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March
1998
Factors
that influence parents' decisions to consent to their child's participation
in clinical anesthesia research.
Tait
AR, Voepel-Lewis T, Stewart M, Malviya S; Anesth Analg 1998;86:50-3.
[ see
abstract below
]
Tait et al have performed a valuable service to those of us who carry
out clinical research in pediatric patients. Although in the past there
has been minimal pharmaceutical support for pediatric studies (see previous
commentaries) the upcoming FDA reform legislation will likely, we hope,
result in an increase in industry supported pediatric studies. Certainly
the position of the American Academy of Pediatrics is to whole heartedly
support and encourage such studies.
Impediments to such studies from industry have been the relatively small
population which would benefit from the drug (small market share), the
excessive cost of such studies (eating too much of the potential profits),
and the possible expense of medical/legal costs if a pediatric patient
volunteer were injured (no known cases to this point in time as far as
I know). The Tait study tells us another impediment that in part explains
why pediatric studies take longer than adult studies and why in fact they
might be more expensive on a per patient basis.
Obtaining a true informed consent for any patient is difficult but in
particular when a study is to be carried out in children, children speak
through their parents whereas adults can easily speak for themselves.
Thus the parent is most concerned with their child's safety. Tait found
that nearly half the non-consenters feared for their child's safety or
were concerned about potential risk while 25% had a strong fear of the
unknown.
Interestingly, factors that strongly resulted in a positive consent were
that the study might benefit other children (84%), there was minimal risk
to their child (86%), the study was explained well (78%), they understood
the study (77%), the study would contribute to medical science (69%),
the risk was small in relation to study importance (69%) or the study
was important (68%).
One of the most important factors was that the parents listened to the
researcher completely and believed that the study was necessary for the
advancement of medical science. It was also interesting to note that when
asked if they would participate again in the future most felt that their
major concern would be potential risk to their child, how well the study
was explained, that the study would not interfere with the care of their
child, and that the researcher would allow their own child to participate.
This study shows the importance of precisely explaining the overall concept
of the proposed study, why the study is needed in children, and why their
particular child's participation is important. This study also shows the
importance of clear, precise and unrushed presentation. This paper is
certainly consistent with my own experiences over the years and why it
is so vital for the principal investigator to be actively involved in
the consent process or at a minimum very responsive to all parental questions.
Return to the Current
Literature Review Front Page , or read the abstract:
ABSTRACT
There is concern that the environment in which consent for anesthesia research
is sought may be coercive. We therefore designed this study to determine
the factors that parents consider in consenting to their child�s participation
in clinical anesthesia research.
The study sample consisted of 246 parents who had been approached for permission
to allow their child to participate in a clinical anesthesia study. Parents
were asked to complete a questionnaire detailing the reasons for their decision
to consent or decline their child�s participation.
There were no differences in the demographics of the consenters (n=168)
and nonconsenters (n=78). Perceived risk and the importance of the study
were the primary factors in the parents� decisions to consent or decline.
Only 2.8% of nonconsenters strongly considered a lack of privacy as a deciding
factor; 15.3% stated that they had insufficient time in which to make a
decision, and 0% reported having felt pressured. Furthermore, only 3.1%
of consenters strongly considered an obligation to consent.
Results of this survey highlight factors that influence parents� decisions
to consent to their child�s participation in clinical anesthesia research.
We hope that this information will be important to researchers in providing
an appropriate environment for obtaining consent for clinical anesthesia
research studies.
Implications: Parents who are approached for permission for their child
to participate in a research study must be fully informed and under no pressure
to consent. This study describes the factors that influence parents� decisions
to consent to their child�s participation in clinical anesthesia research.
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