Institutional Biosafety Committee - Bloomington

Reviews & Renewals

Five-Year Renewal

A five-year protocol resubmission is required in order to renew both exempt and non-exempt research that has been previously approved. A new protocol submission form is required and can be found on the Forms page.

Five-year resubmission of Non-Exempt research:

Upon receiving the five-year resubmission of research that was previously approved under Sections III-A through III-E of the NIH Guidelines, the IBC will review the new protocol form in the same manner as a new study. See the New Study page.

Five-year resubmission of Exempt research:

Upon receiving the five-year resubmission of research that was previously approved under Section III-F of the NIH Guidelines, the IBC administrator(s) will forward the new protocol form to the Biosafety Office (BSO) to ensure that the work is still considered “exempt” prior to final approval. Please note that all work in an exempt submission must fall ONLY under Sec. III-F and/or outline the use of biohazards in order to be considered exempt from the NIH Guidelines.

Annual Review

All research that has been previously approved under Sections III-A through III-E of the NIH Guidelines requires an annual review to assess any changes that have been made during the previous year. This review also verifies that all work has been conducted in accordance with the approved protocol. An IBC continuing review form must be submitted during the month in which the initial protocol submission was approved and can be found on the Forms page.

If a change to the initial protocol has occurred during the previous year and an amendment is required (as per the continuing review form), then a separate amendment form must accompany the continuing review form. The final approval of the continuing review is dependent upon the final approval of the amendment to that protocol. The approval process for any major and/or minor amendment that accompanies a continuing review is the same as if the amendments were submitted independently. See the Amending an Existing Protocol page.

Study Termination

A study may be terminated at any time, although notification of research termination is usually given at the time of annual or five-year renewal.  If previously approved research has been completed, the principal investigator may send an e-mail to the email address located under "Contact us" to the left of this page stating that work has been completed and the study may be terminated. The IBC study number must be referenced in the e-mail and if the e-mail is being sent by a lab manager, post-doc, graduate student, etc., then the principal investigator must be Cc’ed in the notification e-mail.

 

Basic Steps Step 1: What needs to be reviewed? Step 2: Pre-Submission Step 3: New Studies Step 4: Amend Existing Protocol