Department of Defense

POLICY

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.

Key Terms

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.

PROCEDURE

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.

International Research: Researchers have additional responsibilities while conducting research that involves subjects in international setting:

Reporting: The IRB Director will report the following promptly (within 30 days) to the DoD human subjects protection officer:

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:

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).

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:

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.

APPLICABLE REGULATIONS

  1. 32 CFR 219
  2. DoD Directive 3216.2.

REFERENCE TO OTHER POLICIES

1.       Initial Review

ATTACHMENTS

1.       None

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

Document Number:

101-C16

Document Name:

Department of Defense

Approved by:

Executive Director, Research Compliance

Effective:

1 Nov 2011

Revision History:

 1 June 2016, 1 Sept 2016

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

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Committee for the Protection of Human Subjects
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713-500-7943
Fax     713-500-7951
Email cphs@uth.tmc.edu 

IRIS Support 713-500-7960

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