Investigators should request the level of review they feel is appropriate for their project. The IRB Chair, in consultation with committee members if necessary, will determine the correct level of review. Note that for research involving children or vulnerable populations the IRB requires sufficient information on risk/benefit to make a decision and these studies may not qualify for exempt or expedited review.
Not Human Subjects Research
Investigators may request that the IRB determine whether a project meets the regulatory definition of human subjects and/or research. See related link for more information.
Read this page for information about what types of research qualify for an exempt review.
Read this page for information about what types of research qualify for an expedited review.
Any research that does not fall into one of the above categories requires full review by the IRB.
IRB approvals are effective for the duration of one year from the date of the approval. The IRB is required to conduct continuing review of all non-exempt research not less than once a year. Researchers must submit a continuing review application not less than 60 days prior to the end date of their approval to avoid the possibility of a lapse in IRB approval.
Any research study that has not received continuing review and approval by the end of its approval period is automatically considered expired and all research and research-related activities must cease.
If IRB approval for the research study has lapsed less than 30 days and the PI provides the required Continuing Review information, the existing protocol may be reviewed for consideration of continued IRB approval. If IRB approval has lapsed for more than 30 days the study is considered closed and the PI must submit a new application as an initial submission for IRB review and approval.
Changes to Research Protocol
Any proposed changes to the approved protocol must be submitted to the IRB for review and approval before the changes can be implemented.
The IRB committee meets monthly from September through June to review applications. One of the following decisions will be recommended:
Approved – the IRB committee will send an approval letter to the PI
Approved with provisions – an explanation letter is sent to the PI detailing the revisions required. The PI must address the issues and resubmit within two months of the date of the provisional letter, for immediate review of the modified application. Provisional approval expires after two months. Resubmissions made after two months are reviewed at the next convened IRB meeting. The P.I. will not be able to begin the research until the IRB receives the resubmission, is satisfied with the changes addressing the provisions, and gives approval.
Disapproved – an explanation letter is sent to the PI explaining the reasons for disapproval with an outline of revisions necessary for reconsideration of the application. The PI must respond to the questions posed by the committee in detail and resubmit a new application to the full board. The P.I. will be not able to begin the research until re-submission and the IRB approves the application.