01-12974. Office of Research and Development; Department of Veterans Affairs Human Research Protection Accreditation Program

AGENCY:

Department of Veterans Affairs.

ACTION:

Notice of draft accreditation standards.

SUMMARY:

This notice informs interested parties that draft standards for the Department of Veterans Affairs (VA) Human Research Protection Accreditation Program (VAHRPAP) will be available for public comment on the National Committee for Quality Assurance (NCQA) Web site: www.ncqa.org.

DATES:

The public comment period will start May 16, 2001, and will continue through June 1, 2001.

ADDRESS:

The preferred method for receiving comments is as a Microsoft Word file attached to an e-mail message. The e-mail message should be sent to [e-mail] and have “Public Comment” in the subject line. Please include your name, organizational affiliation and telephone number in any e-mail correspondence.

Mail written comments (one original and three copies) to the following address: NCQA, Attn: VAHRPAP, 2000 L Street, NW., Suite 500, Washington, DC 20036. If you sent your comments by e-mail, please do not send duplicate comments by mail.

SUPPLEMENTARY INFORMATION:

The Department of Veterans Affairs awarded a five-year contract to the National Committee for Quality Assurance (NCQA) to conduct an accreditation program, the first of its kind, to help to ensure that VA medical centers are complying with VA and other applicable Federal regulations for the protection of human subjects of research. NCQA is a private, non-profit organization dedicated to improving health care quality, with 10 years of experience in accrediting and certifying health care programs. NCQA will partner with Medical Care Management Corporation (MCMC) to design the program and to recruit, credential and schedule surveyors. MCMC has established a large panel of experienced clinical researchers who evaluate the appropriateness of experimental treatments, conduct technology assessments and review research protocols.

VA conducts biomedical, health services, and rehabilitation research to improve the health care delivered to the Nation's veterans. The Office of Research and Development (ORD) has developed policies, consistent with the Common Rule and the Food and Drug Administration (FDA) regulations, to safeguard human subjects in research. Also, as part of its responsibilities in protecting human subjects, VA's Office of Research Compliance and Assurance (ORCA) collaborates with the Office of Research and Development in carrying out this accreditation contract, and will analyze trends from the accreditation reports for continuing quality improvement. The VA Human Research Protection Accreditation Program (VAHRPAP) will provide a routine external evaluation of compliance with VA and other Federal policies.

FOR FURTHER INFORMATION:

For further information about the accreditation program, contact NCQA Customer Service, at [phone]. For questions about the Department of Veterans Affairs human subjects protection policies or programs, call Brenda Cuccherini, PhD, VA Office of Research and Development, at [phone].

Dated: May 16, 2001.

Anthony J. Principi,

Secretary of Veterans Affairs.