Do Skin Biopsy Donors Really Understand What They Are Consenting To?

McCaughey et al. (2016) investigated just how much participants understand of the information they receive when donating skin biopsies for human induced pluripotent stem cells (iPSCs).¹

While embryonic tissue for research purposes sparks much debate, iPSCs provide an alternative for disease modeling and cell-based therapies. However, there are still ethical issues surrounding their use, such as sample sharing with external parties, chimeric animal generation, future use beyond that outlined in the consent process and commercialization.

Calling on their large collection of iPSCs for biospecimen research, the authors retrospectively explored participant informed consent recall from those who provided a skin biopsy between May 2013 and April 2015. They asked them what they understood of their consent, and whether there were personal or demographic factors affecting their recall. Furthermore, they sought to understand participant motivation for biospecimen donation. The biospecimens had been provided for ophthalmic iPSC research and included samples from healthy individuals and those with inherited eye disorders.

Participants had an opportunity to ask questions relating to their sample on the day of collection and received a verbal overview of the purpose of the research by one of the research investigators. In the present study, McCaughey et al. used a 35-item questionnaire, with four sections:

1. Demographic information
2. Details participants recalled from the consent process, including their motivation for participation
3. Rating of their attitudes and understanding of stem cell research using a four-point Likert scale
4. True-or-false questions, relating again to their understanding and recall of the procedure

Finally, they asked participants how they would improve the consent process.

Of the 234 participants contacted, 141 provided sufficient information to be included in the study. Survey results indicated the following:

• 73% (n = 103) participants did not look for information outside of that provided by the investigators, largely because they trusted the team (85.4%).
• 93.6% (n = 132) of participants felt adequately informed following the consent process, and most also felt able to ask questions (97.8%).
• While most participants felt they understood what a stem cell was (91.5%), very few realized that their sample could be held indefinitely (16.1%).
• Demographics did not affect participant knowledge.
• Only 29.9% of participants realized that pharmaceutical companies could be involved in research with their sample.
• 92.2% of participants provided samples for altruistic reasons and almost half (47.5%) hoped to benefit directly from the research.

McCaughey et al. suggest their study indicates that participants did not have a good understanding of what their consent meant. They note that there is a need for more work to improve communication methods for research on iPSCs to participants.

Reference
1. McCaughey, T. (2016) “Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking,” Cell Tissue Bank, 17(3) (pp. 449–456), doi: 10.1007/s10561-016-9563-8.