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临床研究招募中的角色间保密冲突。

The inter-role confidentiality conflict in recruitment for clinical research.

作者信息

Habiba Marwan, Evans Martyn

机构信息

Leicester-Warwick Medical School, University of Leicester, University Hospitals of Leicester, Leicester, UK.

出版信息

J Med Philos. 2002 Oct;27(5):565-87. doi: 10.1076/jmep.27.5.565.10323.

Abstract

Recruiting patients into clinical research is essential for the advancement of medical knowledge. However, when the physician undertaking the care of the patient is also responsible for recruitment into clinical research, a situation arises of an inter-role breach of confidentiality which is distinguishable from other conflicts of interest. Such discord arises as the physician utilizes confidential information obtained within the therapeutic relationship beyond its primary objective, and safeguards ought to be observed in order to avert this important, and generally overlooked, problem. The moral worth of the pledge of confidentiality is based not on its innate value but on its being a promise on which subsequent interactions and disclosures are founded. Within the patient-doctor interaction, confidentiality is an important facet of the promised fidelity and, as such, a loose interpretation of the notion threatens the essence of the relationship, and any violation thereof requires compelling moral justification. To avoid conflict, patients' confidential information ought not be used for the purpose of recruitment, which needs to be undertaken through general education and non-directed appeals, and a preliminary consent to be approached for research should be obtained from the patient prior to her being identified as a suitable research subject. Securing this prior consent would avoid one source of potential, albeit unintended, coercion.

摘要

招募患者参与临床研究对于医学知识的进步至关重要。然而,当负责照料患者的医生同时也负责招募患者参与临床研究时,就会出现一种角色间违反保密原则的情况,这与其他利益冲突有所不同。这种矛盾的产生是因为医生将在治疗关系中获取的保密信息用于其主要目的之外,因此应该采取保障措施以避免这个重要且通常被忽视的问题。保密承诺的道德价值并非基于其内在价值,而是基于它是后续互动和披露所依据的承诺。在医患互动中,保密是承诺的忠诚的一个重要方面,因此,对这一概念的宽松解释会威胁到关系的本质,任何违反行为都需要有令人信服的道德理由。为避免冲突,患者的保密信息不应被用于招募目的,招募应通过大众教育和非定向呼吁进行,并且在患者被确定为合适的研究对象之前,应先获得其参与研究的初步同意。获得这种事先同意将避免一种潜在的、尽管是无意的强制来源。

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