Background Dynamic consent has been proposed as a process through which participants and patients can gain more control over how their data and samples, donated for biomedical research, are used, resulting in greater trust in researchers. It is also a way to respond to evolving data protection frameworks and new legislation. Others argue that the broad consent currently used in biobank research is ethically robust. Little empirical research with cohort study participants has been published. This research investigated the participants’ opinions (...) of adding a dynamic consent interface to their existing study. Methods Adult participants in the Extended Cohort for E-health, Environment and DNA longitudinal cohort study who are members of the EXCEED Public and Participant Engagement Group were recruited. Four focus groups were conducted and analysed for thematic content. Discussion topics were derived from a review of the current literature on dynamic consent. Results Participants were in favour of many aspects of a dynamic consent interface, such as being able to update their information, add additional data to their records and choose withdrawal options. They were supportive provided it was simple to use and not intrusive. Participants expressed a markedly high level of trust in the study and its investigators and were unanimously happy with their current participation. No strong support was found for adding a dynamic consent interface to EXCEED. Conclusions Trust in the study researchers was the strongest theme found. Openness and good data security were needed to retain their trust. While happy to discuss dynamic consent, participants were satisfied with the current study arrangements. There were indications that changing the study might unnecessarily disturb their trust. This raised the question of whether there are contexts where dynamic consent is more appropriate than others. This study was limited by the small number of participants who were committed to the study and biased towards it. More research is needed to fully understand the potential impact of adding a dynamic consent interface to an existing cohort study. (shrink)

Introduction -- Historical perspectives of medical ethics -- The medical ethics Renaissance: a brief assessment -- Risk disclosure/'informed consent' -- Consent, control and minors: Gillick and beyond -- Sterilisation/best interests: legislation intervenes -- The end of life: total abrogation -- Medical ethics in government-commissioned reports -- Conclusion.

In the United Kingdom, the question of how much information is required to be given to patients about the benefits and risks of proposed treatment remains extant. Issues about whether healthcare resources can accommodate extended shared decision-making processes are yet to be resolved. COVID-19 has now stepped into this arena of uncertainty, adding more complexity. U.K. public health responses to the pandemic raise important questions about professional standards regarding how the obtaining and recording of consent might change or be maintained (...) in such emergency conditions, particularly in settings where equipment, medicines, and appropriately trained or specialized staff are in short supply. Such conditions have important implications for the professional capacity and knowledge available to discuss the risks and benefits of and alternatives to proposed treatment with patients. The government’s drive to expedite the recruitment to wards of medical students nearing the end of their studies, as well as inviting retired practitioners back into practice, raises questions about the ability of such healthcare providers to engage fully in shared decision-making.This article explores whether the legal duty on healthcare practitioners to disclose the material risks of a proposed medical treatment to a patient should be upheld during pandemic conditions or whether the pre-eminence of patient autonomy should be partly sacrificed in such exceptional circumstances. We argue that measures to protect public health and to respect autonomous decision-making are not mutually exclusive and that there are good reasons to maintain professional standards in obtaining consent to treatment even during acute pressures on public health systems. (shrink)

In 2014, Lord Saatchi launched his ultimately unsuccessful Medical Innovation Bill in the UK. Its laudable aim was to free doctors from the shackles that prevented them from providing responsible innovative treatment. Lord Saatchi’s principal contention was that current law was the unsurmountable barrier that prevented clinicians from delivering innovative treatments to cancer patients when conventional options had failed. This was because doctors feared that they might be sued or tried and convicted of gross negligence manslaughter if they deviated from (...) standard practice. Concerns about fear of the law and potential negative effects on medical practice are not new. Fear of litigation has been suggested as the reason for doctors practising “defensive medicine,” by opting for treatments regarded as “grievance-resistant,” rather than clinically indicated, for example, by ordering diagnostic tests or performing certain procedures, which are not strictly medically necessary. Whilst this claim is plausible and apparently accepted by the courts, there is limited empirical evidence in support of it so far as practitioners in the UK are concerned. In this paper, we report on our empirical research which provides a snapshot of medical opinion to begin to rectify this gap. We ran focus groups of different medical specialties, asking what these medical practitioners thought the barriers to medical innovation to be. We found that fear of the law was not the principal barrier to be lowered, and that the answer was far more multifaceted. (shrink)

As the General Medical Council (GMC) is currently in the process of reviewing its ethical guidance on confidentiality, it is a prescient time to consider the legal and ethical issues inherent in it. This paper examines the question of anonymized data, and highlights the fact that the legal position regarding whether it should be classed as confidential is unclear, with the possibility of a change in the law being very real. Indeed, the article argues that the notion that anonymized data (...) is not confidential can be challenged on both legal and ethical grounds, and thus that the GMC should take this into account in its new guidance. Although identifying the fact that this might have implications for epidemiological research, the article highlights an alternative approach that would allow the conduct of such research while not infringing patients' legally protected human rights. (shrink)

Some time ago, Ian Kennedy asked whether consent wasthe great bulwark of “patient's rights”? Is it a necessary nuisance granted as a concession to modish thinking? Is it simply a figment of some lawyer's imagination which practitioners know is meaningless in practice? Is it just part of the rhetoric of “patient power”, sent to try doctors' patience and challenge their authority?

Hard cases make bad law. In a matter of months, two such cases involving assisted reproduction have appeared before the U.K. High Court and legislation has been enacted. The common threads between them are consent and fatherhood. The first case concerns a ‘mistake’ resulting in sperm from the wrong man being used to create an embryo for a couple and the second the revocation of consent by a man to his former partner being allowed to use an embryo they created (...) together. Furthermore, Parliament has intervened, passing legislation which sets out when sperm from a dead man may be used by his former partner to generate an embryo. This note argues that the three developments cannot be reconciled with one another and that the cases in particular, decided on a narrow legal basis, convey contradictory messages, leading in at least one instance to a gross injustice. (shrink)