Clinical Trials is defined in the European Union Directive on Clinical Trials as follows: "Any investigation in human subjects, other that a non-interventional trial intended:
- a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more investigational medicinal products, or
- b) to identify any adverse reactions to one or more such investigational medicinal products, or
- c) to study absorption, distribution, metabolism and excretion of one or more such investigational medicinal products, or
- d) to discover, verify, identify or study any combination of the matters referred to at subparagraphs a), b) and c).
with the object of ascertaining the safety or efficacy of such products, or both"
- For each funded clinical trial a review fee of €1,000 plus €150 per trial site, in case of amendment a fee of €200 will apply. This fee is to cover administrative expenses.
- Please indicate which meeting you are submitting your study for.
- Submit to: The Administrator (REC), The Irish College of General Practitioners, 4-5 Lincoln Place, Dublin 2.
- Please remember when filling in the form that it will be read by and should therefore be comprehensive to some members of the Research Ethics Committee who are not doctors. This is particularly relevant when describing the object of investigation and any risks involved.
- Please note: Expansion of your case need not be restricted to this form.
Each application must be accompanied by:
- Study protocol.
- Application form.
- Data collection instrument (e.g. questionnaire).
- Research participant consent forms.
- Research participant information leaflet.
- Insurance / indemnity certificate (where appropriate).
- Curriculum vitae of the principal investigator.
Please submit all documentation in single bound form i.e. 3 copies x 1-7 above & 11 x 2- 7. These documents should be submitted to the ICGP, Three Weeks prior to the meeting. The attached Ethics Review form should be included and completed as appropriate.
The applicant/investigator/general practitioner must be available to attend for approximately 15-20 minutes at the meeting of the Committee, at the time scheduled. Written confirmation of time schedule will be issued prior to the meeting.
Written confirmation of the Committee's decision will be issued approximately one week from date of meeting.
Please note: In the case of amendments, queries, etc., subsequent to your application please refer to the date of your original submission, the date of the relevant Committee meeting/recommendation, and the study/protocol ref. number where applicable.