SCALE-IT Project_Ethics

SCALE-IT- SCALING UP CAPACITY TO SUPPORT CONDUCT OF CLINICAL TRIALS IN THE EAST AFRICAN COMMUNITY   The East African Community (EAC) has experienced significant increase in volume and complexity of clinical research driven by epidemics of emerging and remerging infectious diseases such as HIV, Ebola and COVID-19, requiring expertise in scientific and ethical review and conduct of research and a robust and pragmatic research regulatory framework. Goal: The overall goal is to strengthen scientific and ethics capacity in EAC for high quality research review, conduct and oversight, at international standards. The specific objectives are:  1. To train NRRA personnel, REC members, researchers and clinicians on scientific and ethics review and conduct of research with emerging and complex study designs including adaptive platform trials 2. To train NRRA personnel and REC members on oversight, monitoring and pharmacovigilance of clinical trials 3. To train NRRA personnel, REC and research administrators on personal effectiveness and leadership skills (PELS) to manage the increasingly complex research processes. SCALE-IT is being implemented within a partnership of Infectious Diseases Institute (IDI), Uganda, Médecins Sans Frontières (MSF) EPICENTRE ,France (EU partner), Kenya Medical Research Institute (KEMRI), Kenya and partners from the 6 EAC states, with East Africann Health Research Commission, EAHRC @EAHRC_eahealth as the nucleus for coordination and dissemination of results. #ethics #scaleit #research

Introducing the First Edition of the SCALE-IT Newsletter! We’re excited to share highlights of our journey so far: ✨ Successful curricula development ✨ Completion of TAC and stakeholder meetings ✨ Comprehensive pieces of training conducted in Uganda, Kenya, Rwanda, and Burundi ✨ A glimpse into the exciting projects ahead Take a moment to explore our milestones and what lies ahead. Enjoy the read! Global Health EDCTP3, Infectious Diseases Institute (IDI), Kenya Medical Research Institute (KEMRI), Mathius Amperiize, Pauline Byakika-Kibwika, Provia Ainembabazi, Stephen Okoboi, Beth Mutumba, Ramadhan NYANDWI, Belinda Twesigye,

Ongoing Online training, Rwanda Cohort: Wrapping up 4 weeks of selfpaced online learning via the Infectious Diseases Institute (IDI)'s online platform! Our Clinical Trial Monitoring and Personal Effectiveness & Leadership Skills courses conclude with virtual sessions to tackle challenging topics. We believe the knowledge, and Skills acquired will improve the Ethics and regulatory capacity for high quality research review and oversight at international standards. We want to thank our trainees, trainers, and the coordinating team. Infectious Diseases Institute (IDI), Makerere University, Kenya Medical Research Institute (KEMRI), Uganda National Council for Science and Technology, Mathius Amperiize, Belinda Twesigye, Pauline Byakika-Kibwika, Stephen Okoboi, Beth Mutumba, Steve Wandiga, Soazic Gardais, Global Health EDCTP3

Day 4 in Rwanda: We kicked off an impactful training on Clinical Trials Monitoring & Personal effectiveness and Leadership Skills. 42 trainees including; REC & NRRA members, clinical trial monitors, researchers, REC, and project administrators joined us for the 2 days of face to face learning. Next up will be 4 weeks of self-paced online training followed by final virtual sessions and certification!. Yesterday, we completed an insightful three days training on emerging and Complex study designs. Kudos to all our partners. #clinicaltrials #capacitybuilding Infectious Diseases Institute (IDI), Global Health EDCTP3, Uganda National Council for Science and Technology, Beth Mutumba, Mutabazi Vincent, Mathius Amperiize, Stephen Okoboi, Pauline Byakika-Kibwika, Kenya Medical Research Institute (KEMRI), National Institute for Medical Research (NIMR) - Tanzania,

Day 4 in Burundi: Today we kicked off training on 2 courses; Clinical Trials Monitoring & Personal Effectiveness & Leadership Skills for REC & NRRA members, researchers, REC & project admins. The courses will run for 2 days F2F, 4 weeks of self-paced online learning, and final virtual sessions leading to certification. Exciting journey ahead! Infectious Diseases Institute (IDI), Provia Ainembabazi, Uganda National Council for Science and Technology, Beth Mutumba, Global Health EDCTP3, Mathius Amperiize, Pauline Byakika-Kibwika, Ramadhan NYANDWI, Makerere University, Belinda Twesigye #capacityBuilding #Leadership #ClinicalTrials #Burundi"

Day 3 & Final Day on Complex and Emerging Study Designs Training of REC & NRRA members, Researchers, and Clinicians in Burundi: Dr BIZIMANA Paul delivering session on Controlled Human Infection Model design "Healthy adult volunteers are given a controlled strain of an infectious agent to help scientists better understand diseases, how they spread and to discover new ways to prevent and treat them" #clinicaltrials #Ethics #Research Infectious Diseases Institute (IDI), Global Health EDCTP3, Pauline Byakika-Kibwika, Mathius Amperiize, Beth Mutumba, Uganda National Council for Science and Technology

Ongoing day 2 in Burundi: Dr NDAYISENGA Ferdinand delivering a session on Adaptive plartform trials. A study pre-planned option to modify certain parts of a study's design or hypotheses based on an analysis of data, typically from interim results from participants during the study. Infectious Diseases Institute (IDI), Pauline Byakika-Kibwika, Beth Mutumba, Uganda National Council for Science and Technology, Mathius Amperiize, Global Health EDCTP3

We would like to congratulate our project Scientific Lead and PI Prof Pauline Byakika-Kibwika upon being appoited the new Mbarara University of Science and Technology (MUST) Vice Chancellor (VC). We want to wish her success in this new role. Provia Ainembabazi, Infectious Diseases Institute (IDI), Mathius Amperiize

Kenya Medical Research Institute (KEMRI) Bulletin captures the SCALE-IT Project_Ethics-IT training hosted by (Scientific Ethics Review Unit (SERU). 🔊 Having completed a one-week training in Kenya at Kenya Medical Research Institute (KEMRI) from June 10th to June 14th, our work has been featured in the latest issue 👨💻 of our partners' bulletin. Check out pages 11 and 12 of the issue 96 for more details. Infectious Diseases Institute (IDI), Provia Ainembabazi, Mathius Amperiize, Stephen Okoboi,