Overview

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 explicit 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.

The Standard Operating Procedures for the Secretariat and HRCDC can be accessed using the link below:

HRCDC Standard Operating Procedures

Legislation

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 1 year period of transition (Amendment No. 1 – S.I.188) 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.

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.

Read the Health Research Regulations Read Amendment No.1 (S.I.188) Read the GDPR Read the Data Protection Act 2018   

Committee Panel

The Committee

The Health Research Consent Declaration Committee (HRCDC) is appointed by and reports to the Minister for Health. The HRCDC comprises a broad base of individuals that are representative of the health research community, including patient and public representatives.

The HRCDC 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 HRCDC to an independent appeal panel appointed by the Minister.

 

The Committee may:

  • Make a consent declaration
  • Make a consent declaration subject to conditions attached
  • Not make a consent declaration
  • Revoke a consent declaration

Applications for a consent declaration will be assessed by a minimum of seven members of the HRCDC, at least one of whom will be the Chairperson or Deputy Chairperson and one of whom is a data subject representative.

 

Additional information and consultation:

  • The HRCDC 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 HRCDC may consult with any person who it believes can assist it in its deliberations.

Secretariat

The Secretariat supports the HRCDC in all aspects of its work. The Secretariat is responsible for the application process which shall to enable researchers seek a consent declaration from the HRCDC.

This Secretariat shall: –

  • Act as the central point of contact and help desk for the health research community;
  • Support the HRCDC’s activities;
  • Facilitate and manage the process for applying for a consent declaration;
  • Monitor declarations made;
  • Oversee the standard operating procedures of the HRCDC;
  • Coordinate training and professional development activities for the HRCDC

The Secretariat staff; 

Dr. Emily Vereker, Programme Manager | evereker@hrcdc.ie

Jonathan Barrett, Project Officer | jbarrett@hrcdc.ie

Caroline Byrne, Administrative Assistant | cbyrne@hrcdc.ie