1st module: Ethical and regulatory issues in animal studies
Guido Cavaletti and Annalisa Canta - 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

Target audience
PhD students with an interest in research ethics, with a specific focus on animal studies

2nd module: Ethics of Research with Living Beings
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 and the participants’ engagement and the compliance with ELSI require-ments become the backbone of the same research protocol, with a par-ticular attention to

• Participatory & Informational processes/tools (raising awareness – scientific citizenship; dynamic consent; Material/Data Transfer Agreement …)
• Risk assessment and risk mitigation
• Framing & processing within a RRI horizon
  Finally, we will discuss when and how
• to present a research protocol to an ethics committee, with ref-erence to the Ethic Committee of the University of Milano-Bicocca,
• query and ask for samples/data to an access committee.

Target audience
PhD students/Researchers responsible of projects involving human beings or using data/samples of human origin or impacting on humans