What's Missing From Current Clinical Trial Guidelines? a Framework for Integrating Science, Ethics, and the Community Context
Sutherland, Heather J.
Meslin, Eric M.
Till, James E.
Journal of Clinical Ethics. 1994 Winter; 5(4): 297-303.
Researchers have been charged with the task of undertaking methodologically rigorous and ethically acceptable clinical trials with human subjects. Guidance to produce proposals of exemplary quality is offered in the many texts that describe the fundamentals of methodologies for clinical trials. In general, these texts have not integrated ethical guidelines with scientific ones in an obvious and practical way, and none have discussed the importance of attention to the context in which a trial takes place or communication with the potential participants. This article proposes a framework which maps the territory of science, ethics, and the community context by describing the relevant and necessary components for research proposals in a way that highlights their inextricable link. We suggest that a more contemporary and comprehensive set of guidelines for planning and conducting trials is required to address the increasing influence of patients' preferences on the successful completion of clinical trials.
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