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This article explores the significance of providing optimal care for Aboriginal and Torres Strait Islander peoples with kidney failure in the Northern Territory of Australia. It emphasizes the importance of addressing health disparities and cultural factors that influence health outcomes in order to improve the well-being of these communities. The article presents a case study of a Torres Strait Islander woman's health journey, highlighting the integration of traditional healing practices with biomedical approaches and the value of patient-centered care. Additionally, the article discusses the role of Storying, a method of knowledge collation and archiving in Aboriginal and Torres Strait Islander cultures, in amplifying marginalized voices and serving as an educational tool for healthcare providers and Indigenous individuals. The article underscores the significance of culturally sensitive care and patient autonomy in achieving positive health outcomes for Indigenous communities, and advocates for a model of care that prioritizes Indigenous self-determination, cultural safety, and acknowledges the social and cultural determinants of health. It also emphasizes the need for sustained support for Indigenous self-determination and the development of a diverse healthcare workforce to comprehensively address Indigenous health needs. [Extracted from the article]

Introduction: There is an emerging propensity to use narrative inquiry as a nursing research methodology. The narrative inquiry aims to understand experiences and reveal the meaning of individual experiences providing crucial knowledge. The relationship between the nurse researcher and the participant is especially relevant in narrative inquiry. Purpose: To discuss ethical conduct in narrative inquiry and examine specific ethical issues at different stages of the narrative inquiry process in nursing research. Methods: Critical reflection supported by scientific evidence. Results: The relational component and the proximity with the participants imply greater responsibility and a strict ethical attitude. Critical ethical issues in research planning, data collection, composing field texts, data analysis and interpretation, and results presentation must be considered and respected in narrative inquiry. Conclusion: Engagement in this methodology involves scrupulous ethical conduct in the relationship with the participants and in using their narratives, respecting scientific rigour.

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. [ABSTRACT FROM AUTHOR]

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward.

This letter focuses on the importance of incorporating implicit bias into research integrity education, and the significant impact it can have on creating an equitable research environment.

Can it be ethical to conduct xenotransplant research on a human brain-dead decedent (HB-DD) whose organs could otherwise be given to persons in need? The ethical consensus is that it is better to save existing persons via organ donation than to devote a HB-DD to research that will not directly benefit anyone. I argue otherwise. Given how rapidly xenotransplant research is progressing, and its clinical promise in the next couple of years or decades, I argue that it can be ethical to conduct xenotransplant research on a HB-DD whose organs could otherwise be given to individuals in need., (© 2024 John Wiley & Sons Ltd.)

Background: Thailand has made significant progress in malaria control efforts in the past decade, with a decline in the number of reported cases. However, due to cross-border movements over the past 5 years, reported malaria cases in Thailand have risen. The Malaria Infection Study in Thailand (MIST) involves deliberate infection of healthy volunteers with Plasmodium vivax malaria parasites, and the assessment of the efficacy of potential vaccine and drug candidates in order to understand acquired protection against malaria parasites., Methods: This paper drew from ethics and social science qualitative study called MIST-ETHICS embedded within the MIST studies. MIST-ETHICS aimed to describe and understand the experiences, perceptions and ethical considerations of the MIST studies. Data were obtained from semi-structured interviews and a focus group discussion. A total of 46 participants participated in MIST-ETHICS ., Results: Three major themes emerged: experiences and perceptions of MIST, reasons for joining MIST, and ethical considerations. We found that although compensation was a motivation for participation, this was secondary to it being beneficial to self (health checks; link to health networks; building merit) and others (medical research contribution; altruism). Participants expressed varied opinions regarding the requirement of a university degree as one of the inclusion criteria for MIST., Conclusions: Our study revealed widespread concerns about long-term health effects and safety. Ethical considerations, including obtaining valid informed consent and ensuring participant inclusivitiy, were deem essential. Despite some debate regarding eligibility criteria, most participants agreed that the informed consent process was robust, accompanied by a strong sense of responsibility to contribute to the greater good. We emphasize the importance of continuously gathering participants' feedback for quality control, such as improving information materials to clarify the purpose of initial phases, their contributing to later phases, and the rationale behind each selection criterion., Trial Registration: This manuscript is part of the clinical trials registered under ClinicalTrials.gov IDs NCT04083508 (MIST1) registered on 5 Sep 2019 and NCT05071079 (MIST2) registered on 28 July 2021. However, the manuscript pertains to a qualitative study that does not require trial registration., Competing Interests: Declarations. Ethics approval and consent to participate: Ethics approval and consent to participate was received from the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (TMEC 19-068) and the Oxford University Tropical Research Ethics Committee (OXTREC 550-19). Informed consent to participate was obtained from all participants. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests. Declaration of interest statement: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2025. The Author(s).)

Background: Institutional review boards (IRBs) have been criticised for delays in approvals for research proposals due to inadequate or inexperienced IRB staff. Artificial intelligence (AI), particularly large language models (LLMs), has significant potential to assist IRB members in a prompt and efficient reviewing process., Methods: Four LLMs were evaluated on whether they could identify potential ethical issues in seven validated case studies. The LLMs were prompted with queries related to the proposed eligibility criteria of the study participants, vulnerability issues, information to be disclosed in the informed consent document (ICD), risk-benefit assessment and justification of the use of a placebo. Another query was issued to the LLMs to generate ICDs for these case scenarios., Results: All four LLMs were able to provide answers to the queries related to all seven cases. In general, the responses were homogeneous with respect to most elements. LLMs performed suboptimally in identifying the suitability of the placebo arm, risk mitigation strategies and potential risks to study participants in certain case studies with a single prompt. However, multiple prompts led to better outputs in all of these domains. Each of the LLMs included all of the fundamental elements of the ICD for all case scenarios. Use of jargon, understatement of benefits and failure to state potential risks were the key observations in the AI-generated ICD., Conclusion: It is likely that LLMs can enhance the identification of potential ethical issues in clinical research, and they can be used as an adjunct tool to prescreen research proposals and enhance the efficiency of an IRB., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Background: Stakeholders in medical research have roles in ensuring that research participants are protected. Medical journals play gatekeeping roles in the responsible conduct of research. They help guard against the publication of findings of unethical research, such as those with compromised participant welfare. Nigerian medical journals are being created to support the growing number of research enterprises. In this study, we aimed to determine the compliance of Nigerian medical journals with guidelines on research participant protection., Methods: This was a descriptive cross-sectional study of Nigerian medical journals and articles. We used a checklist to obtain information on journal characteristics and the presence of recommendations from the International Committee of Medical Journal Editors (ICMJE) on the protection of research participants in the journal instructions to authors and articles. The data were analysed via IBM SPSS version 23., Results: We studied 40 journals and 350 journal articles. Thirty-one (77.5%) journals required ethical approval and the Declaration of Helsinki statement in their instructions to the authors, while informed consent was present in 26 (65.0%) journals; 6 (15.0%) journals had no participant protection guidelines. Forty-one (11.7%) articles complied with all three recommendations on research participant protection, whereas 60 (17.1%) articles did not. Ethical approval was most common in 268 (76.6%) articles, whereas it was least common in statements on the Declaration of Helsinki in 50 (14.3%) articles. The presence of participant protection recommendations in instructions to authors was not associated with compliance with these recommendations in published articles (p > 0.05)., Conclusion: Although there is fairly good compliance of Nigerian medical journals with research participant protection recommendations, there are still gaps, which highlight the need for remedial measures., Competing Interests: Declarations. Ethics approval and consent to participate: Ethical approval was obtained from the University of Nigeria Teaching Hospital Research Ethics Committee, Enugu, with reference to UNTH/HREC/2022/12/502. Consent to participate was waived. The confidentiality of the obtained information was ensured, and no identifying information from the journals, editors, or authors was used. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)

Importance: With the increase in trials assessing comparative effectiveness of approved products and alternative care strategies, guidance is needed to ensure ethical oversight is fit for purpose for the risks, burdens, and constraints on choice this research presents., Observations: US regulations governing human research emerged in response to horrific research abuses, reinforcing the view that research holds greater risks, uncertainties, and potential for abuse than clinical care, and thus protections and oversight are required for research, but not for care. The research oversight system established by these regulations has been effective, with most clinical research reviewed in advance for possible risk and burdens and for threats to autonomy and justice. For clinical research, however, it has become too much of a one-size-fits-all mechanism. As more comparative effectiveness and other research on widely used clinical interventions are conducted, research oversight should be fit for purpose for these kinds of trials, with the degree of oversight based on 2 morally relevant features of a trial. The first of these features is the degree to which risks and burdens increase or change when research is integrated into clinical care compared with what patient-participants would have experienced in care absent the research. The second is whether the activity restricts meaningful patient decision-making about care in morally important ways: (1) does the research restrict a choice or decision that patients ordinarily are or should be involved in and (2) does research participation remove from patients the ability to make a decision that may be meaningful to them, one based, at least in part, on their values, priorities, logistical or practical considerations, and the like? Whether clinical trials add risk or burden to what patients would otherwise have experienced, and whether studies restrict meaningful decisions patients would or should have had the opportunity to make, should help to determine whether clinical studies are designated as greater than vs minimal risk. Further, it is recommended that investigators and oversight bodies consider streamlined consent procedures for research presenting minimal additional risk or burden and that does not constrain meaningful patient decisions, rather than assuming that waiving all consent requirements is the only alternative., Conclusions and Relevance: Ethical oversight of clinical research must be fit for purpose-with greater oversight for studies with greater risks, uncertainties, and impacts on meaningful patient decisions-and more streamlined oversight for other types of research.

Since 1979, The Belmont Report has served as a guidebook for ensuring that basic standards for ethical research are upheld. The Belmont Report calls for special protections of vulnerable research participants, such as people who are incarcerated and economically and educationally disadvantaged individuals who are deemed susceptible to exploitation. With a growing focus on health equity and community-engaged approaches in health equity research, efforts to involve vulnerable participants are increasing. Yet there is little understanding of what matters most to vulnerable populations. This study sought to understand, from participant perspectives, ethical considerations when conducting research with two vulnerable populations: women experiencing homelessness and women who are incarcerated. Health care professionals and staff that work closely with homeless and incarcerated populations were also interviewed. The findings from semistructured interviews with these populations underscore the sustained importance of respect for persons, beneficence, and justice, and further highlight the need for self-determination; privacy/confidentiality; continuous consent; fair treatment; benefit-burden balance; nonauthoritarian relationships; and fair access to research participation. Although The Belmont Report durably serves to ethically guide standard conventional research, the Report's original concepts should be extended to include specific considerations when vulnerable populations are involved in community-engaged research., (© 2025 by The Hastings Center. All rights reserved.)

Moral distress occurs when professionals are constrained from taking what they believe to be ethically appropriate actions or are forced to take actions they believe are ethically inappropriate, challenging their professional identities and representing systems-level issues within organizations. Moral distress has been recognized in a variety of health care-related fields; however, the phenomenon is still comparatively unexplored among clinical research professionals (CRPs). In this qualitative study, we interviewed ten CRPs to unearth root causes of moral distress in this ethically unique profession. Four themes emerged from the data as contributors to moral distress: commodification of research; concern for research participants; compromised science; and structures of hierarchy. The experience of racism as a source of moral distress is also explored. The findings of this study indicate that the existence of moral distress in clinical research is troubling not only for the welfare of CRPs but also for the greater clinical research enterprise., (© 2024 The Author(s). Ethics & Human Research published by Wiley Periodicals LLC on behalf of The Hastings Center.)

This article brings a philosophical perspective to bear on issues of research ethics governance as it is practiced and organized in Canada. Insofar as the processes and procedures that constitute research oversight are meant to ensure the ethical conduct of research, they are based on ideas or beliefs about what ethical research entails and about which processes will ensure the ethical conduct of research. These ideas and beliefs make up an epistemic infrastructure underlying Canada's system of research ethics governance, but, we argue, extensive efforts by community members to fill gaps in that system suggest that these ideas may be deficient. Our aim is to make these deficiencies explicit through critical analysis by briefly introducing the philosophical literature on epistemic injustice and ignorance, and by drawing on this literature and empirical evidence to examine how injustice and ignorance show up across three levels of research ethics governance: research ethics boards, regulations, and training. Following this critique, and drawing on insights from the same philosophical tradition, we highlight the work that communities across Canada have done to rewrite and rework how research ethics as a site of epistemic resistance is practiced., (© 2024 The Author(s). Ethics & Human Research published by Wiley Periodicals LLC on behalf of The Hastings Center.)

Integrating artificial intelligence (AI) into critical domains such as healthcare holds immense promise. Nevertheless, significant challenges must be addressed to avoid harm, promote the well-being of individuals and societies, and ensure ethically sound and socially just technology development. Innovative approaches like Embedded Ethics, which refers to integrating ethics and social science into technology development based on interdisciplinary collaboration, are emerging to address issues of bias, transparency, misrepresentation, and more. This paper aims to develop this approach further to enable future projects to effectively deploy it. Based on the practical experience of using ethics and social science methodology in interdisciplinary AI-related healthcare consortia, this paper presents several methods that have proven helpful for embedding ethical and social science analysis and inquiry. They include (1) stakeholder analyses, (2) literature reviews, (3) ethnographic approaches, (4) peer-to-peer interviews, (5) focus groups, (6) interviews with affected groups and external stakeholders, (7) bias analyses, (8) workshops, and (9) interdisciplinary results dissemination. We believe that applying Embedded Ethics offers a pathway to stimulate reflexivity, proactively anticipate social and ethical concerns, and foster interdisciplinary inquiry into such concerns at every stage of technology development. This approach can help shape responsible, inclusive, and ethically aware technology innovation in healthcare and beyond., (© 2024. The Author(s).)

In a recent paper, Yeo argues that the framing of treatment options by physicians in the contexts of patient's decision-making conflicts with a physician's duty of disclosure. I argue that this conclusion is drawn too quickly, as it is questionable whether the empirical research on which Yeo relies is applicable to the framing of treatment options. This means that Yeo's main assumption is undermined, and we should hold off on concluding that the framing of treatment options is misleading., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Background: The primary objective of this study was to conduct a comprehensive questionnaire survey on the practices of research ethics committees reviewing academic research projects in Czechia. The study aims to provide an unbiased and objective assessment of the current practices of research ethics committees, namely to obtain the missing data on their functioning in the context of academic research, to identify difficulties and shortages that threaten the responsible functioning of research ethics committees in the country and to investigate the implementation of Additional Protocol on Biomedical Research CETS No. 195 in their practice. Such research has never been conducted in Czechia., Methods: This was a mixed-methods study, in which the online survey with closed and open-ended questions was chosen to explore the situation regarding ethics assessment of research involving human participants. We developed a questionnaire containing 18 questions concerning several aspects of the functioning of research ethics committees. The questionnaire was in Czech language and was administered through the Qualtrics platform anonymously. The target group of 61 research ethics committees at research institutions was approached by emails and we received 43 completely filled questionnaires, i.e., response rate of 67%., Results: We obtained valuable data on the functioning of research ethics committees in Czechia in three main domains: the mandate and composition of the committee; the scope of its agenda; the process of evaluation including the voting procedure. In addition, the final set of open-ended questions provided an in-depth look at the problems faced by research ethics committees in Czechia. From the results is evident that the responsible assessment of the ethics of research involving human subjects is still not satisfactorily addressed and established for routine practice in the country., Conclusions: The outcomes of our study revealed that the main problem of research ethics in Czechia is the lack of national legislation on research ethics governance. To address this problem, the country requires a legislative framework accompanied by supportive measures aimed at educating, guiding and advising research ethics committees, especially in the Czech academic environment., Trial Registration Number: Not applicable., Competing Interests: Declarations. Ethics approval and consent to participate: This study was conducted in accordance with international research guidelines and Czech law. No personal data of human subjects were collected during the research and respondents participated in the survey as anonymous representatives of institutional research ethics committees and not as identifiable individuals. Therefore, informed consent to participate in the study is not relevant for this type of research according to the Communication No. 30/2020 Collection of International Treaties. The Research Ethics Committee of Masaryk University stated in document No. EKV-LS-2023-017 that the study does not require formal ethical review and that this situation is in compliance with Czech law. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

The objective of this study was to evaluate Brazilian dental researchers' perceptions of research integrity and open science practices, as well as their perceptions of the way researchers are evaluated for promotion, hiring, and receiving grants. In a self-administered online survey, the respondents were presented with 3 questions on researcher evaluation in Brazil. Additionally, for 25 academic activities or characteristics, researchers rated their perceived importance for a) career advancement, b) science advancement, c) personal satisfaction, and d) social impact. The questionnaire was sent to a total of 2,179 dental researchers working in graduate programs in dentistry in Brazil. Multilevel regressions were performed to statistically confirm the differences between the predefined subgroups. Three hundred and fifty-five (16%) researchers completed the survey. Most respondents (96.1%) considered the current evaluation system to be flawed and indicated the need for improvement. Non-traditional activities were considered more important than traditional ones for science advancement (p < 0.01), and social impact (p < 0.01), whereas traditional activities were perceived to be more important only for career advancement (p < 0.01). Although Brazilian dental researchers recognize the value of open science and research integrity practices for science advancement and impact on society, they perceive that the current evaluation system emphasizes traditional activities, such as publishing many papers in well-recognized journals as criteria for advancing their careers.

St. Ives is an idyllic seaside town on the southwest tip of England. It is a magnet for holidaymakers and artists. In early 2023, its residents were surprised to find that their beloved bay had become the location for an experiment. A technology start-up called Planetary Technologies had gained permission from the local water company to add magnesium hydroxide to a wastewater outlet pipe and pump it a mile offshore. Some within the community were outraged to find out from a national newspaper not only about the planned release of the chemicals, but that a small test had already happened the previous September. That April 2023, more than 300 protesters gathered on the beach, some with slogans on their surfboards. Most of them were concerned about the risks to their ecosystem and its crabs, seals, and lobsters. On finding out more about the company and its ambitions, some of the protesters started to see the experiment in a new light.

The moral status of human brain organoids (HBOs) has been debated in view of the future possibility that they may acquire phenomenal consciousness. This study empirically investigates the moral sensitivity in people's intuitive judgments about actions toward conscious HBOs. The results showed that the presence/absence of pain experience in HBOs affected the judgment about the moral permissibility of actions such as creating and destroying the HBOs; however, the presence/absence of visual experience in HBOs also affected the judgment. These findings suggest that people's intuitive judgments about the moral status of HBOs are sensitive to the valence-independent value of phenomenal consciousness. We discuss how these observations can have normative implications; particularly, we argue that they put pressure on the theoretical view that the moral status of conscious HBOs is grounded solely in the valence-dependent value of consciousness. We also discuss how our findings can be informative even when such a theoretical view is finally justified or when the future possibility of conscious HBOs is implausible., Competing Interests: Declarations. Conflict of interest: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024. The Author(s).)

International ethical standards for research involving persons who have diminished decision-making capacity allow for delegation of the decision to participate in research to a representative who can act as a surrogate decision-maker. However, this approach has been questioned by the Convention on the Rights of Persons with Disabilities (CRPD), according to which all persons with disabilities, regardless of their mental or neurological condition, always have universal legal capacity to make decisions. The incompatibility between ethical standards and the CRPD is clear and impacts the conduct of research involving people with mental disabilities, which is essential for the improvement of their health and well-being. This article advances a proposal that seeks to reconcile the CRPD with ethical standards for informed consent processes in research and provides practical recommendations, especially for Latin American countries that still face challenges in implementing the CRPD in the research field., Competing Interests: Conflicto de intereses Ninguno declarado por los autores.

Purpose: The purpose of this article is to explore the interrelationship between research ethics and research integrity with a focus on the primary forms of research misconduct, including plagiarism, fabrication, and falsification. It also details the main factors for their occurrence, and the possible ways for mitigating their use among scholars. Methods: The method employed a detailed examination of the main ethical dilemmas, as delineated in literature, as well as the factors leading to these ethical breaches and the strategies to mitigate them. Further, the teaching experiences of the primary author are reflected in the development of the model. Results: The results of this article are represented in a model illustrating the interrelationship between research ethics and research integrity. Further, a significant aspect of our article is the identification of novel forms of research misconduct concerning the use of irrelevant or forced citations or references. Conclusion: In conclusion, the article highlights the substantial positive effects that adherence to research ethics and integrity have on the academic well-being of scholars.

AbstractPregnant research participants have long been excluded from early-stage clinical trials. This stance has been considered ethically justifiable because it upholds the principle of nonmaleficence by avoiding potential harm, using the fetus(es) as the point of reference. However, there are unintended consequences with this default approach. To illustrate these consequences, this article will review the inclusion and exclusion criteria of the Phase II and Phase III SARS-CoV-2 vaccine trials, demonstrating a downstream delay of vaccine recommendations, which hindered public health efforts. Incorporating ethical principles in addition to nonmaleficence, the authors propose an intentional effort to include pregnant participants in Phase II and Phase III designs. We consider the goals of Phase II and Phase III research of demonstrating safety and efficacy and propose that pregnant participants can potentially support these goals. Rather than reflexive exclusion, the gestational age of the participant or the pharmacology of the trial intervention may be considered as part of inclusion for pregnant participants. Expanding the principles beyond nonmaleficence, pregnancy may become a demographic variable rather than an exclusion criterion.

Creating simulations of the world can be a valuable way to test new ideas, predict the future, and broaden our understanding of a given topic. Presumably, the more similar the simulation is to the real world, the more transferable the knowledge generated in the simulation will be and, therefore, the more useful. As such, there is an incentive to create more advanced and representative simulations of the real world. Simultaneously, there are ethical and practical limitation to what can be done in human and animal research, so creating simulated beings to stand in their place could be a way of advancing research while avoiding some of these issues. However, the value of representativeness implies that there will be an incentive to create simulated beings as similar to real-world humans as possible to better transfer the knowledge gained from that research. This raises important ethical questions related to how we ought to treat advanced simulated beings and consider if they might have autonomy and wellbeing concerns that ought to be respected. As such, the uncertainty and potential of this line of research should be carefully considered before the simulation begins., Competing Interests: Ethical statement. This article is a philosophical essay and does not involve any human or animal subjects. The content is based solely on theoretical analysis and the interpretation of existing literature., (© 2024. The Author(s) under exclusive licence to Monash University.)

The purpose of a first-in-human (FIH) clinical trial is to gather information about how the drug or device affects and interacts with the human body: its safety, side effects, and (potential) dosage. As such, the primary goal of a FIH trial is not participant benefit but to gain knowledge of drug or device efficacy, i.e., baseline human safety knowledge. Some FIH clinical trials carry significant foreseeable risk to participants with little to no foreseeable participant benefit. Participation in such trials would be a bad deal for participants, and the research is considered justifiable because of the promise of significant potential social benefit. I argue that there is an ethical tension inherent in risky FIH research and that researchers should fairly compensate risky FIH trial participants. This does not make the risk-benefit outcome more favorable for participants; rather, it amounts to a collective reckoning with the ethical tension inherent in the research., Competing Interests: Declarations. Conflict of interest: I declare not competing or conflict of interest., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Bioethics has developed approaches to address ethical issues in health care, similar to how technology ethics provides guidelines for ethical research on artificial intelligence, big data, and robotic applications. As these digital technologies are increasingly used in medicine, health care and public health, thus, it is plausible that the approaches of technology ethics have influenced bioethical research. Similar to the "empirical turn" in bioethics, which led to intense debates about appropriate moral theories, ethical frameworks and meta-ethics due to the increased use of empirical methodologies from social sciences, the proliferation of health-related subtypes of technology ethics might have a comparable impact on current bioethical research. This systematic journal review analyses the reporting of ethical frameworks and non-empirical methods in argument-based research articles on digital technologies in medicine, health care and public health that have been published in high-impact bioethics journals. We focus on articles reporting non-empirical research in original contributions. Our aim is to describe currently used methods for the ethical analysis of ethical issues regarding the application of digital technologies in medicine, health care and public health. We confine our analysis to non-empirical methods because empirical methods have been well-researched elsewhere. Finally, we discuss our findings against the background of established methods for health technology assessment, the lack of a typology for non-empirical methods as well as conceptual and methodical change in bioethics. Our descriptive results may serve as a starting point for reflecting on whether current ethical frameworks and non-empirical methods are appropriate to research ethical issues deriving from the application of digital technologies in medicine, health care and public health., (© 2024. The Author(s).)

Aim: Platforms on social media are increasingly used for public health research. While social media provides an exceptional opportunity to explore communication about public health topics, this practice is not without ethical dilemmas. Our aim was to identify and unfold some of these dilemmas and to suggest possible solutions and ways forward for future research., Methods: Using our own research within a closed forum for people experiencing suicidal thoughts as a case, we explored certain dilemmas and possible answers relating to whether what is to be researched falls under a public or private social media domain; we investigated avenues for obtaining access to participants in an evolving online environment; how to secure informed consent from participants; and ways of ensuring anonymity., Results: We provide recommendations and reflections that we hope will offer inspiration for researchers embarking on similar social media public health research within and beyond suicide research., Conclusions: The ethical framework commonly referred to in health research, based on confidentiality, anonymity, informed consent and doing no harm must be adjusted to be relevant for a social media context where technologies and regulations are constantly being altered., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Even though there is a significant amount of scholarly work examining the ethical issues surrounding human genomics research, little is known about its footing in Malaysia. This study aims to explore the experience of local researchers and research ethics committee (REC) members in developing it in Malaysia. In-depth interviews were conducted from April to May 2021, and the data were thematically analysed. In advancing this technology, both genomics researchers and REC members have concerns over how this research is being developed in the country especially the absence of a clear ethical and regulatory framework at the national level as a guidance. However, this study argues that it is not a salient issue as there are international guidelines in existence and both researchers and RECs will benefit from a training on the guidelines to ensure genomics research can be developed in an ethical manner., (© 2023 John Wiley & Sons Ltd.)

Ethics statements are an essential aspect of research reporting. They aim to ensure the integrity and credibility of scientific research by maintaining high standards of professionalism and placing a strong emphasis on human well-being. Adhering to ethical norms is crucial for promoting data sharing, reproducibility, and overall research integrity. Ethics statements generally include adherence to legislation, disclosure of conflicts of interest, transparency in funding, standards of authorship, ethical treatment of research participants, and the management of sensitive data. The ICMJE, WAME, and COPE organizations offer recommendations to ensure the maintenance of these standards. The significant increase in publication volume in rheumatology research, along with the rise of social media and artificial intelligence, presents new and complex difficulties that require establishing clearer and universally accepted ethical guidelines. Rheumatology journals should prioritize the development of cohesive ethical principles as well as the encouragement of uniform ethics training for researchers, editors, and publishers., Competing Interests: Declarations. Conflict of interest: None., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

There are currently no registered Aboriginal and Torres Strait Islander community controlled HRECs in Victoria, Tasmania or Queensland,[10] and there is no Torres Strait Islander controlled HREC. Keywords: Ethics committees; Ethics, research; Public policy EN Ethics committees Ethics, research Public policy 9 11 3 06/30/23 20230701 NES 230701 Growth in Aboriginal and Torres Strait Islander health research requires urgent investment in Aboriginal and Torres Strait Islander ethical governance Indigenous peoples have been conducting research to understand complex systems of knowledge since time immemorial.[1] The embodiment of principles aligned with Indigenous ways of knowing, being and doing is central to the legacy of this expert research practice. [Extracted from the article]

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New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk–benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research (e.g., only for life-threatening conditions). Instead, we propose that the individual risks for the pregnant woman and the fetus should be justified by the benefits for them and the study's social value. Studies that meet this overall proportionality criterion but have mildly unfavorable risk–benefit ratios for pregnant women and/or fetuses may be acceptable. [ABSTRACT FROM AUTHOR]

A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not necessarily shorten the path to find safe and efficacious interventions for COVID-19. We analyze the trials for COVID-19 treatment and prevention that are registered from LAC countries in the International Clinical Trials Registry Platform, and identify a trend towards small repetitive non-rigorous studies that duplicate efforts and drain limited resources without producing meaningful conclusions on the safety and efficacy of the interventions being tested. We further assess the challenges to conducting scientifically sound and socially valuable research in the LAC region in order to inform recommendations to encourage clinical trials that are most likely to produce robust evidence during the pandemic.

Abstract Currently there is an increasing interest in publications on the use of corpses for research in Brazil and worldwide. Scientific evidence reveal that these studies have little ethical and regulatory control. In Brazil, the regulation of this subject is scarce and scattered among laws and sublegal normative acts, hindering the knowledge of ethical and legal practices adopted by researchers. This article analyzes the laws and norms for scientific research on corpses in Brazil through a corpus that underlies this type of research. From the 1940-2012 period, we found seven documents of the Brazilian legislation that gather information for ethical and clear research. Finally, we present guidelines and a protocol to be followed by researchers for the development of ethical and legal studies with corpses in Brazil.

This article is part of a special series that was designed to assist authors in the process of scientific writing and communication. Among the various forms of ethical misconduct in scientific publishing, plagiarism is increasingly common. Plagiarism is defined as the presentation of a work containing parts authored by another person without due credit. One type of plagiarism that has gained prominence in recent years is self-plagiarism, in which authors themselves reuse their previous work without proper referencing. However, active discussion remains in the scientific community about this type of plagiarism, with the term being extended to some specific forms of misconduct in scientific publication. This practice leads to inauthentic work and ultimately undermines the integrity of science. The purpose of this article is to address in depth the definition of self-plagiarism, the underlying motives for this practice and its consequences for the scientific community. To do so, a non-systematic review of the literature was conducted. Guidance is provided on the major types of self-plagiarism, what can be done to avoid it and how to proceed when it is detected.

This paper is a study of the decisions that researchers take during the execution of a research plan: their researcher discretion. Flexible research methods are generally seen as undesirable, and many methodologists urge to eliminate these so-called 'researcher degrees of freedom' from the research practice. However, what this looks like in practice is unclear. Based on twelve months of ethnographic fieldwork in two end-of-life research groups in which we observed research practice, conducted interviews, and collected documents, we explore when researchers are required to make decisions, and what these decisions entail.An abductive analysis of this data showed that researchers are constantly required to further interpret research plans, indicating that there is no clear division between planning and plan execution. This discretion emerges either when a research protocol is underdetermined or overdetermined, in which case they need to operationalise or adapt the plans respectively. In addition, we found that many of these instances of researcher discretion are exercised implicitly. Within the research groups it was occasionally not clear which topic merited an active decision, or which action could retroactively be categorised as one.Our ethnographic study of research practice suggests that researcher discretion is an integral and inevitable aspect of research practice, as many elements of a research protocol will either need to be further operationalised or adapted during its execution. Moreover, it may be difficult for researchers to identify their own discretion, limiting their effectivity in transparency., Competing Interests: Declarations. Competing Interests: The research leading to these results received funding from the European Research Council under Grant agreement ID: 771483. The authors have no relevant financial or non-financial interests to disclose. Pre-Registration: Our study protocol was pre-registered on the Open Science Framework ( https://osf.io/qmdh5 )., (© 2024. The Author(s).)

Background: Community engagement (CE) is one of the key strategies to optimize ethical integrity in research. However, the knowledge base on how CE should be effectively and ethically conducted, particularly for genetics and genomics research (GGR), is limited. Lessons have not been drawn from the experiences of key stakeholders in GGR, on CE, in Uganda., Aim: To analyze the experiences and perspectives of the key stakeholders (GGR researchers, lay communities, and REC members) on engaging communities in GGR, to consequently inform how communities could be ethically engaged in such research, in Uganda., Method: A cross-sectional qualitative study was conducted at; Makerere University, Uganda Virus Research Institute, and Mulago National Referral Hospital. Twenty-five GGR researchers, twenty REC members, and thirty-eight community members, participated in this study. Data were collected using in-depth interviews guides, and Focus group discussions. Data was analyzed thematically, using NVivo version 12 Plus., Study Findings: Thirteen of the twenty-five GGR researchers had conducted CE in their studies, seven REC members had ever reviewed GGR protocols, and all the community respondents had ever participated in GGR. The goal for CE was reported to depend on the type of GGR as either basic or applied. Planning for CE involved; defining the community and for GGR this includes individuals not directly involved in the research but share the study gene with participants; a bigger CE budget to cover extra costs in GGR. The conduct of CE was reported to mainly occur at sample collection stage, rarely at study conception, and had not occurred at the return of results stage. Implementation of CE involved; engaging leaders first to gain access and acceptance of the research in the community; having a genetic counsellor on the CE team to handle the social issues in GGR., Conclusion: This study provides challenges and facilitators on the conduct of CE in GGR in Uganda. Measures including the building of capacity especially knowledge in both GGR and CE for all the stakeholders, and using this study findings to inform policy, regulation, and further research will potentially contribute to ethical CE in GGR in Uganda and similar research contexts., Competing Interests: Declarations. Ethics approval and consent to participate: Ethical approval for this study was sought from the Makerere University School of Biomedical Sciences Higher Degrees Research and Ethics Committee, Ref No: SBS-2021-66. This was followed by obtaining ethical clearance from UNCST, Ref No: SS1172ES. Participation in the study was voluntary, and participants’ written informed consent was sought. All the methods were carried out in accordance with relevant national and international guidelines and regulations. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Introduction: Given the growing number of Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) genomics research projects and the vulnerabilities of study participants, it is critical to evaluate the literature on the ethical challenges in such studies to ensure high ethical standards., Methods: We conducted a systematic review of the literature on ethical issues in AD/ADRD genomics research. We searched Embase, PsycINFO, CiNAHL, Scopus, and Ovid Medline for empirical and normative papers published in peer-reviewed journals on the ethical issues involved in conducting genomics research among persons with AD/ADRD. We used ethical principles from an existing framework as a priori codes to categorize the ethical issues and adapted another framework of Dementia Research Ethical Issues (DREI) as subcategories for our synthesis. We used the 2021 PRISMA guidelines to guide our study., Results: We screened 5,509 papers and included 27 of these papers in the systematic review after deduplication, title, and full-text review. The papers contained 109 ethical issues that were mapped against 42 out of 75 relevant DREIs. The highest number of DREIs were mapped to "respect for persons and communities", "favorable risk-benefit ratio", "informed consent" and "scientific validity". The least mapped principles to the DREIs were "fair participant selection", "independent review", "social value", and "collaborative partnership"., Conclusion: Our review showed that there is a dearth of literature on the ethical principles of "fair participant selection", "independent review", "social value" and "collaborative partnership" in genomics research on AD/ADRDs. It is difficult to draw firm conclusions from the distribution of attention paid to specific principles because these may only reflect the concerns of AD/ADRD genomics research ethicists in high-income countries. There is need for more research on the ethics of AD/ADRD genomics research in low and middle-income countries for a more balanced account of the important ethical considerations in this field., Competing Interests: Declarations. Ethics approval and consent to participate: This review was approved by the National Health Research Ethics Committee of Nigeria (NHREC/01/01/2007-09/01/2019), and the University of Ibadan/University College Hospital Joint Ethics Committee (UI/EC/19/0121) as part of the “Research ethics of Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD) in Nigeria (READING Project)”. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Background: This study utilizes a Knowledge, Attitude, and Practice (KAP) questionnaire to investigate the awareness of medical professionals in the Ningxia region regarding research integrity and their attitudes towards academic misconduct. A comprehensive analysis of the factors contributing to academic misconduct is performed, with the aim of providing insights for the formulation of policies to enhance research integrity., Methods: This study is a cross-sectional study. It performed between May 2023 and October 2023, and the questionnaires were distributed and collected through Wenjuanxing and WeChat platforms. The research employs a self-designed KAP survey questionnaire distributed online for clinical doctors and nurses in hospital, faculty members in medical higher education institutions, and undergraduates enrolled in medical schools in the Ningxia region., Results: A total of 1013 valid questionnaires were collected, with a majority of participants (76.2%) having received training in research integrity. The survey results indicate that a significant majority of participants (75.04%) cannot tolerate academic misconduct. More than 70% of respondents believe that the main reasons for academic misconduct are a lack of understanding of academic ethical norms, a deficiency in personal integrity awareness, individual inadequacy in research capabilities, and excessive pressure. When it comes to measures for academic misconduct reduction, over 70% of individuals believe that strengthening research integrity training, improving the assessment methods for research outcomes, and enhancing personal research capabilities can decrease instances of academic misconduct. Most respondents demonstrated a basic understanding of research integrity and maintained a resistant attitude towards academic misconduct. However, there exists an insufficient awareness of certain forms of academic misconduct. The study recommends implementing multifaceted measures to enhance the ethical awareness and attitudes of researchers., Conclusion: In this study, a KAP questionnaire was administered to clinicians, nurses, medical faculty and students to find out their understanding of research integrity and their attitudes towards academic misconduct. Most of the respondents had a negative attitude towards academic misconduct, but their understanding of research integrity could be improved. Furthermore, university teachers' understanding of research integrity and their attitudes towards academic misconduct were better than other groups, and university students had lower scores in this area, so it is recommended to take various measures to improve their understanding of research integrity., Competing Interests: Declarations. Ethics approval and consent to participate: Ethics approval for this study was obtained from the ethics review committee of Ningxia Medical University General Hospital. (approval number: KYLL-2024-0544) Consent for publication: Consent for publication was obtained from the participants involved in this study. Competing interests: The authors declare no competing interests. Authors’ contributions: Yiran Jin: Writing – Original draft, Conceptualization, Data curation. Jie Wei: Conceptualization, Investigation. Dan Liu: Funding acquisition, Writing – review & editing, Project administration. Sang Luo: Writing – review & editing, Project administration. Liwei Yuan: Validation. Jingyi Zhang: data analysis. Xiaojie Zou: data analysis. Author Yiran Jin and Author Jie Wei share first authorship. All authors read and approved the final manuscript., (© 2024. The Author(s).)

Background: To identify and to summarize challenges related to the informed consent process for research completed during humanitarian emergencies., Methods: Using relevant search terms, a search of 5 databases was completed, without language, date, or study type restriction. Studies were screened for inclusion, with eligible studies being those that were relevant to the informed consent process for research studies completed in humanitarian emergencies. A Grounded Theory Analysis was completed to identify themes and subthemes., Results: Review identified 30 relevant studies. We identified 11 challenges (lack of trust, therapeutic misconception, reduced capacity, security and privacy concerns, harmful research, power differential, literacy, language/local and cultural context, researcher burden and re-evaluation of ongoing trials) and 7 strategies (engage local research communities, use alternative to standard written consent process, modify traditional process of research ethics board review, dynamic consent, training of research staff, mandating transparency of commercial interests, and mandating reporting of informed consent process in all publications) to confront the challenges. These challenges and strategies were unique to the informed consent process in research conducted during humanitarian emergencies., Conclusions: This scoping review identified an evidence-based guide for researchers and research ethics boards to perform ethical informed consent procedures in humanitarian emergencies., Trial Registration: This trial was not registered as scoping reviews can not be registered as per updated PROSPERO guidelines., Competing Interests: Declarations. Ethics approval and consent to participate: No protocol approval was needed for the survey of data collection as only publicly available data was used. Consent for publication: The authors of this study consent to its publication. No part of this study has been previously published. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Background: Research in children is essential for them to benefit from the outcomes of research but involvement must be weighed against potential harms. In many countries and circumstances, medical research legally requires parental consent until the age of 18 years, with poorly defined recommendations for assent prior to this. However, there is little research exploring how these decisions are made by families and the ethical implications of this., Aim: To explore key ethical debates in decision-making for participation of children and adolescents in a human papillomavirus (HPV) vaccine trial., Methods: Semi-structured interviews were undertaken with Tanzanian girls (aged 9-16 years) who had participated in an HPV vaccine trial (n = 13), their parents or guardians (n = 12), and girls together with their parents (in paired parent-child interviews) (n = 6). The interviews were analysed using thematic analysis. Interview data came from a qualitative acceptability study undertaken as part of the Dose Reduction Immunobridging and Safety Study of Two Human Papillomavirus (HPV) Vaccines in Tanzanian Girls (DoRIS) trial., Results: Girls and parents desired collaborative decision-making, with parents ultimately making the decision to consent. However, girls wanted a larger part in decision-making. Decisions to consent involved many people, including extended social networks, the trial team, media outlets and healthcare professionals and this resulted in conflicts to be negotiated. Deciding where to place trust was central in participants and parents considering decisions to consent and overcoming rumours about trial involvement., Conclusions: Existing models of decision-making help to understand dynamics between parents, adolescents and researchers but neglect the important wider social impacts and the fundamental nature of trust. Children's roles in discussions can be evaluated using the principles of consent: autonomy, freedom and information. Concepts such as relational autonomy help to explain mechanisms families use to negotiate complex consent decisions. Whilst interviewees supported the maintenance of legal parental consent, researchers must design consent processes centring the child to ensure that whole family decision-making processes are supported., Competing Interests: Declarations Ethics approval and consent to participate Ethical approval for the DoRIS qualitative study was granted from the London School of Hygiene and Tropical Medicine Ethics Committee (ref: 11972) and the National Health Research Ethics Committee in Tanzania (ref: NIMR/HQ/R.8a/Vol.IX/2682). Informed consent for participation in the acceptability study was obtained by a qualitative researcher explaining the study, providing written information, and answering any questions. Written informed consent was obtained from the parents, and written informed assent was obtained from the girls. Witnessed informed consent and signing with a thumbprint was obtained in the case of parent/guardian illiteracy, as approved in the ethics committees. Consent for publication Not applicable. Competing interests KB reports grants from BMGF during the conduct of the DoRIS trial, and grant support from Merck Pharmaceuticals outside the submitted work. This constitutes a financial competing interest, but was not felt to have affected the study from proposal to manuscript development. The other authors declare that they have no competing interests. Authors’ information This project was completed as part of a dissertation in partial fulfilment of LF’s MSc Public Health from London School of Hygiene and Tropical Medicine, for which KM was supervising., (© 2024. The Author(s).)

Background: The impetus for policies promoting medical data sharing in China has gained significant traction. Nonetheless, the present legal and ethical framework governing the research use of medical data in China, is characterized by a more restrictive rather than permissive approach. The proportion of Chinese medical data being leveraged for scientific research still has room for improvement at present, indicating a significant untapped potential for advancing medical knowledge and improving healthcare outcomes. Building upon this research, we aim to delve deeper into the challenges researchers encounter in the sharing of medical data through focus group interviews., Methods: We conducted two focus group interviews study with researchers representing diverse disciplines to explore their perspectives on 21 June 2021 and 28 July 2021. A total of seventeen researchers willingly participated in this study, representing various professional backgrounds. Similar codes were merged. Research team discussions were also utilized to select interviewees' statements that were regarded as typical or representative., Results: The respondents demonstrated a strong understanding that medical data should not be disseminated arbitrarily, recognizing the importance of sharing data in compliance with laws. Through the interview, we found that although respondents stressed the importance of careful consideration regarding if and when this information can be responsibly released, none of the respondents raised the issue of necessitating consent from data subjects for the research use of medical data. This observation sharply contrasts with the stringent separate consent provisions for secondary data use outlined in the PIPL., Conclusions: The findings from the focus group studies shed light on researchers' barriers and ethical challenges towards medical data sharing for scientific research, highlighting their deep concern for data security and cautious approach to sharing. The key objectives aimed at facilitating and enabling the reuse of medical data encompass enhancing interoperability, harmonizing data standards, improving data quality, safeguarding privacy, ensuring informed consent, incentivizing patients, and establishing explicit regulations pertaining to data access and utilization., Competing Interests: Declarations Ethical approval and consent to participate This investigation was reviewed and approved by the Health Science Center of Peking University IRB (No IRB00001052-19013). To safeguard the privacy of the respondents, we proactively requested them to mask any identifying characteristics that could potentially lead to recognition. Moreover, all respondents provided informed consent, having received comprehensive written and oral information about the project. This information included details about the objectives and topics of the focus group interviews, the confidentiality measures in place to protect their data, the storage and use of the data for scientific papers and presentations, as well as the option to withdraw from the study at any point without providing a specific reason. Throughout the transcription process, careful consideration was given to protecting the identities of individuals, institutions, and locations involved in the study. Names were changed, and any information that posed a risk of identifying individuals was handled with utmost caution. Consent for publication Not applicable. Competing interests The authors declare no competing interests., (© 2024. The Author(s).)

Ethical publishing practices are vital to tobacco control research practice, particularly research involving Indigenous ( Indigenous peoples : For the purposes of this Special Communication, we use the term Indigenous people(s) to include self-identified individuals and communities who frequently have historical continuity with precolonial/presettler societies; are strongly linked to the land on which they or their societies reside; and often maintain their own distinct language(s), belief and social-political systems, economies and sciences. The authors humbly acknowledge, respect and value that Indigenous peoples are diverse and constitute many nations, cultures and language groups. Many Indigenous peoples also exist as governments in treaty relations with settler-colonial societies, and all Indigenous peoples have inherent rights under international law. The language and terminology used should reflect the local context(s) and could include, but are not limited to, terms such as Aboriginal, Bagumani, Cherokee, First Peoples, First Nations, Inuit, Iwaidja, Kungarakan, Lakota, Māori, Mѐtis, American Indian, Navajo, Wagadagam, Wiradjuri, Yurok, etc) people. These practices can minimise, correct and address biases that tend to privilege Euro-Western perspectives. Ethical publishing practices can minimise and address harms, such as appropriation and misuse of knowledges; strengthen mechanisms of accountability to Indigenous peoples and communities; ensure that tobacco control research is beneficial and meaningful to Indigenous peoples and communities; and support Indigenous agency, sovereignty and self-determination. To ensure ethical practice in tobacco control, the research methodology and methods must incorporate tangible mechanisms to include and engage those Indigenous peoples that the research concerns, affects and impacts. Tobacco Control is currently missing an ethical research and evaluation publishing protocol to help uphold ethical practice. The supporters of this Special Communication call on Tobacco Control to adopt publication practice that explicitly upholds ethical research and evaluation practices, particularly in Indigenous contexts. We encourage researchers, editors, peer reviewers, funding bodies and those publishing in Tobacco Control to reflect on their conduct and decision-making when working, developing and undertaking research and evaluation of relevance to Indigenous peoples. Tobacco Control and other publishers, funding bodies, institutions and research teams have a fundamental role in ensuring that the right peoples are doing the right work in the right way. We call for Tobacco Control to recognise, value and support ethical principles, processes and practices that underpin high-quality, culturally safe and priority-driven research, evaluation and science that will move us to a future that is commercial tobacco and nicotine free., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The burden of research ethics review falls not just on researchers, but also on those who serve on research ethics committees (RECs). With the advent of automated text analysis and generative artificial intelligence (AI), it has recently become possible to teach AI models to support human judgment, for example, by highlighting relevant parts of a text and suggesting actionable precedents and explanations. It is time to consider how such tools might be used to support ethics review and oversight. This essay argues that with a suitable strategy of engagement, AI can be used in a variety of ways that genuinely support RECs to manage their workload and improve the quality of review. It would be wiser to take an active role in the development of AI tools for ethics review, rather than to adopt ad hoc tools after the fact., (© 2024 The Authors. Ethics & Human Research published by Wiley Periodicals LLC on behalf of The Hastings Center.)

Practitioners aim to improve healthcare systems and clinical care through a variety of activities as part of a learning healthcare system. Yet the distinction between projects requiring Research Ethics Board (REB) approval or not is becoming increasingly blurred, making it difficult for researchers and others to classify projects and then navigate the required compliance pathway appropriately. To address this challenge, the Provincial Health Services Authority (PHSA) of British Columbia (BC) created a decision tool called the "PHSA Project Sorter Tool" to serve its diverse community while also meeting the unique needs of the BC regulatory and policy environment. The goal of the tool was to standardize and clarify organizational project review and ensure project leads were referred to the appropriate review body or service provider within the PHSA in the most efficient manner possible. In this paper, we describe the ethics needs assessment that was conducted to inform the tool and the results of our ongoing evaluation of the tool since it was launched in January, 2020. Our project shows that this simple tool can reduce burdens on staff and provide clarity to users by standardizing processes and terms and directing users to appropriate internal resources.

The recent pandemic spurred interest in innovative design for clinical trials. In particular, constraints on the public's ability to gather led to an increase in remote or decentralized clinical trials (DCTs). DCTs present an opportunity to extend the benefits of research to underserved populations, decrease burdens, increase access to trials, and fill knowledge gaps surrounding rare conditions, though they are not without their own unique challenges and risks. These risks are far from irremediable, and the advantages are significant enough to merit attention. There is a scientific and moral case to increase the use of DCTs beyond the context of public health emergencies., (© 2024 by The Hastings Center. All rights reserved.)

More commonly today, research ethics and misconduct are ideas that are frequently violated. The availability of information sources and the dissemination of awareness among researchers can help to reduce this kind of violation. This study highlights how YouTube can be used to promote discussions of research misconduct and ethics. The study looked into how many videos there are on research ethics and misconduct, which colleges actively provide such videos, and how satisfied viewers are with the available videos by analyzing comments. Various software tools, including Webometric Analyst, R-studio, and Microsoft Excel, were applied for data collection and analysis. On 01-24-2023, 515 videos and 6984 comments were retrieved using the correct search queries that is "Research ethics" OR "Research misconduct" OR "Research conduct" OR "Scientific integrity" OR "Research integrity" OR "Scientific misconduct." Results indicate that 2020 was the most significant year, since the most videos (241) were posted in this year. The channels titled "PPIRCPSC, ABRIZAH A, and ALHOORI H" upload 10, 9, and 8 videos respectively, placing them in the first, second, and third positions. By analyzing viewer comments, it was determined that the majority of comments were favorable, indicating that viewers are generally pleased with the available videos.