66 C. MacGregor et al.
Immortalisation of Cell Lines
There are a number of ethical challenges related to the immortalisation
of iPSCs. A central question that cell immortalisation raises is whether
adequate informed consent be obtained if neither researchers nor study
participants are aware of future uses of the samples. This creates an ethi-
cal and legal dilemma for consent in iPSC research. A suggested solu-
tion to this issue is to gain consent from participants for specific studies
and applications that are known at the present time, and regain consent
if future uses arise (Thomas Scott et al. 2012 ). However, this approach
may be labour-intensive, present time limitations and create discom-
fort for research participants who do not wish to be contacted by the
research team. Regaining consent also presents many practical issues
that may make re-establishing contact difficult. For example, tissue
donors may have moved away from their last known contact address, or
may have since died. Additionally, due to factors such as funding limita-
tions and transient research staff, making or re-gaining contact can be
an inefficient, expensive and futile exercise.
An alternative approach is a single consultation consent model, in
which research participants are given as much information as is currently
available, informed by hypothetical uses of the iPSCs, and asked to pro-
vide a broad consent (Wendler 2006 ). This model of consent relies on a
high degree of trust between research participants and researchers. It has
been shown that the majority of participants are comfortable with this
one interaction approach to consent (Thomas Scott et al. 2012 ; Wendler
2006 ). However, Dasgupta et al. ( 2014 ) found that participants expressed
concerns about this model of consent. Participants in their study brought
up the example of Henrietta Lacks and the creation of the HeLa cell line.
Participants were ‘worried’ whether researchers would adhere to the terms
of the signed consent forms, and voiced concerns about the potential for
the commercialisation of their cell lines, which would be at odds with the
sentiment of altruistic donations (Dasgupta et al. 2014 ). Currently, the
International Society for Stem Cell Research (ISSCR) have guidelines for
stem cell research and clinical translation, which outline core principles
and best practices for research, to help ensure confidence and integrity in
stem cell research (Daley et al. 2016 ). However, there is uncertainty about
whether these guidelines have been widely adopted.