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Pressroom:
Press Room
FOR IMMEDIATE RELEASE
July 22, 2005
For Further Information:
Bess Andrews
617-355-6420
elizabeth.andrews@childrens.harvard.edu
Children's Hospital Boston Named Nation's First Pediatric Hospital with AAHRPP-Accredited Human Subject Protection Program
Finding new treatments for childhood diseases is essential to improving health outcomes for children; yet testing drugs and devices on pediatric patients raises important ethical questions. Due to their young age and early developmental stage, in most cases children cannot truly give ''informed consent,'' the ethical linchpin of participation in any experimental therapy. Special protections are required to ensure that the interests, needs and rights of pediatric research subjects are protected.

On June 21, Children's Hospital Boston became the nation's first free-standing children's hospital (not operating under an adult hospital's license) to achieve accreditation by the Association for the Accreditation of Human Research Protection Programs. AAHRPP is a national agency that sets the standards and ethical principles for human research protection in the U.S. Similar to that of the JCAHO (Joint Commission for the Accreditation of Healthcare Organizations), accreditation by AAHRPP is voluntary, but--like the JCAHO--it is the ''gold seal'' of accreditation. The agency's mission is to ensure that institutions not only comply with, but surpass, the standards mandated by state and federal regulations pertaining to the use of human subjects in research, such as the role of Institutional Review Boards (IRBs) and the ethical principles put forth in The Belmont Report. Requisitioned in 1974 as a result of legislation filed by Senator Edward M. Kennedy (D-Mass.), The Belmont Report has become the foundation of all human research subject protections.

Children's Hospital Boston has a long history of clinical innovation, including the world's first surgical repair of a congenital heart defect in 1938 and the first successful remission of leukemia in 1947. In addition, many advances in pediatric treatment have been made because of clinical research conducted at Children's Hospital. Today, Children's Office of Clinical Investigation oversees the protection of human research subjects and provides guidance to 250 physician/investigators conducting 600 research protocols.

To achieve AAHRPP accreditation, Children's underwent a rigorous approval process that included a comprehensive self assessment, on-site evaluation by a team of experts, and approval by the AAHRPP's Council on Accreditation, a body composed of physicians, legal experts, medical researchers, patients and community members chosen to represent public/participant, human research protection, research, and institutional perspectives.

''Nearly all children's hospitals participate in clinical trials and in health research of some type,'' according to Dr. James Mandell, Children's Hospital Boston president and CEO, ''and one-third of children's hospitals operate child health research centers. We believe that we have a responsibility to help set the standard for quality child research and informed parental consent and are therefore delighted to be the first children's hospital to achieve this accreditation.''

To help families learn about clinical research and what it means to participate in a clinical trial, Children's Hospital Boston developed The Parents' Guide to Medical Research. This interactive website, funded through a grant from the National Institutes of Health, is designed to help parents ask questions and gather information that would be useful in deciding whether or not to give permission for their child to be in a research study.

''The leadership that Children's Hospital Boston is taking in the area of human subject protection is critically important,'' said Senator Kennedy. ''Medical research that includes children will mean more successful treatments, but it's essential that children be treated safely and ethically.''
Founded in 1869 as a 20-bed hospital for children, Children's Hospital Boston today is the nation's leading pediatric medical center, the largest provider of health care to Massachusetts children, and the primary pediatric teaching hospital of Harvard Medical School. In addition to its 368 pediatric and adolescent inpatient beds and more than 100 outpatient programs, Children's houses the world's largest research enterprise based at a pediatric medical center, where its discoveries benefit both children and adults. More than 500 scientists, including eight members of the National Academy of Sciences, nine members of the Institute of Medicine and 10 members of the Howard Hughes Medical Institute comprise Children's research community. For more information, visit: www.childrenshospital.org/research.

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