Ethical Guidance Research Articles

Ethical and Legal Obligations for Research Involving Pregnant Persons in a Post-Dobbs Context.

In light of a history of categorical exclusion, it is critical that pregnant people are included in research to help improve the knowledge base and interventions needed to address public health. Yet the volatile legal landscape around reproductive rights in the United States threatens to undue recent progress made toward the greater inclusion of pregnant people in research. We offer ethical and practical guidance for researchers, sponsors, and institutional review boards to take specific steps to minimize legal risks and ensure the ethical conduct of research with pregnant people in an evolving legal environment.

From Constitutional Protections to Medical Ethics: The Future of Pregnant Patients' Medical Self-Determination Rights After Dobbs.

This article argues that the Supreme Court's decision in Dobbs is likely to impact medical decision-making by pregnant patients in a variety of contexts. Of particular concern are situations where a patient declines treatment recommended for its potential benefit to the fetus and situations where treatment is withheld due to potential risk to the fetus. The Court's elevation of fetal interests, combined with a history of courts using abortion jurisprudence to guide their reasoning in compelled treatment cases, means that Dobbs has the potential to limit patient autonomy in a wide array of clinical settings. The article calls on professional medical associations to issue ethical guidance affirming the duty to respect the medical self-determination of pregnant patients.

Journal editors and publishers’ legal obligations with respect to medical research misconduct

As the burden of misconduct in medical research is increasingly recognised, questions have been raised about how best to address this problem. Whilst there are existing mechanisms for the investigation and management of misconduct in medical literature, they are inadequate to deal with the magnitude of the problem. Journal editors and publishers play an essential role in protecting the veracity of the medical literature. Whilst ethical guidance for journal editors and publishers is important, it is not as readily enforceable as legal obligations might be. This article questions the legal obligations that might exist for journal editors and publishing companies with respect to ensuring the veracity of the published literature. Ultimately, there is no enforceable legal obligation in Australia, the United Kingdom, or the United States. In light of this, more robust mechanisms are needed to deliver greater confidence and transparency in the investigative process, the management of concerns or findings of misconduct and the need to cleanse the literature. We show that the law disincentivises journals and publishers from ensuring truth in their publications. There are harmful consequences for medical care and public confidence in the medical profession and health care system when the foundations of medical science are questionable.

Somatic Gene Therapy Research in Pediatric Populations: Ethical Issues and Guidance for Operationalizing Early Phase Trials.

Currently, pediatric research involving investigational gene therapies (GT, used without intending to imply a therapeutic effect) targets a broad range of indications (including rare and ultra-rare diseases) that vary in severity and availability of approved disease-modifying therapies. Because of this diversity of circumstances, there is no one-size-fits-all list of ethical concerns relevant to all uses of investigational GTs in children. Here, we review the main ethical issues, specifically those surrounding the current state of knowledge about GT product-related immunogenicity, toxicity, duration, irreversibility, informed consent/assent, trial design (including the question of who 'goes first'), participant and caregiver burdens, and equity in diagnosis and access to research opportunities. Ethical issues that can be anticipated to arise in pediatric GT clinical trials, e.g., the uncertainty and risk of this research, the resultant preclusion of GT trial participants from other research, the length of follow-up monitoring, and the urgency often felt by caregivers dealing with dire, rapidly progressive conditions, should be proactively identified, addressed in accordance with existing best practices, and transparently discussed among all stakeholders.

Span of Control and Ethical Leadership in Highly Professionalized Public Organizations

Span of control may be a critical structural condition for ethical leadership. According to social learning theory, emulation and vicarious learning processes are mechanisms through which ethical leaders enhance ethical commitment among employees. However, if the span of control (number of employees per manager) is too wide, ethical leadership can be difficult to practice due to a more distant relationship between manager and employees. Using a mixed method design with survey data and interviews, we analyze the relationship between span of control and ethical leadership among doctors in Danish hospitals. Survey results from the study show no statistical association between span of control and clinical directors’ self-reported ethical leadership. Interviews with employees and managers support this finding by showing how ethical guidance unfolds through social exchange relationships where employees can act as moral professionals. This suggests that span of control is not a critical structural condition for intending and perceiving a high level of ethical leadership. Span of control is indirectly relevant through the perceived distance between manager and employees. The findings thus enhance our understanding of how ethical leadership takes place in complex, professionalized public organizations. This might inspire managers to lower the organizational power distance and promote professionalism.

Ethical guidelines for birth defect prevention recommended by experts.

China's maternal and child health work is still facing many challenges, such as unbalanced development and inadequate services. Since the adjustment of the family planning policy, the proportion of older and more productive sub-parturient women have increased, the risk for birth defects has increased, the demand for newborn safety has further increased, and the work of maternal and child health is facing new challenges. The experts from the medicine, medical ethics, sociology, and other fields put forward the principle of ethical guidance for birth defect prevention after full discussion and continuous revision based on expert proposals, which include the principle of life dignity, love, scientific principle, fair principle, respect for autonomy principle, the principle of beneficence and the principle of good privacy protection. The guideline can serve the birth defect prevention clinical practice, be better to respect and safeguard the legitimate rights and interests of people at childbearing age, eliminate ethics cognition pitfalls of birth defect prevention, and regulate the behavior of birth defect prevention-related ethics.

The Unique and Practical Advantages of Applying A Capability Approach to Brain Computer Interface

Intelligent neurotechnology is an emerging field that combines neurotechnologies like brain-computer interface (BCI) with artificial intelligence. This paper introduces a capability framework to assess the responsible use of intelligent BCI systems and provide practical ethical guidance. It proposes two tests, the threshold and flourishing tests, that BCI applications must meet, and illustrates them in a series of cases. After a brief introduction (Section 1), Section 2 sets forth the capability view and the two tests. It illustrates the threshold test using examples from clinical medicine of BCI applications that enable patients with profound disabilities to function at a threshold level through computer mediation. Section 3 illustrates the flourishing test by exploring possible future applications of BCI involving neuroenhancements for healthy people, using examples adapted from research currently underway in the US military. Section 3 applies a capability lens to a complex case involving dual effects, both therapeutic and non-therapeutic, showing how the threshold and flourishing tests resolve the case. Section 4 replies to three objections: neurorights are the best tool for assessing BCI; the two tests are moving targets; and the analysis utilizes a capability view to do work it is not designed for. The paper concludes that a capability view offers unique advantages and gives practical guidance for evaluating the responsible use of present and future BCI applications. Extrapolating from our analysis may help guide other emerging technologies, such as germline gene editing, expected to impact central human capabilities.

Ethical considerations in engaging young people in European obesity prevention research: The CO-CREATE experience.

Engaging youth in obesity prevention research and policy action is essential to develop strategies that are relevant and sensitive to their needs. Research with young people requires critical reflection to safeguard their rights, dignity, and well-being. The CO-CREATE project used various methods to engage approximately 300 European youth aged 15-19 years in the development of policies to prevent adolescent obesity. This paper discusses ethical considerations made in the project pertaining to the youth's voluntary participation, their protection from obesity stigma, respect for their time, data privacy and confidentiality, power balance, and equality of opportunity to participate in the research. We describe measures implemented to prevent or limit the emergence of ethical challenges in our interaction with youth and discuss their relevance based on our experience with implementation. While some challenges seemingly were prevented, others arose related to the youth's voluntary participation, time burdens on them, and the sustainability of participation under the Covid-19 pandemic. Concrete and ongoing ethical guidance may be useful in projects aiming to interact and build collaborative relationships with youth for long periods of time.

Feedback of individual genetic and genomics research results: A qualitative study involving grassroots communities in Uganda.

Genetics and genomics research (GGR) is associated with several challenges including, but not limited to, methods and implications of sharing research findings with participants and their family members, issues of confidentiality, and ownership of data obtained from samples. Additionally, GGR holds significant potential risk for social and psychological harms. Considerable research has been conducted globally, and has advanced the debate on return of genetic and genomics testing results. However, such investigations are limited in the African setting, including Uganda where research ethics guidance on return of results is deficient or suboptimal at best. The objective of this study was to assess perceptions of grassroots communities on if and how feedback of individual genetics and genomics testing results should occur in Uganda with a view to improving ethics guidance. This was a cross-sectional study that employed a qualitative exploratory approach. Five deliberative focus group discussions (FGDs) were conducted with 42 participants from grassroots communities representing three major ethnic groupings. These were rural settings and the majority of participants were subsistence farmers with limited or no exposure to GGR. Data were analysed through thematic analysis, with both deductive and inductive approaches applied to interrogate predetermined themes and to identify any emerging themes. NVivo software (QSR international 2020) was used to support data analysis and illustrative quotes were extracted. All the respondents were willing to participate in GGR and receive feedback of results conditional upon a health benefit. The main motivation was diagnostic and therapeutic benefits as well as facilitating future health planning. Thematic analysis identified four themes and several sub-themes including 1) the need-to-know health status 2) paternity information as a benefit and risk; 3) ethical considerations for feedback of findings and 4) extending feedback of genetics findings to family and community. Participation in hypothetical GGR as well as feedback of results is acceptable to individuals in grassroots communities. However, the strong therapeutic and/or diagnostic misconception linked to GGR is concerning given that hopes for therapeutic and/or diagnostic benefit are unfounded. Viewing GGR as an opportunity to confirm or dispute paternity was another interesting perception. These findings carry profound implications for consent processes, genetic counselling and research ethics guidance. Privacy and confidentiality, benefits, risks as well as implications for sharing need to be considered for such feedback of results to be conducted appropriately.

Navigating Political Disagreement in Social Work: An Analysis of Past Literature, Ethical Guidance, and Case Examples

Political advocacy is a core tenet of the National Association of Social Workers (NASW) Code of Ethics. As a profes-sion, social work has the responsibility to remain aware of trends that threaten the well- being of diverse populations. Th e historic connection between oppression and policy is undeniable, and the standards and principles in the Code of Ethics require social workers to intervene and be aware of political trends. However, at times, social workers’ political views may not refl ect the clients’ views. Navigating situations in which a client expresses political content with the social worker requires careful consideration and improvements in the available guidance. Prior literature addresses the political confl ict in Israel, Palestine, and Northern Ireland during times of extreme tension in those cultures. Yet, stark contrasts between the United States and those cultures exist, thus justifying the need for specifi c guidance for U.S. social workers. Currently, the state of society and social work in the United States requires social workers to dedicate increased attentiveness to these types of situations. As such, the connection between social work and political action is undeniable and worthy of further investigation. To do so, two relevant case examples from a licensed clinical social worker (LCSW) will be assessed in which guidance from the NASW Code of Ethics, existing approaches, and prior literature will be applied. Th e evaluation of these case examples is intended to inform the decisions of other U.S.- based social workers confronting political disagreement with clients in direct practice work.

Clarifying the Ethics and Oversight of Chimeric Research

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human-nonhuman chimeric research. Led by bioethics researchers working closely with an interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human-nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics' previous focus on human-centered questions about the ethics of "humanization" and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less-siloed governance and oversight and more-comprehensive public communication.

Ethical Frameworks for Disclosure of Alzheimer Disease Biomarkers to Research Participants: Conflicting Norms and a Nuanced Policy.

More and more frequently, clinical trials for Alzheimer disease (AD) are targeting cognitively unimpaired individuals who are at increased risk of developing the disease. It is not always clear whether AD biomarker information should be disclosed to research participants: on the one hand, research participants may be interested in learning this information because of its perceived utility, but on the other hand, learning this information may be harmful, as there are very few effective preventive or therapeutic options available for AD. In this article, we bring together three separate sets of ethical guidance literature: on the return of individual research results, on an individual's right to access personal data, and on transparent enrollment into clinical trials. Based on these literatures, we suggest policies for the disclosure of AD biomarker test results in longitudinal observational cohort studies, clinical trials, and hybrid research projects, such as the European Prevention of Alzheimer's Dementia (EPAD) project, in which we served as an ethics team. We also present and critically discuss recommendations for disclosure of AD biomarkers in practice. We underscore that, as long as the clinical validity of AD biomarkers remains limited, there are good reasons to avoid actively disclosing them to cognitively unimpaired research participants.

Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues

Regenerative medicine has emerged as a novel alternative solution to organ failure which circumvents the issue of organ shortage. In preclinical research settings bio-artificial organs are being developed. It is anticipated that eventually it will be possible to launch first-in-human transplantation trials to test safety and efficacy in human recipients. In early-phase transplantation trials, however, research participants could be exposed to serious risks, such as toxicity, infections and tumorigenesis. So far, there is no ethical guidance for the safe and responsible design and conduct of early-phase clinical trials of bio-artificial organs. Therefore, research ethics review committees will need to look to related adjacent fields of research, including for example cell-based therapy, for guidance. In this systematic review, we examined the literature on early-phase clinical trials in these adjacent fields and undertook a thematic analysis of relevant ethical points to consider for early-phase clinical trials of transplantable bio-artificial organs. Six themes were identified: cell source, risk-benefit assessment, patient selection, trial design, informed consent, and oversight and accountability. Further empirical research is needed to provide insight in patient perspectives, as this may serve as valuable input in determining the conditions for ethically responsible and acceptable early clinical development of bio-artificial organs.

Military Healthcare Ethics: Making It Relevant to the Whole Military Care Team.

This article notes the significant increase in academic papers and policy guidance on the subject of ethical practice in military healthcare over the past two decades. This is usually within the domain of "military medical ethics," linking medical ethics as applied to the medical profession (doctors) with ethics as applied within the military (primarily from the perspective of officers). This article argues that this, highly elitist, perspective disenfranchises the majority of the military healthcare team who are nurses and allied health professionals and serve across the entire rank spectrum. We suggest that the subject should be reframed under the banner "military healthcare ethics" to include the concepts within military medical ethics but to emphasize the obligations of all military health professionals to comply with legal, regulatory, and ethical guidance for the practice of healthcare in the military environment. We recommend that the subject should be included in the curricula for education and training for all military health professions across their whole career.

Ethical perspectives of the involvement of vulnerable populations in health research

Abstract Background Public involvement in research has potential to transform public health research processes and outcomes, as well as contribute to sustainable collaborations between academia and the civil society. However, this all relies on public involvement being conducted in an ethical and inclusive way, especially when involving representatives from vulnerable populations. Methods In this empirically informed theoretical reflection, ethical perspectives on involvement of vulnerable populations in health research were explored using data collected within a public involvement evaluation project. By analysing observational and longitudinal qualitative data from research projects involving public representatives from vulnerable groups, ethical aspects were identified. Results Responsibility and decision-making appeared as important ethical aspects, where laws and regulations conflicted with involvement ideals. Similarly, reimbursement and recognition for public contributors became an ethical issue when facing legislation and bureaucracy, especially when involving children or refugees. Another ethical aspect concerned researchers’ concerns in balancing involvement and protection of vulnerable groups, especially when involving contributors living under unstable circumstances. Finally, effectively communicating around research and involvement in an accessible way, for contributors to be involved but not burdened, was a challenge for researchers. Conclusions Public involvement of vulnerable populations led to ethical challenges related to conflicting ideals and practical realities, including balancing involvement and protection of contributors. This highlighted a need for ethical guidance to support ethical decision-making and practice. The findings are used to guide the development of an ethical framework for decision-making in public involvement. Key messages • Researchers involving public contributors from vulnerable groups face ethical challenges which causes barriers to involvement. • There is need for guidance on ethical decision-making for researchers involving representatives from vulnerable groups in research.

International Research and Philanthropy

International Research and Philanthropy

Ethical issues in dementia guidelines for people with dementia and informal caregivers in Denmark: A qualitative thematic synthesis.

Numerous dementia-specific guidelines are offered to support people with dementia and their informal caregivers in dealing with dementia. However, the extent to which such guidelines address ethical issues and provide guidance for dealing with the issues has not yet been assessed. This study investigates the extent to which ethical issues are addressedin those guidelines, which ethical themes are considered and whatrecommendations are offered. We analysed Danish collected via onlinesearch engines and manual contact with relevant governmental, municipal and patient organisations from November 2020 to January 2021. To assess the scope of ethical issues in such guidelines, we devised an analytical framework using Beauchamp and Childress's four principles of biomedical ethics and a data-processing method inspired by systematic reviews. We collected a total 653 dementia guidelines and screened them using formal inclusion criteria, such as publication year, target group and public availability. The guidelines that satisfied these criteria were screened for content related to ethical issues and recommendations. The guidelines that addressed ethical issues were then coded in NVivo 12 and analysed using thematic text analysis. In total, 59 guidelines satisfied the formal inclusion criteria. Among these guidelines, 15 addressed ethical issues, which fell into four transversal themes: (1) being open about the disease, (2) accepting help, (3) the line between dignified behaviour and overstepping boundaries and (4) decision-making and autonomy. The ethical issues addressed in Danish dementia-specific guidelines were diverse. However, the addressed issues did not represent a comprehensive spectrum of ethical issues as identified in relevant literature, and only a few guidelines contained substantial ethical content. In conclusion, this study indicates that the need for guidance on ethical issues is not being met by dementia-specific guidelines and that further research is required to provide additional ethical guidance that benefits people with dementia and their informal caregivers.

Animals and Human Society in Asia: Historical, Cultural and Ethical Perspectives

Animals and Human Society in Asia: Historical, Cultural and Ethical Perspectives

ETHICAL DIMENSIONS OF INFANT MENTAL HEALTH

Infant mental health (IMH) practice presents unique ethical challenges. In this presentation, we consider the ethical issues inherent in clinical work by practitioners in IMH, including child and adolescent psychiatrists, and identify strengths and challenges of current approaches to addressing these ethical issues. We discuss gaps and avenues for future development of ethical guidance in IMH, including the possible role for a code of ethics.

8.2 Current Approaches to Ethical Challenges in Infant Mental Health

The goals of this presentation are: 1) to consider the ethical aspects inherent in clinical work with young children and their caregivers, particularly when their best interests are in conflict; 2) to identify the strengths and challenges of current approaches to addressing these ethical issues; and 3) to discuss gaps and avenues for future development of ethical guidance in work with young children and their caregivers, including the possible role for a code of ethics for infant and early childhood mental health.