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Research Regulatory Oversight Office

The Research Regulatory Oversight Office (R2O2) is responsible for oversight of DoD-conducted and -supported research activities involving humans and animals to ensure compliance with all legal and ethical requirements. Our oversight responsibility includes:

  • Research involving human subjects
  • Research and testing with animals
  • Implementation of the research integrity and misconduct rules

The scope of our oversight includes all institutions under the purview of the Under Secretary of Defense for Personnel and Readiness (P&R).

Our Programs

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Information Sheet Regarding the DoD Addendum to the HHS FWA for the Protection of Human Subjects

Fact Sheet
12/2/2009

This information sheet is a tool for institutions receiving funds from OUSD(P&R) institutions for the purpose of conducting research with human subjects when the DoD or its employees are not involved in the conduct of the research.

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Research Regulatory Oversight Office

DoD Addendum to the Department of Health and Human Services Federalwide Assurance for the Protection of Human Subjects

Form/Template
8/20/2009

This form is a tool to help Institutions with an existing FWA approved by DHHS to know about and acknowledge key DoD policies and requirements since the DHHS FWA does not identify DoD requirements.

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Research Regulatory Oversight Office

Researcher Responsibility Form

Form/Template
4/16/2009

The Office of the Under Secretary of Defense for Personnel and Readiness requires that all research investigators (principal investigators as well as associate investigators) engaged in research with one of its institutions explicitly acknowledge and accept responsibility for protecting the rights and welfare of human research subjects as stated therein.

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Research Regulatory Oversight Office

Transportation, Sale, and Handling of Certain Animals

Policy

The Congress finds that animals and activities which are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce or the free flow thereof, and that regulation of animals and activities as provided in this chapter is necessary to prevent and eliminate burdens upon such commerce and to effectively regulate such commerce.

Protection of Human Subjects in Research Projects

Policy

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to address requirements for the protection of human subjects involved in research projects. The proposed rule contains a clause for use in contracts that include or may include research involving human subjects.

DoD Grants and Agreement-General Matters

Policy

Protection of Human Subjects

Policy

This policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research.

Training Requirements for Authorization of Eligibility to Engage in HSPP Activities

Policy

Under the management plan for the Human Subject Protection Program, all personnel involved in the program, including Component Designated Official (CDO) Oversight Office staff, Institutional Officials, IRB members, administrative staff, and investigators must complete initial and annual refresher training (listed in attached information paper) to be eligible to participate in activities under the purview of the HSPP. These activities include the support, review or conduct of research involving humans.

18 U.S.C. 42-43: Lacey Act

Policy

Final Rule: Animal Welfare

Policy

Often referred to as the "Preamble" to the Animal Welfare Act amendments of 1985, the explanations of the regulations are used to identify the intent of the regulations published in Title 9, Code of Federal Regulations. This issue contains final regulations developed to enact the 1985 amendments to the Animal Welfare Act covering the Definitions and Regulations sections. Extensive commentary is provided to respond to public comments about each of the proposed regulations. Comments and final regulations are provided in many areas including the structure and functions of the Institutional Animal Care and Use Committee; the principal investigator's consideration of alternatives that reduce, refine, or replace animal use; records; licensing; registration; stolen animals; and research facilities.

Belmont Report

Policy

On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations.

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