Doctors involved in vital clinical research have warned that the Department of Health’s interpretation of the new European data protection rules could force them out of research because of a requirement to obtain explicit consent before processing a patient’s data.
A review of the General Data Protection Regulation (GDPR) and the department’s interpretation of it – the Health Research Regulations (HRR) 2018 — says the explicit consent requirement will be “problematic for most (if not all) ongoing research when the re-consenting of patients is required”.
Explicit consent means the patient must give an express statement of consent.
“The participant may not be alive, or, if alive, may wish to put behind the difficulties of a previous illness,” according to the authors of the review published in the Journal of Irish Medical Science. “In this context, re-consenting… could be upsetting and stressful to both living participants and their relatives.”
Further difficulties are posed by the time and resources needed to obtain re-consent, the review says.
Prior to GDPR and HRR, the main aim for researchers was to “strike an appropriate balance between the patient’s right to personal data privacy and the desirability of making data available for research”, the review says.
Gerry McElvaney, president of the academy and co-author of the review, said “at the very least the regulations as applied in Ireland, will place a significant extra burden of work on Ireland’s clinical researchers”.
“And at their worst, they will force individuals and institutions out of the clinical research field, which will result in significant loss of the Irish knowledge economy and lead to the detriment of patient care,” said Prof MvElvaney.
Concerns are also raised in relation to retrospective patient chart reviews for research purposes. Anyone processing patient data in this respect must have some sort of mechanism in place by May 1 that addresses explicit consent. The review says “there is no guidance as to how this can be done”.
Reconsenting is ‘a major issue’ when drawing on biobanks for research purposes, the review says.
“Not using the millions of valuable and carefully documented tissues archived in Irish pathology departments and in the many designated biobanks for research, poses the most serious threat to health research progression,” say the authors.
Explicit consent will be particularly problematic for research involving patients who lack the capacity to consent.
“This is an area of great concern, particularly in the fields of emergency medicine and in the treatment of those with intellectual disability,” the review warns. “There is significant danger that these individuals will be denied access to life-saving treatment in the event of too draconian an application of the HRR.”
According to the review, entitled GDPR: an impediment to research, Ireland is the only country of the 28 EU member states to insist health researchers obtain “explicit consent”.
The review recommends that chart reviews for medical research be permitted for those involved in the care of the patients under review and that broad consent rather than explicit consent be sought for biobanking of tissues.
– The Academy is hosting a public meeting at 6.30pm this evening at the Royal College of Surgeons in Ireland, Stephen’s Green, to discuss the review.
Source: The Irish Examiner
By: Catherine Shanahan