Copy of the Consent under the Health Research Regulations (as amended)
Amendments to the Health Research Regulations took effect on the 21st January 2021 - see government announcement
As a result, a copy of the consent must be provided to the data subject prior to the commencement of health research.
This is now a legal requirement under Irish Data Protection Law.
The Health Research Regulations are silent as to whether the copy of the consent provided should be one that has been signed by the data subject.
In terms of best practice in Beaumont Hospital, it is recommended that a copy of the signed consent be provided.
This may be particularly useful in cases where the data subject may have been given a number of options to choose from in a consent form e.g. to indicate their preferences in terms of being recontacted, or in terms of any future use of their data or samples. Only the signed copy of the consent form will state which options were chosen at the time of consent.