A modification is considered to be any change made to the National Irish COVID-19 Biobank (NICB) in the context of its governance and operations, participant recruitment, bio-sample and data safety and management, and/or any documents, after they have been ethically approved by the NICB Research Ethics Committee (NICB-REC). Modifications maybe considered substantial, or non-substantial.
This modification process will be updated according to any future NICB ethical approvals in due course.
A substantial modification is a change to the biobanking infrastructure which may have a significant effect on any of the following:
- The safety, health, rights, physical or mental integrity of biobank participants
- The scientific value of the biobank, or the robustness of the bio-samples and the integrity of the data stored and curated by the biobank
- The conduct or management of the biobank
A non-substantial modification is any change to the biobank in terms of the NICB-REC application, the protocol or any other supporting documentation that does not meet the definition of a substantial modification.
NICB-REC review process for modifications
Substantial modifications must be reviewed and approved by the NICB-REC before they are carried out.
Non-substantial modifications may not need to be reviewed by the NICB-REC, but applicants may need to notify the National Office of some non-substantial changes or modifications such as change in contact points etc., or other material information.
Where it is unclear whether a modification is substantial or non-substantial, the National Office will make the determination, in consultation with the Chairperson.
Below are some examples of biobank modifications that would be considered substantial or non-substantial.
Examples of substantial modifications
- Inclusion of additional biobank participant cohorts, either prospective or retrospective
- Inclusion of or request for additional participant data to that consented for at recruitment stage
- Inclusion of a new biobank site (not listed in the original application)
- Changes to Governance structures
- Changes to harmonised, multisite biobank operations
- Changes likely to have a significant impact on the scientific value of the biobank
- Changes to biobank bio-sample and/or data management procedures
- Changes that may have a significant impact on the safety or physical or mental integrity of participants
- Significant changes to biobank documentation such as participant information leaflets and informed consent forms (PIL/ICFs), participant questionnaires, biobank protocol, letters to GPs or other clinicians
- Appointment of a new biobank Director or Co-Director
- A change to the insurance or indemnity arrangements for the biobank
- Appointment of a new Site Lead at a biobank site
- A change to the definition of the end of the biobank
- Changes in funding arrangements
- Any other significant change to the biobank protocol
Examples of non-substantial modifications
- Minor changes to the protocol or other biobank documentation, e.g. correcting clerical errors, updating contact points, minor clarifications
- Changes to the biobank administrative team
- Changes in the logistical arrangements for storing or transporting samples
- Extension of the biobank beyond the period specified in the application form.
(Source: some of the content above has been adapted from the UK Health Research Authority’s website.)