Biomedical Engineering Reference
In-Depth Information
16.4.5 Enhancing participants' autonomy
if we want to enable prospective participants to decide autonomously whether
or not to participate, we have to start by acknowledging that the elements
mentioned above may diminish this autonomy. enhancing the autonomy of
the trial participant is consequently desirable.
(1) a considerate amount of energy should be put into informing prospective
participants. This remains first and foremost the task of the study team
(Flory and emanuel, 2004). The use of audio visual material and new media
could prove beneficial as many persons do not understand abstract or highly
specialised language. The use of audio visual material in the informed consent
procedure was beneficial in a number of cases (Rossi
et al
., 2005; Hutchison
et al
., 2007; strevel
et al
., 2007). (2) one could consider the development of
questionnaires to find out whether candidates actually understand what has
been explained to them. (3) given the complexity of the process, persons
asked to participate should be encouraged to seek advice from independent but
knowledgeable persons who can assist them in their decision making process
(Flory and emanuel, 2004; Joffe
et al
., 2001). These 'independent thirds'
can advise on different issues that may be worrying, be they of an ethical,
philosophical or more technical or scientific nature. These 'independent thirds'
can range from other physicians or nurses helping participants to understand
the regenerative character of the BTeP, the technique of the intervention
or rehabilitation processes, to persons versed in the ethical issues that are
associated with the use of specific cell types. The chain of events that leads
to surgery may have to be adapted in order to allow and encourage this
consultation, but this should not be an impediment to the trial itself.
Providing potential participants with all the information and giving
them ample time to discuss the elements of the trial with a third party will
engender trust. Keeping in mind that trust is more easily squandered than it
is regained (Bok, 1995), the importance of trust in BTePs trials should not
be minimised (Kass
et al
., 1996) and every effort should be made to ensure
that confidence in trials is not betrayed in order to prematurely promote one
BTeP to the detriment of a promising development in medicine.
16.5 Follow-up of trial participants
The interaction between the BTeP and the body will result in the gradual
acceptance by the body of the 'foreign' BTeP through which it gradually
loses its 'foreignness'. This is a long-term process that may continue well
beyond the duration of the trial. These events, especially adverse events,
will still have to be identified and analysed (van Zuijlen
et al
., 2001; Wood
et al
., 2006; european Parliament, 2007).
Trials alone will therefore not suffice to make comprehensive projections
