Healthcare Inspection Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research

We conducted this review of informed consent procedures and human subject protections in VA research at the request of U.S. Representative Steve Buyer. The study population consisted of all enrollees of human subjects research projects conducted under VA auspices that were active and required informed consent, and had at least one enrollee as of August 20, 2008. The study used a complex, three-stage sample design that included stratification, clustering, and unequal probabilities of selection. From the 102 facilities that had at least one applicable protocol, we statistically randomly selected 30 (29.4 percent) facilities where we conducted onsite inspections. There were 5,993 sampled participants. We found the following: Insufficient IRB documentation for the waiver for 2 of the 33 sampled research protocols that were waived from the required informed consent process. An estimated 1.7 percent of the 367,103 VA research subject consent forms could not be located; we are 95 percent confident that the true percent value is somewhere between 0.6 percent to 4.5 percent. Thirty-one percent of the VA research subjects consent forms on file were estimated to be noncompliant with VHA standards; 97 percent of the noncompliant forms lacked witness signature. One percent of the 110,231 VA noncompliant forms lacked the subject or subject’s authorized representative signature.