Research Policy Links
To help clarify and summarize applicable medical research guidance, HCE offers information about government policies, as well as applicable rules, guidelines, directives, regulations, and oversight agencies that may be relevant to those pursuing medical research efforts. These include:
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 The report serves as a historical reference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.
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
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.
Regulations Surrounding Animal Use in Research
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
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
Army Regulation 40–33
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
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
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
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.
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
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
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
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 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.