What is the ethical and legal situation regarding use of human tissue?
Hospital Research and Ethics Committees require patient consent for biobanking, and separately approve specific project applications by researchers. More than 95% of patients give consent for biobanking and 95% of those do not wish to be asked to give consent for a second research project using leftover research samples (Mee B, prospective study, 2009). FFPE samples from archived diagnostic pathology specimens can be used for an individual research project following application to the REC to waive patient consent. However, European Union legislation (proposed but not yet enacted in 2015) might in future require researchers to obtain patient consent for each research project. All research projects involving tissue samples must have scientific approval before samples and data will be released from the network hospitals.
The Irish Council for Bioethics reported recommendations on the use of human tissue for research in 2005, but human tissue legislation, as adopted by other countries, is still awaited in Ireland. The UK, including Northern Ireland, is regulated by the Human Tissue Authority.