Research projects that involve experimentation with humans and that may involve a risk for the participants must be submitted for approval by the UniTrento Research Ethics Committee.
As a Scientific Manager of a project requesting access to the CIMeC Facilities, you are responsible for completing the following steps:
1) Before submitting the project to the UniTrento Research Ethics Committee, submit the research project to the Lab Managers / Scientific Advisors of the Facilities where the research will be conducted.
This presentation has the purpose of evaluating in advance the technical-methodological and safety feasibility and the availability of resources and to evaluate any non-standard technical methodological needs.
To organize the presentation of the project, contact the Facility staff by email (see also the specific guidelines indicated in the paragraph “Progetti” of the Access Rules of the Facility):
BABY LAB: babylab.cimec at unitn.it - link to BabyLab Specific Access Rules
EPL: eplab.cimec at unitn.it - link to EPL Specific Access Rules
MEG: meglab.cimec at unitn.it - link to MEG Specific Access Rules
RM: mrilab.cimec at unitn.it - link to the presentation draft and to MRI Specific Access Rules
TBS: tbslab.cimec at unitn.it - link to TBS Specific Access Rules.
2) After receiving the approval from the Facility/ies send the forms of request for approval to cimec at unitn.it at least 1 week before the foreseen submission to the Research Ethics Committee (see Applying for ethical approval /Reserved area).
The Secretariat will make the Director sign the Annex 1.2.2 - “Dichiarazione di disponibilità di tempo, risorse e personale per condurre la ricerca da parte del responsabile del progetto”.
Aggiungere i templates dei vari laboratori
Standard Protocol MRI Lab V3
Research Ethics Committee's meetings calendar
- Documents bearing the signature of the Scientific Responsible are digitally signed.
- Only in the event that the Scientific Responsible does not have a digital signature, he/she will sign (olograph signature), scan the document attaching his/her identity document.
- Each member of the research group signs (olograph signature) the Annex 7.4.1 - "Declaration of commitment to comply with the provisions of the Deontological Rules for treatments for statistical or scientific research purposes" and scans it together with his/her identity document (an attachment 7.4.1 for each member of the research group). The Annex 7.4.1 must also be signed by the Facility’s technicians who have access to the data.
3) Obtain the Research Ethics Committee Approval for the project.
4) As requested by UniTrento, send the CIMeC Secretariat (Valeria Nencini - Mattarello) all the documents containing either holographic signatures or, alternatively, scanned signatures accompanied by the identity document of the signer to allow their storage:
- Dichiarazione Responsabilità
- All. 1.2.2 - Dichiarazione di disponibilità di tempo, risorse e personale per condurre la ricerca da parte del responsabile del progetto
- All. 7.4.1 - Dichiarazione di impegno a conformarsi alle disposizioni delle Regole deontologiche per trattamenti a fini statistici o di ricerca scientifica
- All. 1.3.2 - Dichiarazione di idoneità di eventuali studenti di Corso di Laurea o Corso di Laurea Magistrale o tirocinanti a firma del responsabile del progetto (if applicable)
- all the documents of the of subsequent amendments.
5) Make sure people of your research group who need to use the Facilities complete the mandatory courses, as indicated in the paragraph “Regole di accesso e formazione obbligatoria” of the Access Rules of the Facilities where the experiments will be held.
Course MEDIUM RISK
for Academic staff: you will be directly contacted by UniTrento Ufficio Formazione
for PhD and Master students
6) If you don't have your own funds to reimburse volunteers, contact Luca Turella (for LNiF) or Veronica Mazza (for EPL) to obtain CIMeC funds.
See Project participants/reimbursement
7) If you have your own fund(s) to pay for the use of facilities, check in CLARA that your fund(s) has enough money.
8) Communicate to the Research Ethics Committee and cimec at unitn.it the starting date of your project.
10) After the end of the project, show the scientific results of the research project, by handing in a written report and by giving a presentation Project Results Presentation (PRP).
11) Keep the privacy documents that you made your volunteers sign and at the end of the project, send them to the CIMeC Secretariat (see CIMeC Policy Storage of Documents).
NB: in case of MRI experiments, pay attention to having the volunteers sign the privacy documents of your project. The documents that the MRI staff have the volunteers sign and keep, in fact, do not replace those of your project, but have another purpose.
Inserire la parte o il link di How to di autoiscrizione in Clara.
Remember to cc cimec at unitn.it in any communication you send to the Secretariat of the Research Ethics Committee. This lets the CIMeC Secretariat update the project management system (CLARA) which allows the labs booking system to function correctly.