单位制下伦理委员会审查能力建设

受单位制社会意识的影响,伦理委员会的工作也带有许多单位制的明显特征,制约了伦理审查质量的提高.分析机构伦理委员会建设现状,提出垂直管理机制、资质准入、项目交叉审查、统一标准作业程序、技术性与伦理性审查相对分开等建议.     

提高伦理定期跟踪审查监管的实践经验分享

目的改变定期跟踪审查管理相对薄弱的现状, 进一步提高伦理委员会持续跟踪审查能力。方法通过梳理分析定期跟踪审查中存在的问题, 采取相应的解决措施。细化管理要求, 加强日常监督。专项伦理培训并加强沟通以增强研究者的伦理意识。优化伦理办公室人员分工提高工作效率和委员定期跟踪审查质量。信息化审查系统助力加强定期跟踪提醒等。结果在实践工作中, 定期跟踪的迟报、漏报情况明显减少, 提高了伦理委员会对定期跟踪审查的监管能力。结论定期跟踪审查中, 只有研究机构、伦理委员会、研究者各方足够重视, 各尽其责, 积极配合才能有效提高定期跟踪审查质量。     

某医院近3年206项伦理审查分析

目的通过对某医院伦理委员会近3年206项临床研究伦理审查情况分析,了解医院伦理审查的一般通过率和常见问题.方法查阅伦理会纪录,归类整理并使用ridit的CMH方法和Bootstrap方法统计分析.结果药物试验通过率为36.09%,器械为1 8.42%,课题为14.29%.在伦理审查发现的问题方面,知情同意占63.59%,方案占14.56%,CRF占7.77%,其他占22.82%;国内申办者的问题明显多于国外申办者.药物伦理审查通过率逐年降低,分别是2006年45.83%、2007年38.78%、2008年19.44%,2008年与2006年相比有统计学上的差异,P=0.029.在药物临床试验中修订项目审查国外明显高于国内,P=0.028.结论医院伦理会对临床研究伦理审查十分必要,审查中尤其要关注知情同意书和研究方案等.     

某医院近3年206项伦理审查分析

目的通过对某医院伦理委员会近3年206项临床研究伦理审查情况分析,了解医院伦理审查的一般通过率和常见问题。方法查阅伦理会纪录,归类整理并使用ridit的CMH方法和Bootstrap方法统计分析。结果药物试验通过率为36．09％,器械为18．42％,课题为14．29％。在伦理审查发现的问题方面,知情同意占63．59％,方案占14．56％,CRF占7．77％,其他占22．82％;国内申办者的问题明显多于国外申办者。药物伦理审查通过率逐年降低,分别是2006年45．83％、2007年38．78％、2008年19．440A,2008年与2006年相比有统计学上的差异,P=0．029。在药物临床试验中修订项目审查国外明显高于国内,P=0．028。结论医院伦理会对临床研究伦理审查十分必要,审查中尤其要关注知情同意书和研究方案等。     

某医院近3年206项伦理审查分析

目的通过对某医院伦理委员会近3年206项临床研究伦理审查情况分析,了解医院伦理审查的一般通过率和常见问题.方法查阅伦理会纪录,归类整理并使用ridit的CMH方法和Bootstrap方法统计分析.结果药物试验通过率为36.09%,器械为1 8.42%,课题为14.29%.在伦理审查发现的问题方面,知情同意占63.59%,方案占14.56%,CRF占7.77%,其他占22.82%;国内申办者的问题明显多于国外申办者.药物伦理审查通过率逐年降低,分别是2006年45.83%、2007年38.78%、2008年19.44%,2008年与2006年相比有统计学上的差异,P=0.029.在药物临床试验中修订项目审查国外明显高于国内,P=0.028.结论医院伦理会对临床研究伦理审查十分必要,审查中尤其要关注知情同意书和研究方案等.     

基于Brusselator模型的医学伦理委员会可持续发展研究

目的：基于Brusselator模型探究医学伦理委员会可持续发展的影响因素，为医学伦理委员会组织能力评价和建设提供可量化的新思路。方法：在前人开发的问卷基础上，进一步完善和调整设计出包含52个指标的李克特量表问卷，并在我国东部地区97家三甲医院中开展调查。通过转义法建立医学伦理委员会Brusselator模型。结果：伦理委员会独立性、秘书配置、委员任命条件、意外问题的审查、患者诊疗伦理审查质量和培训总体质量对医学伦理委员会内部环境有不利影响，权重在0.0139～0.0190之间；相关群体消费水平、技术进步程度、相关政策稳定性、相关法律法规健全性和未来发展生命力对医学伦理委员会外部环境产生负面影响，权重在0.1071～0.1296之间。结论：医学伦理委员会组织能力建设受到内外部双重环境影响，应该内外兼修、协同提升，为我国医学伦理委员会可持续发展注入动力。     

浅议提高伦理审查质量的保障体系建设

伦理评审质量的保障体系建设应包括:①组建有能力、高效的伦理委员会为伦理审查提供技术保障;②建立健全制度为伦理评审提供政策保障;③建立符合GCP规范的工作框架为伦理评审提供质量保障;④项目管理为伦理评审提供后续保障;⑤伦理委员会的自我教育为伦理评审提供知识储备的保障.     

我国生物研究的伦理问题及伦理委员会的建设意义

生物科学研究的风险特性、各方利益冲突及危害的存在决定了中国伦理审查委员会能力建设的必要性;生物科研的迅猛发展、我国对生物科研监管的不良状况以及我国伦理审查委员会运作存在着普遍性的缺陷情况则凸显了中国伦理审查委员会能力建设的紧迫性。因此,加强我国伦理审查委员会能力建设有着重大意义。     

医学伦理审查规范流程探讨

在机构医学伦理委员会项目审查过程中,通过一系列规范流程,加强医院临床研究者及伦理委员会工作人员的伦理审查意识,使医院临床研究伦理审查管理水平进一步提高,真实展现伦理审查全过程,从而使伦理委员会切实起到保护受试者权益的功能,同时为临床研究提供科学、真实、准确、完整、可靠的证据。     

河北省医疗机构伦理委员会运行现状评价及其影响因素研究△

目的:以河北省为例,对其医疗机构伦理委员会制度、管理、审查等方面进行评价,分析其影响因素,发现医疗机构伦理委员会运行中的问题并提出建议。方法:通过专家咨询确定伦理委员会评价指标与方法,对河北省44家医疗机构伦理委员会进行评价并采用线性回归分析法分析其影响因素。结果:确定3个一级指标、11个二级指标、29个三级指标,44家医疗机构伦理委员会的评分总分平均为74.75分,不同级别医院差异较大。接受过GCP等伦理培训的成员比例、委员职称、伦理委员会审查范围三个因素是影响伦理委员会运行的相关因素,P <0.05。结论:河北省医疗机构伦理委员会运行情况良好,但仍有较大提升空间,管理水平和审查能力有待进一步提高。     

Ethics,big data and computing in epidemiology and public health

PurposeThis article reflects on the activities of the Ethics Committee of the American College of Epidemiology (ACE). Members of the Ethics Committee identified an opportunity to elaborate on knowledge gained since the inception of the original Ethics Guidelines published by the ACE Ethics and Standards of Practice Committee in 2000.MethodsThe ACE Ethics Committee presented a symposium session at the 2016 Epidemiology Congress of the Americas in Miami on the evolving complexities of ethics and epidemiology as it pertains to “big data.” This article presents a summary and further discussion of that symposium session.ResultsThree topic areas were presented: the policy implications of big data and computing, the fallacy of “secondary” data sources, and the duty of citizens to contribute to big data. A balanced perspective is needed that provides safeguards for individuals but also furthers research to improve population health. Our in-depth review offers next steps for teaching of ethics and epidemiology, as well as for epidemiological research, public health practice, and health policy.ConclusionsTo address contemporary topics in the area of ethics and epidemiology, the Ethics Committee hosted a symposium session on the timely topic of big data. Technological advancements in clinical medicine and genetic epidemiology research coupled with rapid advancements in data networks, storage, and computation at a lower cost are resulting in the growth of huge data repositories. Big data increases concerns about data integrity; informed consent; protection of individual privacy, confidentiality, and harm; data reidentification; and the reporting of faulty inferences.     

Revisiting Bloom's taxonomy for ethics and other educational domains

In the process of developing competency-based health services administration education, the Ethics Faculty Forum Co-Chairs from the Association of University Programs in Health Administration (AUPHA) were asked not only to identify their domains and competencies, but also to review six other faculty fora research outcomes. This article was written by the Ethics Faculty Forum Co-Chairs in response to the AUPHA request. Reviewing the work of the original six faculty fora using Bloom's taxonomy, we found that the fora focused mainly on the cognitive objectives and generally did not consider the affective objectives. The intent of this paper is to help those who teach healthcare ethics refine their current courses to include both cognitive and affective objectives. The paper pursues five objectives: 1. review of Bloom's taxonomy as a framework for creating course objectives in both the cognitive and affective domains; 2. present fora research and their domain outcomes; 3. present an overview of healthcare ethics literature; 4. provide a demonstration of healthcare ethics competencies in both the cognitive and affective domains; and 5. present possible directions for healthcare ethics and other educational domain research.     

Ethics Opinion: Weight Loss Products and Medications

An Ethics Opinion reflects the interpretation or application of the American Dietetic Association (ADA)/Commission on Dietetic Registration (CDR) Code of Ethics for the Profession of Dietetics by the Ethics Committee in response to a specific ethics issue facing dietetics professionals in practice. An ethics opinion is an educational guide for practitioner conduct; it is meant to be a comprehensive review of the issue. The Ethics Committee initiated the following opinion. The situations described are hypothetical.     

Research and hospital ethics committees in Switzerland

This paper presents the situation concerning research and hospital ethics committees (HEC) in Switzerland. In fact, HECs are almost nonexistent. All the so-called "Ethics Committees" deal with the review of research projects. As there is no legislation governing research on human subjects, the Swiss Academy of Medical Sciences (SAMS) has issued guidelines concerning research on human subjects and, more recently, guidelines concerning Research Ethics Committees (REC). There is a wide disparity in the composition and the functioning of these committees, however. Half of them belong to university hospitals. Six of them review two-thirds of all reviewed protocols. Many RECs function more as educational bodies to enhance the quality of submitted protocols than as committees having the task to control and prohibit particular research projects.     

Ethik in der medizinischen Aus- und Weiterbildung

Ethics education is a topic of growing importance in the medical curriculum. Medical ethics can be defined as the skilled professional discourse on moral issues in patient care, medical research and the health-care system. Ethical competence comprises conscientiousness and the ability to give reasons for intuitive moral convictions. In the curriculum, course content and didactic approaches should be aimed at all levels (cognitive, affective, practical), as discussed in this paper. Case based seminars are the gold standard of ethics education. The teacher's responsibility is rooted in their character as role models during case discussions. Ethics education should continue throughout the curriculum. In Germany the compulsory subject "history, theory, ethics of medicine" is predominant in the curriculum, but courses vary greatly between different universities. Further research is needed in the fields of adequate assessment formats and evaluation of final outcomes of ethics education. Interprofessional ethics education (undergraduate and postgraduate) is a major challenge for the future, especially since services for clinical ethics consultation and moral case deliberation are becoming more established in German hospitals.     

A descriptive study of healthcare ethics consultants in Canada: Results of a national survey

As part of a project to examine health care ethics consultation in Canada, we surveyed individuals who were considered by themselves or others to play a significant role in health care ethics consultation. Since one goal of the project was to examine the education and abilities necessary for consultants, we sought to determine the qualifications and skills currently possessed by persons considered to be ethics consultants. For the purposes of the questionnaire, 'health care ethics consultation' was defined broadly to include consultation on ethical issues in clinical care or in clinical research, ethics consultation to Clinical Ethics Committees, Research Ethics Committees, and policy formulation committees in health care institutions; 'clinical ethics work' was defined more broadly still to include, in addition to the above, ethics education, administration, research and writing on bioethics other than the above, and public speaking. Three hundred and fifty questionnaires were sent to individuals and institutions across Canada that were thought to have some involvement in health care ethics consultation. Two hundred and fifty-three questionnaires were returned for a response rate of 72%. This report presents initial findings of the study and attempts to provide a comprehensive overview of the current state of ethics consultation within Canada. The survey examines demographics, educational background, time spent on ethics, institutional affiliations, approaches to the role of consultation, research related issues, and attitudes toward certification. Of the 253 questionnaires returned, 162 were completed by individuals who indicated that they provided some kind of ethics consultation. Of these, 43 indicated that they spent 30% or more of their time in clinical ethics work. These individuals are quite heterogeneous in background, training and activities, and while the great majority of them are based in an academic setting (university or teaching hospital), many act as resources to community hospitals, long-term care facilities and other organizations. Finally, the survey found that respondents' views on the advisability of certification for those offering ethics consultation were split evenly between those in favour of and those against certification. This report serves, then, as a reference point for studying the roles, responsibilities, training and accreditation of ethics consultants in health care.     

ISPOR Code of Ethics for Researchers Background Article—Report of the ISPOR Task Force on Code of Ethics for Researchers

In 2001, ISPOR convened a Task Force on Code of Ethics for Researchers (The Task Force). This Task Force was to build on the previous work of ISPOR Health Science Policy Task Forces and develop a code of ethics that would be applicable to all ISPOR members and to ISPOR itself. The Task Force developed a code of ethics that was subsequently adopted by the ISPOR Board of Directors. The Code of Ethics is appended to this article and can be found on ISPOR's Web page at http://www.ispor.org/workpaper/code_ethic.htm. This article provides supportive information and justification for the ISPOR Code of Ethics for Researchers and includes a discussion of the stakeholders as well as ethical considerations for the researcher on research practices, research sponsorship, research publication and dissemination, and relationships with others. It also includes a discussion of the ethical considerations for the Society.     

Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective

Background  

For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN), to gain insight into the Canadian system.     

Oops,what about ethics?

Ethics approval of research studies is essential for the protection and rights of study subjects, whether this is for prospective research or record reviews. This article shares a painful lesson learned from a field experience where the appropriate steps for obtaining ethics approval were not followed by a young researcher. This researcher had embarked on an operational research project, but had omitted to seek ethics approval from a local ethics committee. Young researchers, particularly from low- and middle-income countries, need to learn about the importance and value of ethics.     

One hospital's attempt to create an institutional code of ethics

Chaplain Linda Smith-Criddle, chair of the ethics committee at Riverside Hospital, Toledo, OH, was kind enough to share with the readers of Hospital Ethics the committee's final (sixth!) draft of a code of ethics [that it would hope will be adopted in toto] by the Hospital Medical Staff and Board of Trustees. With the committee's permission, the entire document is reprinted here, and we invite readers to review and critique the policy and to send any comments or suggestions to either Hospital Ethics or directly to Chaplain Smith-Criddle at Riverside Hospital, 1600 North Superior Street, Toledo, OH 43604.