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VA audit shows documentation of informed consent in human studies sometimes incomplete

The Department of Veterans Affairs Office of Inspector General has released a 37-page "Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research (PDF)." The purpose of the review is "to determine whether VA research involving human subjects had on file either the informed consent forms or a waiver for this requirement from the institutional review board" and to make sure that the requests on file were in compliance with current regulations.

The study estimated that somewhere between 0.6 and 4.5 percent of the consent forms could not be located, and that almost a third of the forms that were located were non-compliant, almost always because they lacked a witness signature. In addition, the VA estimates that 1 percent of the roughly 110,000 non-compliant forms were not signed by the patients themselves.

In the wake of these findings, it was recommended that the VA and its facility directors:

  • Require sufficient IRB written documentation of waiver from informed consent
  • Require facility directors to ensure signed informed consent forms are on file
  • Ensure that informed consents are obtained first, before subjects are added to enrollee lists and/or to annual research progress reports
  • Ensure that witnesses are obtained for all VA consent forms
  • Ensure that IRB-approved informed consent forms consistently contain witness blocks (Or ensure sufficient IRB written documentation of waiver from the witness requirement)