Online application to Ethics Committees
The Ethics Committee of the School of Medicine, University of Zagreb checks and supervises whether the proposed scientific research on human subjects (as part of the registered research programs and projects, thesis proposals, and student research papers) respects and applies ethical and professional principles that all researchers must adhere to. After a positive evaluation of the submitted proposals, the Ethics Committee issues a document Consent of the Ethics Committee of the School of Medicine for Conducting the Proposed Research and delivers that document (depending on the specific subject) to the following persons or committees:
- Leader of the proposed research project and/or program
- Department for Science, Knowledge Transfer and Innovation (for the Vice-dean for Science)
- To the head and ethics committee of each institution (except the School of Medicine) where the said research is planned to be conducted
- To the author of the thesis proposal
- Board for PhD Theses
- Author of the student's research paper
- Committee for Student Research Papers
Regarding the proposals for research projects and programs, the project principal investigators and/or the program director do not need to submit a complete project proposal on the forms of the Ministry of Science and Education to the Ethics Committee of the School of Medicine, but are required to fill in the appropriate forms of the Ethics Committee (available on this website - primary form in any case, and additional forms as needed) and in it accurately and concisely describe the goals and procedures of human research. Please note that in addition to the prescribed forms, you are also required to submit all relevant attachments and certificates (e.g., approvals from the ethics committees of other institutions where the research is conducted, and, especially, the Information for the Respondent and their Consent to Participate - see the list of required attachments and certificates). Relevant attachments and certificates are required to be submitted not only by the project principal investigators and/or program directors, but also by persons who submit thesis proposals or student research work proposals for evaluation.
All necessary documentation is submitted through the Registration Office to the Department for Science, Knowledge Transfer and Innovation (administrative secretary of the Ethics Committee: Ivana Šiprak), Šalata 3, with the subject For the Ethics Committee of the School of Medicine at least 7 days before the regular monthly meeting of the Committee (see the Schedule of the sessions of the Ethics Committee). If the Ethics Committee of the School of Medicine determines that the consent of the Central Ethics Committee for Clinical Trials of Drugs and Medical Products of the Ministry of Health of the Republic of Croatia needs to be obtained for the research in question, it will request that consent. Such additional consent is particularly necessary for research which:
- Test the effectiveness and harmlessness of a drug that is not registered in the Republic of Croatia, but is registered in the countries of the European Union;
- Test the effectiveness and harmlessness of a drug that is registered in the Republic of Croatia, but has not been used so far: (a) for the indication specified in the research, (b) in the age population proposed for research in the project, or (c) in the dose proposed in the project;
- Test the safety and effectiveness of the new diagnostic method (if necessary);
- Test the safety and effectiveness of the new operational approach (if necessary);
- Perform in vitro experiments on human cells (if necessary).
After the School Management approves the proposal of the research project and/or program, i.e. after the thesis proposal is accepted by the Faculty Council, and the proposal of the student's research paper is accepted by the Committee for Student Research Papers, the research principal investigator is obligated to inform the heads of all institutions and organizational units (e.g. deans, directors, heads of departments or clinics) in which the research will be conducted (in accordance with Article 65 of the Health Care Act, Official Gazette 121/03, and Article 20 of the Patients' Bill of Rights, Official Gazette 169 /04).