Should Children Serve as Research Subjects in Exercise
Physiology?
Jonathan N. Mike MS, CSCS, NSCA-CPT
Doctorate Student
Exercise Physiology
The
University
of New Mexico
Albuquerque,
NM
Compared to experimental research
assessing various physiological or psychological components in children, a limited
number of articles has discussed arguments in favor or in opposition of children
serving as research subjects. There is a
consensus that it is important to include children in research regarding their
health and well-being [1]. However, the
Declaration of Helsinki has traditionally limited research involving children
by demanding special justification for inclusion of research that deals with health
matters. They argue that future
considerations require special grounds for excluding children from research.
Due to the considerable variation
in the rate of growth and development of children, research from adult
populations may be invalid and unlikely to transfer. In addition, the Declaration also states that
children’s attitude and research point of view should hold equal importance to
that of adults. Yet, it is clear that using children in research studies
creates special attention and need, not only for potential risks involved but
also the legitimacy of the research. Ethical
issues and boundaries can arise, including such as vulnerability, age, and
informed consent.
The main problem that usually
accompanies research with children is the argument that they have impaired
autonomy and require consent of their parents, legal representation, or
guidance with the decision-making process; all of these considerations bear
directly on whether permission is granted to participate as a research
subject. Interestingly, the research
that has been done indicates that between ages of 7 and 12, children do have
the ability to decide whether they should participation in research or not [2-4]. Kannuken
[5] explains the need for greater attention that is required by researchers to
ensure children are fully informed of and understand the details of the research.
These research points beg the question:
what is the justification for the inclusion of children in research? Certainly, it is a good question that needs to
be dealt with accordingly in order to extrapolate meaningful outcomes. First, certain diseases are considered childhood
diseases or heredity induced. Therefore,
it is reasonable to require extensive research to be performed on
children. Considering that the medical
community continues intense scientific study on both biological and
physiological causes of world wide epidemics, such as obesity, then, such research
should include children to explore all avenues and causes.
<>Second, there are well known
problems in extrapolating pharmacological data from adults to children, due to
growth and developmental differences [6].
Specifically, the effects of certain drugs may pose either dangerous or
diminished outcomes. Because of
age-related metabolic differences, serious consequences may occur. Hence, it is expected that drugs used in
treatment of children must be tested before use, and within all populations,
including children during or within clinical trials. Third, as companies seek treatments for
childhood diseases such as Autism and Attention Deficit Disorder, research must
be performed to determine what normal development is compared to what is
abnormal. To do so, subsequent policies
and practice guidelines to guide treatments must be properly carried out [7].
If the research community agrees
upon the inclusion of children in research (i.e., experimental and/or clinical
trials), it is critical to assess the degree of benefit against any risk of
harm or any pain that might result from the investigation. Within all research
settings, issues of vulnerability can aggravate and potentially worsen the
quality of the research. For example, take
the prevalence and ongoing research on obesity. Children may feel pressured from parental
involvement to participate in an experimental or clinical design to measure up
with current social standards, such as a healthier lifestyle and having
increased self-esteem. This thinking is
necessary to ensure that the protocols carried out in exercise physiology
laboratories are ethical and professional.
The Royal College of Pediatrics
and Child Health guidelines [7] indicate the following clause: “We believe that research in which children
are submitted to more than minimal risk with only slight, uncertain or no
benefit to themselves, deserves serious ethical consideration.” According to the guidelines, low risk includes
procedures that cause brief pain or tenderness, and small bruises or scars. High risk includes ‘lung or liver biopsy” which
are not justified for research purposes alone [7]. Conversely, though, researchers might argue that
the participation of children in such studies might actually be a positive life
experience.
<>There are many physiological
assessments and procedures used in exercise physiology that exhibit pain or
discomfort. Assessing blood lactate
measurements either from a finger prick or the anticubital space is an example
of mild pain or discomfort, especially in children. Previous investigations report
these techniques have been conducted in exercise physiology during
non-theaputic research in adolescence [8-10].
First, the question remains whether or not this is ethically
justifiable, even though it has been accepted by research and laboratory
procedures. Second, how is it in the
child’s best interests to be a research subject under such conditions? Third, what if a child has an untreatable
disease or condition? Does this permit the
child to serve as subjects as a means for pure benefit of future generations? In this regards, however, Sheppard [11] points
out that care should be taken not to exploit the vulnerable in research. He later states: “If the research can be conducted on a less
vulnerable group, then it should be.”
It is difficult to know the right
answer as it pertains to children. Both
sides are justified, while the decision still seems to be situation dependent. Meaning this, what is the experimental
design? What are the risks? What are the
benefits? With regards to the RCPCH
guidelines, it permits children themselves to determine whether an intervention
presents a low or minimal risk. However,
it can only apply when children are capable of making that determination. In
contrast, even older children may not be capable of making the right decision
until after the experimental research. Notwithstanding,
although the research may not induce benefits, it is not necessarily unethical
or illegal. The fact is, research must be done in certain scientific areas in
order to treat or cure certain diseases or conditions. What do think?
References
1.
World
Medical Association.
Declaration of Helsinki. (2000). Ethical principles for medical
research involving human subjects. Geneva: WMA.
2.
Broome
ME. (1999). Consent for research with pediatric patients. Seminar in Oncology
Nursing. 15(2):96-103.
3. Shevell MI. (2002). Ethics of clinical research in
children. Seminar in Pediatric Neurology. 9(1):46-52.
4. Broome ME, Stieglitz KA. (1992) The consent process and
children. Research in Nursing Health. 15(2):147-52.
5. Kankkunen P. (2002).Ethical issues in pediatric
nontherapeutic pain research. Nursing Ethics. 9(1):80-91.
Review.
6. American College of Sports Medicine (2006). Exercise
Testing for Children and Elderly People’, in Guidelines for Exercise
Testing and Presrciption, 7th ed. London: Lippincott, Williams, and
Wilkins. Pp. 237-51.
7. Royal College of Pediatrics and Child Health. (2000).
Guidelines for the Ethical Conduct of Medical Research Involving
Children. Archives of Disease in Childhood. 82: 177-82.
8. Martinez LR, Haymes EM. (1992). Substrate utilization
during treadmill running in prepubertal girls and women. Medicine in
Science Sports Exercise. 24(9):975-83.
9. Alten J, Mariscalco MM. (2005).Critical appraisal of
Perez et al: Jugular venous oxygen saturation or arteriovenous difference
of lactate content and outcome in children with severe traumatic brain
injury. Pediatrics and Critical Care Medicine. 6(4):480-2.
10.Tsalis G, Nikolaidis MG, Mougios V. (2004). Effects of
iron intake through food or supplement on iron status and performance of
healthy adolescent swimmers during a training season. International Journal
of Sports Medicine. 25(4):306-13.
11.Shephard RJ. (2002). Ethics in exercise science
research. Sports Medicine. 32(3):169-83. Review.