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Informed consent questionnaire proposed
by the human Pluripotent Stem Cell Registry (hPSCreg)
Donor consent form & donor information sheet
Yes
No
Unk.
Has consent been obtained from the donor of the tissue from which iPSC have been derived?
Was the consent voluntary given by the donor, custodian or parents?
Was the donor been informed that participation will not directly influence their personal treatment?
Confirm that consent was obtained by a qualified professional
Has the donor agreed to be re‐contacted?
Has the donor been informed about her/his data will protected?
Indicate whether the donated material has been
Pseudonymised
Anonymised
Research
Does consent expressly prevent derivation of iPSC?
Does consent pertain to a specific research?
Does consent permit unforeseen future research, without further consent?
Does the consent permit uses of donated material or derived cell line intended for clinical treatment or human applications?
Commercial exploitation
Does consent expressly prevent development of commercial products?
Does consent expressly prevent financial gain from any use of the donated material including any product made from it?
Storage of and access to material
Does consent expressly permit storage of donated material for an unlimited time?
Does consent expressly permit storage of cells derived from the donated material for an unlimited time?
Does consent prevent the donated biosample from being made available to researchers anywhere in the world?
Does consent prevent cells derived from the donated biosample from being made available to researchers anywhere in the world?
Does consent permit research by an academic institution?
Does consent permit research by a public organisation?
Does consent permit research by a non‐profit company?
Does consent permit research by a for‐profit corporation?
PCC Stem Cells - ESHRE BCN 2018
Data and information
Does consent expressly permit collection of genetic information?
Does consent expressly permit storage of genetic information?
Does consent expressly prevent dissemination of genetic information?
Has the donor been informed that their donated biosample or derived cells may be tested for the presence of microbiological agents/pathogens?
Has the donor consented to receive information discovered during use of donated material that has significant health implications for the donor?
How may genetic information associated with the cell line accessed?
Open access
Controlled access
No information
Benefits
Will the donor expect to receive financial benefit, beyond reasonable expenses, in return for donating the biosample?
Does the consent anticipate that the donor will be notified of results or outcomes of any research involving the donated samples or derived cells?
Withdrawal
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?
Does the consent permit the donor, upon withdraw of consent, to stop delivery or use of information and data about the donor?
Medical records
Does consent permit access to medical records of the donor?
Does consent permit access to any other source of information about the clinical treatment or health of the donor?
PCC Stem Cells - ESHRE BCN 2018
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