Children In Clinical Trials?
One hallmark of ethical clinical research is that participants have a full understanding of the research, including its relative risks and benefits. Participation in a clinical trial cannot really be considered voluntary without complete knowledge and acceptance of what is going to happen. Children, depending upon their intellectual maturity, may or may not be capable of truly understanding the complexities of clinical research. For that reason, children are not usually allowed to decide for themselves that they will volunteer for a clinical trial. Instead, the consent of a parent or guardian is required.
Eighteen is the most commonly accepted age of adulthood, although in some places younger individuals are allowed to decide for themselves. Many clinical trials require, in addition to the written consent of a parent or guardian, the assent of the child herself, if she is able to understand what will be happening to her. In practice, this usually means that a child who indicates he does not wish to participate, by vocalizing or otherwise objecting, is not enrolled into a study except under exceptional circumstances (for example, where the child will surely die if the experimental procedure is not attempted).
What does this really mean, then? Well, it means that, as usual, children don't have much control over this aspect of their lives. This is certainly not a new concept, given that children cannot enter into certain contracts, they cannot serve in the military or vote, and they cannot buy alcohol or tobacco products. There are obvious reasons for imposing these restrictions on children – they are being protected from harm at a time in their lives when they are considered vulnerable. The same holds true for volunteering for clinical trials.
Here's the bad news: Some medications that have been routinely prescribed for children were never tested in children before being marketed. More on this aspect of children in clinical trials in my next entry...
-Joe
Related Topics: Clinical Trials: Too Many Minority Kids, Testing Children's Drugs on Children
Eighteen is the most commonly accepted age of adulthood, although in some places younger individuals are allowed to decide for themselves. Many clinical trials require, in addition to the written consent of a parent or guardian, the assent of the child herself, if she is able to understand what will be happening to her. In practice, this usually means that a child who indicates he does not wish to participate, by vocalizing or otherwise objecting, is not enrolled into a study except under exceptional circumstances (for example, where the child will surely die if the experimental procedure is not attempted).
What does this really mean, then? Well, it means that, as usual, children don't have much control over this aspect of their lives. This is certainly not a new concept, given that children cannot enter into certain contracts, they cannot serve in the military or vote, and they cannot buy alcohol or tobacco products. There are obvious reasons for imposing these restrictions on children – they are being protected from harm at a time in their lives when they are considered vulnerable. The same holds true for volunteering for clinical trials.
Here's the bad news: Some medications that have been routinely prescribed for children were never tested in children before being marketed. More on this aspect of children in clinical trials in my next entry...
-Joe
Related Topics: Clinical Trials: Too Many Minority Kids, Testing Children's Drugs on Children
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