National Ethics Committee Research Articles

Overview of the National Ethics Committee Registry for Biomedical and Health Research in India: Stepping up to safeguard the ethical aspect of research involving human participants.

As notified in the New Drugs and Clinical Trials Rules 2019, ethics committees (ECs), intending to review and oversee the conduct of Biomedical and Health Research (BHR) shall be required to register with the authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research (DHR). The entire process of receiving and processing such applications is done online through the Naitik portal. Vide these rules, it has become mandatory for all institutions/entities whether publicly or privately conducting or intending to conduct BHR involving the human participants, to get their EC, registered with the DHR. A status report of the functioning of the National Ethics Registry and an analysis of ECs registered with the DHR are presented in this manuscript. A workflow of the processing involved in EC registration is given with sectorial segregation, and analysis of data on ECs across the country is made for the dissemination and information. This article elaborates on the registration requirements and process of the EC registry with the necessity of being registered with the DHR. 2100 login requests and more than 1560 applications for registration have been received; private hospitals and medical colleges have been the front-runner in getting their organization registered, and organizations in the commercial sector are faring better in terms of EC registration. Further dissemination and outreach efforts have to be made to draw the attention of various stakeholders regarding this requirement and thereby ensuring that all ECs in the country are registered with the DHR.

Ending a Treatment Relationship

Ending a Treatment Relationship

Study protocol: pneumonia and inhaled corticosteroid treatment patterns in chronic obstructive pulmonary disease – a cohort study using sequence analysis (PICCS)

IntroductionTreatment with inhaled corticosteroids (ICS) is a widely used treatment in chronic obstructive pulmonary disease. The main effects include a reduction in the number of exacerbations and, for some patients,...

Improving cancer care in underserved regions through technology-enabled patient-reported outcomes.

1520 Background: The growing cancer burden in Africa is a major public health challenge. There were 8,944 new cases in Rwanda, with over 6,044 deaths reported in 2020. Unfortunately, there are only 13 oncologists in Rwanda for a population of 13 million people. The use of artificial intelligence (AI) tools and digital health in cancer treatment has the potential to mitigate the oncology workforce shortages, support clinical decision-making, and increase access to care. Hurone AI is a Seattle MedTech startup building culturally sensitive AI applications to address the oncologist-patient gaps and improve drug safety in underserved populations. Hurone’s premier application, Gukiza, launched at the Rwanda Cancer Center in 2022 to conduct beta testing. Gukiza is a remote patient monitoring system that ensures patients can report side effects or symptoms from their phones and oncology care teams can get real-time treatment insights and provide timely and effective care. Methods: Hurone received ethical approval from the Rwanda National Ethical Committee to launch a pilot in September 2022. An initial 45 breast cancer patients aged 20 – 65 who were either newly diagnosed or on active treatment were recruited. Each patient periodically received prompts that asked them about side effects and to score the degree of severity. The questions were adapted from the NCI’s adverse events repository. Gukiza analyzed each response and presented a visual analysis of each patient, enabling the cancer care team to send text-based interventions to the patient’s phone. Potential emergencies are flagged and sent emergency numbers to call. Through Amazon’s cloud analytic tools, Gukiza provides treatment insights to support oncologists' clinical decisions. Results: Results are summarized. Conclusions: Resource-appropriate digital technologies can be a useful tool in mitigating adverse events during cancer treatment and increasing access to timely care for patients. The data built in such systems can be a useful resource to individualize and improve cancer care and treatment outcomes.[Table: see text] [Table: see text]

Strengthening research ethics oversight in Africa: The Kenyan example

Background. Africa has seen an increase in the number of health research projects being conducted on the continent, particularly clinical trials. Ideally, this should be accompanied by a commensurate improvement in research ethics review capacity to competently provide the much-required research ethics oversight. Unfortunately, this is not the case in many African countries, which are still grappling with weak research ethics oversight capacity, not only at national level but also at institutional level. Objectives. To describe the proposal by Kenya’s national research ethics regulatory authority, the National Commission for Science Technology and Innovation (NACOSTI), to build the capacity of its National Scientific and Ethics Committee (NSEC), tasked with providing the required research ethics oversight in the country. Methods. This is the proposal submitted by NACOSTI to the European and Developing Countries Clinical Trials Partnership for funding of a project entitled ‘Strengthening Research Ethics and Oversight in Kenya’ (STReK). It describes the activities involved to strengthen the NSEC to provide the required research ethics in the country, and to build the research ethics capacity of research ethics committees (RECs) it has accredited, through training and mentorship programmes, to enable them to efficiently review research proposals. Results. Proposed activities of the project are presented. Implementation of the activities described is ongoing. Conclusion. Lessons learnt in this regard may be of benefit to other research ethics regulatory authorities in resource-constrained countries aiming to strengthen their research ethics oversight capacity.

Combining intensive rehabilitation with a non-functional isokinetic strengthening program in adolescents with cerebral palsy: a study protocol for a randomized controlled trial.

Cerebral palsy (CP) is the most common brain injury in the pediatric population. CP patients present different affectations such as decreased muscle strength, gait deviations, impaired proprioception, and spasticity. Isokinetic strengthening programs combined with an intensive rehabilitation may improve muscle strength and therefore gait efficiency. Clinical Trials: The protocol has been accepted by the French National Ethics Committee (IDRCB: 2022-A00431-42). The primary aim of this randomized controlled trial is to compare the effect of an intensive rehabilitation combined with a non-functional isokinetic progressive strengthening program to an intensive rehabilitation alone on gait parameters and muscle strength in CP patients. Another goal of the current study is to determine whether adding an isokinetic program to an intensive rehabilitation is more effective than an intensive reha-bilitation alone on decreasing spasticity and improving joint position sense in CP patients. Thirty adolescents with spastic diplegia CP (GMFCS level I to III) will be randomized, by an independent researcher, into a 3-week intensive rehabilitation and isokinetic pro-gressive strengthening group or an intensive rehabilitation control group. Gait param-eters, muscle strength, spasticity and knee joint position sense will be assessed. These variables will be evaluated at baseline (T0) and at the end of the intervention (T1). The intensive rehabilitation will consist of physiotherapy sessions twice a day and hydro-therapy and virtual reality gait training once a day. The isokinetic training group will have a total of 9 supervised isokinetic strength training focusing on knee flexors and extensors with different execution speeds. The protocol has been accepted by the French National Ethics Committee in October 2022. Inclusion of patients will start in November 2022. The combination of an intensive rehabilitation with an isokinetic program on knee flexors and extensors have not been studied yet. The findings of this study may determine if an isokinetic strength training program of knee flexors and extensors is benefic to improve gait parameters, muscle strength, spasticity, and joint position sense in adolescents with spastic diplegia. The protocol has been accepted by the French National Ethics Committee (IDRCB: 2022-A00431-42).

Experience of the National Research Fund of Mozambique

The rapid growth of research units on the African continent has been identified as a preponderant factor in achieving their development. However, this assumption remains a mirage and demands from science managers a deep reflection on the practices of integrity and ethics in research in order to reinforce the quality of its results. Our reflection on the relevance of Integrity and Ethics in research practice, taking the case of Mozambique as an example based on the analysis of legislation and experiences of the National Research Fund (FNI) of Mozambique. The results demonstrated a commitment by the government to boost research based on integrity and ethics, which is evidenced by the fact that in 2007 the country approved the Code of Ethics for Science and Technology through Decree n. 71/2007, of December 24th. However, the rapid growth of research institutions (Universities, institutes and research centers) in the last ten years and the promotion of research by the FNI and other organizations has raised the largest scientific production in the country, with emphasis on the health area that between 2014 -2018 concentrated 60% of all publications in the country. In this way, several government initiatives (MCTES-FNI) and with partners such as UNESCO, are underway to boost national ethics committees in Mozambique.

Editorial

The Foundation for Scientific and Technological Development (FUNDECIT), in partnership with the Center for Advanced Studies in Education and Medical Training (CEDUMED) of the Faculty of Medicine of Agostinho Neto University (FMUAN), took the initiative to organize the Workshop on Integrity and Ethics in Scientific Research. The event brought together professionals from various fields with the aim of promoting dialogue on ethical and bioethical issues related to scientific research. These topics were intended to cover different lines of research coexisting in this area, revealing the epistemological heterogeneity in the field of science and technology, leading to interdisciplinary analysis, both theoretical and methodological. The event allowed researchers to reassess their actions and practices within their institutions and scientific projects with ethical and moral implications. As the first event with this focus and with guiding themes for good functioning, academics, researchers, and scientists from various countries such as Angola, South Africa, Argentina, Brazil, Mozambique, and Portugal were present. The event allowed for an examination of different realities and to verify if the path that the country is following is the most appropriate. Held in a hybrid format (in-person and remote) on March 30 and 31, 2023, at the Epic Sana Hotel, the workshop was aimed at managers of higher education institutions and the entire scientific community in general. The event consisted of two days of lectures and constructive debates between renowned national and foreign guests and participants, where contributions led to reflection on professional teaching practice with an ethical character, aiming to describe the stages of building a scientific project that focuses on addressing the problems and aspirations of the population. Respecting its morality (habits and customs), so that it can be feasible in various dimensions. Along with all these issues, it became clear that each country needs an ethical regulatory instrument to guide research in its territory because international devices cannot cover all the issues inherent in its culture. Hence, in some communications, it was evident that the creation of an entity that would create the same devices and another that would control the investigations carried out (National Ethics Committee and a National Bioethics Advisory Council), with one being deliberative and the other advisory in character. The event also brought to light the need to conform academic and research institutions to the best international practices and recommendations regarding ethical issues in science, technology, and innovation. Without forgetting the Universal Declaration on Bioethics and Human Rights (UDBHR), which is a significant document for the analysis of scientific research protocols. The results presented point to the importance of paying close attention to double standards of research protocol for clinical trials in developing or peripheral countries. Consequently, the speakers raised the urgent need for South-South cooperation to discuss ethical and bioethical problems in the face of the common reality of peripheral countries. Institutional contexts may be definitive and timely in the analysis of the works published by these researchers. By discussing science, technology, and innovation as a parameter for discussion, which will contribute to the realization of paradigm shifts in this area of socio-discursive production (Ethics and Bioethics), this meeting also allowed for networking among speakers from various national and foreign institutions and event participants.

Abstract P6-05-40: Aqua polo: Preliminary feasibility and efficacy study of a programme of adapted, supervised water polo to reduce fatigue and improve women’s psychological and social recovery after breast cancer treatment. A mixed-method design

Abstract Introduction : Physical activity has been shown to have many benefits, including reducing cancer-related fatigue (CRF) and improving psychological and physical recovery from breast cancer. Some authors have shown the benefits of aquatic practice, while others have detailed the benefits of group and supervised practice. We hypothesise that an innovative sports coaching proposal could allow a significant adherence of patients and contribute to their health improvement. The main objective is to study the feasibility of an adapted water polo programme (aqua polo) for women after breast cancer. Secondary we will analyse the effect of such a practice on patients’ recovery and to study the relationship between coaches and participants. The use of mixed methods will allow to question precisely the underlying processes. Methods and analysis : This is a prospective, non-randomised, monocentric study with a sample of 24 breast cancer patients after treatment. The intervention is a 20 week programme (1 session per week) of aqua polo in a real sports setting. The variables measured are patient participation, quality of life (QLQ BR23), CRF (R-PFS) and post-traumatic growth (PTG-I) as well as different variables to observe physical capacity (strength with dynamometer, step-test and arm amplitude). The quality of the coach-patient relationship will be evaluated (CART-Q) to explore its dynamics. Participatory observations and interviews will be carried out to report on the interactions between the coach and the participants during the sessions. Ethics and dissemination : Study procedures have been approved by the Institutional Review Board of the Institute (IPC 2019-028) and the National Ethics Committee (SI:20.01.20.54741). Consent is given in person to each participant. The information collected on the participants contain only a non-identifiable study identifier. The results of this protocol will be published in a scientific paper and communicated to the medical staff of the medical center. Trial registration number ID-RCB: 2019-A03003-54 Keywords: Quality of the relationship, Aquatic exercise, Quality of life, Sport Citation Format: Sarah Cuvelier, Charlène Goetgheluck-Villaron, Monique Cohen, Agnès Tallet, Leonor Lopez Almeida, Jean-Marie Boher, Sophia Jowett, Sébastien Justafré, Pierre Dantin, Patrice Viens, Sarah Calvin. Aqua polo: Preliminary feasibility and efficacy study of a programme of adapted, supervised water polo to reduce fatigue and improve women’s psychological and social recovery after breast cancer treatment. A mixed-method design. [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-40.

Murru Minya–informing the development of practical recommendations to support ethical conduct in Aboriginal and Torres Strait Islander health research: a protocol for a national mixed-methods study

IntroductionConducting ethical and high-quality health research is crucial for informing public health policy and service delivery to reduce the high and inequitable burden of disease experienced by Aboriginal and Torres...

Inter- and intra-observer agreement in the assessment of the cervical transformation zone (TZ) by visual inspection with acetic acid (VIA) and its implications for a screen and treat approach: a reliability study

BackgroundIn low-resource countries, interpretation of the transformation zone (TZ) using the classification of the International Federation for Cervical Pathology and Colposcopy (IFCPC), adopted by the World Health Organization, is critical for determining if visual inspection with acetic acid (VIA) screening and thermal ablation treatment are possible. We aim to assess inter- and intra-observer agreement in TZ interpretation.MethodsWe performed a prospective multi-observer reliability study. One hundred cervical digital images of Human papillomavirus positive women (30–49 years) were consecutively selected from a Cameroonian cervical cancer screening trial. Images of the native cervix and after VIA were obtained. The images were evaluated for the TZ type at two time points (rounds one and two) by five VIA experts from four countries (Côte d’Ivoire, Cameroon, Peru, and Zambia) according to the IFCPC classification (TZ1 = ectocervical fully visible; TZ2 = endocervical fully visible; TZ3 = not fully visible). Intra- and inter-observer agreement were measured by Fleiss’ kappa.ResultsOverall, 37.0% of images were interpreted as TZ1, 36.4% as TZ2, and 26.6% as TZ3. Global inter-observer reliability indicated fair agreement in both rounds (kappa 0.313 and 0.288). The inter-observer agreement was moderate for TZ1 interpretation (0.460), slight for TZ2 (0.153), and fair for TZ3 (0.329). Intra-observer analysis showed fair agreement for two observers (0.356 and 0.345), moderate agreement for two other (0.562 and 0.549), and one with substantial agreement (0.728).ConclusionInterpretation of the TZ using the IFCPC classification, adopted by the World Health Organization, is critical for determining if VIA screening and thermal ablation treatment are possible. However, the low inter- and intra-observer agreement suggest that the reliability of the referred classification is limited in the context of VIA. It’s integration in treatment recommendations should be used with caution since TZ3 interpretation could lead to an important referral rate for further evaluation.Trial registration Cantonal Ethics Board of Geneva, Switzerland: N°2017–0110. Cameroonian National Ethics Committee for Human Health Research N°2018/07/1083/CE/CNERSH/SP.

Acute and repeated impact of sweeteners and sweetness enhancers in solid and semi-solid foods on appetite: protocol for a multicentre, cross-over, RCT in people with overweight/obesity – the SWEET Project

IntroductionIntake of free sugars in European countries is high and attempts to reduce sugar intake have been mostly ineffective. Non-nutritive sweeteners and sweetness enhancers (S&SEs) can maintain sweet taste in...

Scalability of a singing-based intervention for postpartum depression in Denmark and Romania: protocol for a single-arm feasibility study

IntroductionPostpartum depression (PPD) affects around one in seven women globally, with these women in need of non-pharmaceutical treatment strategies. There is a long history of the benefits of singing for...

ImmunoSep (Personalised Immunotherapy in Sepsis) international double-blind, double-dummy, placebo-controlled randomised clinical trial: study protocol

IntroductionSepsis is a major cause of death among hospitalised patients. Accumulating evidence suggests that immune response during sepsis cascade lies within a spectrum of dysregulated host responses. On the one...

Knowledge, opinions and experiences of researchers regarding ethical regulation of biomedical research in Benin: a cross-sectional study

BackgroundEthics in biomedical research is still a fairly new concept in Africa. This work aims to assess the knowledge, attitude and experiences of Beninese researchers with regard to the national ethical regulatory framework of biomedical research in Benin.MethodsThis was a cross-sectional and descriptive study, involving all the researchers fulfilling the inclusion criteria. Data were collected through a face-to-face interview using a questionnaire and analysed. Proportions and means were calculated with their confidence intervals and standard deviations, respectively.ResultsOf the 110 participants included in the study, 40.9% were medical lecturers and 71.1% had been involved in more than 10 biomedical research as researcher. Less than three quarters (69.1%) were able to correctly quote the basic principles from Belmont report. The quarter (25.45%) of them knew the attributions of the National Ethics Committee for Health Research (CNERS in French) and 38.2%, the content of the legislation on health research ethics in Benin. The common ethical rules were known by 69.1% of the participants. A quarter (25.5%) of participants said they always present the study’s briefing note to their study participants and 62.7% said they systematically request informed consent. For those who do not present the briefing note to participants, the main reasons provided were the researchers’ difficulties in writing the note in plain language and the participants’ limitation in understanding it.ConclusionsThe foundations of a good ethical framework for health research exist in Benin. However, the deployment and use of the various legal texts deserve to be improved.

Assessing the Malignancy Risk of a Meningioma by Its Location.

Meningiomas represent 30% of primary intracranial tumors. The current incidence is up to 4.5 cases per 100,000 habitants worldwide. Although there is no prognostic difference among benign histopathological subtypes, atypical meningiomas and malignant meningiomas (WHO grade II and III respectively) may extend to the adjacent brain parenchyma, dura mater, and osseous tissue with a recurrence score (21-49%). This manuscript analyzes the malignancy risk according to neoplastic localization through a logistic retrospective analysis from a total sample of 452 patients with grade I, II, and III (WHO) meningiomas. Detailed data collection through a three-year retrospective analysis (January 2008 to December 2011) was applied at Mexico's National Neurology and Neurosurgery Institute including patients with intracranial or spinal-cord meningioma, preoperative imaging study availability and post-surgical histopathological diagnosis. Formal written consent was not required with a waiver by the appropriate national research ethics committee in accordance with the provisions of the regulations of the general health law of Mexico. Convexity lesions displayed an increased risk of malignancy turning for non-benign meningiomas with an odds ratio of 3.1 (95% CI 1.6 to 5.7, p=0.0002) meanwhile skull-base meningiomas present an inverse risk with an odds ratio of 0.4 (95% CI 0.2 to 0.9, p=0.02), as well as spinal-cord meningiomas with an odds ratio of 0.3 (95% CI 0.1 to 0.9). Skull base and spinal cord meningiomas usually have benign behavior, meanwhile grade II or III meningiomas within this location are rare. The present work provides an additional criterion for decision making, according to the meningioma's location.

Ultrasound performance using the EU-TIRADS score in the diagnosis of thyroid cancer in Congolese hospitals

The thyroid imaging reporting and data systems by the European Thyroid Association (EU-TIRADS) has been widely used in malignancy risk stratification of thyroid nodules. However, there is a paucity of data in developing countries, especially in Africa, to validate the use of this scoring system. The aim of the study was to assess the diagnostic value of the EU-TIRADS score in Congolese hospitals, using pathological examination after surgery as the gold standard in Congolese hospitals. This retrospective and analytical study examined clinical, ultrasound and pathological data of 549 patients aged 45 ± 14 years, including 468 females (85.2%), operated for thyroid nodule between January 2005 and January 2019. In the present study, only the highest graded nodule according to the EU-TIRADS score in each patient was taken into account for the statistical analyses. So 549 nodules were considered. Nodules classified EU-TIRADS 2 and 3 on the one hand, and, on the other hand, 4 and 5, were considered respectively at low and high risk of malignancy. The sensitivity and specificity of the EU-TIRADS score were calculated. The significance level was set at 5%. Of all patients, 21.7% had malignant nodules. They made 48.4% of the nodules in patients younger than and at 20 years old, and 31.1% in those aged 60 or over. Malignant nodules were more frequent in men than in women (30.9% vs. 20.1%; p = 0.024). Papillary carcinoma (67.2%) and follicular carcinoma (21.8%) were the main types. The malignancy rate was 39.7% and 1.5% among nodules rated EU-TIRADS 4 and 5, and those with EU-TIRADS score 2 and 3, respectively (p < 0.001). The EU-TIRADS score had a sensitivity of 96.6% and a specificity of 59.3%. The ROC curve indicated an area under the curve of 0.862. In a low-income country, a well performed thyroid ultrasound, using the EU-TIRADS score, could be an important tool in the selection of thyroid nodules suspected of malignancy and requiring histopathological examination in the Congolese hospital setting.Trial registration: The research protocol had obtained the favorable opinion of the DRC national health ethics committee no. 197/CNES/BN/PMMF/2020. The data was collected and analyzed anonymously.

Home Visitations, Referrals and Linkage by Community Health Volunteers in Supporting Maternal Health Care Services in Dadaab

Background: There is an increase in the involvement of CHVs in healthcare in low and middle-income countries and the model is being used in refugee camps to enhance access to Primary Health Care including maternal health services. This is in line with the idea of optimizing health workers roles which targeted to address critical health worker shortage, by shifting downwards certain tasks to health workers with less training, such as from nurses to Community Health Volunteers (CHVs) to increase universal access to maternal healthcare. The public health adopted the community health strategy that employs CHVs in providing health care services for the refugees in Dadaab. The role of CHVs on maternal healthcare in the refugee camp has not been clearly described. Objectives: The main objective of the study was to determine the roles of community health volunteers in home visitations, referrals, and linkage to promote maternal health care services in the Dadaab refugee camp, Kenya. Methodology: This was a descriptive cross-sectional study with both qualitative and quantitative methods conducted at Ifo-1 camp, in the Dadaab Refugee complex. It targeted the CHVs and some Key Informants (KIs) involved in maternal health care services. The sample size for quantitative data was 74 CHVs selected by simple random sampling while for qualitative was 5 KIs selected purposively, making the study population 79. Data was collected using questionnaires and interviews; analyzed descriptively and thematically and presented in form of tables, graphs, charts, and narratives. Ethical consideration involved study approval by the University of Nairobi Kenyatta National Hospital Ethics Research and Ethics Committee; permission from relevant authorities in Dadaab and obtaining informed consent from the participants. Results: The results showed that CHVs played a significant role in promoting maternal health care through home visitation and referrals. All the CHVs provided home visit services. Majority conducted more than two visits for Antenatal Care 66 (89%) and after delivery to deliver maternal health services. All the respondents conducted referral and follow-up services where 58(78%) identified pregnant mothers for referral; 51(67%) traced defaulters. There was, however, a weaker link after discharge from antenatal care clinics and no framework for implementing home visits and referrals or community maternal healthcare. Conclusion: The CHVs are playing a significant role in promoting the uptake of maternal health services in the Dadaab refugee camp through home visitations and referrals and linkage between the health system and the refugee community. Recommendations: There is a need to establish a framework for implementing community-based maternal health to guide and support, supervise CHVs, and strengthen monitoring of maternal health services in the community. Further, there should be more involvement of the CHVs by the antenatal care (ANC) clinic after discharging antenatal mothers from the clinic to continue with care and follow-up

International Research and Philanthropy

International Research and Philanthropy

Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project

IntroductionThe aim of this randomised controlled trial (RCT) is to investigate whether prolonged consumption of sweeteners and sweetness enhancers (S&SEs) within a healthy diet will improve weight loss maintenance and...