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?     

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.     

Clarifying the concept of the “Social” in risk assessments for human subjects research

International guidelines for the conduct of research with human participants, such as those put forth by the Council for International Organizations of Medical Sciences (CIOMS, 2002), recommend that research review committees account for social risk and benefits to society in their review of proposed research. What do the concepts of the “social” and “society” mean in the context of the review of human participants research? Here we analyze concepts of social and society to define the terms: social harm, social risk, social benefit, and benefits to society. We argue that use of these terms invite more questions than answers and beg for difficult empirical research to determine the nature, likelihood, and magnitude of this category of risk and benefit. Until more research is done and these questions are answered, we advise reviewers to adopt an attitude of provisionalism and caution in their review of specifically “social” risks and benefits and “benefits to society.”     

Guinea Pigs on the payroll: The ethics of paying research subjects

Regulatory bodies and scholars have traditionally conceptualized biomedical research on healthy subjects in the same way as research on patients. Guidelines and regulations have portrayed payment to a healthy subject as a potential constraint, or “undue influence,”; on the subject's free consent. In this essay we suggest an alternative way of conceptualizing research on healthy subjects, which sees the basic issue not as one of undue influence but as one of justice. Healthy subjects generally enroll in research protocols not for humanitarian reasons but for the money they will receive. Many of these protocols are conducted by profit‐driven corporations. Yet current guidelines and regulations prohibit subjects from negotiating for fair payment for the risks, discomforts and inconveniences they undergo, and IRBs are not staffed adequately to monitor the subject's safety. We propose to remedy the situation by regulating payment to healthy subjects as a labor relation.     

A Qualitative Study of Non-Affiliated,Non-Scientist Institutional Review Board Members

In addition to outlining criteria for the approval of human subjects research, federal regulations provide guidance regarding local institutional review board (IRB) membership. IRBs are mandated to include “at least one member whose primary concerns are in nonscientific areas” and “at least one member who is not otherwise affiliated with the institution.” Often a single individual serves both of these roles simultaneously. Although there have been calls for increased representation of lay community members on IRBs, little is known regarding their experiences or their perceptions of human subject protections and the IRB process. Using an ethnographic interview approach, this study seeks to gain a perspective from non-affiliated, non-scientist (NA/NS) IRB members about the process in which they participate. Findings suggest a need for clarification regarding whom NA/NS IRB members represent. They also suggest that NA/NS IRB members’ experiences could be improved by an increased show of respect from the IRB chair, other members, and staff; efforts to make participation more convenient for these volunteer members; and training tailored specifically to NA/NS members. Further research on this important and understudied topic is needed to determine best practice and policy recommendations.     

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.     

Public Service Quality Improvements: A Case for Exemption from IRB Review of Public Administration Research

Should the exemption from Institutional Review Board (IRB) evaluations currently in place for quality improvements research be extended to public administration research that addresses questions of improving the quality of public service delivery? As a means to both reduce the level of disdain held by a group of social science researchers for IRBs and to reduce the cost of review for minimal risk studies, I argue here that much of the current public administration research should also be exempted from normal processes of review by IRBs on the basis of their similarity to Quality Improvements (QI) research, a category of studies already granted exemption. This argument dovetails provisions currently in place for studies of public service and public benefit, but reframes these exemptions in the language of “quality improvements,” which may be a more comfortable language for IRBs concerned to demonstrate compliance for review of all fields. To expedite this argument into the practices of IRBs, I included a checklist that researchers could use to self-identify their studies as QI, not research as such.     

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.     

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.     

Intentional Exposure Studies of Environmental Agents on Human Subjects: Assessing Benefits and Risks∗

In this article, I assess the benefits and risks of studies that intentionally expose research subjects to environmental agents. I describe these types of studies, identify their benefits and risks, compare them to other research methods that can be used to investigate the relationship between environmental exposures and disease, and discuss some issues related to research design and risk minimization. I argue that the benefits of intentional environmental exposure studies outweigh the risks when 1) the knowledge gained is likely to improve our understanding of the relationship between environmental exposure and disease, 2) this knowledge cannot be obtained by other methods, 3) the experiments are well designed, 4) the subjects will receive some benefits, such as medical evaluations, 5) risks are minimized, and 6) the risks to human subjects are less than those encountered in a typical Phase I drug study. Only in rare circumstances (i.e., when an intentional environmental exposure study is needed to implement an important environmental or public health intervention or regulation) may such studies expose research subjects to risks as high as those encountered in a typical Phase I drug trail.     

Intentional exposure studies of environmental agents on human subjects: assessing benefits and risks

In this article, I assess the benefits and risks of studies that intentionally expose research subjects to environmental agents. I describe these types of studies, identify their benefits and risks, compare them to other research methods that can be used to investigate the relationship between environmental exposures and disease, and discuss some issues related to research design and risk minimization. I argue that the benefits of intentional environmental exposure studies outweigh the risks when 1) the knowledge gained is likely to improve our understanding of the relationship between environmental exposure and disease, 2) this knowledge cannot be obtained by other methods, 3) the experiments are well designed, 4) the subjects will receive some benefits, such as medical evaluations, 5) risks are minimized, and 6) the risks to human subjects are less than those encountered in a typical Phase I drug study. Only in rare circumstances (i.e., when an intentional environmental exposure study is needed to implement an important environmental or public health intervention or regulation) may such studies expose research subjects to risks as high as those encountered in a typical Phase I drug trail.     

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.     

全球海洋经济:认知差异、比较研究与中国的机遇

各国对于“海洋经济”的认知和概念界定仍然存在巨大差异。梳理“海洋经济”的概念演进和政策内涵、分析各国对“海洋经济”认识和统计差异后,仍可发现其具有一定的可比性。中国海洋经济则具备比较优势,包括发展速度快、结构持续优化、比重保持稳定、对就业贡献大等等。鉴于“海洋经济”具有广阔的发展前景及其在国家经济和社会发展中趋升的战略地位,中国宜抓住历史机遇,利用自身优势和潜力,加速发展海洋经济和构建海洋强国。政策建议包括:加强海洋经济理论研究和国际交流,尤其是将建立国际通用统计标准作为重点合作领域;倡导建立海洋命运共同体,推动海洋经济国际合作,践行共商共建共享理念,把海上丝绸之路建设作为重要抓手;进一步拓展蓝色伙伴关系,形成广泛而有深度的利益捆绑;新冠疫情背景下把加强冷链运输的安全性纳入全球或区域海上公共卫生体系建设之中;重启蓝色经济,充分挖掘海洋经济潜力。     

Courts,care proceedings and outcomes uncertainty: The challenges of achieving and assessing “good outcomes” for children after child protection proceedings

The professed aim of any social welfare or legal intervention in family life is often to bring about “better outcomes for the children.” But there is considerable ambiguity about “outcomes,” and the term is far too often used in far too simplistic a way. This paper draws on empirical research into the outcomes of care proceedings for a randomly selected sample of 616 children in England and Wales, about half starting proceedings in 2009–2010 and the others in 2014–2015. The paper considers the challenges of achieving and assessing “good outcomes” for the children. Outcomes are complex and fluid for all children, whatever the court order. One has to assess the progress of the children in the light of their individual needs and in the context of “normal” child development, and in terms of the legal provisions and policy expectations. A core paradox is that some of the most uncertain outcomes are for children who remain with or return to their parents; yet law and policy require that first consideration is given to this option. Greater transparency about the uncertainty of outcomes is a necessary step towards better understanding the risks and potential benefits of care proceedings.     

Terrorism and Probability Neglect

When strong emotions are involved, people tend to focus on the badness of the outcome, rather than on the probability that the outcome will occur. The resulting “probability neglect” helps to explain excessive reactions to low-probability risks of catastrophe. Terrorists show a working knowledge of probability neglect, producing public fear that might greatly exceed the discounted harm. As a result of probability neglect, people often are far more concerned about the risks of terrorism than about statistically larger risks that they confront in ordinary life. In the context of terrorism and analogous risks, the legal system frequently responds to probability neglect, resulting in regulation that might be unjustified or even counterproductive. But public fear is itself a cost, and it is associated with many other costs, in the form of “ripple effects” produced by fear. As a normative matter, government should reduce even unjustified fear, if the benefits of the response can be shown to outweigh the costs.     

The preservation of multivariate comparative statics in nonexpected utility theory

This article investigates the preservation of multivariate expected utility comparative statics for “smooth” nonexpected utility representations. Specifically, we answer the following question: if an expected utility comparative statics property depends only on preferences over sure prospects, then when will a nonexpected utility maximizer with identical sure preferences also satisfy that property? We demonstrate that the effects of increased risk aversion are preserved under the “Almost Degenerate Independence” axiom, but that those of distribution changes of exogenous risks are not preserved under stringent assumptions. Hence, nonexpected utility comparative statics may diverge from expected utility, even for “first-order” properties—those whose effect is determinable from restrictions on “local” utility functions.     

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.     

The Inappropriate Use of Risk-Benefit Analysis in the Risk Assessment of Experimental Trauma-Focused Research

A large body of research has explored the impact of questioning participants about traumatic experiences. To determine the level of risk, these studies have relied, to various degrees, upon a risk-benefit calculus, whereby risks are weighed against the benefits that an individual can receive from participating. In the case of trauma-focused studies this approach is erroneous. The procedures involved in trauma-focused studies do not meet the criteria to be considered therapeutic, and the benefits associated with these procedures do not carry the moral weight to offset risk. Applying the risk-benefit calculus to non-therapeutic procedures inevitably leads to inaccurate risk assessments and ethically problematic claims, examples of which can be found throughout traumatic stress literature. This article outlines how the standard approach to risk assessment in trauma-focused studies is fallacious, and presents an established alternative model that researchers can use to accurately assess the risks of asking participants about their traumatic experiences.     

Minimal Risk in Pediatric Research: A Philosophical Review and Reconsideration

Despite more than thirty years of debate, disagreement persists among research ethicists about the most appropriate way to interpret the U.S. regulations on pediatric research, specifically the categories of “minimal risk” and a “minor increase over minimal risk.” Focusing primarily on the definition of “minimal risk,” we argue in this article that the continued debate about the pediatric risk categories is at least partly because their conceptual status is seldom considered directly. Once this is done, it becomes clear that the most popular strategy for interpreting “minimal risk”—defining it as a specific set of risks—is indefensible and, from a pragmatic perspective, unlikely to resolve disagreement. Primarily this is because judgments about minimal risk are both normative and heavily intuitive in nature and thus cannot easily be captured by reductions to a given set of risks. We suggest instead that a more defensible approach to evaluating risk should incorporate room for reflection and deliberation. This dispositional, deliberative framework can nonetheless accommodate a number of intellectual resources for reducing reliance on sheer intuition and improving the quality of risk evaluations.