HIV prevention research and COVID-19: putting ethics guidance to the test.

BACKGROUND: Critical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/AIDS pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs. MAIN BODY: Necessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities. CONCLUSIONS: In the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic.

Observational study of parental opinion of deferred consent for neonatal research.

OBJECTIVE: To evaluate the opinions of parents of newborns following their infant's enrolment into a neonatal research study through the process of deferred consent. DESIGN: Mixed-methods, observational study, interviewing 100 parents recently approached for deferred consent. SETTING: Tertiary-level neonatal intensive care unit, Melbourne, Australia. RESULTS: All 100 parents interviewed had consented to the study/studies using deferred consent; 62% had also experienced a prospective neonatal consent process. Eighty-nine per cent were 'satisfied' with the deferred consent process. The most common reason given for consenting was 'to help future babies'. Negative comments regarding deferred consent mostly related to the timing of the consent approach, and some related to a perceived loss of parental rights. A deferred approach was preferred by 51%, 24% preferred a prospective approach and 25% were unsure. Those who thought prospective consent would not have been preferable cited impaired decision-making, inappropriate timing of an approach before birth and their preference for removal of the decision-making burden via deferred consent. Seventy-seven per cent thought they would have given the same response if approached prospectively; those who would have declined reported that a prospective approach under stressful conditions was unwelcome and too overwhelming. CONCLUSION: In our sample, 89% of parents of infants enrolled in neonatal research using deferred consent considered it acceptable and half would not have preferred prospective consent. The ability to make a more considered decision under less stressful circumstances was key to the acceptability of deferred consent.

National Standards for Public Involvement in Research: missing the forest for the trees.

Biomedical research funding bodies across Europe and North America increasingly encourage-and, in some cases, require-investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what 'good' or 'successful' public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement.

European perspectives on big data applied to health: The case of biobanks and human databases.

INTRODUCTION: The paradigm shift to a knowledge-based economy has incremented the use of personal information applied to health-related activities, such as biomedical research, innovation, and commercial initiatives. The convergence of science, technology, communication and data technologies has given rise to the application of big data to health; for example through eHealth, human databases and biobanks. METHODS: In light of these changes, we enquire about the value of personal data and its appropriate use. In order to illustrate the complex ground on which big data applied to health develops, we analyse the current situation of the European Union and two cases: the Catalan VISC+/PADRIS and the UK Biobank, as perspectives. DISCUSSION AND CONCLUSIONS: Personal health-related data in the context of the European Union is being increasingly used for big data projects under diverse schemes. There, public and private sectors participate distinctively or jointly, pursuing very different goals which may conflict with individual rights, notably privacy. Given that, this paper advocates for stopping the unjustified accumulation and commercialisation of personal data, protecting the interests of citizens and building appropriate frameworks to govern big data projects for health. A core tool for achieving such goals is to develop consent mechanisms which allow truly informed but adaptable consent, conjugated with the engagement of donors, participants and society.

Accommodating quality and service improvement research within existing ethical principles.

BACKGROUND: Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts, should it be considered research for regulatory purposes? Is review by a research ethics committee required? Should healthcare providers be considered research participants? If participation in QSI research entails no more than minimal risk, is consent required? The lack of consensus on answers to these questions highlights the need for ethical guidance. MAIN BODY: Three distinct approaches to classifying QSI research in accordance with existing ethical principles and regulations can be found in the literature. In the first approach, QSI research is viewed as distinct from other types of healthcare research and does not require regulation. In the second approach, QSI research falls within regulatory guidelines but is exempt from research ethics committee review. In the third approach, QSI research is deemed to be part of the learning healthcare system and, as such, is subject to a different set of ethical principles entirely. In this paper, we critically assess each of these views. CONCLUSION: While none of these approaches is entirely satisfactory, we argue that use of the ethical principles governing research provides the best means of addressing the numerous questions posed by QSI research.

Patient perspectives on compensation for biospecimen donation.

BACKGROUND: The purpose of this study was to determine whether biospecimen donors believe they should receive compensation. This is the first study to report biospecimen donors' views on compensation and can potentially improve informed consent and recruitment practices. METHODS: Researchers asked patients undergoing surgical removal of tissue to donate biological materials to a biobank; the request was made at their presurgical appointment or in the preoperative clinic of the Emory University Hospital. We interviewed 126 biospecimen donors within 30 days post surgery regarding their perspective on compensation for biospecimen donation. RESULTS: In response to the question "Should you be paid for your participation in the tissue bank?," 95 (95/126, 75%) participants answered "No." Of these, 55 (55/95, 58%) indicated that donating biological materials should be about altruism, not gaining a monetary reward. Only 11 (11/126, 9%) participants unequivocally believed they should receive compensation, while 14 (14/126, 11%) felt entitled to compensation only under specific circumstances. Eleven (11/14) "Depends" participants indicated that donors should only be compensated when researchers perform for-profit research. Responses varied by race and income level, with whites more likely to not feel entitled to compensation and higher income participants more likely to respond "Depends." CONCLUSIONS: The majority of biospecimen donors stated they should not be paid for tissue bank participation. However, a minority believe they should be paid for donating tissue if the tissue is used in revenue-generating projects. These results provide some support for the current biobanking practice of not providing compensation.

Chronic disease as risk multiplier for disadvantage.

This paper starts by establishing a prima facie case that disadvantaged groups or individuals are more likely to get a chronic disease and are in a disadvantaged position to adhere to chronic treatment despite access through Universal Health Coverage. However, the main aim of this paper is to explore the normative implications of this claim by examining two different but intertwined argumentative lines that might contribute to a better understanding of the ethical challenges faced by chronic disease health policy. The paper develops the argument that certain disadvantages which may predispose to illness might overlap with disadvantages that may hinder self-management, potentially becoming disadvantageous in handling chronic disease. If so, chronic diseases may be seen as disadvantages in themselves, describing a reproduction of disadvantage among the chronically ill and a vicious circle of disadvantage that could both predict and shed light on the catastrophic health outcomes among disadvantaged groups-or individuals-dealing with chronic disease.

Ethics of health policy and systems research: a scoping review of the literature.

Health policy and systems research (HPSR) is increasingly funded and undertaken as part of health system strengthening efforts worldwide. HPSR ethics is also a relatively new and emerging field, with numerous normative and descriptive questions that have largely not been considered. Normative questions include what ethical principles and values should guide HPSR. Descriptive questions include what ethical concerns arise when conducting HPSR. A small but growing body of scholarly work characterizes the various ethics issues inherent in HPSR. Towards informing the future development of ethics guidance for HPSR, a scoping review was undertaken to: (1) identify the range of ethics issues relevant to the conduct of HPSR-with a deliberate (though not exclusive) focus on low- and middle-income country settings and (2) describe existing guidance on key ethics issues relevant to HPSR. Using the Cochrane methods as a basis, the review identified formal and informal literature on HPSR ethics by searching the following databases: PubMed's Medline, Embase, Global Health, Scopus, WHO Global Health Regional Libraries, LILACs, OpenDOAR and Bielefeld Academic Search Engine. In total, 11 062 documents were identified from the formal (10 519) and informal (543) literature. One hundred and seven of these documents (formal 99 and informal 8) met at least one inclusion criterion and underwent thematic analysis. Ethical issues in four main categories were identified: upholding autonomy, identifying and balancing risks and benefits, justice and determination of ethical review requirements. The review indicated that the ethical values behind HPSR place an emphasis on its contributing to the reduction of health disparities. Unsurprisingly then, numerous ethical concerns relating to justice arise in HPSR. However, the majority of existing guidance focuses on obtaining or waiving informed consent and, thus, appears to be insufficient for HPSR. A list of priority ethics issues in HPSR in need of guidance development is provided.

[Ethical considerations for health research regarding Colombian indigenous peoples]. / Consideraciones éticas para la investigación en salud con pueblos indígenas de Colombia.

Health research can produce valuable insights to guide interventions offered to individuals and human groups. However, it requires specific precautions to protect potentially vulnerable subjects, such as indigenous populations. It has been recognized that there has been unethical conduct in research -from the international authorities responsible for outlining ethical standards for research projects- with regards to indigenous peoples. This article presents and discusses national and international guidelines to regulate research involving indigenous peoples. In summary, respect for the autonomy and for the own knowledge are rights that must be met to carry out scientific research with indigenous peoples. In addition to the informed consent, the process of consultation and agreement allows adequate contextualization in relation to the problems, needs, and benefits of research in these populations.

La investigación en salud puede producir conocimientos valiosos para orientar las intervenciones de este tipo ofrecidas a individuos y grupos humanos. No obstante, requiere de especificidades para preservar del daño a sujetos de especial protección ante la ley, tales como las poblaciones pertenecientes a etnias indígenas. Por parte de las autoridades internacionales encargadas de trazar normas éticas para proyectos de investigación, se han reconocido conductas científicas poco éticas en investigaciones que involucran a pueblos indígenas. Por esta razón, se han proclamado principios sobre bioética de aplicación internacional para estos grupos poblacionales. Este artículo presenta, analiza y discute posicionamientos del orden nacional e internacional al respecto. En suma, el respeto por la autonomía y la defensa del conocimiento propio son derechos que deben cumplirse y ser tenidos en cuenta al momento de realizar investigaciones científicas con pueblos indígenas. Además del consentimiento informado individual y comunitario, el uso del proceso de consulta previa y concertación permite obtener una adecuada contextualización respecto a las perspectivas, marcos y conceptos a partir de los cuales se realizará la investigación; así como las problemáticas, necesidades y beneficios de la investigación en estos grupos poblacionales.

Freedom of Information Act: scalpel or just a sharp knife?

The concluding statement of the Burns Commission, established to evaluate whether changes are needed to the Freedom of Information Act (FOIA), ruled no major legislative changes were required. As such Freedom of Information (FOI) legislation still enables anyone to obtain information from public authorities. In this brief report article we explore arguments regarding FOI as an instrument for healthcare research using an international research programme as a case study.

Global Health and Emergency Care: Overcoming Clinical Research Barriers.

OBJECTIVES: There are many barriers impeding the conduct of high-quality emergency care research, particularly in low- and middle-income countries. Several of these barriers were originally outlined in 2013 as part of the Academic Emergency Medicine Global Health and Emergency Care Consensus Conference. This paper seeks to establish a broader consensus on the barriers to emergency care research globally and proposes a comprehensive array of new recommendations to overcome these barriers. METHODS: An electronic survey was conducted of a purposive sample of global emergency medicine research experts from around the world to describe the major challenges and solutions to conducting emergency care research in low-resource settings and rank them by importance. The Global Emergency Medicine Think Tank Clinical Research Working Group at the Society for Academic Emergency Medicine 2016 Annual Meeting utilized a modified Delphi technique for consensus-based decision making to categorize and expand upon these barriers and develop a comprehensive array of proposed solutions. RESULTS: The working group identified four broad categories of barriers to conducting emergency care research globally, including 1) the limited availability of research personnel, particularly those with prior research training; 2) logistic barriers and lack of standardization of data collection; 3) ethical barriers to conducting research in resource-limited settings, particularly when no local institutional review board is available; and 4) the relative dearth of funding for global emergency care research. Proposed solutions included building a diverse and interdisciplinary research team structured to promote mentorship of junior researchers, utilizing local research assistants or technologic tools such as telemedicine for language translation, making use of new tools such as mobile health (mHealth) to standardize and streamline data collection, identifying alternatives to local institutional review board approval and the use of community consent when appropriate, and increased advocacy for global emergency care research funding. CONCLUSIONS: Significant barriers to the conduct of high-quality global emergency care research persist, and innovative strategies need to be adopted to promote and grow the field of global emergency care research. This paper provides a global consensus on the most important barriers identified, as well as recommendations for cost-effective strategies for overcoming these barriers with the overall goal of promoting high-quality research and improving emergency care worldwide.

Individualised and personalised QALYs in exceptional treatment decisions.

Quality-adjusted life years (QALYs) are used to determine how to allocate resources to health programmes or to treatments within those programmes in order to gain maximum utility from those limited, shared healthcare resources. However, if we use those same population- based QALYs when faced with individual treatment decisions we may act unjustly in relation to that individual or in relation to the wider population. A treatment with a population-based incremental cost-effectiveness ratio beyond our willingness to pay threshold may be denied to a patient even if, for that particular patient, the QALYs gained for the cost would fall within that threshold. When considering individual cases, it is proposed that we should take an individualised approach to the cost of treatment and response to treatment ('individualised QALYs') and a personalised approach to the valuation of health states ('personalised QALYs'). Only if we do this, can we maximise utility and give the patient a fair opportunity to benefit. Individualised and personalised QALYs also allow us to express patient choice and religious treatment preferences in terms of utility. Individualised and personalised QALYs are explored in the context of individual funding requests in the National Health Service. In preference to the concept of 'clinical exceptionality', individualised and personalised QALYs provide the potential for better and more consistent decisions and improved utility. Rather than treating unequal patients as if they were equal, individualised and personalised QALYs promote fair and unequal access to resources for some of our most unequal patients. Potential challenges are also considered.

Research Ethics Committees and Participatory Action Research With Young People: The Politics of Voice.

Participatory action research (PAR) is a methodological approach that seeks to maximize the participation of people whose lives it researches. It is underpinned by an ethical concern to research "with" people, rather than "on" people. However, this ethical approach to research is often, paradoxically, problematized by universities' research ethics committees (RECs). This article explores one site of tension between PAR and RECs-the requirement for anonymity for below 18-year-olds. It explores this tension by exploring a case study of a peer-to-peer research project undertaken by young women in East London, and using our own experiences and perspectives, it argues that anonymity can be unjust, disempowering, and unnecessary, and can reduce "pride." Without wanting to develop specific recommendations, given the limited scope of our case study, this article uses firsthand experiences to add weight to the broader discussions calling for a critical rethink of REC guidelines.

Clarifying the best interests standard: the elaborative and enumerative strategies in public policy-making.

One recurring criticism of the best interests standard concerns its vagueness, and thus the inadequate guidance it offers to care providers. The lack of an agreed definition of 'best interests', together with the fact that several suggested considerations adopted in legislation or professional guidelines for doctors do not obviously apply across different groups of persons, result in decisions being made in murky waters. In response, bioethicists have attempted to specify the best interests standard, to reduce the indeterminacy surrounding medical decisions. In this paper, we discuss the bioethicists' response in relation to the state's possible role in clarifying the best interests standard. We identify and characterise two clarificatory strategies employed by bioethicists -elaborative and enumerative-and argue that the state should adopt the latter. Beyond the practical difficulties of the former strategy, a state adoption of it would inevitably be prejudicial in a pluralistic society. Given the gravity of best interests decisions, and the delicate task of respecting citizens with different understandings of best interests, only the enumerative strategy is viable. We argue that this does not commit the state to silence in providing guidance to and supporting healthcare providers, nor does it facilitate the abuse of the vulnerable. Finally, we address two methodological worries about adopting this approach at the state level. The adoption of the enumerative strategy is not defeatist in attitude, nor does it eventually collapse into (a form of) the elaborative strategy.

Public/community engagement in health research with men who have sex with men in sub-Saharan Africa: challenges and opportunities.

BACKGROUND: Community engagement, incorporating elements of the broader concepts of public and stakeholder engagement, is increasingly promoted globally, including for health research conducted in developing countries. In sub-Saharan Africa, community engagement needs and challenges are arguably intensified for studies involving gay, bisexual and other men who have sex with men, where male same-sex sexual interactions are often highly stigmatised and even illegal. This paper contextualises, describes and interprets the discussions and outcomes of an international meeting held at the Kenya Medical Research Institute-Wellcome Trust in Kilifi, Kenya, in November 2013, to critically examine the experiences with community engagement for studies involving men who have sex with men. DISCUSSION: We discuss the ethically charged nature of the language used for men who have sex with men, and of working with 'representatives' of these communities, as well as the complementarity and tensions between a broadly public health approach to community engagement, and a more rights based approach. We highlight the importance of researchers carefully considering which communities to engage with, and the goals, activities, and indicators of success and potential challenges for each. We suggest that, given the unintended harms that can emerge from community engagement (including through labelling, breaches in confidentiality, increased visibility and stigma, and threats to safety), representatives of same-sex populations should be consulted from the earliest possible stage, and that engagement activities should be continuously revised in response to unfolding realities. Engagement should also include less vocal and visible men who have sex with men, and members of other communities with influence on the research, and on research participants and their families and friends. Broader ethics support, advice and research into studies involving men who have sex with men is needed to ensure that ethical challenges - including but not limited to those related to community engagement - are identified and addressed. Underlying challenges and dilemmas linked to stigma and discrimination of men who have sex with men in Africa raise special responsibilities for researchers. Community engagement is an important way of identifying responses to these challenges and responsibilities but itself presents important ethical challenges.

Health Systems Research in a Complex and Rapidly Changing Context: Ethical Implications of Major Health Systems Change at Scale.

This paper discusses health policy and systems research in complex and rapidly changing contexts. It focuses on ethical issues at stake for researchers working with government policy makers to provide evidence to inform major health systems change at scale, particularly when the dynamic nature of the context and ongoing challenges to the health system can result in unpredictable outcomes. We focus on situations where 'country ownership' of HSR is relatively well established and where there is significant involvement of local researchers and close ties and relationships with policy makers are often present. We frame our discussion around two country case studies with which we are familiar, namely China and South Africa and discuss the implications for conducting 'embedded' research. We suggest that reflexivity is an important concept for health system researchers who need to think carefully about positionality and their normative stance and to use such reflection to ensure that they can negotiate to retain autonomy, whilst also contributing evidence for health system change. A research process informed by the notion of reflexive practice and iterative learning will require a longitudinal review at key points in the research timeline. Such review should include the convening of a deliberative process and should involve a range of stakeholders, including those most likely to be affected by the intended and unintended consequences of change.

Health Systems Research Consortia and the Promotion of Health Equity in Low and Middle-Income Countries.

Health systems research is widely identified as an indispensable means to achieve the goal of health equity between and within countries. Numerous health systems research consortia comprised of institutions from high-income countries and low and middle-income countries (LMICs) are currently undertaking programs of research in LMICs. These partnerships differ from collaborations that carry out single projects in the multiplicity of their goals, scope of their activities, and nature of their management. Recent conceptual work has explored what features might be necessary for health systems research consortia and their research programs to promote health equity. Identified features include selecting research priorities that focus on improving access to high-quality health services and/or financial protection for disadvantaged populations in LMICs and conducting research capacity strengthening that promotes the independent conduct of health systems research in LMICs. Yet, there has been no attempt to investigate whether existing consortia have such characteristics. This paper describes the results of a survey undertaken with health systems research consortia leaders worldwide to assess how consistent current practice is with the proposed ethical guidance. The findings suggest that consortia may be fairly well organised to promote health equity, but have scope for improvement, particularly in terms of achieving inclusive priority-setting.