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

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

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)

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

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

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

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

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

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

Thank you!