MSU HRPP Manual Section 2-2-A

2-2-A, U.S. Department of Defense

Identification of U.S. Department of Defense Sponsored Research
This policy applies to all research involving human subjects supported by the U.S. Department of Defense. While all units of the Department of Defense (DoD) abide by the Common Rule, including subparts B-D (protections for vulnerable populations of pregnant women, prisoners, and children), some components have unique policies and procedures that reflect the characteristics of the agency (e.g., leadership, culture, risk tolerance, mission) for approving institutions and assuring compliance for their sponsored research.

When submitting an application for human subject research to the IRB, the principal investigator (PI) must identify the research as sponsored or funded by a DoD component (as defined in Department of Defense Directive 3216.02). The PI is responsible for identifying DoD component requirements specified in the grant application guidelines and for advising the IRB staff and IRB of the requirements.

Responsibility
It is the responsibility of the PI to ensure that all additional DoD and/or Specific component requirements (e.g. Army, Navy, Air Force) requirements for human subject protection are met. It also is the responsibility of the IRB to ensure that all additional requirements for human subject protection have been met before IRB approval of the research study.

Definitions
Research Involving a Human Being as an Experimental Subject
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 [32 CFR 219.102(f), reference (c)]. Examples 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.

DoD Components
Refers collectively to the organizational entities within the DoD that are subject to the human subjects protections laid out in Department of Defense Directive.

Research Monitor
A physician, dentist, psychologist, nurse, or other healthcare provider designated to oversee a specific protocol that involves more than minimal risk, especially issues of individual subject/patient management and safety. The research monitor functions independently of the research team and shall possess sufficient educational and professional experience to serve as the subject/patient advocate.

Prisoner of War
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, he or she is 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.

Specific considerations and Procedures for DOD Research

Surveys
When additional review for DOD sponsored survey research or survey research with the DOD is required, surveys typically require DOD survey review and approval. 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.

Scientific Review
DoD requires scientific review prior to IRB review for all new DoD supported human research. DoD also requires that all substantive amendments to approved DoD research involving human subjects receive scientific review prior to IRB review. Changes that do not qualify as minor in the Human Research Protection Program (HRPP) Manual 8-6 “Revisions to an Approved Research Study” and are submitted to the full IRB constitute substantial amendments. The PI is responsible for providing documentation of the scientific review to the IRB. For non-exempt research, the IRB must consider the scientific merit of the research. The IRB may rely on outside experts to provide an evaluation of scientific merit.

Minimal Risk
The definition of minimal risk based on the phrase “ordinarily encountered in daily life or during the performance of routine physical or physiological examination or tests” shall not be 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.)

Education Requirements
DOD requires initial and continuing mandatory ethics education requirements for human subjects protections. The HRPP Manual 11-1-A “Education: Investigators and Research Staff” for mandatory and continuing education to meet this requirement. The DoD component may evaluate the education policies to ensure the personnel are qualified to perform the research, based on the complexity and risk of the research.

Research Involving International Citizen Populations
For research conducted internationally the IRB will take into consideration subject populations, the cultural context, the languages understood by the human subjects, identifying and considering  local laws, regulations, customs, and practices. In addition determinations are made as to whether the sponsoring DoD Component requires an additional ethics review by the host country to assure the researcher follow all local laws, regulations, customs, and practices. The IRB may require the investigator obtain permission to conduct research in that country by either certification or local ethics review. These additional safeguards might now be applicable to social/behavioral research involving no more than minimal risk.

Reporting Requirements
See the following sections from the HRPP Manual: 8-10 “Site Visits,” 9-1 “Unanticipated Problems Involving Risks to Subjects or Others,” 9-2 “Noncompliance.” All findings of serious noncompliance shall be promptly reported to the DoD (no longer than 30 days). The IRB will report to DoD any of the following for DoD-related research:

  • Suspension or termination of the research
  • Initiation and results of investigations of alleged noncompliance
  • Unanticipated problems involving risks to subjects or others, and/or serious adverse events
  • Any audit, investigation or inspection of DoD-supported research
  • Any audit, investigation, or inspection of the institution’s HRPP conducted by outside government entities (e.g., U.S. Food and Drug Administration, U.S. Office for Human Research Protections)
  • Significant communication between institutions conducting research and other federal departments and agencies regarding compliance and oversight
  • Any restriction, suspension or termination of the institutions’ assurance

The following must also promptly (no longer than within 30 days) by the researcher to the DoD human research protection officer:

  • When significant changes to the research protocol are approved by the IRB
  • The results of IRB continuing review
  • Change of reviewing IRB
  • When MSU is notified by any federal department, agency, or national organization that any part of an HRPP is under investigation for cause involving a DoD-supported research protocol

Multi-Site or Collaborative Research Requirements
When conducting multi-site research, formal agreements may be necessary to ensure that participating institutions understand and accept their scope of work specific roles and responsibilities agreed upon by each site engaged in research. See HRPP Manual 6-9-F “Multiple Research Sites.”

Research Monitor Required: Greater than Minimal Risk Studies
For DoD-sponsored research involving greater than minimal risk to subjects, the DoD requires appointment of an independent research monitor. The IRB can require a research monitor for a portion of the research or studies involving no more than minimal risk if appropriate. The research monitor has the authority to: 1) Stop a research study in progress; 2) Remove individuals from the study; 3) Take any steps to protect the safety and well–being of subjects until the IRB can assess the research monitor’s report. The PI in coordination with the IRB identifies a candidate for the position of research monitor, taking into account the nature and disciplinary focus of the study and the likely type of medical expertise required. The IRB will ensure that the research monitor is independent of the research team.  The independent research monitor is appointed by name. There may be more than one research monitor (e.g. if different skills or experience are needed).   The monitor may be an ombudsman or a member of the data safety monitoring board.  The IRB must approve a written summary of the monitors’ duties, authorities, and responsibilities.  The duties of the research monitor are determined on the basis of specific risks or concerns about the research.  The research monitor may perform oversight functions (e.g. observe recruitment, enrollment procedures, and the consent process, oversee study interventions or interactions, review monitoring plans and unanticipated problems involving risks to subjects or others, oversee data matching, data collection and analysis).  In addition, the monitor may discuss the research protocol with researchers, interview human subjects and consult with others outside of the study.  The monitor will report observations and findings to the IRB or a designated official. The IRB or HRPP official must communicate with research monitors to confirm their duties, authorities, and responsibilities.

Research Involving U.S. Military Personnel as Research Subjects
If any research includes U.S. military personnel as subjects the IRB protocol must include a plan for research subject recruitment that incorporates additional safeguards to minimize undue influence from individuals within a potential subject’s chain of command. The PI is required to consult with the sponsoring DoD Component to ensure the IRB the following safeguards are in place: 1) Officers are not permitted to influence the decision of their subordinates; 2) Officers and senior non-commissioned officers may not be present at the time of recruitment; 3) Officers and senior non-commissioned officers have a separate opportunity to participate; 4) When recruitment involves a percentage of a unit, an independent ombudsman is present. In addition, military personnel cannot receive compensation for participation if it is during regular duty hours, unless it is a blood draw for which a subject may receive up to $50 for each blood draw.  However, once they are no longer on duty they can receive compensation.

Provisions for Research-related Injury
The PI is responsible for informing the IRB if there are any requirements from DoD Component’s 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 General Counsel and Institutional Official. These requirements will also need to be disclosed in the informed consent document

Waiver of Consent and Exception from Informed Consent in Emergency Medicine
If a research subject meets the definition of “experimental subject,” DoD regulations prohibit a waiver of consent unless the PI obtains a waiver from the Assistant Secretary of Defense for Research and Engineering. The Assistant Secretary for Defense for Research and Engineering may waive the requirements for consent when all of the following are met: The research is necessary to advance the development of a medical product for the Military Services; the research may directly benefit the individual experimental subject; and the research is conducted in compliance with all other applicable laws and regulations. The IRB may waive the consent process if the research does not meet the definition of “experimental subject.” DoD regulations prohibit an exception from informed consent in emergency medicine research unless the PI obtains a waiver from the Secretary of Defense. If consent is to be obtained from the experimental subjects’ legal representative, the research must intend to benefit the individual participant. The determination that research is intended to be beneficial to the individual experimental subject must be made by an IRB.

Classified Research
Classified research must receive prior approval from the Secretary of Defense. Classified research is not eligible for review under expedited review process. For classified research, waivers of consent are prohibited.

Prisoner of War
Under no circumstances shall the IRB approve research involving prisoners of war, as defined by the specific DoD Component.

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.

Pregnant Women
When following Department of Defense Requirements: for purposes of applying Subpart B, the phrase “biomedical knowledge” must be replaced with “generalizable knowledge.”  However, the applicability of Subpart B is limited to research involving pregnant women as subjects in research that is more than minimal risk and included interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as subjects.

Prisoners
Research involving prisoners sponsored by the DoD cannot be reviewed by expedited procedure. When the IRB reviews research involving prisoners, at least one prisoner representative must be present.

When a participant becomes a prisoner, if the researcher asserts to the IRB that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner, the IRB chair may determine that the prisoner-participant may continue to participate until the convened IRB can review this request to approve a change in the research protocol and until the organizational official and DoD Component office review the IRB’s approval to change the research protocol. Otherwise, the IRB chair must require that all research interactions and interventions with the prisoner- subject (including obtaining identifiable private information) cease until the convened IRB can review this request to approve a change in the research protocol. The convened IRB, upon receipt of notification that a previously enrolled human participant has become a prisoner, must promptly re- review the research protocol to ensure that the rights and wellbeing of the human subject, now a prisoner, are not in jeopardy. The IRB should consult with a subject matter expert having the expertise of a prisoner representative if the IRB reviewing the research protocol does not have a prisoner representative. If the prisoner-participant can continue to consent to participate and is capable of meeting the research protocol requirements, the terms of the prisoner-participant’s confinement does not inhibit the ethical conduct of the research, and there are no other significant issues preventing the research involving human subjects from continuing as approved, the convened IRB may approve a change in the study to allow this prisoner-participant to continue to participate in the research. This approval is limited to the individual prisoner-participant and does not allow recruitment of prisoners as subjects

Detainee
Research involving a detainee as a human subject is prohibited. This prohibition does not apply to research involving investigational drugs and devices when the same products would be offered to US military personnel in the same location for the same condition.

Children
The exemption for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

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.

Related HRPP Manual Sections

Approved PDF Version

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