If a researcher has concerns regarding an IRB decision, changes that the IRB has requested in a research protocol, or any other aspect of the submission and review process, the researcher may submit a formal appeal. The appeal will involve providing a letter to the OSP staff with a request for a change in the IRB's decision or processes and a justification for why the change is needed. The OSP staff will then submit the letter to the IRB and any additional materials needed for a full consideration of the appeal. The full IRB will consider and vote on a response to the appeal at the next scheduled meeting of the IRB. The IRB will provide the individual who submitted the appeal a letter notifying them of the IRB's response to the appeal and an explanation for the response. The IRB Chair should sign the letter.
However, the IRB may not vote to approve an ad hoc change in the submission and review processes that contravenes written policies and procedures. If a change in policies and procedures is needed, the IRB may vote to begin the process of revising policies and procedures, in consultation with OSP staff, and obtaining approvals for amended policies, as needed, from the Provost, President, and Board of Regents.
Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. Federal regulations make provisions for certain categories of research to be reviewed through an expedited procedure if the research involves no more than minimal risk. Expedited review is intended to enable the institution to conserve administrative resources, provide timely reviews, and focus the convened meetings of the IRB on those research activities involving greater risks or ethical complexities. The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval. Reviews are done on an ongoing basis, meaning that the review is accomplished independently of the IRB meeting schedule.
Researchers seeking expedited review will submit an application package to the OSP. In turn, OSP staff will conduct a preliminary screening of the application package, and once the screening has been completed and any issues with the screening have been addressed, OSP staff will consult with the IRB Chair to determine who will be responsible for the expedited review. The expedited review may be carried out by the IRB Chair, an IRB member designated by the Chair, or the HRPP specialist serving as an alternate IRB member when an IRB member is unavailable to complete the review in a timely manner. It is preferable, however, that an IRB member complete the review.
If the IRB member selected for an expedited review has a conflict of interest with the project in question, it is the responsibility of the IRB member to notify the Chair and OSP staff and recuse themselves. If an IRB member is unable to complete a review because