Guidance

• You can access the application form via this link:  https://sjh-tuh.forms.ethicalreviewmanager.com/
• Complete all required sections of the form using the free-text boxes, tick-boxes, and dropdown menus. Depending on your selections and the information you provide, additional sections will appear that will require completion. Use the information icons to access relevant information about each section.
• When you complete the form you will be asked to sign off the application using the email and password associated with your Infonetica account. This signature locks the form.
• You will now be required to ‘request signature’ from the SJH PI listed in your application. You will be asked to input the email associated with their Infonetica account. The PI will receive an email with a link to review and sign off the application. PLEASE NOTE: Your application is not submitted until your PI signs the application.
• Once your PI signs the form, you will receive  anautomatic email confirmation detailing the review stage steps.
• Additional documentation will also be required, depending on the type of research, e.g. ethics approval, HPRA approval, study protocol, contracts, nondisclosure agreements, consent forms, patient information leaflets etc. If these documents are not available at the time of initial submission, your application can be returned to you in an unlocked format to allow them to be added during the review process.
• The application will be registered with the R&I Office, screened, and forwarded to the appropriate sub-group for review, including the Clinical Research Facility (CRF), the Nursing Research Access Committee (NRAC), the Legal Office, Finance office and CEO Office. Fully completed submissions, which include associated documentation, are reviewed by the CRF weekly, and by the NRAC on a monthly basis. Draft contracts will be reviewed by the Legal Office.
• A submission can be made in parallel with an Ethics Committee and HPRA submission (if required). Please forward confirmation of Ethics Committee and HPRA approval (as applicable) to the R&I Office when received, without which the approval process cannot proceed.
• Hospital approval will be confirmed by the R&I Office upon satisfactory review, and the study cannot proceed until a letter of R&I approval has been issued by the R&I Programme Manager.
• You may be contacted to clarify the information submitted, to provide additional supporting information, or to address any omissions. Your application can be returned at any point in the review process to allow you to respond to comments and amend details.
• Annual progress report summaries are required to be submitted to the R&I Office (research@stjames.ie),
  • in addition to an end-of-trial report upon completion of the study. The update element required and questions include:
  • Did the study begin / take place?
  • If yes above, has the collection of data been concluded?
  • Incidents / issues arising of note (if any)?
  • What dissemination of findings has been done / is planned?
  • Has the ethics committee been provided with an annual update?
  • Did the HPRA inspect the study?
  • If yes, what were the main findings?

   

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 on your R&I application must be an SJH Employee.

The PI has overall responsibility for all aspects of the study, and should be a hospital consultant for high-risk studies (e.g. clinical trials, medical device trials, and clinical research impacting patient care), to ensure the activation of indemnity cover.

Lower-risk studies (retrospective chart reviews, staff studies) may list a Line manager or ADON as PI,. 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  Human Resources Department along with a valid form of ID and valid proof of address Processing takes at least 10 days. The researcher must send the R&I office proof of vetting disclosure once it has been received.

In addition, mandatory training (GDPR and Hand Hygiene) will have to be completed 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.

What is a research study?​

• Designed to generate new, generalisable knowledge.​
• Aim: to answer a question that is new and unknown, usually involves testing a hypothesis, evaluating an intervention or exploring associations​
• Results are applicable beyond the population or service​
• Requires ethical approval​

Examples:​

• Observational research​
• Randomised controlled trial​
• Clinical trial​
• Patient surveys/ interviews to generate new knowledge

What are non-research studies?​

• Non-research studies do not require ethical approval​
• Non-research studies are registered with QSID​
• Typically fall into two categories:​
  • Clinical Audit​
  • Service Evaluation ​

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

• Patient based research requires ethical approval and explicitly informed patient consent. For research based in SJH, ethics submissions should be made to the local ethics committee, which is the Tallaght Hospital / St James's Hospital JREC.
• Details on the JREC Ethics submission process, including the JREC application form can be found on the Tallaght/SJH Joint Research Committee website: Tallaght/SJH Joint Research Committee website
• For clinical trials applications approval must be sought from Clinical Trial Information Systems (CTIS)
• For medical device trials investigating devices that are not CE Marked, ethics applications can be made to National Research Ethics Committees (NRECs)whose remit is to deliver a single national ethics opinion for regulated health research studies Further information on the NREC can be found here: https://www.nrecoffice.ie/about/national-office/ 

Research projects will not be covered by insurance unless ethical approval is in place.

• Informed consent is required for any form of interventional health research.
• Retrospective chart review research does not require explicit consent if it is deemed to be low risk and conducted by an SJH employee or student healthcare practitioner under the supervision of an SJH employee. Ethics approval is required.
• Please see the Department of Health Guidelines on the informed consent process:
• The Tallaght/SJH JREC website also has a template patient consent form and patient information leaflet on their website.

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.
The DPIA is integrated in the R&I application on Infonetica. If you have a DPIA that has been reviewed by the data controller, this can be uploaded to your application instead and will be reviewed by the SJH Data Protection Officer (DPO).

Researchers who obtain or process personal information must ensure that they follow the Principles of Data Protection:

• Obtain and process the information fairly.
• Keep it only for one or more specified and lawful purposes.
• Process it only in ways compatible with the purposes for which it was given
  to you.
• Keep it safe and secure.
• Keep it accurate and up-to-date.
• Ensure that it is adequate, relevant and not excessive.
• Retain it no longer than is necessary for the specified purpose or purposes.
• Provide a copy of his/her personal data to any individual, on request.

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
  obligations.
• 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.