Methodological quality and reporting of ethical requirements in clinical trials.

@article{RuizCanela2001MethodologicalQA,
  title={Methodological quality and reporting of ethical requirements in clinical trials.},
  author={Miguel Ruiz-Canela and Jokin de Irala-Est{\'e}vez and M A Mart{\'i}nez-Gonz{\'a}lez and Enrique G{\'o}mez-Gracia and Joaqu{\'i}n Fern{\'a}ndez-Crehuet},
  journal={Journal of medical ethics},
  year={2001},
  volume={27 3},
  pages={
          172-6
        }
}
OBJECTIVES To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. DESIGN Systematic review using a standardised checklist. MAIN MEASURES Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British… CONTINUE READING

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