Regulation and use of confidential patient information for genomic and medical research during and post COVID-19
1st November 2021
Executive summary
At the start of the COVID-19 pandemic, in March 2020, the government in England introduced measures to enable the use of confidential patient information (CPI) for COVID-19 purposes without consent or another form of approval that would normally be required. These measures, the ‘COPI notices’, set aside the common law duty of confidentiality for a range of purposes, including research into the disease and its impact on health and care. This report considers how these regulatory changes to the governance of confidential patient information have impacted genomic and medical research, and whether these changes should be integrated into the regulatory framework longer-term.
The significant impact of the COPI notices on genomic and medical research
To assess the impact of the COPI notices we reviewed the landscape of data use and linkage for genomic and medical research during the COVID-19 pandemic. We also interviewed key stakeholders from research, public health and population-level data initiatives. We identified a considerable range of data initiatives addressing COVID-19 that have relied (at least in part) on the COPI notices. Many have leveraged existing projects, infrastructures and organisations in order to address COVID-19. They include the COVID-19 Genomics UK (COG-UK) consortium, initiatives established by Public Health England for genomic surveillance, and large-scale genomic research initiatives, such as the GenOMICC study – with linkages to Genomics England and COG-UK, the HOCI study initiated by COG-UK, the SIREN study and research enabled by UK Biobank.
The evidence suggests that the COPI notices have had significant positive impacts in terms of the speed and efficiency of data access for research and also in improving access to sources of data, such as primary care data, which had been hard to obtain prior to the pandemic. The notices are likely to have had an impact in several ways: introducing a new regulatory pathway for research without consent or approval from the NHS Health Research Authority – to enable or mandate disclosure of CPI for COVID-19 purposes; development of new or streamlined processes to facilitate COPI notice-authorised data access and; the powerful signal they have sent about the importance of data sharing and access to combat COVID-19. Untangling these elements will be important in determining whether, and what manner of, changes should be taken forwards on a permanent basis.
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