1. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group
- Author
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Cathy Eng, G. Decoster, H.-J. Schmoll, Al B. Benson, Annette K. Larsen, Alberto Sobrero, A. de Gramont, Charles S. Fuchs, Harry Bleiberg, Masashi Fujii, John Zalcberg, Jean-Yves Douillard, Dominique Sprumont, Roberto Labianca, Edith P. Mitchell, Ph. Rougier, and Benoist Chibaudel
- Subjects
Health Knowledge, Attitudes, Practice ,medicine.medical_specialty ,good clinical practice ,media_common.quotation_subject ,education ,Legibility ,Institution Review Board ,Consent Forms ,03 medical and health sciences ,0302 clinical medicine ,Documentation ,Informed consent ,Neoplasms ,inform consent ,Humans ,Medicine ,030212 general & internal medicine ,Patient participation ,media_common ,Clinical Trials as Topic ,Medical education ,Informed Consent ,business.industry ,clinical trial ,Hematology ,ethics ,Cancérologie ,Clinical trial ,Editor's Choice ,Oncology ,030220 oncology & carcinogenesis ,Family medicine ,oncology ,Practice Guidelines as Topic ,Good clinical practice ,Special Articles ,Position paper ,Patient Participation ,business ,Autonomy ,Hématologie - Abstract
Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents., SCOPUS: ar.j, info:eu-repo/semantics/published
- Published
- 2017