A.W. Musschenga

The evaluation of the risks and benefits of phase II cancer clinical trials by institutional review board (IRB) members: a case study

Objectives: There are indications that institutional review board (IRB) members do not find it easy to assess the risks and benefits in medical experiments, although this is their principal duty. This study examined how IRB members assessed the risk/benefit ratio (RBR) of a specific phase II breast cancer clinical trial. Participants and methods: The trial was evaluated by means of a questionnaire administered to 43 members of IRBs at six academic hospitals and specialised cancer centres in the Netherlands. The questionnaire addressed: identification and estimation of inconvenience, toxicity, psychosocial distress, and benefits of trial participation to patients; identification and estimation of benefits to future patients and medical science; assessment of the trial’s RBR; and assessment of its ethical acceptability. Results: Most IRB members expected trial participation to involve fairly or very serious inconvenience, fairly severe to sometimes life-threatening toxicity, and serious psychological and social consequences. Conversely, the perceived likelihood of benefits to patients was modest. Most regarded the study as important, and the balance between risks and benefits to be favourable, and believed that the protocol should be approved. The IRB members’ final judgement on the trial’s ethical acceptability was significantly correlated with their RBR assessment of the protocol. Conclusions: Because most patients who participate in clinical trials hope this will prolong their lives, it is suggested that patient information should better describe the anticipated benefits—for example, the likelihood of prolonging life. This would allow patients to make decisions regarding participation based on realistic expectations.

Education for Moral Integrity

This paper focuses on coherence and consistency as elements of moral integrity, arguing that several kinds of-mostly second-order-virtues contribute to establishing coherence and consistency in a persons judgements and behaviour. The virtues relevant for integrity always accompany other, substantive virtues, and their associated values, principles and rules. In moral education we teach children all kinds of substantive virtues with integrity as our goal. Nevertheless, many adults do not attain moral integrity, although they are clearly not immoral. What precisely are they lacking? Education for moral integrity should focus on strengthening motivational self-sufficiency, furthering critical and imaginative thinking and promoting moral unity.

Moral Judgement and Moral Reasoning

They should have improved their reasoning skills (such as identifying and evaluating reasons, conclusions, assumptions, analogies, concepts and principles), and their ability to use these skills in assessing other people’s arguments, making decisions and constructing their own reasoning. [. . .] They may have strengthened certain valuable tendencies in themselves – to reason, to question their own reasoning and to be fair minded

Personal and Moral Identity

Preface. Introduction A.W. Musschenga. Part I: Sameness and Unity. Self and Self-Interest M. Schechtman. Responsibility and Personal Identity T. van den Beld. Making and Finding Oneself J. Bransen. Part II: Personal and Moral Identity. Personal and Moral Selfhood D. Carr. Self-Identity and Moral Maturity H. Kamler. Sexual Identity and Moral Virtuousness J. Steutel, B. Spiecker. Development of the Self-Concept G. Snik, et al. Part III: Post-Modern and Constructivist Views. Cultural Identity and Personal Identity T. Wren. Humanism, Anti-Humanism, the Inhuman P. Standish. Personal Identity and Post-Modern Morality H. Kunneman. Notes on the Contributors. Index of Names. Index of Subjects.

The epistemic value of moral intuitions

In this article, I discuss whether intuitive moral judgements have epistemic value. Are they mere expressions of irrational feelings that should be disregarded or should they be taken seriously? In section 2, I discuss the view of some social psychologists that moral intuitions are, like other social intuitions, under certain conditions more reliable than conscious deliberative judgements. In sections 3 and 4, I examine whether intuitive moral judgements can be said not to need inferential justification. I outline a concept of moral intuition as a seeming whose seemingness resides in special, phenomenological features such as a felt veridicality, appropriateness, familiarity, or confidence, and whose justificatory force is influenced by the reliability of the belief-producing procedures and by a subjects competence in applying moral concepts. I argue that subjects can come to realise that the beliefs expressed in their intuitive judgements evoke a sense of non-inferential credibility. In section 5, I fir...In this article, I discuss whether intuitive moral judgements have epistemic value. Are they mere expressions of irrational feelings that should be disregarded or should they be taken seriously? In section 2, I discuss the view of some social psychologists that moral intuitions are, like other social intuitions, under certain conditions more reliable than conscious deliberative judgements. In sections 3 and 4, I examine whether intuitive moral judgements can be said not to need inferential justification. I outline a concept of moral intuition as a seeming whose seemingness resides in special, phenomenological features such as a felt veridicality, appropriateness, familiarity, or confidence, and whose justificatory force is influenced by the reliability of the belief-producing procedures and by a subjects competence in applying moral concepts. I argue that subjects can come to realise that the beliefs expressed in their intuitive judgements evoke a sense of non-inferential credibility. In section 5, I first discuss the contribution of moral expertise to the non-inferential credibility of a persons intuitions. Subsequently, I discuss whether Walter Sinnott-Armstrong is right in saying that we can never claim non-inferential justification for our intuitions because they are subject to all kinds of distorting influences.

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?