Ethos and regula in contemporary clinical research

With new trends in drug development and testing, it must be determined whether the current state of balance of ethos (the moral norm) and regula (the legal framework) can successfully protect patients while keeping the door to scientific innovation open. The rise of the Clinician Investigator (CI) in both academic and private research introduces a challenge to the protection of subjects in the conflicting dual role of physician and scientist. Despite the constant evolution of regulation and ethical standards, questions about the roles' combined effectiveness in relation to this challenge persist. Carl Elliot describes the suicide of a patient-subject enrolled in an industry-funded physician-run anti-psychotic pharmaceutical drug trial in a 2010 Mother Jones article. Elliot provides a personal account of discrepancies seen in the ethical principles of beneficence, respect for subjects and justice. Through analysis of the problems presented in the case as a model for potential dangers in clinical research, the effectiveness of ethics and law in protecting human subjects is examined. While the lag between ethical standard and regulation has historically shown to cause similar issues, the misconception of current regulation and ethical standards may be contributing to the decrease in subject protections. After IRB approval of subject protections in the research protocol, CIs have been shown to downgrade their responsibility to maintaining ethos through the course of the trial. And, despite their experience in patient-centered ethos as a physician, CIs may be inclined to substitute these values for the ethos of a researcher, with the goal to avoid therapeutic misconception. Maintaining personal responsibility for subjects beyond regulatory structure, and promoting the welfare of the subjects in regards to the ethical standard of research investigators, will provide added security for subjects and decrease opportunity for exploitation in future research.