Massive IRB violations at the Arkansas VA

The most damning allegations follow (from the Washington Times)

• In one test the researcher did not sign nearly 200 forms until two months later.
• In four studies reviewed by the Inspector General (IG), times, dates and witness signatures differed on 103 consent forms.
• In a review of several cancer studies involving 1,400 veterans, investigators randomly sampled the files of 105 patients and could locate only 20 consent forms.
• The VA failed to pass on new drug warnings and risks in a timely manner to more than 200 participants in a smoking-cessation study who were also taking the drug Chantix. The eventual warnings of hallucinations and possible suicidal behavior were issued too late for James Elliott, who was subdued by police with a stun gun during a psychotic breakdown.
• The IG said researchers in the smoking study "did not ensure that patients involved in the smoking cessation study were notified of the risk of suicidal thoughts or behavior in a timely manner."
• The IG also said it could not confirm whether warning letters reached the intended study participants, and more than half have not signed and returned amended consent forms advising that the drug may cause hallucinations or psychotic or suicidal behavior.