The HRCDC had refused to grant a consent declaration in respect of a proposed research project relating to the use of a biobank. On appeal, the Appeal Panel granted a conditional consent declaration, meaning that the project could be conducted without the explicit consent of the data subjects whose samples comprised the biobank, but subject to compliance with a number of conditions.

As we have outlined in our previous briefings (available here and here), the Health Research Regulations have substantially altered how and when health research can be conducted in Ireland. In general, data controllers must obtain the explicit consent of participants/patients for the processing of their personal data for the purposes of health research before the health research commences.

Nevertheless , the organisation conducting the research that acts as the data controller can apply to the HRCDC for a declaration that the explicit consent of data subjects is not required, where the public interest in conducting the health research “significantly outweighs” the public interest in obtaining their explicit consent.

In this briefing, we consider the consent declaration application process, and the process for appealing a decision of the HRCDC.

Applying for a Consent Declaration

The transition period for applying for a consent declaration for research that commenced prior to 8 August 2018 has now expired. Data controllers can only apply for declarations for new research (i.e. research that commenced on or after 8 August 2018).

Before making an application, a data controller must demonstrate compliance with a range of measures, including the conduct of a data protection impact assessment and the procurement of approval from a research ethics committee.

The HRCDC must consider the application “as soon as practicable” following receipt of it, and it may consult as appropriate and request further information from the applicant.

Before granting a declaration, the HRCDC must be satisfied that the requirements as set out in the Regulations have been met, and that the public interest in carrying out the research significantly outweighs the public interest in requiring the explicit consent of the data subject.

Appealing a Decision of the HRCDC

The Regulations provide that, where the HRCDC refuses to make a declaration, attaches conditions to a declaration, or revokes a declaration for non-compliance with a condition, the applicant can appeal the decision to the Minister for Health. The Minister will then establish the independent appeal panel.

Approach of the Appeal Panel

  • Procedure – the Appeal Panel does not have the power to send the decision back to the HRCDC, and any appeal is heard as a new hearing.
  • Burden of Proof – the burden of proof rests on the applicant adducing sufficient evidence to justify dispensing with consent. The evidence must show the public interest in the health research “significantly outweighs” the public interest in obtaining explicit consent.
  • Obtaining Consent – Although it is appropriate to consider whether it is “impossible or impracticable” to obtain the consent of data subjects in weighing up the public interest (i.e. the easier it is to obtain consent the weaker the interest in proceeding without obtaining it), the applicant is not required to demonstrate that it is in fact impossible or impracticable to obtain consent in order to receive a consent declaration.
  • Three further points in relation to the applicable test are notable:
    • Applicants are not required by the Regulations to demonstrate patient and public involvement, but evidence of positive engagement may assist in demonstrating that the public interest test has been met.
    • The HRCDC may have regard to any “ethical issues” which are identified by the Regulations as issues “which form the basis of consideration for ethical approval by a research ethics committee,” even though a research ethics committee may have already evaluated those points in granting approval for the research.
    • In some cases, the HRCDC may consider it appropriate to impose a time limit as a condition on the grant of a consent declaration.