As part of its ongoing response to the COVID-19 pandemic and to support the continued need for COVID-19 research and innovation, the Department of Health has recently invested in the National Irish COVID-19 Biobank (NICB): a national integrated biorepository of human biological samples with linked sociodemographic and health data provided by individuals with COVID-19. To protect these individuals’ dignity, autonomy and wellbeing, and to safeguard their data protection and privacy rights, it is crucial that the collection, storage and use of these samples and data is underpinned by the highest standards in ethics, governance and codes of practice. To this end, the Department of Health has mandated the National Office for Research Ethics Committees to establish and support the operations of a single, dedicated research ethics committee (REC) for the NICB.
Remit and scope of the NICB-REC
The remit of the NICB-REC is to provide ethical oversight of the NICB, and ensure it is established, governed, maintained and accessed in accordance with best national and international ethical practices and in compliance with data protection legislative frameworks.
The scope of the NICB-REC does not extend to the ethical assessment of studies requesting to access samples and data from the NICB. Principal Investigators wishing to secure ethical approval for studies looking to draw down samples from the NICB should seek ethical approval from their local research ethics committee.
Guiding legislation and ethical principles
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 assess from an ethical perspective all data protection and governance safeguards to ensure compliance with the EU General Data Protection Regulation and the Irish Health Research Regulations 2018, with the aim of ensuring the fundamental rights and freedoms of individuals participating in the NICB can be exercised and are protected.
The NICB-REC will carry out its ethical assessments on the 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 Operational Framework sets out the role of the National Office and the committee procedures. We have compiled some frequently asked questions on the NICB-REC here. For any other questions, please do not hesitate to contact Dr Anne Costello, NICB-REC Programme Manager, at email@example.com