Table 4.

Topics to be addressed in the informed consent process based on professional’s perspectives.

Efficacy	-The chance of success (%), and the expected type of outcomes (e.g. lifelong insulin independence, reducation in hypoglycemia/hyperglycemia events, decrease in diabetes-related complications and self-management burden) -When the BAP will start working
Risk Assessment	Standardized information -Whether the potential benefits outweigh the risks -Comparison to alternative available treatments, including risks, benefits and implications for daily life -Surgical risks -Potential adverse events -Risk associated with immunosuppression, if necessary, which is drug-specific and generic (such as an increased risk of certain cancers, infections etc.) -Retrievability of the BAP (i.e. whether it could be removed) -Risks of disease recurrence and graft failure -Risk of product leakage or rupture Personalized information -Impact of treatment on lifestyle and quality of life Individual and familial needs (e.g. impact on care-givers)
Safety	-Clinical trials study results
Transplant procedure	-Average duration of hospitalization Surgical invasiveness -Procedural complexity -Anesthesia necessity Wound healing
Size and location	-Size -Visibility -Transplantation location -Accessibility of the BAP in order to check its graft functioning -Durability -Impact of size and location on daily life
(Biological) materials used	-Source of cells (deceases donors, animals and/or genetically modified cells) -Risks associated with the material being used (e.g. zoonoses or tumorigenesis)