According to a report released by the Department of Veterans Affairs Office of Inspector General, an audit of representative VA hospitals found that about 31 percent of informed consent documentation for human studies was incomplete. In the vast majority (97 percent) of cases, this was due to lack of a witness signature.
Among the report’s other findings:
- An estimated 1 percent (1,023) of the 110,231 non-compliant lacked the subject’s signature or that of their authorized representative, rendering them legally ineffective.
- An estimated 1.7 percent of the 367,103 consent forms could not be located, the report extrapolated the national range to be somewhere between 0.6 percent and 4.5 percent.
- In specific situations, Institutional Review Boards can waive informed consent. In two of the 33 such cases examined, sufficient documentation of this waiver was not found.