The Research Ethics Committee of the University of Trento has the main function of evaluating and expressing opinions on research projects involving human subjects presented by individual researchers or research groups belonging to the University or to affiliated Institutions, which imply risks for psychological and physical well-being of participants involved, and which may possibly also limit their right to privacy, information and autonomus decision-making.
In the performance of its duties, the Research Ethics Committee complies, taking a pluralist view, with national, European and international regulations, codes of conduct and codes of ethics. It is inspired by the principles established on the basis of good clinical practice and experiments involving human participants, bearing in mind the current version of the Declaration of Helsinki.
The Research Ethics Committee also aims to foster awareness raising initiatives on ethical issues for all University members and the entire community of citizens.
Applying for ethical approval
All research projects involving experiments with human subjects which imply a risk for the participants must be submitted to the Research Ethics Committee for approval.
Approval requests can be submitted by the Principal Investigator (PI) of the research project, who has to be a member of UniTrento or employed within a grant or a contract lasting at least the entire duration of the project.
The PI of the research project shall submit the approval request to the President of the Research Ethics Committee through its administrative secretariat (segreteriacomitatoetico [at] unitn.it). The request must be submitted in Italian. English version is optional.
The application includes:
- one file with the approval request form, the description of all aspects of the protocol and a declaration of commitment signed by the PI of the research project;
- a file with the list of required attachments (flagging which ones will be included in the request and which will not) and some useful templates;
- Guidelines on how to fill in the approval request.
Approval requests must be drawn up using the templates provided by the Committee itself, available in Infoservizi. PIs are invited to download the updated forms for each new approval request. CER reserves the right to modify the forms based on regulatory updates or the needs relating to new types of research.
The documents must be sent to the Committee's secretariat by email in pdf format, by 2 separate files, 1 for the request and 1 for attachments, and must include scanned copies of all signed declarations, by the deadline scheduled in the Calendar available at the bottom of the page.
The submission of documents by the deadline does not ensure that your documents will be examined in the upcoming meeting, since the agenda is drafted based on the number of requests in chronological order.
The Secretariat reserves the right to not submit to the Committee incomplete protocols or requests drafted on outdated templates.
Based on article 12 of its operational regulation, the Committee has to answer by three months from submission date.
Protocol amendment submission
Amendments to approved research protocols must be submitted by the PI of the research project to the President of the Research Ethics Committee through the Committee secretariat (segreteriacomitatoetico [at] unitn.it). The request must be drafted in Italian.
- amendments request formwith the description and the justification of of changes to an ongoing currently approved protocol;
- required attachments for each specific chamge.
Amendments must be drafted using the template provided by the Research Ethics Committee which is available for download in Infoservizi. Templates are available for:
- extension request;
- notification of changes in the research team;
- new PI designation request;
- experimental procedure change request.
PIs are required to download up-to-date templates for each amendment submission. The Committee reserves the right to update templates periodically according to current legal provisions or requirements for new types of research studies.
Documents must be sent to the Committee's secretariat by email in pdf format in due time and must include scanned copies of all signed declarations. The Committee secretariat reserves the right to not submit to the President incomplete documents or requests drafted on outdated templates.
Based on article 11 of its operational regulation, the Committee may task its President to examine and, if appropriate, approve, any changes to research protocols that have already been approved. The President can be assisted by a sub-committee. The Committee secretariat reserves the right to not submit to the President incomplete documents or requests drafted on outdated templates.
The duration of the process may vary based on the type of request; the change is inserted effectively on the written approval date, signed by the President and sent by the Secretariat to the PI.
Storage of approved research protocols
Under the provisions of regulations on the protection of people with regard to the processing of personal data, i.e. Regulation (EU) 2016/679 and legislative decree no. 196 of 30 June 2003 (Personal Data Protection Code), as modified by legislative decree no. 101 of 10 August 2018, the PI of a research protocol approved by the Research Ethics Committee which includes the processing of personal data is required to store documents regarding the protocol, with the part on the processing of personal data and the original copies of signed declarations, at the premises of the relative Department or Centre for 5 years from the date of the end of the research project.
Amendments to approved protocols must also be filed and stored.
Research Ethics Committee forms
Required forms are available, after logging into MyUnitn, at Infoservizi.
Meetings calendar 2021
- 21 January (documenrts submission deadline: 31/12/2020)
- 18 February (documenrts submission deadline: 28/1/2021)
- 18 March (documenrts submission deadline: 25/2/2021)
- 22 April (documenrts submission deadline: 1/4/2021)
- 20 May (documenrts submission deadline: 29/4/2021)
- 10 June (documenrts submission deadline: 20/5/2021)
- 15 July (documenrts submission deadline: 24/6/2021)
- 9 September (documenrts submission deadline: 19/8/2021)
- 21 October (documenrts submission deadline: 30/9/2021)
- 18 November (documenrts submission deadline: 28/10/2021)
- 16 December (documenrts submission deadline: 25/11/2021)
The submission by the deadline does not necessarily imply that documents will be examined in the immediately upcoming meeting.
Dates may be subject to change.