STBCi045-C

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

zameel.cader@ndcn.ox.ac.uk

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

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

No

Confirm that consent was obtained by a qualified professional

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

Does consent permit unforeseen future research, without further consent?

Yes

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?

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

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?

No

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

NRES Committee South Central - Hampshire A

Approval number

13/SC/0179

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?

NRES Committee South Central - Hampshire A

Approval number

13/SC/0179

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

Yes

Please describe:

DNA sequencing can only be performed for research into donors specified condition. Material shall not be sold, transplanted into any human being or used to create egg or sperm cells (gametes) or embryos. The material shall not be used for direct exploitation. For the purposes of this, Direct exploitation means to develop for commericalization or to commercialize the Material.

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

No