Step 4: Revise IRB Proposal and/or Supporting Documents

The final step in the IRB approval process is one that most researchers encounter, but is not necessarily always required. After the IRB reviews the submission, researchers may be requested to make revisions to their submission by supplementing their responses in the IRB Proposal Form and/or revising their supporting documents. The purpose of this page is to provide researchers with an idea of what to expect following submissions and during the revision process.

What Happens After Submission?

Every proposal undergoes initial processing and review, which typically are conducted jointly by the IRB student worker and a member of the IRB committee. Initial processing and review may begin any time after the proposal is submitted by the researcher to the IRB.

• Pre-Processing: Once the proposal is received, the IRB student worker (usually) or an IRB committee member will download the IRB Proposal Form and all supporting documents. All submitted files will be stored in a record-keeping system. All submissions are checked for completeness and acknowledged by the IRB via email. If the IRB Proposal Form and/or supporting documents are improperly completed or insufficient, the IRB may request immediate revisions without conducting an initial review of the materials.
• Initial Review: If a submission passes pre-processing (i.e., all required elements have been submitted), the proposal is added to the review queue. Reviews are typically completed by the chairperson of the IRB, but may be completed by any IRB committee member designated by the chairperson. During the initial review, the IRB generates a summary record of the proposal, including its basic elements and any concerns about the proposal the IRB may have. When concerns are identified, an email is generated within the summary record outlining the concerns and the requested revisions. The email is then sent to the researcher when the initial review is completed. A submitted proposal may be approved by the IRB following initial review; if this occurs, an approval letter will be sent to the researcher.

When Should I Contact the IRB about My Proposal?

As the academic year begins, the number of proposal submissions received by the IRB increases, usually peaking in November of the fall semester and February during the spring semester. During peak periods, initial review and approval times may increase, leading researchers to wonder if they should inquire about the status of their proposal. The IRB offers the following guidance for inquiries, which are dependent on where a proposal is at in the review process:

• Pre-Processing: Contact the IRB if a confirmation or an immediate request for proposal revisions/supporting documents is not received within 7 days after submitting your proposal.
• Initial Review: Contact the IRB if an approval letter or request for revisions is not received within 14 days after receiving confirmation of the submission from the IRB.

The IRB will report its current status on a daily basis on its website. The page includes average turnaround time to approval. Keep in mind that this average is likely to increase during the academic term. Before emailing, researchers may want to check the current status table to see what the IRB's proposal volume and current turnaround time is.

What if I Am in a Rush for IRB Approval?

Given the average review times and the increasing volume of proposal submissions during the academic year, researchers should plan their intended start dates for research with the IRB review and approval process in mind. However, in certain situations (e.g., 7-week classes that involve thesis research), researchers may find it challenging to navigate the IRB process and complete their research in the same term. For researchers in these, and other similar, situations, the IRB recommends the following:

• Do not email and ask for "expedited" or "rushed" reviews. Time spent responding to these emails is time not spent reviewing and approving proposals.
• Indicate the desired start time for the study in the IRB Proposal Form. When the IRB proposals are in pre-processing, the intended start date is noted and highlighted if it is within two weeks of submission.

Proposals with a more immediate intended start date will be moved up in the review queue to try and accommodate researchers' desired start date. Researchers--along with faculty supervisors and graduate program directors--should encourage student researchers to allot as much time as possible for the IRB review and approval process. Depending on the proposal submission volume, the date a proposal is submitted, and the intended start date, the IRB may not be able to accommodate all researchers' desired start date for their study.

What if I Am Asked to Revise?

Revision of IRB proposals and/or supporting documents is common. Faculty supervisors and instructors are subject-matter and methodology experts, who tend to focus on these areas as they advise students on human subject research projects. The IRB evaluates proposals for compliance to federal, state, and university regulations, potential risks and benefits, and clarity of communication to research participants and other stakeholders. Consequently, faculty supervisors may approve submission of an IRB proposal by a student, yet the IRB may ask for changes to be made in order to approve the study.

What Does a Revision Request Look Like?

The IRB requests revisions to a submitted IRB proposal via email. This email will come from irb@suu.edu, typically from the IRB chairperson. Below you will find an example redacted revision request email. Hover your mouse over the document to scroll up/down or left/right, if you are unable to see the entire document. Note that the contents of each revision request may be different, as each study is different.

How Do I Revise My Proposal?

• Read the email response you receive from the IRB in its entirety. Some revisions may be related across the email, so it may help to read the entire request first rather than immediately begin working down the list of items.
• Prepare responses to any questions you are asked and/or prompts for additional information. You do not need to complete/edit the IRB Proposal Form unless asked to do so by the IRB.
• Revise any supporting documents for which the IRB requests revisions. The most common requests for revision from the IRB involve changes to the Informed Consent Document.
• When finished with revisions (and with approval of faculty supervisor, if applicable), email responses to IRB questions/prompts and supporting document revisions (as attachments) to irb@suu.edu.

What Happens Next?

Once you submit revisions to the IRB, there are two typical outcomes:

• Your study will be approved if the revisions are satisfactory. An approval letter will be sent to the researcher (and faculty supervisor, if applicable).
• If revisions are unsatisfactory, the IRB may request additional revisions. Once again, a revision request email will be sent to the researcher, and the researcher will need to respond to whatever requests the IRB makes.

What if My Study Has To Be Reviewed by the Convened IRB?

When the IRB conducts an initial review, an important part of the process is determining whether the study is eligible for either an Exempt or Expedited review category. Exempt and Expedited review categories are federally defined categories, which permit different levels of oversight by the IRB. If a researcher's submitted proposal is not eligible for one of the Exempt or Expedited review categories, then the study must be reviewed by the convened IRB. The convened IRB schedules monthly meetings and typically only meets if a full board review of a submitted IRB proposal is required. The overwhelming majority of IRB proposal submissions at this institution do not require review by the convened IRB.

What Happens Next?

• After initial review, the IRB will inform the researcher that the IRB proposal must be reviewed by the convened IRB. The chairperson or a designated IRB committee member will inform the researcher of the date of the convened IRB meeting. The researcher will be invited to attend to present the proposal and answer questions from IRB committee members.
• Revisions and/or additional information may be requested. Revisions may address concerns that may be found in all IRB proposal submissions, whether they are eligible for Exempt/Expedited approval or otherwise. Additional information may be requested to help explain the study to the IRB and inform the deliberations of the convened IRB. Researchers should send revisions and/or additional information as soon as possible so these items can be shared with the IRB committee.

What Does an IRB Meeting Look Like for Researchers?

The IRB will convene either in-person or via video to evaluate proposals that are not eligible for Exempt or Expedited approval. The meeting may include business that does not involve the review of proposals. However, when the convened IRB moves to evaluate proposals, the following will occur:

• The IRB chairperson or a designated committee member will briefly introduce the study under review.
• The researcher (or research team) will be invited to briefly describe the proposed study.
• The IRB chairperson or a designated committee member will invite questions for the researcher or research team. Any questions or comments posed by the convened IRB will be discussed.
• Once questions and comments have been exhausted, the IRB will deliberate the study in private during the meeting. Researchers will not participate in the deliberation.
• After deliberations, the IRB will invite researchers to return to the meeting and will inform them of their decision. This deliberation typically yields one of two results:
  • The study is approved.
  • The study is approved with revisions. The IRB will determine whether these revisions can be approved by the chairperson or whether the convened IRB must approve them.