The HSE Primary Care Division supports primary care related research and is mindful of its obligations to ensure that research is both ethical and respectful of service users and providers. Research may inform and contribute to the improvement of primary care services.
All research proposals or requests to engage with primary care services, staff or providers for research or evaluation purposes must be approved by the National Primary Care Research Committee. An internal HSE procedure supports a structure and process for the consideration of such requests.
The procedure is relevant to:
- All HSE staff, who wish to carry out primary care related research which may involve using HSE facilities, engaging with HSE primary care staff, engagement with service users or seeking information pertaining to staff or service users.
- All students on placement with the HSE or students external to the HSE who wish to carry out primary care related research which may involve using HSE facilities, engaging with HSE primary care staff/providers, engagement with service users or seeking information pertaining to staff or service users.
- All researchers, both internal and external to the HSE who wish to carry out primary care related research as part of an academic study course which may involve using HSE facilities, engaging with HSE primary care staff, engagement with service users or seeking information pertaining to staff or service users.
- Primary care service evaluations/reviews for external or academic research purposes needs to be formally submitted to the PCRC.
- Approved research should be subject to periodic review. The frequency of such review should reflect the degree of involvement for service users/participants in the research project. The Primary Care Research Committee should have sight of the final draft report prior to publication and that their opinion will be considered in relation to the publication, in particular items that may have a bearing on the HSE’s reputation.
Out of Scope
- The National Primary Care Research Committee is not recognised by the Department of Health under regulation 7 of the European Communities Regulations (Clinical Trials on Medicinal Products for Human Use (S.I. 190 of 2004)). This procedure therefore excludes clinical trials of medicinal products. Further information regarding applying for ethical review of clinical trials of medicinal products can be found on the Department of Health website http://www.dohc.ie/other_health_issues/clinical_trials/.
- The National Primary Care Research Committee is not a Clinical Ethics Committee and does not deal with or give an opinion on:
- Ethics issues in clinical practice
- Clinical trials involving human participants
- Testing of new treatment or interventions or medical devices.
- Requests for Ethical Approval - This committee does not provide ethical approval and can only accept applications where ethical approval has already been granted by an Academic Ethics Committee.
Activities that do not require PCRC review:
- Research utilising existing publicly available documents or data
- Observational studies in public places in which the identity of the participant remains anonymous
- Case study of one service user with the proviso that written informed consent has been obtained from the relevant study subject/participant
- Quality assurance studies
- Clinical Audits
- Some internal HSE service evaluations/pilot projects may not require committee approval but it is necessary to contact the Committee for further guidance.
Important information for Researchers:
- It is the responsibility of the researcher to be aware of and to adhere to this procedure.
- It is the responsibility of the researcher to ensure and provide evidence of ethical approval granted by an Academic Ethics Committee (where appropriate).
- It is the responsibility of the researcher, if employed by the HSE, to obtain approval to carry out the study/research from his/her relevant HSE Line Manager in the first instance and to then forward it to the Primary Care Research Committee for approval. A favourable decision from the Primary Care Research Committee is not the same as approval from the relevant HSE Line Manager to proceed with the research. Approval from relevant HSE Line Management must be sought separately in the first instance.
- Researchers have a responsibility to know and understand the provisions of the Data Protection Acts 1988 and (amendment) 2003 and their obligations as set out in those Acts. Data collected from primary care service users of the HSE must comply with the Data Protection Acts.
Click on the links below to read the application form and guidance manual for Research in Primary Care
Primary Care Research Application Form.pdf (size 127 KB)
Primary Care Research Application Form .doc (size 120 KB)
Guidance Manual.pdf (size 956.6 KB)
Protocol Document (size 117 KB)
Fill in the Declaration and signature sheet.doc (size 56 KB)
The committee meets on a bi-monthly basis. All completed applications received one working week in advance of the meeting will be include on the agenda.
All documentation can be submitted to email@example.com for consideration by the Primary Care Research Committee.