Carle Institutional Review Board (IRB)

Updated April 2008

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:

1. Risks to subjects are minimized.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
3. Selection of subjects is equitable.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
5. Informed consent will be appropriately documented.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

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 Friday of the month.

Deadlines for upcoming 2008 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 Foundation 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.