European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2022.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2022.
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paragraphs: These Regulations shall come into operation on the 26th of May 2022.
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paragraphs: (1) In these Regulations –
(a) a practising or retired health practitioner,
(b) a person who has professional qualifications or experience relating to the conduct of, or use of statistics in clinical research, unless the said qualifications or experience relate only to the ethics of clinical research or medical treatment, or
(c) a person who is involved in the promotion, organisation or conduct of clinical research;
(a) in relation to an incapacitated subject who is, or is being considered as, a subject for a performance study, means-
(i) a person, other than a person connected with the conduct of the performance study, who by virtue of his or her family or other personal relationship with the individual:
(aa) can provide the best interpretation of the will and preferences relating to healthcare of the individual based on their knowledge of the individual, and
(bb) is available and willing to act for that purpose, or
(ii) if there is no such person, the medical practitioner primarily responsible for the medical treatment provided to the individual where he or she-
(aa) can provide the best interpretation of the will and preferences relating to healthcare of the individual based on their knowledge of the individual,
(bb) is not involved in the conduct of the performance study,
(cc) is of the view that participation in the performance study will not prejudice the health and wellbeing of the individual, and
(dd) is available and willing to act for that purpose, and
(b) in relation to a minor who is, or is being considered as, a subject for a performance study means a guardian within the meaning of the Guardianship of Infants Act, 1964 (No. 7 of 1964);
(2) Subject to paragraph (1), a word or expression which is used in these Regulations and which is also used in the EU Regulation has, unless the context otherwise requires, the same meaning in these Regulations as it has in the EU Regulation.
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paragraphs: (1) (a) There shall be a unit within the Health Research Board which shall be known as the National Office for National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices (in these Regulations referred to as the “National Office”), which shall, subject to subparagraph (b), be a constituent part of the Health Research Board.
(2) The National Office shall be headed by a person who shall, in these Regulations, be referred to as the “Head of the National Office”.
(3) The Head of the National Office shall be appointed by the Health Research Board and he or she shall hold office and be paid such remuneration and any allowances for expenses that may, with the approval of the Minister, be determined by the Health Research Board, given with the consent of the Minister for Public Expenditure and Reform.
(4) The Health Research Board may dismiss the Head of the National Office where it is satisfied that the Head of the National Office –
(a) has become incapable through ill health of effectively performing the functions of the office,
(b) is adjudicated bankrupt,
(c) is convicted of a criminal offence,
(d) has, without reasonable excuse, failed to discharge his or her functions for a continuous period of 3 months beginning not earlier than 6 months before the day of dismissal, or
(e) should be dismissed for any other stated reason.
(5) The Head of the National Office and the officers of the National Office shall be employees of the Health Research Board which shall determine their conditions of employment and duties, and the officers of the National Office shall report to the Head of the National Office in relation to the performance of those duties.
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paragraphs: (1) The Health Research Board shall, to the extent that it is necessary and appropriate in order to assist the National Office in performing its functions efficiently and effectively, provide administrative and operational support to the National Office.
(2) The Health Research Board shall, not later than the 30th day of June each year, submit a statement to the Minister setting out the funding required for the following financial year to provide the administrative and operational support referred to in paragraph (1).
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paragraphs: The National Office shall maintain, and update in a timely manner, a website containing the following –
(a) contact details for the National Office,
(b) contact details for each National REC,
(c) the names of the members of each National REC and their identification as expert members or lay members,
(d) information on the National Office’s operational processes and procedures,
(e) minutes of the meetings of each National REC,
(f) the decisions given under Regulation 21 by a National REC in relation to proposals referred to it by the National Office,
(g) information on appeals and complaints procedures,
(h) any other matters that the National Office considers appropriate.
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paragraphs: The Head of the National Office shall, subject to any general directions by the Minister –
(a) take such actions and initiatives as he or she considers appropriate in order to assist in the development of high performing National RECs,
(b) provide such administrative and other support as he or she considers necessary to enable National RECs to perform their functions efficiently and effectively.
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paragraphs: The National Office shall engage with National RECs to ensure an effective National REC system and may, where it considers it appropriate to do so, develop best practice procedures for the purpose of assisting National RECs in performing their functions.
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paragraphs: The National Office shall provide such advice and training as it considers appropriate for National RECs in relation to the performance of their functions.
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paragraphs: (1) The National Office shall make an Annual Report to the Minister on or before such date as he or she may determine and the report shall include such matters related to the National Office and National RECs as the Minister may determine.
(2) The National Office shall make available a copy of each annual report on its website.
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paragraphs: The Minister may, from time to time, establish one or more than one National Research Ethics Committees (each of which shall, in these Regulations, be referred to as a National REC) to perform ethical reviews and provide opinions on performance studies under the EU Regulation.
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paragraphs: (1) The Minister shall, subject to this Regulation and the Schedule, appoint the members of a National REC.
(2) A National REC shall consist of expert and lay members who, having regard to the functions of the National REC concerned, are suitably qualified in terms of diversity of skills, qualifications, interests and backgrounds to form opinions on applications likely to be made to the National REC under Part 4 and, in relation to lay members, particular regard shall be given to individuals who are patients or representatives of patient organisations.