Research subjects with limited English proficiency: ethical and legal issues

In this article, we examine Institutional Review Board (IRB) policies, international guidelines, and federal regulations and guidance for dealing with Limited English Proficiency (LEP) research subjects. We show that federal and international guidance concerning this topic is insufficient, and there is considerable variation in IRB policies. While some IRBs have thorough and useful policies, others do not. Many IRBs do not provide researchers and IRB member with answers to several important questions relating to language barriers in research. We recommend that federal agencies, international organizations, IRBs, and researchers take steps to fill in the gaps in guidance and policy to help insure that LEP populations will receive equitable and ethical treatment in research.     

Attempts to redefine conflicts of interest

The traditional legal concept of conflict of interest is a practical tool to regulate conduct. In recent years several medical authors have defined conflicts of interest in ways that stray from its original legal meaning. The new definitions cause conceptual confusion and will result in policies that cannot be implemented effectively. We should not follow recent attempts to redefine conflicts of interest because doing so deviates from the legal concept and will lead to deregulation of financial conflicts and overregulation of so-called intellectual conflicts.     

Ethical challenges to the integrity of physicians: financial conflicts of interest in clinical research

Financial conflicts of interest arise when physician's judgment and decision making become compromised by financial gains or interests, and thus create risk of undo harm to research participants, to the integrity of research projects, and, ultimately to society at large. Such conflicts also violate the moral maxims of medicine, and thus damage the integrity of physicians and the medical profession. I submit that key remedies for this problem are the integrity (self-respect) of physicians and the respectful engagement of research participants (whether patients or nonpatient volunteers) as partners in research projects. Accordingly, I consider physicians the primary moral agents, research participants the secondary moral agents, and society the tertiary moral agent with responsibilities for protection against whatever undue harm in clinical research. The latter needs to address the powerful, cultural, commercial, political, and social factors that contribute to physicians' financial conflicts of interest.     

The ethical review of medical research: a social movement to protect the interests of research subjects

This paper is based upon observations made in the United States regarding the operation of the Institutional Review Boards. Institutional Review Boards are an essential part of the American system for the ethical review of human subjects research and it is argued that their importance is due in part to the American approach to the protection of minority groups. It is important to evaluate the effectiveness of the Institutional Review Boards since a similar model is being proposed by the National Health & Medical Research Council as part of the ethical review of medical research projects conducted in Australia.     

Ten steps to developing a national agenda to address financial conflicts of interest in industry sponsored clinical research

Financial liaisons between clinical researchers, research institutions, and industrial sponsors have gained momentum in recent years. In the process, it has been argued by many that trust in the research infrastructure is being eroded by the financial conflicts of interest that emerge from these arrangements. Yet, the financial resources of industry are needed to continue technology transfer from the bench to the bedside. Policy makers and government regulators are currently struggling to determine how to best manage financial conflicts of interest that emerge from these liaisons. Various organizations and government entities have proposed different strategies. This paper explores the limitations of existing measures and recommends that a unified national agenda is needed. We propose 10 steps to develop an agenda to address financial conflicts of interest in industry-sponsored clinical research.     

试论法律合法冲突的制度成因

法律的冲突可以分为违法冲突与合法冲突两类。法律的合法冲突主要由四个方面的因素而引发 :一是立法权限不明确 ,导致法律规范之间的合理冲突 ;二是立法授权不明确 ,由此引发“政出多门” ;三是不确定法律概念的存在 ,使得相关立法依据条款界限不清 ;四是立法的连续过程 ,即法律的废、改、立引起相关规定难以及时配套。因而 ,如何通过相应的制度配置来消除法律之间的合法冲突 ,成为保障法制统一性的重要内容。     

Dissemination to research subjects: operationalizing investigator accountability

Recent articles have argued from principles of bioethics for the right of research subjects to receive the results of the studies in which they have participated. We argue that accountability is a powerful tool of meso-level analysis appropriate to reasoning about answerability in research ethics, and that it captures the responsibility of researchers to disseminate study results to research subjects. We offer the following features of the research situation as relevant to the manner of dissemination to study subject, in addition to factors already proposed in the literature (risk and impact on health outcome): (a) features of the research subject in relation to identity, personal investment, disease, and community; (b) characteristics of the research study and field of inquiry in relation to certainty and significance; and (c) relationships among the research subjects and the healthcare workers involved in their care and in the research.     

Research integrity and conflicts of interest: the case of unethical research-misconduct charges filed by edward calabrese

Special-interest polluters often file research-misconduct (RM) charges against scientists whose research suggests needed pollutant regulation. This article argues that U.S. RM regulations are flawed in requiring RM assessors/experts/accused, but not accusers, to reveal possible conflicts of interest (COI) that could affect RM allegations. It (1) summarizes U.S. RM regulatory history; (2) uses a case study about 2011 RM allegations, filed by chemical-industry-funded toxicologist Edward Calabrese, to illustrate problems with RM regulations; and (3) offers 4 arguments in favor of revising RM regulations so as to require RM-accuser revelation of possible COI and who funded preparation of the RM allegations.     

What a tangled web we weave: ethical and legal implications of deception in recruitment

Deception in human subject research is neither uncommon nor prohibited. The use of deception in the recruitment phase of clinical research has received relatively little attention. Given that informed consent is foundational to human subject research, the practice of misrepresenting the study purpose in clinical research would seem to contradict one of the fundamental tenets of ethical human subjects research. Using the example of prodromal psychosis, this article the ethical and legal implications of deception in recruitment and the sufficiency of current guidance on the practice when the study involves a stigmatizing condition, the collection of genetic samples, or both. I conclude that when these two elements are present, deception should only be used when absolutely necessary and, if used, researchers should be required to debrief participants before the collection of genetic samples and give particular attention to minimizing risks of privacy breaches.     

Disclosing Conflicts of Interest to Research Subjects: An Ethical and Legal Analysis

In this article, I examine the ethical and legal issues related to disclosure of conflicts of interest to research subjects, and discuss some empirical studies related to the topic. I argue that researchers have an ethical obligation to disclose conflicts of interest to research subjects, provided that they take steps to help subjects understand information about conflicts of interest and how to interpret it. Researchers also may have a legal duty to disclose conflicts of interests to subjects, depending on the facts of the case and the court's interpretation of the law. To reinforce and clarify the legal obligation to disclose conflicts of interest, the federal regulations should be amended to include disclosure of conflicts of interest as one of the informed consent requirements. Institutional review boards play a key role in helping researchers to disclose conflicts of interests to subjects in an appropriate manner. Institutional review boards should approve the disclosure language in informed consent documents, and they should require researchers to disclose financial interests to research subjects, if they have any, as a condition of approval.     

Empirically supported ethical research practice: the costs and benefits of research from the participants' view

Researchers and institutional review boards are routinely called upon to evaluate the cost-benefit status of proposed research protocols that involve human participants. Often these assessments are based on subjective judgments in the absence of empirical data. This reliance on subjective judgments is of particular concern for studies involving clinical samples where unfounded assumptions may adversely affect research progress or clinical outcomes. The Reactions to Research Participation Questionnaire (RRPQ) was designed to address this shortcoming and to help promote ethical decision making about research practice. The present study describes development of the RRPQ and presents a series of exploratory and confirmatory analyses investigating its structure. Based on these findings, a revised version of the instrument and suggestions for future research are presented. This approach provides a foundation for scientifically informed protection of human subjects.     

法律文化层次论--兼论中国近代法律文化演进的若干特质

法律文化概念是在20世纪60年代出现的.法律文化结构可分为三个层次物质层次--法律组织机构、法律设施,心物层次--法律制度、政治制度,心理层次--法律价值观、法律意识、法律思维.中国近代法律文化经历了表层变化、表层深化、深层结构的变化三个演变历程,它是在西方法律文化与中国传统法律文化的冲突交融过程中整合而成的.法律文化的演进始终与政治密切结合在一起,法律从属于政治;近代80年间,法律文化变迁的内容也是丰富多样的,在类型上出现了新的变化.     

Conflicts of interest in vaccine safety research

Conflicts of interest (COIs) cloud vaccine safety research. Sponsors of research have competing interests that may impede the objective study of vaccine side effects. Vaccine manufacturers, health officials, and medical journals may have financial and bureaucratic reasons for not wanting to acknowledge the risks of vaccines. Conversely, some advocacy groups may have legislative and financial reasons to sponsor research that finds risks in vaccines. Using the vaccine-autism debate as an illustration, this article details the conflicts of interest each of these groups faces, outlines the current state of vaccine safety research, and suggests remedies to address COIs. Minimizing COIs in vaccine safety research could reduce research bias and restore greater trust in the vaccine program.     

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.