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. |
