The Human Research Ethics Committee of the University of Trento was established in September 2005 to review and provide approval on research projects involving humans presented by academics and research groups of the University.
In the performance of its duties, the Human 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 Ethics Committee also aims to stimulate 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 beings which imply a risk for the participants must be submitted to the Human 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 as long as the project.
The PI of the research project shall submit the approval request to the President of the Ethics Committee through its administrative secretariat (segreteriacomitatoetico [at] unitn.it). The request must be submitted in Italian. English version is optional.
Requests must be drafted using the template provided by the Committee which is available for download in the Reserved area. PIs of the projects are required to download up-to-date templates every time they wish to submit a new approval request. The Committee reserves the right to update templates periodically according to current legal provisions or requirements for new types of research studies.
The application includes:
- a document containing the request for approval of a research protocol, the description of all the aspects of the protocol, and a declaration of commitment signed by the PI of the research project
- a document containing the list of attachments (please flag the documents that will be attached to the request) and some templates that may be useful (declarations that must be signed by the PI of the research project and by the Director of Department/Centre)
- privacy notice templates on the processing of personal and sensitive data with consent form
The documents must be sent to the Committee's secretariat by email in pdf format and must include scanned copies of all signed declarations, by the deadline scheduled in the Calendar available in the download box.
For each meeting of the Ethics committee has been set is a deadline to submit documents. The submission of documents by the deadline does not ensure that your documents will be examined in the upcoming meeting, because the agenda is drafted based on the number of requests in chronological order. Based on article 12 of its operational regulation, the Committee has to answer by three months from submission date.
The Secretariat reserves the right to not submit to the Committee incomplete protocols or requests drafted on outdated templates.
Changes to approved research protocols
Changes to approved research protocols must be submitted by the PI of the research project to the President of the Ethics committee through the committee secretariat (segreteriacomitatoetico [at] unitn.it). The request must be drafted in Italian.
The request for changes includes:
- a document containing the request for changes, with the description of every step of the protocol that will be modified and the justification. It may be necessary to change more parts of the protocols (and their attachments) based on the type of request.
- attachments, both required and optional, for every request for changes (submission depends on the type of protocol or the type of change).
Requests must be drafted using the template provided by the Ethics Committee which is available for download in the Reserved area. Templates are available for:
- requests for extension
- requests to designate a new PI of the research project
- notifications of changes in the research team
For all other changes pleade contact the Committee secretariat.
PIs of the projects are required to download up-to-date templates every time they wish to submit a new approval request. The Committee reserves the right to update templates periodically according to current legal provisions or requirements for new types of research studies.
The 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.
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.
Changes in the research team must be notified by the PI of the research project to the Committee secretariat through the relevant form. This type of change does not require approval from the Ethics Committee, which may request more information if the notification is incomplete or to carry out an evaluation.
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, research work requiring the processing of personal data must include procedures documenting that such processing is necessary and motivated by scientific reasons.
Data processors in research settings must:
- draft a research project:
a) complying with methodological standards of the relevant disciplinary area;
b) proving that the processing of data is carried out properly and effectively for statistical and scientific purposes that will be specified in the document.
- draft the privacy notice on the processing of personal data as required by legislation in force.
- submit the project (point 1) and the privacy notice (point 2) to the relevant department or centre, which will keep it stored as a confidential document for five years after the end of the research project.
The PI of a research protocol approved by the 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 his or her department or centre. The documents will be stored for 5 years from the date of the end of the research project.
Changes to approved protocols must also be filed and stored.
Original copies of signed declarations must be stored as well.
2019 award for dissertations on bioethics and biolaw
The Human Research Ethics Committee launches every year a selection procedure to award a prize to dissertations focusing on subjects regarding bioethics and biolaw, to raise awareness among the University students on the matters it deals with.