Sharon Butler Hughes

Concern re absence of ethical approval for novel scoliosis technique used on 22 children between 2017-2024. Today, I wrote and appealed directly to @CarrollJennifer and @SimonHarrisTD with regards to Mr. Farrell SC’s recommendations and the acceptance of his Scoping Report. Focusing on the Spinal Surgery recommendations, as the pathway that impacted my family; there are several things that are VERY concerning that will not be investigated. The only recommendation that Mr. Farrell made was “Inquire into whether the management of CHI were aware of the use or intended use of the non-CE marked springs in surgeries undertaken at Temple Street Hospital by Consultant A between 2020 and 2022”. It does not look at many other things that I outlined to the Minister (letter below). I drew the Minister's attention to a very concerning example of something which will not be investigated if she accepts the current recommendations. I explained how, in January of 2026, a Temple Street Orthopaedic Consultant who is currently under Independent Review was a co-author on a paper entitled “Screw-Less U-Rod Pelvic Fixation in Early-Onset Scoliosis”. This publication is a retrospective analysis on a surgical technique which was carried out on 22 patients in CHI Temple Street between 2017 and 2024. I am not a clinician, but I am a scientist! Upon reading the paper I noted the wording "At our institution, 22 patients with early-onset scoliosis underwent spinal growing-rod insertion with the U-rod construct between 2017 and 2024. Local ethics committee approval was granted for this study (REC-598-25). I noted that the procedures were carried out 2017-2024 but the ethics approval number is dated 25…. indicative of 2025 approval. The author confirmed ethical approval was for a retrospective review of the notes and x-rays only, but not the original technique. Since the 14th of September CHI Ethics Committee and the National Office for Research Ethics Committees have not responded to my requests for the ethical approval number for introduction of this new device/technique in 2017. Although this Screwless U clamp construct to secure rods for the correction of scoliosis in very young patients was a ‘development’ on previously used techniques, it was novel in CHI Temple Street in 2017, designed in collaboration with the School of Mechanical and Materials Engineering, University College Dublin. HSE Ethics Requirements state that ethical oversight, even at a local governance level by CHI, is required when a procedure is investigating the safety or efficacy of non-established therapy, device or drug treatment; when it involves any clinically significant departure from usual clinical care, or the use of any untested intervention - clinical or system within Ireland. I explained to the Minister, that this paper is in the public domain and that I was drawing her attention to something that has the potential to be ‘as scandalous’ as ‘the springs issue’-for which parents are, today, having to support children from 2-11 years of age as a result of pain which continues to be actively ignored by @CHI_Ireland I asked that she might pause, reflect and think “these parents and children have all been through enough, much more information has been brought to her over the last few weeks since the Scoping Report was published, the recommendations that have been made-especially in regard to Scoliosis Surgery will not answer the majority’s concerns. So, that she does not outright accept the Scoping Recommendations, but sees them as a starting point. To sit down with the parents & develop the steps forward from there”. Will the Minister continue to defend & accept the recommendations from the Scoping Report, in full, which ultimately means that she will be ignoring this raised concern of additional procedures carried out between 2017 & 2024 possibly without appropriate oversight and definitely resulting life-altering implications for children in Ireland?