Research Ethics Committee Standard Application Form (RECSAF)

This page provides public access to researchers and Hospital Research Ethics Committees (RECs) wishing to access documents related to the latest version (V5.5) of the Standard Application Form for the Ethical Review of Health-Related Research Studies, which are not clinical trials of medicinal products for human use as defined in SI190/2004.

In 2009 representatives from some of Ireland’s Hospital Research Ethics Committees agreed to collaborate on the development of a standard application form for research studies and clinical trials not subject to SI190/2004. As well as input from a wide group of RECs, the advice of other stakeholders was also sought including the Data Protection Commission, Irish Medicines Board, Council for Bioethics and the Clinical Indemnity Scheme. By incorporating Irish expertise in this area the Standard Application Form represents “Best Practice” in the Irish context.

Beginning in early 2010 the form was piloted for six months by the RECs of ICGP, HSE South East, St. James's Hospital/Adelaide and Meath Hospital incorporating the National Children’s Hospital and the Mater Misericordiae University Hospital/Mater Private Hospital. In total 150 applications were made using the form and use of the pilot version of the Standard Application Form was evaluated and the findings contained in the Evaluation Report (Download here). Based on the experience of the pilot the Standard Application Form was modified and a Guidance Document was drafted to accompany the form. The Standard Application Form (Version 5.4) and the Guidance Manual were made available for downloading by RECs and others wishing to use them in August 2010. After six months of experience with Version 5.4 of the Standard Form, a six month review was carried out at the end of March 2011. This resulted in some relatively minor modifications aimed at making the form more user friendly and eliminating some areas of duplication. These changes have been incorporated into Version 5.5 of the Standard Application Form.

• Standard Application Form (Version 5.5)
  
• Standard Application Form Guidance Manual For Applicants (version 5.5)
   

Currently, the following Research Ethics Committees in Ireland accept applications using the Standard Application Form:

1. Adelaide and Meath Hospital incorporating the National Children’s Hospital / St. James’s Hospital
2. Beaumont Hospital / St. Ita’s Psychiatric Hospital (Portrane)
3. Bons Secours Health System
4. Connolly Hospital
5. Coombe Women’s and Infant’s University Hospital
6. Cork Teaching Hospitals - University College Cork Clinical Research Ethics Committee
7. Galway Regional Hospitals
8. HSE Midland Area
9. HSE North East
10. HSE South Eastern Area
11. Irish College of General Practitioners
12. Letterkenny General Hospital
13. Mater Misericordiae University Hospital / Mater Private Hospital
14. Mid Western Regional Hospital Complex
15. Naas General Hospital
16. National Maternity Hospital (Holles Street)
17. National Rehabilitation Hospital (Dun Laoghaire)
18. Our Lady’s Children’s Hospital
19. Rotunda Hospital (Parnell Square)
20. Royal Victoria Eye and Ear Hospital
21. Sligo General Hospital
22. St. Francis Hospice (Raheny)
23. St. Luke’s Radiation Oncology Network
24. St. Patrick’s University Hospital
25. St. Vincent’s Healthcare Group
26. St. Vincent’s Hospital (Fairview)
27. University of Pittsburgh (UMPC) Beacon Hospital
 

IT IS IMPORTANT TO CONTACT INDIVIDUAL COMMITTEES DIRECTLY FOR A COPY OF THEIR LOCAL CHECKLIST & LOCAL SIGNATORY PAGE.
 

Important Note for Applicants completing the Standard Application Form (V5.4 and V5.5)

Researchers should be aware that if completing the RECSAF and submitting the same form to multiple committees simultaneously, that they may need to change their response to Question A2 (Name of Principal Investigator), Question A4 (Names of Co-Investigators) and/or Question A5 (Name of Contact Person) depending on each committee's local requirements. While quite a number of committees do not specify who can be named as Principal Investigator (PI) (A2), a number of other committees would prefer the PI to locally based, with a local contract of employment and some specify further that only a hospital consultant or department head can be PI. Where committees do not specify this, some specify that at least one of the co-investigators (A4) should be locally based, or if not, that the contact person be locally based (A5).

 

Other Hospital Research Ethics Committee Applications Forms

A number of Hospital Research Ethics Committees use local, committee-specific research ethics committee application forms as follows:

1. Cappagh National Orthopaedic Hospital (Finglas)
2. Children’s University Hospital (Temple Street)
3. Mayo General Hospital