PFIZi002-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?

No

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

No

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?

Yes

Contact information / weblink

Alternatives to consent

Alternative consent approval number

Has the donor been informed about how her/his data will be protected?

Yes

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?

Yes

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

No

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

No

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

Yes

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

No

an academic institution?

Yes

a public organisation?

Yes

a non-profit company?

Yes

a for-profit corporation?

Yes

Does consent expressly permit collection of genetic information?

Yes

Has the donor been informed that their donated biosample or derived cells may be tested for the presence of microbiological agents / pathogens?

No

Policy for access to genetic information

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?

No

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

Yes

Does consent permit access to medical records of the donor?

Yes

Please describe how access is provided:

Does consent permit access to any other source of information about the clinical treatment or health of the donor?

No

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?

Approval number

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?

Approval number

Please describe:

Are you aware of any further constraints on the use of the donated embryo/tissue or derived cells?

No

Further constraints on use

Is there an MTA available for the cell line?

No

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

Differentiation Potency

Microbiology / Virus Screening