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本文引用的文献

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Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest.专业医学协会及其与行业的关系:关于控制利益冲突的提议。
JAMA. 2009 Apr 1;301(13):1367-72. doi: 10.1001/jama.2009.407.
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Patients and the public deserve big changes in evaluation of drugs.患者和公众理应在药物评估方面看到重大变革。
BMJ. 2009 Mar 31;338:b1025. doi: 10.1136/bmj.b1025.
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STREPTOMYCIN treatment of pulmonary tuberculosis.链霉素治疗肺结核。
Br Med J. 1948 Oct 30;2(4582):769-82.
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Relation between agendas of the research community and the research consumer.研究群体的议程与研究消费者之间的关系。
Lancet. 2000 Jun 10;355(9220):2037-40. doi: 10.1016/S0140-6736(00)02351-5.

学术专业人员或机构与生物医学行业之间项目合作的伦理原则。

Ethical principles for project collaboration between academic professionals or institutions and the biomedical industry.

机构信息

Age Forum, State Board for Research and Age Policies, Odense, Denmark.

出版信息

Clin Epidemiol. 2012;4:95-7. doi: 10.2147/CLEP.S23033. Epub 2012 Apr 16.

DOI:10.2147/CLEP.S23033
PMID:22570569
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3346205/
Abstract

Ethics in biomedical research cannot be defined by etymology, and need a semantic definition based on national and contemporary values. In a Nordic cultural and historic context, key values are solidarity with one's fellow man, equality, truth, justice, responsibility, freedom, and professionalism. In contemporary medical research, such ethics are further subgrouped into research ethics, researcher ethics, societal ethics, and distributive ethics. Lately, public and academic debates have addressed the necessary strengthening of the ethical concerns and interests of patients and society. Despite considerable progress, common ethical definitions and control systems still lack uniformity or indeed do not exist. Among the cooperative partners involved, the pharmaceutical industry have preserved an important role. The same is true for the overall judgments reflected by the European Forum for Good Clinical Practice, leading peer-reviewed journals, the Nuffield Council on Bioethics for developing nations, and the latest global initiative, the Singapore Statement on Research Integrity. To help both institutions and countries, it will be valuable to include the following information in academia-industry protocols before starting a project: international authorship names; fixed agendas and time schedules for project meetings; chairperson shifts, meeting reports, and project plan changes; future author memberships; equal blinding and data distribution from disciplinary groups; an equal plan for exchange of project manuscripts at the proofing stage; contractual descriptions of all procedures, disagreements, publishing rights, prevention, and controls for suspected dishonesty; and a detailed description of who is doing what in the working process.

摘要

生物医学研究中的伦理学不能仅从词源学上进行定义,而需要基于国家和当代价值观进行语义定义。在北欧文化和历史背景下,关键价值观包括对同胞的团结、平等、真理、正义、责任、自由和专业精神。在当代医学研究中,这些伦理价值观进一步细分为研究伦理、研究人员伦理、社会伦理和分配伦理。最近,公众和学术界的辩论都集中在必须加强患者和社会的伦理关注和利益上。尽管取得了相当大的进展,但常见的伦理定义和控制系统仍然缺乏统一性,甚至不存在。在涉及的合作方中,制药业仍然保留着重要的角色。同样的情况也适用于反映在欧洲良好临床实践论坛、领先的同行评审期刊、为发展中国家设立的纳菲尔德生物伦理学理事会以及最新的全球倡议——新加坡研究诚信声明中的总体判断。为了帮助机构和国家,在开始项目之前,在学术-产业协议中纳入以下信息将是有价值的:国际作者姓名;项目会议的固定议程和时间表;主席轮替、会议报告和项目计划变更;未来的作者成员;来自不同学科组的平等盲法和数据分配;在校对阶段交换项目手稿的平等计划;对所有程序、分歧、出版权、预防和控制涉嫌不诚实的合同描述;以及详细描述在工作过程中谁在做什么。