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Amendments to Health Research Regulations
From Department of Health
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The Minister for Health, Stephen Donnelly TD, has made amendments to the Health Research Regulations 2018 (S.I. No. 314 of 2018).
Those amendments deal with the following five substantive areas:
- processing of personal data to establish suitability or eligibility for inclusion in health research
- carrying out low risk retrospective chart reviews
- deferred consent for the processing of personal data for health research in exceptional situations
- informed consent for health research obtained during the time of the EU Data Protection Directive
- explicit consent for processing personal data in a health research context.
The amendments also deal with appeals and technical matters.
Guidance on Appeals and Technical Amendments to the Health Research Regulations - January 2021
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Guidance on Explicit Consent: Amendment to the Health Research Regulations - January 2021
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Guidance on Informed Consent obtained in the time of EU Directive: Amendment to the Health Research Regulations - January 2021
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Guidance on Deferred Consent: Amendment to the Health Research Regulations - January 2021
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