Learning from the past: Old and new ethical responsibilities in health research

Objective: To determine the frequency with which Research Ethics Committees (RECs) identify breaches of ethical principles in research protocols. Theoretical Framework: Ethical principles in human research are established in the Nuremberg Code (informed consent and the common good), the Declaration of Helsinki (protection of vulnerable groups), and the Belmont Report (autonomy, beneficence, and justice). These principles are monitored by RECs to protect participants and ensure fairness in resource use. Informed consent ensures autonomy and the integrity of the research. Method: Searches were conducted in PubMed, Scopus, and Google Scholar up to November 30, 2023. A meta-analysis of single proportions was performed. PROSPERO Registration: CRD42021291893 Results and Discussion: Nine publications were reviewed, revealing violations of the principle of justice in up to 100% of protocols. In Latin America, violations were observed in 9% (95% CI: 7-12) of protocols, while in Europe, the rate was 15% (95% CI: 9-24). Autonomy was observed in 26% (95% CI: 20-33) of protocols, with 17% (95% CI: 13-22) in experimental studies. Observations on beneficence varied between 41.17% and 77.38%. Protocol-specific observations ranged between 5.26% and 27.11%, showing regional disparities among study types. RECs must ensure thorough evaluations to uphold autonomy and maximize benefits for participants. Research Implications: Provide a foundation for future investigations on the work of RECs, the implementation of ethical principles, and equity in research. Originality/Value: The publication of observations on ethical principles made by the Research Ethics Committees is essential for drafting new research protocols.

Clinical research: Protection of the “vulnerable”?

Background: Ethics education is a basic part of midwifery education program. However, there is no evidence to show that ethics education has been able to meet the educational needs of midwifery students. Purpose: This study aimed to explore the educational needs of students for ethics in midwifery program with a focus on the course of history, ethics, and rules of midwifery. Research design and participants: The present study is qualitative descriptive content analysis research, exploring midwifery students' needs of ethics education in bachelor's degrees. We conducted in-depth semi-structured interviews with 11 undergraduate midwifery students, seven midwives working in hospitals and health centers, and seven midwifery faculty members in Urmia University of Medical Sciences. The participants were selected using a purposeful sampling method and invited to join the study from December 2021 to June 2022. The sampling continued until data saturation. Findings: Content analysis identified four categories and associated subcategories: 1. "The client's rights": respecting the dignity of clients, confidentiality, the client's right to choose and make decisions; 2. "Legal and ethical requirements of fertility": abortion, alternative treatment for infertility, domestic violence; 3. "Communication skills": communication with the client, communication with clients' caregivers and communication with colleagues; and 4. "ethical principles in research": compliance with ethical principles in the research process and ethical principles in publishing research findings. Ethical considerations: The study was approved by the Ethics Committee of Urmia University of Medical Sciences. Before filling the questionnaires, written informed consent was obtained from the participants. The participants were assured of the confidentiality of personal information. Conclusion: The educational needs of midwifery students can be met by providing theoretical and practical training on respecting the pregnant mother, communication skills, legal and ethical aspects of the reproductive period, and incorporating ethical principles in related courses.

The goal of medical research is the acquisition and application of new knowledge for the benefit of individual patients and society as a whole. Achieving this goal requires excellence in scientific methodology, honesty in data collection and interpretation, and realistic assessment of the implications of the findings. Underlying all steps in the acquisition of new knowledge is the absolute need for application of the highest ethical standards for research. Occasionally, ethical principles of research are breached because of lack of understanding or the carelessness of researchers. However, researchers have the obligation to know and apply basic principles of research ethics in order to avoid, prevent, or recognize deviations from ethical scientific behavior. When intentional violations of the principles of ethical research occur, the impact to the scientific and lay community can be profound. Misconduct can be prevented if the ethical principles of research are understood and consistently applied. This paper describes the sources and detection of misconduct in the production of science in order to provide emergency researchers with the knowledge needed to prevent misconduct from occurring at all.

Background:In the early 20th century some unfavorable conditions and trends in science and publishing in R. Macedonia and other countries in the South Eastern Europe (SEE) Region were recognized and it became necessary to act to protect the integrity of science and publishing. The increasing number of scientific journals in biomedicine and published papers in them has not always been matched by increased quality in publishing due to lack of information and education of the scientific community, especially of the young scientists, about ethical principles in research and publishing. In addition, some unethical behavior, fraud and attempts by experts for increasing their scientific productivity in research and publishing their results in scientific journals was recognized.Objective:To present the initiatives, chronology of activities and leading role of Academician Momir Polenakovic towards the establishment and initial development of the Macedonian Association of Medical Editors (MAME) which has a mission for advancing the integrity of science and publishing.Method:A retrospective study based on review of the relevant literature, archive materials, minutes from organizational meetings and workshops and other documentation related to activities in the initial process for establishing and defining the mission and objectives of MAME.Results:The expansion of higher education and inappropriate implementation of the Bologna Declaration and the European Credit Transfer System in R. Macedonia from 2004/2005 contributed to a decline of the study criteria for obtaining higher education diplomas and postgraduate education degrees, as well as numerous frauds in scientific research and publishing activities in biomedicine and other fields. The first meeting of the Initiative Board for organizing an SEE Conference on research and publishing integrity and a workshop for editors of scientific journals was held in the Macedonian Academy of Sciences and Arts (MASA) on Nov. 1st, 2013. In April 2014 two preparatory meetings of the Organizational Board were held and the Workshop for editors of scientific journals and the Constitutional meeting for establishing MAME were held on Apr. 25, 2014. The first President of MAME (with a two-year mandate) was Academician Momir Polenakovic and in 2016 he was elected as the first Honorary President of MAME.Conclusion:The establishment of MAME in April 2014 was an important initiative and strategic decision toward raising awareness among editors of scientific journals and other stakeholders for preventing scientific and publishing misconduct and for educating the scientific community for creating an ethical research environment.

Principles of research ethics: A research primer for low- and middle-income countries.

Publication can become a symbol of presenting how meticulously a person has followed ethical principles in research. It is the duty of the investigators or authors to carefully read the instructions to authors and generate data with honesty and genuineness. In fulfillment of the basic requisite to publish, clearly defined instructions to authors should be provided by the journal. To assess the pattern of instructions regarding the ethical requirements given to authors in Indian Dental Journals and tried to compare the same with British Dental Journals. A cross-sectional survey of 'instructions for authors,' for analysis of guidelines on ethical processes, was done. Instructions to authors of Indian and British Dental Journals indexed in PubMed were reviewed for guidelines with regard to seven key ethical issues. Descriptive statistics were used and results were expressed in percentages as well as numbers. Of the 10 Indian Dental Journals, 7 (70%) cited ethical guidelines such as International Committee of Medical Journal Editors, Committee on Publication Ethics, Indian Council of Medical Research guidelines whereas out of 27 British Dental Journals, 16 (59.25%) cited these. Protection of human subjects such as approval from an institutional/independent ethics committee, obtaining informed consent and maintenance of confidentiality of patient records was covered with 8 (80%) Indian and 19 (70.3%) British Dental Journals. Four (40%) Indian and 13 (48.1%) instructed about animals welfare. Nine (90%) of the Indian and 25 (92.5%) British Dental Journals required declaration of conflicts of interest by authors. Publication issues and authorship/contributorship criteria were specified by all 10 Indian and 25 (92.5%) and 24 (88.8%) British journals respectively. 6 (60%) of Indian and 11 (40.75%) of British Journals explained about data management, in case of clinical trials. A significant proportion of Indexed Indian and British Dental Journals did not provide adequate instructions to authors regarding ethical issues.

BackgroundInequalities in early childhood development (ECD) tend to persist into adulthood and amplify across the life course. To date, little research on inequalities in early childhood care and development in...

<p><span lang="EN-US">Social research has attracted significant attention in Vietnam during recent years with more questions and discussions about how to promote the research outputs and publications in this area. However, there is limited information about the knowledge and attitudes of social researchers for research ethics in Vietnam. This paper aims to assess the knowledge and attitudes of social researchers about research ethics in Vietnam. A survey with 1200 questionnaires, through convenience sampling, was sent either printed copies or email to social researchers in the universities and research institutions in Vietnam. Our response rate was 65% (782), with mean age: 35.9 years (sd=.307). The results show that around one fifth had been trained with research ethics (23.5%), which led to significant responses to the "do not know" about the research ethics principles and research ethics committee with 14.3% and 55.3%, respectively. Despite such few experiences on the research ethics, the participants presented a positive understanding of the general principles of research ethics and positive attitudes to the importance of the related general ethics principles to social research in Vietnam. Such understandings and attitudes also led to the readiness to apply the research ethics values and principles while there are no formal ethical guidelines in Vietnam social research. These findings suggest that Vietnamese social researchers understood most critical ethics principles in social research and expect formal ethical guidelines.</span></p>

The study was aimed at assessing academic staff adherence to fundamental ethical principles in research in universities in cross River State, Nigeria. Three research questions were raised and hypothesis. Relevant literature were reviewed according to the variables of the study. The study adopted an expost facto research design with a stratified and purposive sampling technique to select a total of 500 academic staff from the two major universities in the state (Universty of Calabar and Cross River University of Technology, CRUTECH ). A questionnaire developed by the researcher and was well validated and pilot tested using Cronbach alpha reliability estimate whose coefficients for the four sub scales ranged from.78-81 was used for data collection. Data were collected by the researchers and shall be analysed using simple percentage and the result showed that academic staff adherence to ethical principles of informed consent, confidentiality and beneficence has been very poor. It was recommended that staff should be trained on how to apply ethical considerations in their research practices. That papers that are published must show how ethical considerations are followed before accepted for publications. That this aspect of research must be properly emphasized in the research lessons.

Responsible, respectable, and successful engagement in research and scholarship in academia requires adherence to certain basic professional ethical principles to sustain the fidelity of academic work and the integrity of the researcher-scholar. This is more so for works which are intended for dissemination, information, attention, and consumption of audiences beyond the researcher-scholar’s proximal academic habitat. Ethical principles in research and scholarship apply whether the intended work, to be made public, is a conceptual scholarly narrative of ideas and thoughts or a narration of actual scientific-process-based research. This paper explores some of the key ethical principles in research and scholarship, their applications, and implications. Emerging ethical requirements, based on the 2018 updates to the Common Rule for Institutional Review Board, are explored. Criteria for meeting international ethical requirements and processes in research and scholarship are outlined with guidelines for authorship. Implications for current and future need for fidelity, integrity and trustworthiness in the academic enterprise are stressed.

The community service activity was conducted in the form of online training on Zoom and Youtube platforms. The participants were 80 lecturers, teachers, and university students from 28 different institutions. It aimed to facilitate the participants to be able to improve the quality of their scientific articles and to submit their articles to ‘carefully chosen’ journals. It lasted for 100 minutes. There were six important points regarding how the quality of research articles could be maintained and improved. Firstly, the participants should do a lot of reading before writing. Secondly, they should have strong rationales of conducting their studies. Thirdly, they needed to use combination of descriptive and analytical expressions. Fourth, they should write or review only relevant literature in meaty way. Next, they should ensure that all of the in-text citations correspond to the references. Last but not least, they should implement ethical principles in research. Furthermore, regarding how the participants could choose which journal was ‘best’ for their articles, four important points were discussed: choosing a journal which ‘matched’ the quality of the article, choosing a journal with regular publication, adhering to the chosen journal’s template, and asking the journal editors about the duration of the review process. 

The Working Group on Mental Health and Psychosocial Support was convened as part of the 2009 Harvard Humanitarian Action Summit. The Working Group chose to focus on ethical issues in mental health and psychosocial research and programming in humanitarian settings. The Working Group built on previous work and recommendations, such as the Inter-Agency Standing Committee's Guidelines on Mental Health and Psychosocial Support in Emergency Settings. The objective of this working group was to address one of the factors contributing to the deficiency of research and the need to develop the evidence base on mental health and psychosocial support interventions during complex emergencies by proposing ethical research guidelines. Outcomes research is vital for effective program development in emergency settings, but to date, no comprehensive ethical guidelines exist for guiding such research efforts. Working Group members conducted literature reviews which included peer-reviewed publications, agency reports, and relevant guidelines on the following topics: general ethical principles in research, cross-cultural issues, research in resource-poor countries, and specific populations such as trauma and torture survivors, refugees, minorities, children and youth, and the mentally ill. Working Group members also shared key points regarding ethical issues encountered in their own research and fieldwork. The group adapted a broad definition of the term "research", which encompasses needs assessments and data gathering, as well as monitoring and evaluation. The guidelines are conceptualized as applying to formal and informal processes of assessment and evaluation in which researchers as well as most service providers engage. The group reached consensus that it would be unethical not to conduct research and evaluate outcomes of mental health and psychosocial interventions in emergency settings, given that there currently is very little good evidence base for such interventions. Overarching themes and issues generated by the group for further study and articulation included: purpose and benefits of research, issues of validity, neutrality, risk, subject selection and participation, confidentiality, consent, and dissemination of results. The group outlined several key topics and recommendations that address ethical issues in conducting mental health and psychosocial research in humanitarian settings. The group views this set of recommendations as a living document to be further developed and refined based on input from colleagues representing different regions of the globe with an emphasis on input from colleagues from low-resource countries.

the London School of Hygiene and Tropical Medicine.It summarises the launch lecture on the importance of history in the assessment of globalisation.It argues for more involvement of history and historians...

PurposeProper nutrition is essential for brain development during infancy, contributing to the continued development of cognitive, motor, and socio-emotional skills throughout life. Considering the insufficient published data in the Middle East and North Africa, experts drafted a questionnaire to assess the opinions and knowledge of physicians on the impact of nutrition on brain development and cognition in early life.MethodsThe questionnaire consisted of two parts: The first focused on the responders' demographic and professional characteristics and the second questioned the role of nutrition in brain development and cognition. Descriptive statistics were used to summarize respondents' characteristics and their responses to questions.ResultsA total of 1,500 questionnaires were distributed; 994 physicians responded. The majority of the surveyed physicians (64.4%) felt that nutrition impacts brain development in early childhood (0–4 years), with almost 90% of physicians agreeing/strongly agreeing that preventing iron, zinc, and iodine deficiency would improve global intelligence quotient. The majority of physicians (83%) agreed that head circumference was the most important measure of brain development. The majority of physicians (68.9%) responded that the period from the last trimester until 18 months postdelivery was crucial for brain growth and neurodevelopment, with 76.8% believing that infants breast-fed by vegan mothers have an increased risk of impaired brain development.ConclusionThe results of this study show that practicing physicians significantly agree that nutrition plays an important role in brain and cognitive development and function in early childhood, particularly during the last trimester until 18 months postdelivery.