Committee For the Protection of Human Subjects

Department of Defense

POLICY

It is the policy of UTHSC-H 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.

UT Houston has signed the Department of Defense addendum to its Federalwide 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.

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: UT Houston 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.

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: Serious or continuing non-compliance will be reported to DoD as per the CPHS policy on Reporting.

 

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:

§  Participants are not permitted to receive pay of compensation for research during duty hours however, participants may be compensated for research if the participant is involved in the research when not on duty.

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. The research monitor has the authority to:

§  Stop a research study in progress.

§  Remove individuals from study.

§  Take any steps to protect the safety and well being of participants until the IRB or EC can assess.

 

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 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:

ORSC Director

Effective:

1 Nov 2011

Revision History:

 

 

 

 

 

 


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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