Ethical considerations for innovations and clinical trials.
The ethical imperative to improve practice through innovation and research finds justification in the requirements of physicians to help patients, minimize the harms of treatment and disease, and to bring the benefits of scientific medicine to those suffering from illnesses for which satisfactory treatment has not yet been developed. This article discusses the values and principles that underlie clinical trials; the need for evidence-based knowledge; the difference between research and therapy; the ethical duty to improve care through research; the challenge of conflict of interest; the relevance of clinical equipoise; the need for research review and postapproval monitoring; and the value of disseminating results to research subjects, colleagues, and the public. Public confidence and willingness to participate in clinical trials will continue if the ethical standards set by professional, government, and international bodies are met.
Zlotnik-Shaul
Randi
R
Department of Bioethics, The Hospital for Sick Children, University of Toronto, Ontario, Canada.
McKneally
Martin F
MF
D002986:Clinical Trials as Topic; D016265:Conflict of Interest; D028744:Ethics Committees, Research; D032984:Ethics, Research; D007722:Health Knowledge, Attitudes, Practice; D006805:Human Experimentation; D006801:Humans; D009936:Organizational Innovation; D010344:Patient Advocacy