Data handling and Ethics
Working group 5 will establish a consensus on the management of data handling and protection as well as ethical core documents for donation and clinical use of cord blood-derived hiPSC. WG5 is also responsible for the organization of Working Groups including identification of critical dependencies between their objectives.
Objectives
- Establishment of a consensus in the management of data handling and protection.
- Establishment of ethical core documents for donation and clinical use of CB-derived hiPSC.
WG5 Leaders
Description of Work
T5.1
Management Group meeting for Working Group organisation.
T5.2
Experts meeting for data categorisation (e.g., Patent issues, licensing, know-how) and data confidentiality (donor personal data e.g., genetic sequence, donor treatment). Analysis of ethical, legal and social implications.
T5.3
Literature review and experts meeting for agree on CB biobank Informed Consent templates and information provided for donors.
T5.4
Experts meeting: review of CB registry and forward planning.
Deliverables and milestones
D5.1
Report on the activity and management co-ordination and progress monitoring plan (M6).
D5.2
Publication of guidelines for the management of data collection and protection (M30).
D5.3
Proposal for HAPLO-iPS Consent Form and Information sheet to be signed by donors (M21).
M5.1
Organisation of the Working Groups including identification of critical dependencies between Working Group objectives.
M5.2
Consensus document for consent form and information sheet for donors following ethical criteria.