1). 2, which presents noncompliance with VA regulations.) The extent of this problem varied by site. 4). Specific Weaknesses Compromise VA’s Protection of Human Subjects

We identified three specific weaknesses in VA’s system for protecting human subjects: not ensuring that research staff have appropriate guidance, insufficient monitoring and oversight activity, and not ensuring that the necessary funds for human subject protections are provided. Headquarters Has Not Provided Adequate Guidance

VA headquarters has not provided the guidance necessary to ensure that its medical center staff are adequately informed about requirements for the protection of human research subjects. In addition to finding that VA did not have a systemwide educational program, we found problems with VA guidance for documenting consent to participate in research. Although VA has not determined the funding amounts needed for human subject protection activities at the medical centers, research officials at five of the eight medical centers we visited told us that they had insufficient funds to ensure adequate operation of their human subject protection systems. Local Actions Address Problems Identified by Regulators But Systemwide Focus Slow to Develop

Substantial corrective actions have been implemented at three medical centers in response to sanctions by regulatory agencies against their human research programs. VA has, however, been slow to identify systemwide deficiencies and to obtain information needed to step up oversight of human subject protection systems at its medical centers. However, VA’s progress on systemwide improvements to its human subject protection system has been slow. Some facilities we visited and projects we reviewed appeared to have reasonably strong protections for the rights and welfare of participants. Recommendations

To strengthen VA’s protections for human subjects, we recommend that the Acting Secretary of Veterans Affairs direct the Under Secretary for Health to take immediate steps to ensure that VA medical centers, their IRBs— 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; providing periodic training to investigators, IRB members, and IRB staff about research ethics and standards for protecting human subjects; 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; expediting development of information needed to monitor local protection systems, investigators, and studies and to ensure that oversight activities are implemented; and 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. Scope and Methodology

Our objectives were to (1) assess the Department of Veterans Affairs’ (VA) implementation of human subject protections, (2) identify whether weaknesses exist in VA’s system for protecting human subjects, and (3) assess VA’s actions to improve human subject protections at those sites affected by sanctions imposed by regulatory agencies and throughout VA’s health care system. Our results from these eight medical centers cannot be generalized to other sites.
Why GAO Did This Study

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.

What GAO Found

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.