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The U.S. Department of Health and Human Services (HHS) published a final rule that amends subpart B of 45 CFR 46. The rule was published in the Nov. 13, 2001 Federal Register. The rule becomes effective on Dec. 13, 2001. The amended rule provides additional protections for pregnant women and human fetuses involved in research. The final rule continues the protections for both pregnant women and fetuses that have existed since 1975, but makes limited changes in terminology referring to neonates. It also clarifies provisions for paternal consent when research is conducted involving fetuses, clarifies language that applies to research on newborns of uncertain viability, and corrects technical errors.
The American Association of Pharmaceutical Scientists (AAPS) issued guidelines at its 2001 annual meeting held October 2001 in Denver for parents who want to enroll their child in a clinical trial. The guidelines are in response to the growing number of parents using the pediatric exclusivity provision enacted by the Food and Drug Administration (FDA) in 1997. The provision is in the FDA Modernization Act and encourages pharmaceutical companies to conduct clinical trials on medications often prescribed to children. Companies that participate receive a six-month patent extension on the product being tested. The law has a sunset date of Jan. 1, 2002.
AAPS developed guidelines to help parents make a more informed decision regarding enrolling their child in a clinical trial. The guidelines were developed with pharmaceutical scientists with pediatric expertise. For example:
• Share your intentions about participating in a clinical trial with your child’s pediatrician. He or she knows your child’s medical history and can help evaluate the risks and benefits associated with the program.
• Ask detailed questions about the trial length and the expected time commitment. How many days of work and school will you and your child miss? Will you be compensated for your travel or time?
• Question who will be providing medical care to your child. You want a team that is specifically trained in pediatric care so they are sensitive to the special needs of sick children.
• Understand what signs and symptoms exhibited during the trial could indicate a problem.
• What criteria and/or escape clauses exist should you decide to resign your child from the trial?
AAPS is a professional society of more than 11,000 members employed in academia, industry, government and other research institutes worldwide.
The Office of Human Research Protections (OHRP) and the Department of Health and Human Services (HHS) awarded the Bethesda, MD-based Health Improvement Institute a contract to create a national awards program to recognize excellence in protection of human research subjects. The awards will become part of a public-private partnership encouraging continuous improvement in the nation’s system for protection of human research subjects. The awards will give visibility to best practices and reward institutions, investigators, sponsors, and IRBs for their commitments to responsible conduct in human studies.
"These Awards for Excellence in Human Research Protection will encourage institutions, investigators, and sponsors to continually improve their processes. For too long, we have focused on regulatory compliance as an end in itself — what we need to emphasize is prevention of harm," says Greg Koski, director of OHRP. "These awards will heighten awareness of these issues within the research community and among the general public, adding credibility to the research process and raising public confidence in research results. We believe that the research community, industry, and the American public share these goals, and these awards will recognize the best among those who achieve them," he says.
"There is excellent and ethical research being done throughout the United States and these new awards celebrate the individuals and organizations who do it best," says Peter Goldschmidt, MD, president of the Health Improvement Institute.
An advisory board consisting of representatives from government, industry, and scientific communities and advocacy groups will recommend awards to recognize:
[Editor’s note: For more information about the awards or to become an awards program sponsor, contact Kristin Hollingsworth at the Health Improvement Institute, 5272 River Road, Suite 650, Bethesda, MD 20816-1250. Telephone: (301) 652-1818. Fax: (301) 652-1250. E-mail: email@example.com. Web: www.hii.org.]