Molecular Medicine Ireland hosted a seminar on 5th June to discuss the benefits of a single research ethics form for clinical studies not involving medicinal products, and the potential process that could be followed to achieve a national consensus on a common form.

Background

Molecular Medicine Ireland is a charitable company established by TCD, UCD, RCSI, UCC and UCG to foster institutional collaboration between their five respective medical schools and academic hospitals in clinical and translational research and post graduate education. This has led to a number of collaborative initiatives including the Wellcome Trust and Health Research Board (HRB) funded Dublin Centre for Clinical Research (DCCR), the HEA funded Clinician Scientist Fellowship Programme (CSFP) and the HRB/HSE funded Irish Clinical Research Infrastructure Network (ICRIN). Key to the success of these initiatives is the development of a more streamlined approach to clinical research governance and ethical review. To facilitate more investigator-led clinical research activities in Ireland, particularly multi-centre studies, common approaches to research ethics approval procedures are required. To further this aim, Molecular Medicine Ireland invited the Chairs of 31 Research Ethics Committees to a seminar to discuss the benefits of a common form for clinical studies not involving medicinal products and the potential process that could be followed to achieve a national consensus on a common form. This follows the recent circulation of a draft common form by Beaumont Hospital’s Research Ethics Committee.

Seminar Participants

The Seminar was hosted by Molecular Medicine Ireland and Chaired by Dr. Ruth Barrington, Chief Executive of Molecular Medicine Ireland and Mr. Godfrey Fletcher of the Irish Platform for Patients' Organisations, Science and Industry (IPPOSI). The following Research Ethics Committees were represented at the Seminar:
• Letterkenny General Hospital
• Sligo General Hospital
• Beaumont Hospital
• Naas General Hospital
• St. Patrick’s Hospital, Dublin
• Rotunda Hospital
• Mid-Western Regional Hospital Complex
• St. James’s Hospital/Adelaide and Meath and National Children’s Hospital
• Irish College of General Practitioners
• St. Vincent’s Hospital, Fairview

Representatives of other RECs sent regrets for non-attendance and indicated their support for a common form for clinical studies that do not involve medicinal products.

The following speakers made presentations on the challenges for researchers of conducting multi-centre studies in the absence of provision for a single opinion, a common form or an active supervisory body for research ethics committees:
• Mr. Jeremy Towns, Dublin Centre for Clinical Research
• Dr. Marion Rowland, UCD and Children’s Research Centre, Crumlin
• Dr. Robert O’Connor, DCU and ICORG
• Ms. Sabine Louet, Irish Pharmaceutical Healthcare Association
• Ms. Catherine O’Connor, Alpha One Foundation.

Morning Session

The morning session heard presentations from or on behalf of researchers. Without question, Research Ethics Committees are effective in protecting the safety and interests of participants in research and, with the IMB, provide a robust and highly regarded regulatory regime for clinical research in Ireland. However, now that clinical research is required to be of a larger scale and typically involves multiple sites, making applications to multiple RECs is very time consuming and diverts a lot of scarce research resources. Researchers conducting exactly the same study at different sites are required to complete multiple forms and submit varying levels of documentation. Speakers questioned whether spending scarce resources on multiple applications for the same study could itself be deemed to be unethical. For example, it took several years for the Alpha 1 Foundation to implement a registry of patients with Alpha 1 A-Trypsin deficiency – a registry with clear benefits for patients and researchers. The requirements of each REC are similar, but not the same, and more research could be conducted if all RECs could agree on a common approach. Ideally, there would be a single opinion for all multi-centre studies but this may require legislation. In the meantime, some of the burden on researchers could be lifted if there was a common form adopted by RECs. Also, a large investment is being made in training clinical researchers and an important aspect of this training is applying for ethical approval to conduct clinical research. With a common form, more effort could go into training researchers to complete the form. A key message from the morning session is that the current system of hospital research ethics works well for single site studies, but is becoming increasingly cumbersome for multi-site studies. It was reported that between 20% and 30% of the applications received by one research ethics committee involved multi-site studies.