Ethics in clinical trials |
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Affiliation: | 1. Bristol Medical School, University of Bristol, Bristol, UK;2. Renal Unit, Southmead Hospital, Bristol, UK;1. Office of Extramural Research, Education and Priority Populations, Agency for Healthcare Research and Quality (K.B. Mistry and R.D.F. Sagatov), Rockville, Md;2. L&M Policy Research (C. Schur and M. Johnson), LLC, Washington, DC;3. Division of Quality and Health Outcomes (R.E. Fox), Children and Adults Health Programs Group, Center for Medicaid and CHIP Services, Centers for Medicare & Medicaid Services, Baltimore, Md |
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Abstract: | Although one of the first pieces of legislation to address ethical issues in clinical trials was drawn up following the findings from the Nuremberg Trials, only in the more recent clinical research have the principles of beneficence, non-maleficence, autonomy and justice been considered and informed consent plays a major role. In the UK, the National Research Ethics Service and the Medicines and Healthcare Products Regulatory Agency require compliance with Good Clinical Practice. Patients are unlikely to participate in, or clinicians consent their patients to, trials where they do not feel safe or protected - data and safety monitoring assess for loss of clinical equipoise thus ensuring the most efficacious treatment is always available. Honesty and trust are crucial and place an obligation on investigators to disseminate even less favourable trial results, with the ultimate aim being partnerships between patients, their families, and those delivering the research which are mutually beneficial and respectful. |
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Keywords: | Clinical trials equipoise good clinical practice informed consent legislation research research ethics |
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