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Carle Institutional Review Board (IRB)/ Human Subject Protection (HSP)
Updated January 2011
Mission: Facilitate ethical and regulatory compliant research undertaken by and in coordination with the Carle Foundation Hospital, while protecting the rights and welfare of human research subjects.
Goals:
All research studies that will be conducted in part or in whole at Carle Foundation Hospital (CFH), that are supported by CFH, or in which CFH is engaged must receive Carle Institutional Review Board (IRB) review and approval before the research is initiated. After approval, IRB review continues for the life of the study, and occurs at least annually.
Study review and approval may be done by the full committee, the chair, or the chair’s designee, depending upon the nature and characteristic of the study and the applicable regulations. To determine if your study qualifies for review other than by the full committee (exempt or expedited review) refer to the OHRP decision charts.
The primary responsibility of the IRB is to protect the rights and welfare of the research subjects and their community, and ensure compliance with human subject protection regulations and institutional policies. In particular, before approving a study, the IRB must find the following to be true:
IRB Submission deadlines and meeting dates The IRB meets on the third Wednesday of the month. Exceptions to the regular meeting schedule might occur. The submission deadline for review of new protocols and revisions is noon on the first Wednesday of the month.
Deadlines for upcoming 2012 IRB meetings are provided on the Deadlines webpage.
Certain research studies may be eligible for an "expedited" review or be "exempt" from IRB oversight. Please contact a member of the Research Office to learn more about eligibility for expedited/exempt review and for assistance with the submission process.
IRB Membership
The IRB is composed of a minimum of 5 members and is constituted in accordance with the requirements of the federal regulations. The IRB membership (including alternate members) provides a broad range of scientific, clinical, and community expertise to ensure a thorough review of the research, including consideration of the local context. As needed, subject matter experts may also be consulted by the IRB.
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