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Research Information
Department of Science Communication & Society, Leiden University, Leiden, The Netherlands
Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands
A R T I C L E I N F O
A B S T R A C T
Article history:
Received 7 April 2014
Received in revised form 25 November 2014
Accepted 21 December 2014
Objective: Children involved in medical research often fail to comprehend essential research aspects. In
order to improve information provision, a participatory approach was used to develop new information
material explaining essential concepts of medical research.
Methods: A draft of a comic strip was developed by a science communicator in collaboration with
pediatricians. The draft was presented to children participating in a clinical trial and to two school
classes. Children were consulted for further development in surveys and interviews. Subsequently, the
material was revised and re-evaluated in four school classes with children of varying ages and
educational levels.
Results: In the rst evaluation, children provided feedback on the storyline, wording and layout. Children
thought the comic strip was fun and informative. Understanding of 8 basic research aspects was on
average 83% and all above 65%, illustrating that children understood and remembered key messages.
Conclusion: A comic strip was developed to support the informed consent process. Children were
consulted and provided feedback. The resulting material was well understood and accepted.
Practice implications: Involving children in the development of information material can substantially
contribute to the quality of the material. Children were excited to participate and to be a part of science.
2015 Elsevier Ireland Ltd. All rights reserved.
Keywords:
Research information
Informed consent
Children
Adolescents
Participation
1. Introduction
The recent update of the WHO report on Priority Medicines for
Children pleads for more scientic research in children, as 4560%
of medication currently used for children is prescribed off-label
[1]. This plea holds an implicit duty to inform society in general
and parents in particular about what medical research entails and
why it is important to also involve children in research. In most
circumstances, children do not have the legal right to provide
consent for research participation. As children age, their mental
capacity and autonomy to make decisions develop. Therefore,
various rules and regulations require children to assent to research
participation when they are capable of making a decision [2,3].
Offering children the possibility to assent assumes that children
possess sufcient and adequate information to make a decision.
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2. Methods
2.3.1. Set-up
In order to consult more children, a rst evaluation was
performed in two school classes. Feedback was collected by
Fig. 1. Picture from the comic strip Irene Cecile (original version in Dutch). NB: In Dutch, the word onderzoek describes both scientic research and the process of
diagnostic testing and deciding upon treatment. Therefore the distinction between these two types of onderzoek is given special attention.
520
Fig. 2. Example of a Lets repeat exercise Irene Cecile (original version in Dutch).
Table 1
Multiple choice questions on 8 basic research aspects.
Research aspect
Question
Voluntary
Best meds
Withdraw
Randomization
Placebo
Side effects
Anonymity
Therapeutic
misunderstanding
2.3.3. Interviews
Children were asked for an interview at the end of the survey.
The children who volunteered were interviewed after nishing
the survey, either in an individual interview, or in a group of 2
4 children. The interview started with the open question: Tell what
you think of the comic stripyou can say anything that comes to
your mind. The interviews took approximately two to six minutes
and were recorded with a voice recorder. In addition to the open
question on the comic strip, children were asked to explain specic
research concepts (e.g. could you explain to me what a biobank is?),
in order to assess understanding in a deeper way than possible
with the survey.
3. Results
3.1. Evaluation in school classes
Initially, two classes were tested as a pilot: a primary school
group 7 with 28 children from ages 10 and 11, and a high school
rst year vmbo (preparatory middle-level vocational education)
with 15 children ages 1213 (1 non-responder). We interviewed a
total of 16 children in individual interviews (4 boys, 4 girls). The
feedback from these children led to a number of modications of
the comic strip, a selection of which is demonstrated in Table 2.
As biobank research is increasingly used among children, we
added a six-page chapter on this topic. Since children only need to
read chapters relevant to their situation (i.e. either biobank or drug
trial), the extra chapter does not increase the total amount that has
to be read by research participants. Compressing the strip further
would reduce the amount of information given, and therefore
we aimed to improve the structure of the comic strip to enhance
the reading experience.
3.2. Re-evaluation in school classes
3.2.1. Participants
In total 101 children from 4 new school classes participated.
Class 1 was a primary school class group 7, with 28 children aged
1011. Class 2 was primary school group 7/8, with 22 children age
1012. Class 3 was a high school rst year vwo (pre-university
secondary education) with 25 children age 12/13. Class 4 a high
521
Table 2
Common feedback from the children in the survey and interviews, and the reection of this input in the subsequent revision of the comic strip.
Input children
Quotes
Reection in revision
you could better divide it into pieces and read one piece each day. One
boy said I thought it was a bit boring, but when youre ill, maybe you
dont think about that.
One girl thought the comic strip was well thought-off, because
for children it is much more fun to read a comic strip instead of a
story. Another boy said it is more fun than very lengthy texts, and
then you are very easily distracted. One girl told I understood it well,
Table 3
Amount of pages read, per school class.
Class 1
Complete
3039 pages
2029 pages
019 pages
25
2
1
0
Total
28
Class 2
89.3%
7.1%
3.6%
0.0%
100%
8
9
3
2
22
Class 3
36.4%
40.9%
13.6%
9.1%
100%
23
1
1
0
25
Class 4
92.0%
4.0%
4.0%
0.0%
100%
9
11
5
0
25
36.0%
44.0%
20.0%
0.0%
100%
1 person missing, as this person did not ll in how many pages he had read.
522
and it looked nice, it was clear [] if it would have been shorter, then you
would not understand it, because there would be less information in it.
The children thought the comic strip was funny, and they
especially liked the green-nose u. Some children pointed out
that there should be more humor or jokes in the story, because now
it is [] a bit too serious, and we still like some jokes.
The children expressed that the design should be more
appealing, because it was still a draft with simple sketches. One
girl said that she really liked the pages that were already in color
as an example of the nal product. Two other girls indicated
together that they enjoyed the lets repeat exercises in between the
chapters.
3.2.3. Understanding
Understanding of 8 key concepts was assessed in order to
obtain an indication of how well the information connected to the
target group after the revision, and to identify topics that needed
extra attention. As reected in Table 4, classes 1 and 3 achieved
high average scores (86% and 95%) and performance of classes 2
and 4 was substantially lower (77% and 72%). Especially troublesome for class 2 and 4 was anonymity (54% and 42% respectively).
As the chapter on privacy is at the end of the comic strip, it is likely
that the lower score for this topic is partly due to the fact that not
all children read it. In Table 5 the scores for privacy are related to
whether the child read the chapter, a x2-test indicated a signicant
association between answer (correct/incorrect) and having read
the chapter on privacy (p < 0.01).
3.2.3.1. Benets and risks. The majority of children (68.296.0%)
understood that participation does not always benet the child
itself, that a participant does not necessarily receive the best
medication (80.8100%), and that there are risks involved, such as
side effects of a drug (96.2100%). This understanding was
conrmed in the interviews, in which children answered that
they would not necessarily have benet or get well due to research
participation. Explanations were given: the medicines might not
work, so it might take longer before you are well again and I dont
think so, because they dont know yet what the drug does.
Children were asked whether a drug could give side effects and
they answered correctly that this is possible. When asked whether
you always receive the best drug, children responded No, because
they need to know which drug works best; No, because there are
different drugs and I think they dont know which one is the best,
because they have not tested that.
3.2.3.2. Rights. Children demonstrated a good understanding of
the voluntary nature of research participation (69.296.0%), and of
the right to withdraw (57.796.0%). When children were asked to
explain informed consent they were unable to provide an answer.
However when asked if they ask you to participate in a study, do you
have to do so? children answered you can choose whether you want
Table 4
Percentages of correct (+), incorrect ( ) and blank (O) answers, per multiple choice question.
Research aspect
Class 1
Class 2
+
Voluntary
Best meds
Withdraw
Randomization
Placebo
Side effects
Anonymity
Therapeutic misunderstanding
Average
Class 3
O
Class 4
O
Total
O
78.6
92.9
78.6
89.3
89.3
100
82.1
82.1
21.4
7.1
21.4
3.6
10.7
0
17.9
14.3
0
0
0
7.2
0
0
0
3.6
77.3
95.5
81.8
77.3
63.6
100
54.5
68.2
22.7
0
18.2
22.7
36.4
0
40.9
31.8
0
4.5
0
0
0
0
4.5
0
96.0
100
96.0
96.0
96.0
100
80.0
96.0
4.0
0
4.0
4.0
4.0
0
20.0
4.0
0
0
0
0
0
0
0
0
69.2
80.8
57.7
84.6
69.2
96.2
42.3
76.9
26.9
15.4
38.5
11.5
30.8
3.8
57.7
23.1
3.8
3.8
3.8
3.8
0
0
0
0
80.2%
92.1%
78.2%
87.1%
80.2%
99.0%
65.3%
82%
86.6
12.0
1.4
77.3
21.6
1.1
95.0
5.0
72.1
26.0
1.9
83.0
Read chapter
Correct answer
Incorrect answer
53
12
Total
65
100%
13
22
35
37.1%
62.9%
100%
1 person missing, as this person did not ll in how many pages he had read.
523
524
Conict of interest
The authors have no conict of interest to disclose.
Funding source
This work was funded by a project grant from The Netherlands
Organisation for Health Research and Development (113203016).
Acknowledgements
The authors would like to thank Irene Cecile for her important
role in the development of the comic strip. We would like to thank
Ellen van Heijningen and Christa Broekhuizen for their assistance
during school visits. Also we would like to thank Elisa Carolus and
Karlijn Groenendijk for their input in the fundamental stages of the
development.
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