Ethical and Legal Guidange and Tools for Sample and Data Sharing Within and Across Continents

By Olga Tzortzatou, Uppsala University, Sweden

The B3Africa team working on ethical and legal issues (work package 1 – WP 1) elaborated a pathway to sample and data sharing across Africa and between Africa and Europe observing ethics and regulations for personal and scientific data protection (the Ethical and Legal Framework for the B3Africa Platform). This has been done through research, consultations with other projects and stakeholders, such as the H3Africa project and the BCNet initiativea workshop and ELSI forums. A series of guides and tools have been produced:

  • Model Data Management Policy: provides 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 by the users of the B3Africa platform. This policy is implemented as part of the B3Africa final product, the eB3Kit and will pave the way for managing the use of the eB3Kit in control and regulated environments beyond the project’s lifetime.
  • Checklist – For a good governance of transcontinental collaborative biobank research: Basic steps that include sample and personal data sharing & handling of the findings.
  • African States-EU Member States/EU Member States-African States Data Transfer Agreement Guide, which presents a guiding template for developing a Data Transfer Agreement for data transfer between the African States-EU Member States/EU Member States-African States as well as a DTA template.
  • Informed Consent Guide for Biobank and registry-based research (prospective samples)
  • Material Transfer Agreement and Data Transfer Agreement Templates for transfer between the African States-EU Member States/EU Member States-African States.
Participants to the B3Africa Ethics and Regulation Workshop, April 2016, The Gambia

WP1 has produced so far three articles:

  • S. Slokenberga, R. Merino Martinez & J. Reichel, Legal and ethical governance of intercontinental biobanking – some experiences from a H2020-project, Förvaltningsrättslig tidskrift, 2017, p. 169 – 192, and
  • S. Slokenberga, J. Reichel, R. Niringiye, T. Croxton, C. Swanepoel, J. Okal, EU data transfer rules and African legal realities: Is data exchange for biobank research realistic?’ International Data Privacy Law, ipy010, https://doi.org/10.1093/idpl/ipy010;
  • Slokenberga S, ‘Biobanking between EU and third countries – to what extent can privacy facilitate data export to the third countries?’ EJHL 2018 (forthcoming).

Results of WP 1 work have been presented in several conferences; they include

  • Slokenberga S, ‘B3Africa – Bridging Biobanking and Biomedical Research across Europe and Africa’ in Nordic Network for Research in Biomedical Law Conference, Lund, Sweden 2016;
  • Slokenberga S, Reichel J, ‘The protection of privacy in multinational research setting: lessons from B3Africa’ at UNESCO Chair in Bioethics 12th World Conference BIOETHICS, MEDICAL ETHICS & HEALTH LAW, UNESCO, Cyprus, 2017;
  • Slokenberga S, O45, EU data transfer rules and international legal realities: is transcontinental data exchange for biobank research realistic under the GDPR? The case study on bridging biobanking in Europe and Africa, EAHL Bergen, Norway, 2017.