Possible Amendments to the Health Research Regulations 2018 In Ireland

Ireland’s Department of Health is consulting with the Data Protection Commission on specific areas within research regulations, which may lead to possible amendments to the Health Research Regulations (HRR)/Data Protection Act 2018 (Section 36(2))(Health Research) Regulations 2018.

Following the introduction of the Health Research Regulations (HRR) – formally the Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018 – in October 2018, the Health Research Consent Declaration Committee (HRCDC) was established by the Department of Health to reinforce confidence amongst the public in the way health researchers use patient information.

The possible amendments to the HRR were prompted by the Department’s engagement with health researchers, research ethics committees and institutions which support health research in Ireland. The Department have made clear:

“That engagement may lead to amendments to the Health Research Regulations where any such amendments are sound from a policy perspective and legally feasible.”

The Department have stated the possible areas under consideration for amendment could include:

  • Optimising the use of administrative data for health research purposes
  • Forming retrospective chart reviews studies to aid health practitioners and employees of that organisation, provided this is of low risk and of high transparency
  • Providing further clarification on what is meant by “pre-screening” for assessing the suitability of participants included in health research. The current position under Regulation 3(2)(b) has been considered misleading by the Department. The proposed amendment aims to identify the relevant health professionals involved in the care and treatment of individuals without explicit consent; the Department also state that the amendment has the potential to facilitate a process by which “approved” researchers could be engaged in pre-screening
  • Addressing the challenge of explicit consent over “deferred” consent in emergency care interventions
  • Finding a feasible solution for processing the use of personal data where adults lack the capacity to consent; the proposed amendment needs to reflect the Assisted Decision-Making (Capacity) Act 2015 and the Health Service Executive (HSE) National Consent Policy

Any changes to the HRR require, by law, formal consultations by the Data Protection Commission and the Department of Justice and Equality. The notice also states that any proposed changes must also conform to the Data Protection Act 2018.

The notice by the Department of Health on the possible changes to the Health Research Regulations 2018 can be found here.

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Published 12. April 2019 in News Ireland