Research Policy Links

A collection of pages designed to help one understand the HIPAA Privacy Rule, the HIPAA Security Rule, and the Patient Safety Rule, all of which relate to the privacy of individuals and the protection of personally identifiable information. The site also provides information on filling a complaint and enforcing possible violations.

The Belmont Report summarizes research guidelines related to the conduct of research involving human subjects put forth by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The report serves as a historical reference for understanding present-day U.S. regulations on the use of human subjects in biomedical and behavioral research.

This link refers to HHS regulations for the protection of human participants. Subpart A is referred to as the “The Common Rule” or the “Federal Policy for the Protection of Human Subjects,” which contains a collection of regulations related to the protection of human participants agreed to by 17 federal agencies.

This page provides details on the limitations surrounding the use of humans as experimental subjects, which specifies that funds appropriated to the DoD may not be used for research involving a human as an experimental subject unless it meets one of the applicable exceptions (which can be found on said page) or unless the Secretary of Defense waives the prohibition with respect to a specific research project.

The FDA Web site provides information on applicable guidance, including 21 CFR 50, 56, 312, 600, and 812. These guidelines cover, among other topics, informed consent.

The OMB Circulars apply to all federally-funded research. Working cooperatively with grant-making agencies and grantee communities, OMB leads the development of government-wide policy to ensure that grants are managed properly and that federal funds are spent in accordance with applicable laws and regulations. OMB does not award grants. The OMB Circulars relevant to federally-funded research include:

2 CFR 215 OMB Circular (previously A-102 and A-110): “State and Local Governments” and “Institutions of Higher Education, Hospitals, and Other Nonprofit Organizations” [PDF 243 KB]

2 CFR 220 OMB Circular (previously A-21): “Cost Principles” [PDF 383KB]

2 CFR 225 OMB Circular (previously A-87): “State, Local and Tribal Governments” [PDF 361 KB]

2 CFR 230: OMB Circular (previously A-122): “Nonprofit Organizations” [PDF 234 KB]

A-133 OMB Circular: “Audits of States, Local Governments and Nonprofit Organizations” [PDF 172 KB]

This page provides information about CFR Title 42, which requires that all institutions seeking Public Health Service (PHS) funding maintain a written, enforced COI policy. The page provides specific suggestions on how to implement a COI policy that fosters compliance with PHS regulations.

This site contains information on parties that are excluded from receiving federal contracts, certain subcontracts and certain federal financial and nonfinancial assistance.

This page provides an overview of the federal guidance governing the selection, transfer and use of select agents and toxins.

This PDF represents the DoD instruction meant to reissue DoD Directive 3216.02, as well as establish policy and assign responsibilities, for the protection of human subjects in DoD-supported programs in accordance with the implementation of part 219 of the CFR Title 32.

This link contains DoD policies and procedures related to the award and administration of DoD grants and agreements. They are issued under the authority of DoD Directive 3210.6.

This directive specifies detailed DoD procedures and standards for the prevention of research misconduct. The directive is consistent with the “Federal Policy on Research Misconduct,” which calls upon those federal agencies that support or conduct research on an intramural or extramural basis to issue policies and procedures that conform to the federal policy.

This directive establishes policy regarding the use of experimental new drugs in force health protection and designates the Secretary of the Army as the DoD Executive Agent responsible for such matters.

This page contains information regarding the Defense Federal Acquisition Regulation Supplement policy on human research.

This page contains information regarding the Defense Federal Acquisition Regulation Supplement policy on the protection of human subjects.

This directive establishes policy and assigns responsibilities governing the coordination and management of medical research efforts and DoD programs related to prevention, mitigation and treatment of blast injuries.

This instruction provides guidance in the administration and use of personnel surveys to foster the development of effective survey systems, reduce the burden on DoD components and minimize the exposure of DoD personnel, the public and military service members and their families to unwarranted survey solicitations.

This instruction establishes and reissues policies, as well as assigns responsibilities, for the collection of information and paperwork management. Please visit the link above for additional information.

The policy provides guidance to program managers and action officers who need to obtain information from other federal agencies, DoD components or the public, and provides them with the procedures necessary to license their information requirements.

This instruction applies to all human subject research conducted or supported by the Air Force. It applies to research that includes human subjects, whether as the direct object of research or as the indirect object of research in the development and testing of military weapon systems, vehicles, aircraft and other material.

This page provides an overview of the terms and conditions as well as requirements by which recipients of AFOSR grants (specifically those awards subject to 2 CFR Part 215) must abide.

This document provides an overview of the U.S. Air Force’s instruction on the use and protection of human subjects in research.

This regulation prescribes Army policies, procedures and responsibilities for the use of U.S. Food and Drug Administration (FDA)-regulated investigational products, the use of FDA-approved drugs for unapproved indications in humans, and the use of U.S. Drug Enforcement Administration Schedule I controlled substances in humans and animals where Army facilities, personnel or financial support are used.

This regulation prescribes Army policy on the conduct and management of human subjects in testing, including command responsibilities, review process requirements, approval authorities and reporting requirements.

This regulation reflects the present legal requirements pertaining to the use of human subjects participating in clinical investigations and provides guidance for the administration and funding of clinical investigation programs.

This Web site contains service-specific guidance put forth by the U.S. Army.

OHRP provides leadership in the protection of the rights, welfare and well-being of subjects involved in research conducted or supported by HHS. OHPR’s website provides a wealth of guidance to help inform research planning and design.

The Grants Policy and Guidance website provides a comprehensive listing of policy statements, policy notices, award and appropriation information and policy resources.

This policy outlines regulations relating to human subject research to develop, test and evaluate warfighting systems, casualty-care and personnel protection systems, clothing, devices, and vaccines and drugs for disease prevention and treatment.

This Web site provides a variety of resources related to the U.S. Navy’s research policies and guidance.

DoD Office of Naval Research: Rules, Regulations, and Other Links

DON HRPP is a world-class research protection program, dedicated to preserving the rights and protecting the welfare of human subjects in U.S. Navy and Marine Corps-supported research. This page provides an overview of the Surgeon General’s authority in these areas as well as an overview of the program.

This policy outlines rules and regulations for the protection of human subjects in Department of Defense-sponsored research.

This page provides links to VHA handbooks and policies.

This VHA document sets forth the requirements for reporting certain research events to facility officials, relevant research review committees and the Office of Research Oversight (ORO). NOTE: This handbook does not preempt or otherwise alter any other applicable research reporting requirements, whether within the VA or involving other federal or state agencies or commercial sponsors.

This VHA document establishes procedures for determining whether a VHA operations activity constitutes research. It also establishes procedures for verifying and documenting the non-research status of certain operational activities prior to findins publication outside the VA. NOTE: The requirements of this handbook supplement (but do not supersede or replace) other requirements for review, approval or tracking of VA publications (e.g., requirements issued by the VA Office of Public and Intergovernmental Affairs, the VHA Office of Communications or the VHA Office of Research and Development).

This VHA document sets forth procedures for the oversight of research conducted by employees of VHA program offices.

This page provides information on federal laws and regulations that govern animal use in research, testing, teaching and exhibition. It also provides animal welfare guidelines, policies and codes of practices from around the world.

This page includes information about animal welfare guidelines for Cost-Plus-Fixed-Fee research and development contracts with commercial prime contractors.

Link provides a reference to the U.S. Code that relates to the transportation, sale and handling of animals in research. It includes the licensing of dealers and facilities, purchase of cats and dogs, humane standards and other issues.

Link provides additional information regarding the handling of contractor identities and circumstances under which the Secretary of Defense may disclose the identity or location of a person awarded a contract by the DOD.

This instruction establishes policy and assigns responsibilities for the use of animals in DoD programs. It applies to research, development, testing and evaluation (RDT&E) or training that is conducted or supported both within and outside of the continental U.S. It applies to vertebrate animals, alive and dead, including birds, cold-blooded animals and other designated mammalian species.

This component policy implements DODI 3216.01 and is recognized by each respective service as the following:

This regulation creates uniform policies, procedures and responsibilities among DoD entities involved in the use of animals outlined in the regulation. It references federal statutes and regulations as well as other standards related to the care and use of animals. It also establishes policies regarding the care and use of animals whether performed by DoD personnel or contract and/or grant recipients.

• Army Regulation 40–33
• SECNAVINST 3900.38C
• AFMAN 40–401(I)
• DARPAINST 18
• USUHSINST 3203