How can health plans make fair determinations about when “experimental” (and costly) treatments such as high dose chemotherapy with autologous bone marrow transplantation should be covered despite lack of clear clinical consensus about their benefits? Different models for managing “last chance” therapies evolving in some health plans offer promising examples of how issues of fairness and legitimacy in decisionmaking can be addressed.

Objectives: There are indications that institutional review board 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 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. (shrink)

The role of normative reflection and the possibilities of ethical inquiry in technology assessment have been under discussion in the TA community for several years. As an outcome of this discussion the necessity of explicitly dealing with normativity in TA has widely been acknowledged. However, it is still quite unclear in which way this should be done. This paper is dedicated to the role (and limitations) of ethical expertise in this field, especially in HTA. By methodological analysis an approach is (...) developed to show how entry points for ethical expertise could be identified. The result is that ethical expertise can inform moral debates by uncovering underlying assumptions, by making the normative structure of argumentation transparent, and by weighing the strength of the arguments. In this way moral debates in HTA can become more transparent and opened to argumentative reasoning instead of consisting of bargaining processes determined by power distributions. Ethical reflection, however, does not replace decision-making. (shrink)