As a former chancellor of the University of Wisconsin in Madison, I know firsthand the nearly unlimited demands that can legitimately be made on limited resources. Nevertheless, no priority in research is more important than the protection of subjects. Therefore, we must determine the true costs of an exemplary system of protection and ensure that adequate resources are made available. The need to strengthen protections for human subjects is rooted in four recent trends in clinical research. First, researchers may not be doing enough to ensure that subjects fully understand all the potential risks and benefits of a clinical trial.
Full disclosure is a necessary precondition to free choice.
Accordingly, subjects who do not understand the potential risks of a trial cannot be said to have chosen freely to face those risks. The report focused on studies funded by drug companies, which sponsor most clinical research. It noted that aggressive recruiting by researchers who have been offered money or other inducements may be contributing to the erosion of informed consent. As researchers are pressured to recruit subjects quickly in order to discover the next blockbuster drug, they may misrepresent the true nature of a trial, or they may simply appeal to their patients' trust. The report also described misleading promotions and advertisements.