Adding dynamic consent to a longitudinal cohort study: A qualitative study of EXCEED participant perspectives.

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 (EXCEED) 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.

Healthcare Professional Standards in Pandemic Conditions: The Duty to Obtain Consent to Treatment.

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.

Making decisions about decision-making: conscience, regulation, and the law.

The exercise of conscience can have far reaching effects. Poor behaviour can be fatal, as it has occurred in various medical scandals over the years. This article takes a wide definition of conscience as its starting point, and argues that the decision-making processes open to society--legal regulation and professional regulation--can serve to limit the options available to an individual and thus her ability to exercise her conscience. The article charts the law's changing attitude to legal intervention, which now seeks to limit the use of conscience by individuals, and addresses concerns that this may serve to 'de-moralise' medicine. It also examines the reasons for this legal change of approach.

WHO'S IN CHARGE? THE RELATIONSHIP BETWEEN MEDICAL LAW, MEDICAL ETHICS, AND MEDICAL MORALITY?

Medical law inevitably involves decision-making, but the types of decisions that need to be made vary in nature, from those that are purely technical to others that contain an inherent ethical content. In this paper we identify the different types of decisions that need to be made, and explore whether the law, the medical profession, or the individual doctor is best placed to make them. We also argue that the law has failed in its duty to create a coherent foundation from which such decision-making might properly be regulated, and this has resulted in a haphazard legal framework that contains no consistency. We continue by examining various medico-legal topics in relation to these issues before ending by considering the risk of demoralisation.

ONE SIZE FITS ALL? ON PATIENT AUTONOMY, MEDICAL DECISION-MAKING, AND THE IMPACT OF CULTURE.

While both medical law and medical ethics have developed in a way that has sought to prioritise patient autonomy, it is less clear whether it has done so in a way that enhances the self-determination of patients from non-western backgrounds. In this article, we consider the desire of some patients from non-western backgrounds for family involvement in decision-making and argue that this desire is not catered for effectively in either medical law or medical ethics. We examine an alternative approach based on relational autonomy that might serve both to allow such patients to exercise their self-determination while still allowing them to include family members in the decision-making process.

One step forward, two steps back? The GMC, the common law and 'informed' consent.

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.

Negligence and the legal standard of care: what is 'reasonable' conduct?

Medical negligence has become a big issue for medical practitioners. Fear of the law, and of litigation, has led to claims of defensive medical practice among doctors and nurses. At the heart of this lies the legal definition of the standard of care, where the law seeks to determine when conduct is 'reasonable' (and thus not negligent), or 'unreasonable' (and thus a breach of the legal duty of care and potentially negligent). In this article the author clarifies what the law means by 'reasonableness' with respect to nurses, drawing on both the law and the NMC Code. Furthermore, the article shall demonstrate that the law is not something to be fearful of but, rather, demands a standard no higher than that of the NMC.

Informed consent and the rise of autonomy.

Although the need for informed consent to medical treatment should be familiar to health-care professionals, the detail regarding what needs to be disclosed to the patient is less well known and even unclear. This article describes the legal requirements for informed consent, and briefly charts the development of the law over the past 25 years. It highlights the fact that the law has changed considerably, and demonstrates that this judicial activism has been as a result of an increasing prioritization of the concept of patient autonomy. It also shows that, on occasion, the courts are prepared to modify the law in order to protect what they see as the underlying principles behind it.