Legal framework: Human genetic material and biological samples » Directive 2004/23/EC
Ethics requirements related to the human cells/tissues:
Available commercially:
- Details on cells/tissues type
- Provider
- Import licences/MTA
Obtained within the research project:
- Details on cells/tissues type
- Ethical approval/informed consent
Obtained within another research project (secondary use):
- Details on cells/tissues type
- Import licences/MTA
- Authorisation by primary owner of data (including references to ethics approval/informed consent)
Obtained from a biobank:
- Details on cells/tissues type
- Import licences/MTA
- Details on the biobank and statement
Copies of all must be kept on file and submitted upon request following funding.