VA Research: System for Protecting Human Subjects Needs Improvements
Abstract
Conducting medical research is one of VA's core missions. VA researchers have been involved in a variety of important advances in medical research, including development of the cardiac pacemaker, kidney transplant technology, prosthetic devices, and drug treatments for high blood pressure and schizophrenia. Funds from the appropriations for VA medical research and VA medical care support VA researchers and the indirect costs of research, which includes support for the human subject protection system. VA researchers receive additional grants and contracts from other federal agencies such as the National Institutes of Health (NIH), research foundations, and private industry sponsors including pharmaceutical companies. In fiscal year 2000, biomedical or behavioral research involving human subjects is being conducted at about 70 percent of VA medical centers. VA is responsible for ensuring that all human research it conducts or supports meets the requirements of VA regulations, regardless of whether that research is funded by VA, the subjects are veterans, or the studies are conducted on VA grounds. Responsibility for administration and oversight of the research program has rested primarily with the Office of Research and Development (ORD). Recently, VA created the Office of Research Compliance and Assurance (ORCA) to advise the Under Secretary for Health on matters affecting the integrity of research protections, to promote the ethical conduct of research, and to investigate allegations of research impropriety. In addition, some VA research is subject to oversight by two components of the Department of Health and Human Services (HHS). The Food and Drug Administration (FDA) is responsible for protecting the rights of human subjects enrolled in research with products it regulates - drugs, medical devices, biologics, foods, and cosmetics. HHS funded research is subject to oversight by its Office for Human Research Protections (OHRP).
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 28, 2000
- Accession Number
- AD1150543
Entities
People
- Victor S. Rezendes
Organizations
- United States Government Accountability Office