Genetic testing has historically been performed in the context of chronic disease and cancer diagnostics. The timelines for these tests are typically measured in days or weeks, rather than in minutes. As such, the concept that genetic information might be generated and then used to alter management in the acute setting has, thus far, not been feasible. However, recent advances in genetic technologies have the potential to allow genetic information to be generated significantly quicker. The m.1555A>G genetic variant is present (...) in one in 500 individuals and predisposes to profound hearing loss following the administration of aminoglycoside antibiotics. These antibiotics are used frequently in cases of neonatal sepsis and it is estimated that approximately 180 neonates in the UK are at risk of antibiotic induced hearing loss each year because of this genetic change. Knowledge of this variant in the acute setting would allow clinicians to prescribe alternative antibiotics. The Pharmacogenetics to Avoid Loss of Hearing study will implement a genetic point of care test for the m.1555A>G variant within two major UK based neonatal intensive care units. This represents the first trial of a genetic POCT aimed at altering management in the acute setting. This round table discussion outlines the novel ethical issues faced in the development of this trial and the legal barriers to implementation. We ask five stakeholders to provide their opinions on this trial and their perspectives on the concept of genetic testing in the acute setting.Trial registration numberISRCTN-13704894. (shrink)

Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, research (...) “ethics preparedness” constitutes an important foundation for an effective response to infectious disease outbreaks and other health emergencies. A two-day workshop was convened in March 2018 by the World Health Organisation Global Health Ethics Team and the African coaLition for Epidemic Research, Response and Training, with representatives of National Ethics Committees, to identify practical processes and procedures related to ethics review preparedness. The workshop considered five areas where work might be undertaken to facilitate rapid and sound ethics review: preparing national ethics committees for outbreak response; pre-review of protocols; multi-country review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries. In this paper, we present the recommendations that resulted from the workshop. In particular, the participants recommended that Ethics Committees would develop a formal national standard operating procedure for emergency response ethical review; that there is a need to clarify the terminology and expectations of pre-review of generic protocols and agree upon specific terminology; that there is a need to explore mechanisms for multi-country emergency ethical consultation, and to establish procedures for communication between national ethics committees and other oversight bodies and public health authorities. In addition, it was suggested that ethics committees should request from researchers, at a minimum, a preliminary data sharing and sample sharing plan that outlines the benefit to the population from which data and samples are to be drawn. This should be followed in due time by a full plan. It is hoped that the national ethics committees, supported by the WHO, relevant collaborative research consortia and external funding agencies, will work towards bringing these recommendations into practice, for supporting the conduct of effective research during outbreaks. (shrink)

The UK Genethics Club was established in November 2001 in order to provide a national forum of ethics support for the profession of clinical genetics in the UK. The forum brings together health professionals, medical ethicists and lawyers and support is provided through detailed discussion of cases and sharing of good practice. Clinical genetics professionals had previously voiced concerns about making extremely difficult ethical decisions, with profound implications, in something of a vacuum. Professionals saw a lack of guidance in the (...) area and lack of time for discussion of difficult cases as reasons for this. This paper describes the origins of the group and gives (anonymized) examples of some of the types of issues discussed. (shrink)

In this round table response, we discuss some of the problems inherent in insisting on specific consent for an activity that needs to happen rapidly as part of a package of care. The Human Tissue Authority consider that specific consent is mandatory to assess which antibiotics are appropriate on the neonatal unit, but this insistence may actually limit the autonomy which consent aims to promote. While genetic testing to determine which child will react adversely to particular antibiotics has been available (...) clinically for several years, the research proposed here is to assess whether improving the speed of testing allows decisions to be made before treatment starts. Insisting on specific consent before this activity can take place is likely to delay appropriate care in some cases. On admission to the neonatal unit, the unwell infant is routinely subjected to a range of investigations and treatments. A person with parental responsibility will usually be asked to provide consent to undertake treatments for children who do not have capacity to give consent themselves.1 For the acutely unwell child, consent will usually be sought for a package of care: the urgent nature of neonatal medicine often requires clinicians to make many decisions without explicit consent. Doctors must always act in a child’s best interests: their decisions need to protect the health and well-being of a child and hold the child’s welfare paramount in accordance with the Children Act and General Medical Council guidelines.1 2 Thus, for example, ventilation might be initiated, sedation provided, antibiotics commenced or diagnostic investigations requested without separate consent conversations or …. (shrink)

Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees to also participate in ongoing research—including research by industry and commercial companies. In this paper, which draws on 20 interviews with professional (...) stakeholders involved in 100kGP, we investigate the ethical issues raised by this project’s hybrid nature. While some interviewees thought the hybrid nature of 100kGP was its vanguard, interviewees identified several tensions around hybrid practice: how to decide who should be able to participate; how to determine whether offering results might unduly influence participation into wide-ranging but often as yet unknown research and how to ensure that patients/families do not develop false expectations about receiving results. These areas require further debate as 100kGP moves into routine healthcare in the form of the national genomic medicine service. To address the tensions identified, we explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated. We also argue that enabling ongoing transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help to understand and ensure that expectations remain realistic. Our paper aims to encourage a focused discussion about these issues and to inform a new ‘social contract’ for research and clinical care in the health service. (shrink)

It has become almost a truism to describe the interaction between research ethics committees and researchers as being marred by distrust and conflict. The ethical conduct of researchers is increasingly a matter of institutional concern because of the degree to which non-compliance with national standards can expose the entire institution to risk. This has transformed research ethics into what some have described as a research ethics industry. In an operational sense, there is considerable focus on modifying research behaviour through a (...) combination of education and sanctions. The assessment of whether a researcher is ethical is too often based on whether they submit their work for review by an ethics committee. However, is such an approach making a useful contribution to the actual ethical conduct of research and the protection of the interests of participants? Does a focus on ethical review minimise institutional risk? Instead it has been suggested that ethics committees may be distorting or frustrating useful research and are promoting a culture of either mindless rule following or frustrated resistance. An alternative governance approach is required. There is a need for a strong institutional focus on promoting and supporting the reflective practice of researchers through every stage of their work. By situating research ethics within the broader framework of institutional governance, this paper suggests it is possible to establish arrangements that actually facilitate excellent and ethical research. (shrink)

Historians and social scientists view the distinction between research and care as diachronically and synchronically contingent, rather than transcendental, as is often the case in bioethics. Comparing how the notion of total care was used in the 1950s with present-day use of that same term by genomically informed oncology programs, the paper argues that the distinction between research and care needs: to be historicized, by examining its repeated emergence and re-definition, and the shifting relations between these two “ideal-typical” components; and (...) to be problematized, by paying attention to the entities, practices, and institutions that are constitutive of the successive regimens that have punctuated oncology’s development. Shifting to contemporary activities, the paper examines how the recent massive injection of molecular biology and high-throughput genomic technologies in the field of oncology has been accompanied by a reshuffling of the research/care distinction, a process that is leading to new forms of “experimental care”. (shrink)