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.

Responsibility is an adequate requirement for authorship: a reply to Levy.

Neil Levy argues in a recent JME 'Current controversy' paper that responsibility is not an adequate authorship requirement for human researchers, which makes it unjustified to require it from artificial intelligence contributing to research and scientific paper production, although he softens his stance towards the end and accepts that a limited responsibility requirement might after all be reasonable. The main argument provided by Levy against a more extensive responsibility requirement in science is that there are many cases where not all researchers listed as coauthors can assume responsibility for the entire paper or even the central research questions. In this reply, we argue that the more limited responsibility requirement is the ethically reasonable one to ask of all authors, considering the conditions for and value of collaboration, and that this should also have ramifications for the legal regulation of scientific misconduct.

Responsibility is not required for authorship.

The Committee on Publication Ethics (COPE) maintains that AIs (artificial intelligences) cannot be authors of academic papers, because they are unable to take responsibility for them. COPE appears to have the answerability sense of responsibility in mind. It is true that AIs cannot be answerable for papers, but responsibility in this sense is not required for authorship in the sciences. I suggest that ethics will be forced to follow suit in dropping responsibility as a criterion for authorship or rethinking its role. I put forward three options for authorship: dropping responsibility as a criterion for authorship, retaining it and excluding AIs, but at the cost of substantial revision of our practices, or requiring only local responsibility for an intellectual contribution.

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?

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.

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.

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.

Enhancing social value considerations in prioritising publicly funded biomedical research: the vital role of peer review.

The main goal of publicly funded biomedical research is to generate social value through the creation and application of knowledge that can improve the well-being of current and future people. Prioritising research with the greatest potential social value is crucial for good stewardship of limited public resources and ensuring ethical involvement of research participants. At the National Institutes of Health (NIH), peer reviewers hold the expertise and responsibility for social value assessment and resulting prioritisation at the project level. However, previous research has shown that peer reviewers place more emphasis on a study's methods ('Approach') than on its potential social value (best approximated by the criterion of 'Significance'). Lower weighting of Significance may be due to reviewers' views on the relative importance of social value, their belief that social value is evaluated at other stages of the research priority-setting process or the lack of guidance on how to approach the challenging task of assessing expected social value. The NIH is currently revising its review criteria and how these criteria contribute to overall scores. To elevate the role of social value in priority setting, the agency should support empirical research on how peer reviewers approach the assessment of social value, provide more specific guidance for reviewing social value and experiment with alternative reviewer assignment strategies. These recommendations would help ensure that funding priorities align with the NIH's mission and the obligation of taxpayer-funded research to contribute to the public good.

Understanding individualised genetic interventions as research-treatment hybrids.

Until recently, medicine has had little to offer most of the millions of patients suffering from rare and ultrarare genetic conditions. But the development in 2019 of Milasen, the first genetic intervention developed for and administered to a single patient suffering from an ultrarare genetic disorder, has offered hope to patients and families. In addition, Milasen raised a series of conceptual and ethical questions about how individualised genetic interventions should be developed, assessed for safety and efficacy and financially supported. The answers to these questions depend in large part on whether individualised therapies are understood as human subjects research or clinical innovation, different domains of biomedicine that are regulated by different modes of oversight, funding and professional norms. In this article, with development and administration of the drug Milasen as our case study, we argue that at least some individualised genetic therapies are not, as some have argued, either research or treatment. Instead, they are research-treatment hybrids, a category that has both epistemological and pragmatic repercussions for funding, ethics oversight and regulation.

Need for greater post-trial support for clinical trial participants assessing high-risk, irreversible treatments.

There are increasing numbers of clinical trials assessing high-risk, irreversible treatments. Trial participants should only expect knowledge gain to society, no personal therapeutic benefit. However, participation may lead to long-term harms and prevent future therapeutic options. While some discussion has occurred around post-trial access to treatments for participants who received therapeutic benefit, there are no post-trial support requirements for those suffering long-term consequences from trial participation. Participants may be left with significant medical, psychological, social, technical or financial needs. All trials will end at some point, regardless of their success. Subsequently, they should be designed to take into account the post-trial period including the impact on the ongoing health of a participant and their post-trial needs.

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.

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.

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.

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.

The role of ethicists in pediatric hematology/oncology: Current status and future needs.

As pediatric hematology/oncology (PHO) becomes more complex and sub-subspecialized, dedicated PHO ethicists have emerged as sub-subspecialists focused on addressing ethical issues encountered in clinical and research practices. PHO physicians and other clinicians with advanced training in bioethics contribute to the field through ethics research, education, and ethics consultation services. Furthermore, there exists a newer generation of PHO trainees interested in bioethics. This review details the experiences of current PHO ethicists, providing a blueprint for future educational, research and service activities to strengthen the trajectory of the burgeoning sub-subspecialty of PHO ethics. Creating an American Society of Pediatric Hematology/Oncology (ASPHO) ethics Special Interest Group, enhancing clinical ethics education for pediatric hematologists/oncologists (PHOs), developing multi-institutional research collaborations, and increasing attention to ethical issues germane to nonmalignant hematology will serve the interests of the entire field of PHO, enhancing the care of PHO patients and careers of PHOs.

Ethics guidelines use and Indigenous governance and participation in Aboriginal and Torres Strait Islander health research: a national survey.

OBJECTIVES: To assess the use of NHMRC Indigenous research guidelines by Australian researchers and the degree of Aboriginal and Torres Strait Islander governance and participation in Indigenous health research. DESIGN, SETTING, PARTICIPANTS: Cross-sectional survey of people engaged in Indigenous health research in Australia, comprising respondents to an open invitation (social media posts in general and Indigenous health research networks) and authors of primary Indigenous health research publications (2015-2019) directly invited by email. MAIN OUTCOME MEASURES: Reported use of NHMRC guidelines for Indigenous research; reported Indigenous governance and participation in Indigenous health research. RESULTS: Of 329 people who commenced the survey, 247 people (75%) provided responses to all questions, including 61 Indigenous researchers (25%) and 195 women (79%). The NHMRC guidelines were used "all the time" by 206 respondents (83%). Most respondents (205 of 247, 83%) reported that their research teams included Indigenous people, 139 reported dedicated Indigenous advisory boards (56%), 91 reported designated seats for Indigenous representatives on ethics committees (37%), and 43 reported Indigenous health research ethics committees (17%); each proportion was larger for respondents working in Indigenous community-controlled organisations than for those working elsewhere. More than half the respondents reported meaningful Indigenous participation during five of six research phases; the exception was data analysis (reported as apparent "none" or "some of the time" by 143 participants, 58%). CONCLUSIONS: Indigenous health research in Australia is largely informed by non-Indigenous world views, led by non-Indigenous people, and undertaken in non-Indigenous organisations. Re-orientation and investment are needed to give control of the framing, design, and conduct of Indigenous health research to Indigenous people.

Trusted research environments are definitely about trust.

In their highly topical paper, Graham et al argued that Trusted Research Environments (TREs) are not actually about trust because they reduce or remove '…the need for trust in the use and sharing of patient health data'. We believe this is fundamentally mistaken. TREs mitigate or remove some risks, but they do not address all public concerns. In this regard, TREs provide evidence for people to decide whether the bodies holding and using their data can be trusted. TREs may make it easier for people to trust but there is still a need for that trust.

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.

Should authorship on scientific publications be treated as a right?

Sometimes researchers explicitly or implicitly conceive of authorship in terms of moral or ethical rights to authorship when they are dealing with authorship issues. Because treating authorship as a right can encourage unethical behaviours, such as honorary and ghost authorship, buying and selling authorship, and unfair treatment of researchers, we recommend that researchers not conceive of authorship in this way but view it as a description about contributions to research. However, we acknowledge that the arguments we have given for this position are largely speculative and that more empirical research is needed to better ascertain the benefits and risks of treating authorship on scientific publications as a right.

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.