HSE Mid-West Governance
Is HSE Mid-West governance approval required if I already have ethics approval?
Answer:
Yes. Ethics approval alone is not enough. Every study conducted within a HSE Mid-West must also be approved by the Governance Office in the Research Directorate, which risk assesses research studies, checks operational readiness, legal compliance, insurance and data protection compliance.
Can I as a student be a Principal Investigator (PI) to my project?
Answer:
No. The PI must be a qualified staff member who can take full legal and professional responsibility for the study. Students support the study under supervision of the PI.
Can I access patient charts without consent for a retrospective review?
Answer:
Only in certain cases. If the reviewer is a HSE member with normal access to records, and the study is low risk (from a data protection perspective) and approved by the REC, consent may not be required. Otherwise, a consent declaration from the HRCDC is required. Detailed information is available in the HRR January 2021 (Health Research Regulations) on who can access the charts.
Do I need HSE approval if I am just conducting a simple research staff survey?
Answer:
Yes. Research surveys involving HSE staff still require ethics and governance approval if they collect personal data or opinions on sensitive topics. The study falls under the RGMS Framework. These projects also require data protection review..
Can I work with international collaborators?
Answer:
Yes — but legal, data protection, and governance requirements increase. A formal agreement is required, and if the data is transferred outside the EEA, SCCs and Transfer Impact Assessment (TIA) must be submitted.
Can I start recruiting participants before HSE approval is in place?
Answer:
No. Even if you have ethics approval, you must also receive written governance approval from the HSE Mid-West Research Directorate before starting recruitment, data access or advertising the study.
Who can sign off on research agreements on behalf of the HSE?
Answer:
Only the HSE authorised signatory — the Regional Executive Officer, Regional Clinical Director or Director of Research — can approve and sign research agreements. The Research Directorate facilitates the process as delegated by the REO.
Do I need to register my study with the HSE?
Answer:
Yes. All research studies must be formally registered with the Research Directorate. This ensures accountability, transparency, and proper monitoring — even for low-risk or internal projects.
What is the difference between a research project and an audit?
Answer:
Research generates new, generalised knowledge. Audits assess whether care meets a set standard. Research requires ethics and governance approval. Audits typically do not — but must still follow local policy and the audit must be submitted to the Audit Committee prior to commencing audit.
Ethical & Regulatory Approval
Do all research projects need ethics approval?
Answer:
Yes. Any study that falls under the RMGS Framework requires approval from a recognised HSE Research Ethics Committee (REC), even if it’s low risk or observational. This is a legal requirement.
What if I need to change something after my study is approved?
Answer:
You can make three amendments in the lifetime of the study, the first being no sooner than six months following the start of the study. You must submit an amendment to the Ethics Committee. Substantial changes (protocol, sites, consent forms, PI) need approval from the REC. Non-substantial amendments may need notification only — please check with the Ethics Committee in advance to ensure compliance of any amendments.
Insurance and Indemnity
Do I need insurance for academic research?
Answer:
Yes. All research must be insured. If your university is the sponsor, it must provide proof of insurance and complete the Clinical Trial Indemnity Form (CTIF) if the research is Interventional or Regulated. The HSE Mid-West do not insure external research projects.
Can a research project be sponsored by the HSE and have CIS/GIS cover?
Answer:
Only if it meets SCA criteria. The PI must be a HSE employee, the Ethics Committee must approve the research study, the activity must fall within low-risk, the study complies with the RGMS framework and has HSE approval, CIS or GIS may apply.
Data Protection
Do all research studies require a data protection risk assessment?
Answer:
Yes, for all research that falls under the RGMS framework, https://hseresearch.ie/governance-framework/
Do all research studies require a DPIA Screening tool?
Answer:
Yes, for all research that falls under the RGMS framework, a DPIA Screening tool should be completed to evaluate if a DPIA is required. For studies where the HSE is acting as a data controller the HSE Screening tool should be used.
Do all studies require a DPIA?
Answer:
No, a DPIA is required for high-risk studies. You need to use a screening tool to evaluate if the research is considered high risk or low risk, from a data protection perspective.
What is a Data Protection Impact Assessment (DPIA), and do I need one?
Answer:
A DPIA helps identify and reduce privacy risks in research involving personal data. It is required for high-risk studies. A risk assessment should be completed by the data Controller.
Do I need to submit a DPIA even if data is anonymised?
Answer:
If the data is truly anonymised and re-identification is impossible (there is no “key” linking the identification of the participants), a DPIA may not be required. However, a DPIA or screening tool must be completed and submitted as a measure of compliance with data protection, as any processing of personal data prior to anonymization falls under GDPR.
Can I use data collected during routine care for research?
Answer:
If the data was collected for clinical care but are now being reused for research, this requires ethics approval, site approval and patient consent. If the research is deemed high risk (from a data protection perspective) and consent is not feasible, a HRCDC is required. Please liaise with the Ethics Manager should you have any query in relation to ethics approval for your study.
PILs – Contracts and agreements
Do I need a contract for every study?
Answer:
Yes — if the study involves external collaborators, funders, sponsors, CROS, loaning of equipment, access to premises for non HSE-staff, transfer or processing of biological material and/or shared data. Contracts define roles, data responsibilities and liabilities. HSE-approved templates must be used, depending on sponsor type.
Use of biological samples
Can I use “leftover” clinical samples in research?
Answer:
Only under strict conditions. If the sample is completely anonymised and unlinked to data, it may be used with REC and HSE governance approval. If linked to patient data or identifiers, consent or a HRCDC declaration is required if patient consent is not feasible.