Should medical research with children as subjects ever be carried out?
The purpose of this essay is to explore reasons affirmative to medical research on children, without deviating from legal and ethical practices on children . It will discuss in particular, reason’s why children are not little adults, the need for pediatric medicine, the benefits of therapeutic and non-therapeutic research, the difficulties of such research, and a child’s right to promotional well-being.
When it comes to medical research subjects, children are a vulnerable population and so are granted special protection from potential research risks. Researchers in pediatrics often encounter conflicts between protecting the children who are vulnerable research subjects (therapeutic research) and developing generalized knowledge to benefit children as a class (non-therapeutic research).
It is also stated that benefits of medical research must clearly outweigh the risks. Many guidelines tend to shy away from non-therapeutic research, as it does not directly benefit the child, but the thin line between these types of research often inappropriately excludes children from potentially life-saving research and it withholds potentially effective therapies.
Inappropriately excluding children from research effectively denies them the right to promotional well-being. As discussed in the Otago Bioethics Report ,
..Research with children is important for the benefit of all children and should be supported, encouraged and conducted in an ethical manner. In fact, to exclude children from participating in scientifically and ethically sound research may be to deny them a basic human right, as it may impede the promotion of their health and well-being.
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Current policy of Article 24 of the United Nations Convention on the Rights of the Child states that we are to recognize “the child has a right to the enjoyment of the highest attainable standard of health..”, and “to ensure the provision of necessary medical assistance and health care to all children with emphasis on the development of primary health care..” and lastly, “to develop preventive health care.” In order to progress in the field of pediatric medicine, children as subjects are the only way to gain understanding about how to treatment them. This can successfully be done through therapeutic and non-therapeutic research, giving the child direct benefits without undermining their rights, and providing generalized data to treat other cases that may occur.
Attempts to protect children from the risks of medical research may have the unfortunate consequence of perilously harming children by impeding research in pediatric drug development and disease. Based on this concern, children have been termed “therapeutic orphans” in the drug development and pharmaceutical industry. They are called therapeutic orphans because “they are either denied the use of many new medications or exposed to medications that have bypassed rigorous evaluation.”
Because researchers and scientists cannot trial drugs for safe use on children due to restrictive therapeutic guidelines, they are forced to prescribe non-proven treatments to children on a case-by-case basis, which pediatricians argue is of more risk than the clinical trials themselves. Drugs proven only on adults are still prescribed to children in an “off-label” practice, a term used because the drugs say nothing about children or the dosage for children required. To resolve the dangers presented by this problem, reformed guidelines are needed to counteract the lack of pediatric data and give children safer prescriptions.
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A child is not a little adult . Reasons such as metabolism, organ development, anatomy and physiology must be considered. As discussed in the Otago Bioethics Report, “children have additional and unique sets of interests. They frequently suffer from disease processes which are peculiar to their age group.” Treatments that work on adults do not necessarily work just as effectively on children, these differences are essential in learning about how treatments affect children’s unique interests. For example, the proportion of water in young children diminishes as the body grows, therefore the period of time when drugs are eliminated from the body is significantly longer in children as it is in adults (pharmacokinetics).
Organs are still developing in childhood and do react differently to fully developed organs of adults (pharmacodynamics).
Therefore we can not use research only proven on adults as a basis for the treatment of children.
Medical science has successfully conquered childhood infections such as polio, but these breakthroughs are few and far between. Due to inappropriate guidelines, researchers and scientists who specialize in pediatric drug development are rare. By exploring these reasons into why medical research should be conducted with children, it only makes sense to provide children with as much a hope of safe and effective treatment against infections as adults do. Children should not be perilously excluded from important types of medical research, essential to promotional well-being. As advances in the medical world develop, the importance for medical research on children will increase. We simply cannot afford to leave our youngest beneficiaries behind.
Resources
www.newhealth.govt.nz/ethicscommittees/documents/children.doc
http://www.newhealth.govt.nz/ethicscommittees/application.htm
http://www.hrc.govt.nz/root/Ethics/Ethics%20Overview/HRC
http://www.unhchr.ch/html/menu3/b/k2crc.htm
http://www.australianprescriber.com/magazines/vol26no6/pdfs/gazarian.pdf
http://www.laskerfoundation.org/rprimers/cmr.html#policies
http://www.unhchr.ch/html/menu3/b/k2crc.htm
