Racial Equity, Diversity and Inclusion in Bioethics: Recommendations from the Association of Bioethics Program Directors Presidential Task Force.

Recent calls to address racism in bioethics reflect a sense of urgency to mitigate the lethal effects of a lack of action. While the field was catalyzed largely in response to pivotal events deeply rooted in racism and other structures of oppression embedded in research and health care, it has failed to center racial justice in its scholarship, pedagogy, advocacy, and practice, and neglected to integrate anti-racism as a central consideration. Academic bioethics programs play a key role in determining the field's norms and practices, including methodologies, funding priorities, and professional networks that bear on equity, inclusion, and epistemic justice. This article describes recommendations from the Racial Equity, Diversity, and Inclusion (REDI) Task Force commissioned by the Association of Bioethics Program Directors to prioritize and strengthen anti-racist practices in bioethics programmatic endeavors and to evaluate and develop specific goals to advance REDI.

Australian Attitudes Towards Waivers of Consent Within the Context of Genomic Data Sharing.

This research identifies the circumstances in which Human Research Ethics Committees (HRECs) are trusted by Australians to approve the use of genomic data - without express consent - and considers the impact of genomic data sharing settings, and respondent attributes, on public trust. Survey results (N = 3013) show some circumstances are more conducive to public trust than others, with waivers endorsed when future research is beneficial and when privacy is protected, but receiving less support in other instances. Still, results imply attitudes are influenced by more than these specific circumstances, with different data sharing settings, and participant attributes, affecting views. Ultimately, this research raises questions and concerns in relation to the criteria HRECs use when authorising waivers of consent in Australia.

Is AI my co-author? The ethics of using artificial intelligence in scientific publishing.

The recent emergence of Large Language Models (LLMs) and other forms of Artificial Intelligence (AI) has led people to wonder whether they could act as an author on a scientific paper. This paper argues that AI systems should not be included on the author by-line. We agree with current commentators that LLMs are incapable of taking responsibility for their work and thus do not meet current authorship guidelines. We identify other problems with responsibility and authorship. In addition, the problems go deeper as AI tools also do not write in a meaningful sense nor do they have persistent identities. From a broader publication ethics perspective, adopting AI authorship would have detrimental effects on an already overly competitive and stressed publishing ecosystem. Deterrence is possible as backward-looking tools will likely be able to identify past AI usage. Finally, we question the value of using AI to produce more research simply for publication's sake.

Disruptive Technologies and Open Science: How Open Should Open Science Be? A 'Third Bioethics' Ethical Framework.

This paper investigates the ethical implications of applying open science (OS) practices on disruptive technologies, such as generative AIs. Disruptive technologies, characterized by their scalability and paradigm-shifting nature, have the potential to generate significant global impact, and carry a risk of dual use. The tension arises between the moral duty of OS to promote societal benefit by democratizing knowledge and the risks associated with open dissemination of disruptive technologies. Van Rennselaer Potter's 'third bioethics' serves as the founding horizon for an ethical framework to govern these tensions. Through theoretical analysis and concrete examples, this paper explores how OS can contribute to a better future or pose threats. Finally, we provide an ethical framework for the intersection between OS and disruptive technologies that tries to go beyond the simple 'as open as possible' tenet, considering openness as an instrumental value for the pursuit of other ethical values rather than as a principle with prima facie moral significance.

Behind the scenes of research ethics committee oversight: a qualitative research study with committee chairs in the Middle East and North Africa region.

BACKGROUND: Research cites shortcomings and challenges facing research ethics committees in many regions across the world including Arab countries. This paper presents findings from qualitative in-depth interviews with research ethics committee (REC) chairs to explore their views on the challenges they face in their work with the oversight of research involving human populations. METHODS: Virtual in-depth interviews were conducted with chairs (n = 11) from both biomedical and/or social-behavioral research ethics committees in six countries, transcribed, coded and subject to thematic analysis for recurring themes. RESULTS: Two sets of recurring themes impede the work of the committees and pose concerns for the quality of the research applications: (1) procedures and committee level challenges such as heavy workload, variations in member qualification, impeding bureaucratic procedures, member overwork, and intersecting socio-cultural values in the review process; (2) inconsistencies in the researchers' competence in both applied research ethics and research methodology as revealed by their applications. CONCLUSIONS: Narratives of REC chairs are important to shed light on experiences and issues that are not captured in surveys, adding to the body of knowledge with implications for the region, and low- and middle-income countries (LMICs) in other parts of the world. International research collaborations could benefit from the findings.

Tactics of just, equitable, diverse, and inclusive scientific research.

The principles of social justice, equity, diversity, inclusion (JEDI) have received increasing attention in behavior analysis circles, but the conversation has largely centered on implications for applied behavior analysis practice and research. It may be less clear to researchers who conduct basic and translational research how JEDI principles can inform and inspire their work. This article synthesizes publications from behavior analysis and other scientific fields about tactics of JEDI-informed research. We organized this scholarship across five stages of research from developing the research question to sharing findings and curated sources for an audience of behavioral science researchers. We discuss reflexive practice, representation, belongingness, participatory research, quantitative critical theory, and open science, among other topics. Some researchers may have already adopted some of the practices outlined, some may begin new practices, and some may choose to conduct experimental analyses of JEDI problems. Our hope is that those actions will be reinforced by the behavior analysis scientific community. We conclude by encouraging the leadership of this journal to continue to work toward the structural changes necessary to make the experimental analysis of behavior just, equitable, diverse, and inclusive.

Ethical Issues in Implementation Science: A Qualitative Interview Study of Participating Clinicians.

BACKGROUND: Implementation science presents ethical issues not well addressed by traditional research ethics frameworks. There is little empirical work examining how clinicians whose work is affected by implementation studies view these issues. Accordingly, we interviewed clinicians working at sites participating in an implementation study seeking to improve patient handoffs to the intensive care unit (ICU). METHODS: We performed semi-structured interviews with 32 clinicians working at sites participating in an implementation study aiming to improve patient handoffs from the operating room to the ICU. We analyzed the interviews using an iterative coding process following a conventional content analysis approach. RESULTS: Clinicians' greatest concern about involvement was possible damage to interpersonal relations with more senior clinicians. They were divided about whether informed consent from clinicians was necessary but were satisfied with the study's approach of sending out mass communications about the study. They did not think opting out of the implementation portion of the study was feasible but saw this inability to opt out as unproblematic because they equated the study with routine quality improvement. Those clinicians who helped launch the study at their sites recounted several different ways of doing so beyond simply facilitating access. CONCLUSIONS: The risks that clinicians identified stemmed more from their general status as employees than their specific work as clinicians. Implementation researchers should be attuned to the ethical ramifications of involving employees of varying ranks. Implementation researchers using hybrid designs should also be sensitive to the possibility that practitioners affected by a study will equate it with quality improvement and overlook its research component. Finally, the interactions that go into facilitating an implementation study are more various than the "gatekeeping" typically discussed by research ethicists. More research is needed on the ethics of the myriad interactions that are involved in making implementation studies happen.

The readiness of the Asian research ethics committees in responding to the COVID-19 pandemic: A multi-country survey.

Background: COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs' responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods: The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members.The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results: A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions: Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

An Example of a Clinical Research Ethics Committee in Türkiye: Types of Studies Analysed, Their Phases and Investigators.

Clinical studies are reviewed by clinical research ethics committees (CRECs) in order to ensure that they are conducted within the framework of good clinical practice and that the rights of volunteers are respected. Research type, department, status, scope, principal investigator's characteristics and CREC decisions were all evaluated. A total of 1044 research applications were found to have been submitted. In addition, 14.6% of the applications were clinical trials and 48.8% were retrospective studies. Of all the researchers, 50.4% of them were found to have indicated an incorrect type of research. The very low number of interventional clinical trials suggests that researchers tended to be hesitant about conducting such trials or did not have the means to do so. The fact that the applications were often submitted by indicating a wrong type of research method also signifies the investigators' lack of knowledge in this regard.

The self-fulfilling prophecy in medicine.

This article first describes the mechanism of any self-fulfilling prophecy through discussion of its four conditions: credibility, employment, employment sensitivity, and realization. Each condition is illustrated with examples specific to the medical context. The descriptive account ends with the definition of self-fulfilling prophecy and an expansion on collective self-fulfilling prophecies. Second, the normative account then discusses the moral relevance of self-fulfilling prophecies in medicine. A self-fulfilling prophecy is typically considered problematic when the prediction itself changes the predicted outcome to match the prediction (transformative self-fulfillment). I argue that also self-fulfilling prophecies that do not change the outcome but change the ways in which the outcome was realized (operative self-fulfillment), have significant ethical and epistemic ramifications. Because it is difficult to distinguish, retrospectively, between a transformative and an operative self-fulfilling prophecy, and thus between a false or true positive, it becomes equally difficult to catch mistakes. Moreover, since the prediction necessarily turns out true, there is never an error signal warning that a mistake might have been made. On the contrary, accuracy is seen as the standard for quality assurance. As such, self-fulfilling prophecies inhibit our ability to learn, inviting repetition and exacerbation of mistakes. With the rise of automated diagnostic and prognostic procedures and the increased use of machine learning and artificial intelligence for the development of predictive algorithms, attention to self-fulfilling feedback loops is especially warranted. This account of self-fulfilling prophecies is practically relevant for medical research and clinical practice. With it, researchers and practitioners can detect and analyze potential self-fulfilling mechanisms in any medical case and take responsibility for their ethical and epistemic implications.

Ethical assessment of genome resource banking (GRB) in wildlife conservation.

Genome Resources Banks (GRBs) represent vital repositories for the systematic collection, storage, and management of genetic material across various taxa, with a primary objective of safeguarding genetic diversity for research and practical applications. Alongside the development of assisted reproductive techniques (ART), GRBs have evolved into indispensable tools in conservation, offering opportunities for species preservation, mitigating inbreeding risks, and facilitating genetic management across fragmented populations. By preserving genetic information in a suspended state, GRBs serve as backups against population vulnerabilities, potentially aiding in the restoration of endangered species and extending their genetic lifespan. While evidence demonstrates the efficacy of GRBs, ethical considerations surrounding biobanking procedures for wildlife conservation remain largely unexplored. In this article, we will discuss possible ethical issues related to GRBs and the need to ethically monitor biobanking procedures in wildlife conservation. We will then propose a methodological tool, ETHAS, already in use for the ethical self-assessment of assisted reproduction techniques, to assess also biobanking procedures. ETHAS can make it possible to monitor a GRB from its design phase to its actual operation, helping to build biobanking procedures that meet high ethical standards.

Responsible inclusion: A systematic review of consent to social-behavioral research with adults with intellectual disability in the US.

BACKGROUND: In recognition of their status as a health disparities population, there is growing emphasis on conducting research inclusive of adults with intellectual disability to generate new knowledge and opportunities to improve health and equity. Yet they are often excluded from research, and human research participant protection experts and researchers lack agreement on effective consent protocols for their inclusion. OBJECTIVE: We sought to identify approaches to consent in US-based social-behavioral research with adults with intellectual disability. METHODS: We conducted a systematic review on approaches to self-consent with adults with intellectual disability published between 2009 and 2023, identified via searching eight databases and reference list hand searches. We identified 13 manuscripts and conducted a thematic analysis. RESULTS: Our analysis identified themes related to guiding principles, strategies to enhance informed and voluntary consent, approaches to consent capacity, involving individuals subject to guardianship, and strategies for expressing decisions and enhancing ongoing decisions. CONCLUSIONS: Manuscripts largely reflected an emphasis on identifying approaches to consent that reflect disability rights principles to promote the right to be included and make one's own decisions based on assessment of relevant information, risks and benefits, and to employ reasonable modifications to achieve inclusion. To avoid the risks of exclusion and advance the responsible inclusion of adults with intellectual disability, we make recommendations to align consent approaches anchored in contemporary thinking about human research participant protections, including through integration with disability rights.

On "intent" in research misconduct.

Research misconduct, broadly defined as acts of fabrication, falsification and/or plagiarism, violate the value system of science, cost significant wastage of public resources, and in more extreme cases endanger research participants or members of the society at large. Determination of culpability in research misconduct requires establishment of intent on the part of the respondent or perpetrator. However, "intent" is a state of mind, and its perception is subjective, unequivocal evidence for which would not be as readily established compared to the objective evidence available for the acts themselves. Here, we explore the concept of "intent" in research misconduct, how it is framed in criminological/legal terms, and narrated from a psychological perspective. Based on these, we propose a framework whereby lines of questioning and investigation, as defined by legislative terms and informed by the models and tools of psychology, could help in establishing a preponderance of evidence for culpable intent. Such a framework could be useful in research misconduct adjudications and in delivering sanctions.

Ethics and applications of isotope analysis in archaeology.

This synthesis explores specific ethical questions that commonly arise in isotopic analysis. For more than four decades, isotope analysis has been employed in archeological studies to explore past human and animal dietary habits, mobility patterns, and the environment in which a human or animal inhabited during life. These analyses require consideration of ethical issues. While theoretical concepts are discussed, we focus on practical aspects: working with descendant communities and other rights holders, choosing methods, creating and sharing data, and working mindfully within academia. These layers of respect and care should surround our science. This paper is relevant for specialists in isotope analysis as well as those incorporating these methods into larger projects. By covering the whole of the research process, from design to output management, we appeal broadly to archaeology and provide actionable solutions that build on the discussions in the general field.

Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda.

The European Medicines Agency's conditional marketing authorization (CMA) aims to expedite patient access to medicines for unmet medical needs by shifting a part of the drug development process post-authorization. We highlight ethical issues surrounding CMA, comprising (i) the complexity of defining unmet medical need; (ii) poor understanding of CMA and its impact on informed consent; (iii) hope versus unrealistic optimism; (iv) implications of prolonged post-authorization studies and potential patient harm; (v) rights and duties of patients surrounding participation in post-authorization studies; (vi) access to previously authorized CMA medicines; and (vii) the "benefit slippage" phenomenon, defined as the gradual shift of strict criteria to less strict criteria. We propose a comprehensive research agenda to address these ethical issues, and stress the need for multi-stakeholder engagement to ensure patient-centered use of CMA.

Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change.

While considerable scholarship has explored responsibilities owed to research participants at the conclusion of explanatory clinical trials, no guidance exists regarding responsibilities owed at the conclusion of a pragmatic clinical trial (PCT). Yet post-trial responsibilities in PCTs present distinct considerations from those emphasized in existing guidance and prior scholarship. Among these considerations include the responsibilities of the healthcare delivery systems in which PCTs are embedded, and decisions about implementation for interventions that demonstrate meaningful benefit following their integration into usual care settings-or deimplementation for those that fail to do so. In this article, we present an overview of prior scholarship and guidance on post-trial responsibilities, and then identify challenges for post-trial responsibilities for PCTs. We argue that, given one of the key rationales for PCTs is that they can facilitate uptake of their results by relevant decision-makers, there should be a presumptive default that PCT study results be incorporated into future care delivery processes. Fulfilling this responsibility will require prospective planning by researchers, healthcare delivery system leaders, institutional review boards, and sponsors, so as to ensure that the knowledge gained from PCTs does, in fact, influence real-world practice.

COVID-19 ethics: unique aspects and a review as of early 2024.

COVID-19 presents a variety of ethical challenges in a set of arenas, arenas not always considered in past pandemics. These challenges include issues related to autonomy, distributive ethics, and the establishment of policies of equity and justice. Methods are a literature review based on regular editing of an online textbook during the COVID-19 outbreak and a literature review using key ethical terms. Patients are confronted with new issues related to autonomy. Providers need to expand their concepts of ethical issues to include decisions based on proportionality and public health ethics. The public health sector needs to assess the beneficence of alternative modes of disease control. The research community needs to redefine the concept of informed consent in emergent conditions. All elements of the medical spectrum-physicians, scientists, and the community-at-large including the pharmaceutical industry-need to consider the multifaceted methods for preventing future pandemics. This will require giving particular emphasis to public health funding and ending the documented discrimination that exists in the provision of proven therapies. The developing world is especially at risk for most of the ethical issues, especially those related to equity and justice. The ethical issues associated with the COVID-19 outbreak are not unique but provide a diverse set of issues that apply to patients, providers, social groups, and investigators. The further study of such issues can help with preventing future outbreaks.

Developing a Framework for Self-regulatory Governance in Healthcare AI Research: Insights from South Korea.

This paper elucidates and rationalizes the ethical governance system for healthcare AI research, as outlined in the 'Research Ethics Guidelines for AI Researchers in Healthcare' published by the South Korean government in August 2023. In developing the guidelines, a four-phase clinical trial process was expanded to six stages for healthcare AI research: preliminary ethics review (stage 1); creating datasets (stage 2); model development (stage 3); training, validation, and evaluation (stage 4); application (stage 5); and post-deployment monitoring (stage 6). Researchers identified similarities between clinical trials and healthcare AI research, particularly in research subjects, management and regulations, and application of research results. In the step-by-step articulation of ethical requirements, this similarity benefits from a reliable and flexible use of existing research ethics governance resources, research management, and regulatory functions. In contrast to clinical trials, this procedural approach to healthcare AI research governance effectively highlights the distinct characteristics of healthcare AI research in research and development process, evaluation of results, and modifiability of findings. The model exhibits limitations, primarily in its reliance on self-regulation and lack of clear delineation of responsibilities. While formulated through multidisciplinary deliberations, its application in the research field remains untested. To overcome the limitations, the researchers' ongoing efforts for educating AI researchers and public and the revision of the guidelines are expected to contribute to establish an ethical research governance framework for healthcare AI research in the South Korean context in the future.

Ethics of the Use of Social Media as Training Data for AI Models Used for Digital Phenotyping.

Digital phenotyping, or personal sensing, is a field of research that seeks to quantify traits and characteristics of people using digital technologies, usually for health care purposes. In this commentary, we discuss emerging ethical issues regarding the use of social media as training data for artificial intelligence (AI) models used for digital phenotyping. In particular, we describe the ethical need for explicit consent from social media users, particularly in cases where sensitive information such as labels related to neurodiversity are scraped. We also advocate for the use of community-based participatory design principles when developing health care AI models using social media data.