Clinical Investigations are research into clinical health problems for any conditions of concern in providing healthcare to the beneficiaries of the military healthcare system including active duty personnel, dependents, and retired personnel. It is DoD policy that Clinical Investigations are an essential component of medical care and teaching that is intended to achieve the following objectives of the Department of Defense:
- Improve the quality of patient care.
- Support the graduate medical education (GME) programs of the Services and USUHS.
- Generate an atmosphere of inquiry in the GME programs responsive to the dynamic nature of the health sciences.
- Promote high professional standing and accreditation of health education programs.
Summaries of these activities are briefed to Health Affairs annually by the Services and the Uniformed Services University of the Health Sciences (USUHS).
DoD Directives and Regulations
Clinical investigation within the Military Health System (MHS) is governed by the following DoD Directives and regulations:
- DoDI 6000.08, "Funding and Administration of Clinical Investigation Programs," Updated December 3, 2007;
- DoDI 3216.01, "Use of Laboratory Animals in DoD Programs," Updated September 13, 2010;
- DoDI 3216.02, "Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research," Updated November 8, 2011;
- Title 32, Code of Federal Regulations, Part 219, "Protection of Human Subjects," is the DoD implementation of the Common Rule, which follows title 45 Part 46 Subpart A of Department of Health and Human Services (HHS) regulations;
- Title 10, United States Code, Section 980 imposes additional requirements for informed consent on research funded by DoD.
Studies using human subjects are approved and monitored by Institutional Review Boards (IRBs) for each medical center and USUHS. Studies using animals are approved and monitored by Institutional Animal Care and Use Committees for each medical center and USUHS.
The Services and USUHS Clinical Investigations Programs
The Air Force CIP is overseen by the USAF Surgeon General’s Research Oversight and Compliance Division, HQUSAF/SGRC. The purpose of the research program is to: promote and conduct research and medical education in support of aerospace expeditionary operations and military families; support residency and staff training programs; enhance patient care capabilities; ensure protection of human and animal subjects when participating in research; foster research through special congressional appropriations and other federal research programs; and develop programs and provide guidance to implement federal requirements in human research and animal use.
The Clinical Investigation Regulatory Office (CIRO), US Army Medical Center and School, Fort Sam Houston, Texas manages the Army CIP. The Army clinical investigation program (CIP) improves health care and facilitates graduate medical education, graduate dental education, and other professional health education by stimulation of scholarly endeavor, retention of faculty, and introduction of new technology.
The Navy CIP mission is to develop and implement clinical research policy to meet the requirements of Navy Medicine. The vision is to improve the quality of health care available to DoD beneficiaries through research; generate an atmosphere of scientific inquiry as a means to assist in the accreditation of Graduate Medical Education programs; and provide regulatory and ethical review, education, and guidance for human and animal research. Oversight of the protection of human subjects and animals in Navy CIP supported research is provided by the Office of Research Protections at the Bureau of Medicine and Surgery.
Uniformed Services University of Health Sciences (USUHS)
The USUHS research mission is to facilitate, promote, and encourage excellence and leadership for the research activities of USUHS by providing consistent high quality service to each of its three major customers: the faculty, the University, and the research sponsors. They seek and manage intramural program funds to support recruitment and retention of high quality clinician-investigators and biomedical scientists; enhance the USUHS faculty’s ability to compete for extramural research funds; support training of the next generation of government medical research scientists and physicians with sound understanding of the scientific basis of good medicine; and support continued academic accreditation for the University’s programs in higher education. The USUHS program is administered by the Vice President for Research.