Do I Need To Apply

In Ireland, a researcher (whether an individual or an organisation) seeking to process personal data for health research is governed by the Health Research Regulations 2018 (HRR); one requirement of the HRR is to obtain the explicit consent of the individual to process their personal data in that health research study. Consent from the study participant is considered a guiding principle of health research.

However, it is recognised that it may not always be possible to obtain the explicit consent of the study participant to process their personal data in a health research study. For example, the health research study in question may involve participants who do not have the decision-making capacity to provide explicit consent, or the study may also involve the processing of personal data of a large number of participants that obtaining consent is not considered possible.

Where it is determined that the participant consent cannot be obtained, the HRR provides for a statutory process where the researchers apply for a ‘consent declaration’ for their health research study from the Health Research Consent Declaration Committee (HRCDC).

It is not mandatory to apply to the HRCDC. The onus is on the Data Controller of a research study to determine whether an application to seek a declaration is required for their health research study.

It is important to note that the HRCDC or consent declaration application process is not there as an alternative to seeking consent. If applying for a consent declaration, the researcher needs to provide clear rationale why it is not possible to obtain consent.

All decisions are made independently by the HRCDC. All appeals will be made to another equally independent panel (appointed by the Minister).

To determine if a consent declaration should be made, ultimately the HRCDC must be satisfied that the public interest in the research study significantly outweighs the requirement to obtain the explicit consent of the participant. Therefore, through the application process, the Applicant/data controller should make a compelling case to enable the HRCDC to make its decision.

Exemptions: In limited circumstances, explicit consent or a consent declaration may not be required for some specific types of health research studies, subject to that study meeting certain strict criteria and having important safeguards in place. These exemptions are outlined in Amendment 2 to the Health Research Regulations, S.I. No. 18 of 2021. These substantive amendments were made following a process of engagement with stakeholders to identify genuine and meaningful challenges in implementation of the Regulations that have impacted health research and health researchers.

Guidance for researchers on these substantive amendments, which include matters such as pre-screening, low-risk retrospective chart studies and deferred consent in limited specific circumstances, has been prepared collaboratively by the Department of Health, the Secretariat to the Health Research Consent Declaration Committee (HRCDC) and the Health Service Executive and in consultation with the Data Protection Commission.

To help determine if you may need to apply for a consent declaration, please refer to the decision tree document below as well as the website link to the Department of Health’s separate guidance on the substantive amendments made to the Regulations. Also provided below is additional guidance on the amendment relating to Informed Consent under the previous EU Directive.