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.     

Safety First: Recognizing and Managing the Risks to Child Participants in Magnetic Resonance Imaging Research

Specialized and up-to-date knowledge is required to identify and manage the risks associated with advanced biomedical research. Additional complexities need to be considered when the research involves infants or young children. In this article, we focus on recent information about the physical risks of pediatric magnetic resonance imaging research and highlight information gaps. With an eye to assisting institutional review boards and researchers, we consider strategies for the management of these risks and formulate key questions aimed at exposing hidden hazards. Institutional review boards should ask these questions, and researchers should bear them in mind as they develop research protocols.     

Canadian policy on reporting breaches of research integrity: When should Research Ethics Boards be informed?

ABSTRACT

In Canada, institutions that receive research funding from the three federal granting agencies must establish research ethics boards (REBs) to review the ethical acceptability of research involving humans. Institutions are also expected to promote the responsible conduct of research, fostering researchers’ abilities to act with integrity in the conduct of their research. Where a researcher fails to act with integrity in research with humans, institutional policies and procedures of the U15, Canada’s most research-intensive universities, vary in the extent to which they involve their REBs in response to such breaches. Some make no mention of the REB, whereas others state that their REB should be provided with information relating to upheld allegations. In this paper, we argue that when allegations of research integrity breaches are corroborated, the institution’s REB should be identified as a party required to receive that information. Only then can REBs ensure compliance with research ethics standards, which is essential to maintain the public’s trust.     

Sounding Out Vision

ABSTRACT

The late-twentieth century development of a range of digital imaging technologies has led to claims that we are in the midst of a transformation of representation. This essay takes two such technologies—ultrasound and magnetic resonance imaging (MRI)—and considers how their extraordinary mediation of the invisible using radio waves, magnetic fields and sound waves confounds the terms of reference which have governed the way we think not only about images, but about visual perception itself.

The nineteenth-century visual technology of the stethoscope, and its synaesthetic fusion of sound and image, is posed as a way of thinking through medical imaging technologies' sonic and haptic picturing of a world beyond light. Hegel's aesthetics, and his consideration of sound as a more ideal medium than light, is also used to consider the ways in which ultrasound and MRI images mediate the products of sound—the depth, interiority and identity of a body—into the realm of vision and the image.     

Social exclusion and neighborhood support: a case study of empty-nest elderly in urban shanghai

The phenomenon of empty-nest elderly (ENE) has become a significant social issue in China. In this research on ENEs in urban Shanghai, a coastal city in China, case studies were undertaken through in-depth semistructured interviews to examine the social exclusion risks ENEs may face and the influence of neighborhood support on such risks. The results show 5 aspects of social exclusion ENEs are experiencing. Moreover, the neighborhood has the potential for providing different forms of support to reduce social exclusion risks. The research and service implications of our findings for promoting the holistic well-being of ENEs in China are discussed.     

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?     

Student Projects in Medicine: A Lesson in Science and Ethics

Regulation of biomedical research is the subject of considerable debate in the bioethics and health policy worlds. The ethics and governance of medical student projects is becoming an increasingly important topic in its own right, especially in the U.K., where there are periodic calls to change it. My main claim is that there seems to be no good reason for treating student projects differently from projects led by qualified and more experienced scientists and hence no good grounds for changing the current system of ethics review. I first suggest that the educational objectives cannot be met without laying down standards of good science, whatever they may be. Weak science is unnecessary for educational purposes, and it is, in any case, unlikely to produce good researchers in the future. Furthermore, it is curious to want to change the system of ethics review specifically for students when it is the science that is at stake, and when the science now falls largely outside the ethics remit. I further show that ethics review is nevertheless important since students carry a new potential conflict of interests that warrants independent oversight which supervisory support does not offer. This potential conflict may become more morally troublesome the greater the risks to the subjects of the research, and students may impose greater risks on their subjects (relative to professional researchers) by virtue of being inexperienced, whatever the nature of the project. Pragmatic concerns may finally be allayed by organizing the current system more efficiently at critical times of the university calendar.     

The Ethical Issues in Uranium Mining Research in the Navajo Nation∗

We explore the experience of Navajo communities living under the shadow of nuclear age fallout who were subjects of five decades of research. In this historical analysis of public health (epidemiological) research conducted in the Navajo lands since the inception of uranium mining from the 1950s untill the end of the 20th century, we analyze the successes and failures in the research initiatives conducted on Navajo lands, the ethical breaches, and the harms and benefits that this research has brought about to the community. We discuss how scientific and moral uncertainty, lack of full stakeholder participation and community wide outreach and education can impact ethical decisions made in research.     

Queer Youth Space: A Protective Factor for Sexual Minority Youth

Physical, psychological, and social vulnerabilities of sexual minority youth are well documented. Yet factors that protect this population from these risks remain relatively unknown. Previous researchers suggest that (1) a sense of safety, meaningful relationships with others, and positive identity development are protective and (2) social support programs focusing on sexual minority youth (Queer Youth Space) have a positive impact. In this article, Queer Youth Space is explored as a program that may promote protective factors and mediate risks. Theories of attachment, self psychology, and social identity are applied to conceptualize Queer Youth Space and its protective roles. Implications for social work practice and research are discussed.     

The ethical issues in uranium mining research in the Navajo Nation

We explore the experience of Navajo communities living under the shadow of nuclear age fallout who were subjects of five decades of research. In this historical analysis of public health (epidemiological) research conducted in the Navajo lands since the inception of uranium mining from the 1950s untill the end of the 20th century, we analyze the successes and failures in the research initiatives conducted on Navajo lands, the ethical breaches, and the harms and benefits that this research has brought about to the community. We discuss how scientific and moral uncertainty, lack of full stakeholder participation and community wide outreach and education can impact ethical decisions made in research.     

论二十国集团作为气候外交平台的优势与挑战

《联合国气候变化框架公约》（UNFCCC或FCCC）缔约方第15次会议,即哥本哈根气候变化大会结束之后,世界各国的很多决策者和学者对把二十国集团当作推进气候变化外交的另一平台展开了讨论。因此,很有必要研究二十国集团在解决气候变化问题方面存在的风险和可能性。研究结果表明,尽管二十国集团从结构上看起来在解决气候变化问题方面具有很强的吸引力,但是目前二十国集团在推进气候变化谈判方面能力有限,不能替代联合国主导的气候变化谈判框架。     

Bad news about bad news: the disclosure of risks to insurability in research consent processes

One of the phenomena associated with research is "incidental findings," that is, unexpected findings made during the research, and outside the scope of the research, which have potential health importance. One underappreciated risk of incidental findings is the potential loss of the research subject's insurability; or if a research subject fails to disclose incidental findings when applying for insurance, the insurance contract may be voidable by the insurer. In this article, we seek to explain the insurability risks associated with incidental findings and to make recommendations for how researchers and research ethics committees should address the issue of disclosure of these risks.     

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.”     

Information,risk perceptions,and smoking choices of youth

Conventional wisdom maintains that youths take risks because they underestimate probabilities of harm. Presumably if they knew the true probabilities, they would behave differently. We used the National Longitudinal Survey of Youth 1997 to assess whether differences between subjective and objective probabilities that an adverse outcome to self will occur are systematically related to a harmful behavior, initiating smoking. We find that youths are generally pessimistic about probabilities of their own deaths and being violent crime victims. After smoking initiation, youths increase subjective probabilities of death by more than the objective increase in mortality risk, implying recognition of potential harms. Virtually all 12–14 year-olds know that smoking causes heart disease. The minority who believe that smoking causes AIDS are less likely to become smokers; i.e., risk misperceptions deter rather than cause smoking initiation. Messages designed to deter smoking initiation should stress other disadvantages of smoking than just probabilities of harm.     

Benefits Associated with Nutrigenomics Research and Their Reporting in the Scientific Literature: Researchers' Perspectives

Nutrigenomics and nutrigenetics (NGx) are fields of research that have raised significant expectations about their potential benefits. This article presents empirical data from an online survey seeking the opinions of NGx researchers (n = 126) regarding the achievability of the potential benefits of NGx, the time envisioned for their realization, the motives that may lead to their explicit mention in scientific peer-reviewed articles and the audience(s) targeted by NGx researchers when reporting their results in such articles. Results show that caution should be taken to avoid the risks associated with biohype and the premature dissemination of the potential benefits of NGx among various audiences.     

Waivers of parental consent for sexual minority youth

ABSTRACT

The Society for Adolescent Health and Medicine emphasizes the need for research to focus on the health outcomes of sexual minority youth (i.e., lesbian, gay, bisexual, transgender, queer). However, sexual minority youth (SMY) are often less willing to participate in research studies where parental consent is required due to potential victimization and discrimination. This is a major concern given that more research is needed to understand the health needs of this population, especially in terms of suicide, substance use, and HIV prevention. The National Suicide Prevention Strategy classifies SMY as a high-risk group, emphasizing the need to explore suicide risks (along with other health outcomes) among this group. However, this high-risk classification also increases the safeguards necessary to conduct research with this population. Many researchers have argued for waivers of parental consent, but such waivers present with several ethical implications. This article discusses ethical principles, risks, benefits, safeguards, and potential alternative approaches to waivers of parental consent for SMY. We conclude by emphasizing the need for policy changes to allow parental consent waivers for research targeting SMY.     

Children's understanding of mental ill health: implications for risk and resilience in relationships

Research shows that having a parent with a mental health problem has associated risks for children, but some families seem very resilient and do not always suffer these difficulties. In order for social workers to be able to support the development of resilience in families who appear to be at risk, we need to understand what factors may ameliorate some of these risks. Research seems to suggest that children who can conceptualize their parent's mental health problem as something 'outside' their representation of that parent as an attachment figure are likely to have better outcomes than children who see the mental-health problem as part of, and embedded within, their representation of that parent. However, in order to develop an understanding of how this conceptualization affects attachment relationships and outcomes, we need to know what children understand by mental ill health. We also need to consider how this conceptualization might be changed, and it appears that parents, other attachment figures and other support figures may play a key role here. This paper provides a selective review of the research area and discusses the mechanisms which may govern this complex process. The review concludes with recommendations for future research and practice.     

Sleep Safely: Crime Risks May Be Smaller than you Think

Recent events of extreme violence against members of the public such as the Dunblane killings have heightened both media and public perceptions of crime risks. This paper draws upon existing and ongoing research to review how risks are perceived, and the possible role such perceptions may play in the crime risks debate. In particular, are the processes by which we perceive risk and danger prone to exaggeration, and if so, what effect might such exaggerations have upon the formulation and implementation of policies aimed at dealing with crime risks? The impact of such policies upon one section of the criminal justice system, the Probation Service, is considered along with responses that officers and managers in the Probation Service are making to the new imperative to identify and effectively manage offender risks.     

Child protection services and parental reactions to children's behaviour

A commonly used expression in child protection is the term 'physical abuse'. This paper consists of a quantitative and qualitative analysis of a 100% sample of 'physical abuse' child protection cases drawn from research in an Australian state child welfare agency, which shows that about 90% of these concerned incidents in which parents used physical punishment to control children. Resulting physical harms to children (where they occurred) were generally of a very minor nature. The paper examines these results in the light of research findings in the UK and Australia on patterns of physical punishment used by parents to control children. Such findings suggest that those child rearing practices that make frequent and systematic use of physical punishment are located largely amongst lower social class parents, who believe that such practices are an essential and normal component of effective parenting behaviour. One interpretation of child protection services in respect of these cases is that they are concerned primarily with the normalization of child rearing practices. The paper concludes with a discussion of the limited impact of the Swedish anti-spanking law of 1979, which appears to have only reduced the use of physical punishment by those parents who may not necessarily have believed in such measures in the first place. However, legislation of this nature has the potential to criminalize a substantial sector of the population, but at least state intervention under the aegis of a specific criminal law provides a clearer mandate than does intervention under much looser, broader and subjectively interpreted child protection legislation.