NCQA, VA launch human research accreditation
The National Committee for Quality Assurance (NCQA) and the Department of Veterans Affairs (VA) have released final 2001-2002 standards for the first external accreditation program to protect humans participating in research projects. NCQA will develop and administer the new program, which will apply to more than 120 VA medical centers conducting research with human participants.
The accreditation program will set the standard for other federal agencies and private sector organizations engaged in human research, says Jessica Briefer French, NCQA assistant vice president in the Quality Solutions Group.
"Accreditation will enhance existing protections and help ensure that the VA can move ahead with its important research agenda," French says. "The VA is setting an example for the rest of the research community to follow."
A recent report by the Institute of Medicine cited the VA/NCQA program as the preferred model for accrediting human research protection programs. Under the new accreditation program, teams of independent experts will visit each medical center at least once every three years to certify that they are effectively managing research risks. The accreditation standards address these six major areas:
- institutional responsibilities for human research protection;
- structure and operation of institutional review board (IRB);
- IRB consideration of risks and benefits of research;
- IRB consideration of recruitment and subject selection for participation in research;
- IRB consideration of research-related risks to privacy and confidentiality;
- IRB consideration of informed consent for research participants.
Standards will be revised annually to reflect changes in VA policy and other federal regulations and, over time, to more directly emphasize outcomes of human research protection efforts. The VA last year awarded a $5.8 million, five-year contract to NCQA to develop and implement the accreditation program. In 1999, research programs at several universities and affiliated VA medical centers were suspended when federal oversight agencies found shortcomings in review procedures for protecting human subjects. VA responded with a proposal to establish an external accreditation program designed to fortify compliance with its own and other federal regulations.
The program standards are available at NCQA’s VA Human Research Protection Accreditation Program web page: www.ncqa.org.
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