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Inflammatory bowel disease (IBD) represents a chronic, relapsing, remitting, and inflammatory condition categorized into two forms – ulcerative colitis (UC) and Crohn's disease. According to epidemiological data, the trend of IBD has been increasing in the world, including in India. The current management of UC does not aim at curing the patient from the illness but mainly at attenuating the symptoms and improving the daily life of the patient. Drugs such as sulfasalazine and corticosteroids are used to reduce inflammation, but they are associated with multiple side effects and the efficacy is also limited. Hence, there is an unmet need in exploring new drugs to manage UC in a more efficient and less harmful way. There are various animal models which have been used worldwide by researchers to assess new lead compounds before they can be tested in humans. Various types of models comprise of chemical models, bacterial models, immunity transfer models, and genetic models. In this review article, we try to give an overview of these animal models which can be used in drug research.

Background: Cerebral venous thrombosis (CVT) is an uncommon cause of stroke and shares common risk factors with arterial strokes such as hyperhomocysteinemia, tobacco, alcohol, drugs, and hypercoagulable state. These risk factors can alter both arterial and venous health leading to the occurrence of atherosclerosis in CVT patients.Aims: To evaluate carotid hemodynamics in CVT patients.Settings and Design: Prospective hospital-based case-control study.Methods: This study included 50 consecutive CVT patients and 50 healthy controls. The demographic data, vascular risk factors, clinical data, biochemical, and radiological parameters were recorded. Carotid sonography was performed in CVT patients within the first 24 h of admission.Statistical Analysis: MedCalc 17.Results: The age of the patients was 35.04 ± 9.48 years and the controls 38.88 ± 10.41 years with male preponderance in both groups. Risk factors for atherosclerosis among patients included hyperhomocysteinemia (40 patients), diabetes mellitus (4 patients), hypertension (9 patients), alcohol (17 patients), and tobacco (21 patients). Eight patients had abnormal carotid sonography. Six had nonflow-limiting plaques, one had carotid occlusion, two had increased intimal-medial thickness, and one had increased peak systolic velocity. Among the controls, three subjects had nonflow-limiting plaques. There was no difference in carotid hemodynamic parameters between controls and patients; and those with normal and elevated homocysteine.Conclusion: This is the first study to our knowledge looking at carotid health in venous strokes. The relative risk for carotid atherosclerosis in CVT patients is higher and requires long-term follow-up for the initiation of preventive measures. [ABSTRACT FROM AUTHOR]

Computational methods have driven the rapid identification of tobacco microRNAs (miRNAs) from tissue-specific sequence data and witnessed success in associating miRNAs in response to stress, pollutants, viral infection and resistance, and cigarette smoking. Although tobacco exerted medicinal properties through phytochemicals, the role of its miRNAs in regulating tobacco and human genes and related functional implications is not elucidated thoroughly. In this present study, we have identified new and homologous miRNAs using a rigorous workflow of miRNA derivation and target prediction upon a comprehensive collection of tobacco expressed sequence tags and charted its putative roles in gene regulation via inter and intraspecies relationships. Current, computational approach have identified a total of 38 mature miRNAs comprising 31 tobacco-specific miRNAs from plant homologous families, and 7 new miRNA candidates. These seven new miRNAs were studied for tobacco target gene prediction in which most of them encode innate immunity, defense mechanism, plant development, F-box/Leucine rich-repeat protein and other protein kinases. Two out of these seven miRNAs have passed the updated emphasized criteria namely nta-miR403 and nta-miR8036. Interestingly, the workflow succeeded in establishing an intraspecies relationship by distinguishing the molecular targets already known in tobacco and homologous plants. Interspecies relationship between 38 tobacco miRNAs upon human transcriptome data revealed the most significant target CCDC88c (DAPLE) with perfect seed pairing of miR-156, regulating non-canonical WNT signaling pathways in cancer progression and metastasis. These findings may add to existing knowledge of impacting canonical WNT/β-catenin pathways. These decisive findings hold a strong clue for promoting tobacco miRNAs research and outlined the prediction of conserved miRNAs and their functions in inter and intraspecies relationships.

IntroductionDistributed simulations of complex systems to date have focused on scalability and correctness rather than interactive visualization. Interactive visual simulations have particular advantages for exploring emergent behaviors of complex systems. Interpretation of simulations of complex systems such as cancer cell tumors is a challenge and can be greatly assisted by using “built-in” real-time user interaction and subsequent visualization.MethodsWe explore this approach using a multi-scale model which couples a cell physics model with a cell signaling model. This paper presents a novel communication protocol for real-time user interaction and visualization with a large-scale distributed simulation with minimal impact on performance. Specifically, we explore how optimistic synchronization can be used to enable real-time user interaction and visualization in a densely packed parallel agent-based simulation, whilst maintaining scalability and determinism. We also describe the software framework created and the distribution strategy for the models utilized. The key features of the High-Performance Computing (HPC) simulation that were evaluated are scalability, deterministic verification, speed of real-time user interactions, and deadlock avoidance.ResultsWe use two commodity HPC systems, ARCHER (118,080 CPU cores) and ARCHER2 (750,080 CPU cores), where we simulate up to 256 million agents (one million cells) using up to 21,953 computational cores and record a response time overhead of ≃350 ms from the issued user events.DiscussionThe approach is viable and can be used to underpin transformative technologies offering immersive simulations such as Digital Twins. The framework explained in this paper is not limited to the models used and can be adapted to systems biology models that use similar standards (physics models using agent-based interactions, and signaling pathways using SBML) and other interactive distributed simulations.

Abstract Novel SARS-CoV-2, an etiological factor of Coronavirus disease 2019 (COVID-19), poses a great challenge to the public health care system. Among other druggable targets of SARS-Cov-2, the main protease (Mpro) is regarded as a prominent enzyme target for drug developments owing to its crucial role in virus replication and transcription. We pursued a computational investigation to identify Mpro inhibitors from a compiled library of natural compounds with proven antiviral activities using a hierarchical workflow of molecular docking, ADMET assessment, dynamic simulations and binding free-energy calculations. Five natural compounds, Withanosides V and VI, Racemosides A and B, and Shatavarin IX, obtained better binding affinity and attained stable interactions with Mpro key pocket residues. These intermolecular key interactions were also retained profoundly in the simulation trajectory of 100 ns time scale indicating tight receptor binding. Free energy calculations prioritized Withanosides V and VI as the top candidates that can act as effective SARS-CoV-2 Mpro inhibitors.

Clinical trials and research studies are being conducted worldwide at a rampant pace leading to generation of large amount of data. However, to reap the benefits of the data generated it is important that this data is shared with the general public without which it can be deemed useless. Despite its importance being known to us, data sharing does not come without its share of problems and it is not as easy to execute as it sounds on-paper. Over the past few years, multiple coveted organizations around the world involved in research activities have come up with their respective guidelines and initiatives to make sure the sharing of research data is smooth and ethical. Developing countries like India have made a few strides in the right direction with some initiatives in-place, but there still seems a long way to go before unanimous data sharing can be a reality. The stakeholders may have to face certain possible repercussions due to data sharing but there is no doubt that if done in the right way, it can lead to universal development. [ABSTRACT FROM AUTHOR]

Assembling novel genomes from scratch is a never ending process unless and until the homo sapiens cover all the living organisms! On top of that, this denovo approach is employed by RNASeq and Metagenomics analysis. Functional identification of the scaffolds or transcripts from such drafted assemblies is a substantial step routinely employes a well-known BlastX program which facilitates a user to search DNA query against NCBI-Protein (NR:~120Gb) database. In spite of having multicore-processing option, blastX is an elongated process for the bulk of lengthy Queryinputs. Tremendous efforts are constantly being applied to solve this problem by increasing computational power, GPU-Based computing, Cloud computing and Hadoop based approach which ultimately requires gigantic cost in terms of money and processing. To address this issue, here we have come up with SHIVGAMI, which automates the entire process using perl and shell scripts, which divide, distribute and process the input FASTA sequences as per the CPU-cores availability amongst the computational units individually. Linux operating system, NR database and blastX program installations are prerequisites for each system. The beauty of this stand-alone automation program SHIVGAMI is it requires the LAN connection exactly twice: During ‘query distribution’ and at the time of ‘proces completion’. In initial phase, it divides the fasta sequences according to the individual computer's core-capability. Then it will evenly distribute all the data along with small automation scripts which will run the blastX process to the respective computational unit and send back the results file to the master computer. The master computer finally combines and compiles the files into a single result. This simple automation converts a computer lab into a GRID without investment of any software, hardware and man-power. In short, SHIVGAMI is a time and cost savior tool for all users starting from commercial firm to a common man, utilises the "Little Drops of Water make a Mighty Ocean" concept without any requirement of parallel processing. The automation and compilation of SHIVGAMI is under process and will be freely available shortly to the users.

MicroRNAs are a newly discovered class of non-protein small RNAs with 22-24 nucleotides and evolutionary conserved post-transcriptional regulatory RNAs, which shows an enormous role in several biological and metabolic process. Plant derived miRNA entered into the body fluid and regulated the expression of host mRNA. Salvia miltiorrhiza is an important medicinal plant known for its potent cardiovascular and anticancer activity and hence, it was selected to identify the cross kingdom regulatory mechanism between medicinal plant and human. In this study, total 8 highly stable putative novel miRNA were predicted from the publically available ESTs of Salvia miltiorrhiza, out of which 2 miRNA were found to be regulating 32 target genes in human. Functional annotation, gene ontology and network analysis were carried out based on their significance and find out the association with the prominent disease like cancer and cardiac diseases. The network analysis showed the some important network protein like SOCS2, CD274, STAT3, TRAF3 and CXCL2 with their associated pathways. The predicted miRNA have a significant potential role in cytokine, Apoptosis and EGFR receptor signaling pathways and its biological regulation. It may be further validated using in-vivo experiment for broader picture into their miRNA epigenetic mechanism and action.

Next Generation Sequencing (NGS) exhibited rapid developments through its high speed sequence annotation and assembly tasks which has changed the perspectives of genome era. NGS brings the great power to make several new biological observations and discoveries from genomes and helped in the growth of allied areas including Metagenomics, De novo sequencing, Amplicon Analysis, Transcriptomics and Small RNA profiling. Carica papaya small RNA sequencing helps in the understanding the role of known miRNA and identification of novel miRNA. Functional genomics often begins with studying the gene expression patterns and identification of potential targets that relies on the assumption of small RNA and the mRNA (target) sequence complementarity. The identification of Known miRNA sequences are searched through against the current miRBase version and sequences with less than 2 mismatches with known miRNAs in miRBase was considered and 1724 known miRNA depicted. Computational algorithms predict miRNA targets on the basis of the presumed mode of miRNA–mRNA interactions and also depend on the conservation of their binding sites. The mirDeep prediction software is used to predict new miRNAs where 11 novel miRNA are estimated. In addition, the functional studies of small RNAs can rely on conventional genetic strategies. Intriguingly, the advent of fast and cost effective NGS platforms in the recent past has enabled the proliferation of new ideas regarding the application of characteristic gene structures to different species.

Background & objective: Normal saline is the most commonly used fluid in traumatic brain injury (TBI) patients both in resuscitation and maintenance since long time but associated with hyperchloremic metabolic acidosis. Balanced salt solutions (BSS) are recently developed with favorable outcome in resuscitation and intraoperative as a maintenance fluid. We compared normal saline and BSS as maintenance fluids in TBI patients admitted to intensive care unit. Methodology: After institutional ethical committee approval and written informed consent from patients' relatives, 100 patients who meet inclusion criteria were randomly divided into two equal groups; Group NS: to receive normal saline as a maintenance fluids and Group BSS: to receive BSS as a maintenance fluid. Data of serum electrolyte and acid base status were collected on day 1, 3, 5, 7 and 14. Patient outcome was evaluated on day-8. Data was analyzed with appropriate statistical tests. The P < 0.05 indicated that the difference was significant. Results: In both groups pH gradually increased over time and was more alkaline in normal saline group. Base excess was comparable between two groups. In normal saline group, serum sodium and chloride increased gradually and reached on the higher side on day-14, while potassium level dropped to a lower side. Twenty-eight days mortality was more in Group NS than the Group BSS. Conclusion: Balanced salt solution causes lesser alterations in acid base and electrolyte status than the normal saline and is associated with more favorable outcome. [ABSTRACT FROM AUTHOR]

More than 50% of the marketed drugs today are derived from natural sources. There are various cancers and diseases which cannot be managed well with the current available drugs. It is, therefore, important to identify new sources of drugs for the future. The biological diversity offered by the oceans shows promise in expressing some lead compounds for diseases which show a dearth of drug options for management. A handful of marine products have been approved by the United States – Food and Drug Administration (US-FDA) because of the involvement of academia and the pharmaceutical industry. However, there are many challenges involved which deter a better and faster process for drug development from marine sources. The current scenario in India is in a nascent phase, but steps are being taken in the right direction to develop a potential source of new drugs. In this review article, we try to give an overview over the history and impending potential of marine pharmacology, with an overlook on the current approved marine-sourced drugs by the US-FDA. We also take a brief look over the challenges involved in the field of marine pharmacology, its current progress in India and possible future scope.

Introduction: Feeding practices developed in early life can impact a child's nutrition, growth, dental health, cognitive development and lifetime risk of chronic diseases. Substantial evidence suggests ethnic health inequalities, and non-recommended complementary infant feeding practices among UK's South Asian (SA) population. Nurture Early for Optimal Nutrition aims to use women's group participatory learning and action (PLA) cycles to optimise infant feeding, care and dental hygiene practices in SA infants <2 years in East London., Methods and Analysis: A three-arm pilot feasibility cluster randomised controlled trial will assess feasibility, acceptability, costs and explore preliminary effectiveness for proposed primary outcome (ie, reporting on body mass index (BMI) z-score). Multilingual SA community facilitators will deliver the intervention, group PLA Cycle, to mothers/carers in respective ethnic/language groups. 12 wards are randomised to face-to-face PLA, online PLA and usual care arms in 1:1:1 ratio. Primary outcomes are feasibility and process measures (ie, BMI z-score, study records, feedback questionnaires, direct observation of intervention and sustainability) for assessment against Go/Stop criteria. Secondary outcomes are cluster-level and economic outcomes (ie, eating behaviour, parental feeding practices, network diffusion, children development performance, level of dental caries, general practitioner utilisation, costs, staff time). Outcomes are measured at baseline, every 2 weeks during intervention, 14 weeks and at 6 months by blinded outcome assessors where possible. This study will use concurrent mixed-methods evaluation. Quantitative analyses include descriptive summary with 95% CI and sample size calculation for the definitive trial. The intervention effect with CI will be estimated for child BMI z-score. Implementation will be evaluated qualitatively using thematic framework analysis., Ethics and Dissemination: Ethics approval was obtained from University College London (UCL), National Health Service (Health Research Authority (HRA) and Health and Care Research Wales (HRCW)). Results will be published in peer-reviewed journals, presented at scientific conferences/workshops with commissioners, partners and participating communities. Plain language summaries will be disseminated through community groups, websites and social media., Trial Registration Number: IRAS-ID-296259 (ISRCTN10234623)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Aim: During humanitarian emergencies, women and children are particularly vulnerable to health complications and neonatal mortality rates have been shown to rise. Additionally, health cluster partners face challenges in coordinating referrals, both between communities and camps to health facilities and across different levels of health facilities. The purpose of this review was to identify the primary referral needs of neonates during humanitarian emergencies, current gaps and barriers, and effective mechanisms for overcoming these barriers., Methods: A systematic review was performed using four electronic databases (CINAHL, EMBASE, Medline, and Scopus) between June and August 2019 (PROSPERO registration number CRD42019127705). Title, abstract, and full text screening were conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The target population was neonates born during humanitarian emergencies. Studies from high-income countries and prior to 1991 were excluded. The STROBE checklist was used to assess for risk of bias., Results: A total of 11 articles were included in the analysis; these were mainly cross-sectional, field-based studies. The primary needs identified were referrals from homes to health facilities before and during labour, and inter-facility referrals after labour to more specialised services. Some of the main barriers included a lack of roads and infrastructure for transport, staff shortages-especially among more specialised services, and a lack of knowledge among patients for self-referral. Mechanisms for addressing these needs and gaps included providing training for community healthcare workers (CHWs) or traditional birth attendants to identify and address antenatal and post-natal complications; education programmes for pregnant women during the antenatal period; and establishing ambulance services in partnership with local Non-Governmental Organizations., Conclusion: This review benefited from a strong consensus among selected studies but was limited in the quality of data and types of data that were reported. Based on the above findings, the following recommendations were compiled: Focus on local capacity-building programmes to address programmes acutely. Recruit CHWs to raise awareness of neonatal complications among pregnant women. Upskill CHWs to provide timely, appropriate and quality care during humanitarian emergencies., (© 2023 The Authors. The International Journal of Health Planning and Management published by John Wiley & Sons Ltd.)

Background: The COVID-19 pandemic has triggered a greater use of digital technologies as part of the health care response in many countries, including Indonesia. It is the world's fourth-most populous nation and Southeast Asia's most populous country, with considerable public health pressures., Objective: The aim of our study is to identify and review the use of digital health technologies in COVID-19 detection and response management in Indonesia., Methods: We conducted a literature review of publicly accessible information in technical and scientific journals, as well as news articles from September 2020 to August 2022 to identify the use case examples of digital technologies in COVID-19 detection and response management in Indonesia., Results: The results are presented in 3 groups, namely (1) big data, artificial intelligence, and machine learning (technologies for the collection or processing of data); (2) health care system technologies (acting at the public health level); and (3) COVID-19 screening, population treatment, and prevention population treatment (acting at the individual patient level). Some of these technologies are the result of government-academia-private sector collaborations during the pandemic, which represent a novel, multisectoral practice in Indonesia within the public health care ecosystem. A small number of the identified technologies pre-existed the pandemic but were upgraded and adapted for current needs., Conclusions: Digital technologies were developed in Indonesia during the pandemic, with a direct impact on supporting COVID-19 management, detection, response, and treatment. They addressed different areas of the technological spectrum and with different levels of adoption, ranging from local to regional to national. The indirect impact of this wave of technological creation and use is a strong foundation for fostering future multisectoral collaboration within the national health care system of Indonesia., (©Dewi Nur Aisyah, Alfiano Fawwaz Lokopessy, Maryan Naman, Haniena Diva, Logan Manikam, Wiku Adisasmito, Zisis Kozlakidis. Originally published in the Interactive Journal of Medical Research (https://www.i-jmr.org/), 28.02.2023.)

Background: COVID-19 cases are soaring in Asia. Indonesia, Southeast Asia's most populous country, is now ranked second in the number of cases and deaths in Asia, after India. The compliance toward mask wearing, social distancing, and hand washing needs to be monitored to assess public behavioral changes that can reduce transmission., Objective: This study aimed to evaluate this compliance in Indonesia between October 2020 and May 2021 and demonstrate the use of the Bersatu Lawan COVID-19 (BLC) mobile app in monitoring this compliance., Methods: Data were collected in real time by the BLC app from reports submitted by personnel of military services, police officers, and behavioral change ambassadors. Subsequently, the data were analyzed automatically by the system managed by the Indonesia National Task Force for the Acceleration of COVID-19 Mitigation., Results: Between October 1, 2020, and May 2, 2021, the BLC app generated more than 165 million reports, with 469 million people monitored and 124,315,568 locations under observation in 514 districts/cities in 34 provinces in Indonesia. This paper grouped them into 4 colored zones, based on the degree of compliance, and analyzed variations among regions and locations., Conclusions: Compliance rates vary among the 34 provinces and among the districts and cities of those provinces. However, compliance to mask wearing seems slightly higher than social distancing. This finding suggests that policy makers need to promote higher compliance in other measures, including social distancing and hand washing, whose efficacies have been proven to break the chain of transmission when combined with masks wearing., (©Dewi Nur Aisyah, Logan Manikam, Thifal Kiasatina, Maryan Naman, Wiku Adisasmito, Zisis Kozlakidis. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 22.11.2022.)

Introduction: The Nurture Early for Optimal Nutrition (NEON) study is a multiphase project that aims to optimize feeding, care and dental hygiene practices in South Asian children &lt;2 years in East London, United Kingdom. The multiphase project uses a participatory learning and action (PLA) approach facilitated by a multilingual community facilitator. In this paper, we elaborate on the process and results of the Intervention Development Phase in the context of the wider NEON programme., Methods: Qualitative community-based participatory intervention codevelopment and adaptation., Setting: Community centres in East London and online (Zoom) meetings and workshops., Participants: In total, 32 participants registered to participate in the Intervention Development Phase. Four Intervention Development workshops were held, attended by 25, 17, 20 and 20 participants, respectively., Results: Collaboratively, a culturally sensitive NEON intervention package was developed consisting of (1) PLA group facilitator manual, (2) picture cards detailing recommended and nonrecommended feeding, care and dental hygiene practices with facilitators/barriers to uptake as well as solutions to address these, (3) healthy infant cultural recipes, (4) participatory Community Asset Maps and (5) list of resources and services supporting infant feeding, care and dental hygiene practices., Conclusion: The Intervention Development Phase of the NEON programme demonstrates the value of a collaborative approach between researchers, community facilitators and the target population when developing public health interventions. We recommend that interventions to promote infant feeding, care and dental hygiene practices should be codeveloped with communities. Recognizing and taking into account both social and cultural norms may be of particular value for infants from ethnically diverse communities to develop interventions that are both effective in and accepted by these communities., Patient and Public Involvement and Engagement: Considerable efforts were placed on Patient/Participant and Public Involvement and Engagement. Five community facilitators were identified, each of which represented one ethnic/language group: (i) Bangladeshi/Bengali and Sylheti, (ii) Pakistani/Urdu, (iii) Indian/Gujrati, (iv) Indian/Punjabi and (v) Sri Lankan/Tamil. The community facilitators were engaged in every step of the study, from the initial drafting of the protocol and study design to the Intervention Development and refinement of the NEON toolkit, as well as the publication and dissemination of the study findings. More specifically, their role in the Intervention Development Phase of the NEON programme was to: 1. Support the development of the study protocol, information sheets and ethics application. 2. Ensure any documents intended for community members are clear, appropriate and sensitively worded. 3. Develop strategies to troubleshoot any logistical challenges of project delivery, for example, recruitment shortfalls. 4. Contribute to the writing of academic papers, in particular reviewing and revising drafts. 5. Develop plain language summaries and assist in dissemination activities, for example, updates on relevant websites. 6. Contribute to the development of the NEON intervention toolkit and recruitment of the community members. 7. Attend and contribute to Intervention Development workshops, ensuring the participant's voices were the focus of the discussion and workshop outcomes., (© 2022 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Monitoring of pesticide residues in fruits and vegetables and their processed products like jams, pickles, juices, ketchup, dried products and canned products was undertaken. The study was conducted to assess the effect of washing, peeling, heating and cooking on concentration of various pesticides. The stability of various pesticides in samples and their products was assessed. Pesticide residues were extracted using QuEChERS method and analysed by GC-MS. It was observed that pesticides like mancozeb and carbofuron were found to be stable for tomato and potato while chloropyriphos, captan and mancozeb (in other samples) were found to be unstable. It was also observed that peels and pomace showed highest levels of pesticide residues. In this study, washing, peeling and heat processing (boiling and blanching) have been found to be the most effective ways of pesticide residue dissipation., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Authors.)

Objective: The objective of the study is to evaluate the perception of postgraduate pharmacology students toward computer-simulated method (CSM) in comparison to the prevalent isolated live tissue-based bioassay method., Materials and Methods: A questionnaire-based survey was conducted in 30 postgraduate pharmacology students who had used the animal simulation software and had completed at least five isolated tissue experiments. Students' opinions on the usage, logistics, advantages, disadvantages, and usefulness of CSM compared to live animal experiments (LAE) were analyzed., Results: Four tissues were used for LAE, whereas with CSM, students could perform experiments using 11 different tissues. Of the total nine bioassay methods, students had performed six assay methods using both LAE and CSM. Majority of the students (23/30) agreed that CSM reduces anxiety, technical errors and is less time consuming when used before LAE. Most of the students agreed that CSM can be used for difficult, lengthy experiments (19/30), and for UG/PG teaching (19/30). However, opinions regarding replacing LAE with CSM in PG teaching were divided (agree: 7, neutral: 12, and disagree: 12)., Conclusion: CSM should be integrated alongside LAE to complement, reinforce, and enhance learning from other techniques., Competing Interests: There are no conflicts of interest., (Copyright: © 2020 Indian Journal of Pharmacology.)

The monitoring of clinical trials is an integral function of the institutional ethics committee (IEC)to ensure the ethical conduct of research. The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, of the Indian Council of Medical Research, underline a strong need for active monitoring of clinical trials. A previous study by the authors, of research studies initiated between 2008 and 2010, had found many lapses after site monitoring. In the present study, 12 clinical studies-both sponsored and investigator initiated-were monitored by members of the King Edward Memorial Hospital (Mumbai) IEC between 2011 and 2017. The most common violations seen were related to informed consent (8/12 sites). The other violation themes were lack of investigator understanding of protocol (6/12), deviation from the investigational plan (5/12), non-reporting of the study's progress to the IEC (4/12), and patient recruitment prior to IEC approval (2/12). The IEC took various corrective actions, such as ordering retaking of consent and good clinical practice (GCP) re-training and requiring interim reports, explanations for deviations, upgradation of facilities, and payment of pending compensation. The IEC even froze review of protocols from a frequently defaulting Principal Investigator's (PI) site and put study recruitment on hold for the same PI. This study demonstrates that active site monitoring by IECs is a must for ensuring the ethical conduct of studies.