Biomedical Engineering Reference
In-Depth Information
considered to be unclean or sacred, even when religious leaders often take
a more moderate stance (Daar, 1994; rosner, 1999).
Those who do not share these conscientious objections may not be aware
of the weight these issues carry for others and providing this information may
seem to make the informed consent process too cumbersome to be practical.
also, many prospective participants will not be familiar enough with the
science behind the trial to inquire spontaneously on these issues. Yet if the
autonomy of all trial participants, irrespective of their religious, ethical or
philosophical allegiances and respect for their opinon are the fundamental
principles underpinning informed consent, it is clear that this information
should be given to prospective participants, even if this makes the process
more elaborate. not providing this information could be regarded as a breach
of the investigator's duty of care toward the trial participant or as a form of
paternalism (enoch
et al
., 2005). The limited knowledge of lay persons, the
ethical connotations of these issues and the delicacy of the subject warrant
that the composition of the BTeP is discussed before obtaining informed
consent and that conscientious objections are taken seriously.
16.4.4 Communicating risks and benefits
We have already explored the risks and benefits associated with tissue
engineering and the need for investigators to be in equipoise. But not only
does one have to be in equipoise as a researcher, one has also to present the
various issues to trial participants in order to allow them to make up their
minds. Given our limited knowledge of both risks and benefits and given
that there often is no general consensus about what actually is the gold
standard among existing therapies, this calculus will be extremely difficult.
in determining whether there is equipoise in the use of BTePs, both risks
and benefits are clearly taken to a higher level.
in
ex vivo
tissue engineering such as bone tissue engineering a new kind of
trade-off has to be made in dialogue with the prospective participant: against
the enormous benefit stand potentially large risks, probably even unknown
emergent risks owing to the process of regeneration that have never been
encountered before. What is more, some adverse events may only become
apparent after the trial. considering the complexity and the newness of
ex
vivo
tissue engineering, the problematic assessment of risks and benefits
and the availability of reliable alternatives, trial designers and investigators
will have to demonstrate convincingly to participants that the benefits of the
BTeP-treatment will be at least as good as the existing treatment, while the
risks involved in applying the BTeP will not exceed those of the conventional
treatment. if the risks exceed those of conventional treatment, it is reasonable
to expect that the proposed benefits are very likely to be realised and that
they would render the increased risks acceptable.
