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

Abstract

Background: The discovery of induced pluripotent stem cells (iPSCs) opened the possibilities for reprogramming cells back to a pluripotent state. Because of no apparent ethical issues connected with donation and derivation of biomaterial, iPSCs are considered as a research alternative to ethically highly disputed human embryonic stem cells (hESCs). However, the unique character of iPSCs leads to numerous ethical considerations, which mainly concern the issue of donor information and consent for the use of biospecimen in research and drug evaluation. Methods: For the purpose of this analysis, we conducted a review of the literature in the PubMed/MEDLINE and Web of Science databases. The search algorithm led to the identification of 1461 results. After removing duplicates and screening of title and abstract, 90 articles were found to be relevant to the study's objective. Full texts of these articles were apprised and 62 articles were excluded at this step for not properly addressing the study's objective. In the final step, 28 articles were included in the analysis. Analyzed were both research and non-research manuscripts published in peer-reviewed journals. Results: In the case of iPSC research, the information process should be guided by general frameworks established for research on human subjects but also by specific characteristics of iPSCs. We determined four main domains and 12 thematic subdomains that should be included in donor information. Our results show that majority of authors agree to the content of information with regard to the areas of general information, storage of cells, and protection of privacy. Two main issues that are discussed in the literature are donor's consent for use in future studies and the process of donor information. Conclusions: Given the unique character of iPSCs and the possibility of their various uses in the future, the content of donor information should contain specific information central to iPSC research. Effective methods of communicating information to donors should combine written and oral information with the possible use of multimedia.

Content and Method of Information for Participants in Clinical Studies With Induced Pluripotent Stem Cells (iPSCs)

“…Based on our earlier research ( Orzechowski et al, 2020 ), information materials for participants in the studies were analyzed under consideration of four main thematic domains and 11 subdomains for evaluation of the process of information in iPSC research: 1. General information for the donors, 2.…”

“…These concerns consider not only the involvement of human subjects but especially the specific character of the iPSC research. Numerous authors as well as guidelines issued by professional organizations address these issues ( Aalto-Setälä et al, 2009 ; Lowenthal et al, 2012 ; Lomax et al, 2013 ; Greenberg et al, 2015 ; Daley et al, 2016 ; Moradi et al, 2019 ; Orzechowski et al, 2020 ). They recommend inclusion of particular information, which would safeguard donors from violation of their autonomy and allow them to make their own risk-benefit assessment regarding participation in iPSC studies.…”

“…These focus mainly on the scope and method of information for participants in such research ( Greenberg et al, 2015 ). Our previous research identified four main thematic domains and 11 subdomains that should be included in donor information process in iPSC studies ( Orzechowski et al, 2020 ). Because of the possibly endless longevity of derived biospecimen and the variety of potential uses for research and therapy, the provision of robust information and consent procedures becomes central from the ethical point of view.…”

Normative framework of informed consent in clinical research in Germany, Poland, and Russia

“…Using such a type of consent is increasingly important for several fields of medical research, e.g. next-generation genetic sequencing or research with the use of a donor’s genetic material in studies on induced pluripotent stem cells (iPSCs) [ 38 ]. An additional method to inform patients worth exploring is the use of multimedia, social media, and other interactive tools.…”

Cell Banking of hiPSCs: A Practical Guide to Cryopreservation and Quality Control in Basic Research

“…(i) For basic research, donor consent and viral contamination. Points to consider for donor consent, data protection, and derivation of primary cells have been discussed previously (Lomax, Hull, Lowenthal, Rao, & Isasi, 2013; Morrison et al., 2017; Orzechowski, Schochow, Kühl, & Steger, 2020). Before reprogramming, the proband or the primary cells should be tested for HIV and hepatitis (be negative on viral screening for HIV1, HIV2, HBV, and HCV by qPCR; Andrews et al., 2015).…”