Requirements for investigators
swissethics and other organisations have set themselves the goal of improving the quality of clinical research in Switzerland. Unfortunately, recent reports and analyses have revealed a decline in quality, partly due to a lack of awareness of the rules and legislation. It is for this reason that swissethics has decided that GCP certificates obtained before January 1, 2016 are no longer recognised.
Requirements for Courses on Research Ethics and GCP, Investigator Level
Introduction to Research Ethics
Good Clinical Practice
English
2.0
updated: 24.11.2016
Requirements for Courses on Research Ethics and GCP, Sponsor-Investigator Level
In addition to requirements for Investigator Level
English
2.0
updated: 06.03.2015
Requirements for GCP Refresher course
Learning objectives (LO) and list of content (LC): Investigator and Sponsor-Investigator Level
English
1.0
updated: 17.04.2019
Guidance for researchers regarding Research Ethics and GCP Training
English
5.0
updated: 29.12.2025
Selection of recommended literature for investigators
- Forschung mit Menschen. Ein Leitfaden für die Praxis 2., überarbeitete Auflage 2015. Herausgegeben von der Schweizerischen Akademie der Medizinischen Wissenschaften (SAMW). (link)
- Ethical Framework for Responsible Data Processing in Personalized Health Research Version 2 (07.05.2018). ELSI Advisory Group, Swiss Personalized Health Network (SPHN). Ein Projekt der Schweizerischen Akademie der Medizinischen Wissenschaften (SAMW). (link)
- Helsinki-Declaration (1964/2024) Ethical principles for medical research involving human subjects (web link)
- Emanuel E et al., What makes clinical research ethical? JAMA 2000; 283:2701-2711
- Temple R and Ellenberg SS, Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues; Annuals of Internal Medicine 2000; 133:455-463 (link)
- Rid A et al, Evaluating the risks of clinical research, JAMA 2010; 304(13):1472-1479 (web link)
- Grady C, Enduring and emerging challenges of informed consent, NEJM 2015; 372: 855-862
- Guideline for Good Clinical Practice ICH-GCP E6(R3) (web link)