VA Research

The Department of Veterans Affairs (VA) has adopted a system of protections for human research subjects but has had substantial problems with its implementation. For example, medical centers did not comply with all regulations to protect the rights and welfare of research participants. Specifically, VA headquarters has not provided medical center research staff with adequate guidance on protections for human subjects. Insufficient monitoring and oversight of local human subject protections have permitted noncompliance with regulations to go undetected and uncorrected. VA has not ensured that funds needed to for human subject protections are allocated for that purpose at the medical centers. 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 improved protections have been slow to develop. Despite some difficulties, these three medical centers have made progress and each has resumed human research activities. Also, VA has established an Office of Research Compliance and Assurance to monitor human subject protections. GAO summarized this report in testimony before Congress; see: VA Research: System for Protecting Human Subjects Needs Improvement, by Victor S. Rezendes, Assistant Comptroller General for Health, Education, and Human Services Issues, before the Subcommittee on Oversight and Investigation, House Committee on Veterans' Affairs. GAO/T-HEHS-00-203, Sept 28, (11 pages).

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

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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