NHLBIi001-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

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

https://clinicalstudies.info.nih.gov/VisitProtocol.aspx?ID=10-H-0126

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

No

How may genetic information associated with the cell line be accessed?

Open Access

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

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?

NHLBI IRB

Approval number

10-H-0126

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?

NHLBI

Approval number

10-H-0126

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

Analysis of Undifferentiated Cells

Differentiation Potency