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an iPSC, and then generate different tissue from that stem cell, such as
the nerve or retinal tissues at the back of the eye. This breakthrough has
been revolutionary, as it is now possible to study the cells at the back of
the eye without needing to take a sample from the eye itself. By com-
paring how the cells from people with different eye conditions (or dif-
fering risks of eye disease) vary to those from people with healthy eyes,
the research team aimed to identify important gene pathways involved
in disease development and to explore avenues for new treatments.
Through collaborative work, we collected an extensive number of
tissue samples from patients with a variety of blinding ocular diseases,
as well as their relatives and healthy controls (people who have healthy
eyes and no known family history of an eye condition). Through the
tissue donation research, a number of ethical issues particular to the
generation and study of iPSC became evident to researchers, in particu-
lar an understanding about stem cells amongst participants. There was
concern about whether participants fully understood that iPSCs derived
from their tissue would not be destroyed, that cells or derivatives from
their sample could be injected into animals and that iPSCs generated
from the tissue could be shared with other researchers (with appropri-
ate confidentiality protections and Human Research Ethics Committee
approvals). The team considered these issues important to the function-
ing of the research and felt they had an ethical duty to examine the
information that research participants could or could not understand
and to pinpoint more accurately any ethical issues in the informed con-
sent procedure.
This chapter describes this process. First, we outline the ethical issues
concerning iPSC research, and the ways in which these issues are rel-
evant to informed consent. Second, in order to identify potential ethi-
cal or communication issues that may result in research participants not
being fully informed, we discuss the ability of research participants to
recall information about ethics and informed consent procedures in the
tissue donation study. Third, we outline the methods that were trialled
with the research participants, which sought to help improve informed
consent. We focused on comparing three different methods within the
ethical and informed consent procedure: the standard method, the use