CONTEXT: RWR & Regulators | Regulatory Updates | RWR | Ireland | Retrospective Chart Reviews
IMPACT: High = New regulatory framework to support (improve?) the conduct of retrospective chart reviews in Ireland. New mechanism in place means that explicit consent is not required when a specific set of requirements has been met.
READ TIME: 2 mins
22 January 2021 – The Health Research Regulations 2018 (S.I. No. 314 of 2018) have been amended to facilitate low risk retrospective chart reviews that have been approved by a research ethics committee and meet specified transparency requirements.
The requirement for explicit consent will not apply in relation to such a retrospective chart review study where:
i) it has been approved by a REC,
ii) where the REC, as part of that approval, is satisfied and states in writing that the required data protection risk assessment carried out by the controller indicates a low risk to the rights and freedoms of the data subjects whose data wil be accessed and used in the study.
Retrospective chart reviews, by their nature, can present real and practical challenges when it comes to obtaining explicit consent for future unknown studies. The amendment addresses the consent challenge through improved transparency and other safeguards.
URL1 [News]: https://www.gov.ie/en/publication/b46c2-amendments-to-health-research-regulations/
URL2 [(Health Research) (Amendment) Regulations 2021 (S.I. No. 18/2021)]: http://www.irishstatutebook.ie/eli/2021/si/18/made/en/print?q=health+research
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