Biomedical Engineering Reference
In-Depth Information
We argue that the informed consent procedure should also inform the
donor about what will happen to the cells after donation. informed consent
procedures will have to address the issues related to the material value of the
cells and the donor's interests in them (financial and otherwise). If the donation
entails the donor having no say whatsoever in what is going to be done with
the cells he/she donates, then the informed consent form can be regarded as
a blanket consent, as an 'act of abandonement' or an 'act of renunciation'. if
however the donor retains certain rights, such as the right to determine how
others should use these cells or to define the conditions for further transfer
of these cells (e.g. solely for clinical purposes), the informed consent form
will have to stipulate these specific conditions. (Dickenson, 2007)
16.2.4 Cells as carriers of information
Donated cells have two very distinct kinds of value. cells have material value,
that is their capacity for metabolical, replicative and regenerative activity
which lies at the basis of their usefullness in tissue engineering. But cells also
carry genetic information that is valuable to the donor, the tissue engineer
and the future recipient of the tissue engineered product. This informational
value is retained whenever a cell is transferred from donor to intermediary/ies
and on to the final recipient. The consequence of this persistent presence of
informational value is that there is an incomplete 'disentanglement' between
the donor, his or her cells, the tissue engineering community, the BTeP that
is derived from them and the patient receiving the BTeP.
if we add to this incomplete disentanglement the required traceability
of BTePs and their components both upstream and downstream (european
Parliament, 2007), it is clear that the donor continues to have interests
throughout the entire process of donation, cell storage, tissue engineering and
the final application of the BTEP. The informational value associated with the
cells thus remains important even when donating is an 'act of abandonment'
of the material value of the cells by the donor. informed consent procedures
will have to address how the persistent informational value of the BTeP will
be treated and what its consequences are for donors and the exertion of their
rights.
Although retracing donors and informing them of relevant findings may
be an extra burden for tissue engineers, it is advisable that this possibility is
considered. showing respect for the person who contributed to your research
by giving him or her crucial information is a recommendable mode of action,
if not a moral duty. it would, after all, not be very consistent to aspire to the
healing of one person through the application of a BTeP while on the other
hand withholding information that could be crucial for the donor, who has
significantly contributed to your research (CCNE and Nationaler Ethikrat,
2003).
