Analysis of sickness absenteeism in a public university: a temporal statistical study.

Although most countries have ethical oversight systems for health-related research involving human participants, mechanisms for assessing the quality of those systems are not regularly used, particularly in low-resource settings. To address this gap, the Regulatory System Strengthening, Regulation and Safety unit and Health Ethics and Governance unit of the World Health Organization (WHO) recently released a tool for benchmarking ethics oversight of health-related research involving human participants. The tool provides a simple, easy-to-measure set of indicators for assessing the quality of research ethics oversight systems without the need to invest a great deal of resources. The tool comprises 48 indicators divided across three areas: (i) the national context; (ii) research ethics committees; and (iii) institutions that conduct health-related research involving humans, such as academic medical centres. Indicators related to the national context are intended to be evaluated in a single assessment applicable to the country as a whole, whereas indicators related to research ethics committees and research institutions are evaluated on an entity-by-entity basis. Some countries may choose to assess a representative sample of research ethics committees and institutions; alternatively, national authorities might ask research ethics committees and institutions to undertake self-assessments and report the results. Research ethics committees or institutions could also use WHO’s tool on their own as part of a process of quality improvement. WHO is working with global partners to disseminate the tool and support global implementation. Widespread use of the tool is expected to enhance policy coherence in ethics oversight and facilitate multinational research.

BackgroundRecent studies using mass drug administration (MDA) of antibiotics to entire communities have focused global attention on the unique ethical challenges of MDA of antibiotics in research and public health interventions. However, there is no specific guidance for Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) to review such trials. We surveyed the literature to identify the unique ethical challenges and to strengthen the competencies of RECs or IRBs in low- and middle-income countries (LMICs) in their ethical reviews of these trials.MethodsWe employed a desk review. We searched PubMed, Web of Science, and Google Scholar, combining terms for “mass drug administration” with terms for “research ethics committees,” “institutional review boards,” and “ethics.” We reviewed citations of search results to retrieve additional articles. Only articles published and indexed in the above databases up to 6 January 2022 in English were included. s (without full articles), books and articles that had exclusive veterinary and environmental focus were excluded. We synthesized the literature to identify particularly challenging ethical issues relevant to antibacterial MDA trials in LMICs.ResultsThe most challenging ethical issues can be categorised into four broad domains: determining the social value of MDA, assessing risks and benefits, engaging all stakeholders meaningfully, and study design-related ethical challenges. These four domains interact and impact each other. Together, they reveal the need for RECs/IRBs to review MDA studies through a broader lens than that of clinical trials per se. From our findings, we propose a framework to guide the RECs and IRBs in LMICs to perform the initial and continuing review of antibiotic MDA trials. We also recommend strengthening the competencies of LMIC RECs or IRBs through ongoing training and collaboration with RECs or IRBs from high-income countries.ConclusionsREC/IRB review of research using MDA of antibiotics plays a critical role in assuring the ethical conduct of MDA studies. Local RECs/IRBs should be empowered to review MDA studies comprehensively and competently in order to advance scientific knowledge about MDA and promote improved global health.

Technical Issues Encountered During Ethics Review: Quality Assurance in the Research Process

Trial participants' rights after authorisation of COVID-19 vaccines

To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs). We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol. There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues. The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater "consistency."

The objective of the study was to determine the effect of strategic CSR communication on the brand image of selected public universities in Kenya. The study adopted a descriptive research design. The unit of analysis was five public universities that have been in existence for more than 15 years. The study targeted the 1410 employees in these universities. The sample size was 206 employees in public universities. The study used stratified random sampling to select the sample. Primary data was collected in this research. Sourced data was mainly gathered by administering structured questionnaires. Excel and Statistical Package for Social Scientists (SPSS) version 21 was used to analyse data. Data was analysed using inferential and descriptive statistics. Data was presented using means, standard deviation, and distribution tables in tables and figures. Regression of coefficients showed that there was a positive and significant relationship between strategic CSR communication and brand image. The study further concluded that most Kenyan universities had an interactive form of communication that enhanced their brand image. In addition, the use of media channels during corporate social responsibility activities enhances the brand image of the institution. Further, giving true and honest messages during corporate social responsibility activities enhances the brand image of the institution. The Kenyan government, university partners, and university collaborators should offer support to the universities in their corporate image initiatives. It is also important for the Commission of University Education (CUE) as the regulatory body to ensure that universities in Kenya operate in a favorable learning environment necessary for satisfactory service provision.

Ethics in global health research: the need for balance.

Background Public and Patient Involvement (PPI) is now a central component of health and social care research. Despite widespread endorsement, the governance structures overseeing research such as institutional research ethics committees (RECs) have been slower to incorporate PPI in meaningful ways. The Irish PPI Ignite Network has undertaken a programme of work to clarify ethical considerations around PPI and to support inclusion of public contributors in REC governance. This paper reflects on the implementation of PPI membership within a university REC and examines whether expectations established by national guidance aligned with lived experience. Methods This perspective review draws on three linked initiatives undertaken by the PPI Ignite Network: (1) development of a national statement clarifying when REC approval is required for PPI, (2) co-produced guidance for sustaining PPI membership on RECs, and (3) real-world implementation of PPI membership on a university institutional REC. Reflexive narrative accounts from a PPI coordinator and a PPI contributor after more than one year of REC membership were analysed using interpretive thematic analysis. Results Three overarching themes were shared: (1) legitimacy without clarity of impact, (2) learning and cultural translation, and (3) structural readiness versus relational readiness. The REC was welcoming and operationally accessible, but influence on decisions was difficult to perceive. Membership required extended acclimatisation, and ethical deliberation often depended on tacit institutional knowledge. Guidance accurately predicted barriers around training, confidence, and language but underestimated the time needed for integration and the complexity of institutional governance cultures. Conclusions Embedding PPI within RECs is feasible and beneficial, but implementation is developmental rather than procedural. Guidance documents help institutions prepare structurally, yet successful integration depends on relational and cultural change. PPI membership should be considered a long-term governance intervention rather than a discrete inclusion initiative. Evaluation frameworks should shift from measuring decision impact to assessing deliberative quality and ethical reflexivity.

Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation. To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial. Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires. Twenty-four hospitals in 11 European countries. From the 24 hospitals, 23 local investigators responded; 23 answers were analysed. Comparison of research ethics procedures and committee requirements from the perspective of clinical researchers. Comparison of the institutions' procedures regarding patient information and consent. Description of further details such as costs and the duration of the approval process. The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 &OV0556;. In 20 hospitals, a patient information sheet of variable length (half page up to two pages) was provided. Requirements for patients' informed consent differed. Written informed consent was mandatory at 12, oral at 10 and no form of consent at one hospital. Details such as enough time for consideration, possibility for withdrawal and risks/benefits of participation were provided in 25 to 30% of the institutions. There is a considerable variation in the administrative requirements for approval procedures by research ethics committees in Europe. This results in variation of the extent of information and consent procedures for the patients involved. euCPSP in Clinicaltrials.gov identifier: NCT01467102; PAIN-OUT in Clinicaltrials.gov identifier: NCT02083835.

Research in nursing education and the institutional review board/ethics committee.

Background:With a rapidly increasing population of older aged people, epidemiological data regarding the prevalence of mental and physical illnesses are urgently required for proper health planning. However, there is a scarcity of such data from India.Aims:To study the frequency and pattern of psychiatric morbidity present and the association of physical illness with psychiatric morbidity in an elderly urban population.Settings and Design:Cross-sectional, epidemiological study.Materials and Methods:All the consenting elderly persons in a municipal ward division (n=202) were enrolled after surveying a total adult population of 7239 people. A door to door survey was undertaken where the participants were interviewed and physically examined. General Health Questionnaire-12, Mini Mental State Examination, CAGE Questionnaire and Geriatric Depression Scale were used in the interview apart from consulting the available documents. Other family members were also interviewed to verify the information.Statistical Analysis:Chi-square test with Yates correction.Results:Psychiatric illnesses were detected in 26.7% while physical illnesses were present in 69.8% of the population surveyed. Predominant psychiatric diagnoses were depressive disorders, dementia, generalized anxiety disorder, alcohol dependence and bipolar disorder. The most common physical illness was visual impairment, followed by cardiovascular disease, rheumatic illnesses, pulmonary illnesses, hearing impairment, genitourinary diseases and neurological disorders. Presence of dementia was associated with increased age, single/widowed/separated status, nuclear family, economic dependence, low education, cardiovascular disorders, rheumatic disorders and neurological disorders. Depression was associated with female sex, single/widowed/separated status, staying in nuclear families, economic dependence on others and co-morbid physical illnesses, specifically cardiovascular disorders and visual impairment.Conclusions:This study presented a higher rate of dementia and old age depression. The interesting association with several sociodemographic factors as well as physical illnesses may have important implications for health planning.

Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) are rapidly becoming indispensable mechanisms in the overall workings of university institutions. In fact, the ethical dimension is an important aspect of research governance processes present in institutions of higher learning. However, it is often deemed that research in the social sciences do not require ethical appraisal or clearance, because of the alleged absence of harm in conducting such research. This is an erroneous and dangerous assumption given that research in social sciences poses various and complex dilemmas related to ethics. The article aims to gauge the importance of ethical appraisal at a particular institution of higher learning’s Faculty of Humanities. This is done by scrutinising its defunct REC, and the views that Heads of Departments of the Faculty have of ethics in research and the need for ethical appraisal by this REC. Finally, some suggestions are made to proceed to review and restructure the current REC with the ultimate objective to make it functional again. It was found that the development and discussion around ethics in research and ethical appraisal are part of a much needed thrust to sensitise the entire Faculty and the institution on the widespread beneficial repercussions of ethical awareness in research and beyond.

BackgroundThe review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Shared Ethical Debate” (ShED) where multiple committees review the same project. Committee reviews are compared for consistency by analysing the resulting minutes.MethodsWe present a description of the ShED process. We report an analysis of minutes created by research ethics committees participating in two ShED exercises, and compare them to minutes produced in a published “mystery shopper” exercise. We propose a consistency score by defining top themes for each exercise, and calculating the ratio between top themes and total themes identified by each committee for each ShED exercise.ResultsOur analysis highlights qualitative differences between the ShED 19, ShED 20 and “mystery shopper” exercises. The quantitative measure of consistency showed only one committee across the three exercises with more than half its total themes as top themes (ratio of 0.6). The average consistency scores for the three exercises were 0.23 (ShED19), 0.35 (ShED20) and 0.32 (mystery shopper). There is a statistically significant difference between the ShED 19 exercise, and the ShED 20 and mystery shopper exercises.ConclusionsShED exercises are effective in identifying inconsistency between ethics committees and we describe a scoring method that could be used to quantify this. However, whilst a level of inconsistency is probably inevitable in research ethics committee reviews, studies must move beyond the ShED methodology to understand why inconsistency occurs, and what an acceptable level of inconsistency might be.

IntroductionA major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance.DiscussionWe review recommendations related to four key issues, namely standard of prevention, post‐trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants.ConclusionsThere have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re‐certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.

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.