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Ethical Issues in Biomedical Research – AUTUMN 2022 (ENG)

28 Novembre 2022 / 8:00 - 16:00

The increasing knowledge in molecular biology and the development of the techniques for the evaluation of the biological processes and of their interaction have brought about, in preclinical and clinical research, what is called precision medicine, to select the treatment that works best for an individual.
The development of new therapeutic approaches raises many ethical issues, of which investigators’ also and in particular at the preclinical level, should be aware of and take into consideration in their decisions and activities.
The objectives of this course are to increase this awareness of the ethical issues and of their potential impact in the selection and preclinical evaluation of new molecules, in the decision making process, in the care of patients and in the social environment.
In particular,

  •  in the planning and modalities of activation of clinical studies;
  •  in the selection of treatment, relationship and care of patients;
  •  in the collection of data and biological tissues;
  •  in the analysis, report, publication and sharing of data and results;
  •  in the active involvement of patients already at the beginning of the clinical project;
  •  in the registration, selling and marketing of therapeutic compounds in Europe.

This course it is offered also as parts of the PhD Programmes at the Faculty of Biomedical Sciences at USI, ETH and USZ and it is structured as common course (General skills).

Duration: 1 day – 28 November 2022
Credits: 0.5 ECTS, ISFM, Swapp
Language: English

Program

The program may still be subject to changes. Thank you!

PDF program available here

  • 08h30

    Welcome and Introduction

    Prof. Dr. Alessandro Ceschi

  • 08h45

    Introduction to biomedical research ethics

    PD Dr. Marta Fadda, USI BIOMED

    Content:

    1. The core ethical principles of biomedical research
    2. A preliminary understanding of the ethical and social justice issues in various aspects of biomedical research
    3. A structured/systematic ethical analysis to real-world challenges in research

  • 09h30

    Ethics in human research

    Dr. Pietro Gervasoni

    Content:

    1. Basic:
      Ethics and law
      Ethical principles
      Ethical committees
      Ethical requirements
    2. Consent:
      Informed consent
      General consent
      Comprehensibility
      Biobanks
    3. Current challenges
      Data sharing
      Digitalisation
      Genetics
      Personalised medicine
      Artificial intelligence

  • 10h15

    BREAK

  • 10h30

    Clinical research is not scientific if it is not ethical

    Prof. Silvio Garattini

    Content:

    1. Preclinical research
    2. Clinical research

    • Controlled clinical trials

  • 12h00

    LUNCH BREAK

  • 13h00

    The ethics of patient and public involvement (PPI) in academic clinical research

    Mrs. Tamara Kohler, SCTO

    Content:

    1. The concept of PPI
    2. Ethical considerations why patients and the public should be involved in academic clinical research
    3. Ethical principles in the performance of PPI

  • 13h45

    Ethical issues in the statistical analysis of clinical trials

    Dr. Valter Torri

    Content:

    Ethical implications of statistical planning and analysis in clinical experimentation, Focus on
    1. key statistical aspects of design (randomization, choice of control group, use of placebo, type of comparison)
    2. Statistical analysis (interim analysis, multiple tests, reporting of results).

  • 14h30

    BREAK

  • 14h45

    Ethical issues in drug approval and marketing at the European level

    Dr. Rita Banzi

    Content:

    1. Overview of the role and responsibilities of the European Medicines Agency
    2. Ethical aspects in drug development and assessment (i.e., issues in pivotal trials and evaluation criteria)
    3. Ethical issues and accountability (i.e., financing, transparency and data sharing, communication and engagement with the public)

  • 15h30

    General discussion with all partecipants

  • 16h00

    Summary

  • 16h30

    End course

Registration

Ethical Issues
Campus Est – Sector A – A1.03

    Cognome

    Nome

    Professione e Luogo

    Email

    Indirizzo postale Privato (per Fatturazione)

    * Tutti i campi sono obbligatori

    The course fee is CHF 400.- for employees of the Ente Ospedaliero Cantonale and its partners and CHF 650.- for external*.

    By the registration deadline, invoices of the tuition fees will be issued by the Central Accounting and Billing Service (SCCF) of EOC.

    Collaborators of the of the Ente Ospedaliero Cantonale who wish to be reimbursed by their department are kindly invited to make an (electronic) request to EOFORM for authorization.

    In case of cancellation announced less than 2 weeks prior the registration deadline, the fee will be fully requested.

    *For PhD students enrolled in one of the PhD Programmes at the Faculty of Biomedical Sciences at USI, ETH and USZ who present a valid student ID card, no tuition fee will be issued. Registration is still required.

    Registration must be received by November 17, 2022.

     

    For more information:
    clinicaltrialunit@eoc.ch
    Laura Di Petto 091 811 7944

    Dettagli

    Data:
    28 Novembre 2022
    Ora:
    8:00 - 16:00
    Categoria Evento:

    Luogo

    Aula A2.08 Campus Est – USI Lugano
    Via la Santa 1
    Viganello, CH 6962 Svizzera     + Google Maps