In the last couple of years, several new biobanks have been established to enable the study of health developments of people and their families over their entire lifetime. This paper reviews the legal and ethical implications of a loss of decision-making capacity by research subjects in long-term research associated with large biobanks.
Typically anorexia nervosa is diagnosed as a condition of teenage girls where the rates of mortality and morbidity are very high and recovery rates very low. This chapter discusses the condition as experienced in Australia by older women who have either lived with anorexia during adolescence and as young women or who have been diagnosed later in life. The discussion traverses issues of consent to treatment or its refusal, capacity to provide consent, and the application of human right protections arising from various human rights instruments.
This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear. This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines.
The notion of "consent" is frequently referred to as "informed consent" to emphasise the informational component of a valid consent. This article considers aspects of that informational component. One misuse of the language of informed consent is highlighted. Attention is then directed to some features of the situation in which consent would not have been offered had certain information been disclosed. It is argued that whether or not such consent is treated as sufficiently informed must, from a moral point of view, take account of four conditions. When these are applied to the operation of consent in relation to criminal responsibility for HIV transmission, the approach in some recent cases is shown to be morally questionable.
GPs’ representatives voted overwhelmingly this week for a system in which patients opt in to any sharing of medical data with third parties—rather than one in which their consent is assumed unless they opt out, the system favoured by the Department of Health. Clinical confidentiality depends on GPs being the prime data holder of their patients’ medical records, said the BMA’s annual conference of local medical committee representatives in London. It also strongly opposed using implied consent as justification for releasing information on named patients.
SOMERVILLE, Margaret A., 1942-, Consent to Medical care: A Study Paper prepared for the Law Reform Commission of Canada, Ottawa: Law Reform Commission of Canada, 1980, viii, 186 p. (series; Protection of Life Series; Study Papers), ISBN: 0662104528 Part 1: i-viii and 1-103
SOMERVILLE, Margaret A., 1942-, Consent to Medical care: A Study Paper prepared for the Law Reform Commission of Canada, Ottawa: Law Reform Commission of Canada, 1980, viii, 186 p. (series; Protection of Life Series; Study Papers), ISBN: 0662104528 Part 2: 105-186
Since 1991, sperm donors in the UK have had the legal right to withdraw consent for the use of their sperm in fertility treatment. This has the potential to adversely affect patients. It may mean that previous recipients of a donor’s sperm cannot have further children who are full biological siblings to an existing child, and that embryos created from the donor’s sperm and a patient’s eggs must be destroyed. We have informally investigated withdrawal of consent by sperm donors donating after 1 April 2005, when lifelong anonymity for gamete donors ended.
With a national shortage of organ donors, the dilemma faced by surgeons is whether a transplant with what are called "marginal" organs from donors who could be higher risk, such as the elderly or patients with a history of cancer or drug abuse, is better than leaving a patient on a waiting list where they could die before a suitable donor can be found. Figures disclosed to File on 4 reveal that in 1998 13% of donor organs were "marginal", 10 years later this percentage had doubled. Everyone in the transplant field who has talked to the programme agreed the quality of organs from deceased donors was declining, accepting this meant added risks connected to the hearts, lungs, livers and kidneys used for transplants. As one doctor put it, this is a calculated gamble. Arising out of this comes the issue of informed consent. Who should have the final say whether an organ from a dead donor should be used, the professional or the patient?
Cash incentives and the payment of funeral expenses are two ideas being put forward to encourage people to donate human organs and tissue. The Nuffield Council on Bioethics is asking the public if it is ethical to use financial incentives to increase donations of organs, eggs and sperm. Paying for most types of organs and tissue is illegal in the UK. The public consultation will last 12 weeks and the council's findings will be published in autumn 2011.
We provide our bodies or parts of our bodies for medical research or for the treatment of others in a number of ways and for a variety of reasons. However, there is a shortage of bodily material for many of these purposes in the UK. What should be done about it? The Council has set up a Working Party, chaired by Professor Dame Marilyn Strathern, to explore the ethical issues raised by the provision of bodily material for medical treatment and research. Questions to be considered include: * what motivates people to provide bodily material and what inducements or incentives are appropriate? * what constitutes valid consent? * what future ownership or control people should have over donated materials? * are there ethical limits on how we try to meet demand?
Doctors will be allowed forcibly to sedate the 55-year-old woman in her home and take her to hospital for surgery. She could be forced to remain on a ward afterwards. The case has sparked an intense ethical and legal debate. Experts questioned whether lawyers and doctors should be able to override the wishes of patients and whether force was ever justified in providing medical care.
A cancer patient who has a phobia of hospitals should be forced to undergo a life-saving operation if necessary, a High Court judge has ruled. Sir Nicholas Wall, sitting at the Court of Protection, ruled doctors could forcibly sedate the 55-year-old woman - referred to as PS. PS lacked the capacity to make decisions about her health, he said. Doctors at her NHS Foundation trust had argued PS would die if her ovaries and fallopian tubes were not removed. Evidence presented to Sir Nicholas, head of the High Court Family Division, said PS was diagnosed with uterine cancer last year.
Three women in Namibia are suing the state for allegedly being sterilised without their informed consent after being diagnosed as HIV positive. The women say the doctors and nurses should have informed them properly about what was happening. The rights group representing them, the Legal Assistance Centre, says it has documented 15 cases of alleged HIV sterilisation in hospitals since 2008. A march in their support is taking place in Windhoek as the case begins.
Until 2008, if doctors followed the General Medical Council's (GMC's) guidance on providing information prior to obtaining a patient's consent to treatment, they would be going beyond what was technically required by the law. It was hoped that the common law would catch up with this guidance and encourage respect for patients' autonomy by facilitating informed decision-making. Regrettably, this has not occurred. For once, the law's inability to keep up with changing medical practice and standards is not the problem. The authors argue that while the common law has moved forward and started to recognise the importance of patient autonomy and informed decision-making, the GMC has taken a step back in their 2008 guidance on consent. Indeed, doctors are now required to tell their patients less than they were in 1998 when the last guidance was produced. This is an unfortunate development and the authors urge the GMC to revisit their guidance.
A cardiac surgeon with an international reputation has been given a formal warning by the General Medical Council for undertaking an “adventurous” procedure for which he was not adequately trained and for which he did not obtain informed consent.
Farrell and Brazier set out the arguments for obtaining specific informed consent for allogeneic blood transfusion.1 They do not deal with allogeneic blood products, but I think their article can be assumed to cover this too. This subject is controversial, and the question of how to seek and record consent has been the subject of a recent consultation by the Department of Health’s Advisory Committee on the Safety of Blood, Tissues and Organs. A question Farrell and Brazier avoid is who should be responsible for gaining informed consent? Should it be those who provide the blood (the transfusion service, probably most informed about the risks) or those who prescribe it (probably least informed)? This is of crucial importance in the debate and has considerable resource implications.
Within transfusion medicine, the question of whether separate informed consent should be obtained from patients for blood transfusion has provoked considerable debate. There has long been support for such an approach in the United States.1 A BMJ editorial in 1997 made it clear that reform was on the professional agenda in the United Kingdom, despite the established position that obtaining general consent for medical treatment included consent for blood transfusion.2 At the time, however, professional consensus proved elusive because of concerns over a range of practical problems, including who should be responsible for obtaining such consent and in what circumstances it should be obtained.3 The issue has now been brought to the fore again, highlighted by the recent stakeholder consultation launched by the UK government’s independent Advisory Committee on the Safety of Blood, Tissue and Organs.
More than 60,000 Americans were sterilised, many against their will, as part of a eugenics movement that finished in 1979, aimed at keeping the poor and mentally ill from having children. Now, decades on, one state is considering compensation.
ROMA - I punti salienti della legge sul testamento biologico approvata oggi alla Camera, che per il varo definitivo dovrà tornare al Senato, sono almeno due: le dichiarazioni anticipate di trattamento non sono vincolanti per i medici ed escludono la possibilità di sospendere nutrizione e idratazione, salvo in casi terminali. Inoltre, sono applicabili solo se il paziente ha un'accertata assenza di attività cerebrale.
At least 83 Guatemalans are thought to have died after being deliberately infected with syphilis and gonorrhoea in the 1940s, a presidential commission in the United States has heard. US government scientists infected hundreds of Guatemalan prisoners, psychiatric patients and orphans to study the effects of penicillin. None of those infected consented. The head of the commission, Amy Gutmann, called the research a "shameful piece of medical history". The Presidential Commission for the study of Bioethical Issues is due to publish its report in September. President Obama set up the commission when the research came to light last year.
APRIL 19--Meet Philip Winikoff. The 76-year-old Florida man was arrested this morning and charged with sexual battery after he posed as a doctor and went door-to-door--black doctor's bag in hand--offering women free breast exams. According to a Broward County Sheriff's Office report, two women--ages 33 and 36--fell for the scam, which Winikoff allegedly ran in Lauderdale Lakes. Charged with several felonies, Winikoff was booked into the sheriff's lockup, where the below mug shot was snapped. Police are now investigating whether other women may have been tricked into impromptu examinations.
With the capacity of doctors to intervene in pregnancy increasing, the likelihood for conflicts between doctors and hospitals and pregnant women is also increasing. Yet our jurisprudence has failed to clarify the bounds of pregnant women’s autonomy. Indeed, this jurisprudence is marked by confusion, leaving courts in the dark as to how to resolve these conflicts. Therefore, it is useful to carefully enunciate the rights and interests at issue in forced medical care of pregnant women. This includes 1) the distinction between the right to refuse medical care of oneself and the lack of a right to refuse consent to necessary medical care of others, 2) the right not to be forced to rescue others, and 3) the nature of the exceptions to these rights. Careful delineation of these concepts reveals that forced medical care of pregnant women lacks justification when these principles are consistently applied.
A central tenet to much ethical argument within medical law is patient autonomy. Although we have seen a welcome move away from a system governed by largely unchecked paternalism, there is not universal agreement on the direction in which medical law should advance. Competing concerns for greater welfare and individual freedom, complicated by an overarching commitment to value-pluralism, make this a tricky area of policy-development. Furthermore, there are distinct understandings of, and justifications for, different conceptions of autonomy. In this paper, we argue that in response to these issues, there has been a failure by the courts properly to distinguish political concepts of liberty and moral concepts of autonomy.
Nicola Wilding, 35, lost the use of her right arm in a car crash 12 years ago. Nerve transplants have returned some movement to her upper arm, but she's been told she'll never be able to use her hand again. Now, having seen a Newsnight film on the work of Austrian surgeon Oskar Aszmann, she is actively considering having her hand cut off and replaced with a bionic prosthesis.
The paper discusses the issue of family involvement in the process of obtaining consent to treatment. Legally, doctors have a duty to inform the patient, and the patient has a right to be informed before making a decision. In this context, however, there is no requirement to involve relatives or to take into account their interests or requests. Yet, findings from in-depth interviews with NHS general practitioners presented in the paper indicate that in reality relatives have a substantial impact on the process of informed consent. Their presence may lead the doctor to provide more information to the patient and help the patient better understand the information conveyed by the doctor. Ultimately, the relatives' involvement enhances the patient's ability to make an informed decision, even though in some cases – when the relative is dominant – this may have a negative impact on the channel of communication between doctor and patient. These findings reflect a relational approach to patien
The Supreme Court of Canada will go ahead later this year and set a legal framework for when patients in a vegetative state can be withdrawn from life support. The court rejected a request this morning from the family of a severely ill Toronto man, Hassan Rasouli, to withdraw the case from its docket on the grounds that Mr. Rasouli recently passed into a higher degree of consciousness.
This paper analyses elements of the legal process of consent to the donation of ‘spare’ embryos to research, including stem-cell research, and makes a recommendation intended to enhance the quality of that process, including on occasion by guarding against the invalidity of such consent. This is important in its own right and also so as to maximise the reproductive treatment options of couples engaged in in vitro fertilisation (IVF) treatment and to avoid possible harms to them. In Part 1, with reference to qualitative data from three UK IVF clinics, we explore the often delicate and contingent nature of what comes to be, for legal purposes, a ‘spare’ embryo. The way in which an embryo becomes ‘spare’, with its implications for the process of consent to donation to research, is not addressed in the relevant reports relating to or codes of practice governing the donation of embryos to research, which assume an unproblematic notion of the ‘spare’ embryo. Significantly, our analysis demon
A lawyer who advised doctors that they must let a 22-year-old Jehovah's Witness die even though he wanted to live has spoken of the agonising scenes before the young man's death.