Protection of Human Subjects and Scientific Progress: Can the Two Be Reconciled?(Letters‪)‬

To the Editor: Over the past several years, both the professional and lay press have made distressing revelations concerning the research enterprise, including financial conflicts of interest involving investigators, NIH managers, and FDA regulatory procedures; insufficient disclosure of research risks; lack of transparency regarding investigators' commercial ties; ghost writing of clinical trial manuscripts by sponsors; failure to publish negative trial results; trials designed to conceal serious drug side effects; failure to systematically assess what is known from existing research before launching new studies; and inadequacies in the ethics review process, including IRB members' level of preparation and the monitoring of ongoing research. Ironically, these revelations coincide with a rising chorus within the ethics community that advocates relaxing certain well-established norms and values aimed at protecting research subjects. A troubling thread runs through much of the recent literature, both that appearing in the Hastings Center Report on "changing standards of research" and elsewhere. The key ethics question has moved from "How can we balance subject protection with the acquisition of knowledge?" to "How can we facilitate research?" I believe this emphasis on tolerating higher levels of risk erodes protections traditionally provided by ethical protocol design and voluntary and informed consent procedures.