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Ethics Committee and Final Examination

ETHICS COMMITTEE

Each thesis requires an evaluation of the ethical aspects.

Some types of theses must obtain the opinion of the Ethics Committee (EC). There are several Ethics Committees; the one to be contacted depends on the subject of the thesis:

- If patients can be enrolled in a healthcare facility then it depends where the facility is: contact 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 the participants are not enrolled in a healthcare facility, contact the Bioethics Committee;

- If the participants are animals, contact the Animal Welfare Committee.

Pay attention to the timing! It is advisable to consult the schedule of the ethics committees’ meetings and the deadlines for sending requests.

The Supervisor is the reference contact responsible for identifying the type of thesis.

The Department to refer to is the one your Supervisor belongs to. The UNIBO faculty page indicates the relevant Department, which can be reached through the University address book.

TYPES OF THESIS

Compilation thesis

Application thesis with a primarily didactic purpose

Applied thesis with a primarily scientific research purpose

Applied thesis in the non-health sector

Application thesis involving the use of animals

Compilation thesis

Compilation thesis: concerns the analysis, description, and discussion of information already published (conducted mainly on bibliographic documentation).

Include the following exact words in the Introduction of the thesis: "This thesis does not require the opinion of the EC."

 

Application thesis with a primarily didactic purpose

Application thesis with a primarily didactic purpose: collection and / or consultation of clinical data with analysis / monitoring of internal case histories in the Operating Units; clinical audits or similar activities, to improve the quality of health care

  • The opinion of the Ethics Committee is necessary ONLY if the data processed in the thesis may be the subject of scientific publication.
  • Once you have obtained the committee’s opinion, include the following exact wording in the incipit of the thesis: "The study [title], for which [name and surname] is the scientist supervisor, has been authorized by the EC with the following details [reference] and has obtained the authorization from the competent Health Authority with details [reference nulla osta]. During the preparation and drafting of the thesis, specific consent to use pseudonymized or identifying data was given by the company [company name] / body [name of body])."

Applied thesis with a primarily scientific research purpose

Applied thesis with a primarily scientific research purpose: documents that involve observational studies, intervention studies that involve the administration of a drug or dietary supplement, studies using a medical device, surgical technique, or innovative diagnostic tool, studies of new organizational models, and studies using human tissue in vitro.

  • Request the opinion of the Ethics Committee.
  • Once the opinion has been obtained, include the following exact wording in the incipit of the thesis:"The study [title], for which Dr. [name and surname] is the Scientist Responsible, has been authorized by the EC with the following details [reference] and has obtained the authorization from the competent Health Authority with details [reference nulla osta]. During the preparation and drafting of the thesis, specific consent to use pseudonymized or identifying data was given by the company [company name] / body [name of body])."

Do not contact the EC if:

  • The subject of the thesis has already received the opinion of the Ethics Committee. However, it is necessary that the name of the undergraduate / graduate student appears among the investigators and that he / she has been "authorized to process health data".
  • The research concerns a study in which the complete anonymity of the respondent was already guaranteed at the source of the collected data.
  • The research involves cell lines acquired from commercial sources.
  • The study is a secondary research activity (involving a systematic review or meta-analysis).
  • In these cases, include the following wording in the incipit of the thesis: "This thesis does not require the opinion of the EC."

Applied thesis in the non-health sector

Applied thesis in the non-health sector: studies carried out in non-welfare structures and without interventions by qualified health personnel. The University Bioethics Committee has jurisdiction.

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

Application thesis involving the use of animals (or their tissues / cells): The University's Animal Welfare Service has jurisdiction; the project will be submitted to the Ethics Committee for animal testing.

If you are not sure what type your thesis is, you can follow the orientation guide.

ETHICS COMMITEE: WHAT TO DO

  1. Study already approved: Submit the request for the insertion of the undergraduate early enough that s/he can carry out the work. The request must be sent by the supervisor (principal investigator) to the Ethics Committee that approved the original study.
  2. Study not yet approved: The supervisor (principal investigator) must request the opinion of the EC by contacting sam.studiclinici@unibo.it. Keep in mind that the ECs meet approximately monthly and the complete documentation must be uploaded to the SIRER platform at least one month before the session.

PRIVACY: PROCESSING OF PERSONAL DATA IN THE THESIS

According to the provisions of the General Data Protection Regulation EU 2016/679 (GDPR) concerning the protection of individuals with regard to the processing of their personal data, in order to use the data of individuals it is necessary that:

  • the owner of the data expresses the explicit and conscious consent to their use on the basis of the information provided.
  • the user has been designated to process the data.

When the data are used anonymously and / or collected in such a way as to no longer allow the identification of the individual, even by resorting to correlations with other databases, there are no further requirements.

Attention! It should be clear who’s in charge of providing data protection and is therefore the data controller.

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Some useful concepts to address the matter of personal data protection:

  • data controller: natural or legal person, public authority, service or other body which, individually or together with others, determines the purposes and means of the processing of personal data;
  • data processor: natural or legal person, public authority, service or other body that processes personal data on behalf of the data controller;
  • recipient: natural or legal person, public authority, service or other body that receives the personal data;
  • consent of the interested party: any manifestation of the free, specific, informed, and unambiguous will of the interested party expressing consent, by means of a declaration or unequivocal positive action, that his/her personal data are being processed;
  • biometric data: personal data, obtained from a specific technical treatment relating to the physical, physiological, or behavioral characteristics of a person, that allow or confirm the unique identification, such as facial image or fingerprint data;
  • health data: personal data relating to a person’s physical or mental health, including the provision of health care services;
  • pseudonymization: the processing of personal data in such a way that they can no longer be attributed to a specific subject without the use of additional information, provided that such additional information is stored separately.