Application to the Ethics Committee
The Ethics Committee of the Canton of Zurich has been reorganised. Please note that the new structure and the new application process will take effect on 1 October 2009 (revised 6.8.2010). For more information see http://www.kek.zh.ch/ or call 044 255 59 60
Applications can be submitted continuously to the Scientific Office of the Cantonal Ethics Committee, Sonneggstrasse 12, 8091 Zurich, where their content will be evaluated. For this preliminary evaluation only send ONE specimen of the application with one CD. Only after passing this evaluation successfully, the rest of the specimens (required amounts mentioned below) have to be submitted with the corrected application form on CD.
1. Cover letter: short, dated (in letter form) and bearing the signature of the person responsible for the application (full details of sender, including telephone no., fax no. and e-mail address). (15 copies)
2. Application form (see ‘Application form’ on sub-page) for making an application to perform biomedical research, signed and dated. Current list of collaborators with status date. (15 copies)
3. Summary of study protocol (see template on sub-page), in German, understandable for an interdisciplinary committee, dated, no longer than 6 A4 pages. (15 copies)
4. Information for test persons (in German and possibly other languages, date written, version nbr.) according to template on sub-page or under http://www.swissmedic.ch/bewilligungen/00089/00283/index.html?lang=de (15 copies)
5. Declaration of consent for test persons (in German and possibly other languages, with date written, version nbr.) according to template on sub-page or under http://www.swissmedic.ch/bewilligungen/00089/00283/index.html?lang=de (15 copies)
6. Study protocol (template on sub-page): signed by the applicant and the sponsor, dated, final version (in German or English) (4 copies)
7. Amendments to the study protocol (if any): signed and dated.(4 copies)
8. CRF (Case Report Form = Data collection sheets), i.e. a list of the collected parameters. (4 copies)
9. Condensed CV of the person responsible for the application and fellow applicants (up-to-date, dated, signed, excluding publication list but with proof of training and/or experience in GCP). (4 copies)
10. Letters of notification from and correspondence with other Ethics Committees (if any) (4 copies)
11. Insurance certificate (for Balgrist already deposited at the Ethics Committee Office) (4 copies)
12. Contract between researchers/sponsor/CRO, including financial agreements, with the required signatures (from hospital/institute management). For universities: Unitectra tested. (4 copies)
13. Additional information: compensation for test persons, ads/flyers, information letters for general practitioners, questionnaires, interview guidelines, logs, patient record card, scientific literature, vote by SNF, etc.). (4 copies)
14. Investigator's brochure, dated, not more than one year old or any other specialist information (publications, excerpts from compendiums) (2 copies)
15. CD-ROM with entire application. (1x)
Link to the Swiss Ethics Commissions for Clinical Research
|