GENEAe014-A

Was the embryo established purely for research purposes?

No

Have both parents consented to the use of the embryo for ESC derivation?

Yes

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

Alternatives to consent are available?

Yes

Alternatives to consent

IVF patients gave consent for investigations of clinically unsuitable embryos as part of their clinical cycle. This is a clinical process, independent of research. hESC were derived from embryonic outgrowth cells, originally developed for karyotyping, not from embryos and fully informed consent was granted. Multiple documents could not be added here so will send via email.

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

anonymised

Does consent explicitly allow the derivation of pluripotent stem cells?

Yes

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?

GeneaHREC

Approval number

meeting 13/9/2005

Analysis of Undifferentiated Cells

Differentiation Potency