The U.S. Department of Veterans Affairs last week released new accreditation standards it will use to protect humans participating in research projects at more than 120 VA hospitals.
The National Committee for Quality Assurance, Washington, developed the accreditation program under a five-year, $5.8 million contract with the VA. The initiative was in response to a spate of research suspensions in 1999 at several universities and affiliated VA medical centers after federal oversight agencies found shortcomings in review procedures for protecting human subjects. The safety of human research subjects has again become a topic of public concern after the recent death of a young woman in an asthma experiment at a university hospital.
Under the VA's accreditation program, teams of independent experts will visit each medical center at least once every three years to certify that the particular medical center is managing risks to human subjects. Accreditation standards address institutional responsibilities for human research protection and outline the operation of a review board.
That board is charged with considering the risks and benefits of research, recruitment and selection of subjects, research-related risks to privacy and confidentiality, and informed consent for research participants. Standards will be revised annually to reflect changes in VA policy and federal regulations.
Although the program was developed to order for the VA, the agency is "setting an example for the rest of the research community to follow," said Jessica Briefer French, NCQA assistant vice president in its quality solutions group.
Separately last week, President Bush named the 13 members of a new task force to reform healthcare at VA and military hospitals. Bush announced the creation of the task force on Memorial Day and appointed former HCFA Administrator Gail Wilensky and former Rep. Gerald Solomon (R-N.Y.) as co-chairs.
The 13 members named last week include physicians and representatives from veterans groups.