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Background The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change. Main text We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies. Conclusion Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate.

BackgroundHumanitarian crises and emergencies, events often marked by high mortality, have until recently excluded palliative care—a specialty focusing on supporting people with serious or terminal illness or those nearing death. In the COVID-19 pandemic, palliative care has received unprecedented levels of societal attention. Unfortunately, this has not been enough to prevent patients dying alone, relatives not being able to say goodbye and palliative care being used instead of intensive care due to resource limitations. Yet global guidance was available. In 2018, the WHO released a guide on‘Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises’—the first guidance on the topic by an international body.AimsThis paper argues that while a landmark document, the WHO guide took a narrowly clinical bioethics perspective and missed crucial moral dilemmas. We argue for adding a population-level bioethics lens, which draws forth complex moral dilemmas arising from the fact that groups having differential innate and acquired resources in the context of social and historical determinants of health. We discuss dilemmas concerning: limitations of material and human resources; patient prioritisation; euthanasia; and legacy inequalities, discrimination and power imbalances.ImplicationsIn parts of the world where opportunity for preparation still exists, and as countries emerge from COVID-19, planners must consider care for the dying. Immediate steps to support better resolutions to ethical dilemmas of the provision of palliative care in humanitarian and emergency contexts will require honest debate; concerted research effort; and international, national and local ethical guidance.

Background Despite recognition that palliative care is an essential component of any humanitarian response, serious illness-related suffering continues to be pervasive in these settings. There is very limited evidence about the need for palliative care and symptom relief to guide the implementation of programs to alleviate the burden of serious illness-related suffering in these settings. A basic package of essential medications and supplies can provide pain relief and palliative care; however, the practical availability of these items has not been assessed. This study aimed to describe the illness-related suffering and need for palliative care in Rohingya refugees and caregivers in Bangladesh. Methods and findings Between November 20 and 24, 2017, we conducted a cross-sectional study of individuals with serious health problems (n = 156, 53% male) and caregivers (n = 155, 69% female) living in Rohingya refugee camps in Bangladesh, using convenience sampling to recruit participants at the community level (i.e., going house to house to identify eligible individuals). The serious health problems, recent healthcare experiences, need for medications and medical supplies, and basic needs of participants were explored through interviews with trained Rohingya community members, using an interview guide that had been piloted with Rohingya individuals to ensure it reflected the specificities of their refugee experience and culture. The most common diagnoses were significant physical disabilities (n = 100, 64.1%), treatment-resistant tuberculosis (TB) (n = 32, 20.5%), cancer (n = 15, 9.6%), and HIV infection (n = 3, 1.9%). Many individuals with serious health problems were experiencing significant pain (62%, n = 96), and pain treatments were largely ineffective (70%, n = 58). The average age was 44.8 years (range 2–100 years) for those with serious health problems and 34.9 years (range 8–75 years) for caregivers. Caregivers reported providing an average of 13.8 hours of care per day. Sleep difficulties (87.1%, n = 108), lack of appetite (58.1%, n = 72), and lack of pleasure in life (53.2%, n = 66) were the most commonly reported problems related to the caregiving role. The main limitations of this study were the use of convenience sampling and closed-ended interview questioning. Conclusions In this study we found that many individuals with serious health problems experienced significant physical, emotional, and social suffering due to a lack of access to pain and symptom relief and other essential components of palliative care. Humanitarian responses should develop and incorporate palliative care and symptom relief strategies that address the needs of all people with serious illness-related suffering and their caregivers., Megan Doherty and co-workers report on illness, suffering and treatment needs among Rohingya refugees and caregivers in Bangladesh., Author summary Why was this study done? Palliative care and symptom relief have been recognized as essential in humanitarian crises, which by their nature generate a large burden of suffering and mortality. A basic and inexpensive package of essential medicines and supplies can address pain relief and palliative care during humanitarian crises, but the availability of these items during a crisis has not been assessed. There is minimal evidence to guide the implementation of palliative care in humanitarian responses, with few studies describing palliative care needs or programs in these settings. What did the researchers do and find? We conducted a cross-sectional study of individuals with serious illnesses and caregivers to describe the illness-related suffering and need for palliative care in Rohingya refugees in Bangladesh. Many individuals with serious health problems experienced significant pain (62%, n = 96), the pain treatments prescribed were largely ineffective (70%, n = 58), and effective pain treatments were rarely available. Caregivers most commonly assisted with bathing (n = 117, 94%), administering medications (n = 99, 80%), and feeding (n = 98, 79%). Despite having limited training or money, caregivers provided many hours per day of care, which caused sadness, worry, and discrimination. What do these findings mean? In the Rohingya humanitarian crisis, the specific physical, emotional, and social needs of individuals with serious conditions and their caregivers are not being addressed adequately. Efforts to incorporate palliative care must address the barriers to accessing essential medications, supplies, and medical care, including opioid availability. Assessments of palliative care needs during humanitarian crises should be used to direct palliative care priorities and guide the development of effective interventions in these settings. Future research should quantify the occurrence of serious illness-related suffering, evaluate programs designed to alleviate this suffering, and validate published guidelines and recommendations.

In their letter to the Editor in this issue, Kolstoe and Carpenter challenge a core aspect of our recently published case study of research approvals [BMC Medical Ethics 20:7] by arguing that we conflate research ethics with governance and funding processes. Amongst the key concerns of the authors are: 1) that our paper exemplifies a typical conflation of concepts such as governance, integrity and ethics, with significant consequences for claims around the responsibility and accountability of the organisations involved; 2) that, as a consequence of this conflation, we misrepresent the ethics review process, including in fundamental aspects such as the ethics approval-opinion distinction; 3) that it is difficult to see scope for greater integration of processes such as applying for funding, research approvals, Patient and Public Involvement, etc., as suggested by us. Here we present an alternative point of view towards the concerns raised.

In their letter to the Editor in this issue, Kolstoe and Carpenter challenge a core aspect of our recently published case study of research approvals [BMC Medical Ethics 20:7] by arguing that we conflate research ethics with governance and funding processes. Amongst the key concerns of the authors are: 1) that our paper exemplifies a typical conflation of concepts such as governance, integrity and ethics, with significant consequences for claims around the responsibility and accountability of the organisations involved; 2) that, as a consequence of this conflation, we misrepresent the ethics review process, including in fundamental aspects such as the ethics approval-opinion distinction; 3) that it is difficult to see scope for greater integration of processes such as applying for funding, research approvals, Patient and Public Involvement, etc., as suggested by us. Here we present an alternative point of view towards the concerns raised.

BACKGROUND: Electronic Palliative Care Coordination Systems (EPaCCS) are England's pre-eminent initiative in enabling advance care planning and improved communication and coordination at the end of life. EPaCCS have been under development for 8 years after being proposed, as Locality Registers, in the 2008 End of Life Care Strategy for England. EPaCCS are electronic registers or tools and processes for sharing data which aim to enable access to information about dying patients. Striking outcomes have been reported around EPaCCS, such as 77.8% of 'Coordinate My Care' patients dying in their preferred place. EPaCCS have, however, been extremely challenging to develop and implement, with many projects remaining continuously 'under development' or folding. They also continue to be suboptimally integrated with other data sharing initiatives. Rigorous research is non-existent. DISCUSSION POINTS: We discuss the current EPaCCS landscape and way forward. We summarise key facts concerning the availability, uptake, outcomes and costs of EPaCCS. We outline 5 key challenges (scope of projects, unrealistic expectations set by existing guidance, the discrepancy between IT realities in healthcare and our broader lives, information governance and 'death register' associations) and 6 key drivers (robust concept, striking outcomes, national support and strong clinical leadership, clinician commitment, education and funding). CONCLUSIONS: The priorities for advancing EPaCCS we propose include linking to other work streams and reframing the concept, potentially making it less 'end of life', overview of current EPaCCS and lessons learnt, continuing work on information standards, rethinking of national funding and new levels of individual and community involvement.

Background: Electronic Palliative Care Coordination Systems (EPaCCS), enabling data sharing across care settings, have been under development in England for over nine years and are expected to cover all areas of the country by 2020. Data sharing (technically termed “health information exchange”, HIE) projects are, however, amongst the most difficult projects of health information technology (HIT) implementation. We report on a sub-study of “Prepared to Share?”, a mixed methods realist evaluation of The Cambridgeshire and Peterborough Project for Data Sharing in End of Life Care, nested in broader research on data sharing and EPaCCS. Methods: 44 participants were interviewed using principles of realist and episodic interviewing. Preliminary analysis of nine interviews and four existing reviews on HIE and HIT, covering 135 studies, contributed to an initial analysis framework. Framework and thematic analysis principles and “pluralist” coding informed by the philosophy of science of J. Dupré were applied in the analysis. Results: We identified > 460 challenges and > 300 drivers to implementing EPaCCS and data sharing projects more broadly, the majority of them richly described in the interviews. The main sources of challenges were: the existence of “alternatives”, i.e. primarily well entrenched and thus easier ways of working, but also other data sharing solutions; generic resource constraints within the health system; information governance issues; generic IT infrastructure challenges; insufficient adaptability, capacities for personalisation and flexibility of the solution; and generic features of the health system, such as its fragmentation. “Expected benefits” and “training, education and awareness raising” were the only higher-level categories where drivers outweighed challenges. Conclusions: EPaCCS projects and research need to draw on and contribute more to existing HIE and HIT research. EPaCCS teams and users are learning the hard way many lessons which are already described in this broader research literature.

In July this year, the Department of Health published Your Data: Better Security, Better Choice, Better Care. It was the UK Government’s (somewhat delayed) response to last year’s Review of Data Security, Consent and Opt-Outs of the National Data Guardian (NDG) for Health and Care as well as to the Safe Data, Safe Care review of the Care Quality Commission. Something is awry in the debate on patient data sharing. And while it is not the Government’s response that has made it so (not least because it accepts all of its trigger reports’ recommendations), it is likely to make things worse, for at least three reasons.

Objective In the UK, General Practitioners and Practice Managers are key to enabling health information exchange (typically referred to as ‘data sharing’). This study aimed to survey GPs and PMs for familiarity, engagement with and perceptions of patient data sharing. Methods Cross-sectional survey. All 107 general practices in England’s second largest Clinical Commissioning Group, Cambridgeshire & Peterborough CCG. Descriptive statistics; hierarchical logistic regression; thematic analysis. Results 405 (64%) responses were received – from 338 (62%) GPs and 67 (71%) PMs. Familiarity and engagement were highest for local frail elderly and end of life care projects (>76% had used). The greatest difference in use concerned the now suspended national care.data initiative: PMs had odds of reporting use 75 times higher than GP partners (95% CI 27–211). Patient confusion was the most pronounced challenge and improved coordination the most pronounced expected benefit. Frequency of discussions with patients varied with IT competence (OR 4.2 for most competent users relative to least, 95% CI 1.7–10.7) and clinical system (OR 0.3, 95% CI 0.1–0.5). Patient reservations were reported more frequently by respondents who rated their IT competence as highest (OR 3.3, 95% CI 1.5–7.6), perceived more data sharing challenges (OR for a 1-point increase in challenges perception score 3.4, 95% CI 2.1–5.6) and by PMs (relative to GP partners, OR 18.0, 95% CI 7.9–41.3). Conclusions Familiarity with and use of data sharing projects was high among GPs and PMs. Both their individual and organisational characteristics were associated with the reported frequency of discussions and patients’ responses. Improved awareness of the impact of provider characteristics and attitudes on patients’ decisions about data sharing may enhance the equity and autonomy of those decisions.

We explored hindsight bias and retroactive pessimism related to the occupation of Sofia University in 2013–2014, using a memory design. We found partial evidence for hindsight bias for predictions of whether the occupation would achieve its goal (the government's resignation) but not for specific events related to the occupation, which were deemed unlikely from the start and later perceived not to have occurred. We did not find evidence for retroactive pessimism: Hindsight bias indices for the prediction of the government's resignation were not reliably associated with support for the occupation and disappointment with its outcome. We propose using a recall/reconstruct measure as a more rigorous test for retroactive pessimism, which has so far been demonstrated through reassessment.