Research Ethics Review Research Articles

Data Ethics in Library Learning Analytics

Introduction: This study examines data handling and data ethics in library learning analytics research projects involving the use of data about students as library patrons, alongside a baseline evaluation of the benefits of library learning analytics to libraries practicing it. Methods: Citations were gathered via citation chain aggregation from the original Value of Academic Libraries report, then winnowed to projects with English-language artifacts documenting them, collection and/or analysis of library data about students, and a research question about the contribution of student library use to student success. Results and Discussion: Much of this research is reaching publication despite not employing best practices nor documenting respect for human-subjects research ethics, library-specific privacy and confidentiality ethics, and student data-privacy expectations. Very few projects create direct benefits to libraries. This result would not be possible without gaps or lapses in editorial processes, peer review, and upstream research guidance and ethics reviews. Conclusion: Ethics reforms are required at all stages of research and publication to prevent further unethical exploitation of patron data.

Practice and reflections on regional mutual recognition of clinical research ethics review——based on survey results from medical and health institutions in Jiangsu Province

With the continuous advancement of medical research, the number of multi-center clinical studies has been steadily increasing, bringing about significant challenges to ethical review. Improving the efficiency and quality of ethical review has become a necessity driven by national policies and the development of the industry. Mutual recognition of ethical reviews is one of the most effective ways to enhance the efficiency of ethical review in multi-center clinical trials. The promotion of mutual recognition of ethical reviews is both feasible and practically significant; however, progress has been less than ideal. Through conducting surveys, this study attempts to understand the status of mutual recognition of ethical reviews in Jiangsu Province, identify the reasons hindering the implementation of mutual recognition, and propose possible solutions. The results indicate that while most medical and health institutions are aware of the policies related to mutual recognition of ethical reviews, the majority remain in a wait-and-see attitude. Ensuring policy guarantees and the high quality and homogeneity of ethical review across institutions are considered necessary conditions for achieving mutual recognition of ethical reviews.

Evaluating the effects, implementation experience and political economy of primary healthcare facility autonomy reforms within counties in Kenya: a mixed methods study protocol

IntroductionThere is a growing emphasis on improving primary healthcare (PHC) services and granting frontline service providers more decision-making autonomy. In October 2023, Kenya enacted legislation mandating nationwide facility autonomy. There...

Alternative payment models in Dutch hospital care: what works, how, why and under what circumstances? Protocol for a realist evaluation study

IntroductionThe predominant provider payment models in healthcare, particularly fee-for-service, hinder the delivery of high-value care and can encourage healthcare providers to prioritise the volume of care over the value of...

International scope of biomedical research ethics review.

Many countries consider long-term implications for society.

Ethical regulation of biomedical research in Brazil: a quality improvement initiative

BackgroundQ-CEP (Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil’s national system of institutional review boards. The aim of this study was therefore to report on the experience and results of the Q-CEP project.MethodsAn observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies.ResultsIn 2019–2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs.ConclusionsOverall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world’s largest research ethics evaluation systems.

Ethical review of preclinical research

The main goal of medicine has been and remains the desire to preserve the health of the population, increase human life expectancy and its quality. For those purposes, it is necessary to constantly improve treatment measures, create and introduce into medical practice new methods of therapy, innovative medicines, guided by strict rules of evidence of their high effectiveness and safety, study the mechanisms of physiological processes of a living organism in normal conditions and in pathology, the possibilities of correction and prevention of disease processes, and this means the need to conduct research, including those involving animals. The modern ethical and legal framework for research involving animals contains a requirement for mandatory examination of a research project by an ethical committee, monitoring its implementation, and analysis of the results. An ethics committee is a structure implemented into the research process to help researchers navigate the complex network of guidelines, rules and best practices, as well as the existing legal framework for conducting scientific research that guarantees quality results of work that do not violate these principles and restrictions. The local ethics committee is responsible for ensuring that research conducted in the territory under its supervision complies with modern ethical standards. This article presents the experience of the local ethics committee of the Kazan State Medical University in the ethical review of research projects involving animals, and substantiates the list and content of the requirements for documents submitted by the researcher for ethical review. The shortcomings identified in the preclinical research protocols submitted for examination were separately analyzed, and references were provided to the ethical and legal framework existing in the Russian Federation.

Ethics Review of Biomedical Research in Uzbekistan: Policy and Program Gaps.

We describe the national health research ethics review system of Uzbekistan and identify policy and program gaps that impede the protection of human research subjects. We find that the National Ethic Committee (NEC), functioning at the national level, is solely responsible for conducting research ethics review. There is little evidence that regional ethics committees work as intended, and there is no research ethics review at medical institutes and research centers even though they conduct CDTs (clinical drug trials). There is no national policy for the ethical review of non-clinical trials. We recommend the establishment of institutional review boards (IRBs) at medical institutes and research centers while at the same time building capacity at the national level to oversee and support the research ethics review system of the entire country.

Human Research Ethics Review Challenges in the Social Sciences: A Case for Review

Human Research Ethics Review Challenges in the Social Sciences: A Case for Review

Research ethics review during the COVID-19 pandemic: An international study.

Research ethics review committees (ERCs) worldwide faced daunting challenges during the COVID-19 pandemic. There was a need to balance rapid turnaround with rigorous evaluation of high-risk research protocols in the context of considerable uncertainty. This study explored the experiences and performance of ERCs during the pandemic. We conducted an anonymous, cross-sectional, global online survey of chairs (or their delegates) of ERCs who were involved in the review of COVID-19-related research protocols after March 2020. The survey ran from October 2022 to February 2023 and consisted of 50 items, with opportunities for descriptive responses to open-ended questions. Two hundred and three participants [130 from high-income countries (HICs) and 73 from low- and middle-income countries (LMICs)] completed our survey. Respondents came from diverse entities and organizations from 48 countries (19 HICs and 29 LMICs) in all World Health Organization regions. Responses show little of the increased global funding for COVID-19 research was allotted to the operation of ERCs. Few ERCs had pre-existing internal policies to address operation during public health emergencies, but almost half used existing guidelines. Most ERCs modified existing procedures or designed and implemented new ones but had not evaluated the success of these changes. Participants overwhelmingly endorsed permanently implementing several of them. Few ERCs added new members but non-member experts were consulted; quorum was generally achieved. Collaboration among ERCs was infrequent, but reviews conducted by external ERCs were recognized and validated. Review volume increased during the pandemic, with COVID-19-related studies being prioritized. Most protocol reviews were reported as taking less than three weeks. One-third of respondents reported external pressure on their ERCs from different stakeholders to approve or reject specific COVID-19-related protocols. ERC members faced significant challenges to keep their committees functioning during the pandemic. Our findings can inform ERC approaches towards future public health emergencies. To our knowledge, this is the first international, COVID-19-related study of its kind.

The Puzzles in Research-Ethics Review

There are puzzles in research-ethics review that confound researchers in the social sciences. First, how did the biomedical research ethics process capture the research-ethics perspectives in the social sciences? Second, why has it proved impossible to recognize the relevance of stepping outside the biomedical paradigm? Third, what institutional agencies have not permitted researchers in the social sciences to abandon the biomedical paradigm and adopt one that is relevant for social scientists? There are particular elements that characterize the ethics-review process. Some phrases as ‘rigor’ dissuade inductive researchers, the power of hierarchical nature of research-ethics committees inevitably impose the biomedical stance in research, the colonizing nature of research-ethics betrays its American bias, and the insistence that all researchers implement a data-management plan is not relevant to the social sciences. Some of the more common suggestions to improve the situation are unworkable.

Effects of a therapeutic lifestyle modification intervention on cardiometabolic health, sexual functioning and health-related quality of life in perimenopausal Chinese women: protocol for a randomised controlled trial

IntroductionPerimenopause is a critical transitional period in reproductive ageing. A set of physiological and psychological changes can affect perimenopausal women’s quality of life and further threaten their older adult health...

Challenges to the delivery and utilisation of child healthcare services: a qualitative study of the experiences of nurses and caregivers in a rural district in Ghana

BackgroundSub-Saharan Africa has one of the poorest child health outcomes in the world. Children born in this region face significant health challenges that jeopardise their proper growth and development. Even though the utilisation of child healthcare services safeguards the health of children, the challenges encountered by nurses in the delivery of services, and caregivers in the utilisation of these services, especially in rural areas, have contributed to poor child health outcomes in this region.AimThis study explored the experiences of nurses and caregivers in respect of the nursing human resource challenges to the delivery and utilisation of child healthcare services in a rural district in Ghana.MethodsIndividual qualitative interviews were conducted with ten nurses, who rendered child healthcare services; nine caregivers, who regularly utilised the available child healthcare services; and seven caregivers, who were not regular users of these services. These participants were purposively selected for the study. Data were collected using individual semi-structured interview guides and analysed qualitatively using content analysis. Themes and sub-themes were generated during the data analysis. The Ghana Health Service Research Ethics Review Committee and the Nelson Mandela University’s Research Ethics Committee approved the study protocol prior to data collection.ResultsThree main themes emerged from the data analysis. Theme One focused on the shortage of nurses, which affected the quality and availability of child healthcare services. Theme Two focused on inexperienced nurses, who struggled to cope with the demands related to the delivery of child healthcare services. Theme Three focused on the undesirable attitude displayed by nurses, which discouraged caregivers from utilising child healthcare services.ConclusionNurses contribute significantly to the delivery of child healthcare services; hence, the inadequacies amongst nurses, in terms of staff numbers and nursing expertise, affect the quality and availability of child healthcare services. Also, caregivers’ perceptions of the quality of child healthcare services are based on the treatment they receive at the hands of nurses and other healthcare workers. In this respect, the bad attitude of nurses may disincentivise caregivers in terms of their utilisation of these services, as and when needed. There is an urgent need to comprehensively address these challenges to improve child healthcare outcomes in rural areas in Ghana. Relevant authorities should decentralise training workshops for nurses in rural areas to update their skills. Additionally, health facilities should institute proper orientation and mentoring systems to assist newly recruited nurses to acquire the requisite competences for the delivery of quality family-centred care child healthcare services.

A socially interdependent choice framework for social influences in healthcare decision-making: a study protocol

ObjectivesCurrent choice models in healthcare (and beyond) can provide suboptimal predictions of healthcare users’ decisions. One reason for such inaccuracy is that standard microeconomic theory assumes that decisions of healthcare...

Evaluating the impact of different hard hats on the peripheral vision of construction workers

Construction safety is always an issue for construction workers. Hence, personal protective equipment plays a critical role in avoiding potential hazards on construction sites. Among these, hard hats protect against head contact with falling objects on construction sites. This study aims to examine the effects of hard hats with different peak lengths on the field of view at different angles in the upward part and to examine the effects of possible field of view losses caused by the hard hat on the reaction times of the workers. A questionnaire was designed and administered to the construction workers. Experiments were then conducted with a group of subjects to assess their peripheral vision level as well as reaction times. The study found that peripheral vision is affected by the peak size of hard hats. The study further revealed that there is a significant relationship between reaction times and hard hat peak size.

Opportunities and Challenges Of The Ethics Review Of Qualitative Health Services Research: A Survey Of Qualitative Researchers

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.

Safety and efficacy of ultrasound-guided superior hypogastric plexus block combined with conscious sedation in ambulatory patients undergoing percutaneous microwave ablation of uterine myomas: Study protocol for a single-center, double-blinded, randomized controlled trial

BackgroundPain is a major challenge in performing ultrasound-guided percutaneous microwave ablation (PMWA) of uterine myomas. Inadequate analgesia by local anesthetics hinders the possibility of conducting PMWA of uterine myomas in the Ambulatory Surgery Center (ASC) of the Department of Ultrasound. ObjectiveThe superior hypogastric plexus (SHP) forms a suitable target for pain relief through the blockade, as it contains nociceptive afferent fibers from pelvic organs such as the uterus, rectum, and bladder. Superior hypogastric plexus block (SHPB) has demonstrated promise as an alternative treatment option for alleviating pelvic pain, reducing opioid consumption, and improving quality of life. This study aims to evaluate the efficacy of ultrasound-guided SHPB combined with conscious sedation as an alternative anesthesia option for ambulatory patients receiving ultrasound-guided PMWA of uterine myomas. Methods and analysisThis randomized controlled trial (RCT) will be carried out at the Department of Ultrasound, The First Affiliated Hospital of Xiamen University. Women scheduled for ultrasound-guided PMWA of uterine myomas will be eligible. 86 patients will be recruited and randomly assigned to either the intervention or control groups in a 1:1 ratio. The intervention group will undergo ultrasound-guided superior hypogastric plexus block (SHPB) combined with conscious sedation, while the control group will receive local anesthesia combined with conscious sedation. The primary outcome is the success rate of anesthesia, secondary outcomes include vasoactive drug consumption, acetaminophen consumption, sleep quality, sonographer satisfaction score, patient satisfaction score, the detained time in hospital, and adverse events. DiscussionsThis RCT represents the inaugural effort to specifically evaluate the safety and efficacy of ultrasound-guided SHPB combined with conscious sedation in patients undergoing ultrasound-guided PMWA of uterine myomas and will provide valuable evidence and insight into the analgesic management of this ambulatory surgery. Ethics and disseminationThis study has been approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University (Scientific Research Ethics Review 2023, No. 139). The results will be submitted for publication in peer-reviewed journals.

Ethical governance in Chinese universities: an overview of research ethics committees

ABSTRACT This study aims to provide an overview of RECs (research ethics committees) in Chinese universities, encompassing both medical and non-medical studies. The primary objective is to identify major challenges faced by RECs in Chinese universities and draw meaningful implications from the findings. The investigation focuses on 42 comprehensive Chinese universities, and the results reveal that while all universities have implemented RECs in various forms, only 28.6% explicitly stipulate ethical review requirements for non-medical disciplines. Furthermore, RECs in Chinese universities encounter various challenges, including insufficient attention to research ethics review, inadequate ethics review systems and regulations, a lack of education and training, and lacking ethics review for non-medical research. This paper proposes recommendations for establishing robust RECs in Chinese universities, seeking to enhance ethical governance in research. By addressing the challenges identified, these recommendations aim to strengthen ethical oversight, foster a culture of responsible research, and uphold the highest ethical standards across diverse academic disciplines.

Experiences with smoking habits and the need for cessation among habitual smokers in Japan: a qualitative study based on semi-structured interviews

BackgroundAlthough more than half of the habitual smokers recognize that they want to quit smoking cigarettes, approximately half have failed to quit and experienced distress relapse; therefore, there is an urgent need to focus on these populations. When chronic behavior occurs, it is necessary to view the behavior in the context of the entire life of the person involved, considering the history of the person. In this study, we aimed to describe experiences with smoking from the onset to the present and the need for smoking cessation among habitual smokers in Japan and to explore efforts to address them.MethodsSemi-structured interviews that lasted for 55–90 min were conducted with the cooperation of 16 habitual smokers who smoked cigarettes daily. The content of the interviews included demographic characteristics, experiences with smoking from the onset to the present, whether they have attempted to quit and related experiences, and their thoughts on smoking. Interviews were transcribed verbatim and analyzed qualitatively. The Medical Research Ethics Review Committee of Jikei University approved this study (approval number: 33–384(11008)).ResultsThe participants were aged 26–59 years (mean ± SD: 40.8 ± 8.9 years) and included 10 men and 6 women. The participants started smoking between age 13 and 24 years. The highest number of cigarettes smoked in the participants’ lives ranged from 10 to 80 daily, and 12 participants had attempted to quit smoking so far without success. Regarding experiences with smoking from the onset to the present, four themes of “expand one’s world,” “unconscious attachment,” “attempts and failures,” and “losing oneself” were extracted. Regarding the need for smoking cessation, four themes of “empowerment from experts,” “peer interaction,” “social commitment,” and “recovery of confidence” were extracted.ConclusionTo support smoking cessation from the perspective of habitual smokers, in addition to improvements through the existing approaches, it is important to recover their confidence using ongoing activities in peer groups according to the target background and support from experts incorporating visual assessments of lung function, along with multiple short-term goals. It is also necessary to raise awareness in communities through activities.

In Pursuit of Ethical and Inclusive Research: What Ethics Committees and Disability Researchers Can Learn From Each Other

Across disciplines, qualitative researchers have documented epistemological and practical tensions in the ethical review of community-based and participatory research, with many arguing that ethics committees’ decisions perpetuate the exclusion of marginalised communities from research engagement. In the existing literature, the research team and the ethics committee are often characterised as staunch opponents. Conversely, in our recent qualitative research addressing communication about sexuality with young people with cerebral palsy who use communication methods other than speech (augmentative and alternative communication), we found that constructive collaboration between researchers and committee members yielded novel insights. Co-authored by a multi-disciplinary research team and the former chair of a Human Research Ethics Committee, this reflexive case study identified three key tensions which arose in the ethical review of research involving this purportedly marginalised population, which reflected the wider importance of trust. We propose a series of practical recommendations to support productive collaboration in the pursuit of safe, inclusive and community-driven research.