United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Health, Education, and Human Services Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2000-09-28 monographic deposited born digital 62 p. GA 1.13:HEHS-00-155 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-00-155 P0b002ee18038287c f:he00155 DGPO 2010-08-12 2011-03-24 GAOREPORTS-HEHS-00-155 machine generated eng fdlp REPORT GAOREPORTS-HEHS-00-155 HEHS-00-155 Veterans Medical research Health research programs Safety regulation Safety standards Noncompliance Informed consent (medical law) Research program management Letter Report HEHS 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.<p/>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. https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-00-155/html/GAOREPORTS-HEHS-00-155.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-00-155/pdf/GAOREPORTS-HEHS-00-155.pdf GAO/HEHS-00-155 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-00-155 Letter Report GAO/HEHS-00-155; VA Research: Protections for Human Subjects Need to Be; Veterans Medical research Health research programs Safety regulation Safety standards Noncompliance Informed consent (medical law) Research program management