1. Identify your research pathway: Before starting your study, please review the Application Pathway to understand the applicable information and documentation to your pathway.
   
   
2. Applicant and Principal Investigator Information: All studies must include full details for both the applicant and the PI. The PI must be an SJH employee and their institutional email must be provided.
   
   
3. Core Study Information: Provide the short and full study titles, a plain‑English summary, research locations, the associated directorate, study start/end dates, target population, SJH recruitment numbers, and a description of how informed consent will be obtained.
   
   
4. Public and Patient Involvement (PPI): Applicants must state whether PPI informed the study design. If included: describe the input. If not: briefly explain why (e.g., not feasible, not relevant, or not possible at this stage).
   
   
5. Ethical Requirements: Provide ethics committee details, submission date, and approval letter (or confirmation that approval is pending). If ethics approval is not available at submission, applicants may upload it later during the review process.
   
   
6. Data Protection Requirements: Outline how participant data will be collected, handled, stored, transferred, protected, and eventually deleted, anonymised, or archived. Identify the data type and data controller/joint controllers. If required, include: a DPIA, a data‑flow diagram, and relevant data‑protection agreements.
   
   
7. Mandatory Training: All members of the research team must complete the required mandatory training, including GDPR fundamentals and hand hygiene. Where applicable, researchers must also complete Children First and open disclosure training, depending on the nature of the study and the participant group.
   
   
8. Research Team & HR Requirements: Applicants must provide the names and details of all research team members and must indicate whether any non-SJH staff will be involved. Non-SJH researchers coming on site as part of the research must complete non-disclosure agreements.
   
   
9. Legal & Indemnity Requirements: Applicants must confirm their employer and ensure appropriate indemnity/insurance is in place. Where external partners or agreements are involved, hospital sign‑off is required.
   
   
10. Signatures: Every application must be signed by both the applicant and the principal investigator before submission.

1. Multisite clinical research: Studies involving more than one site must clearly identify the principal investigator at SJH, outline participating locations, and upload data-sharing agreements if data is being shared between sites. For multisite studies involving SJH, TUH and/or TCD, there is an overarching data sharing agreement in place so no additional data sharing agreement is required.
   
   
2. Academic research projects: Where the study is being completed as part of an academic degree, applicants must provide the award level and the academic institution.
   
   
3. Participant facing studies: Any study involving participants must upload the participant information leaflet (PIL) and the informed consent form (ICF). Where relevant, applicants must also provide case report forms, questionnaires or any other participant facing materials to be used during the research.
   
   
4. Studies Requiring the Clinical Research Facility (CRF): Where CRF services are needed (e.g., sample processing, specialist rooms, research nursing), applicants must contact the CRF before submitting the R&I form. The applicant must also complete the CRF section of the R&I form.
   
   
5. Studies Involving Nurses or Healthcare Assistants: Where nurses or healthcare assistants are the study participants, the Nursing Research Access Committee section of the R&I form must be completed.
   
   
6. Case Studies Involving Fewer Than Five Patients: This type of study falls under Pathway 2 and may be approved by the R&I Office without ethical approval. If the number of cases reaches five or more, full JREC ethics approval is required.
   
   
7. Staff‑Related Research: Studies where staff are participants can be approved with either JREC and R&I (Pathway 1) or University level ethical approval and R&I (Pathway 2) due to the low-risk nature of this study type.
   
   
8. Regulated Clinical Trials: Regulated clinical trials involving medicinal products must provide detailed regulatory information, including the CTIS or EudraCT number, the trial phase, the investigational medicinal product details, and the sponsor information. Where required, the study must also include details of the EU legal representative and any CRO involved. All relevant regulatory approvals and agreements, such as HPRA approval, NREC or CTIS and clinical trial agreements must be submitted.
   
   
9. Medical Device & In Vitro Diagnostic Device Studies: Studies involving medical devices or IVDs must outline the device classification, indicate whether the device is CE marked and the applicable regulatory article. These studies must provide the sponsor details, the regulatory framework followed and any required documentation, such as conformity assessments or device specific approvals. Applicants will also be required to complete an indemnity form for medical devices.

Informed Consent

• Informed consent is required for any form of interventional health research.
• Retrospective chart review research does not require explicit consent Ethics approval is required.
• Please see the Department of Health Guidelines on the informed consent process.

GDPR Consent Checklist

Definition of consent in Article 4(11) of the GDPR

Article 4(11) of the GDPR defines consent as: “any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her.”

Recital 171 of the GDPR makes clear you can continue to rely on any existing consent that was given in line with the GDPR requirements, and there’s no need to seek fresh consent. However, you will need to be confident that your consent requests already met the GDPR standard and that consents are properly documented.

Email; dataprotection@stjames.ie if you are in doubt about any of the conditions below.

Asking for consent

• Individuals are asked to positively opt in (i.e. no pre-ticked check boxes or other type of default consent)
• The consent form is written in clear, plain language and is easy to understand.
• The consent is specific in why data is collected and what is to be done with it
• There is separate distinct options to consent separately to different purposes and types of processing.
• The relevant organisations and any third party controllers relying on the consent are named.
• Individuals are given the option to withdraw their consent.
• Individuals are given the option to refuse to consent without detriment.
• Consent cannot be a precondition of a service. (i.e. the participant was informed that their usual care would not be negatively affected if they chose not to participate)
• If the consent relates to children age-verification measures (and parental-consent measures for younger children) are in place.

Recording consent

• A record is kept of when and how we got consent from the individual.
• There is a record of exactly what the individual was told at the time of consent (PIL).

Data Protection

The safeguarding of research data is managed by the Principal Investigator, operating on behalf of the Data Controller, who ensures that:

• Researchers apply for permission to access information for research purposes.
• Suitable patient consent is in place.
• Research team members are sufficiently informed about data protection
• Data protection related risks have been considered and mitigated.
• Research data is saved in secure folders on the shared drive, and not stored on the hard disk of a PC, and that paper based records are stored in locked filing cabinets.
• No patient or employee data, images, or other forms of identifiable information are stored on portable storage devices (e.g. memory stick, tablet, laptop, smartphone), transferred by email or other electronic methods, or are accessible to third parties without agreement.
• Research data collected on-site is anonymised or pseudonymised (removing name, Medical Record Number, and other distinguishing information), especially if being taken off site, and if coding is used, the key to re-identify coded data remains on-site and is held by the PI.