Each thesis requires an evaluation of the ethical aspects.

Some types of thesis must include the acquisition of the opinion of the Ethics Committee (EC). There are various Ethics Committees, which can be contacted depending on the subject of study:

If patients can be enrolled in a healthcare facility, depending on where the facility is located, we turn to CE AVEC for the provinces of Bologna and Ferrara, CE CEROM for the Romagna area and CE AVEN for the provinces of Piacenza, Parma , Reggio Emilia and Modena;

If natural persons, outside of healthcare facilities, contact the Bioethics Committee;

If animals, please contact the Animal Welfare Committee.

Pay attention to the timing! It is advisable to consult the calendars in which the ethics committees meet and the deadlines for sending requests.

The Supervisor is the reference figure, who remains responsible for identifying the type of thesis.

The Department to refer to is that of your Supervisor. The indication of the relevant Department is shown on the UNIMORE teacher page, which can be reached through the University address book.

Compilatory thesis

It concerns the analysis, description and discussion of information already published (mainly conducted on bibliographic documentation)

Report the following statement in the incipit of the thesis: "This thesis does not require the opinion of the CE."

Application thesis with a pre-eminent educational purpose

Collection and/or consultation of clinical data with analysis/monitoring of case studies within the Operational Units; clinical audits or similar activities, to improve the quality of healthcare.

The opinion of the Ethics Committee is ONLY necessary if the data treated in the thesis can likely be the subject of scientific publication.

Once the opinion has been obtained, report the following wording in the incipit of the thesis: "The study [title of the study] whose Scientific Director is Dr. [name and surname] has been authorized by the CE with the following details [reference] and has obtained the authorization from the competent Health Authority with the details [authorisation reference]. For the purposes of preparation and drafting, pseudonymized or identifying data were used for which specific consent to processing was granted by the company [company name]/institution [institution name]).

Application thesis with a primary scientific research aim

Papers that involve the conduct of observational studies, interventional studies with the administration of a medicine or food supplement, studies with the use of a medical device, surgical techniques or innovative diagnostic means, studies on new organizational models, studies with human tissues in vitro.

Request opinion from the Ethics Committee

Once the opinion has been obtained, report the following wording in the incipit of the thesis: "The study [title of the study] whose Scientific Director is Dr. [name and surname] has been authorized by the CE with the following details [authorisation reference] and has obtained the authorization from the competent Health Authority with the details [authorisation reference] For the purposes of preparation and drafting, pseudonymised or identifying data were used for which specific consent to processing has been issued by the company [company name]/institution [institution name])"

Do not contact the CE if:

• the study which is the subject of the thesis has already received the opinion of the Ethics Committee. However, the name of the graduating/diploma student must be included among the investigators and must have been "authorized to process health data"
• the research concerns a study in which the data collected guarantees the absolute anonymity of the respondent right from the source
• the research is carried out on cell lines acquired from commercial sources
• the study is a secondary research activity (systematic reviews or meta-analyses)
• in all these cases, report the following statement in the incipit of the thesis: "This thesis does not require the opinion of the CE"

Application thesis in the non-healthcare field

Studies carried out in non-welfare facilities and without interventions by qualified healthcare personnel. The University Bioethics Committee is responsible.

Application thesis involving the use of animals (or their tissues/cells)

The Animal Welfare Service in the University's teaching and scientific structures is responsible and the project will be submitted to the Ethics Committee for Animal Experimentation.

If you have doubts regarding the type of your thesis, you can follow the orientation path.

According to the provisions of the EU General Data Protection Regulation 2016/679 (GDPR) relating to the protection of natural persons with regard to the processing of personal data, to use the data of natural persons it is necessary that:

the owner of the data expresses explicit and conscious consent to the use of the same on the basis of the elements provided for in the information;

the user has been designated to process the same data.

In these cases in which the data is used anonymously and/or collected in such a way as to prevent or no longer allow the identification of the interested party, even by resorting to correlations with other databases, there are no further requirements to be activated.

Attention! It must be verified who has the burden of ensuring data protection and is therefore the data controller. The possibilities are:

The owner of the data is the University of Modena and Reggio Emilia. In this case, in order to be authorized for processing, write to:affarigenerali@unimore.it with the subject “Data processing designation – Thesis”.

The data owner is the healthcare facility (typically when referring to the processing of data deriving from the healthcare company's medical records). In this case it is necessary to request authorization to process the data.

Some useful concepts for dealing with the matter of personal data protection:

data controller: natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data;

data controller: natural or legal person, public authority, service or other body which processes personal data on behalf of the data controller;

recipient: natural or legal person, public authority, service or other body which receives communication of personal data;

consent of the interested party: any free, specific, informed and unequivocal expression of will of the interested party, with which he or she expresses his or her assent, through a declaration or unequivocal positive action, that the personal data concerning him or her be processed;

biometric data: personal data obtained from a specific technical processing relating to the physical, physiological or behavioral characteristics of a natural person which allow or confirm unique identification, such as facial image or fingerprint data;

health data: personal data relating to the physical or mental health of a natural person, including the provision of healthcare services;

pseudonymisation: Processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately.