Among the more serious violations reported by the FDA from 1980 to 1995 were failure to obtain informed consent, forgery of signatures on informed consent forms and failure to tell patients a drug was experimental. Another problem is that the hospital committees charged with overseeing medical research may spend only a couple of minutes reviewing proposals, and fail to monitor experiments once they' under way. A presidential advisory committee investigating radiation experiments on humans found that even in recent studies, as many as one-third had ethical problems in areas such as informed consent. Moreno, who worked on that committee, says it's important for researchers to understand the tremendous hope patients have when they sign up for experimental research. After interviewing nearly 1,900 patients, he says, he was struck by the fact that most of them thought the treatment would help them, even if they were clearly told that it might not.
Hope is really important.
Abusing that hope means that doctors lose a patient's trust. And once you lose that trust, it's hard to get it back. The medical community, says Moreno, still hasn't regained the trust from African-Americans that it lost when the Tuskegee experiments were revealed. Unwavering adherence to the principles of informed consent will help insure that kind of thing doesn't happen again. The policy of informed consent says patients have a right to know what's going on if they volunteer for medical research.