Collecting personal information on tuberculosis patients The Swiss Institute of Tropical and Public Health invites Georgia to participate in the European Research Council-funded project “Linking intra-host and inter-host evolution in multidrug-resistant tuberculosis Mycobacteria” 1) Research projects (HRO) - Research projects related to measuring or sampling biological material or collecting health–related data from humans. 2) Research projects (HRO) - including further use of biological material and personal health-related data Partner in Georgia: National Center for Tuberculosis and Lung Diseases Objective(s) 1) To study the genomic characteristics and evolutionary forces shaping multidrug-resistant Mtb populations in individual tuberculosis patients over time and in various body compartments. 2) Comparison of the genomic and phenotypic properties of multidrug-resistant Mtb populations in individual patients with those circulating in the corresponding patient population. 3) To determine the impact of suboptimal patient treatment and phenotypic drug tolerance on the evolution of drug resistance in Mtb inside participants. 4) Capacity building:Georgian scientists, students and institutions will benefit from the collaboration with Swiss TPH. important! Genetic characterization of clinical and experimental Mtb strains (whole genome sequencing after cultivation and/or directly from a patient sample) Phenotypic characterization of clinical and experimental Mtb strains (in vitro/ex vivo, transcriptomics, proteomics, virulence analysis) ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Correspondence between Zaza Avaliani (National Center for Tuberculosis and Lung Diseases) and Tamar Gabunia, DeputyThe Minister (google translate): 31.08.2020 Tamar, welcome warmly! As we said earlier, TFD has also received a third Horizon 2020 funded project, for which we also received a letter of support from you, for which I would like to thank you once again! This time, we need a letter confirming the Ministry's support for the project for five years, as well as allowing us to fully identify the socio-demographic information about the patients, which will be provided to the partner party by the Swiss Institute of Tropics and Health. Here we are sending you a working version of the support letter in English and the corresponding Georgian translation. If necessary, provide you with the full documentation of the study. With gratitude and respect, Zaza Avaliani, MD PhD Professor Director, National Center for Tuberculosis and Lung Diseases ---------------------------------------------------------------------------------------- 31.08.2020 Mr. Zaza Thank you so much for your letter! Given the sensitivity of the issue, I will go through the legal service, we may need to negotiate with the Ethics Committee, we will also go through the issue of personal data exchange, and then we will be formed. Sincerely, Tamar Gabunia First Deputy Minister Sincerely, Tamar Gabunia, MD, MPH First Deputy Minister ---------------------------------------------------------------------------------------- 31.08.2020 Violet, Hello, And I will send you the final protocol of the study. As stated in the letter, the first and second tasks should be exempt from the need for informed consent. The information and samples will be fully identified, which will be sent to the partners, and data processing will be carried out on the basis of the Personal Data Protection Center of Georgia. In accordance with subparagraph “c” of paragraph 2 of Article 6 of the Law on It should also be noted that the retrospective informed consent of all patients throughout Georgia will make it impossible to implement this part of the project. That is why in the first part of this ERC-1 project, where similar tasks were set, in 2013 we also made a similar request to the Ministry of Health and received consent based on the decision of the Ethics Council (we will send you this letter with an attachment). As for the third and fourth tasks specified in the protocol attached to the current project, prospective patient involvement will be based on informed consent. Informed consents submitted to the Ethics Committee of the Swiss Tropical Institute of Health. I am also including a link. Sincerely, Zaza Avaliani --------------------------------------------------------------------------------------- FUNDING This project is funded by the European Commision (EU) - European Research Council (ERC) with the grant number 883582-ECOEVODRTB. https://cordis.europa.eu/project/id/883582 Horizon 2020-EU.1.1. - EXCELLENT SCIENCE - European Research Council (ERC) Swiss Tropical and Public Health Insitute (Swiss TPH) Website https://www.swisstph.ch/en/projects/project-detail/project/linking-within-host-and-between-host-evolution-of-multidrug-resistant-mycobacterium-tuberculosis/