BIONi034-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

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?

No

If you do not hold the SIGNED Donor Consent Form, do you know who does?

Yes

Contact information / weblink

Allan Vaag, Denmark

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

Has the donor agreed to be re-contacted?

Unknown

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.

anonymised

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 prevent development of commercial products?

Yes

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 expressly permit storage of cells derived from the 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

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?

No

Please describe how access is provided:

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?

Videnskabetiske Komite B for Region Hovedstaden

Approval number

H-3-2014-159

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?

Videnskabetiske Komite B for Region Hovedstaden

Approval number

H-3-2014-159

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

No

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

Analysis of Undifferentiated Cells

Differentiation Potency

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