Keele, 20/07/10 Heike Schmidt-Felzmann Centre of Bioethical Research and Analysis

1. COBRA Centre of Bioethical Research and Analysis Research Ethics in Ireland Keele, 20/07/10 Heike Schmidt-Felzmann Centre of Bioethical Research and Analysis National University of Ireland, Galway

2. General characteristics of REC landscape in Ireland • At least 70 RECs (Irish population in ROI ~4 million), • including state, voluntary and private hospital RECs, academic RECs and RECs of other health and social care related organisations • Institution based system, no aspect of system centralised so far • Department of Health has been nominally in charge of clinical trial RECs, but without exercising any substantial governance functions • Recent transition of governance to Health Information and Quality Authority (HIQA); currently reviewing the situation; intention of providing national guidelines, application form, central allocation and documentation requirements for clinical trials

3. Relevant documentation in Irish context (1) • Binding requirements for review of Clinical Trials: European Clinical Trials Directive 2004 • Non-binding guidance on operational aspects of RECs: Irish Council for Bioethics “Operational Procedures for Research Ethics Committees: Guidance”, 2004 • “Children First” national guidelines on child protection, including confidentiality and its limits • Forthcoming Health Information Bill on informed consent, data protection and other information related concerns (possibly September 2010)

4. Relevant documentation in the Irish context (2) • No national guidelines relating to review content • Specific guidelines in existence relating to research with children (OMCYA, currently being developed) and persons with disability (NDA) • No officially binding common application form • but common form informally adopted by clinical trials committees in 2007 • No documentation requirements for non-clinical trial RECs beyond generic suggestion of producing “annual report” • No guidelines for training

5. Clinical Trials • Review of clinical trials governed by EU Clinical Trials Directive, 2004 which regulates composition of RECs and a number of review parameters, including required documentation and timelines • 13 recognized Clinical Trial Committees in Ireland, most of them hospital based • HIQA review likely to lead to reduction in committee number • Submission to any of the RECs, regardless of location of trials and without central allocation to RECs • Huge disparities in review load & resources

6. Non-clinical trial research in health care contexts • Separate application required for each of intended research sites; standards based on individual institutions • Sometimes multiple review by RECs in health care organisations and academic or other RECs required • Any of the review parameters is variable in non-clinical trial RECs, including application form, timelines, documentation, REC composition etc. • Significant problems when coordinating differing REC requirements in case of multisite studies • Attempt to create dedicated central REC for non-clinical trial multisite studies in 2008, but not implemented (likely due to disagreement from different regional authorities) • Now under authority of HIQA, likely that general guidelines for these committees will be forthcoming

7. Research outside health care contexts • Academic RECs review research by academic researchers, regardless of site of research • Varying remit, e.g. inclusion or exclusion of student research below PhD level depending on individual REC • Academic RECs at different levels, depending on individual REC governance system in each academic institution • University, school or departmental levels • Hierarchical or independent • No integration with health care REC system; individual agreements regarding acceptance of other RECs’ decisions

8. Strengths and difficulties • Sense of ownership of review structures in individual organisations • Possibility of reflection of particular ethos or needs of specific research populations • Absence of guidance, support and training on legal and ethical matters for RECs • Variability of all review parameters • Waste of resources, each organisation “reinventing the wheel” • Significant under-resourcing of RECs

9. How it could be done better Some suggestions from qualitative study of Irish RECs (HSE 2008, OMCYA 2009): • Primary concern raised was lack of standardisation and supports • Have central governance authority for REC standards and documentation - and especially training, guidance and advice for RECs and researchers • Address under-resourcing of committees • Provide common application form with sufficient flexibility to do justice to different forms of research • Provide software for documentation purposes • Provide operational and content guidelines for REC review, e.g. IC, children’s research, vulnerable populations, databases and epidemiological research • Facilitate meetings of REC members from different committees for training and/or sharing of experiences

10. Thank you!