Goodbye to all that. The end of moderate protectionism in human subjects research.

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it is wise to do so, remains to be seen. In May 2000 the Department of Health and Human Services announced new regulatory and legislative initiatives concerning federally sponsored research involving human subjects. In September, the Office for Protection from Research Risks was reconstituted as the Office for Human Research Protections and, with a new director, completed its transition to the Office of the Secretary at DHHS. In the months leading up to these changes, both the OPRR and the Food and Drug Administration had been increasingly active in levying sanctions against institutions whose ethics institutional review boards were malfunctioning or that had engaged in questionable research practices, especially in human genetics trials. Weeks after DHHS secretary Donna Shalala's announcement, a bipartisan group of congressional sponsors led by Congresswoman Diane DeGette, Democrat from Colorado, introduced the Human Research Subjects Protections Act of 2000. Among other reforms, the act would extend informed consent and prior review requirements to all human subjects research, regardless of funding source. Senator Ted Kennedy, Democrat from Massachusetts, introduced a bill that would establish steep civil penalties for investigators and institutions that broke the rules. Leading up to all this activity, there had been since 1997 several congressional hearings on human subjects research as well as numerous reports and recommendations by public and private panels concerning the state of the regulatory system. All these hearings, bills, and reports had one thing in common: They all found or presupposed a need to strengthen the human subjects protections system. Although some individuals representing the community of scientific investigators raised their voices in objection to increased regulation--especially the psychiatric community in response to the National Bioethics Advisory Commission's recommendations concerning research involving persons with mental disorders--theirs were largely lonely voices. Protests that new measures would block important research seemed hard to sustain in light of two decades of remarkable advances under the current system, which at the time of its introduction was itself described as being so burdensome that it would threaten medical progress. Reservations about increased bureaucracy, or even the question whether the proposals being advanced would have avoided any actual patient or subject injuries, were overwhelmed by a historical tide that presages a new era in the history of human subjects regulations, an era that I call "strong protectionism." A New World Order The essence of strong protectionism is the minimization of clinical researchers' discretion in governing their conduct with regard to human subjects. Among the measures implied by strong protectionism are concurrent third party monitoring of consent and study procedures, disclosure of financial arrangements or other potential conflicts of interest, required training of investigators in research ethics and research regulations, and independent review of the decisionmaking capacity of potential subjects. All these and other measures have been proposed, and many may be implemented, in spite of the additional costs in time and money they represent, and regardless of the inference an observer may draw that clinical researchers are simply not to be trusted. …