Priorities of the year, objectives pursued and expected results
The priority for this action is to increase the safety of donation and clinical application of tissues and cells and/or blood by optimising the procedures for donor selection and protection. While EU legislation defines the donor selection criteria in general terms, standardised procedures for gathering the necessary donor information are not developed at EU level. This is a high priority for these sectors because the success of transplantation, assisted reproduction and transfusion programmes relies heavily on achieving robust procedures for both the selection and protection of donors.
The objectives are: (i) to explore existing practices for the selection and protection of donors, including the gathering of donor medical and behavioural history, with particular emphasis on the design of effective questions for donors or their families, and (ii) to reach agreement on best practice for donor selection and protection procedures and questionnaires and develop tools to support its implementation.
This action should result in the development of common EU guidance on the selection and protection of donors and model questionnaires for use when interviewing prospective donors and/or donor families. The questions should be tested and validated to demonstrate that they are effective in terms of eliciting the information required for the application of exclusion criteria as defined in the EU legislation.
Description of the activities to be funded under a call for proposals
This action will bring together individuals and organisations from the tissues and cells and/or blood sectors with donor-facing expertise in those fields (e.g. physicians, key donation personnel from hospital to authority level) to address the following activities: (i) collect and compare EU and national donor selection and protection criteria based on a thorough evaluation of risks for donors and recipients; (ii) identify the information needed from donors or their families to allow the application of appropriate donor deferral or exclusion criteria for the protection of recipients; and (iii) propose approaches to control and minimize these risks, particularly by developing, testing and validating procedures that should gather complex and often sensitive information through an easily understood series of questions taking into account socio-economic, cultural and emotional factors. These approaches should include guidelines for screening donors, a proposal for a standardised donor and donor family questionnaire and proposals for short and long-term care and follow-up of living donors.
This action should build on previous EU-funded projects across the area of substances of human origin, in particular in organ donation/transplantation (e.g. DOMAINE, ELIPSY, ELPAT, and ACCORD). Involvement of relevant professional associations and competent authorities is strongly encouraged.