Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a 'collective' TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism.

Drug trials in children engage with many ethical issues, from drug-related safety concerns to communication with patients and parents, and recruitment and informed consent procedures. This paper addresses the field of neuromuscular disorders where the possibility of genetic, mutation-specific treatments, has added new complexity. Not only must trial design address issues of equity of access, but researchers must also think through the implications of adopting a personalised medicine approach, which requires a precise molecular diagnosis, in addition to other implications of developing orphan drugs. It is against this background of change and complexity that the Project Ethics Council (PEC) was established within the TREAT-NMD EU Network of Excellence. The PEC is a high level advisory group that draws upon the expertise of its interdisciplinary membership which includes clinicians, lawyers, scientists, parents, representatives of patient organisations, social scientists and ethicists. In this paper we describe the establishment and terms of reference of the PEC, give an indication of the range and depth of its work and provide some analysis of the kinds of complex questions encountered. The paper describes how the PEC has responded to substantive ethical issues raised within the TREAT-NMD consortium and how it has provided a wider resource for any concerned parent, patient, or clinician to ask a question of ethical concern. Issues raised range from science related ethical issues, issues related to hereditary neuromuscular diseases and the new therapeutic approaches and questions concerning patients rights in the context of patient registries and bio-banks. We conclude by recommending the PEC as a model for similar research contexts in rare diseases.

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With headlines such as, 'Get smart drugs out of the closet, scientists urge' and 'Smart drugs for straight As', 1 discussions about individuals taking psychopharmaceutical drugs to enhance their cognitive performance 2 are increasingly in the public domain. In the US, drugs such as Modafinil are being used by university students because they provide a more targeted, powerful mental 'sharpening' than traditional stimulants such as caffeine

On the one hand there has been significant publicity about the lack of research into drugs used to treat children but, on the other, widespread criticism about unethical research carried out in the past. In addition, some current professional guidelines in relation to research on children unable to consent have been censured for being too permissive. Now, recent legislation in relation to clinical research actually appears to be unduly restrictive. In this paper, we set out to defend the guidelines from an ethical and legal perspective and propose that an even more rigorous approach could be adopted to ensure children are engaged in research. This is not to advocate that the children should be subjected to undue risk nor that those close to them should not be involved in any decisionmaking process. We hope to demonstrate that a more balanced approach is necessary and timely, in the hope that those working in relevant areas gain sufficient confidence to justify their research proposals robustly rather than avoid them because of fear of castigation at the ethics approval stage. This would ensure children are accorded appropriate recognition of their autonomous interests and that they are afforded the same opportunities to benefit from research as adult subjects.

The Data Protection Act 1998 purports to implement European legislation which aims to protect the privacy of individuals. There were such concerns about the implications of the Act for certain research and audit that it became necessary to enact further legislation to enable such essential activities to continue. Although this empowers the Secretary of State for Health to approve proposals for these purposes, there should still be a requirement that the use of identifiable personal information without consent must be justified on compelling public interest grounds. It is this that can confound those seeking to rely on such justification. There can either be too cavalier an approach to the issue, and/or there is little sense of what considerations should come into play. This paper attempts to highlight some of the difficulties that are theoretically raised by some audit activities and set out the legal framework within which they must operate. However, the key focus is on how ethical considerations might inform the public interest argument.

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