Tallaght University Hospital / St. James's Hospital Joint Research Ethics Committee (REC)
Tallaght University Hospital / St. James's Hospital Joint Research Ethics Committee
** The Data Protection Act 2018 came into effect on 25th May 2018 and the Health Research Regulations 2018 came into effect on 8th August 2018. This legislation has important implications for data processing in health research. See below for further details. **
Remit: The Tallaght University Hospital (TUH) / St. James's Hospital (SJH) Joint Research Ethics Committee (REC) provides ethical review of research studies in which patients (and sometimes healthy people) are direct participants or their medical records or biological samples are used (‘clinical study’). The REC also provides ethical review of non-clinical research but this service is generally restricted to research undertaken at TUH/SJH.
The REC does not generally review audit, service development or usual practice projects as such projects are not classified as ‘research’. Approval for audit or service development projects should be discussed with and obtained through the Quality, Safety and Risk Management Directorate. Although a number of features distinguish ‘research’ from ‘audit’ or ‘service development’, the REC pays particular attention to the intent of the project in determining whether a project is classified as ‘research’, as outlined below.
- If the intent of the project is to generate new and/or generalisable knowledge (i.e. for dissemination outside the local organisation), then the project is classified as ‘research’ and ethical approval through the REC is required.
- If the intent of the project is to generate local knowledge (i.e. for dissemination within the local organisation only), then the project is not classified as ‘research’ and ethical approval through the REC is not required.
Some projects may have elements of ‘research’, ‘audit’ and ‘service development’ and the REC can provide advice on whether research ethics approval is required. Any requests to the REC for advice on the need for research ethics approval are expected to be accompanied by a completed standard application form (see below). The NHS Health Research Authority in conjunction with the UK's Medical Research Council have developed a useful tool to help decide if a project is a research, audit, service evaluation or usual practice (available at: http://www.hra-decisiontools.org.uk/research/index.html).
Clinical Trials: The TUH/SJH REC is approved to provide ethical review of clinical trials of medical products as required under European Communities Regulation (S.I. Number 190/2004). These trials may be international and/or multi-site. The trial sponsor may seek approval from any approved REC in the country, of which there are currently twelve, and approval for each site is required from the local CEO/Hospital Manager. A new European Communities Regulation (536/2014) has been adopted and is expected to be implemented during 2019. Further information is available from the Health Products Regulatory Authority (available at: http://www.hpra.ie/homepage/medicines/regulatory-information/clinical-trials).
Membership: The TUH/SJH REC consists of 21 members, both expert and lay members.
- An expert member means a member who:
o is a practising or retired health practitioner;
o has qualifications or experience relating to the conduct of health research;
o has qualifications or experience in the area of ethics, statistics, social sciences, philosophy or theology;
o is a practising or retired barrister or solicitor.
Most expert members are health practitioners working in TUH/SJH.
- A lay member means a member who is not an expert member (i.e. who does not fall into any of the above categories). Lay members are often current or former patients of TUH/SJH.
The current Chairperson is Professor Richard Deane and Deputy Chairperson is Dr Anne-Marie Tobin. Individuals interested in joining the REC as a member are welcome to contact the Chairperson for further information.
The Committee’s Work: The TUH/SJH REC follows the Operational Procedures for RECs Guidance issued by the Irish Council for Bioethics (2004) (available at: https://health.gov.ie/wp-content/uploads/2014/07/Operational_Procedures1.pdf). The full REC meets ten times each year and reviews between eight and ten applications at each meeting.
Expedited Review (Chair’s Action): Applications that do not raise any material ethical issues (i.e. present minimal risk to participants) may be suitable for an ‘Expedited Review’ (also known as a ‘Chair’s Action’). All applications approved by through an expedited review are endorsed by the full REC.
Decisions: The REC issues one of the following decisions in relation to a valid application:
The study is APPROVED (Final Opinion): The study is approved. The applicant may conduct the research as outlined in the application form submitted to the REC.
The study is PROVISIONALLY APPROVED: The study is approved subject to recommended revisions to the application and/or responses to questions posed. The applicant must resubmit any revisions and/or responses to the REC before receiving final approval for the study. No research may be conducted prior to receiving final approval.
A decision on study approval is DEFERRED: The REC requires further information from the applicant and/or referee (expert opinion) before a decision can be reached.
The study is NOT APPROVED (Final Opinion): The REC has not approved the study. The applicant is given a full explanation of the REC’s decision with or without an invitation to resubmit a substantially altered proposal for reconsideration.
Approximately 75% of all applications are either provisionally approved or approved.
Data Protection Regulations: The Data Protection Act 2018 came into effect on 25th May 2018 and the Health Research Regulations 2018 (S.I. No 314 of 2018) came into effect on 8th August 2018. Further information on the implications of this legislation for researchers is available from the Health Research Board (available at: http://www.hrb.ie/funding/gdpr-guidance-for-researchers/).
** Applications where explicit consent of data subjects is not obtained**: The legislation requires that, in general, the explicit consent of a data subject is obtained in order to use the subject’s personal data for research purposes. All research applications where the explicit consent of data subjects is not obtained must, in addition to obtaining research ethics approval from the local REC, apply to a new national ‘Health Research Consent Declaration Committee’ (HRCDC) who must make a consent declaration on behalf of the data subjects before the application can be approved and research can proceed. In order for the consent declaration to be made by the HRCDC the researcher must demonstrate that the public interest in carrying out the research significantly outweighs the public interest in requiring the explicit consent of the data subject. The Health Research Board have created a flow chart to assist researchers in establishing whether a consent declaration application is required (available at: http://www.hrb.ie/fileadmin/user_upload/Decision_Tree_30072018.pdf).
In relation to the requirement to obtain a consent declaration from the national HRCDC for applications where explicit consent of data subjects is not obtained, researchers should note the following:
- Consent ‘waivers’ issued by RECs (under the HSE’s National Consent Policy 2017) are not an alternative to a consent declaration made by the HRCDC. Therefore, the TUH/SJH REC (or any other REC) is not in a position make a consent declaration – this can only be made by the HRCDC.
- Identifiable and pseudonymised data (e.g. data linked by code) is classified as personal data by GDPR and is subject to this requirement. Fully (irrevocably) anonymised data is not classified as personal data and is not subject to this requirement. However, consent is required to process personal data to make the data fully (irrevocably) anonymised and is subject to this requirement.
- All research applications that receive REC approval on or after the 8th August 2018 are subject to this requirement. However, the HRCDC is yet to be established by the Department of Health / Health Research Board, although an assurance has been given that it will be in place by 1st November 2018. It appears from the legislation that local REC approval is required before an application to the HRCDC can be made. However, as the remit of the local REC in such applications is unclear, the TUH/SJH REC is not in a position to approve any such applications until clarification from the Department of Health / Health Research Board is received.
Submission: All applications must consist of a fully complete application form with accompanying documents. There are different application forms for clinical trials and non-clinical trials. All applications submitted on or after 8th August 2018 must use the revised application form, which is available for download below.
- For non-clinical trials, an electronic submission is accepted but be prepared to submit a hard copy of the application on request;
- For clinical trials, an electronic and hard copy must be submitted.
Meeting Dates & Submission Deadlines: The meeting dates for the full TUH/SJH REC are as follows:
- 26th September 2018 (Submission Deadline: 29th August 2018)
- 31st October (REC Training – The REC will not review any applications this month)
- 21st November 2018 (Submission Deadline: 31st October 2018)
- No meeting is held during the month of December
Submissions must be made at least three weeks prior to the meeting date. Applicants should be aware that there is a limit to the number of studies that can be reviewed at each REC meeting and an application may not be considered at the next meeting if capacity has already been reached even if the application has been submitted before the deadline.
Timeline: Applicants should allow a minimum of three months from submission to receiving a final notification (if applicable).
Fees: The fees for an application are as follows:
|Tallaght University Hospital / St James's Hospital Ethical Approval Application Fees|
|Site Fee (per site)||€150|
|Non-Clinical Trial/Research Amendment||€64|
Please note that fees for clinical trials are non-negotiable.
Contact details: firstname.lastname@example.org
Standard Application Form Non Clinical Trial 5.6
Form 1 Clinical Trial Application
Applicant Checklist for a Clinical Trial
Applicant Checklist for a Non Clinical Trial
Form 3 Site Specific Assessment Form
Form 4 Substantial Amendment
form5 Quarterly and Annual Report
Form 6 Declaration of End of Clinical Trial
Payment Information and Instructions
SJH AMNCH REC Non-Clinical Amendment Request Form
Patient Leaflet Template
Patient Consent Template