Work Package 1 – Ethics and regulation

Jane ReichelEthics and Legal Framework for the Storage, Analysis, and Sharing of Biobanking and Research Data

Work Package leader: Jane Reichel, Uppsala University, Sweden,

Work Package 1 (WP1) is creating a harmonized ethical and legal framework between European and African partner institutions. It has as a point of departure two basic bioethical principles: the requirement of informed consent for handling human biological samples and data, and the need for approval from a research ethics committee before conducting a research project.

WP1 works together with the other Work Packages in order to establish a common understanding of basic concepts and principles. From this, we will define minimum standards for all participants and users of the B3Africa platform, taking into account European Union (EU) and African standards. Further, WP1 will identify legal solutions for allocating the legal responsibilities in each individual case, via data and/or material transfer agreements.

The legal and ethical framework will further be implemented in the B3Africa platform in the form of a Model Data Management Policy (MDMP). The model will provide a set of formal rules, criteria, and priorities that should guarantee a consistent ascertainment of all requirements that should be fulfilled by the platform and its users.

WP1 will work together with Work Package 6 to initiate a dialogue with relevant stakeholders, especially the African Union and the New Partnership for Africa’s Development (NEPAD).

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