Considerable efforts have been made in recent years to improve human subjects protection. However, few data are available demonstrating that these efforts have succeeded. Using previously published quality indicators for assessing Department of Veterans Affairs Human Research Protection Programs (HRPPs), we collected data from informed consent document and regulatory protocol audits conducted between June 1, 2009, and May 31, 2010, at 107 VA research facilities. A total of 89,216 informed consent documents from 3,563 human research protocols were audited. Regulatory audits were conducted in 2,102 human research protocols, 6,787 research personnel, and 11,387 subject case histories. This is the first systematic assessment of VA HRPPs. Although there are no similar data in the literature for comparison, the data presented suggest that the VA has developed a strong and comprehensive system for protecting human subjects participating in VA research.

Key words/concepts: human subjects research, research ethics, informed consent, human research protection program, quality assessment, quality indicators