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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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Part II: DoD and OUSD (P&R) Specific and Unique Requirements

Policy

Outlines specific and unique requirements for Research Oversight.

PHS Policy on Humane Care and Use of Laboratory Animals

Policy

The 2015 reprint of the PHS Policy reflects the following changes from the 2002 reprint: (1) On January 1, 2012, OLAW adopted the Guide for the Care and Use of Laboratory Animals: Eighth Edition (Guide), an update of the 1996 Seventh Edition, released by the National Academy of Sciences Institute for Laboratory Animal Research (ILAR) in 2011.

AVMA Guidelines for Euthanasia of Animals

Policy

The AVMA Guidelines for the Euthanasia of Animals are intended for use by members of the veterinary profession who carry out or oversee the euthanasia of animals. The overriding commitment of these Guidelines is to provide veterinarians guidance in relieving pain and suffering of animals that are to be euthanized.

DoD Instruction 3216.02: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

Policy

This Instruction reissues DoD Directive (DoDD) 3216.02 as a DoD Instruction in accordance with the authority in DoDD 5134.01 to establish policy and assign responsibilities for the protection of human subjects in DoD-supported programs to implement part 219 of title 32, Code of Federal Regulations (CFR) (also known and hereinafter referred to as “the Common Rule.”

Guide for the Care and Use of Laboratory Animals

Policy

The purpose of the Guide for the Care and Use of Laboratory Animals (the Guide), as expressed in the charge to the Committee for the Update of the Guide, is to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate.

Animal Welfare

Policy

48 CFR 252.235-7002: Animal Welfare

DoD Instruction 3216.01: Use of Animals in DoD Programs

Policy

This Instruction reissues DoD Directive (DoDD) 3216.1 (Reference (a)) as a DoD Instruction (DoDI) in accordance with the authority in DoDD 5134.01 (Reference (b)) to establish policy and assign responsibilities for the use of animals in DoD programs. The Reference (a) designation of the Secretary of the Army as the DoD Executive Agent to develop and issue Service regulations to implement Reference (a) has been cancelled pursuant to Deputy Secretary of Defense Memorandum (Reference (c)).

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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