The Health Research Consent Declaration Committee (HRCDC) was established as part of the Health Research Regulations made under the Data Protection Act 2018.

The purpose of those Regulations is to support health research and promote necessary and desirable public confidence in such research.

The Regulations make explicit consent the default position for processing personal data for health research. In other words, a health researcher planning to use an individual’s information for health research must obtain the consent of the individual to do so. This is about empowering the patient in relation to his or her medical records.

However, it is recognised – as it is in other countries – that sometimes, in limited situations, obtaining consent will not be possible and that the public interest of doing the research significantly outweighs the need for explicit consent. It is in cases like this that HRCDC has a decision making role.

The Regulations provide for a statutory consent declaration process. That enables a data controller carrying out health research using personal data to apply for a consent declaration which means that the consent of the individual is not required for the obtaining and use of his or her personal information for the health research concerned.

In order that such applications are carefully considered from a range of perspectives, the Health Research Regulations provide for an independent and representative committee to make decisions on those applications – that is the role of the HRCDC.

In everything that we do, our objective will be to seek to build Transparency, Confidence and Trust.

Read the Regulations


The Health Research Regulations were made under section 36(2) of the Data Protection Act 2018. That Act gave further effect into domestic law of the provisions of the European Union General Data Protection Regulations (GDPR).

It is important that health researchers engage fully with their Data Protection Officers to understand the law in this area as it affects the processing of personal data for health research in Ireland.

Regarding explicit consent, the Health Research Regulations 2018 maintain the existing situation in law where explicit consent is the default position for all processing and further processing of personal data for health research purposes (unless the personal data is wholly anonymised or there is specific legal provision authorising the health research in question).

The Health Research Regulations 2018 provide for a 9 month period of transition (up until 30 April 2019) to allow for current health research projects that commenced on or before 7 August 2018 to reach the consent standard laid down by the GDPR or else to obtain a consent declaration where it can be demonstrated that this consent standard cannot be achieved.

Read the Regulations Read the GDPR Read the Data Protection Act 2018   

The Committee

The Health Research Consent Declaration Committee (HRCDC) is appointed by and reports to the Minister for Health. The Committee is broadly based in terms of representation.

It will consider whether or not a consent declaration should be made on the basis of applications made to it. There is provision for an appeal from the decision of the Committee to an Independent Appeal Panel appointed by the Minister.


The Committee may:

  • Make a consent declaration
  • Make a consent declaration subject to conditions to protect the interests of an individual likely to be affected by the consent declaration
  • Not make a consent declaration
  • Revoke a consent declaration
  • Review the operation of declarations made by it or by the appeal panel.

Applications for a consent declaration will be assessed by a minimum of seven members of the committee at least one of whom will be the chairperson or deputy chairperson.


Additional information and consultation:

  • The committee may request additional information – this information must be provided by the applicant within 15 working days of the request being made or the application will be refused.
  • The committee may consult with any person who it believes can assist it in its deliberations.


The Secretariat will administratively support the HRCDC in all aspects of its work The Secretariat will be responsible for putting in place an application process to enable researchers seek a consent declaration from the Health Research Consent Declaration Committee.

This secretariat is responsible for: –

  • Central point of contact, helpdesk
  • Support Committee’s work
  • Manage process for applying for Consent Declaration
  • Follow up on any Consent Declarations made
  • Prepare guidelines for approval by the Committee.
  • Coordination of training and CPD activities in conjunction with the Committee