Institute of the History, Philosophy and Ethics of Medicine, Ulm University, Parkstraße 11, 89073, Ulm, Germany.
Institute of Biochemistry and Molecular Biology, Ulm University, Albert-Einstein-Allee 11, 89081, Ulm, Germany.
Stem Cell Res Ther. 2020 Mar 19;11(1):126. doi: 10.1186/s13287-020-01644-4.
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.
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.
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.
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.
诱导多能干细胞（iPSCs）的发现为细胞重编程为多能状态开辟了可能性。由于与生物材料的捐赠和衍生没有明显的伦理问题，iPSCs 被认为是一种替代具有高度伦理争议的人类胚胎干细胞（hESCs）的研究选择。然而，iPSCs 的独特性质导致了许多伦理问题，主要涉及到供体信息的问题以及对生物标本在研究和药物评估中的使用的同意。
为了进行本分析，我们在 PubMed/MEDLINE 和 Web of Science 数据库中进行了文献回顾。搜索算法导致了 1461 个结果的识别。在去除重复项并筛选标题和摘要后，发现有 90 篇文章与研究目的相关。评估这些文章的全文后，有 62 篇文章因未正确解决研究目的而被排除。在最后一步，有 28 篇文章被纳入分析。分析的是发表在同行评议期刊上的研究和非研究手稿。
在 iPSC 研究的情况下，信息处理过程应遵循为人类受试者研究制定的一般框架，还应遵循 iPSCs 的具体特征。我们确定了四个主要领域和 12 个主题子领域，这些领域应包含在供体信息中。我们的结果表明，大多数作者同意关于一般信息、细胞储存和隐私保护等领域的信息内容。文献中讨论的两个主要问题是供体同意将其用于未来的研究和供体信息的处理过程。
鉴于 iPSCs 的独特性质和它们在未来可能的各种用途，供体信息的内容应包含与 iPSC 研究相关的具体信息。向供体传达信息的有效方法应将书面和口头信息与多媒体的可能使用结合起来。
