Ethical issues in research with second victims: A scoping review.

BACKGROUND: Second victim is the name given to the healthcare personnel-most often a nursing professional-involved with the error that led to the adverse event to a patient and who, as a result, have experienced negative psychological effects. Research with second victims has increased over the years, however concerns exist with regards to the ethical risks imposed upon these individuals. AIM: To explore the extent to which research with second victims of adverse events in healthcare settings adhere to ethical requirements. METHODS: A scoping review was conducted following Arksey and O'Malley's methodological framework and using the following databases: PUBMED, Web of Science, and SCOPUS. Original research of any study design focused on second victims and published in English, Spanish, or Portuguese in 2014-2023 were included. A critical narrative approach was used to discuss the findings. ETHICAL CONSIDERATIONS: The review followed ethical guidelines emphasizing accurate authorship attribution and truthful data reporting. RESULTS: Fifteen studies using qualitative (n = 2), quantitative (n = 10), and mixed-method (n = 3) designs were included. Over half were not assessed by a research ethics committee, with questionable reasons given by the authors. One-third did not refer to having used an informed consent. In two studies, participants were recruited by their workplace superiors, which could potentially right to autonomy and voluntary participation. CONCLUSION: Over half of the included studies with second victims did not comply with fundamental ethical aspects, with risk to inflict respect for individual autonomy, confidentiality, and of not causing any harm to participants. IMPLICATIONS FOR NURSING RESEARCH: Healthcare personnel involved in adverse events are most often nursing professionals; therefore, any breach of ethics in research with this population is likely to directly affect their rights as research participants. We provide recommendations to promote better research practices with second victims towards safeguarding their rights as research participants.

Is the UN receiving ethical approval for its research with human participants?

This paper examines the institutional mechanisms supporting the ethical oversight of human participant research conducted by the United Nations (UN). The UN has served an instrumental role in shaping international standards on research ethics, which invariably require ethical oversight of all research studies with human participants. The authors' experiences of conducting research collaboratively with UN agencies, in contrast, have led to concern that the UN frequently sponsors, or participates in, studies with human participants that have not received appropriate ethical oversight. It is argued that the institutional mechanisms in place to prevent research with human participants from being undertaken by the UN without ethical oversight do not, at present, extend substantively beyond the provision of guidelines and online training offered by a minority of UN bodies. The WHO and UNICEF are identified as notable exceptions, having implemented various measures to prevent health research with human participants from being undertaken without ethical oversight. Yet, it is highlighted that the WHO and UNICEF are not the only UN bodies that undertake health research with human participants and there are countless actors under the umbrella of the UN system that are regularly involved in non-health research with human participants. Arguments for the pursuit of the highest standard of ethical oversight by UN bodies are presented. Moving forward, the paper asks the question: is it time for the UN to set the standards for the oversight of ethical oversight?

Layered vulnerability and researchers' responsibilities: learning from research involving Kenyan adolescents living with perinatal HIV infection.

BACKGROUND: Carefully planned research is critical to developing policies and interventions that counter physical, psychological and social challenges faced by young people living with HIV/AIDS, without increasing burdens. Such studies, however, must navigate a 'vulnerability paradox', since including potentially vulnerable groups also risks unintentionally worsening their situation. Through embedded social science research, linked to a cohort study involving Adolescents Living with HIV/AIDS (ALH) in Kenya, we develop an account of researchers' responsibilities towards young people, incorporating concepts of vulnerability, resilience, and agency as 'interacting layers'. METHODS: Using a qualitative, iterative approach across three linked data collection phases including interviews, group discussions, observations and a participatory workshop, we explored stakeholders' perspectives on vulnerability and resilience of young people living with HIV/AIDS, in relation to home and community, school, health care and health research participation. A total of 62 policy, provider, research, and community-based stakeholders were involved, including 27 ALH participating in a longitudinal cohort study. Data analysis drew on a Framework Analysis approach; ethical analysis adapts Luna's layered account of vulnerability. RESULTS: ALH experienced forms of vulnerability and resilience in their daily lives in which socioeconomic context, institutional policies, organisational systems and interpersonal relations were key, interrelated influences. Anticipated and experienced forms of stigma and discrimination in schools, health clinics and communities were linked to actions undermining ART adherence, worsening physical and mental health, and poor educational outcomes, indicating cascading forms of vulnerability, resulting in worsened vulnerabilities. Positive inputs within and across sectors could build resilience, improve outcomes, and support positive research experiences. CONCLUSIONS: The most serious forms of vulnerability faced by ALH in the cohort study were related to structural, inter-sectoral influences, unrelated to study participation and underscored by constraints to their agency. Vulnerabilities, including cascading forms, were potentially responsive to policy-based and interpersonal actions. Stakeholder engagement supported cohort design and implementation, building privacy, stakeholder understanding, interpersonal relations and ancillary care policies. Structural forms of vulnerability underscore researchers' responsibilities to work within multi-sectoral partnerships to plan and implement studies involving ALH, share findings in a timely way and contribute to policies addressing known causes of vulnerabilities.

Culturally appropriate consent processes for community-driven indigenous child health research: a scoping review.

BACKGROUND: Current requirements for ethical research in Canada, specifically the standard of active or signed parental consent, can leave Indigenous children and youth with inequitable access to research opportunities or health screening. Our objective was to examine the literature to identify culturally safe research consent processes that respect the rights of Indigenous children, the rights and responsibilities of parents or caregivers, and community protocols. METHODS: We followed PRISMA guidelines and Arksey and O'Malley's approach for charting and synthesizing evidence. We searched MEDLINE, PsycINFO, ERIC, CINAHL, Google Scholar, Web of Science, Informit Indigenous Collection, Bibliography of Native North Americans, and Sociological Abstracts. We included peer-reviewed primary and theoretical research articles written in English from January 1, 2000, to March 31, 2022, examining Indigenous approaches for obtaining informed consent from parents, families, children, or youth. Eligible records were uploaded to Covidence for title and abstract screening. We appraised the findings using a Two-Eyed Seeing approach. These findings were inductively coded using NVivo 12 and analyzed thematically. RESULTS: We identified 2,984 records and 11 eligible studies were included after screening. Three key recommendations emerged: addressing tensions in the ethics of consent, embracing wise practices, and using relational approaches to consent. Tensions in consent concerned Research Ethics Board consent requirements that fall short of protecting Indigenous children and communities when culturally incongruent. Wise practices included allowing parents and children to consent together, land-based consenting, and involving communities in decision-making. Using relational approaches to consent embodied community engagement and relationship building while acknowledging consent for Indigenous children cannot be obtained in isolation from family and community. CONCLUSIONS: Very few studies discussed obtaining child consent in Indigenous communities. While Indigenous communities are not a monolith, the literature identified a need for community-driven, decolonized consent processes prioritizing Indigenous values and protocols. Further research is needed to examine nuances of Indigenized consent processes and determine how to operationalize them, enabling culturally appropriate, equitable access to research and services for all Indigenous children.

Future pandemics and the urge to 'do something'.

Research with enhanced potential pandemic pathogens (ePPP) makes pathogens substantially more lethal, communicable, immunosuppressive or otherwise capable of triggering a pandemic. We briefly relay an existing argument that the benefits of ePPP research do not outweigh its risks and then consider why proponents of these arguments continue to confidently endorse them. We argue that these endorsements may well be the product of common cognitive biases-in which case they would provide no challenge to the argument against ePPP research. If the case against ePPP research is strong, the views of professional experts do little to move the needle in favour of ePPP research.

Addressing bias in artificial intelligence for public health surveillance.

Components of artificial intelligence (AI) for analysing social big data, such as natural language processing (NLP) algorithms, have improved the timeliness and robustness of health data. NLP techniques have been implemented to analyse large volumes of text from social media platforms to gain insights on disease symptoms, understand barriers to care and predict disease outbreaks. However, AI-based decisions may contain biases that could misrepresent populations, skew results or lead to errors. Bias, within the scope of this paper, is described as the difference between the predictive values and true values within the modelling of an algorithm. Bias within algorithms may lead to inaccurate healthcare outcomes and exacerbate health disparities when results derived from these biased algorithms are applied to health interventions. Researchers who implement these algorithms must consider when and how bias may arise. This paper explores algorithmic biases as a result of data collection, labelling and modelling of NLP algorithms. Researchers have a role in ensuring that efforts towards combating bias are enforced, especially when drawing health conclusions derived from social media posts that are linguistically diverse. Through the implementation of open collaboration, auditing processes and the development of guidelines, researchers may be able to reduce bias and improve NLP algorithms that improve health surveillance.

Gain-of-function research and model organisms in biology.

So-called 'gain-of-function' (GOF) research is virological research that results in a virus substantially more virulent or transmissible than its wild antecedent. GOF research has been subject to ethical analysis in the past, but the methods of GOF research have to date been underexamined by philosophers in these analyses. Here, we examine the typical animal used in influenza GOF experiments, the ferret, and show how despite its longstanding use, it does not easily satisfy the desirable criteria for an animal model We then discuss the limitations of the ferret model, and how those epistemic limitations bear on ethical and policy questions around the risks and benefits of GOF research. We conclude with a reflection on how philosophy of science can contribute to ethical and policy debates around the risks, benefits and relative priority of life sciences research.

Sport-related concussion research agenda beyond medical science: culture, ethics, science, policy.

The Concussion in Sport Group guidelines have successfully brought the attention of brain injuries to the global medical and sport research communities, and has significantly impacted brain injury-related practices and rules of international sport. Despite being the global repository of state-of-the-art science, diagnostic tools and guides to clinical practice, the ensuing consensus statements remain the object of ethical and sociocultural criticism. The purpose of this paper is to bring to bear a broad range of multidisciplinary challenges to the processes and products of sport-related concussion movement. We identify lacunae in scientific research and clinical guidance in relation to age, disability, gender and race. We also identify, through multidisciplinary and interdisciplinary analysis, a range of ethical problems resulting from conflicts of interest, processes of attributing expertise in sport-related concussion, unjustifiably narrow methodological control and insufficient athlete engagement in research and policy development. We argue that the sport and exercise medicine community need to augment the existing research and practice foci to understand these problems more holistically and, in turn, provide guidance and recommendations that help sport clinicians better care for brain-injured athletes.

If it walks like a duck : Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is research.

Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is an ethical framework developed by the WHO for using unproven interventions in public health emergencies outside the context of medical research. It is mainly intended for use when medical research would be impracticable, but there is still a need to systematically gather data about unproven interventions. As such, it is designed as something of a middle ground between clinical and research ethical frameworks.However, I argue that MEURI does not truly lie at the intersection of clinical care and research. Due to its intent, structure and oversight requirements, it takes on most of the crucial features of research, to the point that it is best understood as a form of research. As a result, cases where MEURI could practicably be applied should instead make use of existing research frameworks. For those circumstances where research is truly impracticable, a more straightforward oversight system than MEURI is needed. While existing practices of compassionate use have some applicability, proposals to make use of clinical ethics committees to oversee unproven interventions may help achieve the right balance in acting in a patient's best interests when the relevant evidence base is weak.

Research involving the recently deceased: ethics questions that must be answered.

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria-or 'research involving the recently deceased'-can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor's legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically.

Ethical issues in Nipah virus control and research: addressing a neglected disease.

Nipah virus is a priority pathogen that is receiving increasing attention among scientists and in work on epidemic preparedness. Despite this trend, there has been almost no bioethical work examining ethical considerations surrounding the epidemiology, prevention, and treatment of Nipah virus or research that has already begun into animal and human vaccines. In this paper, we advance the case for further work on Nipah virus disease in public health ethics due to the distinct issues it raises concerning communication about the modes of transmission, the burdens of public health surveillance, the recent use of stringent public health measures during epidemics, and social or religious norms intersecting with preventive measures. We also advance the case for further work on Nipah virus disease in research ethics, given ethical issues surrounding potential vaccine trials for a high-fatality disease with sporadic spillover events, the different local contexts where trials may occur, and the potential use of unproven therapeutics during outbreaks. Further bioethics work may help to ensure that research and public health interventions for Nipah virus disease are ethically acceptable and more likely to be effective.

Exploring the ethics of tuberculosis human challenge models.

We extend recent conversation about the ethics of human challenge trials to tuberculosis (TB). TB challenge studies could accelerate vaccine development, but ethical concerns regarding risks to trial participants and third parties have been a limiting factor. We analyse the expected social value and risks of different challenge models, concluding that if a TB challenge trial has between a 10% and a 50% chance of leading to the authorisation and near-universal delivery of a more effective vaccine 3-5 years earlier, then the trial would save between 26 400 and 1 100 000 lives over the next 10 years. We also identify five important ethical considerations that differentiate TB from recent human challenge trials: an exceptionally high disease burden with no highly effective vaccine; heightened third party risk following the trial, and, partly for that reason, uniquely stringent biosafety requirements for the trial; risks associated with best available TB treatments; and difficulties with TB disease detection. We argue that there is good reason to consider conducting challenge trials with attenuated strains like Bacillus Calmette-Guérin or attenuated Mycobacterium tuberculosis.

Trust criteria for artificial intelligence in health: normative and epistemic considerations.

Rapid advancements in artificial intelligence and machine learning (AI/ML) in healthcare raise pressing questions about how much users should trust AI/ML systems, particularly for high stakes clinical decision-making. Ensuring that user trust is properly calibrated to a tool's computational capacities and limitations has both practical and ethical implications, given that overtrust or undertrust can influence over-reliance or under-reliance on algorithmic tools, with significant implications for patient safety and health outcomes. It is, thus, important to better understand how variability in trust criteria across stakeholders, settings, tools and use cases may influence approaches to using AI/ML tools in real settings. As part of a 5-year, multi-institutional Agency for Health Care Research and Quality-funded study, we identify trust criteria for a survival prediction algorithm intended to support clinical decision-making for left ventricular assist device therapy, using semistructured interviews (n=40) with patients and physicians, analysed via thematic analysis. Findings suggest that physicians and patients share similar empirical considerations for trust, which were primarily epistemic in nature, focused on accuracy and validity of AI/ML estimates. Trust evaluations considered the nature, integrity and relevance of training data rather than the computational nature of algorithms themselves, suggesting a need to distinguish 'source' from 'functional' explainability. To a lesser extent, trust criteria were also relational (endorsement from others) and sometimes based on personal beliefs and experience. We discuss implications for promoting appropriate and responsible trust calibration for clinical decision-making use AI/ML.

Medical student attitudes to patient involvement in healthcare decision-making and research.

OBJECTIVE: Patient involvement is used to describe the inclusion of patients as active participants in healthcare decision-making and research. This study aimed to investigate incoming year 1 medical (MBChB) students' attitudes and opinions regarding patient involvement in this context. METHODS: We established a staff-student partnership to formulate the design of an online research survey, which included Likert scale questions and three short vignette scenarios designed to probe student attitudes towards patient involvement linked to existing legal precedent. Incoming year 1 medical students (n=333) were invited to participate in the survey before formal teaching commenced. RESULTS: Survey data (49 participants) indicate that students were broadly familiar with, and supportive of, patient involvement in medical treatment. There was least support for patient involvement in conducting (23.9%), contributing to (37.0%) or communicating research (32.6%), whereas there was unanimous support for patients choosing treatment from a selection of options (100%). CONCLUSION: Incoming members of the medical profession demonstrate awareness of the need to actively involve patients in healthcare decision-making but are unfamiliar with the utility and value of such involvement in research. Further empirical studies are required to examine attitudes to patient involvement in healthcare.

Returning research results to individuals who are incarcerated in the USA.

The return of research results to populations and individuals is increasingly recognised as both important but ethically complicated. In the USA, there are few studies or detailed evidence-based practices on the return of research results to individuals who are incarcerated. In general, return of research results is not required with some exceptions; however, there are reasons to believe that in many cases returning results is most consistent with the ethical conduct of research. With individuals who are incarcerated, specific considerations for this historically disadvantaged population should be addressed. These are privacy, therapeutic misconception, paternalism, actionability and communication. If research results are returned, the initial consent process should consider thoroughness regarding privacy rights, the researchers' role, clarity around next steps and communication methods. Prison leadership should be key stakeholders in the process to streamline communication. Returning research results can be a method to counter historical and current paternalism in the carceral setting, while shifting the culture on how research is understood and conducted in carceral settings. The decision to return results should balance benefits, risks and research ethics. Further research is needed to identify and implement optimal approaches for returning results in this population.

Animus: human-embodied animals.

We review recent research to introduce human brain organoids into the brains of infant rats. This research shows these organoids integrate and function to affect behaviour in rats. We argue that this raises issues of moral status that will imminently arise and must be addressed through functional studies of these new life forms. We situate this research in the broader context of the biological revolution, arguing we already have the technological power to create fully human embodied animals. This raises profound, so far unaddressed ethical issues which call for urgent attention.

Genetic research and the collective good: participants as leaders to reconcile individual and public interests.

This paper problematises the notions of public or common good as weighed against individual sovereignty in the context of medical research by focusing on genetic research. We propose the notion of collective good as the good of the particular collective in which the research was conducted. We conducted documentary and interview-based research with participant representatives and research leaders concerned with participant involvement in leading genetic research projects and around two recent genetic data controversies: the case of the UK Wellcome Sanger Institute, accused of planning unauthorised commercialisation of African DNA samples, and the case of the company Genuity Science, which planned genetic research on brain tumour samples in Ireland with no explicit patient consent. We advocate for greater specificity in circumscribing the collective to which genetic research relates and for greater efforts in including representatives of this collective as research coleaders in order to enable a more inclusive framing of the good arising from such research. Such community-based participant cogovernance and coleadership in genetic research is vital especially when minorities or vulnerable groups are involved, and it centrally requires community capacity building to help collectives articulate their own notions of the collective good.

Principles for Health Information Collection, Sharing, and Use: A Policy Statement From the American Heart Association.

The evolution of the electronic health record, combined with advances in data curation and analytic technologies, increasingly enables data sharing and harmonization. Advances in the analysis of health-related and health-proxy information have already accelerated research discoveries and improved patient care. This American Heart Association policy statement discusses how broad data sharing can be an enabling driver of progress by providing data to develop, test, and benchmark innovative methods, scalable insights, and potential new paradigms for data storage and workflow. Along with these advances come concerns about the sensitive nature of some health data, equity considerations about the involvement of historically excluded communities, and the complex intersection of laws attempting to govern behavior. Data-sharing principles are therefore necessary across a wide swath of entities, including parties who collect health information, funders, researchers, patients, legislatures, commercial companies, and regulatory departments and agencies. This policy statement outlines some of the key equity and legal background relevant to health data sharing and responsible management. It then articulates principles that will guide the American Heart Association's engagement in public policy related to data collection, sharing, and use to continue to inform its work across the research enterprise, as well as specific examples of how these principles might be applied in the policy landscape. The goal of these principles is to improve policy to support the use or reuse of health information in ways that are respectful of patients and research participants, equitable in impact in terms of both risks and potential benefits, and beneficial across broad and demographically diverse communities in the United States.

Constructing appropriate bioprinting regulations: the ethical importance of recognising a liminal technology.

This article provides an analysis of bioprinting personalised medical device technology and its ethical challenges to regulation and research ethics. I argue the inclusion of bioprinting applications within existing regulatory frameworks does not adequately address the technologies disruption to the traditionally siloed activities of research and treatment. Using the conceptual framework of liminality, I offer a meaningful way to engage with this technology and address some identified concerns with how it will be categorised and the appropriate recognition of its evidentiary thresholds. I demonstrate these concerns through the exploration of limited conventional research methodologies tasked with the production of generalisable knowledge, specifically population-based evidence that is derived from Randomised Clinical Trials. I use Australian regulatory amendments introduced in 2021 as an example of current regulatory trajectories and highlight why I believe this approach to be insufficient. The significance of this argument will be to demonstrate the disruption of bioprinting applications to current approaches in medical policy, and how various jurisdictions are enacting regulation that is not fit for purpose.