Biomedical Engineering Reference
In-Depth Information
16.4.2 Surgery
Bone tissue engineering trials require surgery. Trial participants are mainly
concerned about the way the proposed intervention will have an impact on
their health and quality of life (newton-Howes
et al
., 1998; mcgaughey,
2004; el-Wakeel
et al
., 2006). so while the surgery is ancillary to the main
aim of the trial, which is testing the efficacy and safety of the BTEP, it may
entail risks and discomforts for the patient. The construction of the BTeP
may even increase some of the risks and consequences of implant-associated
infections (Kuijer
et al
., 2007). The presence of the BTeP in the trial does
not absolve the investigator from giving all relevant information concerning
the surgery and the foreseeable risks of both BTeP and control.
16.4.3 Use of specific cells in the bone tissue
engineered product
The implant of allogeneic or xenogeneic material not only has a physiological
effect on the recipient in that it is hoped that it will result in a beneficial
evolution of his or her condition; it may also have cultural, religious or
other relevance for the prospective participant. consequently a discussion
on the origin of the cells in the BTeP should be included in the informed
consent process. The issue's relevance is exemplified by the debate in the
european Parliament on the regulation of advanced therapy medicinal
products where the ethical implications of the incorporation of specific cell
types in BTePs raised more concerns than any other subject (euractiv.
com, 2007).
Whenever products containing allogeneic, xenogeneic or embryonic stem
cells become available, the theatre for the discussion on the acceptability
of these cell types is likely to move from the public arena to the surgery.
if, for example, the use of BTePs containing es is legally allowed in a
country, this does not automatically imply that all prospective participants
will consent to receiving them. They retain the right not to take part in the
trial without explaining why. Yet to be able to decide about this, they have
to be informed about the composition of the BTeP.
additionally, the manipulation of human derived, freely donated material
in an environment that is driven by instrumental or commercial values is a
worrying development to some, as is clear from the growing body of literature
on this subject and from the positions taken by, for example, the French and
the german national ethics councils (ccne (France) and nationaler ethikrat
(germany), 2003; ccne, 2007).
if culture media and scaffolds used in BTePs contain non-human animal
derived material, this may also elicit queries from trial participants. some
persons reject all animal derived products, or products derived from animals
