NICB-REC Decisions
The National Irish COVID-19 Biobank Research Ethics Committee (NICB-REC) has issued its first ethical opinion on the governance and operations of the NICB.
A phased and partitioned ethical opinion model
The NICB-REC has implemented a phased and partitioned ethical opinion model, developed by the National Office in consultation with the Committee’s biobanking experts, and discussed with and endorsed by all members of the REC.
The model enables the NICB-REC to issue a separate ethical opinion on individual elements of biobank operations, while reserving an opinion on biobank operations which have not yet commenced. This iterative review process facilitates NICB operations in an expedient and ethically robust way, corresponding to the biobank’s expected milestones towards being fully operational.
NICB-REC opinion
The ethical opinion delivered on 25 July 2023 is as follows:
| Partitioned NICB operations for separate ethical opinions | Ethical opinion |
|---|---|
| 1. Governance: Governance and oversight | Favourable with conditions |
| 2. Participant recruitment: Identification of potential participants; participant-facing information and consent protocols | Favourable with conditions |
| 3. Biological samples and data: collection, storage, processing, cataloguing, general curation, and security aspects | Favourable with conditions |
| 4. Researcher access, downstream impact and commercialisation | Opinion reserved subject to a new application for ethical assessment |
The NICB fulfilled all conditions associated with parts 1, 2 and 3 of the NICB-REC's ethical opinion on 23 October 2023. Ethical approval for part 4 (Researcher access) is subject to a new ethics application. This application will be submitted to the NICB-REC for ethical assessment at a time determined by the biobank.
Further information on the deliberation process and details of the opinions and conditions provided can be found in the minutes of the NICB-REC meetings.
Please direct any questions to nicbrec@nrec.ie