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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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The Committee on Clinical Investigation has revised and clarified its policies on reporting unanticipated problems, adverse events and deviations to the IRB.
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Please click here for more information.
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For information regarding the education requirement for researchers, please see:
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Education Requirement
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Information regarding the continuing education requirement can be found at:
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Continuing Education Requirement
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You can also check the training status of your study team members on-line at:
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Training Status
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The Committee on Clinical Investigation has revised and clarified its policies on reporting minor and significant deviations to the IRB. In addition there is no longer a separate significant deviation form. Please use the newly revised unanticipated problem form which has a specific category for significant deviations. Please see the November 2008 Special Communication Newsletter for more information.
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Please click here for more information.
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Please note the new form for submission of Humanitarian Use Device protocols. This is available on the Forms page, under Other New Submissions.
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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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