NICB-REC Frequently Asked Questions
The Biobanking and BioMolecular resources Research Infrastructure - European Research Infrastructure Consortium, a leading European research infrastructure for biobanking, states that a biobank is ‘a place to store all types of human biological samples, such as blood, tissue, cells or DNA. It also stores data related to the samples as well as other biomolecular resources that can be used in health research’.
The National Standards Authority of Ireland (NSAI) in International Standard ISO 20387:2020 (Biotechnology — Biobanking — General requirements for biobanking) defines biobanking as the “process of acquisitioning and storing, together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data”.
The National Irish COVID-19 Biobank (NICB) is a health research infrastructure involving a network of hospital and university sites across Ireland, that collects and stores biological samples and associated health data, with the aim of supporting Ireland’s research response to COVID-19. Further information can be found on the NICB website.
The purpose of the National Irish COVID-19 Biobank REC (NICB-REC) is to assess, in accordance with best national and international practices and under necessary legislative frameworks, all ethical aspects of the establishment, governance, maintenance of and criteria for access rights to the NICB as a research infrastructure.
The primary role of the Committee will be the protection of the rights, safety, dignity, and well-being of research participants.
The NICB-REC will assess from an ethical perspective all data protection and governance safeguards of the NICB as a biobanking infrastructure and network. This is to ensure compliance with the EU General Data Protection Regulation (GDPR) and the Irish Health Research Regulations 2018, so that the fundamental rights and freedoms of individuals participating in the NICB can be exercised and are protected.
The ethical assessments carried out by the NICB-REC will include compliance of the NICB with the World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, and the WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks Association. It will further seek assurance that the NICB is established in accordance with the ‘European Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine 1997’, more commonly known as the ’Oviedo Convention’.
The NICB-REC will carry out its ethical assessments on the initial application submitted by the NICB Directors, plus subsequent applications for ethics approval for any amendments to the NICB governance structures and operating procedures.
The NICB-REC is a closed committee which assesses ethics applications related to the ethical oversight of the NICB as an infrastructure only. Therefore, only the NICB can submit applications to the NICB-REC.
No. The scope of the NICB-REC does not extend to the ethical assessment of studies that will require access to biological samples and associated health data from the NICB. Principal Investigators wishing to secure ethical approval for studies seeking access to biological samples and associated health data from the NICB should seek ethical approval from their local research ethics committee, in advance of approaching the NICB to access the biological samples and associated data.
The committee compromises 15 members who contribute a diverse spectrum of expertise in areas such as COVID-19, biobanking, bioethics, medical law, respiratory medicine, immunology, genetics and genomics, and epidemiology. The committee includes patient, public and carer involvement (PPI) representative members that bring their lived experiences and perspectives into the ethical assessment of the NICB. This PPI representation is integral to any robust ethics review system, to ensure the perspective of patients, carers and the public are reflected in the decision-making process of the committee.
This diversity of expertise and lived experiences will ensure the ethical assessment of the NICB is comprehensive and robust.
Members were selected based on a diversity of suitable skills, qualifications, interests, backgrounds and lived experience required to effectively assess the ethical robustness of the NICB and to deliver a single national ethics opinion.
The NICB-REC and the local RECs at NICB sites have two distinct roles.
The NICB-REC will provide a single national ethics opinion on the operations and governance of the NICB as a harmonised, multisite, national biobank. To this end, the dedicated NICB-REC comprises specific expertise and lived experiences in the ethical, legal and societal aspects of biobanking, to ensure a robust and high ethical standard is met and maintained by the NICB.
Local RECs at each NICB site are responsible for issuing ethical opinions on all study requests to access NICB biological samples and associated data, to ensure research studies accessing the biobank meet the highest of ethical standards.
The National Office established and operationalised the NICB-REC as mandated by the Minister for Health. The National Office manages all NICB-REC operations and supports the Committee in all aspects of the work it carries out.