The conflicts surrounding clinical trials on children have continued to grow over the past few years. On April 8, 2005 a clinical trial called Children’s Environmental Exposure Research Study (CHEERS) was shut down. This clinical trial was originally intended to estimate how much pesticide a child under the age of three would absorb into his/her system if his/her parents were to spray his/her room with it. The families would receive money and other gifts (such as a video camera) for taking part in the trial. The Environmental Protection Agency (EPA) shut down CHEERS after receiving continuous complaints from the public.
All clinical trials involving humans must follow certain sets of ethical guidelines. It is impossible to avoid all risks during the process of a clinical trial. The key is to try to minimize the negative effects and maximize the positive effects. Everything must be done in the researcher’s power to have the lowest risk to benefit ratio. The potential benefits to an individual or society should be maximized and outweigh the risks. It is also important to test and analyze how children react in a clinical trial that is actually testing something they are or may be exposed to. Also following ethical guidelines must be the payment a research subject and his or her family receives. Payments in forms of small amount of money may be given, but it must be in proportion to the clinical trial and may not be an excessive amount.
This experiment broke all of these rules. This clinical trial had planned on spraying infants’ rooms with pesticide, but there were no pests to be sprayed. The risk vs. benefit ratio had now turned strictly to risk. If no pests were present, then the children were being put in harm for no appropriate reason or logical benefit. This goes against what is asked of all researchers: do no harm. Along with having no possible positive outcomes, this clinical trial also violated laws against bribing. The video camera would have been beyond what was appropriate for the experiment. This clinical trial does not meet strict government standards and was, in my opinion, unethical. As Barbara Boxer (Democratic Senator from California) said about CHEERS: "a reprehensible idea that never should have made it out of the boardroom".
Resources relevant to my post:
http://www.healthy.net/scr/news.asp?Id=9514
http://www.epa.gov/cheers/
http://www.naturalnews.com/019192.html
http://clinicalresearch.nih.gov/ethics_guides.html#6
1 comment:
Astrid’s conclusion that the gifts offered to parents in exchange for offering their children as subjects to CHEERS were a form of bribery and that the test had too low of a benefit to risk ratio accurately describes the unethical nature of the study. However the argument stating that because there were no pests to spray, the children were put in harm for no reason skews the point of the debate. The unethical nature lies not in the fact that there were no pests to be eliminated, but in the fact that the very company that performed this study knew that pesticide has harmful effects and wanted to know the extent to which they manifested in children. Indeed this studies motive was “to help EPA better protect children”(1), but virtuous motives do not erase the unethical nature of such experimentation that aforesaid.
The first aspect of CHEERS that made the ethicality of the project questionable was the fact that the researchers were giving parents gifts in exchange for their child’s participation in the experiment. Although this may have been a researcher’s act of gratitude, it may have triggered the parents’ selfish ambition. Parents, being fallible human beings, may become enchanted by the gifts that appeal to their wants and needs and so may become more inclined to put their child’s health at risk for their own benefit. People should not subject children, who have little to no voice of their own, to risky experimentation if there is no significant hope of substantial benefit to the child’s well-being that outweighs the risks, and the researchers should responsibly do their part and not tempt parents to compromise their child’s well-being.
While presenting gifts to parental “participants” in the study creates skepticism in the ethicality of the study, the fact that the EPA would perform such a study on children knowing that pesticides are harmful points to corruption. The EPA stated that the motivation of CHEERS was to discover how to better protect children, but even before their studies were terminated in 2005, pesticides were recognized as hazardous material, as exemplified through the University of California’s inclination to design a pesticide safety program (2). So why would the EPA subject children under three years of age to a test that most certainly will cause some sort of harm “to help EPA better protect children”(1)?
Though the EPA has various reasons for performing such a pesticide study on children under three—whether it be to protect children or to gain incentive from pesticide companies (3)—the motives do not obliterate the fact that young children were exposed to hazardous material with, as Astrid clearly pointed out, too low a benefit to risk ratio.
(1) http://www.epa.gov/cheers/
(2) http://www.ipm.ucdavis.edu/IPMPROJECT/2004/04pested.html
(3) http://www.healthy.net/scr/news.asp?Id=9514
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