WP 17. Bioethics and legal issues

This area of work will be lead by Partner 1 (KI)

To suggest a uniform ethical praxis within the framework of European and national legislation regarding information and consent procedures related to biosampling for genetic, biochemical and proteomic research in autoimmune diseases such as rheumatoid arthritis and myositis in both children and adults.

An inventory will be made of national legislations and ethical guidelines practiced in the participating countries. Suggestions for harmonisation of ethical praxis focusing at information and consent procedures including information content will be made having regard to ethical theory of biobanking and informed consent as well as relevant EU-directives.

Guidelines for collecting samples will be developed conforming to the current legislation in the countries in which the research will be carried out with approval being obtained from the relevant ethics committees. Certain aspects that are already being used in most research centres in the AUTOCURE consortium should be recognised by all partners. Tissue samples obtained at diagnostic procedures are only collected if in surplus to diagnostic requirements. When blood samples are collected for research purposes efforts should be made to be obtained at time of routine venepuncture for clinical purposes to minimise discomfort and inconvenience.

Informed consent from patients should be obtained before collecting blood or tissue samples for research. A set of standard consent forms that are reasonably balanced with regard to type of research and available procedures for information and consent will be developed.