CUBi001-A

Has informed consent been obtained from the donor of the embryo/tissue from which the pluripotent stem cells have been derived?

Yes

Was the consent voluntarily given?

Yes

Has the donor been informed that participation will not directly influence their personal treatment?

Yes

Can you provide us with a copy of the Donor Information Sheet provided to the donor?

Yes

Provide contact information of the holder of the original Donor Information Sheet:

Do you (Depositor/Provider) hold a copy of the SIGNED Donor Consent Form?

No

If you do not hold the SIGNED Donor Consent Form, do you know who does?

Yes

Contact information / weblink

Dr. Peter Kühnen, Charité, Institut für Experimentelle Pädiatrische Endokronologie

If you do not hold the SIGNED Donor Consent Form, have you obtained a copy of the unsigned Donor Consent Form from the holder?

Yes

Alternatives to consent

Confirm that consent was obtained by a qualified professional

Yes

Has the donor agreed to be re-contacted?

Unknown

Please indicate whether the data associated with the donated material has been pseudonymised or anonymised.

pseudonymised

Does consent explicitly allow the derivation of pluripotent stem cells?

Yes

Does consent pertain to a specific research project?

No

Details on restriction to research project

Does consent permit unforeseen future research, without further consent?

No

Does the consent permit uses of donated embryo/tissue or derived cell line intended for clinical treatment or human applications?

No

Does consent expressly prevent development of commercial products?

No

Does consent expressly prevent financial gain from any use of the donated embryo/tissue, including any product made from it?

No

Does consent expressly permit storage of donated embryo/tissue for an unlimited time?

Yes

Does consent expressly permit storage of cells derived from the donated embryo/tissue for an unlimited time?

Yes

Does consent prevent the DONATED BIOSAMPLE from being made available to researchers anywhere in the world?

No

Does consent prevent CELLS DERIVED FROM THE DONATED BIOSAMPLE from being made available to researchers anywhere in the world?

No

Does consent expressly permit collection of genetic information?

Yes

Policy for access to genetic information

Controlled Access

Will the donor expect to receive financial benefit, beyond reasonable expenses, in return for donating the biosample?

No

Does the consent permit the donor, upon withdrawal of consent, to stop the use of the derived cell line(s) that have already been created from donated samples?

Yes

Does the consent permit the donor, upon withdrawal of consent, to stop delivery or use of information and data about the donor?

Yes

Please describe how access is provided:

Contact data, institution, or website:

Has a favourable opinion been obtained from a research ethics committee, or other ethics review panel, in relation to the Research Protocol including the consent provisions?

Yes

Name of accrediting authority involved?

Ethics Commission of the Charite

Approval number

EA2/013/16

Has a favourable opinion been obtained from a research ethics committee, or other ethics review panel, in relation to the PROPOSED PROJECT, involving use of donated embryo/tissue or derived cells?

Yes

Name of accrediting authority involved?

Ethics Commission of the Charite

Approval number

EA2/013/16

Please describe:

Further constraints on use

For generation of the cell line, who was the supplier of any recombined DNA vectors or commercial kits used?

Constraints for use or distribution

Analysis of Undifferentiated Cells

Transcriptome Characterisation

Differentiation Potency

Microbiology / Virus Screening
Mycoplasma	Negative