Describe a project in one sentence and get a plain-English read on what it is, what approval it needs, and who to talk to — before you fill in a single form.
Ethics (REC) review
Governance (RGMS)
Your first steps
Who to talk to
These two mix-ups are behind a large share of applications that come back for correction. Thirty seconds here saves a fortnight later.
Most common data error
"I swapped the names for study numbers, so the data is anonymised." — Usually not true.
Anonymised
No one can link it back to a person, by any means reasonably likely. No key exists. Falls outside GDPR — but genuinely hard to achieve.
Pseudonymised
Identifiers replaced with a code, but a key still links back. This is still personal data — full GDPR and Health Research Regulations 2018 apply.
The test: if you (or anyone) hold a key that re-links the data, it is pseudonymised, not anonymised — and it is regulated. A spreadsheet of study numbers with a separate "code → name" list is pseudonymised.
Calling pseudonymised data "anonymised" changes which legal basis, consent route, and safeguards apply. Reviewers have to send it back to be corrected. Under the Irish Health Research Regulations 2018, the act of anonymising is itself processing, and explicit consent or a Health Research Consent Declaration may be in play.
Most common scope error
"It's just an audit, so I don't need ethics." — Sometimes right, sometimes the project is actually research.
Audit / Service evaluation / QI
Measures current practice against a standard, or judges a service, to improve local care. Generally no REC — but still covered by GDPR and may need local sign-off.
Research
Aims to create new, generalisable knowledge — a hypothesis, randomisation, deviating from usual care, or sharing beyond local use. Needs REC ethics approval + RGMS governance (per site).
The deciding question: are you measuring against an agreed standard to fix things locally (audit), or trying to discover something new that others could generalise from (research)? The line can be fine — when unsure, ask us before you start.
The HSE National Centre for Clinical Audit publishes a Nomenclature glossary (2025) with clear definitions. Crucially, it is the project lead's responsibility to decide — the REC does not issue "waivers," and an out-of-scope project may still need local governance.
The Research Directorate is your single point of entry — from a small student audit to a full multi-centre study. Everything below is on the Directorate's site.
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