FACILITATE stakeholders’ meet in Cape Town
On 21 February 2023, representatives of WP3 held a FACILITATE stakeholder workshop at Stellenbosch Medical School, Cape Town, South Africa
The workshop was hosted jointly with the Stellenbosch University Research Ethics Office and the Office of Research Integrity. The purpose of the meeting was to elect feedback from expert stakeholders on the developing ethical frameworks for secondary use of clinical trial data and the return of data to participants.
South Africa has a data protection regulation (Protection of Personal Information Act 2013) that is similar to the General Data Protection Regulation (GDPR). Moreover, the country is the site of numerous clinical trials, particularly in HIV and TB, and is collaborating with the international research community and thus cognizant of the issues related to data sharing. Therefore, the South African research community is ideally placed to provide expert feedback on the developing FACILITATE ethical frameworks.
In total of 22 participants with expertise in bioethics, law, clinical trials, policy, research ethics, research integrity, bioinformatics, data management were present. The meeting was opened by outlining FACILITATE, its aims, objectives, ambition, and process of working. Next the qualitative research conducted so far and the results of the literature review were discussed with the participants. Finally, the participants were informed about the ethical frameworks, the principles guiding the frameworks and the preliminary outline of the implementing framework.
The subsequent two-hour discussions focused on the overall project, consent, the proposed governance model and issues that may need to be addressed for non-EU partners who are collaborating with European partners. Overall, transparency and communication were seen as critical to the success of the proposed processes.