VA Research: Protections for Human Subjects Need to Be Strengthened

VA has published two key documents designed to provide research staff with comprehensive guidance regarding the responsibilities of investigators, institutional review boards, and other research staff in protecting the rights and welfare of human research subjects. The Office of Research and Development revised and issued on July 15, 2003, its policy in the form of a handbook describing the requirements for the protection of human subjects in research. The Office of Research Compliance and Assurance renamed the Office or Research Oversight published in September 2001 a guidebook describing standard operating procedures for institutional review boards.

VA has taken several steps to provide training about research ethics and standards for protecting human subjects, including the issuance of biweekly information letters and sponsorship or co-sponsorship of relevant seminars. VA is requiring that investigators who apply for VA research funds be certified as having completed relevant training. VA also reports that many medical centers have increased their educational activities for IRB members and staff. VA's Office of Research Compliance and Assurance has developed a strategic plan that provides educational and training activities for investigators, IRB members, and staff.

VA's Office of Research and Development has issued guidance stating that analyses of adverse events should be provided to institutional review boards for those clinical trials that VA funds at multiple medical centers. In addition, VA requires that all VA facilities that perform human research to be accredited by the end of calendar year 2006. Accreditation entails an onsite survey of research activities by NCQA and includes a review of institutional review boards handling of adverse events. To date, 71 out of 116 facilities have been surveyed.

VA has taken appropriate steps to expedite the development of information needed to monitor local systems for the protection of human subjects, investigators, and studies, and to ensure that oversight activities are implemented. VA has contracted with the National Committee for Quality Assurance (NCQA) to develop an external accreditation program for VA's human subject protections systems. NCQA has finalized its accreditation standards and VA facilities have begun the accreditation process. VA has worked with HHS' Office of Human Research Protections to initiate the first phase of a new federal-wide assurance system. In addition, VA's Office of Research Compliance and Assurance has developed a self-assessment tool for its facilities, and is currently pilot testing the use of that tool in anticipation of full implementation during the fall of 2001.

VA's Office of Research and Development has initiated its own independent evaluation of each VA facility's ability to perform and support human research protection activities. An external accrediting entity, NCQA, carefully and systematically evaluates each VA facility's budget and resources, including personnel, space, capital equipment, materials and supplies dedicated to human research protection to determine if each facility meets stringent accreditation standards.