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 (including quality improvement projects) 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.
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. 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.
Quality improvement projects must also apply through the R&I Office; these include audits, service evaluations and usual practice projects. Information about each type is found in the information icons within the form. Findings that can be generalised to other organisations is another feature of research therefore will require an application to an Ethics Committee from participants.
If you are unsure whether you are conducting research or a quality improvement project please email firstname.lastname@example.org for guidance.
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 email@example.com. 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: