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The use of covert video surveillance in the investigation of suspected life-threatening child abuse and Munchausen syndrome by proxy raises important ethical questions. That the recently reported provision of this facility in North Staffordshire was not presented to a Local Research Ethics Committee (LREC) for approval as a research exercise raises important questions about the ethical review of research and practice. The case made for avoiding such review is first set out and then examined. The three main premisses which form the basis of the view that LREC approval is not required are identified and tested in turn. The conclusion is that there is an undeniable element of research involved in the procedure and that the welfare of all those subjected to the surveillance would be best protected by the submission of the protocol to an independent committee for ethical assessment.

Munchausen syndrome by proxy is an especially malignant form of child abuse in which the carer (usually the mother) fabricates or exacerbates illness in the child to obtain medical attention. It can result in serious illness and even death of the child and it is difficult to detect. Some investigators have used video to monitor the carer's interaction with the child without obtaining consent--covert videoing. The technique presents several ethical problems, including exposure of the child to further abuse and a breach of trust between carer, child, and the professionals. Although covert videoing can be justified in restricted circumstances, new abuse procedures under the Children Act now seem to make its use unethical in most cases. Sufficient evidence should mostly be obtained from separation of the child and carer or videoing with consent to enable action to be taken to protect the child under an assessment order. If the new statutory instruments prove ineffective in Munchausen syndrome by proxy covert videoing may need to be re-evaluated.

In a recent article in this journal our unit was accused of a number of errors of judgment in applying covert video surveillance (CVS) to infants and children suspected of life-threatening abuse. The article implied, that on moving from the Royal Brompton Hospital in London to North Staffordshire Hospital, we failed to present our work to the Research Ethics Committee (REC). We did send our protocol to the REC though we did not consider that, after a total of 16 patients had been documented as being the subject of life-threatening abuse, this was research. The REC in Staffordshire agreed with us. We were also accused of undertaking work that should be pursued by the Police. We agree with this. However, unlike the Metropolitan Police the Staffordshire Police would not undertake CVS. We fail to agree that 'working together' with parents is necessarily practical or safe when trying to protect children from life-threatening abuse of this kind.

This brief reply gives a few references and clarifies some points in order to emphasize that a number of Professor Seedhouse's assertions are debatable and that his criticism of slovenly scholarship and his unbridled ad hominem argumentation are out of place and easily refuted.

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted.

This short communication is about Munchausen's syndrome in a group of pediatric patients and co morbid Munchausen's syndrome by proxy. A 7-year-old girl presented with spontaneous bleeding from forehead, eyes and scalp. The girl was investigated thoroughly by pediatricians at a tertiary care hospital in western India for all possible bleeding disorders, but there was no conclusive diagnosis. After two days, cases with similar complaints were reported among children residing in the same locality and with similar socioeconomic background. All of them were investigated in detail for possible causes of bleeding but nothing came out. There was a media reporting of the cases as a mysterious bleeding disorder. At this point of time, an expert opinion from the psychiatrist was demanded. Covert video surveillance and series of interviews revealed Munchausen's syndrome and possible Munchausen's syndrome by proxy. An in-depth literature review with special reference to Munchausen's syndrome was carried out to come to a final conclusive diagnosis.

In a recent paper Edwards, Kirchin, and Huxtable have argued that research ethics committees (RECs) are often wrongfully paternalistic in their approach to medical research. They argue that it should be left to competent potential research subjects to make judgments about the acceptability of harms and benefits relating to research, and that this is not a legitimate role for any REC. They allow an exception to their overall antipaternalism, however, in that they think RECs should have the power to prohibit the use of financial inducements to recruit research subjects into trials. In this paper it is argued that these claims are unjustified and implausible. A sketch is provided of an alternative model of the role of the REC as an expert body making judgments about the acceptability of research proposals through a consensual weighing of different moral considerations.

One role of research ethics committees (RECs) is to assess the ethics of proposed health research. In some countries, RECs are also instructed to assess its legality. However, in other countries they are explicitly instructed not to do so. In this paper, I defend the claim that public policy should instruct RECs not to assess the legality of proposed research (“the Claim”). I initially defend a presumption in favour of the Claim, citing reasons for making research institutions solely responsible for assessing the legality of their own research. I then consider three arguments against the Claim which may over-ride this presumption–namely, that policy should instruct RECs to assess the legality of research because (1) doing so would minimise the costs of assessing the legality of research, (2) whether research is legal may partly determine whether it is ethical and (3) whether research is legal may constitute evidence for whether it is ethical. I reject the first two arguments and note that whether the third succeeds depends on the answer to a more fundamental question about the appropriate nature of REC ethical deliberation. I end with a brief discussion of this question, tentatively concluding that the third argument also fails.

One role of research ethics committees (RECs) is to assess the ethics of proposed health research. In some countries, RECs are also instructed to assess its legality. However, in other countries they are explicitly instructed not to do so. In this paper, I defend the claim that public policy should instruct RECs not to assess the legality of proposed research (“the Claim”). I initially defend a presumption in favour of the Claim, citing reasons for making research institutions solely responsible for assessing the legality of their own research. I then consider three arguments against the Claim which may over‐ride this presumption—namely, that policy should instruct RECs to assess the legality of research because (1) doing so would minimise the costs of assessing the legality of research, (2) whether research is legal may partly determine whether it is ethical and (3) whether research is legal may constitute evidence for whether it is ethical. I reject the first two arguments and note that whether the third succeeds depends on the answer to a more fundamental question about the appropriate nature of REC ethical deliberation. I end with a brief discussion of this question, tentatively concluding that the third argument also fails.

Research ethics committees, while in many ways an excellent innovation, do have some drawbacks. This paper examines three of these. The first problem of such committees is that their approval of specific projects in their own institutions acquires intrinsic value.

The second problem relates to the possible devolution of responsibility from the investigator to the committee. The committee approves, the investigator feels relieved of some responsibility and things can be done to patients which neither the committee nor the investigator might countenance if they had sole responsibility.

The third problem arises directly from the bureaucratic nature of the committee itself. And one consequence of the resulting rigid guidelines is the insistence, by most committees, on the written consent of patients. Demanding this can, in some circumstances, mean giving the patient very disturbing information. The paper suggests that in patients with a fatal disease where trials compare two accepted therapies committees dispense with written consent.

There is a commentary on this paper by Dr D J Weatherall of the Nuffield Department of Clinical Medicine, University of Oxford.

Ethics committees are the most important practical instrument of clinical ethics in Belgium and fulfil three tasks: the ethical review of experimental protocols, advising on the ethical aspects of healthcare practice, and ethics consultation. In this article the authors examine the current situation of ethics committees in Belgium from the perspective of clinical ethics. Firstly, the most important steps which thus far have been taken in Belgium are examined. Secondly, recent opinion by the Belgian Advisory Committee on Bioethics with regard to ethics committees is presented and the activities of Belgian ethics committees are discussed. Finally, the option to bring research ethics and clinical ethics under the roof of just one committee is criticised using a pragmatic and a methodological argument. Concomitantly, the authors build an argument in favour of the further development of ethics consultation.

This is a response to Professor Fennell's paper on the recent influence and impact of the best interests test on the treatment of patients detained under the Mental Health Act 1983 (MHA) for mental disorder. I discuss two points of general ethical significance raised by Professor Fennell. Firstly, I consider his argument on the breadth of the best interests test, incorporating as it does factors considerably wider than those of medical justifications and the risk of harm. Secondly, I discuss his contention that the apparent permeability of the line between the interests of the patient and the interests of society is something to be concerned about in itself. Since the overarching theme of the paper is the proper place of social and cultural values, my reponse considers the implications of Fennell's arguments in the light of Charlotte Brontë's novel ‘Jane Eyre’, which, through the character of Bertha Mason (the infamous ‘mad woman in the attic’) provides a provocative study of the relationship between mental disorder and society.

The function of local research ethics committees is to consider the ethics of research proposals using human participants. After approval has been given, there is no comprehensive system in place to monitor research and ensure that recommendations are carried out. Some suggest that research ethics committees are ideally placed to fulfil this function by carrying out random monitoring of research they have reviewed. The health service guideline creating local research ethics committees is under review.1 This paper suggests that increasing the monitoring role of ethics committees in the present climate would be inappropriate. This is due to the large workload of the committees, their voluntary nature and the change a monitoring role might cause to the relationship between researcher and ethics committee, which might herald an increasing recourse to judicial review. A radical overhaul of the system would be necessary in order for ethics committees adequately to fulfil a monitoring function.

Key Words: Research ethics committees • audit • monitoring • misconduct

In “Parental Virtues: A New Way of Thinking about the Morality of Reproductive Actions” Rosalind McDougall proposes a virtue-based framework to assess the morality of child selection. Applying the virtue-based account to the selection of children with impairments does not lead, according to McDougall, to an unequivocal answer to the morality of selecting impaired children. In “Impairment, Flourishing, and the Moral Nature of Parenthood,” she also applies the virtue-based account to the discussion of child selection, and claims that couples with an impairment are morally justified in selecting a child with the same impairment. This claim, she maintains, reveals that the flourishing of a child should be understood as requiring environment-specific characteristics. I argue that McDougall’s argument begs the question. More importantly, it does not do justice to virtue ethics. I also question to what extent a virtue ethics framework can be successfully applied to discussions about the moral permissibility of reproductive actions.

When ethics committees evaluate the research proposals submitted to them by biomedical scientists, they can seek guidance from laws and regulations, their own beliefs, values and experiences, and from the theories of philosophers. The starting point of this paper is that philosophers can only be helpful to the members of ethics committees if they take into account in their models both the basic moral intuitions that most of us share and the consequences of people's choices. A moral view which can be labelled as a consequentialist interpretation of mid-level principlism is developed, defended and applied to some real-life and hypothetical research proposals.

The fair innings argument (FIA) is frequently put forward as a justification for denying elderly patients treatment when they are in competition with younger patients and resources are scarce. In this paper I will examine some arguments that are used to support the FIA. My conclusion will be that they do not stand up to scrutiny and therefore, the FIA should not be used to justify the denial of treatment to elderly patients, or to support rationing of health care by age.

There are six issues arising out of the FIA which are to be addressed. First, the implication that there is such a thing as a fair share of life. Second, whether it makes sense to talk of a fair share of resources in the context of health care and the FIA. Third, that 'fairness' is usually only mentioned with regard to the length of a person's life, and not to any other aspect of it. Fourth, if it is sensible to discuss the merits of the FIA without taking account of the 'all other things being equal' argument. Fifth, the difference between what is unfair and what is unfortunate. Finally, that it is tragic if a young person dies, but only unfortunate if an elderly person does.

An assessment of a protocol devised to guide practitioners thinking of using covert video surveillance. Such surveillance is particularly used to help identify cases of Munchausen's syndrome by proxy. The protocol in question has been written by staff at the Academic Department of Paediatrics, North Staffordshire Hospital, Stoke-on-Trent in association with their local Area Child Protection Committee and has been commended by the Department of Health to others wishing to implement covert video surveillance.

In this paper, I have tried to develop a critique of committee procedures and conflict of interest within research advisory committees and ethical review committees (ERCs). There are specific features of conflict of interest in medical research. Scientists, communities and the subjects of research all have legitimate stakeholdings. The interests of medical scientists are particularly complex, since they are justified by the moral and physical welfare of their research subjects, while the reputations and incomes of scientists depend on the success of their science. Tensions of this kind must at times produce conflict of interest. It is important to recognise that conflicts of interest may unwittingly lead to manipulation of research subjects and their lay representatives on research committees. It is equally important to recognise distinctions between the legal and moral aspects of conflict of interest. Some practical suggestions are made which may go some way towards resolving these difficulties. They indicate what might be needed to ensure the validity of ethical discourse, and to reduce the risks associated with conflict of interest.

On 1 May 2004 research ethics committees became legally accountable to a new government body, the United Kingdom Ethics Committee Authority. This marks the end of the self regulation of research ethics. This paper describes how this change in research ethics committee status has come about and explores the implications for research subjects, researchers, institutions, and for regulation of research.

BACKGROUND: It can be argued that the ethical conduct of research involves achieving a balance between the rights and needs of three parties-potential research participants, society, and researchers. Local Research Ethics Committees (LRECs) have a number of roles and functions in the research enterprise, but there have been some indications that LREC members, researchers and the public can have different views about these responsibilities. Any such differences are potential sources of disagreement and misunderstanding. OBJECTIVES: To compare the views of LREC members, researchers and the public towards the roles and functions of LRECs. DESIGN: A questionnaire that contained items concerned with a variety of such roles was distributed to general practice patients (as proxies for potential research participants), researchers and LREC members. FINDINGS: While general practice patients believed that the main function of LRECs is to ensure that research participants come to no harm, LREC members were more concerned with the protection of participants' rights. There was also some disagreement between members and researchers with regard to the consideration of proposals on the grounds of scientific merit. CONCLUSIONS: Local Research Ethics Committee members need to be aware of potential differences in views, that they ought to make their priorities clear, and that membership of LRECs ought to reflect the views of both researchers and potential research participants.

Assessment of ethical aspects and authorization by ethics committees have become a major constraint for health research including human subjects. Ethical reference values often are extrapolated from clinical settings, where emphasis lies on decisional autonomy and protection of individual's privacy. The question rises if this set of values used in clinical research can be considered as relevant references for HBM research, which is at the basis of public health surveillance. Current and future research activities using human biomarkers are facing new challenges and expectancies on sensitive socio-ethical issues. Reflection is needed on the necessity to balance individual rights against public interest. In addition, many HBM research programs require international collaboration. Domestic legislation is not always easily applicable in international projects. Also, there seem to be considerable inconsistencies in ethical assessments of similar research activities between different countries and even within one country. All this is causing delay and putting the researcher in situations in which it is unclear how to act in accordance with necessary legal requirements. Therefore, analysis of ethical practices and their consequences for HBM research is needed.

This analysis will be performed by a bottom-up approach, based on a methodology for comparative analysis of determinants in ethical reasoning, allowing taking into account different social, cultural, political and historical traditions, in view of safeguarding common EU values. Based on information collected in real life complexity, paradigm cases and virtual case scenarios will be developed and discussed with relevant stakeholders to openly discuss possible obstacles and to identify options for improvement in regulation. The material collected will allow developing an ethical framework which may constitute the basis for a more harmonized and consistent socio-ethical and legal approach. This will not only increase the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of European citizens and establish trustful relationships between science and society, based on firmly rooted ethical values within the EU legislative framework.

These considerations outline part of the research on legal, socio-ethical and communication aspects of HBM within the scope of ECNIS (NoE) and NewGeneris (IP).