Access rules

General rules

Before accessing the Facility, all users must complete the general safety training supplied by UNITN via an online procedure~~:

• The “Health and Safety at Work Course - General” (for Principal Investigators and Research Fellows: / forPhD students and students). If the user has not already completed this, the course is provided by UNITN and has unlimited validity; once passed, the user must enter the result into CLARA by uploading the course completion certificate;
• The "Guidelines to Privacy and the General Data Protection Regulation (GDPR)” Course and the specific module “Guidelines to Privacy and the General Data Protection Regulation (GDPR) - RESEARCH MODULE" (https://didatticaonline.unitn.it/ateneo/). The courses are supplied by UNITN; once passed, the result must be entered into CLARA, by uploading the course completion certificates certificate of successful completion of both courses.

 

Users must also complete a specific training, which depends on the type of study to be conducted (behavioural or EEG, further details below). 

Once the necessary training has been completed, access to the BabyLab must be booked (see Booking system). Users can only access the resources (laboratories and/or equipment) strictly necessary for conducting their studies, as described in CLARA.

Behavioural studies

Behavioural studies are usually associated with low risk. For this reason, users intending to conduct behavioural studies must have successfully completed the basic training course “Health and Safety at Work Course - SPECIFIC TRAINING - Low Risk” prepared by UNITN. Once passed, the result must be entered into CLARA by uploading the course completion certificate.

Users must also attend a brief internal training regarding:

•  The acquisition of the guidelines described in this Regulation;
•  The correct use of the equipment for behavioural studies;
•  Appropriate conduct in interacting with infants and their parents/legal guardians based on respect for safety measures, the protection of privacy and, in general, the need to ensure that the infants and the adults accompanying them feel safe and at ease at all times.

Users who have completed the training described above will receive a training certificate to be uploaded to CLARA; once entered, they will then be able to access the BabyLab room dedicated to behavioural studies by booking it on CLARA.

Laboratory activities relating to behavioural studies – including booking resources – can be carried out autonomously, even by students/trainees after having completed the specific training delivered by the Lab Manager and/or those responsible for the research project who have previously completed this same training.

Because all behavioural studies carried out at the BabyLab involve infants, authorisation of the associated research project by the corresponding Ethics Committee is required.

EEG studies

For EEG studies, in addition to the general training listed above, a “medium risk” safety course must also be completed (https://didatticaonline.unitn.it/ateneo/). If the user has not completed it yet, the course is provided by UNITN and is valid for 5 years; once passed, the user must certify it in CLARA by uploading the course completion certificate .

The use of the EEG system is also subject to possession or acquisition of the skills necessary to use them. Inexpert users must complete an internal training course managed by the BabyLab Facility staff, which grants access on two levels:

•  Level 1 - Non-expert user: access to the laboratory and equipment, but only when supervised by a level-2 user (expert user).
•  Level 2 - Expert user: autonomous access to the laboratory and equipment.

Level 1 authorisation (non-expert user)

Level 1 access authorisation allows the user to access all premises of the Facility and all EEG equipment but only when supervised by a level-2 user (expert user). To obtain this access, the user must complete a brief general training on:

•  The acquisition of all the guidelines described in this Regulation;
•  The correct use of the EEG equipment;
•  Appropriate conduct in interacting with infants and their parents/legal guardians based on respect for safety measures, the protection of privacy and, in general, the need to ensure that the infants and the adults accompanying them feel safe and at ease at all times.          

Users who have completed the training described above will receive a training certificate to be uploaded to CLARA; once entered, they will then be able to take part in EEG studies, supervised by an expert user.

Level 2 authorisation (expert user)

Level 2 access authorisation allows the user to access all premises of the Facility and all EEG equipment autonomously. Granting of level-2 user status occurs following completion of an internal training course focussed on the data acquisition procedure. This involves a period of shadowing an expert user during EEG studies and concludes with a final test of skills acquired, during which the users must show that they are able to autonomously conduct an entire experimental session and correctly apply all rules, particularly those relating to privacy and data security. After long periods of inactivity or any proven failure to observe procedures, an assessment of the degree of user autonomy may be conducted.

Users who have completed this training will receive a training certificate to be uploaded to CLARA; once entered, they will then be able to access the BabyLab by booking it on CLARA and can conduct EEG studies autonomously.

NB: Students/trainees can obtain level 1 authorisation; they cannot obtain level 2.

Each EEG study carried out in the BabyLab Facility must be accompanied by advance approval from the corresponding Ethics Committee, before beginning.

To guarantee maximum safety in managing such a delicate population, there must be at least two investigators present for all EEG studies.

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