DoD component. The non-DoD institution must make records that document compliance or noncompliance with DoD Instruction 3216.02 accessible for inspection and copying, as determined by DoD HRPP personnel, by authorized DoD representatives.

Part 219 of Title 32, CFR, requires all institutions engaged in DoD-conducted or DoD-supported human subject research to retain records for at least 3 years after the completion of the research, or longer if required by DoD Manual 6025.18, the Privacy Act, FDA regulations, or other applicable requirements.

The MSU PI is responsible for informing the MSU HRP if records need to be maintained longer than three years after completion of the research.

Classified Research

The DoD Office for Human Research Protections is the final approval authority for all DoD-conducted or DoD-supported classified human subject research. See DoD Instruction 3216.02 for requirements. MSU does not accept classified projects. See MSU Manual Business Procedures Section 315: Sponsored Projects, Fee-for-Service, and Gifts.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 7-19-2011. Revision 1 approved by VP Research & Graduate Studies on 7-13-2016. Revision 2 approved by Assistant VP Regulatory Affairs on 11-27-2021. Revision 3 approved by Associate VP Research Regulatory Support on 7-23-2022.

Human Research Protection Program Office of Research Regulatory Support