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The Clinical Research Facility is a dynamic and expanding department dedicated to advancing patient care through excellence in clinical research. The multidisciplinary team is led by the Head of Research, Dr Sadhbh O'Neill Scanlon, and Clinical Lead, Prof. Patrick Mitchell, and includes Clinical Nurse Manager and Clinical Trial Coordinator, Saoirse Collins; Contracts Officer, Deirdre O'Brien; and Research Assistant, Caoimhe Murphy.
The CRF works closely with key hospital departments, including the Cancer Clinical Trials Office, Radiology, Pharmacy, and the Meath Laboratory, to ensure the seamless delivery of research studies from start-up to completion. This integrated approach supports efficient study conduct, timely sample processing, and consistently high standards of patient care.
As a research-active facility, we are committed to providing a supportive environment for investigators, sponsors, and participants. We deliver clinical trials to the highest standards of quality, safety, and regulatory compliance, adhering to the principles of Good Clinical Practice and maintaining a strong focus on participant experience.
Our growing research portfolio reflects our commitment to innovation, collaboration, and the generation of evidence that improves outcomes for patients and contributes to the advancement of healthcare.
CONTACT DETAILS:
Saoirse.Collins@tuh.ie, 087 220 2614, Deirdre.obrien@tuh.ie or Sadhbh.oneill@tuh.ie
Information for Sponsors
- The TUH CRF employs a structured governance framework to facilitate an efficient and responsive feasibility assessment process. During the feasibility stage of a clinical trial, application forms are completed and submitted to the relevant healthcare departments required for trial delivery, including Pharmacy, Radiology, and Laboratory Services.
- Should any issues arise during this process, every effort is made to support the relevant department in addressing challenges associated with trial delivery. The CRF works collaboratively with all stakeholders to identify practical solutions and ensure that trial activities can be conducted effectively. As a busy academic hospital, TUH is committed to overcoming the day-to-day challenges associated with clinical research and maintaining a supportive environment for trial conduct.
- TUH is strongly committed to expanding its clinical research portfolio and has established the growth of clinical trial activity as a key strategic objective for the organisation.
During the site feasibility stage of a clinical trial, the Research Office/CRF uses Infonetica to manage and communicate the feasibility assessment process. Applicants must provide study details and then select the resources required for their study. The most commonly requested resources are Pharmacy, Radiology, and the Meath Laboratory. If additional resources are required, applicants outline these additional resources in the assessment form and the CRF CNMII will liaise with that department to assess capacity.
Pharmacy capacity assessment is the first step in the process, where applicants complete a Clinical Trial Feasibility Form and provide details of the investigational medicinal product (IMP), storage requirements, expected stock levels, and relevant pharmacy manuals. The Pharmacy Clinical Trials Team reviews the application and may request further information through Infonetica. The Pharmacy Clinical Trials Team will notify the applicant is capacity is confirmed or liaise directly with the Research Office/CNMII if capacity is not available at this time.
The application then progresses to Radiology (where required), followed by the Meath Foundation Laboratory. Each department reviews the study requirements and may request additional information via Infonetica. Confirmation of capacity are sent at each stage and a final letter of TUH capacity is sent at the end of the process.
Throughout the process, Infonetica acts as the central platform for applications, departmental reviews, and communication between applicants and the relevant teams.
| Location |
Third Floor Tallaght Hospital |
| Phone |
01-5834975 |
| Visiting Hours |
Strict Visiting times are 3pm-4pm and 6.30pm - 8.30pm |
Clinical Research Platform (CRP) is an Irish Site Management Organisation dedicated to supporting and expanding clinical research opportunities across Ireland. Established in 2017, CRP works in partnership with hospitals, clinicians, sponsors and CROs to increase patient access to clinical trials and innovative treatments.
CRP provides operational support for the delivery of clinical research, including study feasibility, start-up, regulatory and ethics support, study coordination, research nursing and day-to-day study management. By providing dedicated research infrastructure and support, CRP enables clinicians to participate in clinical research while maintaining focus on patient care.
CRP currently supports a number of clinical studies in TUH, facilitating both commercial and academic studies across a wide range of therapeutic areas and helping to increase research capacity, improve patient access to new treatments and strengthen TUH's position as a destination for high-quality clinical research.
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The review and execution of Clinical Trials & Studies contracts is managed by Dr. Sadhbh O’Neill Scanlon (Sadhbh.oneill@tuh.ie).
Ms. Deirdre O’Brien, the Clinical Trials and Studies Contracts Officer is the first line of contact for contract review and execution.
Deirdre is available from Tues to Fri 9:30am – 3:30pm at deirdre.obrien02@tuh.ie or (01) 414 2952.
Clinical Trial Documentation
The following documents are required to be reviewed for a Clinical Trial:
- Sponsor DPIA or Sponsor Statement of Compliance to accompany the TUH Data Protection Compliance Form
- Clinical Trial Agreement (CTA) / Contract / Research Collaboration Agreement
- The sponsor, or legal representative of the sponsor must be established within the European Economic Area
- Including Financial Appendix / Budget
- Budget should include CTA/DPA Review Fee of €3,000
- Data Protection Agreement (DPA) - Can be a section in the contract, appendix or standalone document
- Site Specific Assessment (SSA) or Site Specific Template (SST). Must be signed and dated by Principal Investigator
- Clinical Trial Indemnity Form - State Claims Agency template, Version 4 to be used
- Research Ethics Committee favourable opinion, CTIS Approval Part 1. Must list TUH as a site and TUH Principal Investigator name
- HPRA granted Authorisation for Clinical Trial – CTIS Part 2 approval
- Sponsor Insurance Certificate
- The following documents may also be requested:
- Letter of Authorisation/delegation of Authority
- Standard Contractual Clauses (SCCs)
- Transfer Impact Assessment (TIA)
- HRCDC Approval
The following documents are required to be reviewed for an Observational Study:
- Data Protection Impact Assessment (DPIA) – Section 4 of the SJH/TUH JREC Application form
- Observational Study Agreement / Contract
- The sponsor, or legal representative of the sponsor must be established within the European Economic Area
- Including Financial Appendix / Budget, if applicable
- Data Protection Agreement (DPA). Can be a section in the contract, appendix or standalone document
- Research Ethics Committee favourable opinion. Must list TUH as a site and TUH Principal Investigator name.
- The following documents may also be requested:
- HPRA granted Authorisation for Clinical Trial
- Sponsor Insurance Certificate
- Letter of Authorisation/delegation of Authority
- Standard Contractual Clauses (SCCs)
- Transfer Impact Assessment (TIA)
- HRCDC Approval
When this documentation is reviewed and agreed, we make a submission to AON for approval through the Clinical Indemnity Scheme. On receipt of this final approval we can proceed to signing the contract.
Please Note:
- The CEO must be the final signature on the contract after all the documents outlined above are approved for sign off by the Clinical Trials and Studies Contracts Officer
- The Adelaide and Meath Hospital, Dublin, incorporating The National Children's Hospital is the legal name for TUH and must be used on all documentation
- The Principal Investigator, Pharmacy, CRF CNMII, Radiology and other stakeholder departments within TUH must approve the budget
- Where the Pharmacy Department (pharmacy.clinicaltrials@tuh.ie) are involved in the trial they must approve the pharmacy budget. This approval must be sent to the Clinical Trial and Studies Contracts Office
Information for Clinical Trial Sponsors
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TUH Research Data Protection Officer: Dr. Sadhbh O’Neill, Saidhbh.ONeill@tuh.ie
GDPR, the Data Protection Act of 2018 and the Health Regulations (HRR) required consent to be sought for all research taking place. However in January 2021 amendments to the HRR were enacted by the DoH and the Data Protection Commission. These amendments concerned a number of areas but of particular interest to researchers are the amendments to:
- Retrospective Chart Reviews - Consent is no longer required for this type of study BUT only when the study meets certain low risk criteria: (i) the data is protected by a unique coding system (ii) a data protection risk assessment has concluded that the study is low risk (iii) it is performed by a healthcare practitioner who is an employee of TUH or a student healthcare practitioner (iii) is another employee of TUH who in their normal duties has access to medical records (iv) the data will not be shared unless completely anonymous (v) the published results will not identify any individual and (vi) the Research Ethics Committee must review and approve the study.
- Pre-screening – pre-screening is the process researchers used to identify patients that may be suitable for the research study they wish to undertake. This involves accessing medical records for the purpose of identifying patients but no data is removed/copied/recorded prior to consent. This can only be conducted by a healthcare practitioner employed by the controller (hospital, primary care centre, GP practice etc) or a person studying to be a health practitioner who is under the direction and control of the controller. That means that there are formal governance arrangements in place that include specifying that the controller rather than the supervising health practitioner is responsible for all data protection matters relevant to the student; • An employee of the controller (for example, a medical records clerk) who in the course of his or her duties for the controller, would ordinarily have access to the personal data of individuals held by the controller (that were obtained for the provision of health care to those individuals); or • A person referred to an “authorised person” (see next slides). Who can be an authorised person? The amendment specifies certain persons who can be authorised by the controller holding the personal data to carry out the pre-screening element of health research without explicit consent. Those persons can be employees of the following organisations: (a) an institution of higher education within the meaning of section 1(1) of the Higher Education Authority Act 1971 (No. 22 of 1971), (b) a body or person that has as its principal activity the provision, management or development of a health practitioner, or (c) a registered charitable organisation within the meaning of the Charities Act 2009 (No. 6 of 2009), one of whose objects is to support research and education in the health services. Should they be deemed suitable they will be contacted in order to provide them with information about the study and, if they feel comfortable and happy, to obtain their consent. This first contact should be made health practitioner of the controller or an authorised person who is a health practitioner.
- Health Research Consent Declaration Committee
- Research involving patients who lack capacity to provide their own informed consent for their participation in research require a consent declaration by the Health Research Consent Declaration Committee (HRCDC)
- The data controller must apply to the HRCDC for a consent declaration
- The HRCDC is a separate committee to the Ethics committee. Their role is to review applications regarding the processing of a patient's data without seeking consent from the patient
I. Personal data (i.e. name. address, MRN, email address, DOB, etc)
II. Personal sensitive data (i.e. patients medical data)
- The HRCDC committee make a decision as to whether there is significant public interest in the study and this public interest outweighs an individual's right to give their consent for their data to be processed
- The HRCDC will require assent to be sought from the patient’s proxy.
- More information and the HRCDC application form can be found at the link above
Consent for Health Research must be dual consent, (i) consent for participating in research and (ii) consent for processing a patient’s data. The DoH have published their guidance for seeking explicit consent from patients. Please also consult the HSE consent policy for health and social care research (https://www2.healthservice.hse.ie/organisation/national-pppgs/hse-national-policy-for-consent-in-health-and-social-care-research/)
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Contact Details: Dr. Sadhbh O’Neill Scanlon (Sadhbh.oneill@tuh.ie) directly and cc the ResearchEthics@tuh.ie
The Chair of the JREC is Prof Anne-Marie Tobin. Please contact Dr. Sadhbh O’Neill Scanlon and queries will be forwarded to Prof Tobin.
PURPOSE OF THE JREC
- The St. James’ Hospital (SJH) / Tallaght University Hospital (TUH) Joint Research Ethics Committee (REC) provides ethical review of research studies in which patients, staff and sometimes healthy volunteers are either:
- Direct participants
- Their medical records medical data are accessed and collected
- Their biological samples are used
- The aim of the SJH/TUH JREC is to ensure the safety of our participants at all times
HOW THE SJH/TUH JREC FUNCTIONS
- The SJH/TUH jREC follows the Operational Procedures for RECs Guidance issued by the Irish Council for Bioethics (2004) (available at: Irish Council for Bioethics)
- The full SJH/TUH JREC meets nine times each year and reviews between 6 and 10 applications at each meeting.
- Researchers must submit all research studies to the SJH/TUH JREC for review via the online Ethics Review Manager - Infonetica
- For studies reviewed at a committee meeting, Minutes are written following the meeting and approved by the Chair. Once approved a letter with reviewer comments will be issued to the applicant via Infonetica
- For Studies reviewed by a Chairman’s Action, the Head of Research will review the submission and liaise directly with the Applicant via Infonetica until ready for approval. The study will then be sent to the Chair for approval and a letter issued once approved.
Figure 1 below illustrates the process of review for a new study submitted for initial review
Figure 2 illustrates the process of review for all other types of submissions, i.e. amendments, response to comments, resubmissions, reports
Decisions:
The full SJH/TUH JREC issues one of the following decisions in relation to a valid application:
- The study is APPROVED (Final Opinion): The applicant may conduct the research as outlined in the application form submitted to the SJH/TUH JREC incorporating any requirements by the SJH/TUH JREC.
- The study is APPROVED pending CLARIFICATIONS: The study can begin once clarifications are submitted to the SJH/TUH JREC via the correspondence section of Infonetica.
- 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 SJH/TUH JREC before receiving final approval for the study. No research may be conducted prior to receiving final approval.
- Further Information required: The SJH/TUH REC requires further information from the applicant and/or referee (expert opinion) before a decision can be reached.
- The study is DECLINED: 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.
The Chairman’s Action issues the following decisions in relation to a valid application:
- The Head of Research liaises directly with the applicant requesting additional information.
- Once all queries are addressed and the application is ready to be approved the Head of Research will send the application to the Chair for Chairman’s Approval via Infonetica. Subsequently an approval letter will be issued via Infonetica.
ADDITIONAL INFORMATION
Health Research Consent Declaration Committee (HRCDC):
Researchers conducting studies involving patients who lack capacity to give their own informed consent or researchers who do not plan on seeking explicit consent from the patient must apply to the HRCDC for a consent declaration for the processing of the patients data. Provisional SJH/TUH JREC approval must be in place before applying to the HRCDC. This type of study will require a full SJH/TUH JREC review and is not eligible for a Chairman’s Action.
Health Products Regulatory Authority (HPRA):
Research involving Investigational Medicinal Products or Devices may require approval from the HPRA. Please consult with the HPRA regarding your study before applying to the JREC.
Committee Meeting Dates 2026 and 2027:
- September 16th 2026
- October 21st 2026
- November 18th 2026
- January 20th 2027
- February 24th 2027
- Mar 31st 2027
- April 21st 2027
- May 19th 2027
- June 16th 2027
- September 15th 2027
- October 20th 2027
- November 17th 2027
All submissions made to the JREC are reviewed and assigned to the next available meeting. It is not possible to submit for a particular meeting.
90% of submissions are approved via a Chairman’s Action and 10% via a full JREC Meeting. The Head of Research determines eligibility for a Chairman’s Action.
TYPES OF STUDIES THE SJH/TUH JREC REVIEW
Clinical Audit:
Clinical audit is the systematic review and evaluation of current practice against standards with a view to improving clinical care for service users
Quality Improvement Initiatives:
Improving quality means making healthcare safe, effective, patient – centred, timely, efficient and equitable.
Quality Improvement (QI) provides a structured approach to enhancing how care is delivered. Because healthcare is made up of thousands of interlinked processes, QI involves defining these processes, measuring and analysing, them, implementing improvements and ensuing those improvements are maintained.
Service Evaluation:
An internal evaluation of a service provided to a select set of patients for a given period of time in order to identify issues/good practice and implement appropriate changes if necessary.
** The JREC will not review these types of studies ethically but the JREC will issue a letter stating the type of study being conducted**
- Registration is made via the Registration Form
Contact Details: Ms Sinead Palmer, Quality & Change Manager – Sinead.Palmer@tuh.ie, 01-414 2855
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