0A4F4F9BD490A749D5437F821CF06DF1
National Research Ethics Committees Bill
https://assets.gov.ie/22009/ccd42817dbb54f6c96124bd42b46ec20.pdf
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Examining the file media/Synopses/76C42E6B3CD5F59750A16A1432AE048D.html:
This file was generated: 2020-07-14 08:53:51
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator unlawful:
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p.(None): bodily samples, which appears to the court to be associated with or arise from the commission of the offence to be
p.(None): destroyed, erased or forfeited.
p.(None): (2) The court shall not make an order under subhead (1) in relation to data or material where it considers that some
p.(None): person other than the person convicted of the offence concerned may be the owner of, or otherwise interested in, the
p.(None): data unless such steps as are reasonably practicable have been taken for notifying that person and giving him or her an
p.(None): opportunity to show cause why the order should not be made.
p.(None): Explanatory Note
p.(None):
p.(None): This provision allows for the possibility of any samples or data associated with or arising from the research where an
p.(None): offence has been committed to be destroyed, erased or forfeited by way of a court order. It also provides for a
p.(None): situation where the court order may not make such an order.
p.(None):
p.(None):
p.(None): Part 7 Miscellaneous Provisions
p.(None):
p.(None):
p.(None): Head 33 No requirement to provide personal data Provide that-
p.(None): Nothing in this Act shall be construed as
p.(None):
p.(None): (a) requiring any person to provide personal data to a person whose proposal has been approved under Part 5.
p.(None): (b) authorising any person to disclose personal data to a person whose proposal has been approved under Part 5 where
p.(None): such disclosure would otherwise not be authorised in law.
p.(None): Explanatory Note
p.(None):
p.(None): The purpose of this provision is to make clear that ethical approval by a National REC or an Appeals Panel does not
p.(None): create any obligations on any person to release personal data to the researcher or to permit a disclosure that would
p.(None): otherwise be unlawful.
p.(None):
p.(None):
p.(None): Head 34 Complaints to the National Office about a National REC Provide that-
p.(None): (1) An applicant under Head 19 or an appellant under Head 27 who is of the view that he or she has been affected by the
p.(None): procedural conduct of an National REC or a member of a National REC, in the performance of its or his or her functions
p.(None): under this Act may, in accordance with subhead (2), make a complaint to the National Office about that conduct not
p.(None): later than 6 months after the date of the conduct to which the complaint relates.
p.(None): (2) Any person making a complaint under this head shall do so-
p.(None):
p.(None): (a) in the form and manner specified by the National Office, and
p.(None):
p.(None): (b) set out the grounds for the complaint.
p.(None):
p.(None): (3) Where the National Office receives a complaint under subhead (1) it shall (where the prescribed fee, if any, has
p.(None): accompanied the complaint), without delay, investigate the complaint and-
p.(None): (a) the complainant, and
p.(None):
p.(None): (b) the National REC and members of the National REC concerned,
p.(None):
p.(None): shall co-operate with the National Office in carrying out the investigation under this head.
p.(None):
p.(None): (4) The National Office carrying out an investigation under this head may, after such consideration as appears
p.(None): necessary-
p.(None): (a) dismiss a complaint if it considers it frivolous or vexatious, or
p.(None):
p.(None): (b) seek to resolve the complaint through informal resolution.
p.(None):
p.(None): (5) Where the National Office carrying out an investigation under this head dismisses a complaint under subhead (4)(a)
p.(None): it shall notify-
p.(None): (a) the complainant, and
p.(None):
p.(None): (b) the National REC and members of the National REC of the decision and the reasons for it.
...
Political / Prosecuted
Searching for indicator prosecuted:
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p.(None): (1) A person is guilty of an offence if, for the purposes of an application under Head 19, an appeal under Head 27 or a
p.(None): complaint under Head 34 or Head 35, he or she–
p.(None): (a) makes any statement or representation, whether oral or written, that he or she knows to be false or
p.(None): misleading in any material respect, or
p.(None): (b) knowingly conceals any material fact.
p.(None):
p.(None): (2) A person is guilty of an offence if, in relation to the monitoring of health research under
p.(None): Head 13, he or she–
p.(None):
p.(None): (a) makes any statement or representation, whether oral or written, that he or she knows to be false or
p.(None): misleading in any material respect, or
p.(None): (b) knowingly conceals any material fact.
p.(None):
p.(None): (3) A person is guilty of an offence if he or she-
p.(None):
p.(None): (a) makes any statement or representation, whether oral or written, that health research that he or she is
p.(None): carrying out, or is planning to carry out or has carried out, has been approved by a National REC if he or she knows
p.(None): the statement or representation to be false or misleading, or
p.(None): (b) makes any statement or representation, whether oral or written, about the terms of an approval under Part 5
p.(None): that he or she knows to be false or misleading in any material respect.
p.(None): (4) A person guilty of an offence under this Head is liable-
p.(None):
p.(None): (a) on summary conviction, to a class B fine, or
p.(None):
p.(None): (b) on conviction on indictment, to a fine not exceeding €100,000.
p.(None):
p.(None): (5) Summary proceedings for an offence under this head may be brought and prosecuted by the Head of the National
p.(None): Office.
p.(None): Explanatory Note
p.(None):
p.(None): This head provides for offences where false or misleading statements or representations are made with persons convicted
p.(None): of an offence being subject to a fine. While the system of research ethics approval being put in place under this Part
p.(None): of the Bill is voluntary it is nonetheless important (given the value of health research and the need to maintain
p.(None): public confidence in it) that there are penalties with regard to deliberate actions that undermine the system.
p.(None):
p.(None):
p.(None): Head 29 Offences by bodies corporate Provide that-
p.(None): (1) Where an offence under this Act is committed by a body corporate and it is proved that the offence was committed
p.(None): with the consent or connivance, or was attributable to any wilful neglect, of a person who was a director, manager,
p.(None): secretary or other officer of the body corporate, or a person purporting to act in that capacity, that person, as well
p.(None): as the body corporate, shall be guilty of an offence and may be proceeded against and punished as if he or she were
p.(None): guilty of the first-mentioned offence.
p.(None): (2) Where the affairs of a body corporate are managed by its members, subsection (1) applies in relation to the acts
p.(None): and defaults of a member in connection with his or her functions of management as if he or she were a director or
p.(None): manager of the body corporate.
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision in an offences section where a body corporate may have been involved in the offence
p.(None): concerned.
p.(None):
p.(None):
p.(None): Head 30 Hearing of proceedings Provide that-
p.(None): The whole or any part of proceedings under this Act may, at the discretion of the court, be heard otherwise than in
p.(None): public.
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision relating to the hearing of proceedings.
p.(None):
p.(None):
p.(None): Head 31 Proceedings for offences Provide that-
p.(None): Summary proceedings for an offence under this Act may be brought and prosecuted by the National Office.
p.(None):
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision relating to the summary prosecution of offences.
p.(None):
p.(None): Head 32 Destruction, erasure or forfeiture of data or other material Provide that-
p.(None): (1) Where a person is convicted of an offence under this Act, the court may order any data or material, including
p.(None): bodily samples, which appears to the court to be associated with or arise from the commission of the offence to be
p.(None): destroyed, erased or forfeited.
p.(None): (2) The court shall not make an order under subhead (1) in relation to data or material where it considers that some
p.(None): person other than the person convicted of the offence concerned may be the owner of, or otherwise interested in, the
p.(None): data unless such steps as are reasonably practicable have been taken for notifying that person and giving him or her an
p.(None): opportunity to show cause why the order should not be made.
p.(None): Explanatory Note
p.(None):
p.(None): This provision allows for the possibility of any samples or data associated with or arising from the research where an
p.(None): offence has been committed to be destroyed, erased or forfeited by way of a court order. It also provides for a
p.(None): situation where the court order may not make such an order.
p.(None):
p.(None):
p.(None): Part 7 Miscellaneous Provisions
p.(None):
p.(None):
p.(None): Head 33 No requirement to provide personal data Provide that-
p.(None): Nothing in this Act shall be construed as
p.(None):
p.(None): (a) requiring any person to provide personal data to a person whose proposal has been approved under Part 5.
p.(None): (b) authorising any person to disclose personal data to a person whose proposal has been approved under Part 5 where
p.(None): such disclosure would otherwise not be authorised in law.
...
Political / criminal
Searching for indicator criminal:
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p.(None): the Government as he or she considers appropriate and such other persons or bodies as he or she considers
p.(None): appropriate.
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision to ensure that the legislation is working as intended and meeting its objectives. However,
p.(None): it is worth noting that the Minister will be concerned to ensure from the outset that the new framework is embedded
p.(None): quickly.
p.(None):
p.(None):
p.(None): Part 2: National Office for Research Ethics Committees Head 6 Establishment of the National Office
p.(None): Provide that-
p.(None):
p.(None): (1) The National Office for Research Ethics Committees is established as a statutory office within the Board.
p.(None): (2) The National Office shall be headed by a person, known in this Act as the Head of the National Office, appointed by
p.(None): the Board and shall hold office and be paid such remuneration and any allowances for expenses that the Board
p.(None): may determine with the approval of the Minister given with the consent of the Minister for Public Expenditure and
p.(None): Reform.
p.(None): (3) The Board may dismiss the Head of the National Office from his or her office if satisfied that the Head of the
p.(None): National Office-
p.(None): (a) has become incapable through ill health of effectively performing the functions of the office,
p.(None): (b) is adjudicated bankrupt,
p.(None):
p.(None): (c) is convicted of a criminal offence,
p.(None):
p.(None): (d) has without reasonable excuse failed to discharge his or her functions for a continuous period of 3
p.(None): months beginning not earlier than 6 months before the day of dismissal, or
p.(None): (e) should be dismissed for any other stated reason.
p.(None):
p.(None): (4) The other employees of the National Office shall also be employees of the Board which shall determine their
p.(None): conditions of employment and duties and they shall report to the Head of the National Office in relation to the
p.(None): performance of those duties.
p.(None): Explanatory Note
p.(None):
p.(None): In terms of providing a “home” for the new National Office, the Minister has considered that creating a new statutory
p.(None): body for that purpose should only be proposed if existing bodies cannot be adapted and utilised. Conscious generally
p.(None): of limited resources, it is proposed that the National REC Office should be located as a statutory office (with
p.(None): specified functions as set out in the Bill) within the Health Research Board (HRB) in a way broadly similar to that of
p.(None): the Office of the Chief Inspector of Social Services within HIQA under the Health Act 2007.
p.(None): The National Office rather than the Health Research Board will be responsible for the National RECs and the Board will
p.(None): have no role whatsoever in applications coming before the National RECs or appeals made to the Appeals Panel. Further,
p.(None): it will be the Minister who
p.(None):
p.(None): appoints the members of the National RECs (see Head 16) and approves the Corporate Plan and Business Plan of the
p.(None): National Office (see Head 7).
...
Political / vulnerable
Searching for indicator vulnerable:
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p.(None):
p.(None): This head provides for the development and support functions of the National Office in relation to the National RECs.
p.(None): These will be critical to the success of the new National REC structure.
p.(None):
p.(None):
p.(None): Head 11 Preparation and Issuing of Guidelines Provide that-
p.(None): (1) The National Office may prepare and issue such guidelines as it considers appropriate in relation to the operation
p.(None): of a National REC either with regard to a particular National REC or more generally.
p.(None): (2) The purpose of any guidelines issued under this head is to assist a National REC to perform its function under this
p.(None): Part in an effective and efficient manner.
p.(None): (3) Before issuing guidelines under this head, the National Office shall consult with any person and invite
p.(None): representations from any person as it considers appropriate.
p.(None): (4) After considering any representations made in relation to any guidelines proposed under this head, and making any
p.(None): changes deemed necessary by it, the National Office shall publish the guidelines on its website.
p.(None): (5) A National REC shall have regard to the guidelines issued when performing its functions.
p.(None):
p.(None): (6) Where the National Office is of the view that the guidelines are not adhered to it shall take such actions as it
p.(None): considers appropriate.
p.(None): Explanatory Note
p.(None):
p.(None): This head provides that the National Office may prepare and issue guidelines in relation to the operation of the
p.(None): National RECs either with regard to a particular National REC or more generally. The scope for such guidelines
p.(None): is wide-ranging but is likely to include, for example, standard operational procedures, how to deal with
p.(None): research proposals involving vulnerable groups generally or specific vulnerable group.
p.(None): The head also sets out the consultative procedure to be used when it comes to issuing Guidelines under
p.(None): this head.
p.(None): Given the direct relationship between the National Office and the National RECs it is not considered
p.(None): appropriate or necessary that the guidelines should be mandatory with penalties for non-observance. If the guidelines
p.(None): are not being adhered to, the National Office will be aware and can take such actions as it considers appropriate.
p.(None): That could include talking to the
p.(None):
p.(None): Chairperson of the Committee (see Head 12) about the matter or making a report to the Minister (also
p.(None): Head 12).
p.(None):
p.(None):
p.(None): Head 12 Monitoring and oversight by National Office of National RECs
p.(None):
p.(None): (1) The National Office shall monitor the performance of a National REC and in doing so shall have particular regard to
p.(None): the guidelines issued under head 11.
p.(None): (2) Where the National Office forms a view that a National REC is not performing its functions properly it shall notify
p.(None): the Chairperson of the National REC concerned setting out its concerns and the reasons for those concerns.
p.(None): (3) A chairperson of a National REC who receives a notification under subhead (2) shall reply to that notification
p.(None): within 30 days of receiving it.
p.(None): (4) The National Office shall consider the reply received under subhead (3) and may seek additional information from
p.(None): the chairperson which the chairperson shall provide as soon as practicable.
p.(None): (5) When such additional information has been received or if it has not been received within 30 days of the request for
p.(None): information under subhead (4) the National Office shall, having considered all the information it has available to it,
...
Health / Cognitive Impairment
Searching for indicator impairment:
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p.(None): (4) A person who is consulted under subhead (2) may be paid a fee by the National REC where this is agreed by the
p.(None): National Office.
p.(None): Explanatory Note
p.(None):
p.(None): When considering research applications, subhead (1) allows the National REC to consult with other persons who may have
p.(None): expertise in the research area under consideration.
p.(None): Transparency is addressed under subhead (2) which provides that the views of a person consulted under subhead (1) shall
p.(None): be recorded by the Committee in the minutes of the meeting where the proposal concerned was considered
p.(None):
p.(None): Subhead (3) deals with matters of material interest between the research and the expert being consulted. Subhead (4)
p.(None): allows for the possibility of a fee to be paid.
p.(None):
p.(None):
p.(None): Head 22 Ethical Matters to be considered by National REC Provide that-
p.(None): A National REC to which a proposal is transmitted for consideration under Head 19 shall consider the ethics of the
p.(None): health research on the basis of the following matters to the extent that they are relevant to the proposal concerned-
p.(None): (a) whether the health research is likely to assist in:
p.(None):
p.(None): (i) the advancement or protection of human health, whether of the population as a whole or of any part of the
p.(None): population,
p.(None): (ii) the scientific understanding of human health,
p.(None):
p.(None): (iii) the understanding of social factors affecting human health,
p.(None):
p.(None): (iv) the identification, prevention or treatment of illness, disease or other medical impairment, or
p.(None): (v) the effective management of health services, including improvements in the delivery of those services,
p.(None): (b) whether the person making the proposal has identified and assessed the potential benefits and risks associated with
p.(None): the carrying out of the health research,
p.(None): (c) whether the person making the proposal will make every effort to ensure that the participation of individuals in
p.(None): the health research will be informed and voluntary,
p.(None): (d) whether the person making the proposal is qualified to carry out the health research concerned,
p.(None): (e) whether there are adequate safeguards in place to protect the privacy of individuals participating in the health
p.(None): research and the confidentiality of their personal data,
p.(None): (f) whether there is anything in the health research concerned that will undermine or decrease public confidence in
p.(None): health research generally,
p.(None): (g) whether the research methodology proposed is appropriate,
p.(None):
p.(None): (h) any guidelines on ethical consideration issued by the National Office under Head 11.
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This head identifies the matters to be considered by a National REC in making its decision on ethical approval.
p.(None):
p.(None):
p.(None): Head 23 Decisions on applications Provide that-
p.(None): (1) Where a National REC has considered the relevant matters in Head 22, the National REC may refuse to give its
p.(None): ethical approval to the proposal if is not satisfied that one or more of those matters has not been met.
p.(None): (2) Where a National REC has considered the relevant matters in Head 22, the National REC shall give its ethical
p.(None): approval to the proposal if it is satisfied that those matters have been met.
...
Health / Drug Usage
Searching for indicator influence:
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p.(None): (4) The National Office may recover, as a simple contract debt in any court of competent jurisdiction, from the person
p.(None): by whom it is payable any amount due and owing to it as a result of a fee payable under this Part.
p.(None): Explanatory Note
p.(None):
p.(None): While it is not intended that a researcher making an application to have his or her research project considered by a
p.(None): National REC under this Act will have to pay a fee, it is nonetheless considered prudent to have that possibility
p.(None): provided for in the Act. Further, the head provides that different fees may be payable in relation to
p.(None): different areas of research or by different classes of persons. This could, for example, be used where the
p.(None): application is made by a not for profit applicant. It is likely that a fee may be payable in relation to an appeal
p.(None): against the decision of a National REC but refunded where the appeal is successful.
p.(None):
p.(None):
p.(None): Head 40 Prohibition on seeking or receiving payments or benefits Provide that-
p.(None): (1) No member of a National REC or an appeal panel may seek or receive any payment, fee, financial or other benefit
p.(None): from a person in respect of any application or appeal made under Part 5.
p.(None):
p.(None): (2) Where a member of a National REC or appeal panel receives any payment, fee, financial or other benefit from a
p.(None): person in respect of any application or appeal under Part 5 he or she shall return it to the person concerned and
p.(None): advise the National Office accordingly.
p.(None): Explanatory Note
p.(None):
p.(None): This head is intended to ensure that no undue influence is exercised on members of National RECs or appeal panela and
p.(None): that where such influence is sought to be brought to bear that it is reported to the National Office.
p.(None):
p.(None):
p.(None): Head 41 Application for Consent Declaration Provide that-
p.(None): A person making an application under head 19 shall indicate, as part of the application, whether it is intended to make
p.(None): an application for a consent declaration to the Health Research Consent Declaration Committee established by the
p.(None): Minister under the Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018 (Statutory Instrument
p.(None): Number 314
p.(None): of 2018).
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): As consent is a very significant ethical issue, it is considered important that where it is not intended to seek
p.(None): consent for the processing of personal data for health research and to seek instead a consent declaration under the
p.(None): Health Research Regulations (SI 314 of 2018) that that matter is highlighted in the application made under head 19.
p.(None): It may well also be that the Consent Declaration Committee which makes such declarations may become part of the
p.(None): National REC framework at some future date (as an integrated regulatory research infrastructure and accompanying
p.(None): application process is developed) and this head is considered useful in that regard.
p.(None):
p.(None):
p.(None): SCHEDULE
p.(None):
...
p.(None): 5. (1) The chairperson or, in the absence of the chairperson, a deputy chairperson of the National REC, shall convene a
p.(None): meeting of the National REC as
p.(None): (a) required to efficiently and effectively dispatch the work of the National REC in terms of proposals referred to it,
p.(None): or
p.(None): (b) requested by the Head of the National Office.
p.(None):
p.(None): (2) At least 5 working days before a meeting of the National REC, a notice in writing, signed by or on behalf of the
p.(None): chairperson of the National REC, or in the absence of the chairperson, by or on behalf of a deputy chairperson, shall
p.(None): be sent to every member of the National REC which shall specify the agenda for that meeting.
p.(None): (3) At a meeting of the National REC-
p.(None):
p.(None): (a) the chairperson of the National REC shall, if present, be the chairperson of the meeting,
p.(None): (b) if and so long as the chairperson of the National REC is not present, or if that office is vacant, a deputy
p.(None): chairperson shall be the chairperson of the meeting.
p.(None): Decision Making
p.(None):
p.(None): 6. (1) Every question arising at a meeting of the National REC duly convened shall be determined by a majority of the
p.(None): votes of the members of the National REC present and voting on the question at a meeting of the National REC.
p.(None): (2) In the case of an equal division of votes on any question arising at a meeting of the National REC, the chairperson
p.(None): of the meeting shall have a second or casting vote.
p.(None): (3) Where a member of the National REC has a material interest in any matter which falls to be considered by the
p.(None): National REC he or she shall-
p.(None):
p.(None): (a) disclose to the National REC the nature of the interest in advance of any consideration of the matter,
p.(None): (b) neither influence nor seek to influence a decision relating to the matter,
p.(None):
p.(None): (c) withdraw from a meeting or that part of a meeting at which the matter is being discussed or considered, and
p.(None): (d) take no part in any deliberation or decision relating to the matter.
p.(None):
p.(None): (4) Where a material interest is disclosed under paragraph (3), the disclosure shall be recorded in the minutes of the
p.(None): meeting concerned and, for so long as the matter to which the disclosure relates is being dealt with by the meeting,
p.(None): the member of the National REC by whom the disclosure is made shall not be counted in the quorum for the meeting.
p.(None): (5) Where, at a meeting of the National REC, a question arises as to whether or not a course of conduct, if pursued by
p.(None): a member of the National REC, would constitute a failure by him or her to comply with the requirements of subparagraph
p.(None): (3), the question may, subject to subparagraph (6), be determined by the chairperson of the meeting, whose decision
p.(None): shall be final, and where such a question is so determined, particulars of the determination shall be recorded in the
p.(None): minutes of the meeting.
p.(None): (6) Where, at a meeting of the National REC the chairperson of the meeting is the person in respect of whom a matter to
p.(None): which subparagraph (3) applies falls to be determined, the other members of the National REC attending the meeting
p.(None): shall choose one of their number to be chairperson of the meeting for the purposes of subparagraph (5).
p.(None): (7) Where the Minister is satisfied that a member of the National REC has not complied with subparagraph (3), the
p.(None): Minister may remove that member from office and that person shall then be disqualified from being a member of the
p.(None): National REC.
p.(None): Minutes
p.(None):
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.(None): operation of this Act.
p.(None): (2) The Minister shall, not later than one year after the commencement of the review, make a report to each House of
p.(None): the Oireachtas of the Minister’s findings and conclusions resulting from the review.
p.(None): (3) In undertaking a review under this head, the Minister shall consult with such other Ministers of
p.(None): the Government as he or she considers appropriate and such other persons or bodies as he or she considers
p.(None): appropriate.
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision to ensure that the legislation is working as intended and meeting its objectives. However,
p.(None): it is worth noting that the Minister will be concerned to ensure from the outset that the new framework is embedded
p.(None): quickly.
p.(None):
p.(None):
p.(None): Part 2: National Office for Research Ethics Committees Head 6 Establishment of the National Office
p.(None): Provide that-
p.(None):
p.(None): (1) The National Office for Research Ethics Committees is established as a statutory office within the Board.
p.(None): (2) The National Office shall be headed by a person, known in this Act as the Head of the National Office, appointed by
p.(None): the Board and shall hold office and be paid such remuneration and any allowances for expenses that the Board
p.(None): may determine with the approval of the Minister given with the consent of the Minister for Public Expenditure and
p.(None): Reform.
p.(None): (3) The Board may dismiss the Head of the National Office from his or her office if satisfied that the Head of the
p.(None): National Office-
p.(None): (a) has become incapable through ill health of effectively performing the functions of the office,
p.(None): (b) is adjudicated bankrupt,
p.(None):
p.(None): (c) is convicted of a criminal offence,
p.(None):
p.(None): (d) has without reasonable excuse failed to discharge his or her functions for a continuous period of 3
p.(None): months beginning not earlier than 6 months before the day of dismissal, or
p.(None): (e) should be dismissed for any other stated reason.
p.(None):
p.(None): (4) The other employees of the National Office shall also be employees of the Board which shall determine their
p.(None): conditions of employment and duties and they shall report to the Head of the National Office in relation to the
p.(None): performance of those duties.
p.(None): Explanatory Note
p.(None):
p.(None): In terms of providing a “home” for the new National Office, the Minister has considered that creating a new statutory
p.(None): body for that purpose should only be proposed if existing bodies cannot be adapted and utilised. Conscious generally
p.(None): of limited resources, it is proposed that the National REC Office should be located as a statutory office (with
p.(None): specified functions as set out in the Bill) within the Health Research Board (HRB) in a way broadly similar to that of
p.(None): the Office of the Chief Inspector of Social Services within HIQA under the Health Act 2007.
p.(None): The National Office rather than the Health Research Board will be responsible for the National RECs and the Board will
p.(None): have no role whatsoever in applications coming before the National RECs or appeals made to the Appeals Panel. Further,
...
p.(None): the functions of the National REC are suitably qualified in terms of diversity of skills, qualifications, interests and
p.(None): backgrounds to make decisions on applications likely to be made to the National REC.
p.(None): (2) A person is not eligible for appointment as a member of a National REC if the person is not a fit and proper
p.(None): person.
p.(None): 2. (1) A National REC shall have not fewer than 11 persons and not more than 21 persons, including a chairperson and 2
p.(None): deputy chairpersons and at least one quarter of members shall be lay members.
p.(None): (2) The chairperson, deputy chairpersons and ordinary members of the National REC shall be appointed by the Minister.
p.(None): (3) (a) The chairperson and the deputy chairpersons of a National REC shall each hold office for the period of 4 years
p.(None): from the date of his or her appointment.
p.(None): (b) An ordinary member of the National REC shall hold office for the period of 3 years from the date of his or her
p.(None): appointment.
p.(None): (4) A member of the National REC whose term of office expires by the efflux of time shall be eligible for reappointment
p.(None): to the National REC.
p.(None): (5) A person who is reappointed to the National REC in accordance with paragraph (5) shall not hold office for more
p.(None): than 2 consecutive terms.
p.(None): 3. (1) A member of the National REC may resign by written notice of resignation signed by him or her to the Minister
p.(None): and the resignation shall take effect on the date of the National REC meeting next held after written notice of
p.(None): resignation is received by the Minister.
p.(None): (2) The Minister may at any time remove from office a member of the National REC if, in the Minister’s opinion—
p.(None): (a) the member has become incapable through ill-health of performing his or her functions,
p.(None): (b) the member has committed stated misbehaviour of a type that would make him or her unsuitable for membership of the
p.(None): National REC,
p.(None):
p.(None): (c) the removal of the member appears to the Minister to be necessary for the National REC to perform its functions
p.(None): effectively and with public confidence.
p.(None): (3) If a casual vacancy occurs among the members, the Minister shall appoint a person to fill the vacancy and the
p.(None): person so appointed shall hold office for that period of the term of office of the member who occasioned the casual
p.(None): vacancy concerned that remains unexpired at the date of his or her appointment or such other period not exceeding 3
p.(None): years as the Minister may specify.
p.(None): Meetings
p.(None):
p.(None): 4. (1) The quorum for a meeting of the National REC shall be 7, and at least one of those present shall be the
p.(None): chairperson or a deputy chairperson.
p.(None): (2) Subject to subparagraph (1), the proceedings of the National REC shall not be invalidated by any vacancy among its
p.(None): members.
p.(None): 5. (1) The chairperson or, in the absence of the chairperson, a deputy chairperson of the National REC, shall convene a
p.(None): meeting of the National REC as
p.(None): (a) required to efficiently and effectively dispatch the work of the National REC in terms of proposals referred to it,
p.(None): or
p.(None): (b) requested by the Head of the National Office.
p.(None):
p.(None): (2) At least 5 working days before a meeting of the National REC, a notice in writing, signed by or on behalf of the
p.(None): chairperson of the National REC, or in the absence of the chairperson, by or on behalf of a deputy chairperson, shall
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Health / Physically Disabled
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p.(None): REC of his or interest in or association with the proposal being considered.
p.(None): (4) A person who is consulted under subhead (2) may be paid a fee by the National REC where this is agreed by the
p.(None): National Office.
p.(None): Explanatory Note
p.(None):
p.(None): When considering research applications, subhead (1) allows the National REC to consult with other persons who may have
p.(None): expertise in the research area under consideration.
p.(None): Transparency is addressed under subhead (2) which provides that the views of a person consulted under subhead (1) shall
p.(None): be recorded by the Committee in the minutes of the meeting where the proposal concerned was considered
p.(None):
p.(None): Subhead (3) deals with matters of material interest between the research and the expert being consulted. Subhead (4)
p.(None): allows for the possibility of a fee to be paid.
p.(None):
p.(None):
p.(None): Head 22 Ethical Matters to be considered by National REC Provide that-
p.(None): A National REC to which a proposal is transmitted for consideration under Head 19 shall consider the ethics of the
p.(None): health research on the basis of the following matters to the extent that they are relevant to the proposal concerned-
p.(None): (a) whether the health research is likely to assist in:
p.(None):
p.(None): (i) the advancement or protection of human health, whether of the population as a whole or of any part of the
p.(None): population,
p.(None): (ii) the scientific understanding of human health,
p.(None):
p.(None): (iii) the understanding of social factors affecting human health,
p.(None):
p.(None): (iv) the identification, prevention or treatment of illness, disease or other medical impairment, or
p.(None): (v) the effective management of health services, including improvements in the delivery of those services,
p.(None): (b) whether the person making the proposal has identified and assessed the potential benefits and risks associated with
p.(None): the carrying out of the health research,
p.(None): (c) whether the person making the proposal will make every effort to ensure that the participation of individuals in
p.(None): the health research will be informed and voluntary,
p.(None): (d) whether the person making the proposal is qualified to carry out the health research concerned,
p.(None): (e) whether there are adequate safeguards in place to protect the privacy of individuals participating in the health
p.(None): research and the confidentiality of their personal data,
p.(None): (f) whether there is anything in the health research concerned that will undermine or decrease public confidence in
p.(None): health research generally,
p.(None): (g) whether the research methodology proposed is appropriate,
p.(None):
p.(None): (h) any guidelines on ethical consideration issued by the National Office under Head 11.
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This head identifies the matters to be considered by a National REC in making its decision on ethical approval.
p.(None):
p.(None):
p.(None): Head 23 Decisions on applications Provide that-
p.(None): (1) Where a National REC has considered the relevant matters in Head 22, the National REC may refuse to give its
p.(None): ethical approval to the proposal if is not satisfied that one or more of those matters has not been met.
p.(None): (2) Where a National REC has considered the relevant matters in Head 22, the National REC shall give its ethical
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p.(None): the Oireachtas of the Minister’s findings and conclusions resulting from the review.
p.(None): (3) In undertaking a review under this head, the Minister shall consult with such other Ministers of
p.(None): the Government as he or she considers appropriate and such other persons or bodies as he or she considers
p.(None): appropriate.
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision to ensure that the legislation is working as intended and meeting its objectives. However,
p.(None): it is worth noting that the Minister will be concerned to ensure from the outset that the new framework is embedded
p.(None): quickly.
p.(None):
p.(None):
p.(None): Part 2: National Office for Research Ethics Committees Head 6 Establishment of the National Office
p.(None): Provide that-
p.(None):
p.(None): (1) The National Office for Research Ethics Committees is established as a statutory office within the Board.
p.(None): (2) The National Office shall be headed by a person, known in this Act as the Head of the National Office, appointed by
p.(None): the Board and shall hold office and be paid such remuneration and any allowances for expenses that the Board
p.(None): may determine with the approval of the Minister given with the consent of the Minister for Public Expenditure and
p.(None): Reform.
p.(None): (3) The Board may dismiss the Head of the National Office from his or her office if satisfied that the Head of the
p.(None): National Office-
p.(None): (a) has become incapable through ill health of effectively performing the functions of the office,
p.(None): (b) is adjudicated bankrupt,
p.(None):
p.(None): (c) is convicted of a criminal offence,
p.(None):
p.(None): (d) has without reasonable excuse failed to discharge his or her functions for a continuous period of 3
p.(None): months beginning not earlier than 6 months before the day of dismissal, or
p.(None): (e) should be dismissed for any other stated reason.
p.(None):
p.(None): (4) The other employees of the National Office shall also be employees of the Board which shall determine their
p.(None): conditions of employment and duties and they shall report to the Head of the National Office in relation to the
p.(None): performance of those duties.
p.(None): Explanatory Note
p.(None):
p.(None): In terms of providing a “home” for the new National Office, the Minister has considered that creating a new statutory
p.(None): body for that purpose should only be proposed if existing bodies cannot be adapted and utilised. Conscious generally
p.(None): of limited resources, it is proposed that the National REC Office should be located as a statutory office (with
p.(None): specified functions as set out in the Bill) within the Health Research Board (HRB) in a way broadly similar to that of
p.(None): the Office of the Chief Inspector of Social Services within HIQA under the Health Act 2007.
p.(None): The National Office rather than the Health Research Board will be responsible for the National RECs and the Board will
p.(None): have no role whatsoever in applications coming before the National RECs or appeals made to the Appeals Panel. Further,
p.(None): it will be the Minister who
p.(None):
...
p.(None): backgrounds to make decisions on applications likely to be made to the National REC.
p.(None): (2) A person is not eligible for appointment as a member of a National REC if the person is not a fit and proper
p.(None): person.
p.(None): 2. (1) A National REC shall have not fewer than 11 persons and not more than 21 persons, including a chairperson and 2
p.(None): deputy chairpersons and at least one quarter of members shall be lay members.
p.(None): (2) The chairperson, deputy chairpersons and ordinary members of the National REC shall be appointed by the Minister.
p.(None): (3) (a) The chairperson and the deputy chairpersons of a National REC shall each hold office for the period of 4 years
p.(None): from the date of his or her appointment.
p.(None): (b) An ordinary member of the National REC shall hold office for the period of 3 years from the date of his or her
p.(None): appointment.
p.(None): (4) A member of the National REC whose term of office expires by the efflux of time shall be eligible for reappointment
p.(None): to the National REC.
p.(None): (5) A person who is reappointed to the National REC in accordance with paragraph (5) shall not hold office for more
p.(None): than 2 consecutive terms.
p.(None): 3. (1) A member of the National REC may resign by written notice of resignation signed by him or her to the Minister
p.(None): and the resignation shall take effect on the date of the National REC meeting next held after written notice of
p.(None): resignation is received by the Minister.
p.(None): (2) The Minister may at any time remove from office a member of the National REC if, in the Minister’s opinion—
p.(None): (a) the member has become incapable through ill-health of performing his or her functions,
p.(None): (b) the member has committed stated misbehaviour of a type that would make him or her unsuitable for membership of the
p.(None): National REC,
p.(None):
p.(None): (c) the removal of the member appears to the Minister to be necessary for the National REC to perform its functions
p.(None): effectively and with public confidence.
p.(None): (3) If a casual vacancy occurs among the members, the Minister shall appoint a person to fill the vacancy and the
p.(None): person so appointed shall hold office for that period of the term of office of the member who occasioned the casual
p.(None): vacancy concerned that remains unexpired at the date of his or her appointment or such other period not exceeding 3
p.(None): years as the Minister may specify.
p.(None): Meetings
p.(None):
p.(None): 4. (1) The quorum for a meeting of the National REC shall be 7, and at least one of those present shall be the
p.(None): chairperson or a deputy chairperson.
p.(None): (2) Subject to subparagraph (1), the proceedings of the National REC shall not be invalidated by any vacancy among its
p.(None): members.
p.(None): 5. (1) The chairperson or, in the absence of the chairperson, a deputy chairperson of the National REC, shall convene a
p.(None): meeting of the National REC as
p.(None): (a) required to efficiently and effectively dispatch the work of the National REC in terms of proposals referred to it,
p.(None): or
p.(None): (b) requested by the Head of the National Office.
p.(None):
p.(None): (2) At least 5 working days before a meeting of the National REC, a notice in writing, signed by or on behalf of the
p.(None): chairperson of the National REC, or in the absence of the chairperson, by or on behalf of a deputy chairperson, shall
p.(None): be sent to every member of the National REC which shall specify the agenda for that meeting.
p.(None): (3) At a meeting of the National REC-
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Social / Police Officer
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p.(None): the statement or representation to be false or misleading, or
p.(None): (b) makes any statement or representation, whether oral or written, about the terms of an approval under Part 5
p.(None): that he or she knows to be false or misleading in any material respect.
p.(None): (4) A person guilty of an offence under this Head is liable-
p.(None):
p.(None): (a) on summary conviction, to a class B fine, or
p.(None):
p.(None): (b) on conviction on indictment, to a fine not exceeding €100,000.
p.(None):
p.(None): (5) Summary proceedings for an offence under this head may be brought and prosecuted by the Head of the National
p.(None): Office.
p.(None): Explanatory Note
p.(None):
p.(None): This head provides for offences where false or misleading statements or representations are made with persons convicted
p.(None): of an offence being subject to a fine. While the system of research ethics approval being put in place under this Part
p.(None): of the Bill is voluntary it is nonetheless important (given the value of health research and the need to maintain
p.(None): public confidence in it) that there are penalties with regard to deliberate actions that undermine the system.
p.(None):
p.(None):
p.(None): Head 29 Offences by bodies corporate Provide that-
p.(None): (1) Where an offence under this Act is committed by a body corporate and it is proved that the offence was committed
p.(None): with the consent or connivance, or was attributable to any wilful neglect, of a person who was a director, manager,
p.(None): secretary or other officer of the body corporate, or a person purporting to act in that capacity, that person, as well
p.(None): as the body corporate, shall be guilty of an offence and may be proceeded against and punished as if he or she were
p.(None): guilty of the first-mentioned offence.
p.(None): (2) Where the affairs of a body corporate are managed by its members, subsection (1) applies in relation to the acts
p.(None): and defaults of a member in connection with his or her functions of management as if he or she were a director or
p.(None): manager of the body corporate.
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision in an offences section where a body corporate may have been involved in the offence
p.(None): concerned.
p.(None):
p.(None):
p.(None): Head 30 Hearing of proceedings Provide that-
p.(None): The whole or any part of proceedings under this Act may, at the discretion of the court, be heard otherwise than in
p.(None): public.
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision relating to the hearing of proceedings.
p.(None):
p.(None):
p.(None): Head 31 Proceedings for offences Provide that-
p.(None): Summary proceedings for an offence under this Act may be brought and prosecuted by the National Office.
p.(None):
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision relating to the summary prosecution of offences.
p.(None):
p.(None): Head 32 Destruction, erasure or forfeiture of data or other material Provide that-
p.(None): (1) Where a person is convicted of an offence under this Act, the court may order any data or material, including
p.(None): bodily samples, which appears to the court to be associated with or arise from the commission of the offence to be
p.(None): destroyed, erased or forfeited.
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Social / Property Ownership
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p.(None): (2) The National Office shall be headed by a person, known in this Act as the Head of the National Office, appointed by
p.(None): the Board and shall hold office and be paid such remuneration and any allowances for expenses that the Board
p.(None): may determine with the approval of the Minister given with the consent of the Minister for Public Expenditure and
p.(None): Reform.
p.(None): (3) The Board may dismiss the Head of the National Office from his or her office if satisfied that the Head of the
p.(None): National Office-
p.(None): (a) has become incapable through ill health of effectively performing the functions of the office,
p.(None): (b) is adjudicated bankrupt,
p.(None):
p.(None): (c) is convicted of a criminal offence,
p.(None):
p.(None): (d) has without reasonable excuse failed to discharge his or her functions for a continuous period of 3
p.(None): months beginning not earlier than 6 months before the day of dismissal, or
p.(None): (e) should be dismissed for any other stated reason.
p.(None):
p.(None): (4) The other employees of the National Office shall also be employees of the Board which shall determine their
p.(None): conditions of employment and duties and they shall report to the Head of the National Office in relation to the
p.(None): performance of those duties.
p.(None): Explanatory Note
p.(None):
p.(None): In terms of providing a “home” for the new National Office, the Minister has considered that creating a new statutory
p.(None): body for that purpose should only be proposed if existing bodies cannot be adapted and utilised. Conscious generally
p.(None): of limited resources, it is proposed that the National REC Office should be located as a statutory office (with
p.(None): specified functions as set out in the Bill) within the Health Research Board (HRB) in a way broadly similar to that of
p.(None): the Office of the Chief Inspector of Social Services within HIQA under the Health Act 2007.
p.(None): The National Office rather than the Health Research Board will be responsible for the National RECs and the Board will
p.(None): have no role whatsoever in applications coming before the National RECs or appeals made to the Appeals Panel. Further,
p.(None): it will be the Minister who
p.(None):
p.(None): appoints the members of the National RECs (see Head 16) and approves the Corporate Plan and Business Plan of the
p.(None): National Office (see Head 7).
p.(None): The employees of the National Office will be employees of the Board and the Board will provide an operational
p.(None): infrastructure for the National Office and have a related operational oversight (as per head 7).
p.(None): That approach will avoid potential conflict of interest possibilities that might arise from the HRBs other functions as
p.(None): the Office will be distinct from the funding side of the HRB. This approach also helps build on the existing
p.(None): well-established Health Research Board brand and expertise.
p.(None):
p.(None):
p.(None): Head 7 Governance of National Office Provide that-
p.(None): (1) The Board shall be responsible for providing infrastructural support and routine operational oversight of the
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Social / Religion
Searching for indicator faith:
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p.(None): clinical trial and to organise the involvement of ethics committees, has this to say about the membership of research
p.(None): ethics committees-
p.(None): “Member States should ensure the involvement of laypersons, in particular patients or patients' organisations. They
p.(None): should also ensure that the necessary expertise is available. In accordance with international guidelines, the
p.(None): assessment should be done jointly by a reasonable number of persons who collectively have the necessary
p.(None): qualifications and experience.”
p.(None):
p.(None): Another point about membership of National RECs is that some administrative or professional incentives, but not
p.(None): payment, will be important to ensure optimal participation by specialist clinicians. For example, consideration is
p.(None): being given to mechanisms deployed by other countries to ensure that the time spent by clinicians on such National
p.(None): Committees is recognised as critical to performance of their day-to-day healthcare role. It is not considered that
p.(None): this needs to be addressed in the Bill unless at the drafting stage it becomes essential to do so.
p.(None): However, it is important to recognise that the work of the Chairperson (and Deputy Chairpersons) of the National RECs
p.(None): will, given the inevitable workload involved with those positions, require some remuneration if the right persons are
p.(None): to be attracted. This will be subject to discussion with the Department of Public Expenditure and Reform.
p.(None): It will also be necessary to provide, in the usual way, for indemnity for non-public servants carrying out, in good
p.(None): faith, their bona fides duties as members of National RECs.
p.(None):
p.(None):
p.(None): Head 3 Regulations Provide that-
p.(None): 3. (1) The Minister may by regulations provide for any matter referred to in this Act as prescribed or
p.(None): to be prescribed.
p.(None): (2) Without prejudice to any provision of this Act, regulations under this Act may contain such incidental,
p.(None): supplementary and consequential provisions as appear to the Minister to be necessary or expedient for the purposes of
p.(None): the regulations.
p.(None): (3) Every regulation made under this Act shall be laid before each House of the Oireachtas as soon as may be after it
p.(None): is made and, if a resolution annulling the regulation is passed by either such House within the next 21 days on
p.(None): which that House sits after the regulation is laid
p.(None):
p.(None): before it, the regulation shall be annulled accordingly, but without prejudice to the validity of anything previously
p.(None): done under the regulation.
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision.
p.(None):
p.(None):
p.(None): Head 4 Expenses Provide that-
p.(None): 4. The expenses incurred by the Minister or any other Minister of the Government in the administration
p.(None): of this Act shall, to such extent as may be sanctioned by the Minister for Public Expenditure and Reform,
p.(None): be paid out of moneys provided by the Oireachtas.
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision.
p.(None):
p.(None):
p.(None): Head 5 Review of operation of Act Provide that-
p.(None): 5. (1) The Minister shall, not later than 5 years after the passing of this Act, commence a review of the
p.(None): operation of this Act.
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Searching for indicator belief:
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p.(None): not satisfied with the measures taken it may withdraw the approval given under Part 5.
p.(None): Explanatory Note
p.(None):
p.(None): This Head deals with the making and investigation of complaints against researchers carrying out health research
p.(None): ethically approved under Part 5. It covers complaints that may be made by a person affected by the ethical conduct of
p.(None): a person carrying out the approved research.
p.(None):
p.(None):
p.(None): Head 36 Annual Report Provide that:
p.(None): (1) The National Office shall make an Annual Report to the Minister on such date as the Minister may determine and
p.(None): covering such matters as the Minister may specify and that report should be made available on the website of the
p.(None): National Office.
p.(None): (2) The annual report of the Board shall report on such matters related to the National Office as are considered
p.(None): appropriate by the Board.
p.(None): Explanatory Note
p.(None):
p.(None): This provision ensures that the operation of the National Office and National RECs are subject to annual reporting.
p.(None):
p.(None):
p.(None): Head 37: Power of National Office to specify the form of documents Provide that-
p.(None): 33. (1) The National Office may specify the form of any documents (including in relation to application and appeals
p.(None): under Part 5) required for the purposes of this Act as it thinks fit.
p.(None): (2) The power of the National Office under subhead (1) may be exercised in such a way as to include in the specified
p.(None): form of any document referred to in that subsection a statutory declaration—
p.(None): (i) to be made by the person completing the form, and
p.(None):
p.(None): (ii) as to whether the particulars contained in the form are true and correct to the best of that person’s knowledge
p.(None): and belief.
p.(None): (3) The form of a document specified under this head shall be—
p.(None):
p.(None): (a) completed in accordance with such directions and instructions as are specified in the document, and
p.(None): (b) accompanied by such other documents as are specified in the document. so provided in the manner (if any) specified
p.(None): in the document.
p.(None): Explanatory Note
p.(None):
p.(None): This gives the National Office the power to specify forms. This will allow information to be provided in a manner that
p.(None): meets the needs of the National Office. It complements other provisions such as head 19 dealing with applications.
p.(None):
p.(None):
p.(None): Head 38 Power of National Office to extend time Provide that-
p.(None): Where—
p.(None):
p.(None): (a) a provision of this Act specifies a period not later than which a person is required to provide any information to
p.(None): the National Office or a National REC, and
p.(None): (b) the National Office is satisfied, on the basis of a submission made to it by that person in that regard, that it is
p.(None): not reasonably practicable for the person to provide that information to the National Office or National REC within
p.(None): that period, the National Office may, by a notice in writing given to the person, extend that period by such further
p.(None): period as the National Office is satisfied is a period within which it is reasonably practicable for the person to
p.(None): provide that information.
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This provision gives some flexibility in relation to timelines for providing information to the National Office and
p.(None): National RECs.
p.(None):
p.(None):
p.(None): Head 39 Fees Provide that-
p.(None): (1) The Minister may, after consulting with the Minister for Business, Enterprise and Innovation and any other Minister
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p.(None): Subhead (2) makes sure that the same criteria are applied when considering the appeal as should be
p.(None): applied when considering an initial application.
p.(None):
p.(None): Part 6: Offences
p.(None):
p.(None): Head 28 Offence - False or misleading statements or representations Provide that-
p.(None): (1) A person is guilty of an offence if, for the purposes of an application under Head 19, an appeal under Head 27 or a
p.(None): complaint under Head 34 or Head 35, he or she–
p.(None): (a) makes any statement or representation, whether oral or written, that he or she knows to be false or
p.(None): misleading in any material respect, or
p.(None): (b) knowingly conceals any material fact.
p.(None):
p.(None): (2) A person is guilty of an offence if, in relation to the monitoring of health research under
p.(None): Head 13, he or she–
p.(None):
p.(None): (a) makes any statement or representation, whether oral or written, that he or she knows to be false or
p.(None): misleading in any material respect, or
p.(None): (b) knowingly conceals any material fact.
p.(None):
p.(None): (3) A person is guilty of an offence if he or she-
p.(None):
p.(None): (a) makes any statement or representation, whether oral or written, that health research that he or she is
p.(None): carrying out, or is planning to carry out or has carried out, has been approved by a National REC if he or she knows
p.(None): the statement or representation to be false or misleading, or
p.(None): (b) makes any statement or representation, whether oral or written, about the terms of an approval under Part 5
p.(None): that he or she knows to be false or misleading in any material respect.
p.(None): (4) A person guilty of an offence under this Head is liable-
p.(None):
p.(None): (a) on summary conviction, to a class B fine, or
p.(None):
p.(None): (b) on conviction on indictment, to a fine not exceeding €100,000.
p.(None):
p.(None): (5) Summary proceedings for an offence under this head may be brought and prosecuted by the Head of the National
p.(None): Office.
p.(None): Explanatory Note
p.(None):
p.(None): This head provides for offences where false or misleading statements or representations are made with persons convicted
p.(None): of an offence being subject to a fine. While the system of research ethics approval being put in place under this Part
p.(None): of the Bill is voluntary it is nonetheless important (given the value of health research and the need to maintain
p.(None): public confidence in it) that there are penalties with regard to deliberate actions that undermine the system.
p.(None):
p.(None):
p.(None): Head 29 Offences by bodies corporate Provide that-
p.(None): (1) Where an offence under this Act is committed by a body corporate and it is proved that the offence was committed
p.(None): with the consent or connivance, or was attributable to any wilful neglect, of a person who was a director, manager,
p.(None): secretary or other officer of the body corporate, or a person purporting to act in that capacity, that person, as well
p.(None): as the body corporate, shall be guilty of an offence and may be proceeded against and punished as if he or she were
p.(None): guilty of the first-mentioned offence.
p.(None): (2) Where the affairs of a body corporate are managed by its members, subsection (1) applies in relation to the acts
p.(None): and defaults of a member in connection with his or her functions of management as if he or she were a director or
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.(None): the carrying out of the health research,
p.(None): (c) whether the person making the proposal will make every effort to ensure that the participation of individuals in
p.(None): the health research will be informed and voluntary,
p.(None): (d) whether the person making the proposal is qualified to carry out the health research concerned,
p.(None): (e) whether there are adequate safeguards in place to protect the privacy of individuals participating in the health
p.(None): research and the confidentiality of their personal data,
p.(None): (f) whether there is anything in the health research concerned that will undermine or decrease public confidence in
p.(None): health research generally,
p.(None): (g) whether the research methodology proposed is appropriate,
p.(None):
p.(None): (h) any guidelines on ethical consideration issued by the National Office under Head 11.
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This head identifies the matters to be considered by a National REC in making its decision on ethical approval.
p.(None):
p.(None):
p.(None): Head 23 Decisions on applications Provide that-
p.(None): (1) Where a National REC has considered the relevant matters in Head 22, the National REC may refuse to give its
p.(None): ethical approval to the proposal if is not satisfied that one or more of those matters has not been met.
p.(None): (2) Where a National REC has considered the relevant matters in Head 22, the National REC shall give its ethical
p.(None): approval to the proposal if it is satisfied that those matters have been met.
p.(None): (3) Subject to subhead (4), a National REC shall, not more than
p.(None):
p.(None): (a) 40 days, or
p.(None):
p.(None): (b) a period for ethical consideration of health research specified in a national or European Union enactment,
p.(None): after receiving the proposal under Head 19, notify the person proposing to carry out the health research in writing of
p.(None): its decision.
p.(None): (4) Where an National REC makes a request for additional information, the number of days specified in subhead (3) for
p.(None): the consideration of the proposal shall be suspended from the time the National REC makes the request up until the time
p.(None): the information is provided within a period specified by the National REC or agreed with the person making the
p.(None): application.
p.(None): (5) If the decision of the National REC is that the proposal is approved (with or without conditions), the notification
p.(None): under subhead (3) shall include a statement of-
p.(None): (a) conditions, if any, to which the health research is to be subject, and
p.(None):
p.(None): (b) matters identified as possible adverse events that must be reported by the person to the National Office should
p.(None): they occur in the carrying out of the research.
p.(None): (6) If the decision of the National REC is that the proposal is refused the notification under
p.(None): subhead (3) shall include-
p.(None):
p.(None): (a) the reasons for the refusal, and
p.(None):
p.(None): (b) a statement that the person may appeal the refusal under Head 27.
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This head directly follows on from head 22 which sets out the ethical matters to be considered by a
p.(None): National REC in making a decision.
p.(None): It makes clear that where a National REC has considered the relevant matters in head 22, it may refuse to give its
p.(None): ethical approval to the proposal if is not satisfied that one or more of those matters has not been met. Where a
p.(None): National REC is satisfied that the relevant matters in head 22, have been met it must give its ethical approval to the
...
p.(None): information made by the National Office under this subhead.
p.(None): Explanatory Note
p.(None):
p.(None): This Head is very important to the success of the ethical approval structure provided for under this Part
p.(None): of the Bill in terms of ensuring that a decision by a National REC to grant ethical approval cannot be revisited by
p.(None): institutions or other RECs.
p.(None):
p.(None):
p.(None): Head 26 Appeals Panel
p.(None):
p.(None): (1) The Minister shall, subject to the provisions of this head, establish an appeals panel to hear appeals from the
p.(None): decisions of a National REC under this Part.
p.(None): (2) The provisions of subheads (4) to (7) of head 16 shall apply, as appropriate, to the appointment of persons to an
p.(None): appeals panel.
p.(None): (3) An appeals panel established under subhead (1) shall consist of 7 persons, one of whom shall be appointed by the
p.(None): Minister to be the chairperson and another to be the deputy chairperson, who in the opinion of the Minister and having
p.(None): regard to the functions of the appeals panel are suitably qualified in terms of diversity of skills, qualifications,
p.(None): interests and backgrounds to make decisions on appeals likely to be made under head 27.
p.(None): (3) At least two of the members of an appeals panel shall be lay persons.
p.(None):
p.(None): (4) None of the persons appointed to an appeals panel to hear an appeal shall have been a member of the National REC
p.(None): against which the appeal is made.
p.(None): (5) An appeal panel shall determine its own procedure.
p.(None):
p.(None): (6) An appeal made under subhead (1) shall be considered by an appeals panel within 40 days or such other period that
p.(None): may be set out in a national or European Union enactment in relation to the type of research concerned.
p.(None): (7) Having considered an appeal under this head the appeal panel shall—
p.(None):
p.(None): (a) confirm the decision,
p.(None):
p.(None): (b) vary the decision, or
p.(None):
p.(None): (c) allow the appeal,
p.(None):
p.(None): and shall notify the appellant and the National Office of the decision and the reasons for the decision.
p.(None): (8) The National Office shall provide such administrative and other support as is necessary for the appeal panel to
p.(None): perform its functions under this head in an efficient and effective manner.
p.(None): (9) There may be paid by the National Office to the members of an appeals panel such allowances in respect of
p.(None): reasonable expenses properly incurred by them in the performance of their duties and responsibilities.
p.(None): (10) (a) An appeal on a point of law may be made by the appellant from a decision of the appeals panel to the Circuit
p.(None): Court within 30 days of having being notified of the decision.
p.(None): (b) The person making the appeal under subhead 10 (a) shall inform the National Office that an appeal has been made.
p.(None): Explanatory Note
p.(None):
p.(None): In the interests of fairness, there needs to be an appeals process where an application for ethical approval is refused
p.(None): by a National REC. This head provides the mechanism –an appeals panel- and head 27 sets out the appeals procedure and
p.(None): decision making process. The head also provides, again in the interests of fairness, that an appeal, on a point of
p.(None): law, may be made to the Circuit Court from a decision of the appeals panel.
p.(None):
p.(None):
p.(None): Head 27 Appeal from a decision under Head 23
p.(None):
p.(None): Provide that-
p.(None):
p.(None): (1) An application for an appeal to an appeals panel established under head 26 shall be made to the National Office-
...
Social / education
Searching for indicator educational:
(return to top)
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): NATIONAL RESEARCH ETHICS COMMITTEES BILL GENERAL SCHEME
p.(None): July 2019
p.(None):
p.(None): NATIONAL RESEARCH ETHICS COMMITTEES BILL DRAFT GENERAL SCHEME
p.(None):
p.(None): Part 1: Preliminary and General
p.(None):
p.(None): 1. Short Title and commencement
p.(None):
p.(None): 2. Interpretation
p.(None):
p.(None): 3. Regulations
p.(None):
p.(None): 4. Expenses
p.(None):
p.(None): 5. Review
p.(None):
p.(None):
p.(None): Part 2: National Office for Research Ethics Committees
p.(None):
p.(None): 6. Establishment of the National Office
p.(None):
p.(None): 7. Governance of National Office
p.(None):
p.(None):
p.(None): Part 3: Functions of National Research Ethics Committees Office
p.(None):
p.(None): 8. Functions of National Office
p.(None):
p.(None): 9. Information on the internet in relation to National Office
p.(None):
p.(None): 10. Development and support of National RECs
p.(None):
p.(None): 11. Preparation and issuing of Guidelines
p.(None):
p.(None): 12. Monitoring and oversight by National Office of National RECs
p.(None):
p.(None): 13. Monitoring and oversight by National Office of health research approved under Part 4.
p.(None):
p.(None): 14. Advice, educational outreach and training for RECs
p.(None):
p.(None):
p.(None): Part 4: National Research Ethics Committees
p.(None):
p.(None): Head 15 Establishment of National REC Head 16 Membership of National RECs Head 17: Sub-committees of National RECs
p.(None):
p.(None): Head 18 Functions of National RECs
p.(None):
p.(None):
p.(None): Part 5: Applications to and Decisions of National RECs
p.(None):
p.(None): Head 19 Application to National Office for referral of health research proposal to National REC
p.(None): Head 20 Proposals for health research to which this Act applies Head 21 Consultations by National RECs
p.(None): Head 22 Ethical matters to be considered by National REC Head 23 Decisions on applications
p.(None): Head 24 Notification of acceptance of decision or intention to appeal Head 25 Effect of approval
p.(None): Head 26 Appeals Panel
p.(None):
p.(None): Head 27 Application for an appeal from a decision under Head 23
p.(None):
p.(None):
p.(None): Part 6: Offences
p.(None):
p.(None): Head 28 False or misleading statements Head 29 Offences by bodies corporate Head 30 Hearing of proceedings
p.(None): Head 31 Proceedings for offences
p.(None):
p.(None): Head 32 Destruction, erasure or forfeiture of material and data
p.(None):
p.(None):
p.(None): Part 7: Miscellaneous
p.(None):
p.(None): Head 33 No requirement to provide personal data
p.(None):
p.(None): Head 34 Complaint to National Office about a National REC
p.(None):
p.(None): Head 35 Complaint about the ethical conduct of a person carrying out research Head 36 Annual Report
p.(None): Head 37 Power of National Office to specify documents
p.(None):
p.(None): Head 38 Power of National Office to extend time Head 39 Fees
...
p.(None): Helsinki - Ethical Principles for Medical Research Involving Human Subjects) which states that
p.(None): “The [research ethics] committee must have the right to monitor ongoing studies. The researcher must provide
p.(None): monitoring information to the committee, especially information about any serious adverse events. No
p.(None): amendment to the protocol may be made without consideration and approval by the committee. After the end of
p.(None): the study, the researchers must submit a final report to the committee containing a summary of the study’s
p.(None): findings and conclusions.”
p.(None): It is considered that the National Office with its full time staff is better suited to the monitoring
p.(None): process than the part-time National REC that gave the ethical approval under Part 5.
p.(None): For the purposes of being effective, the National Office will have certain powers to request information and reports
p.(None): and a failure by a National REC to co-operate with the National Office may lead to the ethical approval granted under
p.(None): Part 5 being withdrawn.
p.(None): The provisions in subheads (4) and (5) place an onus on a person whose research proposal has been approved under Part 5
p.(None): to notify the National Office in writing of any proposed change in a material fact or of a material circumstance which
p.(None): relates to the carrying out of the health research concerned. Similarly with adverse events that arise from or are
p.(None): connected with the carrying out of the health research concerned. A failure to comply with those requirements may lead
p.(None): to ethical approval being withdrawn by the National REC.
p.(None):
p.(None):
p.(None): Head 14: Advice, educational outreach and training for RECs Provide that-
p.(None): The National Office may-
p.(None):
p.(None): (a) in relation to National RECs provide such advice and training as it considers appropriate for such
p.(None): committees in the performance of their functions, and
p.(None): (b) in relation to research ethics committees that are not approved research committees under
p.(None): this Act, provide educational outreach and training as the National Office considers appropriate for the
p.(None): promotion, maintenance and development of health research ethics in the State.
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This Head is about allowing the National Office to provide advice and training to National RECs and educational
p.(None): outreach and training to other research ethics committees with a view to raising the overall operational and
p.(None): decision-making quality of all RECs operating in the State. This is a necessary and desirable provision given that
p.(None): local/ institutional RECs will remain part of the overall REC framework in Ireland.
p.(None):
p.(None):
p.(None): Part 4: National Research Ethics Committees Head 15 Establishment of National Research Ethics Committees
p.(None): (1) A National REC is a research ethics committee established, with the approval of the Minister after he or she has
p.(None): consulted with the Board, by the Head of the National Office, for the purposes of giving an ethical decision with
p.(None): effect throughout the State on proposals for health research transmitted to it by the National Office under head 19.
p.(None): (2) The Minister shall prescribe the descriptions, categories or types of health research that may be considered under
p.(None): Part 5 by a National REC.
p.(None): (3) The Head of the National Office shall in establishing a National REC under subhead (1) have regard to ensuring that
p.(None): there are so many National RECs as he or she considers necessary and appropriate for-
p.(None): (a) the proper consideration of different descriptions, categories or types of health research that have been
p.(None): prescribed by the Minister for the purposes of this Act to be considered by a National REC, and
p.(None): (b) the efficient and effective consideration of proposals likely to be considered by the National RECs.
p.(None): (4) The Minster may, after consulting with the Board, direct the Head of the National Office to establish a National
...
Social / employees
Searching for indicator employees:
(return to top)
p.(None): it is worth noting that the Minister will be concerned to ensure from the outset that the new framework is embedded
p.(None): quickly.
p.(None):
p.(None):
p.(None): Part 2: National Office for Research Ethics Committees Head 6 Establishment of the National Office
p.(None): Provide that-
p.(None):
p.(None): (1) The National Office for Research Ethics Committees is established as a statutory office within the Board.
p.(None): (2) The National Office shall be headed by a person, known in this Act as the Head of the National Office, appointed by
p.(None): the Board and shall hold office and be paid such remuneration and any allowances for expenses that the Board
p.(None): may determine with the approval of the Minister given with the consent of the Minister for Public Expenditure and
p.(None): Reform.
p.(None): (3) The Board may dismiss the Head of the National Office from his or her office if satisfied that the Head of the
p.(None): National Office-
p.(None): (a) has become incapable through ill health of effectively performing the functions of the office,
p.(None): (b) is adjudicated bankrupt,
p.(None):
p.(None): (c) is convicted of a criminal offence,
p.(None):
p.(None): (d) has without reasonable excuse failed to discharge his or her functions for a continuous period of 3
p.(None): months beginning not earlier than 6 months before the day of dismissal, or
p.(None): (e) should be dismissed for any other stated reason.
p.(None):
p.(None): (4) The other employees of the National Office shall also be employees of the Board which shall determine their
p.(None): conditions of employment and duties and they shall report to the Head of the National Office in relation to the
p.(None): performance of those duties.
p.(None): Explanatory Note
p.(None):
p.(None): In terms of providing a “home” for the new National Office, the Minister has considered that creating a new statutory
p.(None): body for that purpose should only be proposed if existing bodies cannot be adapted and utilised. Conscious generally
p.(None): of limited resources, it is proposed that the National REC Office should be located as a statutory office (with
p.(None): specified functions as set out in the Bill) within the Health Research Board (HRB) in a way broadly similar to that of
p.(None): the Office of the Chief Inspector of Social Services within HIQA under the Health Act 2007.
p.(None): The National Office rather than the Health Research Board will be responsible for the National RECs and the Board will
p.(None): have no role whatsoever in applications coming before the National RECs or appeals made to the Appeals Panel. Further,
p.(None): it will be the Minister who
p.(None):
p.(None): appoints the members of the National RECs (see Head 16) and approves the Corporate Plan and Business Plan of the
p.(None): National Office (see Head 7).
p.(None): The employees of the National Office will be employees of the Board and the Board will provide an operational
p.(None): infrastructure for the National Office and have a related operational oversight (as per head 7).
p.(None): That approach will avoid potential conflict of interest possibilities that might arise from the HRBs other functions as
p.(None): the Office will be distinct from the funding side of the HRB. This approach also helps build on the existing
p.(None): well-established Health Research Board brand and expertise.
p.(None):
p.(None):
p.(None): Head 7 Governance of National Office Provide that-
p.(None): (1) The Board shall be responsible for providing infrastructural support and routine operational oversight of the
p.(None): National Office established under this Act.
p.(None): (2) Where the Board is concerned about any matter of infrastructural support or routine operational oversight
p.(None): concerning the National Office it shall investigate or cause the matter to be investigated and prepare and forward a
p.(None): report to the Minister on the findings from the investigations with recommendations, if any, for actions to be taken.
p.(None): (3) The Minister, where he or she considers it necessary for maintaining public confidence in the National Office, may
p.(None): investigate or otherwise arrange for the investigation of the National Office.
p.(None): Explanatory Note
p.(None):
p.(None): This head provides that the Health Research Board is responsible for providing infrastructural support and routine
p.(None): operational oversight of the National Office. Where the Board is concerned about any matter of
p.(None): infrastructural support or routine operational oversight concerning the National Office, it can investigate
p.(None): the matter and forward a report to the Minister on the findings from the investigations with
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): examination of the matters referred to in Head 22 be done.
p.(None): (2) Where an institution or research ethics committee referred to in subhead (1) makes a request or imposes a
p.(None): requirement of the nature specified in subhead (1), the person whose research has been approved under Head 23 or Head
p.(None): 27 shall notify the National Office of the request or the requirement.
p.(None): (3) Upon receipt of a notification under subhead (2), the National Office shall write to the institution or research
p.(None): ethics committee concerned and the institution or research ethics committee shall co-operate with any request for
p.(None): information made by the National Office under this subhead.
p.(None): Explanatory Note
p.(None):
p.(None): This Head is very important to the success of the ethical approval structure provided for under this Part
p.(None): of the Bill in terms of ensuring that a decision by a National REC to grant ethical approval cannot be revisited by
p.(None): institutions or other RECs.
p.(None):
p.(None):
p.(None): Head 26 Appeals Panel
p.(None):
p.(None): (1) The Minister shall, subject to the provisions of this head, establish an appeals panel to hear appeals from the
p.(None): decisions of a National REC under this Part.
p.(None): (2) The provisions of subheads (4) to (7) of head 16 shall apply, as appropriate, to the appointment of persons to an
p.(None): appeals panel.
p.(None): (3) An appeals panel established under subhead (1) shall consist of 7 persons, one of whom shall be appointed by the
p.(None): Minister to be the chairperson and another to be the deputy chairperson, who in the opinion of the Minister and having
p.(None): regard to the functions of the appeals panel are suitably qualified in terms of diversity of skills, qualifications,
p.(None): interests and backgrounds to make decisions on appeals likely to be made under head 27.
p.(None): (3) At least two of the members of an appeals panel shall be lay persons.
p.(None):
p.(None): (4) None of the persons appointed to an appeals panel to hear an appeal shall have been a member of the National REC
p.(None): against which the appeal is made.
p.(None): (5) An appeal panel shall determine its own procedure.
p.(None):
p.(None): (6) An appeal made under subhead (1) shall be considered by an appeals panel within 40 days or such other period that
p.(None): may be set out in a national or European Union enactment in relation to the type of research concerned.
p.(None): (7) Having considered an appeal under this head the appeal panel shall—
p.(None):
p.(None): (a) confirm the decision,
p.(None):
p.(None): (b) vary the decision, or
p.(None):
p.(None): (c) allow the appeal,
p.(None):
p.(None): and shall notify the appellant and the National Office of the decision and the reasons for the decision.
p.(None): (8) The National Office shall provide such administrative and other support as is necessary for the appeal panel to
p.(None): perform its functions under this head in an efficient and effective manner.
p.(None): (9) There may be paid by the National Office to the members of an appeals panel such allowances in respect of
p.(None): reasonable expenses properly incurred by them in the performance of their duties and responsibilities.
p.(None): (10) (a) An appeal on a point of law may be made by the appellant from a decision of the appeals panel to the Circuit
p.(None): Court within 30 days of having being notified of the decision.
...
p.(None): an application for a consent declaration to the Health Research Consent Declaration Committee established by the
p.(None): Minister under the Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018 (Statutory Instrument
p.(None): Number 314
p.(None): of 2018).
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): As consent is a very significant ethical issue, it is considered important that where it is not intended to seek
p.(None): consent for the processing of personal data for health research and to seek instead a consent declaration under the
p.(None): Health Research Regulations (SI 314 of 2018) that that matter is highlighted in the application made under head 19.
p.(None): It may well also be that the Consent Declaration Committee which makes such declarations may become part of the
p.(None): National REC framework at some future date (as an integrated regulatory research infrastructure and accompanying
p.(None): application process is developed) and this head is considered useful in that regard.
p.(None):
p.(None):
p.(None): SCHEDULE
p.(None):
p.(None): MEMBERSHIP AND OPERATION OF NATIONAL RESEARCH ETHICS COMMITTEE
p.(None):
p.(None):
p.(None): Membership
p.(None):
p.(None): 1. (1) A National REC shall consist of expert and lay persons who in the opinion of the Minister and having regard to
p.(None): the functions of the National REC are suitably qualified in terms of diversity of skills, qualifications, interests and
p.(None): backgrounds to make decisions on applications likely to be made to the National REC.
p.(None): (2) A person is not eligible for appointment as a member of a National REC if the person is not a fit and proper
p.(None): person.
p.(None): 2. (1) A National REC shall have not fewer than 11 persons and not more than 21 persons, including a chairperson and 2
p.(None): deputy chairpersons and at least one quarter of members shall be lay members.
p.(None): (2) The chairperson, deputy chairpersons and ordinary members of the National REC shall be appointed by the Minister.
p.(None): (3) (a) The chairperson and the deputy chairpersons of a National REC shall each hold office for the period of 4 years
p.(None): from the date of his or her appointment.
p.(None): (b) An ordinary member of the National REC shall hold office for the period of 3 years from the date of his or her
p.(None): appointment.
p.(None): (4) A member of the National REC whose term of office expires by the efflux of time shall be eligible for reappointment
p.(None): to the National REC.
p.(None): (5) A person who is reappointed to the National REC in accordance with paragraph (5) shall not hold office for more
p.(None): than 2 consecutive terms.
p.(None): 3. (1) A member of the National REC may resign by written notice of resignation signed by him or her to the Minister
p.(None): and the resignation shall take effect on the date of the National REC meeting next held after written notice of
p.(None): resignation is received by the Minister.
p.(None): (2) The Minister may at any time remove from office a member of the National REC if, in the Minister’s opinion—
p.(None): (a) the member has become incapable through ill-health of performing his or her functions,
p.(None): (b) the member has committed stated misbehaviour of a type that would make him or her unsuitable for membership of the
p.(None): National REC,
p.(None):
p.(None): (c) the removal of the member appears to the Minister to be necessary for the National REC to perform its functions
p.(None): effectively and with public confidence.
p.(None): (3) If a casual vacancy occurs among the members, the Minister shall appoint a person to fill the vacancy and the
p.(None): person so appointed shall hold office for that period of the term of office of the member who occasioned the casual
p.(None): vacancy concerned that remains unexpired at the date of his or her appointment or such other period not exceeding 3
p.(None): years as the Minister may specify.
p.(None): Meetings
p.(None):
p.(None): 4. (1) The quorum for a meeting of the National REC shall be 7, and at least one of those present shall be the
p.(None): chairperson or a deputy chairperson.
p.(None): (2) Subject to subparagraph (1), the proceedings of the National REC shall not be invalidated by any vacancy among its
p.(None): members.
p.(None): 5. (1) The chairperson or, in the absence of the chairperson, a deputy chairperson of the National REC, shall convene a
p.(None): meeting of the National REC as
p.(None): (a) required to efficiently and effectively dispatch the work of the National REC in terms of proposals referred to it,
p.(None): or
p.(None): (b) requested by the Head of the National Office.
p.(None):
p.(None): (2) At least 5 working days before a meeting of the National REC, a notice in writing, signed by or on behalf of the
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): includes action taken to establish whether an individual may be suitable for inclusion in the research;
p.(None): lay member”, in relation to a National REC, means a member of the committee who is not an expert member;
p.(None):
p.(None): "member", in relation to an National REC, means a person who is appointed to the committee in accordance with Head 16
p.(None): and the Schedule;
p.(None): “Minister” means the Minister for Health;
p.(None):
p.(None): “National Office” means the Office of National Research Ethics Committees established under Head 6;
p.(None): “National REC” means a National Research Ethics Committee established under Head 15.
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This head sets out the key definitions. The most important of which is the wide-ranging definition of health research
p.(None): which is drawn from the definition used in the Health Research Regulations (SI 314 of 2018) which itself is based on
p.(None): the definition that is applicable to the Health Research Board.
p.(None): The other key definitions relate to the (new) National Research Ethics Committees (see Part 4 and 5) which will make
p.(None): decisions on the ethical dimension of health research projects that come to them and the (also new) National Office for
p.(None): Research Ethics Committees (see Parts 2 and 3) which will support, develop and oversee the new national REC framework.
p.(None): The National Office will be located as a separate statutory office within the Health Research Board. This is based on
p.(None): Part 7 of the Health Act 2007. That Act established the Health Information and Quality Authority and Part 7
p.(None): established the Office of the Chief Inspector of Social Services as a distinct statutory office within the Authority.
p.(None): In order to ensure the independence of the National RECs and avoid potential conflicts of interests, the role of the
p.(None): Health Research Board is effectively limited to employing the staff of the National Office and related general
p.(None): operational oversight of the National Office. The Board will have no role in relation to the work of the National RECs
p.(None): or decisions made by the National RECs (or the Appeals Panels set up to hear appeals from decisions of the National
p.(None): RECs). The Minister will appoint the members of the National REC and the Appeals Panels. The National Office will
p.(None): prepare its Corporate Plan and Business Plan for approval by the Minister and establish National RECs with the approval
p.(None): of the Minister. These matters are addressed fully in Parts 2, 3, 4 and 5.
p.(None): The right membership, in terms of skills, expertise and general backgrounds, of the new National RECs will be essential
p.(None): to their success. Given the nature of the work of health research ethics committees and the matters they consider it
p.(None): is a longstanding principle that the composition of such committees should be made up of expert and lay members.
p.(None): Accordingly, one important element of all research ethics committees is that they should be broadly based in terms of
p.(None): membership. There has always been a difficulty in recruiting lay members. That difficulty can be compounded by having
p.(None): an over-expansive definition of “expert member” especially today where so many people have academic or professional
p.(None): qualifications. For example, should a person with a legal qualification be best regarded as an
p.(None):
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.(None): and different classes of persons.
p.(None): (3) Fees forwarded under this head shall be regarded as reducing the income of the National Office.
p.(None): (4) The National Office may recover, as a simple contract debt in any court of competent jurisdiction, from the person
p.(None): by whom it is payable any amount due and owing to it as a result of a fee payable under this Part.
p.(None): Explanatory Note
p.(None):
p.(None): While it is not intended that a researcher making an application to have his or her research project considered by a
p.(None): National REC under this Act will have to pay a fee, it is nonetheless considered prudent to have that possibility
p.(None): provided for in the Act. Further, the head provides that different fees may be payable in relation to
p.(None): different areas of research or by different classes of persons. This could, for example, be used where the
p.(None): application is made by a not for profit applicant. It is likely that a fee may be payable in relation to an appeal
p.(None): against the decision of a National REC but refunded where the appeal is successful.
p.(None):
p.(None):
p.(None): Head 40 Prohibition on seeking or receiving payments or benefits Provide that-
p.(None): (1) No member of a National REC or an appeal panel may seek or receive any payment, fee, financial or other benefit
p.(None): from a person in respect of any application or appeal made under Part 5.
p.(None):
p.(None): (2) Where a member of a National REC or appeal panel receives any payment, fee, financial or other benefit from a
p.(None): person in respect of any application or appeal under Part 5 he or she shall return it to the person concerned and
p.(None): advise the National Office accordingly.
p.(None): Explanatory Note
p.(None):
p.(None): This head is intended to ensure that no undue influence is exercised on members of National RECs or appeal panela and
p.(None): that where such influence is sought to be brought to bear that it is reported to the National Office.
p.(None):
p.(None):
p.(None): Head 41 Application for Consent Declaration Provide that-
p.(None): A person making an application under head 19 shall indicate, as part of the application, whether it is intended to make
p.(None): an application for a consent declaration to the Health Research Consent Declaration Committee established by the
p.(None): Minister under the Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018 (Statutory Instrument
p.(None): Number 314
p.(None): of 2018).
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): As consent is a very significant ethical issue, it is considered important that where it is not intended to seek
p.(None): consent for the processing of personal data for health research and to seek instead a consent declaration under the
p.(None): Health Research Regulations (SI 314 of 2018) that that matter is highlighted in the application made under head 19.
p.(None): It may well also be that the Consent Declaration Committee which makes such declarations may become part of the
p.(None): National REC framework at some future date (as an integrated regulatory research infrastructure and accompanying
...
Orphaned Trigger Words
p.(None):
p.(None): Head 18 Functions of National RECs
p.(None):
p.(None):
p.(None): Part 5: Applications to and Decisions of National RECs
p.(None):
p.(None): Head 19 Application to National Office for referral of health research proposal to National REC
p.(None): Head 20 Proposals for health research to which this Act applies Head 21 Consultations by National RECs
p.(None): Head 22 Ethical matters to be considered by National REC Head 23 Decisions on applications
p.(None): Head 24 Notification of acceptance of decision or intention to appeal Head 25 Effect of approval
p.(None): Head 26 Appeals Panel
p.(None):
p.(None): Head 27 Application for an appeal from a decision under Head 23
p.(None):
p.(None):
p.(None): Part 6: Offences
p.(None):
p.(None): Head 28 False or misleading statements Head 29 Offences by bodies corporate Head 30 Hearing of proceedings
p.(None): Head 31 Proceedings for offences
p.(None):
p.(None): Head 32 Destruction, erasure or forfeiture of material and data
p.(None):
p.(None):
p.(None): Part 7: Miscellaneous
p.(None):
p.(None): Head 33 No requirement to provide personal data
p.(None):
p.(None): Head 34 Complaint to National Office about a National REC
p.(None):
p.(None): Head 35 Complaint about the ethical conduct of a person carrying out research Head 36 Annual Report
p.(None): Head 37 Power of National Office to specify documents
p.(None):
p.(None): Head 38 Power of National Office to extend time Head 39 Fees
p.(None): Head 40 Prohibition on receiving payment or benefit Head 41 Application for Consent Declaration
p.(None):
p.(None):
p.(None): Part 1: Preliminary and General
p.(None):
p.(None): Head 1
p.(None):
p.(None): Short title and commencement Provide that-
p.(None): 1. (1) This Act may be cited as the National Research Ethics Committees Act 2019.
p.(None):
p.(None): (2) This Act shall come into operation on such day or days as may be appointed by order or orders made by the Minister,
p.(None): either generally or with reference to a particular purpose or provision, and different days may be so appointed for
p.(None): different purposes and different provisions.
p.(None): Explanatory Note
p.(None):
p.(None): This is a standard provision providing for the short title of the Act and commencement provisions.
p.(None): General Note
p.(None):
p.(None): It is important to note at the outset of reading this General Scheme that a particular legislative approach is being
p.(None): adopted to bring about the desired outcome of a unified National Research Ethics Committee framework for all health
p.(None): research.
p.(None): Given the need for urgent reform of the current REC system for clinical trials of medicinal products and the need to be
p.(None): ready for the full entry into force of the new EU Clinical Trials of Medicinal Product Regulation 2014, it will be
p.(None): necessary to set up the National Clinical Trials of Medicinal Products REC as soon as possible. That will be done by
p.(None): amending the current statutory instrument (SI no 190 of 2004) and future proofing it against the Regulation.
p.(None): This National Research Ethics Committee Bill provides for the establishment of all other National RECs.
p.(None): The same National Office for Research Ethics Committee will be responsible for all of the National RECs.
p.(None): This approach is designed to ensure consistency between all National RECs in all relevant matters except where, for
p.(None): example, the Clinical Trials Regulation provide specifically for something to be done in particular way
p.(None): or by a particular date –for example, timelines in relation to making decisions or the making of
p.(None): applications through the Clinical Trials Information System.
p.(None):
p.(None): Head 2 Interpretation Provide that-
p.(None): “appeals panel” means a panel established under head 26;
p.(None):
p.(None): “Board” means the Health Research Board;
p.(None):
p.(None): “expert member”, in relation to an National REC, means a member of the committee who–
p.(None):
p.(None): (a) is a practising or retired health practitioner,
p.(None):
p.(None): (b) has qualifications or experience relating to the conduct of health research (other than as a member of a research
p.(None): ethics committee),
p.(None): (c) has qualifications or experience in the area of ethics, or
p.(None):
p.(None): (d) belongs to a class or category of persons prescribed by the Minister for the purposes of this definition for the
p.(None): purpose of membership of a particular National REC;
p.(None): “health research” means any of the following types of scientific research for the purpose of human health:
p.(None): (i) research with the goal of understanding normal and abnormal functioning, at molecular, cellular, organ system and
p.(None): whole body levels;
p.(None): (ii) research that is specifically concerned with innovative strategies, devices, products or services for the
p.(None): diagnosis, treatment or prevention of human disease or injury;
p.(None): (iii) research with the goal of improving the diagnosis and treatment (including the rehabilitation and palliation) of
p.(None): human disease and injury and of improving the health and quality of life of individuals;
p.(None): (iv) research with the goal of improving the efficiency and effectiveness of health professionals and the health care
p.(None): system;
p.(None): (v) research with the goal of improving the health of the population as a whole or any part of the population through a
p.(None): better understanding of the ways in which social, cultural, environmental, occupational and economic factors determine
p.(None): health status; and
p.(None): includes action taken to establish whether an individual may be suitable for inclusion in the research;
p.(None): lay member”, in relation to a National REC, means a member of the committee who is not an expert member;
p.(None):
p.(None): "member", in relation to an National REC, means a person who is appointed to the committee in accordance with Head 16
p.(None): and the Schedule;
p.(None): “Minister” means the Minister for Health;
p.(None):
p.(None): “National Office” means the Office of National Research Ethics Committees established under Head 6;
p.(None): “National REC” means a National Research Ethics Committee established under Head 15.
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This head sets out the key definitions. The most important of which is the wide-ranging definition of health research
p.(None): which is drawn from the definition used in the Health Research Regulations (SI 314 of 2018) which itself is based on
p.(None): the definition that is applicable to the Health Research Board.
p.(None): The other key definitions relate to the (new) National Research Ethics Committees (see Part 4 and 5) which will make
p.(None): decisions on the ethical dimension of health research projects that come to them and the (also new) National Office for
p.(None): Research Ethics Committees (see Parts 2 and 3) which will support, develop and oversee the new national REC framework.
p.(None): The National Office will be located as a separate statutory office within the Health Research Board. This is based on
...
p.(None):
p.(None):
p.(None): Head 17 Sub-committees of National RECs Provide that-
p.(None): (1) A National REC may appoint, after advising the National Office, one or more sub- committees to provide advice and
p.(None): assistance to it with its work.
p.(None): (2) The acts of a sub-committee are subject to confirmation by the National REC unless the National REC dispenses with
p.(None): the necessity for confirmation.
p.(None): (3) A National REC may, at any time, dissolve a sub-committee.
p.(None):
p.(None): (4) A decision under Part 5 may not be made by a sub-committee of a National REC.
p.(None):
p.(None): Explanatory Note
p.(None):
p.(None): This Head deals with sub-committees which may be appointed by a National REC to help it with its work. As per subhead
p.(None): (2), the acts of the sub-committee are subject to confirmation by the committee unless the committee decides the
p.(None): confirmation is not necessary. Subhead
p.(None): (3) states that the committee may at any time dissolve a sub-committee. This may be appropriate if the
p.(None): purpose for which the sub-committee was set up is no longer required.
p.(None): Subhead (4) makes it expressly clear that a sub-committee is not empowered to make a decision on any
p.(None): matter arising for decision under Part 5.
p.(None):
p.(None):
p.(None): Head 18 Functions of National RECs Provide that-
p.(None): The functions of a National REC are those set out in Part 5 and include such incidental, supplementary and
p.(None): consequential actions as are necessary or expedient for the purposes of carrying out those functions.
p.(None): Explanatory Note
p.(None):
p.(None): This is a self-explanatory provision. For clarity, the specific functions of National RECs are set out in Part 5.
p.(None):
p.(None):
p.(None): Part 5: Applications to and decisions of National Research Ethics Committees
p.(None):
p.(None): Head 19 Application to National Office for referral of a research proposal to a National REC
p.(None): Provide that-
p.(None):
p.(None): (1) A person proposing to carry out health research to which this Act applies may apply to the National Office for his
p.(None): or her proposal to be considered by a National REC for a decision on the ethics of the proposed research.
p.(None): (2) An application under subhead (1) shall be-
p.(None):
p.(None): (a) made in the form and manner specified by the National Office, and
p.(None):
p.(None): (b) accompanied by the prescribed fee, if any.
p.(None):
p.(None): (3) The National Office shall, as a preliminary matter, decide whether the proposal is-
p.(None):
p.(None): (a) one to which this Act applies, or
p.(None):
p.(None): (b) one to which this Act does not apply, and shall notify the applicant accordingly.
p.(None): (4) The National Office shall put in place such procedures as it considers appropriate to facilitate the transmission
p.(None): of a proposal for consideration by a national REC.
p.(None): (5) A National REC may only consider proposals that the National Office has transmitted to it under subhead (4) or that
p.(None): another national or EU enactment provides for it to consider.
p.(None): Explanatory Note
p.(None):
p.(None): This head sets out the procedure for a person making an application to the National Office for his or her proposal to
p.(None): be considered by a National REC for a decision on the ethics of the health research.
p.(None): To ensure uniformity in applications, they must be made in the form and manner specified by the National Office and
p.(None): accompanied by the prescribed fee, if any.
p.(None): When an application is received by the National Office, the Office must as a preliminary matter, decide whether the
p.(None): proposal is one to which this Act applies or not, as the case may be. This is covered in Head 19. Where it decides
p.(None): the proposed research does not fall under the Act, it must advise the applicant of that fact.
p.(None): It is the National Office that will forward the application to an appropriate National REC for consideration. For
p.(None): example, if the area of research is genomics and a specialist genomic
p.(None):
p.(None): National REC has been established then the National office will forward the application to that National REC.
p.(None): A National REC may only consider proposals that the National Office has transmitted to it under this head.
p.(None):
p.(None):
p.(None): Head 20 Proposals for health research to which this Act applies Provide that-
p.(None): The National Office shall specify on its website, health research prescribed by the Minister under head 15, in relation
p.(None): to which applications can be made under Head 19.
p.(None): Explanatory Note
p.(None):
p.(None): Given the number of health research projects undertaken in the State every year, it is important that the National RECs
p.(None): are not overwhelmed with applications and that has been addressed in head 15. This information head requires the
p.(None): National Office to set out publicly on its website health research in relation to which applications can be made for
p.(None): consideration by National RECs.
p.(None):
p.(None):
p.(None): Head 21 Consultation by a National REC Provide that-
...
p.(None): Where the decision is to refuse ethical approval to the health research concerned, the applicant must be provided with
p.(None): the reasons for the refusal and be informed that an appeal can be made.
p.(None):
p.(None):
p.(None): Head 24 Notification of acceptance of decision or intention to appeal a decision Provide that-
p.(None): Where a person who has been notified of a decision under Head 24, he or she shall notify the National REC that made the
p.(None): decision, in writing, not later than 10 days after the notification is sent, that he or she-
p.(None): (a) accepts the decision,
p.(None):
p.(None): (b) does not accept the decision but does not intend either to appeal it under Head 27
p.(None): or make a complaint under Head 34, or
p.(None):
p.(None): (c) does not accept the decision and intends either to appeal it under Head 27 or make a complaint under Head 34.
p.(None): Explanatory Note
p.(None):
p.(None): Where a person has been notified of a decision that his or her proposal to carry out health research has been ethically
p.(None): approved, with or without conditions, or has not been approved, he or she must notify the National REC, in writing, no
p.(None): later than 10 days after the notification is sent, that he or she-
p.(None): (a) accepts the decision,
p.(None):
p.(None): (b) does not accept the decision but does not intend either to appeal it or make a complaint in
p.(None): relation to the National REC, or
p.(None): (c) does not accept the decision and intends either to appeal it or make a complaint in relation to the National REC.
p.(None):
p.(None): Head 25 Effect of approval under Head 23 or Head 27
p.(None):
p.(None): Provide that-
p.(None):
p.(None): (1) Where a proposal to carry out health research is approved under Head 23 or Head 27 no institution that is in
p.(None): receipt of any funding from the State or research ethics committee established or jointly established by such an
p.(None): institution shall request or require, as a condition of the research being carried out in that institution, that any
p.(None): examination of the matters referred to in Head 22 be done.
p.(None): (2) Where an institution or research ethics committee referred to in subhead (1) makes a request or imposes a
p.(None): requirement of the nature specified in subhead (1), the person whose research has been approved under Head 23 or Head
p.(None): 27 shall notify the National Office of the request or the requirement.
p.(None): (3) Upon receipt of a notification under subhead (2), the National Office shall write to the institution or research
p.(None): ethics committee concerned and the institution or research ethics committee shall co-operate with any request for
p.(None): information made by the National Office under this subhead.
p.(None): Explanatory Note
p.(None):
p.(None): This Head is very important to the success of the ethical approval structure provided for under this Part
p.(None): of the Bill in terms of ensuring that a decision by a National REC to grant ethical approval cannot be revisited by
p.(None): institutions or other RECs.
p.(None):
p.(None):
p.(None): Head 26 Appeals Panel
p.(None):
p.(None): (1) The Minister shall, subject to the provisions of this head, establish an appeals panel to hear appeals from the
p.(None): decisions of a National REC under this Part.
p.(None): (2) The provisions of subheads (4) to (7) of head 16 shall apply, as appropriate, to the appointment of persons to an
p.(None): appeals panel.
p.(None): (3) An appeals panel established under subhead (1) shall consist of 7 persons, one of whom shall be appointed by the
...
p.(None): a member of the National REC, would constitute a failure by him or her to comply with the requirements of subparagraph
p.(None): (3), the question may, subject to subparagraph (6), be determined by the chairperson of the meeting, whose decision
p.(None): shall be final, and where such a question is so determined, particulars of the determination shall be recorded in the
p.(None): minutes of the meeting.
p.(None): (6) Where, at a meeting of the National REC the chairperson of the meeting is the person in respect of whom a matter to
p.(None): which subparagraph (3) applies falls to be determined, the other members of the National REC attending the meeting
p.(None): shall choose one of their number to be chairperson of the meeting for the purposes of subparagraph (5).
p.(None): (7) Where the Minister is satisfied that a member of the National REC has not complied with subparagraph (3), the
p.(None): Minister may remove that member from office and that person shall then be disqualified from being a member of the
p.(None): National REC.
p.(None): Minutes
p.(None):
p.(None): 7. (1) The chairperson of the meeting shall cause proper minutes of each meeting to be prepared which shall be approved
p.(None): by the National REC at the next National REC meeting and, after they are approved, published on the website of the
p.(None): National Office.
p.(None): (2) The names of all members present at a meeting of the National REC shall be recorded in the minutes of the meeting.
p.(None): Payments and Expenses
p.(None):
p.(None): 8. There may be paid by the National Office to the chairperson, deputy chairpersons and the members of the National REC
p.(None): such allowances in respect of reasonable expenses properly incurred by them in the carrying out of their duties and
p.(None): responsibilities as chairperson, deputy chairperson or members with the consent of the Minister for Health and the
p.(None): approval of the Minister for Public Expenditure and Reform.
p.(None):
p.(None): Procedures
p.(None):
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| belief | Religion |
| conviction | Religion |
| criminal | criminal |
| educational | education |
| employees | employees |
| faith | Religion |
| home | Property Ownership |
| ill | ill |
| illness | Physically Disabled |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| influence | Drug Usage |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| prosecuted | Prosecuted |
| undue influence | Undue Influence |
| union | Trade Union Membership |
| unlawful | Illegal Activity |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| belief | ['faith', 'conviction'] |
| conviction | ['faith', 'belief'] |
| faith | ['belief', 'conviction'] |
Trigger Words
capacity
consent
cultural
ethics
protect
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input