This week, the inadequate ethical and regulatory structures under which Ireland permits DNA research has been exposed yet again, raising persistent questions about why Ireland remains one of the few countries without a national public genomics programme.
Yet again, patients, their relatives, and patient advocates expressed frustration and concern over an unexpected Monday deadline by which people needed to request that brain tumour tissue taken from them, or a deceased relative, be removed from an enormous database project between Beaumont Hospital and a commercial third party, Genuity (the recently-rebranded GMI).
Genuity – a restructured, now-independent company affiliated with a large Chinese health conglomerate – collects and analyses DNA samples for databases that are marketed to third parties. It has expressed a goal of gathering DNA samples from 10 per cent of Irish people, a percentage exceeding that at which an entire national population could be genetically profiled, according to the publication New Scientist.
Contrary to what usually would happen with DNA data, which is granted special-protected status under the General Data Protection Regulation (GDPR), individuals here must explicitly opt out of having these tissues included in the database.
This form of permission – which several medical and privacy experts, including the Irish Council for Civil Liberties (ICCL) believe violates GDPR guidelines – was granted after researchers appealed a decision made late last year by the new oversight board, the Health Research Consent Declaration Committee.
Originally, the committee criticised this opt-out consent, and concluded “it was not evident that GMI’s use and commercialisation of [tissue sample DNA] would directly and significantly benefit the public”, and refused the proposal.
Were you or anyone you know treated for a brain tumour in Beaumont Hospital between the 29th Nov 1987 and the 7th Aug 2018? If so, your archived brain tissue samples will be used in a new research study, unless you opt-out by Monday. Please watch for info. pic.twitter.com/1Gxr9kFyeI
— Roisin Shortall (@RoisinShortall) September 10, 2020
But research permission was granted by a separate appeals committee. No patient or data privacy experts were consulted during the appeal. GMI/Genuity engaged a barrister (generally not allowed in research appeals internationally) who argued that that it might upset people to be contacted directly for permission. Beaumont and Genuity were instead allowed to run ads in print newspapers during the pandemic.
In a short video posted to her Twitter account last Sunday, Social Democrats TD Róisín Shortall once again raised the alarm about a deadline that she’d already managed to postpone once. In June, at the time of the first deadline, she’d highlighted concern in the Dáil about this questionable consent framework after being contacted by worried patients and families. A new deadline was set, for this week.
And this week, just as last June, more affected individuals, unaware of this project, were shocked to learn about it from social media. Many were outraged the burden fell on them to arrange to remove this sensitive personal data from automatic inclusion in a database.
Callers rang RTÉ’s Liveline to voice anger that they hadn’t been contacted directly. Also of deep concern was the lack of clarity about the role of a commercial partner Genuity – presented in the information campaign as a “research partner” – and the possibility that tissue data would be marketed in for-profit databases to unknown parties for years to come. The deadline was postponed again, but the controversial opt-out structure remains.
Understandably, some callers expressed support for facilitating research that might possibly find new treatments for devastating illnesses. But finding new treatments is not at issue; rather, it’s how this is best done. The details of the creation and usage of genomic databases matter: the processes surrounding the gathering, protection and utilisation of data, who benefits, and who profits. In non-public projects, such details can be obscured as commercially sensitive.
Most science-focused modern nations prioritise significant national control over genomics databases. Much research is funded nationally, research partners are publicly known, and clear, public-benefitting conditions are placed on the research.
Leaving database gathering and management in the hands of private companies significantly limits national control – especially in Ireland’s vague and lacking regulatory environment – and places domestic researchers in a funding bind, where a commercial entity is the only option.
It’s not clear from the information website for the Beaumont/Genuity brain tissue project that Genuity is a commercial partner that could sell tissue databases to other commercially-driven third parties here and abroad. There’s no indication of any direct benefit to the Irish population. No details of the partnership are publicly offered.
This is an inappropriate information void. In our national genomic vacuum, where regulation already is at some variation with international operational and ethical norms, private, multinational, for-profit companies have become the only, de facto national genome project – the gatherers, significant controllers and monetisers of Ireland’s rich, sensitive, commercially-exploitable national genomic resources.
Does it benefit the Irish people, or advance Irish or EU research? In Ireland’s fraught and uncertain DNA and genomics research situation, we cannot know, and Irish researchers have few alternatives. Ireland needs to enter the 21st century and before this revealing national resource slips entirely into private, multinational hands establish a national genomics project.