如何处理临床研究中研究者的经济利益冲突?--主体、原则与方法

临床研究中研究者的经济利益冲突可能会影响到受试者的安康和研究的客观性、可靠性.我们是否应该处理这种利益冲突?应该由谁处理?根据哪些伦理原则处理?具体采取哪些措施处理?围绕这些问题,本文批判地分析了反对处理利益冲突的观点,主张研究者、研究机构、行业组织、政府部门和学术期刊多方共同努力,根据公正、有利/不伤害、尊重三个伦理原则,采取公开、管理和禁止等措施,处理研究者的经济利益冲突,以保护受试者的安康和研究的客观性.     

我刊关于论文报告利益冲突的声明

利益冲突声明:(1)研究者有责任向监管机构公开自身与资助单位的财政利益关系,并保证研究的独立性和科学性,在必要时还应向公众公开。作者在投稿时有责任声明可能引起文章发生偏倚的利益冲突。作者应该说明资助     

2021年中国发布临床实践指南利益冲突与经济学证据的调查分析

目的 评价2021年中国发布的临床实践指南中利益冲突和经济学证据的情况，并与2017年和2018年发布的临床实践指南进行对比，充分了解中国指南制订变化情况，为进一步完善我国临床实践指南的制订提供参考。方法 系统检索中国知网（CNKI）、中国生物医学文献数据库（CBM）和万方数据库（WanFang Data），搜索2021年1月1日至2021年12月31日我国发布的临床实践指南。由2名研究者独立进行文献筛选、提取纳入指南的利益冲突和是否考虑经济学证据等相关信息后，使用Microsoft Excel 2019软件进行统计分析。结果 共纳入临床实践指南164部，其中112部（68.29%）声明了利益冲突，70部（42.68%）报告了资金来源，在临床实践指南推荐意见形成及治疗中考虑经济学证据的只有30部（18.29%），三方面同时报道的指南仅有16部（9.76%）。相较于2017年与2018年，2021年我国发布的临床实践指南在利益冲突声明和资金投入力度方面均有改善，但经济学证据关注仍然很低。结论 建议进一步完善我国临床实践指南对利益冲突的声明和管理及对经济学证据的关注，使指南制订更加客观、透...     

医学伦理视角下的SCI生物医学英语论文

通过实例,分析刊登在国际著名SCI医学期刊上的生物医学英语论文中常见的与医学伦理和科研道德相关问题,着力讨论生物医学英语论文写作过程中应注意的作者署名和贡献问题、材料与方法部分所涉及人体或动物为研究受试体时的伦理问题、致谢辞的撰写、参考文献选取,有关利益冲突等问题,并进一步论述了上述问题的相关处理方法。     

我刊关于论文报告利益冲突的声明

利益冲突声明:(1)研究者有责任向监管机构公开自身与资助单位的财政利益关系,并保证研究的独立性和科学性,在必要时还应向公众公开。作者在投稿时有责任声明可能引起文章发生偏倚的利益冲突。作者应该说明资助人在研究设计、收集、分析和解释数据、文章撰写和发表决     

基于Cytoscape的生物医学本体参数化SPARQL查询系统

大量生物医学本体数据的出现需要一种工具供生物医学研究者查询SPARQL。但完全手工输入SPARQL查询语句不仅非常复杂而且容易出错。在分析传统SPARQL查询构建器的基础上,利用参数化思想研发了一个基于Cytoscape的参数化SPARQL查询系统,该系统可以把SPARQL查询条件以参数的形式做成模板,生物医学研究者可以更快速便捷地对数据源中多个生物医学本体知识库直接进行参数化查询,而不用每次手动输入相同的条件。     

《中国全科医学》杂志关于论文报告利益冲突的声明

利益冲突声明:(1)研究者有责任向监管机构公开自身与资助单位的财政利益关系,并保证研究的独立性和科学性,在必要时还应向公众公开。作者在投稿时有责任声明可能引起文章发生偏倚的利益冲突。作者应该说明资助人在研究设计、收集、分析和解释数据、文章撰写和发表决定方面的作用。(2)期刊编辑在     

利益冲突下干细胞治疗的伦理原则思考

干细胞技术具有非常可观的医学应用前景,但同时也存在很多伦理问题。尤其是在干细胞的临床治疗中,除了技术本身的伦理问题,卫生系统内部各方的利益冲突、医患之间的利益冲突以及研究者、投资者与医疗机构及患方之间的利益冲突等问题更加值得关注。为了促进干细胞治疗技术沿着正确的方向发展,必须尽快规范干细胞治疗技术的临床试验研究,建立健全准入制度和管理及评估机制,严格遵循干细胞治疗的伦理原则,即严格准入原则、不伤害原则、知情同意原则、非商业化原则.     

医疗投诉管理与经营

医疗投诉是患者及其家属在接受医疗保健过程中，对医疗机构或医务人员提供的服务不满意而向有关部门反应问题的一种行为。医疗投诉是医患之间利益冲突的一种表现形式．广义上也属于医疗纠纷的范畴，但与医疗纠纷相比，冲突方式比较温和，影响范围比较小，解决方式相对简单。它是患者对医疗服务的期望和要求与医院的服务水平之间的失衡的结果，[第一段]     

Bioethics for clinicians: 17. Conflict of interest in research, education and patient care

A conflict of interest occurs in a situation in which professional judgement regarding a primary interest, such as research, education or patient care, may be unduly influenced by a secondary interest, such as financial gain or personal prestige. Conflicts of interest exist in every walk of life, including medicine and science. There is nothing inherently unethical in finding oneself in a conflict of interest. Rather, the key questions are whether one recognizes the conflict and how one deals with it. Strategies include disclosing the conflict, establishing a system of review and authorization, and prohibiting the activities that lead to the conflict.     

Research, ethics and conflicts of interest.

In this paper, I have tried to develop a critique of committee procedures and conflict of interest within research advisory committees and ethical review committees (ERCs). There are specific features of conflict of interest in medical research. Scientists, communities and the subjects of research all have legitimate stakeholdings. The interests of medical scientists are particularly complex, since they are justified by the moral and physical welfare of their research subjects, while the reputations and incomes of scientists depend on the success of their science. Tensions of this kind must at times produce conflict of interest. It is important to recognise that conflicts of interest may unwittingly lead to manipulation of research subjects and their lay representatives on research committees. It is equally important to recognise distinctions between the legal and moral aspects of conflict of interest. Some practical suggestions are made which may go some way towards resolving these difficulties. They indicate what might be needed to ensure the validity of ethical discourse, and to reduce the risks associated with conflict of interest.     

Policies on faculty conflicts of interest at US universities

CONTEXT: Despite federal regulations on faculty conflicts of interest in federally funded research, academic-industry ties are common, and evidence exists that financial considerations bias the research record. Public scrutiny of these ties is increasing, especially in cases where researchers have financial interests in the corporate sponsors of their clinical research. OBJECTIVE: To review policies on conflict of interest at major biomedical research institutions in the United States. DESIGN: Cross-sectional survey and content analysis study conducted from August 1998 to February 2000. SETTING AND PARTICIPANTS: The 100 US institutions with the most funding from the National Institutes of Health in 1998 were initially sampled; policies from 89 institutions were available and included in the analysis. MAIN OUTCOME MEASURES: Process for disclosure, review, and management of conflicts of interest and specified management strategies or limitations, according to the institutions' faculty/staff conflict of interest policies. RESULTS: Content of the conflict of interest policies varied widely across institutions. Fifty-five percent of policies (n = 49) required disclosures from all faculty while 45% (n = 40) required them only from principal investigators or those conducting research. Nineteen percent of policies (n = 17) specified limits on faculty financial interests in corporate sponsors of research, 12% (n = 11) specified limits on permissible delays in publication, and 4% (n = 4) prohibited student involvement in work sponsored by a company in which the faculty mentor had a financial interest. CONCLUSIONS: Most policies on conflict of interest in our sample of major research institutions in the United States lack specificity about the kinds of relationships with industry that are permitted or prohibited. Wide variation in management of conflicts of interest among institutions may cause unnecessary confusion among potential industrial partners or competition among universities for corporate sponsorship that could erode academic standards. It is in the long-term interest of institutions to develop widely agreed-on, clear, specific, and credible policies on conflicts of interest. JAMA. 2000;284:2203-2208.     

Potential research participants' views regarding researcher and institutional financial conflicts of interest

BACKGROUND: Financial conflict of interest in clinical research is an area of active debate. While data exist on the perspectives and roles of academic institutions, investigators, industry sponsors, and scientific journals, little is known about the perspectives of potential research participants. METHODS: The authors surveyed potential research participants over the internet, using the Harris Interactive Chronic Illness Database. A potential research participant was defined by: (1) self report of diagnosis by a health care professional and (2) willingness to participate in clinical trials. Email invitations were sent to 20 205 persons with coronary artery disease, breast cancer, or depression; a total of 6363 persons were screened; of these, 86% or 5478 met inclusion criteria and completed the survey. The outcome measures were respondents' ratings on: importance of knowing conflict of interest information, whether its disclosure ought to be required, and its effect on willingness to participate-across seven widely discussed scenarios of financial conflicts of interest (ranging from commercial funding to equity ownership). RESULTS: Majority responded that knowing conflict of interest information was "extremely" or "very" important; a larger majority felt financial conflicts of interest should be disclosed as part of informed consent (64% to 87%). In all seven scenarios, a majority was still willing to participate but in some scenarios a sizable minority would be wary of participation. Respondents were more wary of individual than institutional conflicts of interest. Illness group and sociodemographic factors had modest effects and did not affect the main trends. CONCLUSIONS: The prevailing practice of non-disclosure of financial conflicts of interest in clinical research appears contrary to the values of potential research participants.     

浅析新世纪我国生物医学科技发展的趋势与重点

我国生物医学科技的发展必须把握住历史的机遇 ,把我国生物医学研究推向发展的最前沿 ,这对提高我国新世纪医学科技事业的国际地位具有重大的意义。因此 ,确立新纪我国生物医学科技发展战略应以我国新时期卫生工作方针为指导 ,保护和促进人民健康 ,防治疾病。提高卫生服务质量必须依靠医学科技与教育的创新与发展。     

Australia needs an office of academic integrity

Institutions investigating allegations of research misconduct are vulnerable to claims that their processes are inadequate or that they have an institutional conflict of interest. The Office of Research Integrity in the United States sets down standards for and reviews the adequacy of investigations of research misconduct by institutions; recognises that internal politics and the involvement of non-experts can lead to honest mistakes being regarded as serious misconduct; requires complainants and investigators to act "in good faith"; and reduces damaging publicity when complaints are misconceived or false. Australia needs an office of academic integrity to ensure that all complaints are thoroughly investigated; the investigative procedures meet international standards; fair processes are provided for complainants and respondents; and institutions are protected from claims of "cover-up" and institutional conflict of interest.     

生物医学科学专业课程体系的比较

上海交通大学于2016年增设中国内地首个生物医学科学专业,借鉴其他学校的成功经验,将有助于该专业的更好发展。对于生物医学科学专业的培养方案和课程设置的比较及分析显示,牛津大学注重学生多元化发展,悉尼科技大学着眼于基础与临床的结合,香港大学则强调临床、科研及转化的多方面整合。而对于上海交通大学生物医学科学专业的课程体系的详细剖析则揭示了其夯实基础、强化综合、激发兴趣、能力拓展、创新提高等五大创新点。基于上述案例的分析也显示,开展生物医学科学教育还需解决课程体系整合、科研实践教育等问题,最终促进优秀生物医学科学人才的培养,推动未来生物医学科学领域的蓬勃发展。     

Foundational biomedical informatics research in the clinical and translational science era: a call to action

Advances in clinical and translational science, along with related national-scale policy and funding mechanisms, have provided significant opportunities for the advancement of applied clinical research informatics (CRI) and translational bioinformatics (TBI). Such efforts are primarily oriented to application and infrastructure development and are critical to the conduct of clinical and translational research. However, they often come at the expense of the foundational CRI and TBI research needed to grow these important biomedical informatics subdisciplines and ensure future innovations. In light of this challenge, it is critical that a number of steps be taken, including the conduct of targeted advocacy campaigns, the development of community-accepted research agendas, and the continued creation of forums for collaboration and knowledge exchange. Such efforts are needed to ensure that the biomedical informatics community is able to advance CRI and TBI science in the context of the modern clinical and translational science era.Over the past decade the health and life sciences communities have experienced a marked and dramatic shift toward translational and team science-based approaches to both basic and applied research.^{1 2} This transition is due in part to policy and funding initiatives at the national level, such as the clinical and translational science award (CTSA) program. A common theme spanning this evolution is recognition of the critical need to apply biomedical informatics theories and methods to enable the collection, exchange, management, analysis and dissemination of multidimensional datasets and knowledge collections. For example, complex clinical phenotype data describing large populations must be integrated with similarly large amounts of genomic data in order to support the identification of clinically relevant phenotype–genotype correlations. These types of needs have catalyzed an explosion of informatics research and development targeting the clinical and translational research domains. Such efforts have enabled numerous advancements in applied clinical and translational research informatics knowledge and practice. However, at the same time, the maturation of clinical research informatics (CRI)¹ and translational bioinformatics (TBI)³ is at risk of failing to meet expectations if commensurate foundational research in those same areas is not conducted.     

医学科研过程中的伦理学思考

伴随着前沿科研的不断进步,人类伦理也随之发生一些修正,但似乎科研永远回避不了与伦理的冲突。因此,在生物医学相关的科研活动中,作为实施者和管理者,我们不仅要考虑研究本身是否可以产出成果,同时,必须考虑在研究过程中涉及研究对象的一系列伦理道德方面的问题。因此,深入思考医学科研与伦理两者之间的相互关系。对于日后更好地开展科研工作是必不可少的。