临床试验安全性均势伦理探讨

均势原则是临床试验中的一项方法规则,同时也是临床试验研究的伦理规则。均势原则指导下的临床试验仍然存在设计缺陷、忽视安全风险评估、均势判定主体失当等方面的安全性伦理问题。这需要进一步确立安全性均势伦理准则,以强调在临床均势试验研究中不能对受试者造成生命健康方面的明显伤害,包括风险受益全面合理性评估原则、受试者生命安全底线原则以及利益相关者安全责任原则。落实安全性均势伦理原则需要采取多学科协作评估、优化均势判定主体结构及明确判定标准等基本规范策略。     

守护受试者的权益——对“药物研究与应用的伦理监督”

如何保障和守护临床试验研究中受试者的权益?这既是医生、患者(受试者)、工业界与公众注目的问题,也是医院伦理委员会工作面临并要解决的基本而至关重要的问题。从华西医院伦理委员会工作角度出发,分析了临床试验研究中的权益冲突和对受试者权益的科学、伦理与政策守护的要素,论述了如何保障受试者权益问题。     

守护受试者的权益--对"药物研究与应用的伦理监督"

如何保障和守护临床试验研究中受试者的权益?这既是医生、患者(受试者)、工业界与公众注目的问题,也是医院伦理委员会工作面临并要解决的基本而至关重要的问题.从华西医院伦理委员会工作角度出发,分析了临床试验研究中的权益冲突和对受试者权益的科学、伦理与政策守护的要素,论述了如何保障受试者权益问题.     

构建合理的科研诚信观

建设科研诚信、遏制科研不端需要我们树立合理的科研诚信观。在反思科学契约论和委托代理理论的科研诚信观基础上,从利益相关者视角出发,科研诚信建设既不能单纯依靠科研共同体及其成员的自律,也不能单纯依靠公共机构的监督,而是应当将公众也纳入科研诚信建设的主体。科研共同体、公共机构和公众三者是利益相关者关系,科研诚信建设实质上是要正确处理科研诚信利益相关者各方的利益关系,需要利益相关者各方的共同参与。     

生物医学人体受试者研究未来面临的挑战

人体受试者研究的伦理问题在今后将会愈益引起关注,如何看待知情同意的代理权？如何处理不同文化背景下的知情同意原则？在商业利益诱惑下背离本人健康利益和知情同意是否有效？受试者的利益回报,以及体试验研究要求的双盲,随机、对照等原则可能面临的新问是,都是人体受试者研究未来面临的挑战。     

经济体制对社会道德的影响

经济体制与道德的关系,在目前理论研究中尚未受到重视.然而,事实上社会经济体制的变革,是会强烈地引起社会价值观和道德原则规范的变化的.因此,在研究经济与道德的关系时,除了应着眼于经济制度与道德的相关分析外,还应注意经济体制对社会道德的影响.利益是道德的基础.人们的经济利益是由社会的生产关系规定的.生产关系中,生产资料所有制决定着社会制度的本质,规定着生产关系的其它方面的总体倾向.但是,生产资料所有制并没有规定社会生产用什么样的经济体制来进行运转.在保持社会所有制格局不发生     

牵涉人类受试者的生物医学研究的国际伦理学准则

牵涉人类受试者的生物医学研究的国际伦理学准则国际医学科学组织委员会一、受试者的知情同意１．个体知情同意对于牵涉人类受试者的所有生物医学研究,研究人员必须获得未来受试者的知情同意,或个体不能做出知情同意的情况下,必须获得正当委任的代理人的代理同意。２．...     

权利优先、还是义务优先——对涉及人的生物医学研究中受试者权利与义务关系的理性思考

对“权利与义务”从“公正”方面进行了解读,论述了在涉及人的生物医学研究中,受试者权利与义务之间的复杂关系,提出“受试者权利优先”是平衡两者关系的基本原则;确立了“受试者权利优先”的具体策略：首先尊重受试者的权利（首要性）;当受试者的权利与受试者的义务出现一定矛盾时,应该把尊重受试者的权利放在首位（至上性）;在尊重受试者的权利中,化解两者矛盾。     

美国人体研究的监督：科学发展中的伦理与规定

美国保护人体受试者的制度建立在伦理学基础之上,并正式通过相关法律。对人体研究的监督是保护受试者个人的健康和权益,确保研究的有效性,整体性,以及科学与社会更大范围的利益,监督审查机构是联邦卫生部下属的两个机构-食品与药品管理局（FDA）和人体研究保护办公室（OHRP）,大部分人体研究受两机构监督。美国人体受试者保护系统的基础部分是伦理审查委员会（IRB）及知情同意,IRBU电在提供一种机制,以进行客观的审查,同意和研究过程听持续监督;知情同意意在保证个人在了解与实验相关的风险,不适,收益后能自由做出参加与否的决定,美国人体研究保护制度正面临着挑战。美国也为促进人体受试者保护在进行新的努力。     

商业银行信贷中的道德风险及控制

商业银行信贷道德风险是由于信贷利益各方道德不确定性使信贷内部或外部利益遭受损失的可能,具有关系复杂性、形式多样性、后果严重性等特点。由于信贷人员的道德缺失、信贷社会责任的忽视、信贷主体目标的冲突、信贷机构制度的漏洞等原因导致了商业银行信贷道德风险的产生,必须从信贷制度、信贷主体的道德素质等方面入手加强对商业银行信贷中的道德风险控制。     

Institutional Conflicts of Interest in Academic Research

Science and Engineering Ethics - Financial relationships in academic research can create institutional conflicts of interest (COIs) because the financial interests of the institution or...     

Commercialism and Universities: An Ethical Analysis

This paper questions the ethicality of commercial relationships between universities and external donors. By examining cases such as technology transfer and the outside funding of research interests, we identify possible conflicts of interest between the external provider of financial support and academic institutions. The reality today is that university administrators, who have significant decision-making powers, proactively seek large corporate sources of funding that may compromise academic values including academic freedom and the ability to make institutional decisions without the influence of commercial interests. For example, Coca-Cola and Pepsi-Cola have provided extensive funding to universities in return for exclusivity rights to market their product on campuses even though such products may not be healthy alternatives to other soft drinks. Pharmaceutical and biotechnology companies may have opposing interests to faculty and universities if the results of research do not meet the expectations of the sponsors. Curricula issues may be slanted to promote the interests of a corporation or other provider of outside funding. Corporate partnerships between universities and companies such as Nike raise ethical questions when students or other members of the campus community object to the acceptance of financial support from a company that allegedly practices anti-social labor practices in developing countries. On the other hand, corporate funding can be used to supplement diminishing financial resources available to academic institutions, especially for public universities. One benefit of external funding is that it supports pharmaceutical and technology-oriented research and development into new products and processes that have the potential to serve the public good. One cost of such funding arrangements is that the acceptance of financial support from commercial interests solely to market their products on campus restricts the choices available to students that should exist in a free market economy such as in the U.S. The ethicality of the relationship between universities and commercial interests is a matter of concern because of the potential influence of providers of external funds to universities that can compromise academic freedom and objective decision making.     

Intrinsic conflicts of interest in clinical research: a need for disclosure

Protection of human subjects from investigators' conflicts of interest is critical to the integrity of clinical investigation. Personal financial conflicts of interest are addressed by university policies, professional society guidelines, public standards, and government regulation, but "intrinsic conflict of interest"--conflicts of interest inherent in all clinical research--have received relatively less attention. Such conflicts arise in all clinical research endeavors as a result of the tension among professionals' responsibilities to their research and to their patients and both academic and financial incentives. These conflicts should be disclosed to research subjects and managed as assiduously as are financial conflicts of interest.     

医学研究者的经济利益冲突对临床试验的影响——美国的经验与启示

研究者的经济利益冲突对医学临床试验可能会产生消极影响。本文依据美国的研究成果,利用大量的统计数据和真实的案例,分析了研究者在临床试验中的主要经济利益,揭示了这些经济利益如何对研究的设计、执行和报告产生影响,以及可能造成的危害。     

How Financial Constraints Influence Consumer Behavior: An Integrative Framework

Financial constraints are economic limitations on behavior. Given that millions of people experience chronic or episodic financial constraints, we sought to review research that provides insight into how they affect consumer behavior. We propose an integrative framework that draws insights from multiple literatures that have examined financial constraints from different perspectives. The framework distinguishes between four perspectives, which are rooted in literatures on resource scarcity, choice restriction, social comparison, and environmental uncertainty and highlights different temporal stages of responding to financial constraints, distinguishing between reacting, coping, and adapting. Beyond the obvious negative effects of financial constraints, our framework emphasizes consumer resilience, highlighting that consumers often successfully cope with and devise adaptive strategies to deal with financial constraints. By broadening the behavioral and temporal scope of financial constraints considered within consumer psychology, this framework helps us to understand the often strong and sometimes counterintuitive effects of financial constraints on consumer behavior.     

公共政策制定程序对政策可接受性的影响

根据程序公正理论提出公共政策制定程序与公众对政策的可接受性的关系问题。研究一通过访谈不同领域的学者,初步揭示了公共政策及其制定程序存在的问题——对公共问题不敏感,解决问题的措施成效低。研究二用问卷调查公众对一个制定中的公共政策的态度,恰与政策制定者的愿望相反,公众并不认可政府解决问题的设想,也不认同政府举行的听证会的结果。研究三设计了一个非等组前后测准实验,在两个互联网站的电子公告板上比较根据不同的公共政策制定程序的政策的可接受性。结果证明,制定政策时了解公众态度可增强政策的针对性,提高解决问题措施的成效和可接受性     

Financial interests of authors in scientific journals: A pilot study of 14 publications

Disclosure of financial interests in scientific research is the centerpiece of the new conflict of interest regulations issued by the U.S. Public Health Service and the National Science Foundation that became effective October 1, 1995. Several scientific journals have also established financial disclosure requirements for contributors. This paper measures the frequency of selected financial interests held among authors of certain types of scientific publications and assesses disclosure practices of authors. We examined 1105 university authors (first and last cited) from Massachusetts institutions whose 789 articles, published in 1992, appeared in 14 scientific and medical journals. Authors are said to “possess a financial interest” if they are listed as inventors in a patent or patent application closely related to their published work; serve on a scientific advisory board of a biotechnology company; or are officers, directors, or major shareholders (beneficial owner of 10% or more of stock issued) in a firm that has commercial interests related to their research. Applying the criteria to the reference population of journals and Massachusetts academic authors, we measured the following frequencies for lead authors: .20 for serving on a scientific advisory board; .07 for being an officer, director, or major shareholder in a biotechnology firm; and .22 for being listed as an inventor in a related patent or patent application. The joint frequency of articles in the journals reviewed with a lead author that meets one of the three conditions is .34. Implications of these results for the new conflict of interest guidelines and disclosure policies are discussed.     

Financial satisfaction and financial stressors in marital satisfaction

Using a sample of 310 married respondents from one U.S. Midwestern state, a test was conducted to examine the association of financial satisfaction and financial stressors in a spouse's decision to stay married to the same person or leave the relationship. The role of demographic and socioeconomic variables, religiosity, psychological constructs, financial satisfaction, and financial stressors as factors influencing marital satisfaction was tested. Financial stressors were measured using a list of financial stressors adapted from the literature. Financial satisfaction was measured with a one-item scale. The Kansas Marital Satisfaction Scale was used as a validation tool to assess whether individuals would marry or not marry again. Religiosity and financial satisfaction were positively associated with marital satisfaction. A negative interaction between financial satisfaction and financial stressors was also noted. Findings suggest that respondents who are financially satisfied tend to be more stable in their marriages.     

Managing financial conflicts of interest in clinical research

Upholding public trust in clinical research necessitates that human subjects be protected from avoidable harm and that the design, interpretation and reporting of research results be shielded from avoidable bias. On both counts, managing financial conflicts of interest is critically important, especially in the modern era when the opportunities for investigators to benefit personally from the commercialization of their intellectual property are overtly encouraged and rapidly expanding. Efforts are underway in the United States to provide more useful guidance to universities and medical schools for purposes of strengthening the oversight and management of financial conflicts of interest in clinical research. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Perinatal substance abuse and human subjects research: are privacy protections adequate?

Privacy incursions in the clinical care of substance abusing pregnant women have gained lay and professional attention recently as the result of a high-profile Supreme Court finding in Ferguson vs City of Charleston et al. In March, 2001 the Supreme Court determined that nonconsensual drug screening of pregnant women by clinicians in a public hospital violated the women's Fourth Amendment rights to be secure against unreasonable search and seizure. Coercive or punitive policy approaches to perinatal substance abuse are often based on mistaken assumptions about the nature of addiction and the outcomes of punitive interventions. Much attention has been given to efforts to criminalize pregnancy for drug using women, and civil laws are also coming under increasing scrutiny. Although no state has passed a law criminalizing pregnancy and drug use, an estimated 250 women in more than 30 states have been prosecuted around the country on theories of "fetal abuse." A growing number of states (eighteen to date) have amended their civil child welfare laws to address specifically the subject of a woman's drug use during pregnancy. No one has examined how these laws and social policies could affect research that includes pregnant and parenting women; women (and their families) who stand to lose a great deal should their drug use be brought to the attention of child welfare or criminal justice authorities. We examine the adequacy of current protective mechanisms, such as federal certificates of confidentiality, in protecting research subjects (and investigators) who may be subject to punitive civil or criminal sanctions. We determine that current protective mechanisms may be insufficient to protect research subjects and that investigators and IRB members are often ignorant of the risks imposed by punitive policy approaches to perinatal substance abuse or fall prey to the same mistaken assumptions that inform punitive policies. We conclude that investigators and IRB members have a moral responsibility to understand local, state and national policies and laws governing perinatal substance abuse. Investigators and IRB members should balance the harms of punitive interventions against the protections that may, or may not be afforded to prospective research subjects as well as the prospective benefits, individual and social, of the research. In situations where criminal or punitive policies are in effect, investigators and IRB members should consider whether adequate protections can be achieved. In the context of inadequate protections, potential risks to prospective research subjects and their families may outweigh the individual or social benefits that accrue from the research. Clinical researchers are professionally obligated to work toward amending laws and policies that are not in the best interests of prospective research subjects.