Dáil Éireann Debate, Wednesday - 3 March 2021
1017. Deputy Róisín Shortall asked the Minister for Health the reason explicit consent or ethical approval is not required when a controller obtains personal data to establish if a person may be suitable or eligible for inclusion in research; the criteria used to ascertain if research is preliminary or substantive (details supplied); and if he will make a statement on the matter. [12165/21]
View answerThe Health Research Regulations include explicit consent as a safeguard when an individual’s personal data is being processed for health research. However, before health research can be carried out it is invariably critical to establish whether there would be enough potential suitable or eligible research participants for the study to proceed. It seems reasonable to allow that process to be undertaken without explicit consent and that is what the pre-screening amendment to the Health Research Regulations allows subject to very clear rules and safeguards. Moreover, the requirement for explicit consent is still applicable for the substantive research if the pre-screening process indicates a sufficient number of potential participants for the study to commence.
The same logic applies to the research ethics committee (REC) condition for the pre-screening process and REC approval is still required should the research proceed following the pre-screening.
The Guidelines prepared by my Department, in collaboration with the HSE, Health Research Board and Health Research Consent Declaration Committee, in consultation with the Data Protection Commission set out the actions that are to be regarded as pre-screening actions. They are:
(a) reviewing the personal data of a data subject in order to assess whether he or she might be suitable or eligible for inclusion in a health research study.
(b) analysing the pre-screening data and documenting the findings,
(c) sharing the findings (in a non-identifiable way) with others involved in the research team.
(d) approaching an individual found to be eligible or suitable to determine their interest in participation in the study and it is considered best practice that the approach to the prospective research subject to establish their interest should always be done only by a health practitioner.
(e) sharing the identity of the individual with the research team on a confidential basis where the individual has consented to be contacted by the research team.
