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LATVIAN

BIOMEDICAL

RESEARCH AND STUDY CENTRE


RESEARCH AND EDUCATION IN BIOMEDICINE FROM GENES TO HUMAN

Project Title:DECIDE – Development of a dynamic informed consent system for biobank and citizen science data management, quality control and integration.”

Funding: European Regional Development Fund (ERDF), Measure 1.1.1.1 “Support for applied research”

Project No.: 1.1.1.1/20/A/047

Period: 1 March 2021 – 30 November 2023

Project costs: 540 540.54 EUR

Principle Investigator: Dr. biol. Vita Rovīte

Cooperation partner: SIA “KleinTech Software”

Project summary:

The scientific objective of the project is to develop dynamic consenting and survey system prototype to integrate academic research conducted in biobank with citizen science initiatives maintaining data credibility via hierarchical metadata harmonization and assessing ethical, legal and social implications (ELSI).

Informed consent is the foundation of any biological sample and data-related research in biomedicine, that is used to protect the right of an informed decision of the individual whether to take or not take part in the research. The specific form of dynamic informed consent is used to ensure that an individual participating in research can modify his or her decision about the research that is conducted with his sample and data and actively follow research results that could be of importance to him or his immediate relatives. Dynamic consent concept is especially important in case if an individual has donated sample/data to the biobank

Information published 01.03.2021.

Progress of the project:

1 March 2021 – 31 May 2021

During this project implementation period, the definition of the hierarchical levels of metadata has been carried out for the various types of questionnaires, in order to align this system with those systems used elsewhere in Europe for the categorisation of biobanks and medical research data. Prototype programming has been started and the development of prototype classification, notification and audit modules is in progress. A prototype schematic content module has been created and plan for ethics-by-design implementation has been created for the inclusion of ethical and legal aspects in the prototype development process.

Information published 31.05.2021.

Progress of the project:

1 June 2021 – 31 August 2021

During this project implementation period, the definition of the hierarchical levels of metadata has been continued for the various types of questionnaires, in order to align this system with those systems used elsewhere in Europe for the categorisation of biobanks and medical research data. Prototype programming has been continued and the development of prototype classification, notification and audit modules is in progress. Detailed description of implementation of ethics-by-design principle in registration module have been developed.

Information published 31.08.2021.

Progress of the project:

1 September 2021 – 30 November 2021

During this project period, work on prototype consent and survey metadata levels has been carried out. Work on quality criteria has been continued to be included in the prototype. Prototype programming has been continued, technical interviews have been conducted on prototype development. Prototype creation is carried out according to calendar plan. Work on identifying regulatory and ethical aspects for inclusion in prototype development has been continued.

Information published 30.11.2021.

Progress of the project:

1 December 2021 – 28 February 2022

During this project period, work on prototype survey metadata levels and prototype quality control levels has been carried out. Technical interviews have been conducted and work on prototype development has been continued, mockups of public system have been created and accepted by research team. Work on identifying regulatory and ethical aspects for inclusion in prototype development has been continued. Literature analysis on research result reporting via online systems based on ethical principles has been started.

Information published 28.02.2022.

Progress of the project:

1 March 2022 – 31 May 2022

During this project period, implementation of prototype survey metadata levels and prototype quality control levels has been started. Technical interviews have been continued and work on prototype development has been continued, the testing environment has been established and first round of technical specifications delivered. Study of regulatory and ethical aspects for inclusion in prototype development has been continued. Literature analysis on research result reporting via online systems based on ethical principles has been continued.

Information published 31.05.2022.

Progress of the project

1 June 2022 – 31 Augusts 2022

During this project period, implementation of prototype survey metadata levels and prototype quality control levels has been continued. Technical interviews have been continued and next round of technical specifications delivered. Literature analysis on research result reporting via online systems based on ethical principles has been continued. The work on survey on citizen science activities have been started.

Information published 31.08.2022.