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This article investigates the lawfulness of isolating residents of care and group homes during the COVID-19 pandemic. Many residents are mobile, and their freedom to move is a central ethical tenet and human right. It is not however an absolute right and trade-offs between autonomy, liberty and health need to be made since COVID-19 is highly infectious and poses serious risks of critical illness and death. People living in care and group homes may be particularly vulnerable because recommended hygiene practices are difficult for them and many residents are elderly, and/or have co-morbidities. In some circumstances, the trade-offs can be made easily with the agreement of the resident and for short periods of time. However challenging cases arise, in particular for residents and occupants with dementia who 'wander', meaning they have a strong need to walk, sometimes due to agitation, as may also be the case for some people with developmental disability (e.g. autism), or as a consequence of mental illness. This article addresses three central questions: (1) in what circumstances is it lawful to isolate residents of social care homes to prevent transmission of COVID-19, in particular where the resident has a strong compulsion to walk and will not, or cannot, remain still and isolated? (2) what types of strategies are lawful to curtail walking and achieve isolation and social distancing? (3) is law reform required to ensure any action to restrict freedoms is lawful and not excessive? These questions emerged during the first wave of the COVID-19 pandemic and are still relevant. Although focussed on COVID-19, the results are also relevant to other future outbreaks of infectious diseases in care and group homes. Likewise, while we concentrate on the law in England and Wales, the analysis and implications have international significance.

There is an urgent need for an ethical framework to help us address the local and national challenges that we face as clinicians during the COVID-19 pandemic. We propose four key commitments from which a practical and consistent ethical approach can be derived. These commitments are to articulate the needs, rights and interests of the different stakeholders affected by any policy; to be accountable and transparent, recognising that people are autonomous individuals with values and concerns of their own; to consider the impact of our actions on the sustainability of the NHS, infrastructure, service demands and staff welfare; and to treat everybody equitably, with all deserving of consideration and care. Implementing these commitments will require a number of specific actions. We must put in place frameworks enabling clear advocacy for each competing objective; communicate policy and practice effectively to the public; promote integration of decision-making among social, primary, secondary and tertiary care and reduce or stop unnecessary or inefficient interventions; minimise health inequalities; and build spare capacity into the system. In this article, we expand on these actions, and note the legal context in which this would be delivered.

"The COVID-19 pandemic has taught us the terrible cost of being unprepared for global health emergencies. The lack of treatments, vaccines, and sufficiently coordinated responses resulted in many unprecedented challenges that must now be analyzed and tackled rapidly. The crisis has raised awareness of the urgent need to improve the design of health systems, as well as the practical implementation of new strategies and technical solutions to better prepare for future pandemics. These preparations must also consider harms secondary to the pandemic, including the resulting effects on antimicrobial resistance (AMR). While drug-resistant infections pose a well-known and severe threat to human and animal health, the COVID-19 pandemic is compounding this already problematic situation. Although often considered only a medical problem, antimicrobial resistance is an evolutionary challenge accelerated by social, cultural and economic factors that lead to the misuse, overuse and abuse of life-saving antimicrobial medicines. The antimicrobial resistance challenge is compounded by inadequate attention to disease prevention and response, global circulation of people and products, differences in industry and market regulations across countries, and a fragile pipeline of new antibiotics and their alternatives. While the discovery of new antimicrobials will provide temporary solutions, sustainable success requires rigorous social science research that explores the drivers of antimicrobial resistance. These solutions should promote balance between equitable access to, conservation of, and innovation for antimicrobials, adapted to local conditions across the globe. To encourage collaboration and to address this challenge, we have created the International Network for Antimicrobial Resistance Social Science (INAMRSS).12 The network is an open consortium of social science researchers focused on addressing the global challenge of antimicrobial resistance. We believe antimicrobial resistance is only surmountable through efforts that consider social, political and economic factors. We intend to champion social science as part of a broadly defined One Health perspective to inform global initiatives. INAMRSS is a member of the Global AMR R&D Hub stakeholder group, which has built a system to track antimicrobial resistance research investment, but has not yet started monitoring relevant social science research funding. We endorse the recommendation of the United Nations Interagency Coordination Group on Antimicrobial Resistance for creating an Independent Panel on Evidence for Action against such resistance, with appropriate expertise across disciplines including the social sciences, and with a focus on the ways that humans are driving this problem and can contribute to solutions" (Less)

COVID-19 is a highly contagious infection with no proven treatment. Approximately 2.5% of patients need mechanical ventilation while their body fights the infection.1 Once COVID-19 patients reach the point of critical illness where ventilation is necessary, they tend to deteriorate quickly. During the pandemic, patients with other conditions may also present at the hospital needing emergency ventilation. But ventilation of a COVID-19 patient can last for 2–3 weeks. Accordingly, if all ventilators are in use, there will not be time for patients to ‘queue up’ to wait for those who arrived earlier to recover. Those who need a ventilator will die if they do not receive access to one quickly. Many nations now face the prospect that they failed to prepare appropriately for this foreseen risk of pandemic (another issue worthy of legal analysis) and that their populations will need far more ventilators than the health service can supply. For many weeks, the UK has been anticipating a surge of COVID-19 infections that could leave patients queuing in hospitals for ICU care. Luckily, social distancing has ‘flattened the curve’ and this problem might not arise. There is still a degree of risk, however, and other countries will not be so lucky. At some point, during this pandemic or the next, all countries will need to answer hard questions about whether and when scarce ICU resources (such as ventilators, beds and staff) should be either withheld or withdrawn from certain groups of patients solely for the purpose of providing them to others. Attempts to answer these questions can be found in a wide range of ICU triage protocols and ethical guidance documents, many of which embrace the foundational principle of ‘save the most lives’. Unfortunately, this worthwhile goal has generated many suggestions that could violate the law. This article identifies …

Recent US Supreme Court decisions have invalidated patent claims on isolated genomic DNA, and testing methods that applied medical correlations using conventional techniques. As a consequence, US genetic testing laboratories have a relatively low risk of infringing patents on naturally occurring DNA or methods for detecting genomic variants. In Europe, however, such claims remain patentable, and European laboratories risk infringing them. We report the results from a survey that collected data on the impact of patents on European genetic testing laboratories. The results indicate that the proportion of European laboratories that have refrained from providing associated testing services owing to patent protection has increased over the last decade (up from 7% in 2008 to 15% in 2017), and that the non-profit sector was particularly strongly affected (up from 4% in 2008 to 14% in 2017). We renew calls for more readily available legal support to help public sector laboratories deal with patent issues, but we do not recommend aligning European law with US law at present. Watchful monitoring is also recommended to ensure that patents do not become a greater hindrance for clinical genetic testing laboratories.

Adverse outcomes from sub-optimal organs – including the death of two kidney recipients in the UK in 2013 – raise questions about the potential for surgeons to be held liable for using sub-optimal rather than standard or optimal organs. Could surgeons, transplant teams, ICU physicians, or hospitals be liable if the sub-optimal organ passes on an infection or cancer? When should transplant teams decline the offer of an organ from a compromised donor? How much detailed information should transplant teams pass on to potential recipients about the risks associated with the sub-optimal organ? If the recipient accepts the risks associated with a sub-optimal organ, does this absolve the surgeon of responsibility for those risks? This paper set the scene for an interdisciplinary academic discussion of these questions on 18 November 2016 at the University of Cambridge. The paper encourages readers to engage with higher order questions about regulatory design.

Overly strict interpretation of the law is hampering epidemiological research. Here, one research team shows why regulators and organisations holding data should adjust their approach

Eleri Jones and Kathleen Liddell argue that objections to paying according to risk are paternalistic, but John Saunders (doi:10.1136/bmj.b4145) thinks that it would lead to people being exposed to unacceptable danger

This report records the views of a working group of the Vienna Initiative to Save European Academic Research (VISEAR). VISEAR, an association of European researchers predominantly from the public sector, seeks to improve European regulation of medical research. It is organised and financially supported by the University of Vienna, the Vienna School of Clinical Research and the Office of the Ethics Committee. The report discusses: (1) the implementation of the EU Directive 2001/20/EC ('the Clinical Trials Directive') insofar as it related to research involving adult patients unable to consent; (2) legal, ethical and practical difficulties experienced as a result of implementation of the Clinical Trials Directive; and (3) possible solutions to the problems experienced. The report is concerned with a broad variety of research involving incapacitated persons including research about mental illness, intellectual disability, age-related illness, critical care and emergency medicine (e.g. stroke, cardiac arrest, traumatic head injury). The Working Group makes the following recommendations: Implementation 1. Member States should monitor the impact of their laws on research involving incapacitated patients, particularly Member States which have applied the conditions of the Clinical Trials Directive to medical research other than clinical drug trials. 2. The European Commission ('EC') and Member States should publish guidance to assist researchers and ethics committees with the interpretation of the Directive and implementing legislation. Risk Assessment 3. The EC and Member States should recognise that in circumstances of clinical equipoise (which is an ethical requirement for enrolling patients in clinical trials) there will be substantial uncertainty whether administering a medicinal product will benefit a patient. The requirement that the trial be expected to produce benefits outweighing risks (or no risk at all) must be interpreted in light of this. 4. The EC and Member States should publish guidance about 'component analysis' to clarify that when assessing whether a trial will produce a benefit to the patient outweighing the risks (or no risk at all), the judgment should be made with reference to the benefits and risks associated with the research component of the trial (rather than components of the trial that reflect accepted medical therapies or treatments in equipoise). 5. In conjunction with component analysis, the EC and Member States should review or clarify the requirement that the trial produce 'a benefit to the patient outweighing the risks or produce no risk at all'. It should allow a protocol to include non-therapeutic components (e.g. scans, chart checks, blood tests) of no benefit to the individual, provided they represent no more than minimal risk, are minimised and proportionate to the knowledge gained. 6. When national legislation implementing the Directive covers more than clinical drug trials, Member States should ensure it permits research with no therapeutic benefit for the individual, provided it poses them no more than minimal risk (for example observational studies, research using human tissue samples or health records, and pathophysiological research). 7. Researchers should document instances when non-therapeutic research has been unwisely prohibited by inappropriate implementation or extension of the Directive. 8. The EC and Member States should support ethical and legal research to develop guidelines for difficult risk comparisons. Ethics Committee Review 9. The EC and Member States should increase the resources available for Ethics Committees to secure members or advisors with specialist knowledge relevant to clinical trials with incapacitated patients. 10. The EC and Member States should develop centralised bodies, guidelines and records of precedent decisions for ethics committees to increase the efficiency, consistency and predictability of their decisions. Revocation of Consent 11. The EC and Member States should clarify the extent of a legal representative's power to revoke the individual's participation in a clinical trial with reference to the future analysis for research purposes of data or tissue already collected. Permitted Investigations 12. Ethics committees should ensure that they interpret the phrase 'research...directly related to a life-threatening or debilitating clinical condition' appropriately, and not too narrowly. The interpretation should permit research in non-neurological conditions accompanied by incapacity, research in settings where incapacity is the consequence of essential therapy, research that addresses the common complications of incapacitating conditions, and research to improve methods of supportive therapy. Legal Representatives for Proxy Consent 13. Further legal research should be undertaken to ascertain the definitions of 'legal representative' that apply in Member States. This could be used as a resource to ensure the lawfulness of international trials; for the basis of public debates and discussion papers discussing whether to broaden current definitions; and to analyse the extent to which current definitions cause problems for research about emergency and critical illness. Emergency and Critical Illness Research 14. Article 5(a) of the Directive should be construed purposively or amended if necessary (by extension, waiver or deferral) to permit and harmonise emergency research involving incapacitated persons where treatment must be commenced as a matter of urgency. 15. Member States should implement systems for legal representation that are compatible with critical illness research. Countries which ordinarily rely on court appointed representatives should check the system is making timely appointments. Countries which usually rely on family members to act as legal representatives should permit decisions to be made by other persons (unconnected with the research) when family members are too stressed to decide, or should waive or defer the consent requirement.

0 d University of Birmingham (for the European Society of Intensive Care Medicine), Birmingham, UK Department of Intensive Care and Department of Neurosurgery, Erasmus MC University Medical Center, he Netherlands Service de Reanimation Medicale, Hop Henri Mondor (AP-HP) et Univ Paris XII, Creteil, France Ethics Committee of the Medical University of Vienna, Austria Medical School University of Zagreb, Croatia Medical University of Innsbruck, Austria Central Hospital of Bolzano, Italy Department of Emergency Medicine, Medical University Vienna

New regulations are necessary to make useful research possible Many authorities have expressed reservations about some provisions in the human tissue bill, which parliament will debate again at the end of June. Although these general concerns remain relevant, we must draw attention to another issue that has been largely glossed over—namely, the use of tissue and genetic information obtained from people with mental incapacity. The human tissue bill is one of several pieces of legislation which in their current form are likely to make research involving adult patients with critical illness, learning disability, or mental illness, either difficult or impossible. One of the central themes of the human tissue bill is that “appropriate consent” or “qualifying consent” must be obtained before tissue from a living person may be used, stored, or genetically analysed. Failure to do so constitutes a criminal offence. Where the tissue comes from a living adult, the person himself or herself must give the consent.1 This indicates it may become a criminal offence to use, store, or genetically analyse human tissue taken from adults who lack capacity to make a decision themselves. Responding to these concerns, the government stated that an additional piece of proposed legislation, the mental capacity bill, would make it possible for a third party …