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This website is designed to assist the clinical research community in safeguarding the rights and welfare of human subjects who participate in research. Children's Hospital has established a human research protection program to assure full compliance with all federal regulations, state laws and hospital policies governing the use of human subjects in research.
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In an effort to improve the IRB review process, a second significant policy change has been implemented to reduce the number of adverse events that need to be reported to the IRB. This change is coupled with the requirement that PIs provide the IRB with more meaningful information regarding data and safety monitoring activities. Please carefully review the attached newsletter that contains more detailed information.
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Click here for more information.
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In an effort to improve the IRB review process, several significant changes will take place during the next few months. The changes result from recommendations made during the AAAHRP re-accreditation review process and from an IRB subcommittee charged with improving the IRB's efficiency. The first major change is the elimination of the three year rewrite review process and the strengthening of the continuing review process. This change is effective immediately.
Please feel free to contact the CCI office if you have any questions.
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CONTACT US:
333 Longwood Ave.
4th Floor
Boston, MA 02115
Tel: 617-355-7052
Fax: 617-730-0226
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