What is it? Why is it important?

The Federal Stem Cell Research Act (StRA) regulates conditions under which it is permissible for human embryonic stem cells to be derived from surplus embryos and used for research purposes.

 

The aim of the act is to:

  • Prevent the misuse of surplus embryos and embryotic stem cells
  • Protect human dignity

 

The act does not apply to clinical studies using embryonic stem cells for transplantation purposes.

What do I need to do?

As a SP-INV performing stem cell studies, you are required to know and comply with the requirements of the StRA act.

Read the StRA act and based on your study:

  • Be familiar with the organisation of the various chapters and sections
  • As applicable, tag articles you are required to comply with

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

Swiss Law

StRA – see in particular article

  • Art. 1 Subject, purpose and scope
Abbreviations
  • CTU – Clinical Trials Unit
  • SCRO – Stem Cell Research Ordinance
  • SP-INV – Sponsor Investigator
  • StRA – Stem Cell Research Act
Basic ↦ Ethics and Laws ↦ Swiss Law ↦ Stem Cell Research Act
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Swiss Law ↦ Stem Cell Research Act

Please note: the Easy-GCS tool is currently under construction.