Dáil Éireann Debate, Wednesday - 3 March 2021
1012. Deputy Róisín Shortall asked the Minister for Health if he conducted patient and public engagement prior to enacting SI No. 18/2021 Data Protection Act 2018 (section 36(2)) (Health Research) (Amendment) Regulations 2021; and if he will make a statement on the matter. [12160/21]
View answerSince the Data Protection Act 2018 (section 36(2)) (Health Research) Regulations (SI 314 of 2018) were made in August 2018, my Department has engaged widely and publicly on the amendments that have now been set out in SI 18 of 2021. It had due regard to all the views put forward which came from a range of groups and individuals, including groups like the Medical Research Charities Group which plays an important role in highlighting patient perspectives on research and in ensuring that the patient voice is central to decisions made about health research. That engagement is reflected in the balanced nature of the amendments.
Giving an ongoing tangible voice to patients and the public is ensured in the amendments where it is expressly provided that the consultations to be undertaken by a researcher making an application for a consent declaration are not just with data subjects but now extend to patients and the public too.
Further, the appeals mechanism in the Health Research Regulations has been strengthened to allow the appeal panel to invite submissions from any person that it considers appropriate and consult with any person who it believes could assist in the consideration of an appeal. This will allow patients and the public to be heard in the appeals process.
