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Table 1 Overview of the main domains and sub-domains of the patient information in research on iPSCs

From: Donor information in research and drug evaluation with induced pluripotent stem cells (iPSCs)


Topic of information

1. General information for the donor

 Study’s background information

The aim and method of the study

Collection of donor’s personal data

Biospecimen’s collection

Contact information

 Genetic modification

Genetic modification of the biomaterial in the course of the study

 Commercial potential of the research

Property of body tissues

Financial compensation for the donor

Commercial result of the research

Individual and commercial interests of the researchers

2. Storage of the cell lines and protection of privacy and confidentiality

 Storage of cells and cell lines

Information on the possibility of indefinite storage

Destruction of the biomaterial

Storage in repositories

 Protection of privacy and confidentiality

Association of biomaterial with particular individuals

Possibility of reidentification

Data sharing

Measures for the protection of donor’s privacy

 Incidental findings

Possibility of acquisition of incidental medical findings

Procedures for the return of incidental findings

3. Research with the use of biospecimen

 Future research

Use of biomaterial in other studies

Acquisition of the consent for other studies

 Reproductive research

Use of biomaterial for creation of gametes and embryos

Use of biomaterial for the creation of human clones

 Transplantation of cells and organs

Use of biomaterial in regenerative medicine

Use of biomaterial for growing human organs

 Research on animals

Grafting of iPSCs into non-human animals

Creation of human-animal chimeras

4. Process of donor information

 Provision of information

Methods of donor information

 Clarification of information

Evaluation of donor’s understanding of provided information