The evolution of informed consent: failures of the current system of human protection.

The reliance of subjects and researchers on the current regulatory scheme for human subject protection is misplaced. Investigators often assume that compliance with the requirements of the Common Rule, including Institutional Review Board approval of their research project, adequately fulfills the spirit of the federal regulation and protects them from liability for lack of adequate informed consent. Subjects and physicians referring subjects, believe that institutional approval of studies assures that they are scientifically valid and ethical. Unfortunately the current scheme of human research protection has failed to fulfill the spirit of the Nuremberg Code and The Belmont Report. Not only are large numbers of studies left out of the current protection scheme but the scheme is also flawed on several levels. This leaves researchers at risk for liability and subjects may have their right to autonomy violated even while the requirements of the current regulatory scheme are satisfied. It is time for a wholesale restructuring of human subject protection. If physician researchers ignore the deficits of the current system we will lose control and input into the formulation of the new scheme.