ESi046-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?

No

Contact information / weblink

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

Alternative consent approval number

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?

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

Generation and banking of human induced pluripotent stem cells (iPS) from somatic adult cells of healthy donors and patients with genetic diseases

Does consent permit unforeseen future research, without further consent?

No

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 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?

No

a for-profit corporation?

No

Does consent expressly permit collection of genetic information?

Yes

Does consent expressly permit storage of genetic information?

Yes

Does consent prevent dissemination of genetic information?

No

Has the donor been informed that their donated biosample or derived cells may be tested for the presence of microbiological agents / pathogens?

No

Has the donor consented to receive information discovered during use of donated embryo/tissue that has significant health implications for the donor?

No

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

Controlled Access

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

No

Does the consent anticipate that the donor will be notified of results or outcomes of any research involving the donated samples or derived cells?

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

Please describe how access is provided:

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

No

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?

Ethics Board of The Center of Regenerative Medicine of Barcelona

Approval number

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?

Ethics Board of The Center of Regenerative Medicine of Barcelona

Approval number

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?

Yes

Further constraints on use

Is there an MTA available for the cell line?

Yes

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

Are you aware of any constraints on the use or distribution of the cell line from the owner or any parties identified in the query above?

No

Constraints for use or distribution

Analysis of Undifferentiated Cells

Differentiation Potency

Microbiology / Virus Screening
Mycoplasma	Negative