Table 1.

Recommendations for ethical and legal requirements

#		Guidance 1. Recommendations for ethical and legal requirements
Consent: EBiSC recommends that iPSC research projects ensure the PIS and ICF selected for use explicitly cover:
1.1		that tissue samples and demographic data have been freely and voluntarily donated for research use and that lack of donation will not affect their medical care in any way
1.2		that samples will be used to generate derivative cell lines, such as iPSC lines, that can be retained indefinitely in culture
1.3		that collected samples and derived cell lines may be characterized, including genomic analysis
1.4		that derived cell lines and data (including genomic data) may be shared with researchers worldwide, including for-profit and not-for-profit organizations
1.5		the rights of the donor regarding data associated with them, their donated sample(s), and any associated dataset(s); e.g., that genomic data may be stored in secure databases and shared to researchers as managed access data. This includes the inherent risks of data sharing, how these risks will be minimized, and how these data may be stored and shared
1.6		how the study participant's identity will be protected at all times
1.7		that the study participant will get no financial or legal benefits from donating a sample, including lack of financial benefit from any products or services that may be derived from the sample or derivatives
1.8		whether derived cell lines may be used in research using animal models
1.9		that derived cell lines may be used in as-yet undefined research activities, for the purpose of biological research purposes, avoiding any unintentional research use restrictions such as limiting research use to specific disease areas
1.10		that the donor has the right to withdraw consent for use of the donated sample, but that only the original tissue sample will be destroyed and, if iPSC lines have already been generated, the lines and associated dataset(s) cannot be destroyed. However, any “pseudonymized” link between the donor and the donated sample can be completely severed. See section “nomenclature and data management” for further information on data management
LEGAL: EBiSC recommends that iPSC research projects ensure the following legal aspects are assessed at project start:
1.11	investigate and understand licensing implications of using iPSC derivation reagents and methods and ensure these are understood and recorded before committing any resource to technical procedures such as reception of donor materials, iPSC generation, and gene editing
1.12	clarify and agree ownership of iPSC lines and which party/parties may administer responsibility for deposition or distribution
1.13	ensure transfer of any and all cell material is explicitly recorded in a locally acceptable legal agreement (such as a MTA or other) that is signed by all involved parties. This includes transfer of cell material between collaborative partners and for distribution of cell lines to users
1.14	where feasible, operate an intellectual property horizon scanning activity focused on general iPSC resource operation by utilizing industry links and liaison with relevant patent office information