S.I. No. 314/2018 - Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018

1. (1) The Committee shall have not fewer than 15 persons and not more than 21 persons, including a chairperson, and 2 deputy chairpersons.

(2) The chairperson, deputy chairpersons and ordinary members of the Committee shall be appointed by the Minister.

(3) The Committee shall consist of persons who in the opinion of the Minister, having regard to the functions of the Committee, are suitably qualified, including

(

a

) persons with knowledge of data protection law, research ethics, statistics or other relevant knowledge;

(

b

) persons with experience in healthcare or health research;

(

c

) persons who are representative of data subjects.

(4)(

a

) The chairperson and the deputy chairpersons of the Board shall each hold office for the period of 4 years from the date of his or her appointment.

(

b

) An ordinary member of the Committee shall hold office for the period of 3 years from the date of his or her appointment.

(5) A member of the Committee whose term of office expires by the efflux of time shall be eligible for reappointment to the Committee.

(6) A person who is reappointed to the Committee in accordance with paragraph (5) shall not hold office for more than 2 consecutive terms.

2. (1) A member of the Committee may resign by written notice of resignation signed by him or her to the Minister and the resignation shall take effect on the date of the Committee meeting next held after written notice of resignation is received by the Minister.

(2) The Minister may at any time remove from office a member of the Committee if, in the Minister’s opinion—

(

a

) the member has become incapable through ill-health of performing his or her functions,

(

b

) the member has committed stated misbehaviour of a type that would make him or her unsuitable for membership of the Committee,

(

c

) the removal of the member appears to the Minister to be necessary for the Committee to perform its functions effectively and with public confidence.

(3) If a casual vacancy occurs among the members, the Minister shall appoint a person to fill the vacancy and the person so appointed shall hold office for that period of the term of office of the member who occasioned the casual vacancy concerned that remains unexpired at the date of his or her appointment, or such other period not exceeding 3 years as the Minister may specify.

Meetings

3. (1) The quorum for a meeting of the Committee shall be 7, and at least one of those present shall be the chairperson or a deputy chairperson.

(2) Subject to subparagraph (1), the proceedings of the Committee shall not be invalidated by any vacancy among its members.

4. (1) The chairperson or, in the absence of the chairperson, a deputy chairperson of the Committee, shall convene a meeting of the Committee—

(

a

) six or more times in any twelve month period,

(

b

) when requested to do so by a requisition signed by not less than 40 per cent of the members of the Committee, or

(

c

) when requested to do so by the Minister.

(2) At least 5 working days before a meeting of the Committee, a notice in writing, signed by or on behalf of the chairperson of the Committee, or in the absence of the chairperson, by or on behalf of a deputy chairperson, shall be sent to every member of the Committee which shall specify the agenda for that meeting.

(3) At a meeting of the Committee—

(

a

) the chairperson of the Committee shall, if present, be the chairperson of the meeting,

(

b

) if and so long as the chairperson of the Committee is not present, or if that office is vacant, a deputy chairperson shall be the chairperson of the meeting.

Decision Making

5. (1) Every question arising at a meeting of the Committee duly convened shall be determined by a majority of the votes of the members of the Committee present and voting on the question at a meeting of the Committee.

(2) In the case of an equal division of votes on any question arising at a meeting of the Committee, the chairperson of the meeting shall have a second or casting vote.

(3) Where a member of the Committee has a material interest in any matter which falls to be considered by the Committee he or she shall-

(

a

) disclose to the Committee the nature of the interest in advance of any consideration of the matter,

(

b

) neither influence nor seek to influence a decision relating to the matter,

(

c

) withdraw from a meeting or that part of a meeting at which the matter is being discussed or considered, and

(

d

) take no part in any deliberation or decision relating to the matter.

(4) Where a material interest is disclosed under subparagraph (3), the disclosure shall be recorded in the minutes of the meeting concerned and, for so long as the matter to which the disclosure relates is being dealt with by the meeting, the member of the Committee by whom the disclosure is made shall not be counted in the quorum for the meeting.

(5) Where, at a meeting of the Committee, a question arises as to whether or not a course of conduct, if pursued by a member of the Committee, would constitute a failure by him or her to comply with the requirements of subparagraph (3), the question may, subject to subparagraph (6), be determined by the chairperson of the meeting, whose decision shall be final, and where such a question is so determined, particulars of the determination shall be recorded in the minutes of the meeting.

(6) Where, at a meeting of the Committee the chairperson of the meeting is the person in respect of whom a matter to which subparagraph (3) applies falls to be determined, the other members of the Committee attending the meeting shall choose one of their number to be chairperson of the meeting for the purposes of subparagraph (5).

(7) Where the Minister is satisfied that a member of the Committee has not complied with subparagraph (3), the Minister may remove that member from office and that person shall then be disqualified from being a member of the Committee.

Minutes

6. (1) The chairperson of the meeting shall cause proper minutes of each meeting to be prepared which shall be approved by the Committee at the next Committee meeting and, after they are approved, published on the Committee’s website.

(2) The names of all members present at a meeting of the Committee shall be recorded in the minutes of the meeting.

Expenses

7. (1) The Minister shall provide, or cause to be provided, to the Committee such administrative and secretarial assistance as he or she considers appropriate for the Committee to carry out its tasks under these Regulations and may consult with the chairperson of the Committee on that matter.

(2) There may be paid by the Minister to the Committee such allowances in respect of reasonable expenses properly incurred by it in the performance of its functions as the Minister may, with the consent of the Minister for Public Expenditure and Reform, determine.

Procedures

8. Subject to these Regulations, the Committee shall determine its own procedures.

GIVEN under my Official Seal,

7 August 2018.

SIMON HARRIS,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation)

These Regulations are made under

section 36

of the

Data Protection Act 2018

. They set out mandatory suitable and specific safeguards that will apply to the processing of personal data for the purposes of health research and for related matters. These safeguards which arise under the General Data Protection Regulation (GDPR) are separate from the requirements in the GDPR to have a ground in Article 6 and to meet a condition in Article 9.

1 OJ No. L 281, 23.11.1995, p.31

2 OJ No. L 281, 23.11.1995, p.31

3 OJ No. L 281, 23.11.1995, p.31

4 OJ No. L 158, 27.5.2014, p.1

9. A person who has been notified by the Committee that a declaration has been made in respect of his or her application under these Regulations shall confirm in writing to the Committee his or her acceptance of the declaration within 30 working days of the date of the notification of the decision and where such confirmation is not received by the Committee within that period the declaration shall lapse.

10. (1) The Committee may revoke a declaration where it is satisfied that the conditions imposed by it are not being met.

(2) Before proceeding under paragraph (1) the Committee shall give a notice in writing to the person to whom the declaration was made notifying the person—

(

a

) of the Committee’s intention to revoke the declaration,

(

b

) of the reasons for the proposed revocation, and

(

c

) that the person may make written representations to the Committee, within 10 working days of the date of the giving of the notice, as to why the declaration should not be revoked.

(3) The Committee shall not proceed under paragraph (1) before the expiry of the period referred to in paragraph (2)(

c

).

(4) The Committee shall consider written representations received under paragraph (2)(

c

) before deciding whether or not to revoke the declaration.

(5) The Committee shall, as soon as may be after it decides whether or not to revoke the declaration, give notice in writing to the person notifying the person—

(

a

) of its decision and the reasons for making the decision, and

(

b

) where a decision is made to revoke the declaration, that the person may appeal that decision under Regulation 11(1).

11. (1) Where the Committee—

(

a

) attaches conditions to a declaration under Regulation 8(4)(

b

),

(

b

) refuses to make a declaration under Regulation 8(4)(

c

), or

(

c

) revokes a declaration under Regulation 10(1),

the applicant or, as the case may be, person who is notified under Regulation 10(5) of the decision to revoke a declaration (in this Regulation referred to as the “appellant”), may within 30 working days from the date of the giving of the notice under Regulation 8(5) or 10(5), give a notice in writing to the Minister and the Committee of his or her intention to appeal that decision and request the Minister to establish a panel (in this Regulation referred to as the “appeal panel”) for the purposes of considering such an appeal by that appellant under this Regulation.

(2)(

a

) The Minister shall, within 40 working days of the date of the receipt of a request in writing from an appellant, establish an appeal panel to consider an appeal made under this Regulation.

(

b

) Where the Minister considers it appropriate in all the circumstances, an appeal panel may be established to hear and determine more than one appeal.

(3)(

a

) An appeal panel established under paragraph (2) shall consist of 3 persons, one of whom shall be appointed by the Minister to be the chairperson, who in the opinion of the Minister and having regard to the functions of the appeal panel are suitably qualified.

(

b

) None of the persons appointed to an appeal panel shall be a person who is a member of the Committee.

(

c

) An appeal panel shall determine its own procedure.

(4) An appeal made under paragraph (1) shall be considered by the appeal panel as soon as practicable following the establishment of the appeal panel under paragraph (2).

(5) Having considered an appeal under this Regulation the appeal panel shall—

(

a

) confirm the decision,

(

b

) vary the decision, or

(

c

) allow the appeal,

and shall notify the appellant and the Committee of the decision and the reasons for the decision.

(6) An appeal panel, having considered the appeal in relation to which it has been established under paragraph (2) and having made a decision and notified the appellant and the Committee under paragraph (5), shall stand dissolved.

(7) There may be paid by the Minister to the appeal panel such allowances in respect of reasonable expenses properly incurred by it in the performance of its functions as the Minister may, with the consent of the Minister for Public Expenditure and Reform, determine.

12. (1) The Committee shall, not later than 31 March in each year, furnish a report on its activities in the immediately preceding year to the Minister.

(2) The Committee shall publish on a website maintained by it the following—

(

a

) the names of its members and, where appropriate, their professional details,

(

b

) information on its processes and procedures,

(

c

) summary information about applications made to it and scheduled for consideration by the Committee,

(

d

) minutes of its meetings,

(

e

) decisions made by the Committee and the appeal panel under these Regulations and the reasons for them,

(

f

) guidance and other material that relates to its work, and

(

g

) the report furnished to the Minister under paragraph (1).

13. (1) The Committee may review the operation of declarations made by it or by an appeal panel under these Regulations from time to time and may, for the purpose of that review, seek information from a person to whom a declaration was granted in relation to any aspect connected with the operation of that declaration.

(2) A person to whom a declaration is made shall co-operate with any review carried out under paragraph (1).

14. Nothing in these Regulations shall be construed as imposing an obligation on a person to disclose personal data to a person who processes personal data for the purpose of health research under these Regulations but, where a declaration is made, any disclosure made by the first mentioned person shall not be in breach of any requirement to obtain consent under these Regulations provided that the disclosure is in accordance with the declaration or any condition to which it may be subject.

15. Where a data subject consents to participation in health research activities in clinical trials, the relevant provisions of Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014

4

on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC shall apply and the processing of personal data related to those clinical trials shall be in accordance with these Regulations.

16. The Minister shall review these Regulations no later than 3 years after the date they come into operation and shall publish a report of the review on a website maintained by him or her.

SCHEDULE

COMMITTEE

Membership

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

10

th August

, 2018.

I, SIMON HARRIS, Minister for Health, in exercise of the powers conferred on me by

section 36

(2) of the

Data Protection Act 2018

(No. 7 of 2018), and having duly complied with subsections (5)(

b

) and (6) of

section 36

of the

Data Protection Act 2018

, hereby make the following regulations