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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?
No
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?
Yes
If you do not hold the SIGNED Donor Consent Form, have you obtained a copy of the unsigned Donor Consent Form from the holder?
No
Is there other documentation provided to the donor for consenting purposes?
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
Research into developmental disorders
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?
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 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
Does consent expressly permit collection of genetic information?
Yes
Has the donor been informed that their donated biosample or derived cells may be tested for the presence of microbiological agents / pathogens?
Yes
How may genetic information associated with the cell line be accessed?
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?
Yes
Does consent permit access to medical records of the donor?
No
Does consent permit access to any other source of information about the clinical treatment or health of 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?
Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals
Approval number
H-27549
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?
Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals
Approval number
H-27549
Do you have obligations to third parties in regard to the use of the cell line?
Yes
Please describe:
Restricted to research into Developmental Disorders
Are you aware of any further constraints on the use of the donated embryo/tissue or derived cells?
No
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?
A connective tissue cell which secretes an extracellular matrix rich in collagen and other macromolecules. Flattened and irregular in outline with branching processes; appear fusiform or spindle-shaped.
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