VA Research: Protections for Human Subjects Need to Be Strengthened

摘要

Every year thousands of veterans volunteer to participate in biomedical orbehavioral research projects under the auspices of the Department of Veterans Affairs (VA). They do so for different reasons, including to improve the medical conditions of themselves and others, advance science, and serve their country. But research is not without risks. 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 who agree to become subjects in VA research are given accurate and understandable information about procedures, risks, and benefits so that they can make informed decisions about volunteering. Public attention has recently been focused on concerns about the safety of research subjects in other public and private research institutions. Department of Health and Human Services (HHS) investigations of violations of human subject protections have led to the suspension of research activities at several universities and hospitals. Furthermore, the HHS Office of Inspector General has raised concerns about the adequacy of current human subject protections nationwide in a series of reports. We reviewed VA regulations and guidance and interviewed headquarters officials responsible for human subject research activities. We visited eight VA medical centers to review their policies, procedures, and practices for protecting human subjects. We selected these medical centers to reflect major differences in VA research programs, including the number of studies they conduct with human subjects and the institutions responsible for operating the local institutional review board (IRB), the committee tasked with reviewing a research study's protections for human subjects. At these medical centers, we examined IRB activities to determine whether appropriate protections for human subjects were in place. We also visited three other VA medical centers affected by recent restrictions of their human research programs and reviewed the changes implemented there in response to HHS regulators. We talked with senior research officials at two additional VA medical centers similarly affected by sanctions applied by regulatory agencies. Because research programs at five of the VA facilities we visited involved university affiliates, we also reviewed documents and interviewed officials responsible for human subject protection issues at those institutions. We performed our work from June 1999 through August 2000 in accordance with generally accepted government auditing standards.