Programme : What is the role of informed consent in medical research? : Abstract of keynote presentation
The moral and regulatory importance of the distinction between research and practice
Tom L. Beauchamp
Georgetown University, Department of Philosophy & Kennedy Institute of Ethics, USA
The research-practice distinction serves to bifurcate the biomedical world into two separate domains governed by different universes of moral norms: the domain of medical practice and the domain of scientific research. But this distinction has begun to break down in the biomedical world, and we now have good reasons to challenge the way the distinction has been brought to bear on moral and regulatory questions. Traditionally, the distinction holds that to qualify as practice two conditions must be satisfied--(1) an intervention aimed at benefiting a patient and (2) the intervention has a reasonable probability of success. By contrast, to qualify as research the two conditions that must be satisfied are (1) protocol-controlled design to test a hypothesis and (2) an organized aim at generalizable scientific knowledge. This elegantly simple schema has had enormous influence in biomedical ethics and regulatory policy, and it appears still today to be the received view.
However, this bifurcation need to be rethought in medical ethics and research ethics so that it better serves the interests of patients and subjects. Innovative or nonvalidated activities may be riskier than either standard treatments or research with healthy volunteers, and informed consent standards likely will be lower in contexts of innovation than research guided by a scientific protocol. Segregating research from practice may here cause us to lose sight of the best interest of patients. Perhaps we should do more to protect patients by prior review and scrutiny of consent, much as we protect research subjects from risk and uninformed consent. The need for such an added protection for patients is one side of the problem, but there is another side: potential risk for patients. Sometimes bringing experimental procedures under the full array of protections afforded by the review of research may do more to harm than to protect some patients.
Clinical research today is often closely in contact with clinical practice. In this environment, the research-practice distinction, and our understanding of clinical ethics and research ethics, may need considerable modification in order to best protect the interests of patients and subjects.
Email: beauchat@georgetown.edu
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This conference is arranged by Cesagen at the universities of Lancaster and Cardiff and the Centre for Research Ethics & Bioethics at Uppsala University.