VA Research:

Protections for Human Subjects Need to Be Strengthened

HEHS-00-155: Published: Sep 28, 2000. Publicly Released: Sep 28, 2000.

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Pursuant to a congressional request, GAO reviewed rights and welfare of veterans who volunteer to participate in research at Department of Veterans Affairs (VA) and the effectiveness of its human subject protection system, focusing on: (1) VA's implementation of human subject protections; (2) whether weaknesses exist in VA's system for protecting human subjects; and (3) VA's actions to improve human subject protections at those sites affected by sanctions applied by regulatory agencies and throughout VA's health care system.

GAO noted that: (1) VA has adopted a system of protections for human research subjects, but GAO found substantial problems with its implementation of these protections; (2) medical centers GAO visited did not comply with all regulations to protect the rights and welfare of research participants; (3) among problems GAO observed were failures to provide adequate information to subjects before they participated in research, inadequate reviews of proposed and ongoing research, insufficient staff and space for review boards, and incomplete documentation of review board activities; (4) GAO found relatively few problems at some sites that had stronger systems to protect human subjects, but GAO observed multiple problems at other sites; (5) although the results of GAO's visits to medical centers cannot be projected to VA as a whole, the extent of the problems GAO found strongly indicates that human subject protections at VA need to be strengthened; (6) three specific weaknesses have compromised VA's ability to protect human subjects in research; (7) VA headquarters has not provided medical center research staff with adequate guidance about human subject protections and thus has not ensured that research staff have all the information they need to protect the rights and welfare of human subjects; (8) insufficient monitoring and oversight of local human subject protections have permitted noncompliance with regulations to go undetected and uncorrected; (9) VA has not ensured that funds needed for human subject protections are allocated for that purpose at the medical centers, with officials at some medical centers reporting that they did not have sufficient resources to accomplish their mandated responsibilities; (10) to VA's credit, substantial corrective actions have been implemented at three medical centers in response to sanctions by regulatory agencies taken against their human research programs, but VA's systemwide efforts at improving protections have been slow to develop; (11) medical centers affected by sanctions have taken numerous steps to improve human subject protections; and (12) VA has, however, been slow to take action to identify any systemwide deficiencies and obtain necessary information about the human subject protection systems at its medical centers.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: 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.

    Recommendation: To strengthen VA's protections for human subjects, the Acting Secretary of Veterans Affairs should direct the Under Secretary of Health to take immediate steps to ensure VA medical centers, their IRB's-- whether operated by VA or not--and VA investigators comply with all applicable regulations for the protection of human subjects by expediting development of information needed to monitor local protection systems, investigators, and studies and to ensure that oversight activities are implemented.

    Agency Affected: Department of Veterans Affairs

  2. Status: Closed - Implemented

    Comments: 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.

    Recommendation: To strengthen VA's protections for human subjects, the Acting Secretary of Veterans Affairs should direct the Under Secretary of Health to take immediate steps to ensure VA medical centers, their IRB's-- whether operated by VA or not--and VA investigators comply with all applicable regulations for the protection of human subjects by developing a mechanism for handling adverse event reports to ensure that IRBs have the information they need to safeguard the rights and welfare of human research participants.

    Agency Affected: Department of Veterans Affairs

  3. Status: Closed - Implemented

    Comments: 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.

    Recommendation: To strengthen VA's protections for human subjects, the Acting Secretary of Veterans Affairs should direct the Under Secretary of Health to take immediate steps to ensure VA medical centers, their IRB's--whether operated by VA or not--and VA investigators comply with all applicable regulations for the protection of human subjects by providing periodic training to investigators, IRB members, and IRB staff about research ethics and standards for protecting human subjects.

    Agency Affected: Department of Veterans Affairs

  4. Status: Closed - Implemented

    Comments: 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.

    Recommendation: To strengthen VA's protections for human subjects, the Acting Secretary of Veterans Affairs should direct the Under Secretary of Health to take immediate steps to ensure VA medical centers, their institutional review boards (IRB)-- whether operated by VA or not--and VA investigators comply with all applicable regulations for the protection of human subjects by providing research staff with current, comprehensive, and clear guidance regarding protections for the rights and welfare of human research subjects.

    Agency Affected: Department of Veterans Affairs

  5. Status: Closed - Implemented

    Comments: 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.

    Recommendation: To strengthen VA's protections for human subjects, the Acting Secretary of Veterans Affairs should direct the Under Secretary of Health to take immediate steps to ensure VA medical centers, their IRB's-- whether operated by VA or not--and VA investigators comply with all applicable regulations for the protection of human subjects by determining the funding levels needed to support human subject protection activities at medical centers and ensuring an appropriate allocation of funds to support these activities.

    Agency Affected: Department of Veterans Affairs

 

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