This series of articles argues for a different relationship between investigators and subjects of clinical research based on partnership in shared aims and recognition, by each, of their duties within this partnership. This second essay describes how those duties arise and explores the basis on which, and by and to whom, they are owed. The conclusion that patients have duties in research raises a number of moral issues which, ultimately, question the concept of consent. Discussion of these will be continued (...) in future articles. (shrink)

The concept of responsibility for health is a significant feature of health discourse and public health policy, but application of the concept is poorly understood. This paper offers an analysis of the concept in two ways. Following an examination of the use of the word ‘responsibility’ in the nursing and wider health literature using three examples, the concept of ‘responsibility for health’ as fulfilling a social function is discussed with reference to policy documents from the UK. The philosophical literature on (...) moral responsibility is introduced, and in considering two versions, reactive attitudes and accountability, it is argued that in application both can be regarded, though with different emphasis, as being constituted in three parts: a responsible agent; having obligations ; and being susceptible to being held responsible if he fails to meet them. The three‐stage model is consistent with the examples of the word responsibility in use, but application to the social function model causes a number of problems for healthcare practice, especially for the reactive attitudes account. Apart from considerable problems in stating what exactly the obligations are and how they can be justified; and how blame might justly be apportioned and by whom, the very ideas of obligation and blame are in conflict within healthcare systems and professional nursing practice which have foundations deeply embedded in the notion of the supremacy of personal autonomy. It is concluded that current application of the concept of responsibility for health is conceptually incoherent, and if it is to retain its place in health policy and discourse, urgent remedy is required. (shrink)

This paper is an examination of how research ethics committees have evolved from being advisory committees to more formal regulatory authorities. It is argued that the role of ethics committees should be broader than simple ethical review. Inconsistency in outcome should not be taken to signal failure. Procedural fairness is of the utmost importance. Nor should ethics committees be seen to diminish the ethical responsibilities of researchers themselves.

Most courts around the world have been refusing wrongful life actions. The main argument invoked is that the supposed compensable injury cannot be classified as such, since life is always a blessing no matter how hard and painful it is.In opposition to mainstream scholars and the dominant case law, this article sustains that life must be distinguished from living conditions, the former being the real injury at stake, since some living conditions are so intolerable that in themselves they justify a (...) compensation within wrongful life actions. (shrink)

This paper is a response to a paper by John Coggon ‘Best Interests, Public Interest, and the Power of the Medical Profession'. It argues that certain legal judgements in relation to best interests seek to change and curtail the role of the medical profession in this arena while simultaneously extending the jurisdiction of the courts. It also argues that we must guard against replacing one professional standard, that of the medical profession, with another, that of the judiciary in this area.

The growing scope of gamete donation and themanipulation of gametes makes it essential to developa coherent theory of the nature of gametes and theclaims which may be made in relation to them. Thenature of gametes is ambiguous, they blur thedistinctions between persons and property, but thecurrent legal framework which governs gamete donationand manipulation fails to address their status. Thisleaves unanswered fundamentally important questionsabout control of processes involving gametes andrights to use or control the gametes themselves andthe information which they represent. (...) These areclaims which are rooted in the concept ofproperty. A property based analysis highlights thethemes of autonomy, personhood and control which lieat the heart of the claims made in relation to gametesand an account based on the notion of property forpersonhood offers a more coherent justification forrecognising claims in gametes and mediating disputes. This perspective exposes the inadequacies andinconsistencies of the legal construction of gametesand the legal regulation of gamete donation. Thepresent legal framework has not sought to develop acoherent construction of gametes, but to constrain thepractices of the assisted reproductive technologies(including gamete donation) within a framework whichis presented as least damaging to the traditionalideologies of the creation of the family. (shrink)

The current rise in malpractice litigation has led to concern in the research community as to the prospect of litigation against researchers. Clearly as the responsibility for the day-to-day conduct of the research falls upon the researchers they will be potentially liable should there be negligence in the conduct of the research project itself. But to what extent can the research ethics committee and its members be held liable should harm result to the research subject? How far does the prospect (...) of the threat of litigation equate with the reality of the prospect of liability? Although the NHS research governance framework suggests that primary responsibility for the conduct of the trial is with the researcher this does not mean that REC members will be immune from actions in tort where research subjects suffer harm in the conduct of a research project approved by their NHS REC. This paper focuses upon the prospect for liability in the law of tort of NHS RECs and their members. While in practice the vast majority of such claims are unlikely to be successful members of RECs may incur resultant legal costs as a consequence of involvement in proposed litigation. It is submitted that the scope of indemnity provision provided to RECs and their members should be precisely determined, otherwise there is a real prospect that the risk of malpractice litigation may deter individuals from serving on such committees. (shrink)

A patient's informed consent is required by the Nuremberg code, and its successors, before she can be entered into a clinical trial. However, concern has been expressed by both patients and professionals about the beneficial or detrimental effect on the patient of asking for her consent. We examine advantages and drawbacks of popular variations on consent, which might reduce the stress on patients at the point of illness. Both informed and uninformed responses to particular trials, and trials in general, are (...) discussed. The selection by doctors of patients, to whom entry to trials will be offered, is explored. (shrink)

In the first part of the paper, the author discusses the origin and obligation of the medical profession and argues that the duty of fidelity in the context of a patient–professional relationship (PPR) is the central obligation of medical professionals. The duty of fidelity entails seeking the patient’s best interests even at the expense of the professional’s own, and refusing to treat a risk-patient infected by SARS is a breach of fidelity because the medical professional is involved in a situation (...) of conflict of interests and places his/her own health interests ahead of the patient. The author attributes the failure to the fact that professional ethical codes are not legally enforceable, and this failure at the microethical level damages the integrity of the profession at the macroethical level. The author argues that professional autonomy must be subordinated to professional fidelity for the medical profession to survive as a social institution. In the second part of the paper, the author shows that the PPR has most of the important attributes of a fiduciary relationship, and analyzes several important court cases in some common law jurisdictions to illustrate the increasing importance of fiduciary law in adjudicating disputes between patients and medical professionals, and appeals to law courts and legislatures to apply more stringent fiduciary principles on the medical profession to ensure that the professional duty of fidelity is enforced and the goal of medicine fulfilled for the interests of members of the community who has established the medical profession in the first place. (shrink)

Providing patients with information is fundamental to respecting autonomy. However, there may be circumstances when information may be withheld to prevent serious harm to the patient, a concept referred to as therapeutic privilege. This paper provides an analysis of the ethical, legal and professional considerations which impact on a decision to withhold information that, in normal circumstances, would be given to the patient. It considers the status of the therapeutic privilege in English case law and concludes that, while reference is (...) made to circumstances when information (primarily in relation to risk disclosure) may be withheld, further clarification is required on the status of therapeutic privilege. I suggest there has been shift in English law relating to the standard of information disclosure towards one set by the test of the reasonable, prudent patient. It is this shift that necessitates the existence of a therapeutic privilege which enables doctors to withhold information that would usually be given to the patient in order to prevent serious harm. I then explore the professional guidance in relation to information disclosure and how this relates to the legal position. There are strong ethical arguments in favour of disclosure of information to patients. In light of these, further clarification is required to identify and define the grounds on which this exception exists, the information that could lawfully be withheld and how this exception extends to rest of the health care team, particularly nurses. As such, explicit ethical and legal scrutiny of therapeutic privilege is needed in order to consider how this concept might be articulated, constrained and regulated. (shrink)

International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used (...) in numerous ways in the research ethics literature. Because social value justifies involving human participants, especially in early human trials, this is problematic. (shrink)

This article seeks to broaden the debate on the recruitment of REC lay members by arguing that the recruitment of good members requires that there is initially a need to heighten awareness among potential candidates of the nature of the lay contribution. The article offers a recruiting process model of: awareness; advocacy; characterization; recruitment, and training, and focuses on the first three steps in that process. The current position is that there is sparse awareness and advocacy of the role of (...) the lay member at a time of rapid change, both in the ‘research ethics service’ and the lay contribution thereto. Thus it is seen as imperative that positive steps are taken to change this position, filling a lacuna that appears to exist. Given that the candidate pool can become larger and have a fuller understanding of the ‘research ethics service’, better recruitment and hence better-trained members should result. As a way forward, practical ways and means to do this are suggested, providing topics that will engender a wider debate and perhaps as an outcome, some new initiative. (shrink)

This paper investigates legal and moral justificationsof coerced treatment for psychiatric patients who aredetained on the grounds that they may harm others.While the general issues concerning compulsorytreatment and detention have been widely canvassed, ithas seldom, if ever, been noticed that the moralreasons that we may have to detain a person whoappears to be dangerous to others are different fromthe moral reasons we may have to treat him or her. For example, it has not been noticed that compulsorydetention and compulsory treatment (...) are supported bytwo different moral principles, namely the Principleof Harm and the Principle of Beneficence, and,therefore, that the arguments which support compulsorydetention do not also support compulsorytreatment. The conceptual confusion between legitimacyof compulsory detention and legitimacy of compulsorytreatment is exacerbated by the ambiguous wordingutilised in S 3 of the UK Mental Health Act, whichimplies that treatment may be necessary for theprotection of others. Failure to pay attention to these distinctions has led to tragic consequences, in terms of violations of individual autonomy and in terms of public safety. (shrink)

The purpose of this paper is to consider the role that values play in priority setting through the use of EBP. It is important to be clear about the role of values at all levels of the decision making process. At one level, society as a whole has to make decisions about the kind of health provision that it wants. As is generally accepted, these priority setting questions cannot be answered by medical science alone but involve important judgements of value. (...) However, as I hope to show values come into priority setting questions at another level, one not often explicitly recognised in much of the literature: that of the very definition of the effectiveness of treatments. This has important consequences for patient care. If we do not recognise that the effectiveness of a treatment involve subjective elements — a patient's own assessment of the value of the treatment — then this could lead to the belief that we can purchase one treatment that is the most effective for all patients. This might result in a detrimental reduction in the range of options that a patient is given with some patients not receiving the treatment that is most effective for them. (shrink)

This note suggests that, viewed from a feminist perspective, the reforms contained in the Human Fertilisation and Embryology Act 2008 represent a missed opportunity to re-think the appropriate model of regulation to govern fertility treatment and embryology research in the UK. It argues that reform of the legislation was driven largely by the government’s desire to avoid re-igniting controversies over the legal status of the embryo and abortion and to maintain Britain’s position at the forefront of embryo research and related (...) biotechnologies. It also highlights the importance of media debates, which were highly selective, to the reform process, and suggests that in order to inject feminist values into the process of legislative reform, feminists need to become more media savvy. In the short term, it suggests that there is little prospect of a radical re-thinking of the appropriate ethico-legal response to the wide variety of family forms that reproductive technologies potentially enable, much less of considering our ethical obligations to the new forms of embryos that are now permitted by the 2008 Act. In the meantime, however, it argues that these issues provide productive opportunities for feminist legal theorists to address questions that have been erased or obscured in the course of the 2008 reforms. (shrink)

This paper will examine a sample case encountered by ambulance staff in the context of the basic principles of medical ethics.An accident takes place on an intercity highway. Ambulance staff pick up the injured driver and medical intervention is initiated. The driver suffers from a severe stomach ache, which is also affecting his back. Evaluating the patient, the ambulance doctor suspects that he might be experiencing internal bleeding. For this reason, venous access, in the doctor's opinion, should be achieved and (...) the patient should be quickly started on an intravenous serum. The patient, however, who has so far kept his silence, objects to the administration of the serum. The day this is taking place is within the month of Ramadan and the patient is fasting. The patient states that he is fasting and that his fast will be broken and his religious practice disrupted in the event that the serum is administered. The ambulance doctor informs him that his condition is life-threatening and that the serum must be administered immediately. The patient now takes a more vehement stand. ‘If I am to die, I want to die while I am fasting. Today is Friday and I have always wanted to die on such a holy day,’ he says. The ambulance physician has little time to decide. How should the patient be treated? Which type of behaviour will create the least erosion of his values? (shrink)

In 2006, the Chief Medical Officer for England published the report Good Doctors, Safer Patients in a call for strengthened regulation of the medical profession. The changing relationship between patients and doctors in the United Kingdom arises from the interplay between societal expectation and clinical governance, personal formation and professional practice, private being and public doing. The wisdom of professional practice is in the habits of professionals, a practical wisdom that is the reflex of professional identity. Socialization into a profession (...) is the formation of such identity through the legitimate peripheral participation of the apprentice, oriented towards the contingent granting of admission to the community of practice. The conditional nature of continued insider status, permitting members to interact with clients across the professional boundary, is essential to the contract through which the profession enjoys the privileges conferred by society. The governance of the profession is therefore also necessarily circumscribed, a political reality that is currently evidenced in the regulation of medical practice in the United Kingdom. (shrink)

One probable success (the case of Mrs Tonge) is not a great deal to set against the courts' overwhelming reluctance to play a part in challenging resource allocation decisions. Nevertheless, where such decisions are inherently unreasonable—for example, as Margaret Brazier has suggested,11 a refusal to treat patients because they are divorced, or because they are Labour Party members—a remedy would be available through the courts. Presumably gender biased rationing decisions would similarly be susceptible to judicial review, although there might be (...) evidential difficulties. Age-related denial of treatment would probably not in itself be considered to be ‘Wednesbury unreasonable’. If it could be shown that within the one health authority a particular patient or a group at a set age were denied treatment others at the same age received, there might be scope for an application to the courts. Evidence sufficient to satisfy judges ‘notoriously unwilling to overturn doctors' decisions’11 would be hard to collect.While courts cannot be expected to determine health care policy, their refusal to examine in any detail the decision-making processes of Health Service authorities has ratified ‘the opacity of current decision-making’.12 Instead of forcing authorities to take decisions in a reasoned and justified manner, the courts by their very conservative application of the Wednesbury decision have allowed them to hide from public scrutiny. (shrink)

Some ethicists argue that patient confidentiality is absolute and thus should never be broken. I examine these arguments that when critically scrutinised, become porous. I will explore the concept of patient confidentiality and argue that although, this is a very important medical and bioethical issue, this needs to be wisely delivered to reduce third party harm or even detriment to the patient. The argument for absolute confidentiality is particularly weak when it comes to genetic information and inherited disease.

It was only a matter of time before the portmanteau term “genethics” would be coined and a whole field within bioethics delineated. The term can be dated back at least to 1984 and the work of James Nagle, who claims credit for inventing the word, which he takes “to incorporate the various ethical implications and dilemmas generated by genetic engineering with the technologies and applications that directly or indirectly affect the human species.” In Nagle’s phrase, “Genethic issues are instances where (...) medical genetics and biotechnology generate ethical problems that warrant societal deliberation.” The great promises and terrific threats of developments in scientific understanding of genetics, and the power to enhance, modify, or profit from the knowledge science breeds, naturally offer a huge range of issues to vex moral philosophers and social theorists. Issues as diverse as embryo selection and the quest for immortality continue to tax analysts, who offer reasons as varied as the matters that might be dubbed “genethical” for or against the morality of things that are actually possible, logically possible, and even just tenuously probable science fiction. (shrink)

Over the last few years, policies have been introduced in the UK that identify and treat patients as potential organ donors before death. Patients incapacitated due to catastrophic brain injury may now undergo intensive ante-mortem interventions to improve the chances of successfully transplanting their organs into third parties after death. The most significant ethical and legal problem with these policies is that they are not based on the individual’s specific wishes in the circumstances. Policy-makers appear reluctant to inform potential registrants (...) on the Organ Donor Register about ante-mortem donor optimisation procedures and to provide an opportunity to record specific wishes in advance. They are reliant on blind trust in the organ donation programme, which as I argue in this paper, presents significant risks for the achievement of its aim of securing an adequate supply of organs for transplantation. I argue that informed trust, based on accurate information about the future consequences of registra... (shrink)

ABSTRACT This essay is an attempt to examine the idea that a professional code of practice can entail ethical conduct. It is focused around two differing perspectives on ethics. It will be argued that the professions have, perhaps too hastily, adopted one theory without considering the merits, or the objections offered by the alternative account. This alternative, a ‘cognitivist’ theory, is sketched, and the possible advantages of such an approach are discussed. Such a perspective means adopting a radically different approach (...) to the nature of ethics and what it is to be a moral agent, and could have interesting consequences for professional practice. Even if a cognitivist account is ultimately unconvincing, it does provide a number of worrying arguments for those professionals who believe that ethical conduct is generated by following a code of practice, and these arguments need to be addressed. (shrink)

As medical technology continues to advance and we develop the expertise to keep people alive in states undreamt of even 20 years ago, there is increasing interest in the ethics of providing, or declining to provide, life-sustaining treatment. One such issue, highly contentious in clinical practice as well as in the media (and, through them, the public), is the use of do-not-attempt-resuscitation orders. The main group of patients affected by these orders is older people. This article explores some of the (...) arguments regarding who should make the decision to implement such an order, with particular reference to older people and the unique issues they face in relation to resuscitation. The author concludes by arguing that official guidelines, while representing an ideal, are not easily applied in a typical acute setting where decisions regarding resuscitation are most commonly made, and makes suggestions as to how they may be implemented more successfully. (shrink)

Neither the English courts nor the National Health Service (NHS) have been immune to the modern mantra of patient choice. This article examines whether beneath the rhetoric any form of real choice is endorsed either in law or in NHS policy. I explore the case law on ‘consent’, look at choice within the NHS and highlight the dilemmas that a mismatch of language and practice poses for clinicians. Given the variance in interpretation and lack of consistency for the individual patient (...) I argue for a semantic change that obviates the use of ‘choice’, focussing instead on the options for treatment that are available and accessible, with due acknowledgement of individual patient preferences, without raising unfettered and false expectations. (shrink)

: The Islamic jurists utilized the discipline of maqāṣid al-sharīʿah,in its capacity as the philosophy of Islamic law, in their legal and ethicalinterpretations, with added interest in addressing the issues of modern times.Aphoristically subsuming the major themes of the Sharīʿah, maqāṣid play apivotal role in the domain of decision-making and deduction of rulings onunprecedented ethical discourses. Ethics represent the infrastructure of Islamiclaw and the whole science of Islamic jurisprudence operates in the lightof maqāṣid to realize the ethics in people’s lives. (...) Scrutinizing the key themesof maqāṣid-based ijtihād and scope of ethics in maqāṣid, this article delvesinto the discourse on the application of maqāṣid to medical ethics. As a casestudy, this research analyses the extent of medical confidentiality in the light ofmaqāṣid and arrives at the conclusion that limited confidentiality goes more inline with the maxims of maqāṣid. (shrink)