Scientific Research Ethics Committee

Applicants should send the documents required to obtain the approval of the Scientific Research Ethics Committee only by email to etica.cercetare@umfcluj.ro in an archived folder (rar) named Principal Investigator_Name, which includes separate files (word or pdf, not scanned) with each document requested by the Ethics Committee, saved under the name: Name_Name_type document (Principal Investigator’s first and last name, document type – e.g. Form Advice (FA), Informed Consent Form (ICF), Research Protocol (PC), Non-Technical Summary (NTS), etc. ). Files sent to other addresses will not be considered!

If there are requests to modify or complete the documents, they will be sent by email to the applicant, who will have to make the changes and highlight them (possibly with track changes), and the modified document will be sent back to the committee at the same address ( etica.cercetare@umfcluj.ro ), the evaluation period being suspended until the file is completed.

For studies involving human subjects, the dossier should contain an Application without a prescribed format including the type of study (prospective clinical, retrospective, observational, time and place of conduct – Attention! The period proposed for the conduct of the study must be subsequent to obtaining the Ethics Committee’s opinion and must take into account the time required to obtain this opinion), the Protocol of the study to be submitted for approval (Attention, it is not equivalent to the research project of which it is part), the approval form completed on both pages under the following headings: title of the project and name of the investigator, place of the study, attached documents to be assessed (research protocol, form for obtaining informed consent, questionnaires applied, non-technical summary, etc., depending on the type of study), as well as the Personal Data Processing Agreement (for clinical trials; to be filled in by the subjects participating in the study), other information (e.g. Questionnaires applied). The Guidance Model for drafting informed consent, Information to be included in the Clinical Trial Protocol, Recommendations for obtaining the Ethics Committee’s opinion can be found on the Intranet page, in the section Scientific Prorectorate, Studies involving human subjects.

For projects involving animal experimentation, the Ethics Committee examines the following documents: Application without a required format to the Research Ethics Committee for the evaluation of the study, Application to the University Management specifying the principal investigator, the work/project of which the study is part, the source of funding, the Research Protocol, the Non-Technical Summary (Appendix 4), the Opinion Form completed on both pages under the following headings: Project title and name of the investigator, Location of the study, Attachments to be assessed (research protocol, informed consent form, questionnaires applied, non-technical summary, etc. , depending on the type of study) and evidence of the competences required to carry out the activity in the field of breeding, supply and use of animals for scientific purposes.

The following documents are required for the authorisation of the experiment by ANSVSA: Favourable opinion of the Ethics Committee, Conclusions of the Ethics Committee, Application for authorisation of the project, Annex 1 – Application for authorisation of the project, Annex 4 – Non technical summary, Annex 5 – Declaration of no previous project, Authorisation of the biobank. The authorisation of the biobank where the experiment will actually be carried out must be attached: UMF Biobank, Medfuture Research Centre Biobank, Physiology Biobank or Physiopathology Biobank. Templates for the preparation of these documents, the authorisations of the 4 biobanks and further information are available on the Intranet page, in the section Prorectorat Scientifique, Experimental studies on animal models.

All documents will be submitted to the Secretariat of the Scientific Research Ethics Committee from the outset. From 21.02.2021 the Methodological Rules on minimum requirements for education and training and requirements for obtaining, maintaining and demonstrating competence to carry out work in the field of breeding, supply and use of animals for scientific purposes entered into force – please consult the information available on the Intranet before completing the documents. After obtaining the veterinary authorisation, in order to conduct the procedures smoothly, it is essential to carry out a schedule of procedures. Scheduling should be done 3 months before the start of the experiment at the following email address: biobazaumf@gmail.com , attaching a copy of the authorisation and specifying the number of animals required.