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.

Regardless of the clinical (or non-clinical) classification of the study, whenever the protocol foresees 1) the involvement of patients, 2) or involves procedures that fall under the direct or agreed responsibility of the Provincial Health Service 3) or that aim to the production of knowledge objectives with a direct health relevance (diagnostic, therapeutic, health care), the study must be considered under the responsibility of the Territorial Ethics Committee of the Autonomous Province of Trento for clinical trials (CET-PAT).

application/pdfRegolamento Comitato Etico per la Ricerca(PDF | 418 KB)
application/pdfCodice etico di Ateneo(PDF | 386 KB)
application/pdfOperational procedures (in italian)(PDF | 104 KB)

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.

Ethics-Self-Assessment

The University provides an Ethics-Self-Assessment (ESA) questionnaire to support researchers in evaluating the type of risk of their research protocol, based on which four different outcomes and procedures are identified:

A − The level of risk determines the need to request an opinion from the CER UniTrento through the completion of the opinion request form and the preparation of necessary attachments.

B − The risk type and the nature of the research project are outside the competencies of the CER UniTrento and require an opinion from the Territorial Ethics Committee of the Autonomous Province of Trento for clinical trials (CET-PAT).

C − The risk level concerns exclusively data treatment. Therefore, there is no need to request an opinion from any Ethics Committee. In this case, the completion of the project privacy form is required, with support from the Privacy Office if necessary.  However, the researcher may in any case decide to request an opinion from the CER if deemed appropriate..

D − The risk level does not determine the need to request an opinion from the CER through the completion of the form and the preparation of necessary attachments. However, the researcher may in any case decide to request an opinion from the CER if deemed appropriate.

In cases C and D, the researcher, after saving and sending the .pdf file containing the provided answers and the obtained results to the email address segreteriacomitatoetico [at] unitn.it, can request the issuance of a CER document certifying that, based on the researcher’s statements, the project does not present ethical issues.

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 includes:

  • 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; 
  • changes in the research team request; 
  • 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 2024

  • 25 January (document submission deadline 31/12/2023)
  • 22 February (document submission deadline 1/2/2024)
  • 21 March (document submission deadline 29/2/2024)
  • 18 April (document submission deadline 28/3/2024)
  • 16 May (document submission deadline  25/4/2024)
  • 20 June (document submission deadline 30/5/2024)
  • 18 July (document submission deadline 7/6/2024)
  • 19 September ( document submission deadline 29/8/2024) 
  • 17 October (document submission deadline 26/9/2024) 
  • 14 November (document submission deadline 24/10/2024)
  • 12 December (document submission deadline 21/11/2024) - full session
  • n.b. for the January 2025 session, the deadline for submitting documents is 31/12/2024.

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.