The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Ireland
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1 The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Ireland Question 1: What laws or regulations apply to an application for conducting a clinical trial in Ireland? The European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, The Control of Clinical Trials Acts 1987 to 2006 (for any other clinical trials on medicinal products not covered by the above Regulations). No other legislation is involved for other clinical research projects. Question 2: Which government, legal or authoritative body or bodies is or are responsible for the establishment and/or accreditation of (research) ethics committees for IMPs, and for their supervision and quality? Are there different (research) ethics committees reviewing other projects? Ethics committees with the competence to review clinical trials of investigational medicinal products (IMPs) must be recognised by the Ethics Committees Supervisory Body, currently the Minister for Health, who heads the Department of Health and Children. When recognising an ethics committee, the Supervisory Board must specify whether it may act for all areas within the Republic of Ireland and the description or class of clinical trials for which the committee may act. Currently, various different bodies establish these recognised committees, including hospitals, universities, the Irish College of General Practitioners and in two areas the local Health Services Executive. Only ethics committees recognised by the ECSB are authorised to assess clinical trials. For research involving human subjects other than those involving medicinal products there is currently no specific legislation. However, the Department of Enterprise, Trade and Employment has established the Irish Council for Bioethics as a wholly autonomous body that has issued Operational Procedures for Research Ethics Committees: Guidance These guidelines have no statutory status but are generally supported. Ireland - 1
2 The ECSB does not have responsibility for any other ethics committees, but the Guidance issued by the Irish Council for Bioethics (see above) informally applies to all ethics committees reviewing research projects involving human subjects. Question 3: What is the process for achieving clinical trial authorisation from the competent authority in Ireland? The sponsor must apply for clinical trial authorization to the Irish Medicines Board which is the competent authority for Ireland. The website for the Irish Medicines Board is at Question 4: What is the process for obtaining ethical review of a clinical trial protocol by a competent (research) ethics committee in Ireland? The chief investigator must apply for an ethics committee opinion to a single ethics committee recognised by the Ethics Committees Supervisory Board, in writing, accompanied by the details set out in Article 8 of the Directive 2001/20/EC, and the appropriate fee. The list of recognised ethics committees in Ireland is available on: Question 5: Is there a single organisation to which to apply for ethical review of a clinical trial for an investigational medicinal product, regardless of whether this is for a single site or multiple sites? Question 6: What is the website for the organisation that issues guidelines on the ethical review of a clinical trial for an investigational medicinal product? The website, where this information can be found, is at: The standard application form (Form 1) to be used for all applications to an EC, is included within the guidance note available on this site. Question 7: Is there a procedural interaction between the national or local competent authority and the (research) ethics committee during the approval process? Ireland - 2
3 Question 8: Does the application to the REC and to the competent authority have to be submitted in parallel, or, if not, in which order? The applications may be made either sequentially (in either order) or in parallel. Question 9: How many (research) ethics committees are there in Ireland? Thirteen. Question 10: How are RECs funded in Ireland? Do they charge fees? If yes, what is their scale of fees? Funding is provided by the appointing authority (see 2 above) augmented by fees that are payable to the appointing authority as follows: a) For industry-sponsored trials a fee of in connection with each application and a fee of in respect of each trial site to which the application relates. b) For non-industry-sponsored trials, the application fee is reduced to c) Notification of amendments attracts a fee of 200 (industry) or 50 (nonindustry). Question 11: Who is responsible for submitting the request for ethical review to the competent (research) ethics committee for single-site and for multi-site clinical trials? The chief investigator submits the request. This applies to both single-site and multisite trials. Question 12: How is a single opinion achieved for multi-site studies? A single application for ethical review is made to a recognised ethics committee by the chief investigator who, in that single application, will list any other investigator taking part in that clinical trial anywhere in Ireland. No site-specific assessment is carried out by any other body. However, it is still possible for an institution responsible for a site at which a trial is to be conducted, to insist that the trial be reviewed on its behalf before it may be conducted at that site. Question 13: How many members serve on a REC? A maximum of 21, of which at least one third shall be lay members and at least one half of those lay members shall never have been health care professionals. All members may have designated deputies. Ireland - 3
4 Question 14: How many members constitute a quorum? Seven, of which one is the chairperson, one is a lay person who has never been a health care professional or served on or was employed by a health service body, and one is an expert member. Question 15: How are REC members appointed? Members are appointed by the appointing authority (see 2 above) as they see fit and consist of expert members and lay members. The appointment of members is subject to the supervision of the ECSB and the members serve in accordance with the terms of the Regulations and the instrument appointing him or her as a member. Vacancies are not advertised and lay members are difficult to recruit. Question 16: How is the independence of members ensured? There is no statute that directly covers this, but, if asked, the names, professions and any affiliations and interests would be made available and on an ongoing basis is subject to supervision of the ECSB, the recognition of which must be maintained. There are currently no governance arrangements nor standard operating procedures for ethics committees reviewing IMPs, but it is intended that these will be introduced by the Ethics Committees Supervisory Board, through the Department of Health and Children, during Question 17: How are conflicts of interest of REC members avoided? There are no specific statutory requirements for members of ethics committees to declare conflicts of interest but the Guidelines published by the Irish Council for Bioethics state that any conflict of interest should be declared and that any members concerned should withdraw themselves from the discussion. Furthermore, the Code of Practice for the Governance of State Bodies, applies as appropriate to Ethics Committees and their members. Question 18: What backgrounds and/or qualifications of members are actively sought? Clinicians, nurses and pharmacists are normally sought as expert members. In the case of lay members, persons who would be seen as being impartial such as lawyers, or church ministers, are actively sought. Question 19: How do RECs obtain specialist expertise? Committees may co-opt persons with the necessary expertise. Trials involving children will always be reviewed by a committee that includes a paediatrician or has available to it essential advice from a paediatrician. Ireland - 4
5 Question 20: What are the training requirements for members of RECs? None are laid down. Question 21: What training programmes are available for REC members in Ireland? There are none. However, the Irish Council for Bioethics booklet entitled Operational Procedures for Research Ethics Committees: Guidance 2004 is generally available. Question 22: What are the timelines for the assessment of single- and multi-site studies? A recognised ethics committee must complete the single ethical review of any CTIMP within 60 days of receipt of a valid application. This includes the necessary sitespecific assessments. Question 23: How are substantial amendments submitted during the review process dealt with? Substantial amendments to IMPs should be notified in writing, using the European Commission notice of amendment form, to the single recognised ethics committee that originally reviewed the submission, together with the appropriate fee (see 9 above). The ethics committee has 35 days from receipt of the notice of amendment to give an opinion. Where an unfavourable opinion is given on a substantial amendment, the sponsor may submit a modified amendment on which the ethics committee has 14 days to give an opinion. Question 24: How does a REC assess the suitability of investigators and of sites? It is the responsibility of the ethics committee to assess the suitability of investigators and sites as it thinks fit. There is no regulation that covers this, nor is this topic dealt with in the Irish Council on Bioethics Guidance document. Question 25: How are the requirements for (research) ethics committees to review the contractual or financial arrangements in clinical trials for both investigators and hospitals handled? This is not covered. Ireland - 5
6 Question 26: How are the requirements for (research) ethics committees to review the compensation arrangements for study subjects handled? No specific guidance has been issued. Until recently this was a responsibility of the Irish Medicines Board. The Ethics Committees Supervisory Board, through the Department of Health and Children, is considering the issue of guidance on how ethics committees should satisfy themselves that compensation issues have been adequately addressed. Question 27: Is there an ongoing quality assurance process (e.g. audits, inspections, internal SOP) for (research) ethics committees in Ireland? This is not yet in place. It is a condition of recognition that each Committee is subject to an audit of its procedures. Question 28: Is there an appeal mechanism? Question 29: How do RECs deal with SUSAR reports and Annual Safety Reports? These are usually reviewed by or on behalf of the chairpersons and where necessary are brought to the attention of the Committee. Question 30: How are substantial amendments defined? According to the Department of Health and Children substantial amendments are as defined in the regulations. However, these are limited to an amendment to the terms of the application for an ethics committee opinion in relation to the clinical trial; or an amendment to the particulars or documents that accompanied that application. No other definitions are specified. Question 31: What are the indemnity insurance requirements for research projects? Ethics committees are required to ensure that pharmaceutical companies will provide full indemnity cover, either by insurance or other indemnity arrangements. There is a similar requirement for non-industry funded research. Where an investigator holding an appointment in a public hospital carries out such a non-industry trial, an Enterprise Liability scheme exists which provides an indemnity for harm that may be caused during such a clinical trial. Ireland - 6
7 Question 32: What are the indemnity insurance requirements for (research) ethics committee members themselves? The Enterprise Liability scheme (see 31 above) also covers the liability of ethics committee members. Question 33: How is informed consent obtained from vulnerable subjects who are potentially to be involved in a clinical trial? The conditions and principles which apply in relation to an incapacitated adult are set out in Part 5 of Schedule 1 of the 2004 Regulations. The Irish Council on Bioethics document refers to the need for an ethics committee to consider the provisions made for participants incapable of giving consent personally and to consider whether there is clear justification for the intention to include participants who cannot consent and a full account of the arrangements for obtaining consent for the participation of such individuals. Question 34: How do RECs assess the progress and outcome of research projects that they have approved? The chief investigator is generally expected to provide annual progress reports and a summary final report to the ethics committee that originally approved the trial, though this is not laid down in the 2004 Regulations. Question 35: How does the REC ensure reception of the Annual Safety Report and the Summary of the Final Report of a research project that it has approved? It is the responsibility of the sponsor to ensure that annual safety reports are submitted. The ethics committee administrator will issue reminders if annual progress reports or annual safety reports are not submitted, and a reminder letter 12 months after the declaration of the end of the trial if the summary final report has not been received. Question 36: Do national regulations in Ireland allow research on healthy volunteer children (subjects under 16)? Yes. Question 37: Do national regulations in Ireland allow payment, (other than expenses), to children taking part in research? No, other than expenses for attending extra clinic sessions, etc. Ireland - 7
8 Question 38: Do RECs invite or allow a) applicants or b) observers to attend committee meetings? Yes, applicants are specifically invited to attend and observers may occasionally attend. Applicants are required to leave when their case is being considered, and observers must take no part in the decision-making process. Question 39: Are the minutes of (research) ethics committee meetings made public? Question 40: Is there any scope for Chairman s actions in between meetings? Only to assist the Secretary in answering any queries. Question 41: Do (research) ethics committees ever appoint subcommittees for any specific purpose? They might appoint a subcommittee to look at particularly difficult cases, but not for reviewing substantial amendments, etc. But all Irish RECs have their own SOPs, so there is no uniformity of approach. Question 42: Is there a national policy on the registration of clinical trials before they start? Question 43: If the answer to Question 42 is yes, do (research) ethics committees have any role to play in reviewing such registration? N/A Question 44: If the answer to Question 42 is yes, is this register of clinical trials made available to the public? N/A EFGCP May 2011 Ireland - 8
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