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Federal Research "Protections" Committee Recommends Waiving Parental Consent Before Enrolling Teenagers in Drug Trials

September 8, 2001

The National Human Research Protections Advisory Committee (NHRPAC) decided July 30 to urge the Food and Drug Administration to allow teenagers to enroll in experimental drug trials without their parents' consent or knowledge, according the Washington Post (July 31). NHRPAC committee member Alan Fleischman of the New York Academy of Medicine noted, "We [NHRPAC members] don't want it [the waiver of parental consent] to be used in any wholesale way to change the role of parents, [but] there does come a time when the interests of adolescents may outweigh the involvement of their parents in specific circumstances."

One member of the NHRPAC working group opposed waiving parental consent. Vera Sharav of the Alliance for Human Research Protection asked, "What happens when a child is harmed? Do you bring the parent back [into the decision-making process]?"

It's also important to consider whether teenagers really understand the future implications of sharing their genetic information for research purposes and whether they are capable of deciding the risks versus benefits of enrolling in genetic-based studies.

Why New Push for Enrolling Teenagers?

Many pharmaceutical companies are eager to enroll children and teenagers in drug trials (including genetic-based studies) because doing so would permit them to extend patents on certain drugs. That incentive was established as part of the FDA Modernization Act of 1997. Former President Clinton established the 17-member NHRPAC in 2000. The Committee falls under the auspices of the U.S. Department of Health and Human Services (HHS), currently headed by Tommy Thompson. Parents should contact Secretary Thompson to voice their objections or support for waiving parental consent:

Secretary Tommy Thompson
U.S. Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Ave., SW
Washington, DC 20201

This article was originally published in the July/August 2001 issue of Health Freedom Watch.

What happens when a child is harmed in an experimental drug study and the parents were never informed of their child's participation?