PFIZi011-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?

Yes

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

Yes

Is there other documentation provided to the donor for consenting purposes?

No

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?

Yes

Details on restriction to research project

Research into developmental disorders

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 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 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

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?

Yes

Policy for access to genetic information

No 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?

No

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

No

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?

Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals

Approval number

H-27549

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?

Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals

Approval number

H-27549

Do you have obligations to third parties in regard to the use of the cell line?

Yes

Please describe:

Research into developmental disorders

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

No

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

Analysis of Undifferentiated Cells

Microbiology / Virus Screening
HIV 1	Negative
HIV 2	Negative
Hepatitis B	Negative
Hepatitis C	Negative
Mycoplasma	Negative