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.

Ethical concerns around use of artificial intelligence in health care research from the perspective of patients with meningioma, caregivers and health care providers: a qualitative study.

BACKGROUND: As artificial intelligence (AI) approaches in research increase and AI becomes more integrated into medicine, there is a need to understand perspectives from members of the Canadian public and medical community. The aim of this project was to investigate current perspectives on ethical issues surrounding AI in health care. METHODS: In this qualitative study, adult patients with meningioma and their caregivers were recruited consecutively (August 2018-February 2019) from a neurosurgical clinic in Toronto. Health care providers caring for these patients were recruited through snowball sampling. Based on a nonsystematic literature search, we constructed 3 vignettes that sought participants' views on hypothetical issues surrounding potential AI applications in health care. The vignettes were presented to participants in interviews, which lasted 15-45 minutes. Responses were transcribed and coded for concepts, frequency of response types and larger concepts emerging from the interview. RESULTS: We interviewed 30 participants: 18 patients, 7 caregivers and 5 health care providers. For each question, a variable number of responses were recorded. The majority of participants endorsed nonconsented use of health data but advocated for disclosure and transparency. Few patients and caregivers felt that allocation of health resources should be done via computerized output, and a majority stated that it was inappropriate to delegate such decisions to a computer. Almost all participants felt that selling health data should be prohibited, and a minority stated that less privacy is acceptable for the goal of improving health. Certain caveats were identified, including the desire for deidentification of data and use within trusted institutions. INTERPRETATION: In this preliminary study, patients and caregivers reported a mixture of hopefulness and concern around the use of AI in health care research, whereas providers were generally more skeptical. These findings provide a point of departure for institutions adopting health AI solutions to consider the ethical implications of this work by understanding stakeholders' perspectives.

Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands.

BACKGROUND: Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands. METHODS: We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together. RESULTS: Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories - evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation - were exempted by one country each. The remaining categories were exempted by two or three countries. CONCLUSIONS: Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers.

Public health and service delivery programmes, interventions and policies (collectively, 'programmes') are typically developed and implemented for the primary purpose of effecting change rather than generating knowledge. Nonetheless, evaluations of these programmes may produce valuable learning that helps determine effectiveness and costs as well as informing design and implementation of future programmes. Such studies might be termed 'opportunistic evaluations', since they are responsive to emergent opportunities rather than being studies of interventions that are initiated or designed by researchers. However, current ethical guidance and registration procedures make little allowance for scenarios where researchers have played no role in the development or implementation of a programme, but nevertheless plan to conduct a prospective evaluation. We explore the limitations of the guidance and procedures with respect to opportunistic evaluations, providing a number of examples. We propose that one key missing distinction in current guidance is moral responsibility: researchers can only be held accountable for those aspects of a study over which they have control. We argue that requiring researchers to justify an intervention, programme or policy that would occur regardless of their involvement prevents or hinders research in the public interest without providing any further protections to research participants. We recommend that trial consent and ethics procedures allow for a clear separation of responsibilities for the intervention and the evaluation.

Ethical considerations in prehospital ambulance based research: qualitative interview study of expert informants.

BACKGROUND: Prehospital ambulance based research has unique ethical considerations due to urgency, time limitations and the locations involved. We sought to explore these issues through interviews with experts in this research field. METHODS: We undertook semi-structured interviews with expert informants, primarily based in the UK, seeking their views and experiences of ethics in ambulance based clinical research. Participants were questioned regarding their experiences of ambulance based research, their opinions on current regulations and guidelines, and views about their general ethical considerations. Participants were chosen because they were actively involved in, or in their expert capacity (e.g. law) expressed an interest in, ambulance based research. RESULTS: Fourteen participants were interviewed including principal investigators, researchers, ethicists and medical lawyers. Five major themes were identified: Capacity, Consent, Clinical Considerations, Consultation and Regulation. Questions regarding consent and capacity were foremost in the discussions as all participants highlighted these as areas for concern. The challenges and use of multiple consent models reflected the complexity of research in this environment. The clinical theme referred to the role of paramedics in research and how research involving ambulance services is increasingly informing improvements to patient care and outcomes and reducing the burden on hospital services. Most felt that, although current regulations were fit for purpose, more specific guidance on implementing these in the ambulance setting would be beneficial. This related closely to the theme of consultation, which examined the key role of ethics committees and other regulatory bodies, as well as public engagement. CONCLUSIONS: By interviewing experts in research or ethics in this setting we were able to identify key concerns and highlight areas for future development such as improved guidance.

Building the case for actionable ethics in digital health research supported by artificial intelligence.

The digital revolution is disrupting the ways in which health research is conducted, and subsequently, changing healthcare. Direct-to-consumer wellness products and mobile apps, pervasive sensor technologies and access to social network data offer exciting opportunities for researchers to passively observe and/or track patients 'in the wild' and 24/7. The volume of granular personal health data gathered using these technologies is unprecedented, and is increasingly leveraged to inform personalized health promotion and disease treatment interventions. The use of artificial intelligence in the health sector is also increasing. Although rich with potential, the digital health ecosystem presents new ethical challenges for those making decisions about the selection, testing, implementation and evaluation of technologies for use in healthcare. As the 'Wild West' of digital health research unfolds, it is important to recognize who is involved, and identify how each party can and should take responsibility to advance the ethical practices of this work. While not a comprehensive review, we describe the landscape, identify gaps to be addressed, and offer recommendations as to how stakeholders can and should take responsibility to advance socially responsible digital health research.

Do we understand the intervention? What complex intervention research can teach us for the evaluation of clinical ethics support services (CESS).

BACKGROUND: Evaluating clinical ethics support services (CESS) has been hailed as important research task. At the same time, there is considerable debate about how to evaluate CESS appropriately. The criticism, which has been aired, refers to normative as well as empirical aspects of evaluating CESS. MAIN BODY: In this paper, we argue that a first necessary step for progress is to better understand the intervention(s) in CESS. Tools of complex intervention research methodology may provide relevant means in this respect. In a first step, we introduce principles of "complex intervention research" and show how CESS fulfil the criteria of "complex interventions". In a second step, we develop a generic "conceptual framework" for "ethics consultation on request" as standard for many forms of ethics consultation in clinical ethics practice. We apply this conceptual framework to the model of "bioethics mediation" to make explicit the specific structural and procedural elements of this form of ethics consultation on request. In a final step we conduct a comparative analysis of two different types of CESS, which have been subject to evaluation research: "proactive ethics consultation" and "moral case deliberation" and discuss implications for evaluating both types of CESS. CONCLUSION: To make explicit different premises of implemented CESS interventions by means of conceptual frameworks can inform the search for sound empirical evaluation of CESS. In addition, such work provides a starting point for further reflection about what it means to offer "good" CESS.

Interviewing a Person with Bipolar Disorder Under Involuntary Commitment: A Case Report.

In this case report, we report an ethical problem that we faced in the course of an interview study on open-door policies in psychiatry with persons under involuntary commitment. One of the interviewees was a young woman with bipolar disorder who was under involuntary commitment at the time of the interview. While the woman had been assessed as competent and gave informed consent to research participation, her manic symptoms increased when the interview became increasingly distressing for her. Because of this, we decided to break off the interview and resume it at a later point of time. Within the research team, we raised the following ethical questions: (1) Was the participant, contrary to the initial assessment, unable to give consent for the study? (2) Was the voluntariness of her research participation compromised by her manic symptoms and involuntary commitment? (3) Should the participant have been excluded from the study against her expressed wish? (4) Should we have refrained from interviewing persons who were still under involuntary commitment?

The ethical oversight of learning health care activities in Switzerland: a qualitative study.

OBJECTIVE: This study aims to identify the key issues regarding the ethical oversight of health care improvement activities in Switzerland. DESIGN: Individual semi-structured qualitative interviews, analysed using conventional content analysis. SETTING: Interviews were conducted in Switzerland between July 2017 and February 2018. PARTICIPANTS: A purposive sample of 38 key stakeholders from four different groups: health care improvement researchers and practitioners (n = 19), representatives of clinical trial units (n = 3), clinical ethicists (n = 5), quality heads of university hospitals (n = 5), and cantonal ethics committee members (n = 6). RESULTS: There appears to be widespread uncertainty regarding when certain learning health care activities require ethical review by a research ethics committee in Switzerland. This situation is exacerbated by legislative ambiguity and limited guidance. It was reported that the lack of other oversight mechanisms for activities outside of the Human Research Act is also leading many investigators to submit projects to research ethics committees to avoid barriers to publication. CONCLUSIONS: The continuous, integrated, and dynamic nature of learning health care poses significant challenges to the current regulatory framework. It will be important that more clarification and guidance is provided regarding which activities require ethical review, and that it is considered how the ethical oversight of activities falling outside human research legislation can be strengthened. However, the traditional model of ethical oversight is poorly suited to learning health care and may need to be replaced with new systemic oversight approaches.

Patient and public involvement: Two sides of the same coin or different coins altogether?

Patient and public involvement (PPI) has gained widespread support in health research and health policy circles, but there is little consensus on the precise meaning or justifications of PPI. We argue that an important step towards clarifying the meaning and justification for PPI is to split apart the familiar acronym and draw a distinction between patient and public involvement. Specifically, we argue that patient involvement should refer to the practice of involving individuals in health research or policy on the basis of their experience with a particular condition, while public involvement should refer to the practice of involving individuals in health policy or research based on their status as members of a relevant population. Analyzing cases from the UK, Australia, and the USA, we show how our proposed distinction can deliver much needed clarity to conversations on PPI, while guiding the development and evaluation of future PPI-based policies.

Tight Ties in Collaborative Health Research Puts Research Ethics on Trial? A Discussion on Autonomy, Confidentiality, and Integrity in Qualitative Research.

Collaborative research involving different stakeholders is increasingly becoming a preferred way of doing qualitative research to improve health care services. However, ethical research dilemmas arise when collaborative ties are tight. Based on lessons learned from two qualitative collaborative health care research projects in two different municipalities in Norway and Denmark, respectively, this article illuminates ethical research dilemmas around ethical principles and guidelines of autonomy (informed consent), confidentiality (anonymity), and integrity of research. Accordingly, there is a need to revisit and resume international ethical research guidelines formulated in the Declaration of Helsinki, when it comes to research guidelines of informed consent, anonymity, and integrity of research. Moreover, we suggest that collaborators contemplate and negotiate these ethical research issues to avoid unnecessary misunderstandings, conflicts, and pressures when doing research with stakeholders when collaboration ties are tight.

Ethics and patient and public involvement with children and young people.

Patient and public involvement (PPI) is important both in research and in quality improvement activities related to healthcare services . While PPI activities do not require formal ethical approval, they can raise a number of ethical concerns, through the introduction of complex technical medical concepts, challenging language or sensitive subject areas. There is very little published literature to guide ethical practice in this area. We have been conducting PPI with children and young people throughout a research study in paediatric palliative care. PPI started during the application process and continued to guide and shape the research as it progressed. Ethical issues can arise at any time in PPI work. Although many can be predicted and planned for, the nature of PPI means that researchers can be presented with ideas and concepts they had not previously considered, requiring reflexivity and a reactive approach. This paper describes how we considered and addressed the potential ethical issues of PPI within our research. The approach that emerged provides a framework that can be adapted to a range of contexts and will be of immediate relevance to researchers and clinicians who are conducting PPI to inform their work.