The hospital has put in place a number of research application procedures to ensure that the wellbeing and rights of hospital patients and staff, and the hospital’s resources, are safeguarded at all times. Staff conducting any form of research related project are required to submit an application form to the R&I Office, to register their study and to allow further review by one of the relevant subgroups for the purposes of approval, oversight and feedback. Projects must not commence until an official approval email is received from the R&I Office.
From January 1st, 2025 the R&I application process will move to the SJH/TUH Joint Research Ethics Committee (JREC) online system, which can be found at: https://sjh-tuh.forms.ethicalreviewmanager.com/
We have created a helpful Guide to assist you while completing the new R&I Application form:
R&I Application Guidance Document 2025 & R&I Application Guidance PowerPoint 2025
List of Trainings for Researchers in Health Research:
Data Protection & Health Research Regulations This workshop covers the relevant law and guidelines under The Health Research Regulations, introduced by the Department of Health in 2018, including amendments to the original legislation. Participants will be offered practical guidance around the legal issues facing the research community when conducting health research, so they are armed with the necessary knowledge to ensure their research is compliant and meets best practice. The training will be delivered by Evelyn Fox, Solicitor and TCD Deputy Data Protection Officer (Research). Training options: Registration – Tuesday 11th March, 12pm-1pm |
New Research Staff Induction Tour The new research staff induction tour is an online event to welcome new researchers, at all levels, to the School of Medicine. We recognise the importance of researchers as the drivers of research excellence and that the burden of administration, policies and procedures presents challenges. This workshop is designed to offer easy signposting to College and School of Medicine contacts, functions, policies and processes which underpin the successful conduct of research. As well as signposting help and assistance in Financial Services, Contracts and Research Development, attendees will find out about resources for early career researchers in mentoring, research funding support, Grant application planning, TCD Research Database (RSS), and bibliometrics and altmetrics platforms. Registration – Wednesday 19th March, 12pm-1pm |
How to craft a compelling research impact narrative This workshop is designed to improve understanding around research impact and to help researchers better identify, evidence, and communicate the impact of their research. Researchers will learn the importance of demonstrating that impact extends beyond academia to encompass effects on the economy, society, culture, public policy or services, health, the environment, or quality of life. The seminar will also touch upon the utilisation of the University's Research Support System (RSS) and external bibliometric databases for capturing and reporting research and engagement activity indicators. Another objective of the training will be to help researchers understand the importance of tailoring their impact narratives for various audiences, and will cover the use of communication channels like websites and social media . Registration – Thursday 27th March, 12pm-1pm |
Guidelines on drafting a DORA compliant CV This workshop is designed to equip researchers with the knowledge and skills to develop CVs and Track Record statements that align with the principles of the San Francisco Declaration on Research Assessment (DORA). The training will provide researchers with concrete practical guidance and examples to follow to move beyond a sole reliance on bibliometrics and incorporate broader indicators of research impact and engagement in individual CVs and Track Record statements. Researchers will be guided on how to identify and incorporate broader merits of distinction such as more diverse research outputs, engagement activities, service to the research community and teaching and supervision which will strengthen the unique aspects of their CV. Registration – Wednesday 16th April, 12pm-1pm |
The Research & Innovation (R&I) Office are asking all Principal Investigators & researchers to create a user account on the JREC system (using the above link) before January 1st, 2025, to ensure a smooth transition. Principal Investigators & researchers who have previously completed research ethics applications to JREC will already have a user account.
New users can create accounts by following the step below;
The steps for R&I approval will remain the same.
However, the benefits of integration with the JREC system are as follows:
Further updates will be posted on the R&I Intranet Webpage to keep Principal Investigators and researchers informed.
Abbreviations
CRF: Clinical Research Facility
DPIA: Data Protection Impact Assessment
HPRA: Health Products Regulatory Authority
JREC: Joint Research Ethics Committee
NRAC: Nursing Research Access Committee
PI: Principal Investigator
R&I: Research and Innovation
SJH: St James’s Hospital
The PI is the lead researcher and the individual responsible for the on-site conduct of the study, and the team lead when the study is conducted by a research team. The PI has overall responsibility for all aspects of the study, and should be a hospital consultant for large and high-risk studies (e.g. clinical trials, medical device trials, funded studies and clinical research at the level of Masters or above), to ensure the activation of indemnity cover. Smaller studies can be run by researchers with the approval of local managers, in addition to R&I Office approval. It is recommended that you add your line manager in the Principal Investigator/Supervisor section so that they can approve the application form. External researchers require a local hospital based PI collaborator or supervisor to conduct patient related research in the hospital. NRAC applicants will require a “gatekeeper” to facilitate local logistics.
External research personnel will need to be suitably qualified, the study that they are involved with will need to be under the direction of a suitable PI, they will require the supervision of an appointed hospital staff member, and agreements will need to be place, including a non-disclosure agreement. For external research personnel who plan to come on-site and to have direct patient contact, they will also need Garda Vetting confirmation (from organisations that the hospital has an information exchange agreement in place with), or a full Garda Vetting submission. There are two Garda Vetting forms to be completed (available
from the R&I Office), which request information including, full name, date of birth, current address (including Eircode), email address, contact number, and the role being vetted for.
The documents must be presented to the R&I Office along with two suitable forms of ID, which will be validated and photocopied, and sent to the hospital Human Resources Department. Processing takes at least 10 days. In addition, mandatory trainingwill have to be completed via HSELand, including Children First and Clinical Hand Hygiene training, with certificates of completion sent to the R&I Office.
If the purpose of your project is to generate new knowledge then this indicates that you are conducting research. Findings that can be generalised to other organisations is another feature of research therefore will require an application to an Ethics Committee from participants. The research could involve an intervention or could involve data analysis only. Either way, the research will require an application to an Ethics Committee from participants.
From 6th August 2024, Quality, Safety and Improvement Directorate (QSID) will be reviewing non-research studies such as Clinical Audit, Service Evaluation or Usual Practice Study. Applicants for these studies are asked to register with QSID by completing a Clinical Effectiveness Study Form on the Hospital’s Quality and Safety Information Management System.
You can access this registration system via the ‘useful links’ tab on the Hospital Intranet Page.
If you remain unsure if your project is ‘research’ or ‘non-research’, we have a helpful guide: Is my project “research” or “non-research”?
If you have any further questions, please contact research@stjames.ie
o clinical trials on medicinal products
o clinical investigations of medical devices
o performance studies of in vitro diagnostic medical devices
o national Irish COVID19 biobank.
Further information on the NREC can be found here: https://www.nrecoffice.ie/about/national-office/
St James’s Hospital is committed to the provision of a safe and secure environment for patients and staff, and embraces its obligation to protect individuals' rights to privacy and confidentiality. Individuals conducting research must comply with the SJH data protection policies and national regulation.
A DPIA must be completed for any projects that involve processing personal data.
You can access the DPIA template in the ‘forms and booklets’ section of the R&I intranet page. Please send the completed form to research@stjames.ie. Remember when completing the form that your focus should be on how the data is collected, used, stored etc.
Researchers who obtain or process personal information must ensure that they follow the Principles of Data Protection:
The safeguarding of research data is managed by the Principal Investigator,
operating on behalf of the Data Controller, who ensures that: