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This open letter presented by the UCD PPI Ignite executive committee outlines five concerns with regard the Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018 . We request that that Department of Health outline a process as to how seldom heard voices will be involved in the Consent Declaration committee and request that national participation information leaflet templates are co-designed. We request for clarity as to how that act relates to the FAIR data principles and how the burden of reconsenting will be reduced. We ask that the act is linked with the Assisted Decision-Making (Capacity) Act 2015 and request the urgent development of codes of practice to support and integrate assisted decision-making into the regulations that should be underpinned with ongoing education to enable a shared understanding.

Ensuring we involve seldom heard voices in supporting the Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018