Has informed consent been obtained from the donor of the embryo/tissue from which the pluripotent stem cells have been derived?
Was the consent voluntarily given?
Has the donor been informed that participation will not directly influence their personal treatment?
Can you provide us with a copy of the Donor Information Sheet provided to the donor?
Provide contact information of the holder of the original Donor Information Sheet:
This iPS cell line was derived from the BJ Fibroblast cell lines that are readily available through ATCC. As far as we know there was no consent. The derivation was considered Not Human Subjects Research. I am not answering some of the questions below because there is no consent so the questions are not applicable.
Alternatives to consent are available?
Alternatives to consent
There is no consent available for these lines because they were derived from the BJ fibroblast cell line distributed by ATCC and the derivation was Not Human Subjects Research. Attached is the letter that the iPS Core Repository received when the lines were deposited into the repository for distribution. The lines are not currently distributed from the repository.
Alternative consent approval number
Please indicate whether the data associated with the donated material has been pseudonymised or anonymised.
How may genetic information associated with the cell line be accessed?
Will the donor expect to receive financial benefit, beyond reasonable expenses, in return for donating the biosample?
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?
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?
Do you have obligations to third parties in regard to the use of the cell line?
Is there an MTA available for the cell line?
For generation of the cell line, who was the supplier of any recombined DNA vectors or commercial kits used?