Pádraig Rice (Cork South-Central, Social Democrats)
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171. To ask the Minister for Health the status of the national research ethics bill, approved by Government in 2019; to expand on the comment “work is ongoing”, as per the Autumn Legislative Programme; if her attention has been brought to the views of a representative organisation (details supplied); and if she will make a statement on the matter. [50614/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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A government decision was taken in July 2019 not to progress the initial draft National Research Ethics Bill and to instead prioritise secondary legislation to support national level committees for clinical trials, medical device clinical investigations and performance studies of in vitro diagnostic medical devices. Since 2022 a National Office for National Research Ethics Committees has provided administrative support for high-functioning national committees while extensive deliberations are also underway in terms of enhancing the efficiency and effectiveness of HSE research ethics committees.

Officials in my Department are continuing to review the full range of appropriate legislative provisions that will be required to support our national objectives including what steps we need to take in preparing for the forthcoming European Health Data Space Regulation, enhancing the national clinical trials landscape and ensuring a robust and sustainable research ethics system.