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Discussions of nonhuman research ethics tend to focus on what we owe nonhuman research subjects in laboratory settings only. But humans make critical decisions about these animals outside the lab, too, during breeding, transportation, and end-of-study protocols. This article reviews extra-lab risks and harms to nonhuman research subjects, focusing on the most commonly and intensively used animals like rodents and fishes, and argues that extra-lab risks and harms merit ethical consideration by researchers and institutional review., (Copyright 2024 American Medical Association. All Rights Reserved.)

Biobanks' activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first-hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU., (© 2023 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.)

A complex network of ethico-legal rules makes it difficult for health researchers in South Africa to lawfully recruit adolescents to the kinds of sensitive studies where it may be ethically appropriate to proceed without notifying parents or obtaining parental consent. This article responds to a recent proposal to amend the blanket requirement for mandatory parental consent presently contained in section 71 the South African National Health Act 61 of 2003 [NHA]. The proposed amendment is intended to bring the NHA into alignment with South Africa's 2015 Department of Health Guidelines on Ethics in Health Research by permitting greater flexibility for a health research ethics committee to waive parental consent, and permit adolescents to consent independently. A lacuna in this proposal is highlighted with reference to the requirements of South Africa's Protection of Personal Information Act 4 of 2013 [POPIA]: Even if the NHA is amended as proposed, the goal of aligning South African law with prevailing ethics norms in South Africa would not necessarily be attained, as parental consent may still be required by POPIA. This article investigates whether this goal (of aligning the law with ethics) can be attained in a way that is compliant with POPIA. It is concluded that this is indeed possible in a number of ways, and that the best way to attain this goal is by requesting the South African Information Regulator to issue a guidance note to the effect that all health research projects that are approved by institutional health research ethics committees are to be regarded as being in the public interest, which would qualify such health research projects to be exempted from POPIA's consent requirements., (© 2023 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.)

Nonhuman animal research has contributed to human health advancements but raises questions about the extent to which humans protect nonhuman animals during such endeavors. This series of drawings explores several ethics and empirical questions from a visual point of view., (Copyright 2024 American Medical Association. All Rights Reserved.)

Research ethics committees (RECs) have played a crucial role in expediting the review of research protocols amidst the COVID-19 pandemic. To improve their performance and identify areas of enhancement, a multicentric study was conducted in India by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). The study aimed to evaluate the preparedness of Indian RECs during the COVID-19 outbreak while conducting protocol reviews and comprehend the challenges they encountered. After obtaining ethics committee approval, a cross-sectional observational study was conducted using two validated questionnaires, one for REC member secretaries/chairpersons and another for REC members. The questionnaires consisted of 13 multiple-choice questions, 10 yes or no questions, and 2 open-ended questions each. The study was distributed to multiple RECs. A total of 109/200 participants, including 13 REC member secretaries, 12 chairpersons and 84 REC members from a total of 34 REC's, consented to participate in the study. During the COVID-19 pandemic, 23/25 (92%) of the RECs conducted online meetings. The most common challenges faced by RECs included risk-benefit analysis (12/25 RECs), review of informed consent (12/25 RECs), and protocols involving vulnerable populations (10/25 RECs). 65% of the REC members reported the need for ethics review training, and 66/84 REC members agreed or strongly agreed that RECs require training in COVID-19 protocol review. Additionally, 62/84 REC members agreed or strongly agreed that central/joint RECs should review multicenter COVID-19 protocols. RECs in India encountered difficulties while reviewing risk-benefit analyses, informed consent documents (ICDs), and COVID-19 protocols and they suggested providing training on these topics., (© 2023 John Wiley & Sons Ltd.)

The Principles of Humane Experimental Technique established what many know today as the "3 R's"-refinement, reduction, and replacement-when it was published in 1959. Since their formulation, these principles have guided decision-making for many about nonhuman animal subjects' uses in laboratory-based research. Discussion about how to amend or replace the 3 R's is ongoing, driven mainly by philosophical ethics approaches to nonhuman animal rights and by scientific advancement. This article explores merits and drawbacks of possible updates to and interpretations of the 3 R's., (Copyright 2024 American Medical Association. All Rights Reserved.)

Historically, most discussions about nonhuman animal experimentation consider what has become known as the 3 R's: refinement, reduction, and replacement. Refinement and reduction receive the most attention, but recent modeling advances suggest that suitable replacement of nonhuman animal testing would bolster human research and increase translatability to human health outcomes. This article discusses these modeling advances and advocates their use, especially as replacements to nonpredictive nonhuman animal protocols, and discusses growing momentum in biomedical research communities and federal agencies that favors replacement of animal testing., (Copyright 2024 American Medical Association. All Rights Reserved.)

Purpose: Adolescent participation in health research studies is critical yet complex given the lack of clarity around issues such as consent. This study aimed to understand how those conducting research in Australia navigate research ethics in health research involving adolescents, through qualitative interviews., Methods: Purposive sampling was used to recruit 23 researchers involved in adolescent health research using semi-structured in-depth interviews. Interviews were conducted via Zoom and audio-recorded after obtaining informed consent. Thematic analysis was used to construct themes and data were organised using NVivo., Results: Two contrasting positions emerged from the data: (1) framing of adolescents as inherently vulnerable, their participation in research understood in terms of risk and protection and (2) adolescent engagement in research is understood in terms of empowerment, emphasising their capacity to make decisions about research participation. We traced these positions through three key themes, particularly in relation to the role of ethics committees: (1) competing positions as a result of inferior or superior knowledge about adolescent lives, (2) competing positions resulting in a risk averse or an empowerment approach, and (3) reflections on processes of obtaining consent which involves gatekeeping and tokenism., Discussion: Our study highlights the contentious topic of navigating ethics committee requirements for the needs of adolescents. Majority of participants felt the current research ethics establishment is not favourable for researchers or adolescents themselves. While it is imperative that perceptions of ethics committees also be studied in the future, our study provides preliminary understanding of how experiences and perceptions shape how researchers interact with the research ethics establishment., (Copyright © 2024 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

In order to study early human development while avoiding the burdens associated with human embryo research, scientists are redirecting their efforts towards so-called human embryo-like structures (hELS). hELS are created from clusters of human pluripotent stem cells and seem capable of mimicking early human development with increasing accuracy. Notwithstanding, hELS research finds itself at the intersection of historically controversial fields, and the expectation that it might be received as similarly sensitive is prompting proactive law reform in many jurisdictions, including the Netherlands. However, studies on the public perception of hELS research remain scarce. To help guide policymakers and fill this gap in the literature, we conducted an explorative qualitative study aimed at mapping the range of perspectives in the Netherlands on the creation and research use of hELS. This article reports on a subset of our findings, namely those pertaining to (the degrees of and requirements for) confidence in research with hELS and its regulation. Despite commonly found disparities in confidence on emerging biotechnologies, we also found wide consensus regarding the requirements for having (more) confidence in hELS research. We conclude by reflecting on how these findings could be relevant to researchers and (Dutch) policymakers when interpreted within the context of their limitations., Competing Interests: Declarations. Conflicts of Interest/Competing Interests: Annelien L. Bredenoord is a member of the ISSCR Ethics Committee, the IQVIA’s Ethics Advisory Panel and the Dutch Senate. Ana M. Pereira Daoud, Wybo J. Dondorp and Guido M.W.R. de Wert have no relevant financial or non-financial interests to disclose. Ethics Approval: This study was approved by the Research Ethics Committee (REC) of the Faculty of Health, Medicine, and Life Sciences of Maastricht University (approval number: FHML-REC/2020/018). Consent to Participate: Written informed consent was obtained from all individual participants included in the study., (© 2024. The Author(s).)

The research and development of emerging technologies has potential long-term and societal impacts that pose governance challenges. This essay summarizes the development of research ethics in China over the past few decades, as well as the measures taken by the Chinese government to build its ethical governance system of science and technology after the occurrence of the CRISPR-babies incident. The essay then elaborates on the current problems of this system through the case study of ethical governance of brain-computer interface research, and explores how the transition from research ethics to translational bioethics, which encourages interdisciplinary collaboration and focuses on societal implications, may respond to the challenges of ethical governance of science and technology., (© 2024 by The Hastings Center. All rights reserved.)

This illustration depicts important biomedical advancements generated by nonhuman primate (NHP) research. NHPs' value in human-centered research is their unique evolutionary proximity to humans., (Copyright 2024 American Medical Association. All Rights Reserved.)

Research institutions often lack policies addressing the risks and benefits of enrolling "invested parties" such as investigators, research staff, and patient, caregiver, and community representatives (groups most affected by a disease or intervention) in studies where they have direct involvement. Invested parties may have both strong motivations to study the condition or intervention and to participate as study subjects. More guidance is needed to promote appropriate access to research participation and mitigate potential risks. This article addresses the gap in guidance by presenting an ethical framework and practical guidelines for the enrollment of invested parties. Drawing from experiences with the Researching COVID to Enhance Recovery (RECOVER) Initiative, a large multisite observational cohort study, we argue that invested parties should not be categorically excluded from enrollment in their own research studies if certain criteria are met and appropriate safeguards are in place. We underscore the need to balance inclusion with fairness, promote valid voluntary informed consent, ensure data privacy, protect scientific validity, and mitigate unique risks to invested parties as participants. Additionally, we recommend regular reporting and empirical assessment to evaluate the impact of enrolling invested parties on participants and study outcomes., (© 2024 The Authors. Ethics & Human Research, published by Wiley Periodicals LLC on behalf of The Hastings Center.)

If we assume that nonhuman animals experience pain or distress, then ethically justifying human-centered research with only nonhuman animals as subjects likely requires that the research's benefits to humans must, at least, outweigh harms suffered by the nonhuman animals. Yet this reasoning does not seem to account well for the ethical view that nonhuman animals are morally valuable in their own right. This commentary on a case considers this ethical tension and discusses how clinician-researchers should navigate it. This commentary also suggests why clinician-researchers' reasoning about the nature and scope of their obligations to nonhuman animals extends beyond governing regulations and federal oversight, which is silent on or ambiguous about nonhuman animals as morally valuable in their own right., (Copyright 2024 American Medical Association. All Rights Reserved.)

Nonhuman animals used in biomedical research frequently suffer and are harmed as part of their use as experimental models. The Institutional Animal Care and Use Committee (IACUC) of a given institution is meant to ensure that research protocols follow federal guidelines, but research protocols such as those described in this case can generate unnecessary suffering; this problem suggests limitations of IACUCs' capacity to protect nonhuman animals' welfare. This commentary on the case considers how to more fully protect nonhuman animals used in scientific research and identifies barriers to more comprehensive protection of nonhuman animals' welfare., (Copyright 2024 American Medical Association. All Rights Reserved.)

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Objective: To evaluate the knowledge and attitude of the students of Kerman dental school (Iran) about ethics in dental research. Material and Methods: This cross-section study was conducted on 307 dental students selected through the census sampling method. Data were collected by a researcher-made questionnaire consisting of 12 items about knowledge and 17 items about attitude toward research ethics. Data analyzed in SPSS software using t-test and linear regression test. P-values of less than 0.05 were considered statistically significant. Results: Of the respondents, 33.9% were male and 66.1% were female, and 44% had good knowledge and 20.8% had a positive attitude about research ethics. A significant correlation was found between knowledge and attitude. A significant correlation was also observed between knowledge and participation in research workshops. Knowledge and attitude showed no significant correlation with gender or year of admission. Conclusion: Participants had appropriate knowledge and attitude about research ethics. There is some room for improvement in research ethics education concerning experimental works and retrospective studies on biologic samples. Holding research workshops with an introduction to ethical codes of research is recommended.

Abstract Background Precision medicine (PM) is an emerging approach to individualized care. It aims to help physicians better comprehend and predict the needs of their patients while effectively adopting in a timely manner the most suitable treatment by promoting the sharing of health data and the implementation of learning healthcare systems. Alongside its promises, PM also entails the risk of exacerbating healthcare inequalities, in particular between ethnoracial groups. One often-neglected underlying reason why this might happen is the impact of structural racism on PM initiatives. Raising awareness as to how structural racism can influence PM initiatives is paramount to avoid that PM ends up reproducing the pre-existing health inequalities between different ethnoracial groups and contributing to the loss of trust in healthcare by minority groups. Main body We analyse three nodes of a process flow where structural racism can affect PM’s implementation. These are: (i) the collection of biased health data during the initial encounter of minority groups with the healthcare system and researchers, (ii) the integration of biased health data for minority groups in PM initiatives and (iii) the influence of structural racism on the deliverables of PM initiatives for minority groups. We underscore that underappreciation of structural racism by stakeholders involved in the PM ecosystem can be at odds with the ambition of ensuring social and racial justice. Potential specific actions related to the analysed nodes are then formulated to help ensure that PM truly adheres to the goal of leaving no one behind, as endorsed by member states of the United Nations for the 2030 Agenda for Sustainable Development. Conclusion Structural racism has been entrenched in our societies for centuries and it would be naïve to believe that its impacts will not spill over in the era of PM. PM initiatives need to pay special attention to the discriminatory and harmful impacts that structural racism could have on minority groups involved in their respective projects. It is only by acknowledging and discussing the existence of implicit racial biases and trust issues in healthcare and research domains that proper interventions to remedy them can be implemented.

Academic nurses or midwives and those employed by health sectors as independent researchers rarely deliver direct clinical care; juxtaposed with clinical nurses and midwives who typically have positions without any included seconded or protected research time. Although the end goal of greater investment in nursing- and midwifery-led research is to improve health care outcomes, it is possible that a push for more researchers could further exacerbate clinical nursing and midwifery shortages. Keywords: Ethics, research; Clinical trials as topic EN Ethics, research Clinical trials as topic 514 516 3 11/14/22 20221115 NES 221115 The largest health workforce has the greatest research potential; investing in nursing and midwifery researchers is an investment in better care and cost outcomes For the Medical Research Future Fund (MRFF) to achieve its full impact, it is necessary for health practitioners to be trained and reliably funded to deliver research and translation alongside their clinical work.1 We offer insight into current systems, concerns and suggestions as this applies to clinical research in nursing and midwifery. [Extracted from the article]

Abstract Background Reasonable disagreement about the role awarded to gamete donors in decision-making on the use of embryos created by gamete donation (EGDs) for research purposes emphasises the importance of considering the implementation of participatory, adaptive, and trustworthy policies and guidelines for consent procedures. However, the perspectives of gamete donors and recipients about decision-making regarding research with EGDs are still under-researched, which precludes the development of policies and guidelines informed by evidence. This study seeks to explore the views of donors and recipients about who should take part in consent processes for the use of EGDs in research. Methods From July 2017 to June 2018, 72 gamete donors and 175 recipients completed a self-report structured questionnaire at the Portuguese Public Bank of Gametes (response rate: 76%). Agreement with dual consent was defined as the belief that the use of EGDs in research should be consented by both donors and recipients. Results The majority of participants (74.6% of donors and 65.7% of recipients) were willing to donate embryos for research. Almost half of the donors (48.6%) and half of the recipients (46.9%) considered that a dual consent procedure is desirable. This view was more frequent among employed recipients (49.7%) than among non-employed (21.4%). Donors were less likely to believe that only recipients should be involved in giving consent for the use of EGDs in research (25.0% vs. 41.7% among recipients) and were more frequently favourable to the idea of exclusive donors’ consent (26.4% vs. 11.4% among recipients). Conclusions Divergent views on dual consent among donors and recipients indicate the need to develop evidence-based and ethically sustainable policies and guidelines to protect well-being, autonomy and reproductive rights of both stakeholder groups. More empirical research and further theoretical normative analyses are needed to inform people-centred policy and guidelines for shared decision-making concerning the use of EGDs for research.

Challenges and limitations of dynamic consent There is no ideal dynamic consent platform at present. Indeed, it has been argued that dynamic consent is necessary for personalised and precision medicine to achieve its goals.23,24 For example, the dynamic consent platform CTRL has recently been developed for the Australian Genomics study.21 Participants are invited to register for CTRL after they provide written consent to the study during a face-to-face recruitment meeting. Keywords: Informed consent; Confidentiality; Ethics, research; Privacy; Communication; eHealth; Internet; Mobile applications; Review article; Molecular medicine; Consumer health information EN Informed consent Confidentiality Ethics, research Privacy Communication eHealth Internet Mobile applications Review article Molecular medicine Consumer health information 547 549 3 06/21/22 20220615 NES 220615 Dynamic consent has the potential to facilitate personalised medicine delivering on its goals In Australia, guidelines for ethical conduct of human research are defined in the National Statement on Ethical Conduct in Human Research, which states: "consent should be a voluntary choice, and should be based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it".1 The conventional one-off approach to consent aims to encompass all aspects of the proposed research. [Extracted from the article]

The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach. [ABSTRACT FROM AUTHOR]

The ethical decision making of researchers has historically been studied from an individualistic perspective. However, researchers rarely work alone, and they typically experience ethical dilemmas in a team context. In this mixed-methods study, 67 scientists and engineers working at a public R1 (very high research activity) university in the United States responded to a survey that asked whether they had experienced or observed an ethical dilemma while working in a research team. Among these, 30 respondents agreed to be interviewed about their experiences using a think-aloud protocol. A total of 40 unique ethical incidents were collected across these interviews. Qualitative data from interview transcripts were then systematically content-analyzed by multiple independent judges to quantify the overall ethicality of team decisions as well as several team characteristics, decision processes, and situational factors. The results demonstrated that team formalistic orientation, ethical championing, and the use of ethical decision strategies were all positively related to the overall ethicality of team decisions. Additionally, the relationship between ethical championing and overall team decision ethicality was moderated by psychological safety and moral intensity. Implications for future research and practice are discussed., (© 2024. The Author(s).)

How good a research scientist is ChatGPT? We systematically probed the capabilities of GPT-3.5 and GPT-4 across four central components of the scientific process: as a Research Librarian, Research Ethicist, Data Generator, and Novel Data Predictor, using psychological science as a testing field. In Study 1 (Research Librarian), unlike human researchers, GPT-3.5 and GPT-4 hallucinated, authoritatively generating fictional references 36.0% and 5.4% of the time, respectively, although GPT-4 exhibited an evolving capacity to acknowledge its fictions. In Study 2 (Research Ethicist), GPT-4 (though not GPT-3.5) proved capable of detecting violations like p-hacking in fictional research protocols, correcting 88.6% of blatantly presented issues, and 72.6% of subtly presented issues. In Study 3 (Data Generator), both models consistently replicated patterns of cultural bias previously discovered in large language corpora, indicating that ChatGPT can simulate known results, an antecedent to usefulness for both data generation and skills like hypothesis generation. Contrastingly, in Study 4 (Novel Data Predictor), neither model was successful at predicting new results absent in their training data, and neither appeared to leverage substantially new information when predicting more vs. less novel outcomes. Together, these results suggest that GPT is a flawed but rapidly improving librarian, a decent research ethicist already, capable of data generation in simple domains with known characteristics but poor at predicting novel patterns of empirical data to aid future experimentation., Competing Interests: Competing interests statement:Cangrade builds AI-driven tools for businesses, but is not affiliated with OpenAI.

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria-or 'research involving the recently deceased'-can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor's legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically., Competing Interests: Competing interests: WA is a founder, equity stockholder, and scientific advisor of PhageNova Bio and of MBrace therapeutics. PhageNova Bio and MBrace Therapeutics partially support his academic laboratory through Sponsored Research Agreements. WA has previously out-licensed intellectual property related to findings potentially discovered and/or validated through translational research involving recently deceased human subjects or terminal-wean patients at the end of life. These relationships are currently managed according to established institutional conflict of interest policies of Rutgers, The State University of New Jersey. BP directs transplant ethics and policy research which is in part supported by a gift from United Therapeutics., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Nipah virus is a priority pathogen that is receiving increasing attention among scientists and in work on epidemic preparedness. Despite this trend, there has been almost no bioethical work examining ethical considerations surrounding the epidemiology, prevention, and treatment of Nipah virus or research that has already begun into animal and human vaccines. In this paper, we advance the case for further work on Nipah virus disease in public health ethics due to the distinct issues it raises concerning communication about the modes of transmission, the burdens of public health surveillance, the recent use of stringent public health measures during epidemics, and social or religious norms intersecting with preventive measures. We also advance the case for further work on Nipah virus disease in research ethics, given ethical issues surrounding potential vaccine trials for a high-fatality disease with sporadic spillover events, the different local contexts where trials may occur, and the potential use of unproven therapeutics during outbreaks. Further bioethics work may help to ensure that research and public health interventions for Nipah virus disease are ethically acceptable and more likely to be effective., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is an ethical framework developed by the WHO for using unproven interventions in public health emergencies outside the context of medical research. It is mainly intended for use when medical research would be impracticable, but there is still a need to systematically gather data about unproven interventions. As such, it is designed as something of a middle ground between clinical and research ethical frameworks.However, I argue that MEURI does not truly lie at the intersection of clinical care and research. Due to its intent, structure and oversight requirements, it takes on most of the crucial features of research, to the point that it is best understood as a form of research. As a result, cases where MEURI could practicably be applied should instead make use of existing research frameworks. For those circumstances where research is truly impracticable, a more straightforward oversight system than MEURI is needed. While existing practices of compassionate use have some applicability, proposals to make use of clinical ethics committees to oversee unproven interventions may help achieve the right balance in acting in a patient's best interests when the relevant evidence base is weak., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Ethics standards reference the need for special consideration of vulnerable populations, such as pregnant women, incarcerated individuals, and minors. The concept of vulnerability is poorly conceptualized in the medical sciences where it originated, and its application to the social sciences is even more challenging. Social science researchers may unwittingly fail to appreciate preexisting vulnerabilities and indeed may be responsible for inducing new research-related vulnerability. In this paper, we present the first comprehensive coding of country-level vulnerability designations. Specifically, we coded all 355 official documents governing social/behavioral human subjects research for the 107 countries with such regulations and identified 68 distinct vulnerability categories. The data reveal substantial regional variation, overemphasis of categories derived from medical sciences, neglect of critical categories such as displacement, and likely heterogeneity within and across groups. The article provides a conceptual framework that shifts the problem away from static, enumerated categories toward emphasis on research-induced vulnerability. Based on our conceptualization and coding, we present a framework for assessing vulnerability and implementing appropriate protections., Competing Interests: Competing interests statement:The authors declare no competing interest.

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., (© 2024. The Author(s).)

Sharing research data has great potential to benefit science and society. However, data sharing is still not common practice. Since public research funding agencies have a particular impact on research and researchers, the question arises: Are public funding agencies morally obligated to promote data sharing? We argue from a research ethics perspective that public funding agencies have several pro tanto obligations requiring them to promote data sharing. However, there are also pro tanto obligations that speak against promoting data sharing in general as well as with regard to particular instruments of such promotion. We examine and weigh these obligations and conclude that all things considered funders ought to promote the sharing of data. Even the instrument of mandatory data sharing policies can be justified under certain conditions., (© 2024. The Author(s).)

Structures for and practices of research integrity (RI) and research ethics (RE) differ among countries. This study analyzed the processes and structures for RI and RE in Europe, following the framework developed at the World Conferences on Research Integrity. We present RI and RE Country Report Cards for 16 European countries, which included the information on RI and RE structures, processes and outcomes. While some of the countries are front-runners when it comes to RI and RE, with well-established and continually developing policies and structures, others are just starting their journey in RI and RE. Although RI and RE contextual divergences must be taken into account, a level of harmonization among the countries is necessary so that researchers working in the European area can similarly handle RI and RE issues and have similar expectations regardless of the organization in which they work. RI and RE Country Report Cards can be a tool to monitor, compare, and strengthen RE and integrity across countries through empowerment and inspiration by examples of good practices and developed systems.

Existing research integrity (RI) guideline development methods are limited in including various perspectives. While co-creation methods could help to address this, there is little information available to researchers and practitioners on how, why and when to use co-creation for developing RI guidelines, nor what the outcomes of co-creation methods are. In this paper, we aim to address this gap. First, we discuss how co-creation methods can be used for RI guideline development, based on our experience of developing RI guidelines. We elaborate on steps including preparation of the aims and design; participant sensitization; organizing and facilitating workshops; and analyzing data and translating them into guidelines. Secondly, we present the resulting RI guidelines, to show what the outcome of co-creation methods are. Thirdly, we reflect on why and when researchers might want to use co-creation methods for developing RI guidelines. We discuss that stakeholder engagement and inclusion of diverse perspectives are key strengths of co-creation methods. We also reflect that co-creation methods have the potential to make guidelines implementable if followed by additional steps such as revision working groups. We conclude that co-creation methods are a valuable approach to creating new RI guidelines when used together with additional methods.

As relatively new economies to the global research arena, East Asian nations have fully realized the importance of research integrity in recent decades. This article conducts document analysis to demonstrate and discuss the current situation of research integrity campaigns in Taiwan, Korea, and Japan, nations that have similar cultural backgrounds and socioeconomic statuses. This article emphasizes the common situations faced by these three nations both individually and collectively. Based on a four-pillar framework, research integrity campaigns in these nations are making progress in terms of policies and regulations, institutional management, researchers' education and training, and the handling of misconduct cases. Various issues and challenges have also emerged in this context, although these efforts may have had positive impacts on research communities in these three nations. Challenges associated with research integrity governance, institutional willingness, RCR instructor qualifications, the effectiveness of education, and the standardization of definitions of misconduct and noncompliance are also highlighted. The issues discussed in this article are expected to have implications for research communities and policy-makers in these three nations as well as in a global context.

Concerns about research's environmental impacts have been articulated in the research arena, but questions remain about what types of role responsibilities are appropriate to place on researchers, if any. The research question of this paper is: what are the views of UK health researchers who use data-intensive methods on their responsibilities to consider the environmental impacts of their research? Twenty-six interviews were conducted with UK health researchers using data-intensive methods. Participants expressed a desire to take responsibility for the environmental impacts of their research, however, they were unable to consolidate this because there were often obstacles that prevented them from taking such role responsibilities. They suggested strategies to address this, predominantly related to the need for regulation to monitor their own behaviour. This paper discusses the implications of adopting such a regulatory approach as a mechanism to promote researchers' role responsibilities using a neo-liberal critique., (© 2024. The Author(s).)

Competing Interests: Competing interests: None declared.

Many countries consider long-term implications for society.

The establishment of clinical research resource platforms, including research databases and bio-sample library, is an important development in the field of clinical research. The international academic community proposes broad informed consent to regulate the ethical management of the issue. However, the broad informed consent fails to capture the main features of incomplete informed consent and authorization, misleads researchers and managers and leads to miss ethical management for clinical research projects. Therefore, the author proposes a named partial informed consent to improve ethical management for clinical research projects. Partial informed consent separates ethical management for establishing clinical research resource platforms and clinical research projects. After reviewing the legal and ethical foundation of clinical research ethics management, the author discussed the similarities and differences between project management and task management in the two informed consent solutions, the basis for approval of exempted informed consent signatures by the ethics committee, issues to be noted in the ethics management of multi-center research at the task level, and explained the substantive differences between broad informed consent and partial informed consent.

The application of artificial intelligence (AI) technologies in scientific research has significantly enhanced efficiency and accuracy but also introduced new forms of academic misconduct, such as data fabrication and text plagiarism using AI algorithms. These practices jeopardize research integrity and can mislead scientific directions. This study addresses these challenges, underscoring the need for the academic community to strengthen ethical norms, enhance researcher qualifications, and establish rigorous review mechanisms. To ensure responsible and transparent research processes, we recommend the following specific key actions: Development and enforcement of comprehensive AI research integrity guidelines that include clear protocols for AI use in data analysis and publication, ensuring transparency and accountability in AI-assisted research. Implementation of mandatory AI ethics and integrity training for researchers, aimed at fostering an in-depth understanding of potential AI misuses and promoting ethical research practices. Establishment of international collaboration frameworks to facilitate the exchange of best practices and development of unified ethical standards for AI in research. Protecting research integrity is paramount for maintaining public trust in science, making these recommendations urgent for the scientific community consideration and action., Competing Interests: The authors have no funding and conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Competing Interests: Disclosures Dr Sebastian reports employment by the University of Calgary. Dr de Souza reports compensation from Boehringer Ingelheim for other services. Dr Cano-Nigenda reports compensation from Boehringer Ingelheim for consultant services and grants from AstraZeneca. Dr Ferguson reports employment by the Heart Foundation, compensation from the National Stroke Foundation for other services, compensation from the Cardiac Society of Australia and New Zealand for other services, and employment by the National Health and Medical Research Council.

Research ethics and integrity are essential topics that researchers should always be concerned about and are emphasized by academic communities around the world. However, there is currently little information about the mechanisms to regulate research ethics and integrity in Thailand. Therefore, the aims of this study were to determine the approaches that universities used to support research ethics and integrity in Thailand and also to identify the barriers that may obstruct the development. A questionnaire was used to explore the strategies about research ethics of 44 Thai universities. It was found that the first three mechanisms used to foster research ethics and integrity were establishment of institutional regulatory research committees (84%), conduction of research ethics training programs (77%), and policy adoption (68%). Interestingly, there was a significant association between the sizes of universities and establishment of institutional regulatory research committees. The medium and small universities might need more support to develop their own research ethics regulatory mechanisms. The results here indicated good signs for Thailand about preparing basic structures for fostering research ethics and integrity. The recognition of this current status could provide the useful information for future development of research integrity in Thailand.

Research integrity is guided by a set of principles to ensure research reliability and rigor. It serves as a pillar to uphold society's trust in science and foster scientific progress. However, over the past 2 decades, a surge in research integrity concerns, including fraudulent research, reproducibility challenges, and questionable practices, has raised critical questions about the reliability of scientific outputs, particularly in biomedical research. In the biomedical sciences, any breaches in research integrity could potentially lead to a domino effect impacting patient care, medical interventions, and the broader implementation of healthcare policies. Addressing these breaches requires measures such as rigorous research methods, transparent reporting, and changing the research culture. Institutional support through clear guidelines, robust training, and mentorship is crucial to fostering a culture of research integrity. However, structural and institutional factors, including research incentives and recognition systems, play an important role in research behavior. Therefore, promoting research integrity demands a collective effort from all stakeholders to maintain public trust in the scientific community and ensure the reliability of science. Here we discuss some definitions and principles, the implications for biomedical sciences, and propose actionable steps to foster research integrity., Competing Interests: Declaration of competing interest D.M. is a member of the editorial board for the Journal of Clinical Epidemiology. K.D.C. is co-chair of the San Francisco Declaration on Research Assessment (DORA). A.C.V.A. has no competing interest to declare., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

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., 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.

This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research., (© 2024 The Authors. Ethics & Human Research published by Wiley Periodicals LLC on behalf of The Hastings Center.)

Artificial Intelligence (AI) and other large language models are rapidly infiltrating the world of education and educational research. These new technological developments raise questions about use and ethics throughout the world of educational research, particularly for qualitative methods given the philosophical and structural foundations of its associated designs. This paper seeks to interrogate the perceived ethics around the use of AI in qualitative research and draws on survey data from qualitative researchers ( n  = 101) collected from April-May 2023. Findings indicate that researchers were more apt to embrace the use of AI for transcription purposes, and to a lesser extent for preliminary coding. Researchers from high research productivity (R1) universities were generally less accepting of AI's use in the research process than other researchers., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.