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Open Access The Role of the Clinical Trial Nurse in the Informed Consent Process Le rôle de l'infirmière d'essai clinique dans le processus d'obtention du consentement éclairé

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Abstract:

The purpose of this descriptive study was to elicit information about the current practice of clinical trial nurses in the informed consent process. A 50-item self-administered anonymous questionnaire was completed by a sample of 95 nurses from hospitals affiliated with McGill University in Montreal, Quebec, Canada, who were members of a clinical trial research team whose principal investigator was a physician and whose research participants were competent adults. The nurses were all members of the provincial nurses' association. Clinical trial nurses were found to have an important role in the informed consent process and to experience conflict of interest and other ethical dilemmas as members of clinical trial research teams. There is a need to develop specific practical and ethical guidelines for nurses involved with clinical trial research and to develop educational programs for nurses working in clinical research.

French
Cette étude descriptive visait à recueillir de l'information sur le rôle que jouent les infirmières d'essai clinique dans le processus d'obtention du consentement éclairé. On a fait remplir un questionnaire auto-administré de 50 éléments à 95 infirmières employées dans des hôpitaux affiliés à l'Université McGill à Montréal, Québec, Canada, qui participaient à un projet de recherche clinique dont le chercheur principal était un médecin et les sujets des adultes compétents. Les infirmières étaient toutes membres de l'association provinciale des infirmières. L'analyse révèle que les infirmières d'essai clinique jouent un rôle important dans l'obtention du consentement éclairé et qu'elles vivent des conflits d'intérêts et des dilemmes d'ordre éthique dans l'exercice de ce rôle. L'étude confirme la nécessité d'élaborer des lignes directrices précises en matière de pratique et d'éthique pour guider les infirmières en recherche clinique, ainsi que des programmes de formation.

Keywords: CLINICAL TRIAL; ETHICS; INFORMED CONSENT; NURSE; RESEARCH ETHICS

Document Type: Research Article

Publication date: 2007-06-01

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