The derivation of human embryonic stem cells (hESCs) may involve the prior cryopreservation of embryos. In such cases the following rules governing the requirements, responsibilities and procedures must be strictly adhered to.
You intend to derive human embryonic stem cells from surplus embryos (DER) The process requires the prior cryopreservation of the surplus embryos (CRYO). The cells are being derived with a view to conducting a specific stem cell research project
Requirements (d, c and b subject to a)
a) Approval of the stem cell research project (RP-SC) by the competent ethics committee
b) Reference number from the Federal Office of Public Health for the stem cell research project (RP-SC)
RP-SC).(allocation of a reference number = approval of research project)
c) Licence from the Federal Office of Public Health to derive human embryonic stem cells from surplus embryos (DER).
d) Licence from the Federal Office of Public Health to cryopreserve surplus embryos (CRYO)
Responsibilities
a) Competent ethics committee
b) Federal Office of Public Health
c) Federal Office of Public Health
d) Federal Office of Public Health
How to proceed
In advance: three applications
1. Application to the competent ethics committee for approval of the stem cell research project (RP-SC):
Application dossier comprises:
2. Application to the Federal Office of Public Health for a licence to derive human embryonic stem cells from surplus embryos (DER), including notification of the stem cell research project (RP-SC) to receive a reference number:
3. Application to the Federal Office of Public Health for a licence to cryopreserve surplus embryos (CRYO):
Afterwards: notification and final report
4) Notification to the Federal Office of Public Health within 15 days of completion or termination of derivation of human embryonic stem cells from surplus embryos (DER):
5. Final report to the Federal Office of Public Health within 6 months of completion or termination of derivation of human embryonic stem cells from surplus embryos (DER):
Relating to the stem cell research project (RP-SC)
Notification and final report
6. Notification to the competent ethics committee and the Federal Office of Public Health within 15 days of completion or termination of stem cell research project (RP-SC):
7. Final report to the competent ethics committee and the Federal Office of Public Health within 6 months of completion or termination of stem cell research project (RP-SC):
Last modification 17.05.2021
Contact
Federal Office of Public Health FOPH
Division of Biomedicine
Human Research Section
Schwarzenburgstrasse 157
3003
Bern
Switzerland
Tel.
+41 58 463 51 54