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Informed Consent for Placebo-Controlled Trials: Do Ethics and Science Conflict?
Feldman, Hope A; Feldman, James A; Miller, Charles C; Walsh, Garrett; Tyson, Jon E.
Afiliación
  • Feldman HA; Research fellow in the Department of Thoracic and Cardiovascular Surgery at the University of Texas MD Anderson Cancer Center.
  • Feldman JA; Senior investigator in the Department of Emergency Medicine at the Boston Medical Center at the Boston University School of Medicine.
  • Miller CC; Associate vice president of clinical research at the University of Texas Health Science Center at Houston in the McGovern Medical School.
  • Walsh G; Professor of surgery in the Department of Thoracic and Cardiovascular Surgery at the University of Texas MD Anderson Cancer Center.
  • Tyson JE; Vice dean for clinical research at the University of Texas Health Science Center at Houston in the McGovern Medical School.
Ethics Hum Res ; 44(5): 42-48, 2022 Sep.
Article en En | MEDLINE | ID: mdl-36047276
ABSTRACT
The use of a placebo has been considered the best method for controlling bias in a prospective randomized clinical trial and provides the most rigorous test of treatment efficacy for evaluating a medical therapy. Placebos commonly produce clinically important effects particularly in studies where the primary outcomes are subjective. Yet the potential beneficial or harmful effects of placebos are often not addressed in designing a clinical trial, calculating the sample size, seeking consent, or interpreting clinical trial results. In this manuscript, we use an actual study to indicate three approaches that might be considered in seeking informed consent for placebo-controlled trials, and we explore the fundamental ethical and scientific complexities involved with each.
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Proyectos de Investigación / Consentimiento Informado Tipo de estudio: Clinical_trials / Observational_studies Idioma: En Revista: Ethics Hum Res Año: 2022 Tipo del documento: Article

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Proyectos de Investigación / Consentimiento Informado Tipo de estudio: Clinical_trials / Observational_studies Idioma: En Revista: Ethics Hum Res Año: 2022 Tipo del documento: Article