Search

Copyright of Studia Socjologiczne is the property of Studia Socjologiczne 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.)

Copyright of Basic & Clinical Medicine is the property of Editorial Office of Basic & Clinical Medicine 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.)

Modern biomedical technology is in an era of dramatic development, which brings unprecedented challenges to the work of ethics review and provides a turning point for the construction of ethics review system. The current ethics review committee (ERC) in China is executed with low efficiency and quality, which can hardly meet the current needs of biomedical research involving human beings. This paper summarizes the main connotations and roles of the sign system technique and the discipline mechanism through the idea of Foucault’s Panopticism, and proposes to incorporate the Panopticism into the construction of the ethics review system and establish the sign system and discipline mechanism of ethics review, in order to build an ethics review system and the operation system of the ethics review committee suitable for China’s national conditions.

Background: It has been argued that ethics review committees—e.g., Research Ethics Committees, Institutional Review Boards, etc.— have weaknesses in reviewing big data and artificial intelligence research. For instance, they may, due to the novelty of the area, lack the relevant expertise for judging collective risks and benefits of such research, or they may exempt it from review in instances involving de-identified data. Main body: Focusing on the example of medical research databases we highlight here ethical issues around de-identified data sharing which motivate the need for review where oversight by ethics committees is weak. Though some argue for ethics committee reform to overcome these weaknesses, it is unclear whether or when that will happen. Hence, we argue that ethical review can be done by data access committees, since they have de facto purview of big data and artificial intelligence projects, relevant technical expertise and governance knowledge, and already take on some functions of ethical review. That said, like ethics committees, they may have functional weaknesses in their review capabilities. To strengthen that function, data access committees must think clearly about the kinds of ethical expertise, both professional and lay, that they draw upon to support their work. Conclusion: Data access committees can undertake ethical review of medical research databases provided they enhance that review function through professional and lay ethical expertise. [ABSTRACT FROM AUTHOR]

Guiding legislation and associated bureaucracy for the ethical review of clinical trials observational studies and food related research play an important role in the competitiveness of a nation in the face of tough global competition to attract sponsors and investigators. This is of particular relevance in the case of multicentre trials and multidisciplinary research. Accordingly, in this report we tried to gather in-depth knowledge of the current role and practices of ethics committees nationwide in both clinical and research settings. This mini-review aims to describe the formulation and organization of ethical committees in Italy in order to provide a focus for deliberations on ethical issues in medical and scientific research in line with human rights, as set out in the European Union charter. Furthermore, we evaluated the impact of an institution's ethical committee intervention on reducing the time required to obtain an opinion from Research Ethics Committees by guiding investigators in addressing ethical issues in their proposed studies.

This article is devoted to an ethical review of planned real-world studies. The legal basis of such examinations has also been considered. Most real-world studies are non-interventional, so the ethical review of such studies is similar to that of observational studies.

A large number of investigator-initiated clinical trials (IIT) were conducted in China, some of them should play an important supporting role in new drug development. Due to the large number, small scale and uneven quality of IIT in China, especially a big gap between the IIT and industry-sponsored trials in terms of protocol design, quality management and ethical review, many IIT can’t be used to support the new drug development. Therefore, it is necessary for regulatory authorities, sponsors, research institutions, ethics committees and researchers to improve their understanding of the role of IIT. In order to support the new drug development with high-quality IIT, formulating supervising system, establishing an effective quality management system, enhancing the training of researchers and improving the ability of ethical review should be implemented effectively.

Background: Research Ethics Committees (RECs) review the ethical, legal, and methodological standards of clinical research. Complying with all requirements and professional expectations while maintaining the necessary scientific and ethical standards can be challenging for applicants and members of the REC alike. There is a need for accessible guidelines and resources to help medical researchers and REC members navigate the legal and ethical requirements and the process of their review., Methods: We employed an explorative search for resources on the websites of a purposively selected sample of relevant stakeholders, including 12 national umbrella organizations (six German-language and six English-language), three English-language international umbrella organizations, and 16 national RECs of major university hospitals (eight German- and eight English-language). We qualitatively mapped the identified resources onto the guiding principles of ethical clinical research and 35 related checkpoints. To describe the content of the resources, we conducted a thematic analysis., Results: We extracted a total of 233 resources, including templates (n = 134, 58.5%), guidelines/recommendations (n = 62, 26.6%), checklists (n = 23, 9.9%), tools (n = 5, 2.2%), flowcharts (n = 5, 2.2%), glossaries (n = 3, 1.3%), and one (0.4%) software program. We extracted 101 German and 132 English resources created between 2004 and 2023. The majority (n = 204; 87.6%) could be assigned to one checkpoint. The remaining 29 (12.5%) resources were considered unspecific (e.g., a checklist which documents to be submitted for a German drug trial). The specific resources are discussed per checkpoint., Conclusion: While much support is available for some aspects, such as participant information and informed consent forms, it is lacking in other areas, such as study design, analysis, and biometrics. More support should be provided in these areas to ensure that research projects are methodologically sound. A more detailed analysis of the quality of available resources could help identify other areas of need., Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: The authors declare that they have no competing interests., (© 2025. The Author(s).)

A growing body of literature critical of ethics review boards has drawn attention to the processes used to determine the ethical merit of research. Citing criticism on the bureaucratic nature of ethics review processes, this literature provides a useful provocation for (re)considering how the ethics review might be enacted. Much of this criticism focuses on how ethics review boards deliberate, with particular attention given to the lack of transparency and opportunities for researcher recourse that characterise ethics review processes. Centered specifically on the conduct of ethics review boards convened within university settings, this paper draws on these inherent criticisms to consider the ways that ethics review boards might enact more communicative and deliberative practices. Outlining a set of principles against which ethics review boards might establish strategies for engaging with researchers and research communities, this paper draws attention to how Deliberative communication, Engagement with researchers and the Distribution of responsibility for the ethics review might be enacted in the day-to-day practice of the university human ethics review board. This paper develops these themes via a conceptual lens derived from Habermas' (The theory of communicative action. Volume 1: Reason and the rationalization of society, 1984) articulation of 'communicative action' and Fraser's (Social Text, 25(26), 56–80, 1990) consideration of 'strong publics' to cast consideration of the role that human ethics review boards might play in supporting university research cultures. Deliberative communication, Engagement with researchers and the Distribution of responsibility provide useful conceptual prompts for considering how ethics review boards might undertake their work. [ABSTRACT FROM AUTHOR]

Tim Schutte,1,2 Fedde Scheele,3,4 Scheltus van Luijk5 1Department of Internal Medicine, Amsterdam UMC, Amsterdam, The Netherlands; 2Department of Internal Medicine, Zaans Medisch Centrum, Zaandam, The Netherlands; 3Athena Institute for Transdisciplinary Research, VU University, Amsterdam, The Netherlands; 4Department of Healthcare Education, OLVG Hospital, Amsterdam, The Netherlands; 5Institute for Post Graduate Education MUMC+, Medical University Hospital, Maastricht, The NetherlandsCorrespondence: Tim Schutte Email t.schutte@amsterdamumc.nlAbstract: Recently, the balance between value and necessity of ethical review of health professions education research has been debated. At present, there are large differences in how ethical review of research proposals for health professions education is organized. We present a framework that describes the organization of ethical review in health professions education research, based on the interpersonal circumplex model, also known as Leary’s Rose. The framework is based on the two main balances in ethical review of health professions education research, being the protectiveness for the subjects and how ethical review is organized and responsibilities are shared. The axis/balance of protectiveness ranges between the extremes “paternalistic protective” to “liberal permissive”. The axis/balance of organization and responsibility ranges between the extremes of “centralized” to “local/decentralized”. This model offers insight in the position of an ethical review board and shows the dynamics of the decisions for ethical approval and the consequences of the different approaches to the organization of ethical review of health professions education research.Keywords: ethical review, health professions education research, ethical approval of health professions education research

Abstract Background Suicide research aims to contribute to a better understanding of suicidal behaviour and its prevention. However, there are many ethical challenges in this research field, for example, regarding consent and potential risks to participants. While studies to-date have focused on the perspective of the researchers, this study aimed to investigate the views and experiences of members of Human Research Ethics Committees (HRECs) in dealing with suicide-related study applications. Methods This qualitative study entailed a thematic analysis using an inductive approach. We conducted semi-structured interviews with a purposive sample (N = 15) of HREC Chairs or their delegates from Australian research-intensive universities. The interview guide included questions regarding the ethical concerns and challenges in suicide-related research raised by HREC members, how they dealt with those challenges and what advice they could give to researchers. Results The analysis identified four main themes: (1) HREC members’ experiences of reviewing suicide-related study applications, (2) HREC members’ perceptions of suicide, suicide research, and study participants, (3) Complexity in HREC members’ decision-making processes, and (4) HREC members’ relationships with researchers. Conclusions Reliance on ethical guidelines and dialogue with researchers are crucial in the assessment of suicide-related study applications. Both researchers and HREC members may benefit from guidance and resources on how to conduct ethically sound suicide-related studies. Developing working relationships will be likely to help HRECs to facilitate high quality, ethical suicide-related research and researchers to conduct such research.

International internet-based studies could be accessible by participants from various countries worldwide. However, the jurisdiction of research ethics committees (RECs) or institutional review boards (IRBs) is bound to geographical state or country borders. How can researchers deal with the geographical boundaries in the jurisdiction of RECs/IRBs versus the worldwide, open character of international internet-based research? Should ethical approval be sought in each country where participants will be recruited? In this paper, we want to share our challenges in setting up the ethical review procedures in an international internet-based mHealth intervention study, to further the discussion on ethical procedures in internet-based research.

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

Any research involving human participants requires review and approval from an authorized research ethics committee to safeguard participant's rights, dignity and welfare while ensuring the scientific validity of the research. Ethical approval is mandatory before initiating or ecruiting study participants. It is also a prerequisite for publishing research findings in scientific journals contributing to ensuring the quality of scientific knowledge. The ethical review process focuses on the assessment of potential risks to the participants as well as the research team focusing on how such risks are identified, minimized and managed. This paper provides an overview of the Nepal Health Research Council's ethical review and approval process for both national and international researchers intending to conduct health research in Nepal. Despite this, the Nepalese ethics committee and researcher face several challenges, including limited awareness of responsible conduct of research, limited training opportunities, unclear clinical trial guidelines, bureaucratic hurdles, and frequent staff turnover in research governance. This paper highlights these challenges and aims to support both researchers and the Ethics Committee in promoting the responsible conduct of health research in Nepal. Keywords: Ethical issues; ethical review and approval; Nepal and research.

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

Objective: To analyze the fundamentals used by members of Research Ethics Committees in solving ethical and/or moral problems experienced during their activities in these Committees. Methods: Qualitative study, using a self-administered online questionnaire on the Google Forms Platform, which involved 39 effective members of 10 Research Ethics Committees, from Salvador, Bahia, Brazil. Data analyzed from the Triadic, Humanist, Existentialist, Personalist Configuration. Results: Among the foundations used by members of the Research Ethics Committees to solve moral and/or ethical problems experienced are the instructions and normative documents within the scope of research involving human beings, bioethics, principles and values. Conclusion: The members of the Ethics Committees use norms and bioethics principles to solve moral and/or ethical problems experienced in their activities, with a view to developing research in line with the appropriate ethical and scientific aspects. [ABSTRACT FROM AUTHOR]

BackgroundFederal regulations in the United States have shaped Institutional Review Boards (IRBs) to focus on protecting individual human subjects. Health services research studies focusing on healthcare institutions such as hospitals or clinics do not have individual human subjects. Since U.S. federal regulations are silent on what type of review, if any, these studies require, different IRBs may approach similar studies differently, resulting in undesirable variation in the review of studies focusing on healthcare institutions. Further, although these studies do not focus on individual human subjects, they may pose risks to participating institutions, as well as individuals who work at those institutions, if identifying information becomes public.DiscussionUsing two recent health services research studies conducted in the U.S. as examples, we discuss variations in the level of IRB oversight for studies focusing on institutions rather than individual human subjects. We highlight how lack of IRB guidance poses challenges for researchers who wish to both protect their subjects and work appropriately with the public, journalists or the legal system in the U.S. Competing interests include the public's interest in transparency, the researcher's interest in their science, and the research participants' interests in confidentiality. Potential solutions that may help guide health services researchers to balance these competing interests include: 1) creating consensus guidelines and standard practices that address confidentiality risk to healthcare institutions and their employees; and 2) expanding the IRB role to conduct a streamlined review of health services research studies focusing on healthcare institutions to balance the competing interest of stakeholders on a case-by-case basis.SummaryFor health services research studies focusing on healthcare institutions, we outline the competing interests of researchers, healthcare institutions and the public. We propose solutions to decrease undesirable variations in the review of these studies.

Empirical evidence of the ethical review of clinical and biomedical research in Malaysia is limited. We have conducted a convergent mixed methods research, which comprises an online survey and semistructured interviews to examine the challenges in the ethical review of clinical and biomedical research. Data collected reveal that the ethics review process is inconsistent, duplicate, and inadequate. The results indicate a strong need for a centralized ethical review mechanism and a national system for mutual recognition of ethics reviews to improve the effectiveness and efficiency of the ethics review system in Malaysia. A joint research ethics committee review between Malaysia and sponsoring countries for multinational research should also be encouraged as it could address the concerns of the lack of expertise and training. [ABSTRACT FROM AUTHOR]

Parenting books and early childhood policy documents increasingly refer to neuroscience to support their parenting advice. This trend, called 'neuroparenting' has been subject to a growing body of sociological and ethical critical examination. The aim of this paper is to review this critical literature on neuroparenting. We identify three main arguments: that there is a gap between neuroscientific findings and neuroparenting advice, that there is an implicit normativity in the translation from neuroscience to practice, and that neuroparenting is a form of neoliberal self-management. We will critically discuss these arguments and make suggestions for ethically responsible forms of neuroparenting that can foster child development but avoid pitfalls. [ABSTRACT FROM AUTHOR]

There has been considerable debate around the ethical issues raised by data-driven technologies such as artificial intelligence. Ethical principles for the field have focused on the need to ensure that such technologies are used for good rather than harm, that they enshrine principles of social justice and fairness, that they protect privacy, respect human autonomy and are open to scrutiny. While development of such principles is well advanced, there is as yet little consensus on the mechanisms appropriate for ethical governance in this field. This paper examines the prospects for the university ethics committee to undertake effective review of research conducted on data-driven technologies in the university context. Challenges identified include: the relatively narrow focus of university-based ethical review on the human subjects research process and lack of capacity to anticipate downstream impacts; the difficulties of accommodating the complex interplay of academic and commercial interests in the field; and the need to ensure appropriate expertise from both specialists and lay voices. Overall, the challenges identified sharpen appreciation of the need to encourage a joined-up and effective system of ethical governance that fosters an ethical culture rather than replacing ethical reflection with bureaucracy. [ABSTRACT FROM AUTHOR]

Copyright of Tabayyun is the property of Arab Center for Research & Policy Studies 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.)

Research ethics remains a cornerstone of the scientific enterprise as it defines the boundaries of responsible conduct of research. Our aim was to systematically identify, review and test online training courses in research ethics which could be considered most appropriate for future training at the University of Botswana (UB). We used an evaluative tool that included both descriptive and evaluative criteria for assessing the strengths, weaknesses and appropriateness of 10 online research ethics courses which are publicly accessible. We then assembled Focus Group Discussions (FGDs) to engage the UB community to select the best 2–3 online courses that are considered most suited for use in future training of research ethics at UB. Twenty respondents participated in three FGDs. Our findings show that there is limited research ethics training capacity in low resourced academic institutions like UB. Online training opportunities could be used to address this challenge. Our analysis reveal that out of the 10 online courses reviewed, CITI program, Family Health International, and Training and Resource in Research Ethics Evaluation have characteristics that would make them suitable for utilization in Botswana. We believe the findings from this case study will be of value to other similarly situated research institutions.

Science and its arm, technology, may focus on an anthropocentric logic if they insist on satisfying only human needs at the expense of the mastery (or destruction) of nature and coexisting species. It is also possible that they serve to economic and political powers and investigate only under a logic focused on profit. Within this panorama, a call is made to an act of conscience for the proposal of the German philosopher Hans Jonas on responsibility principle, which claims for a reflection beyond the immediate relations, including nature, animals and future generations in the formulation of a new ethics that should be taught and practiced from the academy.

Ethical review of both human and animal research is critical to ensuring that studies are conducted with due regard to the welfare and safety of enrolled subjects and to the integrity of the data. However, differences exist in laws, policies, and best practices between human and animal studies. Ethical review is required for most human studies. While the laws and standards are clear for humans and for laboratory animals, the laws and standards for clinical research for client-owned animals are not as well-defined. Here, we discuss gaps in ethical review of clinical animal research in the United States of America and propose expanded functions for veterinary clinical studies committees as a solution.

Background: China's ethics committees alone are unable to meet the growing need for human participant protection. Several scandals in recent years indicate weaknesses in the protection of human participants in China. Objectives: The aim of the study is to summarize the status and problems of human research protection program in China and to explore its establishment proposals at national and hospital levels. Research design: To conduct literature retrieval, Chinese National Knowledge Infrastructure, Chinese Biomedical Document Database, and English databases Web of Science and PubMed were searched; laws, guidelines, and regulations were also searched on web by Google and Chinese search engine Baidu. Ethical considerations: No data were collected from human participants, and ethical review was not required. Findings: There are problems for China's Human Research Protection Program, such as weak relevant legal systems, insufficient administrative supervision, and incompetent ethics committee capacities. To fully protect human participants, China should promote the development of Human Research Protection Program, which can formulate ethics-related laws, improve regulations for the protection of the safety and rights of human participants, strengthen supervision, and enforce compensation for human participants. Owing to the frequency with which human participants are recruited in hospitals in China, hospitals can utilize existing ethics committees and establish data and safety monitoring committees, quality control, fund and contract management, and conflict of interest management offices. Discussion: As a growing program, it remains necessary to learn from the experience of developed countries with high ethics standards and reformulate them to fit China's conditions to explore potential future development. The program will also be an experience for other developing countries. Conclusion: Human Research Protection Program can strengthen communication and coordination among various hospital departments to effectively protect the rights and welfare of human participants. [ABSTRACT FROM AUTHOR]

This paper challenges current dominant thinking in Universities about the processes of ethical appraisal of research studies in the Social Sciences. It considers this to be founded on unjustifiable and inappropriate principles, the origins of which are presented before discussing alternative, more inclusive and ethically defensible approaches. The latter are based on dialogic processes to sustain respectful and empowering ethical reviews which appreciate the situated nature of research. The empirical evidence for this comes from papers about ethnographic studies with children and adults in various educational spaces in Western Europe, originally a symposium on the practice of ethics in educational ethnography at ECER, 2017, now forming a book published by Routledge, 2019. The dialogic processes help researchers to carry out culturally-appropriate research with the demonstrable ethical integrity that participants and stakeholders reasonably expect. The authors argue that currently risk-averse Universities need to change their research cultures to support all research methodologies and fieldwork practices that have ethical integrity and create valuable research that is socially beneficial, to enhance their lustre. [ABSTRACT FROM AUTHOR]

Background: Suicide research aims to contribute to a better understanding of suicidal behaviour and its prevention. However, there are many ethical challenges in this research field, for example, regarding consent and potential risks to participants. While studies to-date have focused on the perspective of the researchers, this study aimed to investigate the views and experiences of members of Human Research Ethics Committees (HRECs) in dealing with suicide-related study applications.Methods: This qualitative study entailed a thematic analysis using an inductive approach. We conducted semi-structured interviews with a purposive sample (N = 15) of HREC Chairs or their delegates from Australian research-intensive universities. The interview guide included questions regarding the ethical concerns and challenges in suicide-related research raised by HREC members, how they dealt with those challenges and what advice they could give to researchers.Results: The analysis identified four main themes: (1) HREC members' experiences of reviewing suicide-related study applications, (2) HREC members' perceptions of suicide, suicide research, and study participants, (3) Complexity in HREC members' decision-making processes, and (4) HREC members' relationships with researchers.Conclusions: Reliance on ethical guidelines and dialogue with researchers are crucial in the assessment of suicide-related study applications. Both researchers and HREC members may benefit from guidance and resources on how to conduct ethically sound suicide-related studies. Developing working relationships will be likely to help HRECs to facilitate high quality, ethical suicide-related research and researchers to conduct such research. [ABSTRACT FROM AUTHOR]

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.)

Ethics committees ensure compliance with ethical principles in medical research. They are oriented towards clinical studies, but also review e. g., qualitative research. Using a semi-structured online survey, we collected data on experiences of qualitative researchers with the review by ethics committees and analysed them via content analysis. In July 2019, 73 researchers took part in the survey. Five main topics were derived from their statements regarding the ethics review of qualitative research: 1. relevance of qualitative research expertise; 2. cooperation between researchers and ethics committees; 3. transparency of review criteria; 4. dealing with formal review requirements; 5. evaluation of the review's significance for qualitative research. The results show the potential of ethics review for reflection on ethical questions in qualitative research. Prerequisites for this are the fit with the characteristics and quality criteria of qualitative research, the presence of qualitative research expertise in ethics committees, the transparency of the ethics review process as well as openness to different professional cultures and a constructive communication culture., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Background: Qualitative Humanities research is perturbed by ethical review processes that routinely invoke epistemological assumptions skewed towards positivistic or deductive research, giving rise to several concerns, including increased risk aversion by University Research Ethics Committees (URECs) and the evaluation of qualitative research designs according to STEM standards., Methods/materials: This paper presents findings from an AHRC-funded research network built to better understand how research ethics frameworks and processes might be reformed to more appropriately fit ethically challenging qualitative methodologies., Results: There remains dissatisfaction with the current processes for awarding ethical approval and the subsequent management of ethical dimensions of projects. In spite of recent developments, UREC frameworks remain seriously flawed, with a wide divergence in the quality of expertise, procedures, and practices, leading to inconsistency in ethical approval awards., Conclusions: These factors downgrade UK Higher Education research power in the Humanities and undermine our commitments to the researched. We propose a series of recommendations for reform.

Background: Medical research in complementary and alternative medicine (CAM) has increased recently, raising ethical concerns about the moral status of CAM. Medical academic journals are responsible for conducting ethical review (ER) of manuscripts to protect the interests of human subjects and to make ethical results available before deciding to publish. However, there has been no systematic analysis of the ER in CAM journals. This study is aim to evaluate the current status of ethical requirements and compliance in CAM journals., Methods: This is a cross-sectional study. We reviewed instructions for authors (IFAs) of CAM journals included in the Journal Citation Reports (2021) ( https://jcr.clarivate.com ) for general information and requirements for ER. We also browsed the manuscripts regarding randomized controlled trials published by CAM journals in Q1 and Q2 section from January to June, 2023, to check the actual situation of ethical requirement. Descriptive statistics and Fisher's exact test were used for statistical analysis., Results: 27 journals and 68 manuscripts were ultimately included. 92.6% (25/27) IFAs included keywords of ER, indicating the presence of ethical considerations. However, no specific ER was required for CAM (n = 0). We categorized journals by Geographic origin, JCR section, Year of electronic JCR, Types of studies, % of OA Gold to explore the factors that could influence CAM journals to have certain ethical review policies. The results showed there was no statistical significance in certain ethical review policy in any classification of journals (p > 0.05). All RCT manuscripts included in the study generally met the requirements of the published journals for ethical review., Conclusions: All IFAs discussed ER, but the content was scattered, unfocused, and there were no specific ER requirements regarding CAM. Although the manuscripts basically met the requirements of the journal, it was not possible to get closer to the process of ER in the manuscript. To ensure full implementation of these policies in the future, CAM journals should require authors to provide more details, or to form a list of items necessary for CAM ethical review., (© 2024. The Author(s).)

Many countries consider long-term implications for society.

BACKGROUND To ensure ethical oversight, researchers wanting to conduct “research” involving human beings are typically required to obtain prior approval from an independent ethics committee. However, it can sometimes be unclear if a project needs to be submitted for ethics approval. Swiss researchers can contact research ethics committees via a “jurisdictional inquiry” for clarification whether a project needs to be submitted for ethics approval. AIMS OF THE STUDY (1) To examine the characteristics of Swiss jurisdictional inquiries, and (2) to identify possible uncertainties regarding the correct interpretation of existing legislation in Switzerland. METHODS All jurisdictional inquiries submitted to Swiss research ethics committees between July and December 2017 were reviewed using qualitative content analysis. We then conducted an online survey between June 2018 and July 2018 with all researchers who had submitted a jurisdictional inquiry including a descriptive quantitative analysis. RESULTS The review included 271 jurisdictional inquiries. Analysis identified three groups of jurisdictional inquiries: 80.4% (218/271) sought clarification whether the project had to be submitted for ethical approval; 18.5% (50/271) requested a “declaration of no objection”; and 1.1% (3/271) asked for a clarification about which of the two ordinances was applicable to the project. Analysis identified eight distinct legal issues that appeared to be the main cause for a number of jurisdictional inquiries, with the two most frequently identified issues being whether the project will produce generalisable knowledge, and whether the project uses fully anonymised data. Overall, research ethics committees decided that 78.6% (213/271) of the jurisdictional inquiries were outside their jurisdiction and did not require ethical approval, and that 15.6% required submission for ethical approval. The online survey achieved a 56.8% response rate. The majority of respondents (94/166; 56.6%) reported that all the questions they were asked during the submission of the jurisdictional inquiry were easy to understand. Respondents reported that 88% (147/166) of all projects were started or planned to start. The vast majority (154/166; 93%) of respondents also agreed with the decisions made by the research ethics committee. CONCLUSIONS Jurisdictional inquiries are an important means for researchers to clarify whether their project requires ethical oversight. However, this mixed-methods study has identified some difficulties in the interpretation of legal terms, which often reflect persistent structural issues that many other countries also face. More detailed guidance may be helpful to reduce the researchers’ uncertainties and ethics committees’ workloads in relation to jurisdictional inquiries.

Abstract Objective: To know the positions and practices adopted by nursing students in scientific initiation programs about the principles of scientific integrity in the different stages of the process of doing science. Method: An exploratory study of a quantitative nature, in which nursing student participants of the Scientific Initiation Program from the Federal District were interviewed. Results: Fifty (50) nursing students participated in the study. Most of the interviewed participants presented good notions about the process of conducting research in its different stages. Nevertheless, it was found that even though they were familiar with good scientific practices, students did not always behave in the most responsible manner. It was observed that the knowledge on topics related to the ethics of the scientific process was predominantly obtained through formal education, consisting of classes and courses. Nonetheless, the importance of complementary spaces such as research and research groups is recognized. Conclusion: Research experiences are important educational and vocational training spaces for students. Therefore, good research practices need to be included early in the academic curriculum.

There has been growing consensus to develop relevant guidance to improve the ethical review of global health policy and systems research (HPSR) and address the current absence of formal ethics guidance. [ABSTRACT FROM AUTHOR]

Ethical review and analysis of health policy may help to ensure policies address the needs of society and align with relevant values and principles. Indeed, researchers and bioethicists have recognized the need for ethical frameworks specifically for public health applications. The objective of this research was to compile structured tools for ethical review of (drafted or existing) health policy and to analyze these tools for their scope and philosophical underpinnings. A systematic search and review of academic and grey literature was conducted to compile existing tools designed for health policy ethics review. The search yielded 13 health policy ethical review tools. Qualitative content analysis revealed that all of the tools were influenced by multiple ethical values and that a majority were influenced by more than one ethical theory. The most common values were non-maleficence and beneficence (92.3%). The most common influencing ethical theory was the Principles Approach (92.3%). The structure of the tools demonstrates a heterogeneity of methodology designs to approach policy ethics review. This research offers a unique contribution to the bioethics field that provides a useful resource and understanding of the current ethical review tools for health policy. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has put lot of pressure on management of laboratory animals. With the risk of human infection and the lockdown, specific measures had to be arranged. Unfortunately, these often included depopulation of animal facility. Wild-type and genetically modified rodents had to be culled and breeding had to be reduced, to be able to provide standard care all the time. Being animal care staff essential workers, they were coming to check animals also instead of researchers, who were not able to access the facility. Undergoing experiments had to be stopped to avoid animal welfare issues in a time when personnel wouldn't be available as usual. At the same time, new in vivo studies for COVID-19 projects had to be evaluated by the Ethics Committee, raising many questions: how do you objectively review the study and assess harms on animals when only few scientific information is available and we don't even know what is the best model for the disease? Has it been right to stop all other research areas in favour of COVID-19 related research? The pandemic has shown many weakness points in how animals are used, how projects are reviewed and funded, and how staff care for animals, so, perhaps, we will be better prepared for the next pandemic. [ABSTRACT FROM AUTHOR]

Chiropractic case reports that describe the clinical care of one patient or of several patients with similar conditions provide valuable insight to the practicing clinician and offer information for the design of clinical trials. Clinical case studies are not generally subject to federal ethics regulation or review and oversight by research ethics committees protecting human research subjects. Nonetheless, journal editors sometime require authors of clinical case reports to provide proof of evaluation by independent ethics committees. We describe the procedures, guidance, and materials that our institution developed for clinician-authors to obtain ethics documentation and facilitate the publication of their clinical case reports. [ABSTRACT FROM AUTHOR]