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Ethics Committee for University Research

Introduction

The Ethics Committee for University Research (CERA) is an independent body established at the University of Brescia, based on principles of expertise and interdisciplinarity.

It operates in compliance with current regulations, adhering to the ethical, legal, and deontological principles set out in national, EU, and international documents on scientific research. Its primary goal is to protect the following within the context of university research activities:

a) the rights, dignity, integrity, and well-being of human participants;
b) the respect for all other living organisms;
c) the protection of the environment in all its dimensions and components;
d) the integrity, freedom, and promotion of science.

The Committee provides advices, evaluations and checks upon the request of the Principal Investigator of a research project, ensuring that the research is carried out in accordance with the ethical principles established at international and national levels, as well as the internal Ethics Code.

The following fall outside the Committee's scope:

  • Functions reserved by law for Ethics Committees overseeing clinical trials (Territorial or National Ethics Committees), in accordance with Article 2 of Law No. 3/2018 and subsequent implementing regulations. Specifically, these include the evaluation for the authorization of:
    • Clinical trials of medical devices and human pharmaceuticals in phases I, II, III, and IV, particularly the assessment detailed in Part II of the evaluation report, as per Article 7 of EU Regulation No. 536/2014;
    • Pharmacological observational studies;
    • Compassionate use of drugs;
    • Surgical and clinical procedures, as well as any other diagnostic, therapeutic, or preventive interventions;
  • Functions assigned by law to Ethics Committees of other entities, particularly Hospital Ethics Committees (Clinical Practice Ethics Committees);
  • Duties reserved to other University Bodies, including those related to the Animal Welfare Organization (OPBA) and the Data Protection Officer.

Additionally, the Committee promotes reflection, training and public discussion to foster the development of ethical awareness and sensitivity in research activities within the University.

In collaboration with the relevant offices, the Committee may also develop an information plan for the university's staff and student body.

Further information about the committee, its work and training initiatives is available on the Italian version of the page.

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