The market for (Ir)reproducible econometrics

Context: As the volume and complexity of research have increased, the amount of time spent on Institutional Review Board (IRB) review has decreased. The complexity of research has expanded, requiring increasingly specialized knowledge to review it. Dilemma: Under the current system, increasing numbers of research studies requiring expertise in ethics, new technologies or diverse study designs place a substantial burden upon local IRBs and often result in substantial variability among their reviews. This lack of uniformity in the review process creates uneven human subjects’ protection thus undermining the intent of the Common Rule. Objectives: To outline a scenario for expert centralized IRB review via implementation of a national virtual IRB review system overseen by the Office for Human Research Protections (OHRP). Conclusions: The complicated ethical issues and science involved in much of current research warrant an expert review panel. Centralized review would enable expert review specific to the research at hand, ensure consistency in human subjects protection, reduce the burden on local IRBs, and may reduce time spent obtaining approval. A centralized virtual system would allow IRB members to remain at their institutions while providing unprecedented expert review through currently available technology, and make information regarding monitoring and adverse event reporting available online in real-time.     

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 members 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.     

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.     

Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices

Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.     

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 interest 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.     

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research

One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks.     

Participatory research meets validated outcome measures: Tensions in the co‐production of social care evaluation

Funding for care service research is increasingly subject to the satisfaction of two requirements: public involvement and adoption of validated outcome tools. This study identifies competing paradigms within these requirements and reveals significant challenges faced by researchers who seek to satisfy them. The focus here is on a study co‐produced between academic researchers and people with experience of adult social care services. It examines to what extent research studies can conduct high‐quality public involvement and genuine co‐production of knowledge, whilst attempting to produce quantifiable outcome scores. Findings add to debate around how to incorporate diverse perspectives in research, which may draw on incommensurate accounts of validity and reliability. Findings also highlight constructive attempts by academic and co‐researchers to make the combination of approaches work in the field. These small scale acts of researcher agency indicate some scope to combine the two approaches in future research studies. However, conclusions foreground the importance of broader awareness of how tensions and power imbalances related to this combination of approaches play out in social policy research practice.     

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.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro-research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Resolving Beecher's Paradox: Getting beyond IRB reform

Protection of persons participating as research subjects is an essential element of ethical research conduct. There is growing concern that the existing system of institutional review boards (IRBs) and informed consent may not be adequate and is in need of reform. When science and medicine are “merged”; in clinical research, confusion of roles and conflicts of interests arise in relationships between patient‐subjects and physician‐investigators. IRBs have always had a primary role in protection of research participants. Their efforts to protect research subjects may make it more difficult for investigators to conduct research. This tension has lead to the development of an adversarial relationship between IRBs and investigators. Investigators and IRBs are also subject to external pressures that could impact efforts to protect research subjects. Efforts are underway to address these concerns. IRB reform, while needed, is not likely to be sufficient. Adoption of a new paradigm in which IRBs, investigators and research sponsors collectively accept protection of research subjects as their primary and shared responsibility may provide a more effective and efficient model that will be better able to deal with difficult ethical and social issues in clinical research.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro‐research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Medical school guidelines for investigating misconduct and fraud in science

Institutional review boards (IRBs) are legally required to determine whether the balance between the risks and benefits (the risk-benefit ratio or RBR) of a proposed study is “reasonable” or “proportional”. This obligation flows from their duty to protect the interests of research subjects. It has been argued that it is difficult, perhaps even impossible for IRBs to determine the RBR of studies, because the risks and benefits are not only heterogeneous, but also incommensurable. After arguing that the relevant meaning of incommensurability is incomparability, we discuss whether the risks of participating in a trial and the benefits are comparable. We conclude that at least the risks and the benefits to participants are comparable. In the last section we show that the main problem of RBR analyses is that of interpersonal incompensability. IRBs have to assume that risks to research subjects be compensated by benefits to others. The question is: To what extent? When does it become unreasonable to ask that patients accept the risks of participating in a trial for the benefit of science and/or future patients?     

Are risks and benefits of oncological research protocols both incommensurable and incompensable?

Institutional review boards (IRBs) are legally required to determine whether the balance between the risks and benefits (the risk-benefit ratio or RBR) of a proposed study is "reasonable" or "proportional". This obligation flows from their duty to protect the interests of research subjects. It has been argued that it is difficult, perhaps even impossible for IRBs to determine the RBR of studies, because the risks and benefits are not only heterogeneous, but also incommensurable. After arguing that the relevant meaning of incommensurability is incomparability, we discuss whether the risks of participating in a trial and the benefits are comparable. We conclude that at least the risks and the benefits to participants are comparable. In the last section we show that the main problem of RBR analyses is that of interpersonal incompensability. IRBs have to assume that risks to research subjects be compensated by benefits to others. The question is: To what extent? When does it become unreasonable to ask that patients accept the risks of participating in a trial for the benefit of science and/or future patients?     

Evaluation of Research Ethics Committees: Criteria for the Ethical Quality of the Review Process

Repeatedly, adequacy, performance and quality of Ethics Committees that oversee medical research trials are being discussed. Although they play a crucial role in reviewing medical research and protecting human subjects, it is far from clear to what degree they fulfill the task they have been assigned to. This eventuates in the call for an evaluation of their activity and, in some places, led to the establishment of accreditation schemes. At the same time, IRBs have become subject of detailed legislation in the process of the ongoing global juridification of medical research. Unsurprisingly, there is a tendency to understand the evaluation of RECs as a question of controlling their legal compliance. This paper discusses the need for a quality evaluation of IRBs from an ethical point of view and, by systematically reviewing the major ethical guidelines for IRBs, proposes a system of criteria that should orientate any evaluation of IRBs.     

Is Contracting out of Public Services still the Great Panacea? A Systematic Review of Studies on Economic and Quality Effects from 2000 to 2014

This article presents the results of a systematic review of international studies on economic and quality effects of contracting out published in the period from 2000 to 2014. We conducted a comprehensive search of the literature and identified 49 relevant studies. There are three main findings of the systematic review: (1) cost savings documented in international contracting out literature have been decreasing over time; (2) cost savings have been much greater in technical services than in social services; and (3) economic effects have been twice as large in Anglo‐Saxon countries compared with other countries. With regard to measuring the effect of contracting out on service quality, which is a vital component of any service delivery arrangement, very few studies assess this issue in a comprehensive manner. There is also a significant lack of studies that include measures of transaction costs, thereby making it difficult to evaluate the impact of contracting out on overall cost‐effectiveness of public service delivery. We conclude that generalization of effects from contracting out should be made with caution and are likely to depend, among other things, on the transaction costs characteristics of the service, the market situation and the institutional/regulatory setting.     

浅谈社区公共服务的概念

社区公共服务是社区服务主体,在以人为本理念指导下,为了满足社区的公共需求,为全体社区居民提供的社会公共服务。对社区公共服务的含义进行探讨,不仅有利于社区公共服务实践的发展,也能够在一定意义上推动社区公共服务理论的发展;同时,社区公共服务概念的提出及其理论研究的发展,是在社会学、社会政策、社会工作、社区发展、公共管理等学科或理论界域内的本土化理论成果的具体体现。     

广告语在公益广告中的巧妙运用与策略

公益广告是为公众事业、公益利益提供传播服务的。公益广告的文字语言和画面一起共同承载着公益广告传播的重任。公益广告的语言表达是公益广告创意环节中的前期工作,是整则广告创意的指导思想和灵魂。在公益广告的创意过程中不要顾此失彼,在注重视觉冲击力的同时,也要重视广告语的巧妙运用,以全面取得公益广告传播的最佳效果。     

The expanding purview: institutional review boards and the review of human subjects research

The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research that is being conducted. The intersection between IRB review and free speech is also explored. In general, it is argued that the review system for human subjects research (HSR) should be modified in order to limit the scope of IRB review.     

转型期公共行政模式的变迁--由管制行政到服务行政

从计划经济到市场经济的转型所带来的社会变革,对公共行政的理念、规则乃至职能的履行模式都产生了深刻影响。在世界范围内,公共行政的变革以及科学发展观的本质要求也在推动公共行政模式由管制行政走向服务行政。由管制行政向服务行政的转变,意味着要转变行政理念、扩大行政主体以及变革管理方式。在为管制行政向服务行政变迁提供制度以及组织保障的同时,也要警惕行政对民众权利的侵犯、政府对应有职责的放弃等服务行政“异化”现象的发生。     

改善社区公共服务,促进和谐社区建设

改善社区公共服务,丰富社区公共服务产品,是建设和谐社区的重要内容之一。政府公共管理职能的不清晰与社会管理的不完善是社区公共服务供需矛盾的根本原因。现代社会的发展,国家权力将逐步向社会组织转移,改善社区公共服务就要建立“党委领导、政府负责、社会协同、公众参与”的社会管理格局。建立有效的社区公共服务供给体系,要求政府更加注重履行社会管理和公共服务的职能,科学地整合社会管理资源。因而,政府不断创新公共服务体制,改进公共服务方式,将促进社区公共服务的改善和和谐社区的建设。