The Schedule attached to the Health Research Regulations 2018 describes the structure of the "Committee of Persons" which will have the authority to assess and make consent declarations.
This Health Research Consent Declaration Committee will comprise 15 - 21 members including:
- chairperson and two deputy chairpersons
- persons with knowledge of data protection law, research ethics, statistics or other relevant knowledge,
- persons with experience in healthcare or health research
- persons who are representative of data subjects.
Applications for a consent declaration will be assessed by a minimum of 7 members of the committee at least one of whom will be the chairperson or deputy chairperson.
- 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
- refuse to make a consent declaration
- revoke a consent declaration
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
An applicant may appeal:
- the refusal of the committee to make a declaration or
- any of the conditions attached to the making of a declaration
- the revocation of a declaration
An applicant or the person who is notified of the decision to revoke a consent declaration must notify the Minister for Health and the Health Research Consent Declaration Committee of their intention to appeal within 30 working days from the date of notification of the decision by the committee.
The appeal will be decided by an independent appeals panel appointed by the Minister for Health. No member of the Health Research Consent Declaration Committee will sit on an appeals panel.
- The committee will provide applicants with the reasons for its decisions (whether the decision is to make or not make a consent declaration)
Acceptance of a consent declaration by the applicant
- If a researcher is granted a consent declaration by the committee, then he or she must confirm in writing his or her acceptance of the consent declaration within 30 working days of the date of notification
- Where such confirmation is not received by the committee within that period the consent declaration shall lapse.
Revoking a consent declaration
- The committee may revoke a decision to make a consent declaration made under the Health Research Regulations 2018 where it becomes aware, and is satisfied, that the conditions imposed by it are not being met.
However, prior to implementing this decision, the committee will notify the applicant of:
- its intention to revoke the declaration, and
- the reasons for the proposed revocation,
- the right of the applicant to make written representations to the committee as to why the declaration should not be revoked. This written representation must be submitted to the committe no later than 10 working days after the date on which the notice was sent.
Health Research Regulations 2018, Regulations 7 - 13 and the Schedule
This guidance has been prepared by the HRB to help researchers in the health domain comply with GDPR requirements.
It is intended to be general guidance for educational and informational purposes only.
It is not legal advice.