SAS The 3Rs: Ethics, scientific validity, and alternative methods within legal and regulatory frameworks, Hochschule für Life Sciences FHNW

You will learn through case studies and practical insights how to apply the 3Vs (Construct Validity, Internal Validity, External Validity) and the concept of indispensability in animal use in research, testing, and education while navigating complex ethical review processes.

After completing the SAS, you will be able to:

• Understand the ethical foundations and societal contexts of animal experimentation.
• Assess and apply validity (the 3Vs) and the 3Rs frameworks in research pipelines and regulatory decision-making.
• Understand the concept of indispensability and its role in the ethical evaluation of animal use in research.
• Interpret key international and Swiss regulatory frameworks governing animal experimentation.
• Interpret key international and Swiss regulatory frameworks governing regulatory implementation of alternative approaches such as New Approach Methodologies (NAMs).
• Understand the ethical approval process and apply the Harm–Benefit Analysis for research proposals involving animal use.

This SAS is for you if you operate at the interface of regulation, science and institutional practice and you are seeking practical ways to advance 3Rs implementation beyond minimum compliance and integrate them more strategically within your organisation.

It is particularly suited for professionals involved in animal experimentation and its governance in research institutions, universities, regulatory bodies and public authorities, as well as in the pharmaceutical, biotechnology, chemical and consumer goods industries.

It is especially relevant for:

• Heads and managers of animal facilities
• 3Rs officers, animal welfare officers and designated veterinarians
• Members of cantonal animal experimentation committees and veterinary authorities
• Preclinical and translational researchers
• Study directors, principal investigators and senior scientists
• Research strategy, governance and compliance professionals
• Regulatory affairs professionals

This SAS is the first of four modules within the CAS Strategic 3Rs Implementation in Biomedical Research and Testing. Day one is onsite at the FHNW Campus Muttenz, day two to four are online.

This SAS provides a comprehensive introduction to the ethical, scientific, legal and regulatory foundations of the 3Rs (Replacement, Reduction and Refinement) in animal research. Participants will explore the historical development of animal experimentation, the 3Vs framework for scientific validity, and the concept of indispensability in the ethical evaluation of animal use. The SAS further examines Swiss and international legal and regulatory frameworks governing animal experimentation and alternative approaches, including New Approach Methodologies (NAMs). Through practical examples and case-based learning, participants will gain insight into ethical review processes and the application of Harm–Benefit Analysis in research and testing. By the end of the SAS, participants will be able to critically assess the necessity and justification of animal use and apply ethical, scientific and regulatory principles to support responsible implementation of the 3Rs in research and testing.​

At the end of the SAS, a multiple-choice questionnaire (pass/fail) is available, if you would like to receive ECTS credits. The SAS can be allocated to the CAS Strategic 3Rs Implementation in Biomedical Research and Testing within 3 years. ​

The following programme admission requirements apply:

• Tertiary A: Higher education qualification (at least a Bachelor’s degree) and at least 2 years’ practical experience relevant to the programme,
• Tertiary B: Colleges of Higher Education Diploma (HF), Advanced Federal Diploma of Higher Education (HFP) or Federal Diploma Higher Education (BP), and at least 5 years’ practical experience relevant to the programme,
• Individuals without a Tertiary A or B qualification may be admitted if they cumulatively meet the following admission criteria:
• at least 10 years’ professional experience in a field relevant to the programme, of which at least 5 years in a managerial or senior specialist role
• additional qualifications (various non-formal, extensive further training courses or partial completion (>50%) of a tertiary qualification)
• evidence of knowledge of academic work or a willingness to acquire this in advance.