Before you begin any project, it’s essential to understand whether your work is considered research, as this determines what approvals you must obtain at St James’s Hospital (SJH). All research requires ethical approval and R&I approval, while non‑research activities follow different governance routes.

What is considered research?

A project is considered research when it is designed to generate new, generalisable knowledge. Research typically involves systematic investigation, testing a hypothesis, evaluating an intervention, or exploring associations.

Different types of clinical research:

  • Retrospective Chart Review
  • Observational Research Study
  • Translational Research Study
  • Device Trials
  • Randomised Controlled Trial
  • Pilot Study
  • Feasibility Study
  • Staff or patient surveys
  • Staff or patient interviews or focus groups
  • Case Studies
  • Cohort study

If your project is research, you MUST obtain:

  • Ethical approval (JREC, NREC, CTIS or institutional ethics)
  • R&I approval (hospital governance approval)

Both approvals are mandatory before beginning any research activity.

What is not research?

Some projects aim to evaluate or monitor current practice rather than generate new knowledge. These projects do not require ethical or R&I approval.

Clinical Audit  Service Evaluation Quality Improvement Initiatives 

Clinical Audit: It is the systematic review and evaluation of current practice against current and defined standard(s), with the aim of improving clinical care for service users.

Findings are measured against these standards and results are typically binary (met or not met). Clinical audit is usually limited to a single site or service and does not require ethics approval.

Examples:

  • Reviewing compliance with hand hygiene standards.
  • Auditing the management of intravenous (IV) lines.
  • Assessing standardised documentation in a nurse‑led leg ulcer clinic.

Service Evaluation: An internal assessment of a service provided to a defined group of patients over a specific period of time. Its purpose is to understand what is happening in practice, identify good practice or areas for improvement, and implement changes where necessary. Unlike clinical audit, service evaluation does not compare practice against a predefined standard.

Service evaluation often focuses on the effectiveness, efficiency, and acceptability of a service and is informed by patient and staff feedback.

Examples:

  • Evaluating patient satisfaction following attendance at nurse‑led clinics.
  • Reviewing virtual consultations to understand when and how they work best, based on patient and staff feedback.

Quality Improvement Initiative: Quality improvement focuses on making healthcare safe, effective, patient‑centred, timely, efficient, and equitable. It provides a structured framework for systematically improving how care is delivered to patients. Healthcare is made up of many interlinked processes within a complex system, and quality improvement works by defining these processes, measuring performance, analysing data, implementing improvements, and sustaining change over time.

Quality improvement initiatives are ongoing and support continuous improvement in everyday practice.

Examples:

  • Improving clinical handover by defining clear steps and workflows.
  • Reducing delays in medication administration by analysing bottlenecks and strengthening checking processes.

 

These must be registered with QSID, and they do not require an R&I application.

If you are unsure

Research* Non‑research
Registration with: Research & Innovation Registration with: QSID
• Clinical Trial
• Medical Device Trial
• Retrospective Chart Review 
• Observational Research Study
• Translational Research Study
• Device Trial (Not Subject to Medical Device Regulation)
• Pilot Study
• Feasibility Study
• Case Studies^
• Pre‑screening*		 • Clinical audit
• Service evaluation
• Usual practice project
• Quality improvement Initiative

 

 

The following projects can be classified as research and/or non‑research depending on the purpose of the project:

  • Retrospective Chart Review
  • Hospital Staff – Survey/Questionnaire
  • Hospital Staff – Interview/Focus Group
  • Patient – Survey/Questionnaire
  • Patient – Interview/Focus Group

Note: Some activities listed above may be classified as either research or non‑research depending on purpose. Where the activity is undertaken for service evaluation or quality improvement only, registration as non‑research may be appropriate.

It is important to correctly classify your project as either research or non‑research, as projects classified as research require ethics approval, as per the Health Research Regulations 2018. Failure to obtain ethics approval may impact on insurance and Clinical Indemnity.

The Research & Innovation Office can help you classify your project. Email us at research@stjames.ie

  • Feature​

    Research​

    Audit​

    Service Evaluation​

    Main Aim​

    Generate new, generalisable knowledge​

    Measure care against a standard​

    Understand how a service is working​

    Generalisable (beyond SJH)​

    Yes​

    No​

    No​

    Reference point​

    Research question​

    Predefined standard/guideline​

    No standard — describes current service​

    Ethics approval​

    Required​

    Not Required​

    Not Required​

    Governance ​

    Ethical approval + Hospital R&I Approval​

    QSID Registration​

    QSID Registration​

    ​

    Example​

    Retrospective chart Review to see if patients on one medication had better outcomes than another​

    ​

    Patient survey on unmet needs​

    ​

    Randomised controlled trial on efficacy of an intervention​

    Checking compliance with infection control guidelines,​

    ​

    Auditing compliance with antibiotic prescribing guidelines​

    Patient satisfaction survey​

    ​

    Retrospective Chart Review to check compliance with allergy documentation policy​

    ​

    Reviewing referral patterns to see how many patients are seen within 6 weeks​