Backgrounder: The Approval Process
June 6, 2006
What process did the Daley Lab follow to have this research approved?
The research protocol being performed in the Daley Lab was approved by the Institutional Review Boards (IRBs) of both Children's Hospital Boston and Partners Health Care. Both institutions' Embryonic Stem Cell Research Oversight (ESCRO) committees also approved the protocols.
How long did the approval process for the protocol take?
Dr. Daley began the long process of seeking approval for these experiments soon after his arrival in November of 2003, initially through a series of informal meetings with representatives of the IRB and hospital administration at both the Children's and Brigham and Women's Hospitals. Dr. Daley presented informational seminars to the IRB and to the Division of Obstetrics and Gynecology at the Brigham and Women's Hospital, a member of Partners Health Care. The formal application for approval was submitted to the Partner's Health Care IRB in November 2004. It received conditional approval in April 2005, and final approval in January 2006. Approvals from the Children's Hospital Boston IRB and the ESCRO Committee was likewise received in January 2006. From beginning to end, the approval process took approximately two years.
Who sits on the Children's Hospital Boston IRB and ESCRO committees?
The IRB is composed of Children's staff from a broad range of clinical and administrative areas, representatives from the Children's patient/family population and from the community. For more information on Children's IRB, click here...
As specified by the Guidelines for Human Embryonic Stem Cell Research of the National Academy of Sciences, the ESCRO committees are composed of scientists with expertise in stem cell biology and assisted reproductive medicine, ethicists, and members of the lay public.
Is the research at Children's Hospital Boston compliant with the Massachusetts stem cell research legislation?
Children's Hospital Boston is registered to do this work in Massachusetts, as the state law requires. The protocol was reviewed under Massachusetts state law and found to be in compliance. In connection with the approval of this work, there was an onsite inspection by members of the Children's Hospital research administration to assure that no federal funds, materials, or resources are being used in this work.
Children's Hospital Boston is home to the world's largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 500 scientists, including eight members of the National Academy of Sciences, nine members of the Institute of Medicine and 11 members of the Howard Hughes Medical Institute comprise Children's research community. Founded as a 20-bed hospital for children, Children's Hospital Boston today is a 347-bed comprehensive center for pediatric and adolescent health care grounded in the values of excellence in patient care and sensitivity to the complex needs and diversity of children and families. Children's also is the primary pediatric teaching affiliate of Harvard Medical School. For more information about the hospital and its research visit: www.childrenshospital.org/research.
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