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一项药物生物伦理学咨询服务:六年描述性特征及反馈调查结果

A Pharmaceutical Bioethics Consultation Service: Six-Year Descriptive Characteristics and Results of a Feedback Survey.

作者信息

Van Campen Luann E, Allen Albert J, Watson Susan B, Therasse Donald G

机构信息

Eli Lilly and Company.

Eli Lilly and Company (Retired).

出版信息

AJOB Empir Bioeth. 2015 Apr 3;6(2):53-62. doi: 10.1080/23294515.2014.957363. Epub 2014 Oct 10.

Abstract

: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. : Data on the descriptive characteristics of bioethics consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. : Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. : Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues.

摘要

生物伦理咨询在多种场所开展,包括医院、大学和其他研究机构,但关于在制药公司等企业环境中进行的生物伦理咨询的信息却很少。本文旨在描述一家制药公司的生物伦理咨询服务,报告该服务在六年期间完成的咨询的特点,并分享咨询反馈调查的结果。

从2008年到2013年收集了生物伦理咨询的描述性特征数据,并在Excel 2007中进行分析。分类数据通过数据透视表功能进行分析,基于时间的变量通过公式进行分析。反馈调查于2009年至2012年向咨询请求者进行,并也在Excel 2007中进行分析。

在这六年期间,共进行了189次生物伦理咨询。咨询次数从2008年的每年5次增加到2013年的大约每周1次。在此期间,咨询服务的形式从仅由委员会处理的方式转变为分层方式(根据案例需求定制)。五个最常见的主题是知情同意、临床试验的提前终止、益处和风险、人类生物样本以及患者权利。反馈调查结果表明,该咨询服务总体上受到好评,被视为易于接近、有帮助且响应迅速。

制药生物伦理咨询是生物伦理咨询的一个独特类别,主要侧重于药物研发,但也涉及临床伦理、商业伦理和组织伦理等方面。结果表明,该制药公司内部对分层生物伦理咨询服务有需求,且所提供的建议受到重视。该公司的经验表明,生物伦理咨询服务提高了对生物伦理的认识,使员工有能力提出生物伦理问题,并帮助他们理性思考具有挑战性的问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946b/4688593/491f4ec4bea3/uabr_a_957363_f0001_b.jpg

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