National Ethics Committee Research Articles

P16 Journey of psoriasis registry in Nigeria (prince study)

Abstract The prevalence of Psoriasis in African populations ranges from 0.05 to 1%, compared with 2–3% reported in Caucasian populations.1,2 Some postulate that the low prevalence in African studies may be due to missed or misdiagnoses as tinea corporis or non-specific dermatitis by non-dermatologists due to a scarcity of dermatologists and dermatopathologists.1,2 Information on psoriasis in Nigerians is needed, being the most populous dark-skinned nation in the world, as clinical and genetic variations could influence therapeutic approaches to its management. This project was to develop a psoriasis registry, the first in Nigeria, that will document psoriasis patients’ clinical, epidemiological and biochemical characteristics. Our Roadmap included developing the Psoriasis Registry team, writing the proposal, and seeking ethics clearance from the National Human Research and Ethics Committee of Nigeria and the committees at the participating centres. Investigators were trained on diagnosis, assessment, and instruments, including PASI, DLQI, and body surface area, as well as datasheets and protocols and data entry into the website https://psoriasis.org.ng. Bimonthly meetings are held to assess the challenges and progress. This collaborative effort comprised the principal investigator (PI), three co-PIs, and over 60 co-investigators from Dermatology clinics across Nigeria’s six geopolitical regions. The proposal and protocols have received approval from the National Human Research and Ethics Committee of Nigeria (NHREC/01/01/2007 – 08/11/202333). Data entry started in January, and we are about 6 months into the project. Preliminary results show about equal frequencies of psoriasis in both males and females. Chronic plaque psoriasis is the most common clinical type, and all the clinical types have been documented. This study, with the cohort developed, will form the foundation for further studies of psoriasis in Nigeria, particularly genetic studies. It will potentially improve the understanding and management of psoriasis across Nigeria’s six geopolitical zones and the skin of colour population.

Adherence and quality of life in patients with epilepsy in Cyprus

Abstract Introduction Epilepsy affects about 50 million people globally1. Patients often struggle with medication adherence due to forgetfulness, side effects, or lack of understanding, yet consistent use is vital for reducing seizures and improving quality of life2. Community pharmacists can improve outcomes by educating patients, aiding adherence, and clarifying drug effects and interactions, beyond just dispensing prescriptions. Aim The study aimed to assess epileptic patients’ adherence and quality of life in Cyprus. Methods This quantitative study, conducted from September 2022 to October 2023, received ethical approval from the Cyprus National Ethics Committee. Data were collected via phone calls using tools translated into Greek to assess adherence among epileptic patients. These tools included the MMAS-8 Morisky, with 8 items (7 Yes/No questions and 1 Likert 5-Point question), and the Readiness for Change scale, featuring a 0-10 ruler and 3 open-ended questions. The MARS-5, with 5 Likert 5-Point questions, and the QOLIE-31 were also used, along with demographic data collection. Inclusion criteria were patients over 18 with epilepsy, on antiepileptic therapy, and Greek-speaking. Of the 151 patients in the registry, 16 were excluded by the Neurologist of the Limassol's General Hospital due to factors like communication issues, recent stroke, quadriplegia, brain paralysis, mental retardation, and Down syndrome. Statistical analysis was performed using SPSS V28. Results In total, 85 epileptic patients participated in the study (out of the 135 patients- response rate 62.96%). The study's demographics included 47 males (55.3%) and 38 females (44.7%), with 18 participants aged 18-34 (21.2%), 46 participants aged 35-64 (54.1%), and 21 participants over 65 (24.7%). Additionally, the age of epilepsy onset was categorised as follows: 39 participants (45.9%) had an onset before 18 years of age, and 46 participants (54.1%) had an onset at 18 years of age or older. The Morisky MMAS-8 results showed 47 participants (55.3%) with high compliance, 26 (30.6%) with medium, and 12 (14.1%) with low compliance. The MARS-5 results indicated 79 participants (92.9%) had high compliance (≥20), while 6 (7.1%) had low compliance (<20). The readiness for change ruler had a mean score of 9.48 (SD = 0.16). Specifically, the distribution of scores was as follows: 1 participant (1.2%) scored 2, 4 participants (4.7%) scored 5, 2 participants (2.4%) scored 7, 4 participants (4.7%) scored 8, 2 participants (2.4%) scored 9, and 72 participants (84.7%) scored 10. The overall quality of life (QoL) score averaged 75.3 (SD = 2.16). Discussion/Conclusion This study is the first comprehensive assessment of adherence and quality of life among epileptic patients in Cyprus. Some patients did not participate due to lack of time and interest. Using the Morisky MMAS-8 and MARS-5 scales, over half showed high medication compliance, but a significant portion had medium to low compliance, indicating a need for targeted interventions. The findings underscore the critical role of community pharmacists in supporting adherence and enhancing quality of life through education, counseling, and personalized care. This study provides a foundation for future research and interventions to improve epilepsy management in Cyprus.

Plasmodium falciparum molecular surveillance to inform the Mozambican National Malaria Control Programme strategy: protocol

IntroductionMalaria molecular surveillance has the potential to generate information on biological threats that compromise the effectiveness of antimalarial interventions. This study aims to streamline surveillance activities to inform the new...

Barriers and hurdles delaying governance approval for an ethically approved nationwide clinical trial in pancreatic cancer.

Streamlined, expedited clinical research is fundamental to rapidly test, translate and implement novel treatments into routine care to improve patient outcomes. The National Mutual Acceptance (NMA) scheme was designed to expedite the ethics approval process, however, growing concerns exist about the fragmented time-consuming governance process needed to actually commence clinical research in Australia. This study reports hurdles and barriers encountered while seeking governance approval for the SCANPatient trial. SCANPatient is a nationwide multi-centre trial comparing standard narrative radiological reporting of CT scans for suspected pancreatic ductal adenocarcinoma. with an alternative structured approach. SCANPatient was approved by a national Human Research Ethics Committee under the NMA. The documents, time, costs and platforms required to obtain governance approval and open the trial at 30 participating hospitals were analysed. Wide variation exists in research governance office (RGO) requirements for local approval, resulting in extra costs (>$117 000), delays of up to 4 months in commencing the trial at some participating sites, unplanned adjustment of the study design, and ultimately the loss of several potential sites. There were inconsistencies among RGOs minimum requirements and processes across jurisdictions and sites, with delays in obtaining approval signatures, time-consuming processes, differing platforms used to submit governance reviews and inflexibility of RGO processes all contributing to delays in progressing the trial and obtaining governance approval. The current governance process is time- and cost-consuming and undermines the NMA scheme's efforts to streamline the clinical trials review process.

Evaluation of an electronic clinical decision support algorithm to improve primary care management of acute febrile illness in rural Cambodia: protocol for a cluster-randomised trial

IntroductionAcute febrile illness (AFI), traditionally attributed to malaria, is a common reason for seeking primary healthcare in rural South and Southeast Asia. However, malaria transmission has declined while health workers...

Running shoe cushioning properties at the rearfoot and forefoot and their relationship to injury: study protocol for a randomised controlled trial on leisure-time runners

Previous work has demonstrated the protective effect of shoe cushioning on injury risk in leisure-time runners, but most models currently available on the market have greater cushioning than those investigated...

The human foetus as ‘donor’ of tissues and organs

The possibility of using the foetus as a ‘donor’ of tissues and organs is coming up more and more frequently in the field of transplantation and is being considered by numerous institutional and national ethics committees, as well as by international bodies that have drawn up and are drawing up guidelines.

Data sharing policies across health research globally: Cross-sectional meta-research study.

Data sharing improves the value, synthesis, and integrity of research, but rates are low. Data sharing might be improved if data sharing policies were prominent and actionable at every stage of research. We aimed to systematically describe the epidemiology of data sharing policies across the health research lifecycle. This was a cross-sectional analysis of the data sharing policies of the largest health research funders, all national ethics committees, all clinical trial registries, the highest-impact medical journals, and all medical research data repositories. Stakeholders' official websites, online reports, and other records were reviewed up to May 2022. The strength and characteristics of their data sharing policies were assessed, including their policies on data sharing intention statements (a.k.a. data accessibility statements) and on data sharing specifically for coronavirus disease studies. Data were manually extracted in duplicate, and policies were descriptively analysed by their stakeholder and characteristics. Nine hundred and thirty-five eligible stakeholders were identified: 110 funders, 124 ethics committees, 18 trial registries, 273 journals, and 410 data repositories. Data sharing was required by 41% (45/110) of funders, no ethics committees or trial registries, 19% (52/273) of journals and 6% (24/410) of data repositories. Among funder types, a higher proportion of private (63%, 35/55) and philanthropic (67%, 4/6) funders required data sharing than public funders (12%, 6/49). Data sharing requirements, and even recommendations, were insufficient across health research. Where data sharing was required or recommended, there was limited guidance on implementation. We describe multiple pathways to improve the implementation of data sharing. Public funders and ethics committees are two stakeholders with particularly important untapped opportunities.

Délai d’obtention d’une première décision finale par un Comité de Protection des Personnes pour débuter une étude de recherche clinique en France : Etude rétrospective entre 2019 et 2023

IntroductionThe study reported the time (from the initial submission to the final decision) to evaluate a clinical research project by one of the 39 French national ethics committees. The times from this final decision to the first participant inclusion and study achievement (first patient inclusion to the end of the last patient's follow-up) were also reported. MethodsClinical research projects submitted between January 1st 2019 and June 30th 2023 were analyzed according to their type (research on drugs, clinical investigations, performance studies, research implying human person), and the promotor (industry, university hospital, general hospital, private medical institution, others). The times of assessment of the project by the ethic committee (from the initial submission to the final decision), of the first participant inclusion (from the approval of the project) and of study achievement (first patient inclusion to the end of the last patient's follow-up) were calculated. ResultsAmong 467 submitted clinical research projects, 424 were approved (90.8 %). The median time [Q1–Q3] to evaluate a project was 73 days [51–98] whatever the types of projects and promotors. In 307 accepted projects, the first patient inclusion occurred after 134 days [61–237] and was being waited for 347 days [306–510] in 39 other ones. In 122 projects, the time for study achievement was 446 days [230–731]. In 185 other projects, the inclusions were still in progress for 699 days [397–1098]. ConclusionIn this concerned ethic committee, a final decision was edited after a median assessment time of 73 days (with >90 % approvals), shorter than the times to include the first patient and for achieving the study.

The role of the hospital pharmacist to guarantee access and continuity of care for the management of epilepsy

In this article the pivotal role of hospital pharmacists in the multidisciplinary management of epilepsy is discussed. Hospital pharmacists are members of national and local ethics committees, oversee clinical trials, and ensure adherence to regulations for patient access to novel therapeutic treatments. They actively contribute to regulatory processes and the definition of prescribing centers. In the post-launch phase, hospital pharmacists are a key member in the multidisciplinary team, they are involved in decisions relating to the local introduction of drugs, in the management of the drug within the hospital structure and with the direct distribution, and to ensure proper and timely treatment. The pharmacovigilance network, including hospital and community pharmacists, monitors and prevents adverse effects related to epilepsy medications and enhances a collaborative approach with specialists to promote prescription appropriateness, targeting therapy for better patient outcomes. Finally, the potential benefits of deprescribing are briefly discussed, underscoring the importance of a multidisciplinary approach involving doctors and clinical pharmacists to gather comprehensive data and enhance patient care in epilepsy management.

Effectiveness of an institution-based adapted physical activity programme versus a home-based self-management programme for chronic poststroke adults: protocol for a randomised controlled study

IntroductionPhysical activity (PA) protects the cardiovascular system and reduces the risk of stroke recurrence. However, most stroke survivors have significantly lower daily PA levels than those recommended. Adapted PA programmes...

Rectal versus vaginal progesterone administration for luteal phase support in the hormone replacement therapy frozen embryo transfer (HRT-FET) cycle: protocol for a non-inferiority randomised controlled trial

IntroductionThis study compares rectal administration with vaginal administration of progesterone as luteal phase support in hormone replacement therapy frozen embryo transfer (HRT-FET) cycles. The reason for comparing the two routes...

Acceptability of artificial intelligence for cervical cancer screening in Dschang, Cameroon: a qualitative study on patient perspectives

BackgroundCervical cancer is the fourth most frequent cancer among women, with 90% of cervical cancer-related deaths occurring in low- and middle-income countries like Cameroon. Visual inspection with acetic acid is often used in low-resource settings to screen for cervical cancer; however, its accuracy can be limited. To address this issue, the Swiss Federal Institute of Technology Lausanne and the University Hospitals of Geneva are collaborating to develop an automated smartphone-based image classifier that serves as a computer aided diagnosis tool for cancerous lesions. The primary objective of this study is to explore the acceptability and perspectives of women in Dschang regarding the usage of a screening tool for cervical cancer relying on artificial intelligence. A secondary objective is to understand the preferred form and type of information women would like to receive regarding this artificial intelligence-based screening tool.MethodsA qualitative methodology was employed to gain better insight into the women’s perspectives. Participants, aged between 30 and 49 were invited from both rural and urban regions and semi-structured interviews using a pre-tested interview guide were conducted. The focus groups were divided on the basis of level of education, as well as HPV status. The interviews were audio-recorded, transcribed, and coded using the ATLAS.ti software.ResultsA total of 32 participants took part in the six focus groups, and 38% of participants had a primary level of education. The perspectives identified were classified using an adapted version of the Technology Acceptance Model. Key factors influencing the acceptability of artificial intelligence include privacy concerns, perceived usefulness, and trust in the competence of providers, accuracy of the tool as well as the potential negative impact of smartphones.ConclusionThe results suggest that an artificial intelligence-based screening tool for cervical cancer is mostly acceptable to the women in Dschang. By ensuring patient confidentiality and by providing clear explanations, acceptance can be fostered in the community and uptake of cervical cancer screening can be improved.Trial registrationEthical Cantonal Board of Geneva, Switzerland (CCER, N°2017–0110 and CER-amendment n°4) and Cameroonian National Ethics Committee for Human Health Research (N°2022/12/1518/CE/CNERSH/SP). NCT: 03757299.

Ethics considerations for precision medicine research and genetic testing in low- and middle-income countries.

Genetic data transfer within multicentre clinical trials conducted in low- and middle-income countries is common and must be communicated to study participants as part of ethical requirements. To analyse ethics practices in precision medicine research in low- and middle-income countries and make useful recommendations. We conducted a narrative review of published literature and existing ethics frameworks regarding underrepresentation of low- and middle-income countries in genomic databases, informed consent and data security discussions, as well as the potential for exploitation and limited access to benefits. The findings highlight the need for increased diversity in research participation, robust ethical frameworks, and knowledge sharing between developed and developing countries. The findings show that strengthening national research ethics committees and fostering collaboration can help low- and middle-income countries in addressing unique challenges and harnessing the potential of precision medicine while ensuring ethical conduct and equitable access for all. Our review emphasizes the importance of ethical considerations in precision medicine research to ensure that its benefits reach all affected populations, promoting a more just and more equitable healthcare future. There is a need to ensure that research participants are accorded the rights, whether in the ownership of their samples or the right to know what type of genetic studies have been conducted on their samples. It is important to have binding agreements that will allow clinical trial participants to access drugs that proof effective based on the trials they participated in.

Oversight of Dual-Use Research: What Role for Ethics Committees?

The World Health Organization (WHO) Global Guidance Framework for the Responsible Use of the Life Sciences addresses the governance of biorisks, including dual-use research, for countries. It emphasizes engaging multisectoral stakeholders such as governments, scientific bodies, health and research institutes, standard-setting organizations, funding bodies, and others. Ethics constitutes a key component of the framework. Given the high social impact of such research and the importance of trust, risk, and benefit, national ethics committees could make a valuable contribution by providing ethical guidance in the decisionmaking process. The purpose of this study was to examine the role of national ethics committees in the context of governance and oversight of dual-use research at the national level. We conducted a landscape analysis of the activities of ethics committees in dual-use research oversight. We also searched the WHO database on National Ethics Committees for publications related to dual-use research and/or misuse of life sciences research and gathered additional documentation from national ethics committees websites and through author contacts. Results showed that in the context of the wide range of oversight mechanisms for dual-use research in countries, national ethics committees have contributed to guiding policy and assessing dual-use research risks in only a limited number of countries. Recommendations from those countries include establishing a multistakeholder, coordinated oversight mechanism at the country level; strengthening international linkages to guide, harmonize, and reinforce national and international efforts; and involving ethics committees as an expert resource in the governance and oversight process.

Impact evaluation of a cash-plus programme for children with disabilities in the Xiengkhouang Province in Lao PDR: study protocol for a non-randomised controlled trial

IntroductionMore than 170 countries have implemented disability-targeted social protection programmes, although few have been rigorously evaluated. Consequently, a non-randomised controlled trial is being conducted of a pilot ‘cash-plus’ programme implemented...

Protocol for cost-effectiveness analysis of a randomised trial of mHealth coaching (Bump2Baby and Me) compared with usual care for healthy gestational weight gain and postnatal outcomes in at-risk women and their offspring in the UK, Australia, Ireland and Spain

IntroductionGestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs...

Prospects for the use of medicinal plants extracts (Mallotus oppositifolius and Kalanchoe crenata) as antimicrobials against salmonellosis in poultry

This study is a contribution to the search for alternatives to combat antibiotic resistance in Salmonella strains in poultry farming. The objective of this work is to highlight the main phytochemical compounds of 2 Ivorian medicinal plants (Mallotus oppositifolius and Kalanchoe crenata) and to evaluate their acute oral toxicity with a view to their use in the poultry sector, to fight against certain avian pathologies, including Salmonellosis. The phytochemical compounds of the different extracts of the plants used in this study were highlighted by colouring and precipitation methods. Acute oral toxicity was adapted to broilers according to the guideline OECD 425, 2008. This experimental study, which is the very first adapted to broiler chickens, was carried out with the agreement of the National Ethics Committee for Life and Health Sciences. The phytochemical screening carried out showed that each of these three antibacterial extracts possesses at least the major phytochemical groups sought. At the end of the acute oral toxicity study, no mortality was observed and the biochemical analysis of the subjects' blood showed creatinine values ​​≤ 10 mg/L.; aspartate aminotransferase (ASAT) ≤ 275 IU/L; alanine aminotransferase (ALT) ≤ 50 IU/L, urea=0.01g/L, CRP≤6 mg/L; and blood sugar was between 2 and 5 g/L in subjects from different batches. Ultimately, the aqueous and ethanolic extracts of Mallotus oppositifolius and the ethanolic extract of Kalanchoe crenata can be used as an antibacterial in broiler farming.

The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms.

Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0-59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.Study registration: NCT04910750 and NCT05065320.

The role of National Ethics Committees in the changing research environment

No abstract available.