|
Research
Ethics Committee
The Research Ethics
Committee (REC) at Sligo General Hospital (SGH) is charged with the
responsibility of independent review and surveillance of Clinical Trials
referred to it under the European Communities (Clinical Trials on
Medicinal Products for Human Use) Regulations 2004. The Committee shall
act in relation to clinical trials of all descriptions and classes other
than those to which Regulation 13 (4) refers( i.e. gene therapy, somatic
cell therapy etc.).
Click here to view the list of recognised RECs in Ireland.
The REC will also be
available to carry out review of research studies in the SGH catchment
area (Counties Sligo, Leitrim, South Donegal and West Cavan) that are
not classified as clinical trials and which involve human subjects.
New Application Form
In September 2010, the REC
adopted a new standard application form for non-clinical trials. This
form is the outcome of a collaboration with other RECs in Ireland,
various national stakeholders (IMB, State Claims Agency, Office of Data
Protection Commissioner, Irish Council for Bioethics) and was
facilitated by Molecular Medicine Ireland. The REC would welcome
feedback from applicants using the new form.
Committee
Chairman:
Dr. John Williams
Sligo
General Hospital
Sligo
071 91 71111 ext 4636
Administrator:
Mette Jensen Kavanagh
ETC Building
Sligo
General Hospital
Sligo
071
91 71111 ext 4204
mette.jensen at hse.ie
NB: Please
make contact with the REC administrator (preferably by email) before
forwarding your study in hard copy.
All
submissions must include:
NB: Applicants
for Multicentre Clinical Trials, please complete the DoHC standard
application form. Applicants for all other studies, please complete
the SGH REC application form
Where
applicable the PI must also submit:
-
Application fee of
€1,000 (Clinical Trials only)
-
Application fee of
€600 for industry sponsored studies that fall outside the remit of
SI190 (reduced fee of €150 for studies that have already been
approved by another recognised REC)
-
Consent
form (1 hard copy & 1 e-copy)
-
Subject
information sheet (1 hard copy & 1 e-copy)
-
Advertisement
for subjects (1 hard copy & 1 e-copy)
-
GP/Consultant
information letter (1 hard copy & 1 e-copy)
-
Interview
schedule (1 hard copy & 1 e-copy)
-
Letter
of invitation to research subjects (1 hard copy & 1 e-copy)
-
Questionnaire
(1 hard copy & 1 e-copy)
-
Investigative
brochure or data sheet for IND (1 hard copy)
-
Letter
of Medical Indemnity (1 hard copy)
-
Letter
of confirmation of insurance (1 hard copy)
-
Irish
Medical Board approval for IND (1 hard copy)
Note:
All questions on the application form must be addressed.
Incomplete
forms will be deemed invalid and will not be reviewed by the REC.
Submissions
to the REC must arrive with the administrator three weeks prior to a REC
meeting. All submissions/correspondence
must be directed to the REC Administrator
Click
here to download:
REC
Standard Application Form for non-clinical trials
Guidance Manual to Standard
Application Form
Check
list for applicants to REC SGH
Signature page for REC SGH
Applicants
DoHC standard application form
Sample Research
Subject Information Sheet (General)
Sample
Research Subject Information Sheet (Qualitative Research)
Sample Research
Subject Information Sheet (Survey)
Consent
Form
Annual Status
Report Form
Termination
Report Form
Amendment
Notification Form
Sample
introductory letter
REC Terms of Reference Sept 2010
REC meeting dates
2012
|
