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ACHRE Report

Part III

Chapter 14


The Federal Policy for Human Subject Protections (The Common Rule)

Research Involving Ionizing Radiation

Scope of Programs of Research Involving Human Subjects

Administravtive Structures and Procedures for Research Oversight

Federal Responses to Violations of Human Subjects Protections

Protections for Human Subjects in Classified Research


Chapter 14: Scope of Programs of Research Involving Human Subjects

The six federal departments and agencies (DHHS, DOD, DOE, NASA, VA, and CIA) all conduct or support research involving human subjects. Each agency's program is distinctive in terms of its scope, organization, and focus, all of which reflect the primary mission of the agency.

DHHS is the largest federal sponsor of research involving human subjects, with approximately $367 million in intramural funding and $2.4 billion in extramural support for clinical research in fiscal year 1992, the latest year for which an estimate of extramural research funding is available.[14] Intramural research is usually conducted by agency staff members at various field sites, while extramural research is conducted outside the agency by contractors or grantees such as universities. Most of this research is biomedical, and some involves the use of radiation in experimental diagnostic and therapeutic procedures or as tracers in basic biomedical research.[15] The U.S. Public Health Service (PHS) is the operating division of DHHS and the principal health agency of the federal government.[16]

The DOD conducts biomedical and behavioral research involving human subjects within each of the military services and through several additional defense agencies, primarily in areas that support the mission of the department. In fiscal year 1994 DOD spent an estimated $77 million on intramural and $107 million on extramural human subjects research.[17]

The VA operates 171 inpatient medical centers, including short-term hospitals, psychiatric and rehabilitation facilities, and nursing homes. The VA's largely intramural biomedical research program focuses on the health care needs of veterans. The VA spends approximately $114 million annually in appropriated research money on human subjects research, along with another $110 million in staff clinicians' time. Other federal agencies and private entities also support research in VA facilities.[18]

The DOE conducts and supports research, both intramurally and extramurally, involving human subjects that ranges from diagnostic and therapeutic applications in nuclear medicine to epidemiological and occupational health studies. DOE laboratories also receive funding from other federal agencies such as the NIH and from private sponsors of research. DOE spends $46 million annually on human subjects research, more than $20 million of which is devoted to the Radiation Effects Research Foundation (RERF) in Japan, which is charged with studying the health effects of exposure to radiation from atomic weapons.[19]

Both intramurally and extramurally, NASA conducts ground-based and in-flight biomedical research involving human subjects related to space life. In fiscal year 1994 NASA spent approximately $25 million on ground-based human subjects research.[20]

The CIA supports or conducts a small number of intramurally and extramurally conducted studies involving human subjects each year.[21] No figure for the annual dollar amount spent by the CIA was made available to the Advisory Committee.

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