Search

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]

Abstract Background Current requirements for ethical research in Canada, specifically the standard of active or signed parental consent, can leave Indigenous children and youth with inequitable access to research opportunities or health screening. Our objective was to examine the literature to identify culturally safe research consent processes that respect the rights of Indigenous children, the rights and responsibilities of parents or caregivers, and community protocols. Methods We followed PRISMA guidelines and Arksey and O’Malley’s approach for charting and synthesizing evidence. We searched MEDLINE, PsycINFO, ERIC, CINAHL, Google Scholar, Web of Science, Informit Indigenous Collection, Bibliography of Native North Americans, and Sociological Abstracts. We included peer-reviewed primary and theoretical research articles written in English from January 1, 2000, to March 31, 2022, examining Indigenous approaches for obtaining informed consent from parents, families, children, or youth. Eligible records were uploaded to Covidence for title and abstract screening. We appraised the findings using a Two-Eyed Seeing approach. These findings were inductively coded using NVivo 12 and analyzed thematically. Results We identified 2,984 records and 11 eligible studies were included after screening. Three key recommendations emerged: addressing tensions in the ethics of consent, embracing wise practices, and using relational approaches to consent. Tensions in consent concerned Research Ethics Board consent requirements that fall short of protecting Indigenous children and communities when culturally incongruent. Wise practices included allowing parents and children to consent together, land-based consenting, and involving communities in decision-making. Using relational approaches to consent embodied community engagement and relationship building while acknowledging consent for Indigenous children cannot be obtained in isolation from family and community. Conclusions Very few studies discussed obtaining child consent in Indigenous communities. While Indigenous communities are not a monolith, the literature identified a need for community-driven, decolonized consent processes prioritizing Indigenous values and protocols. Further research is needed to examine nuances of Indigenized consent processes and determine how to operationalize them, enabling culturally appropriate, equitable access to research and services for all Indigenous children.

Background: Current requirements for ethical research in Canada, specifically the standard of active or signed parental consent, can leave Indigenous children and youth with inequitable access to research opportunities or health screening. Our objective was to examine the literature to identify culturally safe research consent processes that respect the rights of Indigenous children, the rights and responsibilities of parents or caregivers, and community protocols. Methods: We followed PRISMA guidelines and Arksey and O'Malley's approach for charting and synthesizing evidence. We searched MEDLINE, PsycINFO, ERIC, CINAHL, Google Scholar, Web of Science, Informit Indigenous Collection, Bibliography of Native North Americans, and Sociological Abstracts. We included peer-reviewed primary and theoretical research articles written in English from January 1, 2000, to March 31, 2022, examining Indigenous approaches for obtaining informed consent from parents, families, children, or youth. Eligible records were uploaded to Covidence for title and abstract screening. We appraised the findings using a Two-Eyed Seeing approach. These findings were inductively coded using NVivo 12 and analyzed thematically. Results: We identified 2,984 records and 11 eligible studies were included after screening. Three key recommendations emerged: addressing tensions in the ethics of consent, embracing wise practices, and using relational approaches to consent. Tensions in consent concerned Research Ethics Board consent requirements that fall short of protecting Indigenous children and communities when culturally incongruent. Wise practices included allowing parents and children to consent together, land-based consenting, and involving communities in decision-making. Using relational approaches to consent embodied community engagement and relationship building while acknowledging consent for Indigenous children cannot be obtained in isolation from family and community. Conclusions: Very few studies discussed obtaining child consent in Indigenous communities. While Indigenous communities are not a monolith, the literature identified a need for community-driven, decolonized consent processes prioritizing Indigenous values and protocols. Further research is needed to examine nuances of Indigenized consent processes and determine how to operationalize them, enabling culturally appropriate, equitable access to research and services for all Indigenous children. [ABSTRACT FROM AUTHOR]

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]

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]

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.)

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.)

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.)

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.

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.)

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.)

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).)

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.

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.

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.)

The primary objective of any research, regardless of its domain such as health, technology, psychology, or any other subject, is to enhance the overall well-being of individuals. Rigorous processes are involved in conducting research ethically and in communicating its outcomes to society. However, as publishing research has become a mandatory requirement for career advancement and appointments, academics are resorting to several unethical practices to get substandard work published quickly. Consequently, predatory publishing markets have emerged, which publish data that is falsified and fabricated, along with plagiarised textual matter. The emergence of "paper mills" is a further step in the corruption of research, where a group of persons or automated systems generate papers for publication. Anyone desirous of publishing a paper can purchase one, akin to any desired fast-moving consumer product, with the added guarantee of publication in indexed journals. Therefore, paper mills and their unethical modus operandi are discussed in this paper in detail, with relevant examples. The article unfolds the consequences of publishing such fraudulent research papers and concludes with the challenges in combating paper mills.

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.

A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection- and efficiency-based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate., (© 2024 by The Hastings Center. All rights reserved.)

Online participant recruitment ("crowdsourcing") platforms are increasingly being used for research studies. While such platforms can rapidly provide access to large samples, there are concomitant concerns around data quality. Researchers have studied and demonstrated means to reduce the prevalence of low-quality data from crowdsourcing platforms, but approaches to doing so often involve rejecting work and/or denying payment to participants, which can pose ethical dilemmas. We write this essay as an associate professor and two institutional review board (IRB) directors to provide a perspective on the competing interests of participants/workers and researchers and to propose a checklist of steps that we believe may support workers' agency on the platform and lessen instances of unfair consequences to them while enabling researchers to definitively reject lower-quality work that might otherwise reduce the likelihood of their studies producing true results. We encourage further, explicit discussion of these issues among academics and among IRBs., (© 2024 The Authors. Ethics & Human Research published by Wiley Periodicals LLC on behalf of The Hastings Center.)

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.)

Background: Institutional review boards (IRBs) face delays in reviewing research proposals, underscoring the need for optimized standard operating procedures (SOPs). This study assesses the abilities of three artificial intelligence (AI) platforms to address IRB challenges and draft essential SOPs. Methods: An observational study was conducted using three AI platforms in 10 case studies reflecting IRB functions, focusing on creating SOPs. The accuracy of the AI outputs was assessed against good clinical practice (GCP) guidelines. Results: The AI tools identified GCP issues, offered guidance on GCP violations, detected conflicts of interest and SOP deficiencies, recognized vulnerable populations, and suggested expedited review criteria. They also drafted SOPs with some differences. Conclusion: AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions., Competing Interests: Declaration of Conflicting InterestsThe authors declared no actual or potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

This paper discusses the historical context of collaborative research and authorship disputes, exemplified by the complex relationship between Dutch anatomist and physician Gerard L. Blaes and his East-Central European mentee, Daniel Gödtke, during the study of medulla spinalis. The study employs historical analysis to unravel the dynamics of scholarly collaboration, emphasizing the significance of mentorship in scientific progress and the communal nature of knowledge exchange. This historical analysis is based on primary sources and historical records. It underscores Blaes's strategy to circumvent public confrontations regarding the authorship of the seminal work 'Anatome medullae spinalis, et nervorum inde provenientium' (1666). As a teacher, he facilitated his student's participation in a public disputation to avert public authorship conflicts over the book. This ultimately led to the publication of two distinct versions of 'Anatome medullae spinalis.' The first one was co-authored by the mentor and his mentee, while the latter was solely attributed to the mentor. This historical narrative raises essential questions about attributing individual contributions in medical sciences, echoing concerns still pertinent in contemporary academia. Additionally, it makes visible the power dynamics inherent in faculty-students relationships and the potential repercussions of authorship disputes on scholars' reputations. By drawing parallels between historical and modern authorship dilemmas, this study contributes to ongoing discussions on equitable authorship in scientific research and publishing. It not only highlights a historical precedent for the complex dynamics of mentor-mentee collaborations and authorship disputes but also illuminates how these practices continue to influence contemporary academic and publishing customs., (© 2024 American Association for Anatomy.)

Background: There are intense discussions about the ethical and societal implications of biomedical engineering, but little data to suggest how scientists think about the ethics of their work. The aim of this study is to describe how scientists frame the ethics of their research, with a focus on the field of molecular systems engineering., Methods: Semi-structured qualitative interviews were conducted during 2021-2022, as part of a larger study. This analysis includes a broad question about how participants view ethics as related to their work, with follow up probes about the topics they consider most important. Interviews were transcribed, inductively coded by two researchers to consensus, and analyzed thematically., Results: Twenty-four scientists participated in the study. Interviewees hold positions as professors, principal investigators, and senior staff researchers in universities or research institutes in the United States and Europe. Among those scientists who reported reflecting on ethical considerations in their work, many equated ethics with research ethics topics (e.g., safety, replicability), or with regulation and guidelines. Participants expressed the view that ethical issues are primarily relevant for clinical trials of bioengineered products, or for those working with animal or human subjects. Scientists described their research as "too early" or "not examining anything living" with regard to ethical reflection. Finally, many felt that ethics is seen as territory for experts and therefore beyond scientists' competencies., Conclusions: Molecular systems engineering scientists currently focus on regulatory aspects as the framework for their ethical analyses. They describe using a framework to define when life arises, as a means to determine when further ethical engagement is warranted. Further research is needed to investigate how scientists relate to the ethics of their scientific work, and build consensus around concepts of life, autonomous behavior, and physiological relevance of bioengineered systems.

Objective: This review explores the ethico-cultural and implementation challenges associated with the individual-based informed consent (IC) model in the relatively collectivistic African context and examines suggested approaches to manage them. Methods: We searched four databases for peer-reviewed studies published in English between 2000 to 2023 that examined the ethico-cultural and implementation challenges associated with the IC model in Africa. Results: Findings suggest that the individual-based IC model largely misaligns with certain African social values and ethos and subverts the authority and functions of community gatekeepers. Three recommendations were proffered to manage these challenges, that researchers should: adopt a multi-step approach to IC, conduct a rapid ethical assessment, and generate an African-centered IC model. Conclusions: A pluriversal, context-specific, multi-step IC model that critically harmonizes the cultural values of the local population and the general principles of IC can minimize ethics dumping, safeguard the integrity of the research process, and promote respectful engagement.

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.

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.

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.

Authorship of academic publications is central to scientists' careers, but decisions about how to include and order authors on publications are often fraught with difficult ethical issues. To better understand scholars' experiences with authorship, we developed a novel concept, authorship climate , which assesses perceptions of the procedural, informational, and distributive justice associated with authorship decisions. We conducted a representative survey of more than 3,000 doctoral students, postdoctoral researchers, and assistant professors from a stratified random sample of U.S. biology, economics, physics, and psychology departments. We found that individuals who tend to have more power on science teams perceived authorship climate to be more positive than those who tend to have less power. Alphabetical approaches for assigning authorship were associated with higher perceptions of procedural justice and informational justice but lower perceptions of distributive justice. Individuals with more marginalized identities also tended to perceive authorship climate more negatively than those with no marginalized identities. These results illustrate how the concept of authorship climate can facilitate enhanced understanding of early-career scholars' authorship experiences, and they highlight potential steps that can be taken to promote more positive authorship experiences for scholars of all identities.

Although adherence to Mertonian values of science (i.e., communism, universalism, organized skepticism, disinterestedness) is desired and promoted in academia, such adherence can cause friction with the normative structures and practices of Open Science. Mertonian values and Open Science practices aim to improve the conduct and communication of research and are promoted by institutional actors. However, Mertonian values remain mostly idealistic and contextualized in local and disciplinary cultures and Open Science practices rely heavily on third-party resources and technology that are not equally accessible to all parties. Furthermore, although still popular, Mertonian values were developed in a different institutional and political context. In this article, we argue that new normative structures for science need to look beyond nostalgia and consider aspirations and outcomes of Open Science practices. To contribute to such a vision, we explore the intersection of several Open Science practices with Mertonian values to flesh out challenges involved in upholding these values. We demonstrate that this intersection becomes complicated when the interests of numerous groups collide and contrast. Acknowledging and exploring such tensions informs our understanding of researchers' behavior and supports efforts that seek to improve researchers' interactions with other normative structures such as research ethics and integrity frameworks.

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.)

N/a.

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]

Copyright of Revista Bioetica is the property of Conselho Federal de Medicina and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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.