Start date of consultation: 10 October 2022

Closing date of consultation: 28 October 2022

The National Office for Research Ethics Committees invites comments on proposed ethics application fees for 2023 for:

• clinical trials of medicinal products, conducted under the Clinical Trial Directive,
• clinical trials of medicinal products, conducted under the Clinical Trials Regulation,
• performance studies of in vitro diagnostic medical devices, conducted under the In Vitro Diagnostic Medical Devices Regulation,
• clinical investigations of medical devices, conducted under the Medical Device Regulations.

Public consultation document

Read the Public Consultation on proposal for NREC Fees – Financial year 2023 here.

The document summarises the outcome of the review of fees, sets out the legislative and operating environment, service levels and activities, and details anticipated changes in service levels and activities from next year. Specifically, it outlines the implications on fees, and provides a proposed payment schedule and fee breakdown for review.

The Health Products Regulatory Authority has commenced its independent public consultation on proposed HPRA fees for 2023.

To contribute

Please email your comments to nationaloffice@nrec.ie with subject “NREC fees consultation” by 28 October 2022.

How responses will be used

Information shared by respondents will be used to inform the finalisation of fees charged for ethics assessment of applications to the NRECs in 2023. Response documents will be published on the National Office website and will provide a general overview of the comments received and the changes made to the proposal as a result.