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The ethics of human experimentation once again are the focus of intense scrutiny. The participation of children in clinical research studies and the use of people in biological and chemical weapons research are 2 lively topics of consideration and debate.
In 1997, the Food and Drug Administration (FDA) broke with tradition and spelled out rules in part of the FDA Modernization Act that would encourage pharmaceutical companies to voluntarily study drugs in children. Financial incentives were proposed to allow for further patent protection if a drug were tested in children--the pediatric exclusivity provision. The Pediatric Final Rule, which became effective on April 1, …