Procedure for requesting the opinion of the Ethics Committee

The opinion of the Ethics Committee can only be requested online via the online form (see below);
In order for the request to be inserted into the order of the day, the online form must be filled out and sent 15 days before the Committee is due to sit. If this does not happen, the matter will be examined in the following meeting.
 
The figure responsible for the research project in question (Principal Investigator) can be summoned by the Ethics Committee in the event of a particularly complex project.
 
The opinion of the Ethics Committee is communicated to the applicant by the Administration Department within seven days of the Committee minutes being approved;
In the event that the Committee requests modifications, clarifications or additional documentation, the Principal Investigator must respond as quickly as possible (this can be done via email);
 
The members of the Committee then express their opinion or formulate any additional observations within 3 (three) days of receiving a response to their request for additional findings;
The Ethics Committee administration will then ensure they communicate the definitive opinion to the Principal Investigator within seven days of definitive approval.
Instructions for requesting the opinion of the Ethics Committee - Step 1: Opinion request forms

The Committee has prepared two types of opinion request forms - one for experiments involving humans or human biological material and another for experiments involving other living beings/animals;
Opinion request form for experimentation on human beings or studies involving human biological material
Opinion request form for experimentation on living beings/animals

 

Step 2: Frameworks for informed consent/consent to participate in research

Step 2: Frameworks for informed consent/consent to participate in research
For research projects involving human beings, the Ethics Committee has produced a number of frameworks designed to help the Principal Investigator in producing “Informed consent to participate in research” documentation. The frameworks have been produced based on European and Italian legislation and with consideration to the current ethics and legal debates around relevant matters. This means that the frameworks comply with the ethical and legal requirements, something that has been verified by the Ethics Committee itself. They must be used as a base/model upon which to produce the informed consent document for individual research projects.

Step 3: Data processing authorisation forms for adults and minors

In accordance with the University's Data Protection Officer (RPD), the Ethics Committee has also produced a number of forms designed to assist with obtaining authorisation for personal data processing for scientific purposes.

Steps 4 and 5: Attachments and online form instructions

In addition to the above forms and frameworks, the online form requires applicants to upload additional attachments (all points indicated in the form refer to the field of research in question).
The online form must include the following attachments:

  • Completed opinion request form;
  • Principal Investigator CV (only if external to UNIMIB);
  • CVs of other participating researchers (only if external to UNIMIB);
  • Copy of information flyer or letter and invitation to participate in research;
  • Letter of authorisation from relevant bodies for access to data or involvement of participants;
  • Signed declaration by the head of the facility in which the research is to take place;
  • Bibliography;
  • Comprehensive insurance contract;
  • Consent information and declarations (frameworks);
  • Personal data processing information and authorisation (forms).

Fill out the online form:

Opinion request - experimentation on human beings or studies involving human biological material
Opinion request - experimentation on living beings/animals

Step 6: Notification of delivery of opinion request

Notification of compilation of the online form is sent:

  • to the applicant; 
  • to the Ethics Committee;
  • to the Protocol Office.

By compiling the form online, applicants do not need to send the file electronically to the Ethics Committee or present a paper copy to the Protocol Office.

Contacts

For more information and support on placing an opinion request, please write to us at: comitatoetico@unimib.it

contact:
Ms Barbara Facciotto – Tel. 02 6448 6581
Supervisor: Ms Emanuela Mazzotta – Tel. 02 6448 6437
Institutional Affairs and Communications Department
Regulations, Bodies and Elections Office
Building U6, fourth floor
Piazza dell'Ateneo Nuovo 1, Milan

by Ufficio Affari Istituzionali e Comunicazione, last updated on 15/06/2020