Monitoring a clinical trial with waiver of informed consent: Diaspirin cross-linked hemoglobin for emergency treatment of post-traumatic shock

In 1996, the FDA and DHHS regulations were modified to allow randomized controlled trials in emergency settings with a waiver of informed consent (from patients or surrogates) under specified conditions. The first large multi-center trial under the new regulations was sponsored by Baxter Laboratories, comparing a semi-synthetic hemoglobin to standard care in the initial resuscitation of adults presenting with post-hemorrhagic shock. In addition to the familiar problems that the Data Monitoring Committee had to face, there were new issues, such as reviewing procedures for community disclosure and community consultation, and a heightened sense of scrutiny because of the waiver of traditional consent. The trial was terminated because of higher than expected mortality in the group receiving the experimental treatment. The number of trials initiated under the regulations seems to be less than anticipated, perhaps because the regulatory burden is seens as too onerous.