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Vital Irish health research ‘being terminated’

By Mindo - 20th Aug 2019 | 13 views

Important health research projects that could lead to “life-changing therapies” are being terminated due to new Irish data protection regulations, the RCPI’s Faculty of Pathology has warned.

In a statement to the Medical Independent (MI) the Faculty said it was concerned about the impact that new data protection legislation and Health Research Regulations 2018 implemented by the Department of Health will have for patients, the public and researchers. It specifically referred to the General Data Protection Regulation (GDPR), effective in EU countries from 25 May 2018 and Health Research Regulations, effective from 8 August last year in Ireland only.

Speaking on behalf of the Faculty, Prof Aurelie Fabre, Consultant Histopathologist, said: “The new legislation will now require that any research which commenced on or before 7 August 2018 will in all probability need re-consenting of patients to meet the new legislative requirements. Researchers and investigators will need to establish a data protection impact assessment, and reasonable efforts must be made to re-consent research participants. In clinical practice and with the current Irish medical and research staffing levels, contacting all patients and relatives to re-consent is unrealisable and is now resulting in the termination of research projects, the majority of which would benefit society at large.

“Such research may result in the development of life-changing therapies for patients. The importance of patients and the public having control over their health data is acknowledged, however these new, uniquely Irish Health Research Regulations are causing well-founded concerns about the feasibility of obtaining retrospective consent of patients for ethically-approved research.”

Regarding chart reviews, Prof Fabre said “the retrospective chart review lies at the heart of much Irish medical research. On April 8, 2019, in the last hours before a meeting of Irish researchers concerned over the impact of the Health Research Regulations on Irish research, the Department of Health, responding to the gravity of the situation, issued a statement on possible amendments to the Health Research Regulations… ”

However, to date no such amendment has been passed. The requirement for explicit consent for retrospective chart review studies will continue to be deferred pending the conclusion of discussions between the Department and Data Protection Commissioner. The Department said an amendment to the regulations is with the Attorney General’s Office for drafting and “will formalise the situation” in relation to retrospective chart reviews that meet a number of stipulations, including low privacy risk and high transparency features.

Meanwhile, the Rotunda Hospital told MI the “stance adopted” by the Department through the Health Research Regulations is “more restrictive and burdensome than any of our European counterparts, effectively creating a double consent mechanism which may have a harmful impact on research activity”.

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