ABSTRACT
Human experimentation had elements in common with all of these, helping to ensure that its scandals would produce structural change. Nevertheless, the scandals deeply affected public attitudes and brought an unprecedented degree of regulation and oversight to the laboratory. The exposes had an especially critical impact on the leadership of the National Institutes of Health (NIH), by far the most important source of funds for clinical research, and the Food and Drug Administration (FDA), responsible for overseeing the testing and licensure of all new drugs. FDA officials issued a "Statement on Policy Concerning Consent for the Use of Investigational New Drugs on Humans", not only defining all the terms in the 1962 law but setting down what William Curran, one of the most astute students of NIH and FDA policies, described as "comprehensive rules regarding patient consent in clinical drug trials".
