Department of Defense
It is the policy of UTHealth that when human subjects research is funded or supported by the Department of Defense (DoD) or one of its components, CPHS will ensure compliance with DoD Regulations for “Protection of Human Subjects” at 32 CFR 219 and with DoD Directive 3216.2.
UTHealth has signed the Department of Defense addendum to its Federal-Wide Assurance (FWA) assuring that it will apply the DoD regulations human subjects research involving the DoD.
Research Involving a Human Being as an Experimental Subject is defined as 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.
Minimal Risk refers to risks 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.)
Research involving humans as experimental subject include research 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 does not include activities that are not considered research involving human subjects, activities that meet the exemption criteria and research involving the collection or study of existing data, documents, records, or specimens from living individuals.
Research Monitor refers to 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.
Educational Requirements: UTHealth requires all key study personnel to pass the online CITI test every three years. There may be specific DoD educational requirements or certification required. The Principal Investigator is responsible for ensuring that the research staff have completed all the educational requirements of the specific DoD component policy. Researchers may contact the Program Officer at DoD or DoD Component for more information on the educational requirement specific for the DoD component. CPHS staff and members refer to the Research Involving Department of Defense policy to ensure that the specific requirements contained in Department of Defense regulations and directives are met.
Scientific Review: Initial proposals and subsequent substantive amendments to approved research must undergo scientific review. This requirement may be met by scientific review by the departmental committee or scientific review conducted by appropriately qualified CPHS members as part of the CPHS review process.
Vulnerable Subjects: Research involving pregnant women, prisoners, and children are subject to the DHHS Subparts B, C. and D.
- For purposes of applying Subpart B, the phrase “biomedical knowledge” shall be replaced with “generalizable knowledge.”
- The applicability of Subpart B is limited to research involving pregnant women as participants 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 participants.
- Fetal research must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.
- Research involving prisoners cannot be reviewed by the expedited procedure.
- When the IRB reviews research involving prisoners, at least one prisoner representative must be present for quorum.
- If consent is obtained from experimental subjects’ legal representative, the research must intend to benefit the individual subject. The determination that the research is intended to beneficial to the individual experimental subject must be made by the IRB.
- In addition to allowable categories of research on prisoners in Subpart C, epidemiological research is also allowable when:
- The research describes the prevalence or incidence of a disease by identifying all cases or studies potential risk factor association for a disease.
- The research presents no more than minimal risk.
- The research presents no more than an inconvenience to the participant. If 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 shall 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, shall 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 participants 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 participants.
- Research involving a detainee as a human participants is prohibited.
- This prohibition does not apply to research involving investigational drugs and devises when the same products would be offered to US military personnel in the same location for the same condition.
- 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.
International Research: Researchers have additional responsibilities while conducting research that involves subjects in international setting:
- Researcher must obtain permission to conduct research in that country by certification or local ethics review.
- Researcher must follow all local laws, regulations, customs, and practices.
Reporting: The IRB Director will report the following promptly (within 30 days) to the DoD human subjects protection officer:
- IRB determinations of serious or continuing noncompliance,
- Suspensions and terminations of IRB approval,
- Unanticipated problems involving risks to subjects or others,
- Significant changes approved by the IRB,
- Results of IRB continuing review,
- Change of reviewing IRB,
- Any for cause investigation of DoD support research by federal departments, federal agencies or national organizations.
Records on compliance or noncompliance with DoD requirements shall be made available for inspection and copying by representatives of the DoD at reasonable times and in a reasonable manner.
Research Involving Department of Defense Personnel: Surveys performed on Department of Defense personnel must be submitted, reviewed, and approved by the Department of Defense after the research protocol is reviewed and approved by the IRB.
Research Involving US Military Personnel: When research involves U.S. military personnel the proposed research must have additional protections for military research participants to minimize undue influence:
- Officers are not permitted to influence the decision of their subordinates.
- Officers and senior non-commissioned officers may not be present at the time of recruitment.
- Officers and senior non-commissioned officers have a separate opportunity to participate.
- When recruitment involves a percentage of a unit, an independent ombudsman is present.
- When research involves U.S. military personnel, policies and procedures require limitations on dual compensation:
- Federal employees while on duty and non-Federal persons may be compensated for blood draws for research up to $50 for each blood draw.
- Non-federal persons may be compensated for research participation other than blood draws in a reasonable amount as approved by the IRB.
Multi-site Research: When conducting multi-site research, a formal agreement between organizations is required to specify the roles and responsibilities of each party.
Research Involving Greater than Minimal Risk: When research involves greater than minimal risk, CPHS will require the appointment of a research monitor. CPHS may require a monitor for a portion of the research or studies involving no more than minimal risk, if appropriate. The Principal Investigator must appoint an independent research monitor 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 IRB or HRPP official shall communicate with research monitors to confirm their duties, authorities, and responsibilities.
- The duties of the research monitor are determined on the basis of specific risks or concerns about the research, such as:
- Perform oversight functions (e.g. observe recruitment, enrollment procedures, and the consent process, oversee study interventions and interactions, review monitoring plans and unanticipated problems involving risks to participants or others, oversee data matching, data collection and analysis).
- Discuss the research protocol with researchers, interview human subjects, and consult with others outside of the study.
- Report observations and findings to the IRB or a designated official.
Research Related Injuries: CPHS reviewer will ensure that the disclosure includes that provisions for research-related injury follow the requirements of the DoD component.
Waiver of Consent: If the research participant meets the definition of “experimental subject,” policies and procedure prohibit a waiver of the consent process unless a waiver is obtained from the Assistant Secretary of Defense for Research and Engineering. The Assistant Secretary of Defense for Research and Engineering may waive the requirement for informed consent when all of the following are met:
- The research is necessarily to advance the development of a medical product for the Military Services.
- The research might benefit the individual experimental subject.
- The research is conducted in compliance with all other applicable laws and regulations.
An exception from consent in emergency medicine research is prohibited unless a waiver is obtained from the Secretary of Defense. If the research participant does not meet the definition of “experimental subject,” policies and procedures allow the IRB or EC to waive the consent process.
Prisoner of War: Research involving prisoners of war is prohibited.
- 32 CFR 219
- DoD Directive 3216.2.
REFERENCE TO OTHER POLICIES
1. Initial Review
If you find errors in this document, contact firstname.lastname@example.org
Department of Defense
Executive Director, Research Compliance
1 Nov 2011
|1 June 2016, 1 Sept 2016|
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