Titolo

Scientific ethics of research with living beings

Docente(i)

The course is organized through 2 modules:

  1. Prof. Guido Cavaletti, Dr. Luca Crippa – Ethical and regulatory issues in animal studies
  2. Dr.ssa Sara Casati - What ethical and regulatory framework for a Responsible Research involving human beings or using data/samples of human origin 

Lingua

1stmodule - Since the course is aimed at the discussion of the Italian law/regulation and Ministry authorization form must be filled in Italian, the course will be held in Italian

2ndmodule - Italian (if foreign students will be enrolled English)

Breve descrizione

Target audicence: PhD students with an interest in research ethics, with a specific focus both on animal studies and studies involving human beings or using data/samples of human origin


1st module: Ethical and regulatory issues in animal studies

Guido Cavaletti, Luca Crippa – 4 hrs

The 2 topic of the course will be

- analysis of the contents of the “DECRETO LEGISLATIVO 4 marzo 2014, n. 26”

- description of the form to be filled in to request permission for animal studies

The first part of the course will be a lecture, the second part will be based on group practical activities (exercise) on a mock proposal.

At the end of the lecture the students will have the fundamentals of the current regulation according to EU and Italian laws and will be able to draft a full proposal for Ministry of Health approval.

At the end of the exercise the students will have the mock proposal evalu-ated by the teacher and by general discussion to identify strengths/weaknesses of the proposal according to EU and Italian laws.

2nd module: What ethical and regulatory framework for a Responsible Research involving human beings or using data/samples of human origin

Sara Casati – 4 hrs

We will share the ethical-legal-social - ELSI horizon for research involving human beings or based on data and/or biological samples of human origin. Through the analysis of concrete projects by the PhD students, we will identify the fundamental steps where both the protection of the rights of participants and the compliance with ELSI requirements become the backbone of the same research protocol. Finally, we will discuss when and how to present a research protocol to an ethics committee, with particular reference to the Ethic Committee of the University of Milano-Bicocca.

Notes: The ELSI course will have a deliberative setting based on interaction and on proactive analysis of regulations as well as concrete projects. In particular, we work in small groups simulating the drafting of an informed consent rather than the articulation of a request for an opinion to the ethics commit- tee from specific projects of the participants.

CFU / Ore

CFU 1

Hours 8

Periodo di erogazione

23/05/2022 9.00 am - 1.00 pm

24/05/2022 9.00 am - 1.00 pm

Title

Scientific ethics of research with living beings

Teacher(s)

The course is organized through 2 modules:

  1. Prof. Guido Cavaletti, Dr. Luca Crippa – Ethical and regulatory issues in animal studies
  2. Dr.ssa Sara Casati - What ethical and regulatory framework for a Responsible Research involving human beings or using data/samples of human origin 

Language

1stmodule - Since the course is aimed at the discussion of the Italian law/regulation and Ministry authorization form must be filled in Italian, the course will be held in Italian

2ndmodule - Italian (if foreign students will be enrolled English)

Short description

Target audicence: PhD students with an interest in research ethics, with a specific focus both on animal studies and studies involving human beings or using data/samples of human origin


1st module: Ethical and regulatory issues in animal studies

Guido Cavaletti, Luca Crippa – 4 hrs

The 2 topic of the course will be

- analysis of the contents of the “DECRETO LEGISLATIVO 4 marzo 2014, n. 26”

- description of the form to be filled in to request permission for animal studies

The first part of the course will be a lecture, the second part will be based on group practical activities (exercise) on a mock proposal.

At the end of the lecture the students will have the fundamentals of the current regulation according to EU and Italian laws and will be able to draft a full proposal for Ministry of Health approval.

At the end of the exercise the students will have the mock proposal evalu-ated by the teacher and by general discussion to identify strengths/weaknesses of the proposal according to EU and Italian laws.


2nd module: What ethical and regulatory framework for a Responsible Research involving human beings or using data/samples of human origin

Sara Casati – 4 hrs

We will share the ethical-legal-social - ELSI horizon for research involving human beings or based on data and/or biological samples of human origin. Through the analysis of concrete projects by the PhD students, we will identify the fundamental steps where both the protection of the rights of participants and the compliance with ELSI requirements become the backbone of the same research protocol. Finally, we will discuss when and how to present a research protocol to an ethics committee, with particular reference to the Ethic Committee of the University of Milano-Bicocca.

Notes: The ELSI course will have a deliberative setting based on interaction and on proactive analysis of regulations as well as concrete projects. In particular, we work in small groups simulating the drafting of an informed consent rather than the articulation of a request for an opinion to the ethics commit- tee from specific projects of the participants.


CFU / Hours

CFU 1

Hours 8


Teaching period

23/05/2022 9.00 am - 1.00 pm

24/05/2022 9.00 am - 1.00 pm

Enrolment methods

  • Manual enrolments

Staff

    Teacher

  • Picture of Sara Casati
    Sara Casati
  • Picture of Guido Angelo Cavaletti
    Guido Angelo Cavaletti
  • Picture of Luca Crippa
    Luca Crippa