Ethics Instruction Increases Graduate Students' Responsible Conduct of Research Knowledge but not Moral Reasoning

The purpose of this study was to assess the short-term effectiveness of ethics courses in enhancing responsible conduct of research (RCR) knowledge and moral judgment among graduate students in health-related disciplines. Forty-eight graduate students completed a questionnaire about research experience, knowledge and judgments about appropriate research practices, and a standardized test of moral judgment at the beginning and end of a semester-long ethics course. Knowledge about RCR but not moral judgment increased significantly in some areas. The results are discussed in terms of implications for RCR instruction and of future research designed to improve RCR instruction.     

实现行政道德责任的道德人格性依据及制度正义原则的建构

作为公共权力的运作者和实施者,公务员应承诺包括行政道德责任在内的许多责任。现实中,行政道德责任的落实并不容易甚至出现缺失状况。为此,应该强化道德人格,坚持制度正义原则。道德人格是实现行政道德责任的依据,制度正义原则是实现行政道德责任的保障,二者相辅相成,共同促进责任的实现。     

International Standards for Research Integrity: An Idea Whose Time has Come?

A movement to promulgate international ethics standards covering areas of conduct other than research with human subjects has now begun to gain momentum. This commentary explains why it is important to develop international research integrity standards and some of the problems that must be overcome to bring them to fruition.     

Prevalence of Industry Support and its Relationship to Research Integrity

Most U.S. clinical trials are funded by industry. Opportunities exist for sponsors to influence research in ways that jeopardize research objectivity. The purpose of this study was to survey U.S. medical school faculty to assess financial arrangements between investigators and industry to learn about investigators' first hand knowledge of the effects of industry sponsorship on research.

Here we show first-hand knowledge that compromises occurred in: research participants' well-being (9%), research initiatives (35%), publication of results (28%), interpretation of research data (25%), and scientific advancement (20%) because of industry support. Financial relationships with industry were prevalent and considered important to conducting respondents' research.     

The Cycle of Bias in Health Research: A Framework and Toolbox for Critical Appraisal Training

Recognizing bias in health research is crucial for evidence-based decision making. We worked with eight community groups to develop materials for nine modular, individualized critical appraisal workshops we conducted with 102 consumers (four workshops), 43 healthcare providers (three workshops), and 33 journalists (two workshops) in California. We presented workshops using a “cycle of bias” framework, and developed a toolbox of presentations, problem-based small group sessions, and skill-building materials to improve participants' ability to evaluate research for financial and other conflicts of interest, bias, validity, and applicability. Participant feedback indicated that the adaptability of the toolbox and our focus on bias were critical elements in the success of our workshops.     

Protecting the Nation's Military May Include the Use of Investigational New Drugs

Clinician researchers have a number of roles, each of which carries specific obligations. There are times when these obligations may be in competition (up to and including conflict) with each other. Using a narrative case study that describes a group of colleagues discussing their clinical department's participation in an industry-sponsored research protocol, we illustrate a number of the obligations faced by clinician researchers, and discuss how competing interests and obligations can lead to ethical problems. The case study is followed by a discussion of the effect of university–industry relations on competing interests and obligations in both clinical research and the role of the university, and a suggested framework that could be used to determine when university involvement in commercial research is ethically acceptable.     

Policies and quality assurance in the pharmaceutical industry 1

The pharmaceutical industry is engaged in a critical undertaking of research, development, and marketing of drugs to patients. In this complex process there are a number of important steps involving corporate policies that require adherence by top management and personnel. The clinical trials, especially phase I—where drugs are first introduced into man, is one of these key steps that requires careful ethical consideration. The generic problem of varied conflict of interest among the personnel and departments can be the main contributing factor to decline in faith and confidence in the industry. It is argued in this paper than an effective and comprehensive quality assurance program that depends on internal and external review process and augumented by periodic externally conducted data audit is essential for corporations in developing and marketing safe and effective drugs. External quality assurance programs and data audit can make recommendations to management to avoid conflict of interests. The comprehensive key points of a high quality assurance program is proposed.     

Moral emotions in early childhood: Validation of the Chinese moral emotion questionnaire

Moral emotions such as pride, guilt and shame play an important role in the social-emotional development of preschool children. However, there are not many instruments available for measuring moral emotions in the preschool age. Moreover, relatively few research had examined cross-cultural validity of measures for moral emotions. The present study tested the Chinese version of the Moral emotion questionnaire (MEQ) upon a group of (N = 182) Chinese preschool children aged from 2 to 6 years. The Chinese MEQ is a parent-report translated from Dutch, assessing behavioural responses of pride, guilt and shame in preschool children. Confirmatory factor analysis showed satisfactory goodness-of-fit indexes for a three-factor structure (Pride, Guilt, Shame) with 15 loading items. For concurrent relations, the results suggested an adaptive role of pride and guilt and a maladaptive role of shame in the social-emotional development of preschool children. We could conclude that the 15-item Chinese MEQ is a valid and reliable instrument for measuring pride, guilt, and shame in 2–6-year-old children in the Chinese context.     

Taking Financial Relationships into Account When Assessing Research

Many scientific journals, government agencies, and universities require disclosure of sources of funding and financial interests related to research, such as stock ownership, consulting arrangements with companies, and patents. Although disclosure has become one of the central approaches for responding to financial conflicts of interest (COIs) in research, critics contend that information about financial COIs does not serve as a reliable indicator of research credibility, and therefore, studies should be evaluated solely based on their scientific merits. We argue that, while it is indeed important to evaluate studies on their scientific merits, it is often difficult to detect significant influences of financial relationships that affect research credibility. Moreover, at least five factors can be examined to determine whether financial relationships are likely to enhance, undermine, or have no impact on the credibility of research. These include as follows: whether sponsors, institutions, or researchers have a significant financial stake in the outcome of a study; whether the financial interests of the sponsors, institutions, or researchers coincide with the goal of conducting research that is objective and reliable; whether the sponsor, institution, or researchers have a history of biasing research in order to promote their financial goals; how easy it is to manipulate the research in order to achieve financial goals; and whether oversight mechanisms are in place which are designed to minimize bias. Since these factors vary from case to case, evaluating the impact of financial relationships depends on the circumstances. In some situations, one may decide that the financial relationships significantly undermine the study's credibility; in others, one may decide that they have no impact on credibility or even enhance it.     

COI Policies: Tax Dollars Should Not Be Used to Fund U.S. Institutions Not Making the Grade

Over two billion dollars was awarded by the U.S. Department of Health and Human Services (HHS) in research funding from 2010 to March 2012 to institutions receiving a grade of “C,” “D,” or “F” on their conflict of interest policies, as determined by the American Medical Student Association's scorecard on conflict of interest policies. More institutional oversight is needed with regard to assuring conflict of interest policies at U.S. research institutions are adequate. As stewards of public funds, HHS should require a minimum standard which institutional conflict of interest policies should meet, beyond current regulatory requirements, before granting funding.     

Managing Conflict of Interest in Research: Some Suggestions for Investigators

Conflict of interest situations threaten to compromise objectivity and tempt researchers to act wrongly. Allowing oneself to drift into such situations without appropriate preparation is negligence which is, itself, a sort of wrongdoing. Since conflict of interest is unlikely to be eliminated or tamed by the professional---and institutional---level safeguards currently under discussion, individual researchers must make their own preparations. We offer individuals ten strategies for managing their own conflicts of interest.     

Conflict of Interest Policies and Industry Relationships of Guideline Development Group Members: A Cross-Sectional Study of Clinical Practice Guidelines for Depression

Because of increased attention to the issue of trustworthiness of clinical practice guidelines, it may be that both transparency and management of industry associations of guideline development groups (GDGs) have improved. The purpose of the present study was to assess a) the disclosure requirements of GDGs in a cross-section of guidelines for major depression; and, b) the extent and type of conflicts of panel members. Treatment guidelines for major depression were identified and searched for conflict of interest policies and disclosure statements. Multi-modal screens for undeclared conflicts were also conducted. Fourteen guidelines with a total of 172 panel members were included in the analysis. Eleven of the 14 guidelines (78%) had a stated conflict of interest policy or disclosure statement, although the policies varied widely. Most (57%) of the guidelines were developed by panels that had members with industry financial ties to drug companies that manufacture antidepressant medication. However, only a minority of total panel members (18%) had such conflicts of interest. Drug company speakers bureau participation was the most common type of conflict. Although some progress has been made, organizations that develop guidelines should continue to work toward greater transparency and minimization of financial conflicts of interest.     

论知识经济下高校德育工作的改进

21世纪是知识经济的时代,知识经济将使中国高校的德育工作背景发生深刻变化。基于知识经济下增强民族凝聚力和大学生个体道德发展的要求,我们必须改进高校德育工作,实现教育理念及对大学生从教会“顺从”到教会“选择”的转变,实现全面提高德育工作者素质,实现德育工作手段的现代化,实现德育工作的不断创新。     

Researchers’ Views of the Acceptability of Restrictive Provisions in Clinical Trial Agreements with Industry Sponsors

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators’ academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.     

改革开放30年来思想道德教育发展的回顾与探索

改革开放30年来,思想道德教育的发展大致经历了从"‘滑坡’与‘爬坡’的争论"到"边调整边发展"和"在创新中跨越"三个大的时期。国家不仅重视经济建设,而且也重视道德教育,且更加讲求实效。改革开放初期这些方面存在某些失误,尤其对中国传统文化的重视和继承不够,使青少年的基础道德素养较差等。今后应从日常行为入手,把中华民族传统美德作为思想道德教育的重要内容,进一步改革和改进教育教学方法,加强道德自律,树立健康的网络观,注重生态道德教育。其目的在于从心灵深处解决学生思想困惑与人格缺失问题,端正其理想信念,唤醒他们的民族使命感和社会责任心。     

西方若干道德观念在我国表现的实证研究

为了进一步了解西方观念对普通中国公众的影响程度,在最近进行的问卷调查中设置了相关提问。通过对回收的有效问卷的数据分析,不难发现,与行为相关的观念如提前消费观念、婚前财产公证、平等的朋友关系等易于并且已经被多数人所接受;而与价值相关的观念如个人本位意识、宽恕精神等不易被人们所认同。这表明,西方观念对中国人的影响仍停留在外在的行为方面,价值观念方面的影响并不显著。     

道德冷漠感剖析

"道德冷漠感"一词在现今的社会中正为人们所知,它是社会道德的一种消极现象,是人们道德感的麻木和冷漠,也是人们的道德行为畸形发展的一种状态。道德冷漠感产生的原因在于文化、社会制度及个体等诸多层面。面对这样一种消极现象,应从个人、政府和社会三个层面进行矫治。     

我国企业文化中社会责任的缺失及对策

企业社会责任在本质上属于企业文化,是企业文化的新内容,但在我国企业文化建设中,缺少了企业社会责任的建设,因此我国必须完善企业文化中的社会责任建设,把社会责任建设上升到文化层次。     

Developing a clinical trial governance framework for pharmaceutical industry-funded clinical trials

ABSTRACT

Rising concerns relating to pharmaceutical sponsor bias in the conduct of clinical trials have compelled the need to develop a clinical trial governance framework. This article describes the development of the Conflict of Interest in Research (COIR), a clinical trial governance framework. The COIR, consisting of three process phases (initiation, concurrent, and ongoing), developed following a needs assessment, using a four-stage methodology, and evaluated against the International Conference on Harmonization--Good Clinical Practice (ICH-GCP) guidelines. The Conflict of Interest Resolution algorithm, the backbone of COIR, enables constant surveillance to detect/resolve conflicts at all stages of the clinical trial life-cycle. COIR promotes interaction between the regulatory system and the sponsors, independent of individuals. COIR enables rapid detection of scientific and financial conflicts, to prevent subject harm and, to assure optimal funds utilization, the latter feature helped to reduce a significant burden for the ethics committee, as it lacks financial expertise. COIR is a semi-automated Oracle system, requires manpower, and is affected by human expertise and subjectivity. Complete automation to overcome this limitation will still need human expertise to scale changing trial regulations. Nevertheless, the COIR has won the distinction of the “most favored site” from pharmaceutical sponsors and is anticipated to be adopted by other clinical trial sites.