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