The Centre for Professional Ethics at the University of Central Lancashire (UCLAN) in the UK has been working closely with the EBMT to evaluate how to overcome ethical and legal challenges for trans-national SCT research. David Coles and Doris Schroeder are the lead participants from UCLAN. 

There are 2 key deliverables under this work package are:

• a workshop and report on national legislative uptake of the EU Clinical Trials Directive, describing discrepancies in ethical/legal guidelines and regulations that hinder trans-national cooperation in research in SCT
• a workshop and report on issues arising in relation to Informed Consent and Data Protection in the context of trans-national SCT research

Project Report:

A literature review on material relevant to the implementation of the Clinical trials Directive across Europe and its impact on national regulatory systems and multinational academic clinical trials, particularly for SCT research has been completed.

A questionnaire aimed at gathering information on the legal and regulatory aspects of trans-national access to clinical trials was prepared and implemented as a digitised web questionnaire in the ProMISe software in collaboration with Work Package 4. At the beginning of February all EBMT transplant centres in the EU, Norway and Switzerland were invited to participate in the survey. The findings and participants recommendations were presented in March 2008 at the CLINT Workshop in Florence. One of the outcomes of this workshop was to suggest that two shorter, more focused follow-up surveys be sent to two groups: EBMT investigators and national study groups, to collect additional data. By the end of the study, EBMT will identify key problems, develop methodologies, and make policy recommendations to facilitate the measures required to conduct academic trans-European clinical trials in stem-cell transplantation. A report will be produced as deliverable 16 at month 18 and will be shared with EU and national authority officials.

Over the course of 2008 a similar evaluation will be completed on issues related to Informed Consent and Data protection for discussion during a second workshop session at the EBMT 2009 meeting in Göteborg.

Deliverables:  April 2007 – September 2009