What Does a Donor Need to Know? Content Analysis of Informed Consent Documents Used for Brain Organoid Research

Donors of cells used to create induced pluripotent stem cells (iPSCs) and brain organoids may not understand what brain organoids are, how they will be used, or the long-term implications of the research. Informed consent documents (ICDs) often contain highly technical language and are written at reading grade levels higher than those attained by the target population. Our goal was to evaluate informed consent documents used for brain organoid research. We compared 20 currently active, IRB-approved consent documents to published templates/guidelines for iPSC research consent. Analyzed ICDs adhered to guidelines in explaining risks and benefits, de-identification, commercial potential, storage, and results sharing. However, descriptions of current and future use were lacking in detail, and the average reading level of ICDs far exceeded that of the general population. Our findings suggest additional transparency in ICDs would assist participants in making an informed choice about participation in iPSC and brain organoid research.