Objective The increased number of Clinical Trials taking place in Africa as well as the complexity of Clinical Trials designs require that the countries have the regulatory capacity to review, monitor and utilize data generated from the research. Research Ethics Committees/Institutional Review Boards, Institutional Animal Care and Use Committees and National Regulatory Agencies (NRAs) are required to be abreast with the evolving landscape thus require continuous capacity building as well as have platforms to share Clinical Trials information with both the public and private sector. The 11th Annual National Research Ethics Conference held in 2021 in Uganda highlighted challenges in the low and middle income countries for research ethics and open science specifically, the lack of infrastructure for open data sharing and fair data management. Specifically, i) lack of the national and regional guidelines and codes of conduct for scientific integrity ii) limited training and education in responsible conduct of research and pharmacovigilance. This proposal focuses on strengthening ethics and responsible conduct of Clinical Trials in East and Sub-Saharan Africa project through the establishment of a research ethics and integrity framework, open data access framework for Clinical Trials, E-learning platform for the Good Research Regulatory Research Practice Course and establishing Research Ethics Committees in National Regional Hospitals. The consortium will leverage on the legal establishment of the institutions, collaborative efforts with the partner institutions, East African Health Research Commission (EAHRC), African Vaccine Regulatory Forum (AVAREF). Having a robust regulatory system, encompassing research integrity and open science will ensure that Clinical Trials is conducted to the highest ethical standards and in compliance with existing polices and laws, hence protection of safety, rights and welfare of the individual participants, community, researcher and sponsors. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccinessocial scienceslaw Keywords Ethics Research integrity clinical trials Programme(s) HORIZON.2.1 - Health Main Programme Topic(s) HORIZON-JU-GH-EDCTP3-2022-CALL1-01-05 - Strengthening regulatory capacity for supporting conduct of clinical trials Call for proposal HORIZON-JU-GH-EDCTP3-2022-01 See other projects for this call Funding Scheme HORIZON-JU-CSA - HORIZON JU Coordination and Support Actions Coordinator UNIVERSITEIT MAASTRICHT Net EU contribution € 205 000,00 Address Minderbroedersberg 4 6200 MD Maastricht Netherlands See on map Region Zuid-Nederland Limburg (NL) Zuid-Limburg Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Participants (4) Sort alphabetically Sort by Net EU contribution Expand all Collapse all UGANDA NATIONAL COUNCIL FOR SCIENCE AND TECHNOLOGY Uganda Net EU contribution € 189 700,00 Address Nasser road 3-5-7 N/A Kampala See on map Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 TANZANIA COMMISSION FOR SCIENCE AND TECHNOLOGY Tanzania Net EU contribution € 93 000,00 Address Ali hassan mwinyi Dar es salaam See on map Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 KAMUZU UNIVERSITY OF HEALTH SCIENCES Malawi Net EU contribution € 55 800,00 Address Off mahtma ghandi road 312225 Blantyre See on map Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 KENYA MEDICAL RESEARCH INSTITUTE Kenya Net EU contribution € 55 500,00 Address Off mbagathi way 00200 Nairobi See on map Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00
