To facilitate  assurance of compliance with federal regulations for the protection of  human subjects, VA awarded a contract to the National Committee for  Quality Assurance (NCQA) to provide external accreditation of its medical  centers’ human research protection programs in August 2000. The specific  actions we recommended involved guidance, training, monitoring and  oversight, handling of information about adverse events, and funding of  human subject protection activities. VA concurred with our  recommendations. Insufficient Action Taken to Strengthen Protections for Human Subjects, Although VA Has Made Some Progress

VA has not taken sufficient action to strengthen protections for human  subjects since we made our recommendations nearly 3 years ago although  it has taken some important steps. Moreover, VA has not established 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 and it  has not ensured that sufficient resources are allocated to support human  subject protection activities. On the other hand, VA has strengthened  aspects of its human subject protection systems. VA also instituted an external accreditation  program that has the potential to further strengthen VA’s oversight of  human subject protections. Policy for Human Subject Protections Has Not Been Revised, but Other Important Guidance Was Issued

In 2000, we reported that we had found problems with VA’s policy for  implementing federal regulations for the protection of human subjects. The Institute of Medicine recommended that the NCQA  standards be strengthened, for example, by specifying how research  subjects will be involved in human subject protection systems. Since then, VA has not developed a mechanism for handling adverse event  reports to ensure that IRBs have information that can help them interpret  reports of actual adverse events that research subjects experience while  participating in studies. Recent Reorganization Appears to Maintain Independent Compliance Function, but Other Roles and Responsibilities Unclear

In 2003, VA began a reorganization of its research offices without adequate  planning and notice. We found that VA did not initially ensure the  independence of compliance activities, although more recent actions  appear to have restored the integrity of the compliance function. In  addition, VA has not clarified responsibilities for education, training, and  policy development. It is not clear to  what extent VA’s efforts to strengthen its human subject protections will  bring to bear the collective expertise of the staff in its compliance and  operational research offices. GAO/HEHS-00-155. VA Research: System for Protecting Human Subjects Needs  Improvements.
Why GAO Did This Study

Every year thousands of veterans volunteer to participate in research projects under the auspices of the VA. Research offers the possibility of benefits to individual participants and to society, but it is not without risk to research subjects. VA studies, like other federally funded research programs, are governed by regulations designed to minimize risks and protect the rights and welfare of research participants. VA must ensure that veterans have accurate and understandable information so that they can make informed decisions about volunteering for research. In September 2000, GAO reported on weaknesses it found in VA's systems for protecting human subjects. VA concurred with GAO's recommendations that its human subject protections could be strengthened by taking actions in five domains--guidance, training, monitoring and oversight, handling of adverse event reports, and funding of human subject protection activities. (VA Research: Protections for Human Subjects Need to Be Strengthened, (GAO/HEHS-00-155, Sept. 28, 2000)). GAO was asked to assess whether VA has made sufficient progress in implementing the recommendations and to examine the recent changes in VA's organizational structure for monitoring and overseeing human subject protections.

What GAO Found

VA has not taken sufficient actions to strengthen its human subject protection systems since GAO made recommendations nearly 3 years ago. Continuing weaknesses VA has not sufficiently addressed include ensuring that its policy for implementing federal regulations for the protection of human subjects is up to date; training occurs periodically for all personnel involved in human subject protections; those charged with reviewing risks have information that can help them interpret reports of adverse events; and sufficient funding is allocated to support human subject protection activities. VA has taken some important steps to strengthen aspects of its human subject protections by providing some necessary guidance and offering training to research personnel. Moreover, it strengthened its internal oversight and instituted an external accreditation program, with reviews of all its medical centers' human subject protection programs scheduled through summer 2005. VA is now in the midst of a reorganization of its headquarters research offices that was begun without adequate planning and notice. VA did not initially ensure the independence of compliance activities although more recent actions appear to have restored the integrity of the compliance function. VA has not clarified responsibilities for education, training, and policy development. Until it does so, it is unclear how the reorganization will affect VA's efforts to further strengthen its human subject protections.