Protocol Review Process and Timelines

The IRB is responsible for reviewing research proposals and verifying exemption, confirming that these projects are low risk. Belmont University does not allow faculty, staff or students to make their own exemption verifications; however, as stated above, the online pre-protocol diagnostic survey will help investigators determine whether their research may quality as exempt, which will be confirmed by the IRB chair or reviewer designee.

To qualify for exempt verification, the proposed study will be reviewed by the IRB chairperson (or designee) or an appropriate Departmental Review Committee (e.g., Psychology Department). Divisions without a DRC will rely on the University IRB for review. The IRB chair, vice-chair, and designated IRB board members are responsible for exempt verifications.

Exempt applications do not have deadlines and will be reviewed on an ongoing basis during fall, spring, and summer (excluding University-designated breaks and holidays). Initial reviews of exempt protocols will generally occur within two weeks of submission. Investigators will be notified via email of any areas for clarification or needs for revision. The timeline for completion of the review will depend on how many revisions are required; therefore, investigators should allow sufficient time between their initial submission and start date of their project (no less than a month).

The IRB chairperson or designee will verify that the research is in a category appropriate for exemption, officially noting the category, and will notify the investigator of the verification via email. Once verified, unless there are amendments to the protocol, the investigator does not have additional reporting requirements to the IRB. However as with all human subject research, the investigator must ensure that the study conforms to the principles of sound research ethics: respect for persons, beneficence, and justice (see “Resources” on the University IRB webpage for more information.)

The IRB chairperson or designee will confirm that the research is in a category appropriate for expedited review, officially noting the category, and that the research involves no more than minimal risk for the research subjects.

Expedited applications are reviewed each semester, including summer, excluding holidays and breaks. There are no deadlines for expedited review submissions; however, investigators should plan sufficient amount of time for review and possible revisions. If applications are incomplete or completed without sufficient detail to University and federal IRB requirements, the length of review could be extended, delaying the start of a project.

Expedited reviews are typically assigned to one member of the IRB committee. Expedited applications are typically reviewed within 15 business days. The length of the review process depends on the need for revisions; therefore, investigators should ensure that a thorough and professional application is submitted to reduce the length of time for completion of the review. Investigators will be notified via email by the assigned reviewer of any areas for clarification or need for revisions. Reviewers will notify the IRB chair once their review is complete so that the chair can finalize the review process and notify the PI of approval.

IRB approval means the IRB has determined that the research has been reviewed and may be conducted at Belmont University within the constraints set forth by the IRB and by other institutional and federal requirements.

Expedited reviewers may exercise all of the authorities of the IRB except that they may not deny a protocol. If the expedited reviewer does not support approval, the protocol goes to "full" review and is placed on the agenda for the next IRB meeting.  

The IRB chair or vice chair will send a certificate (i.e., notification) of approval to the responsible investigator via email. Approval shall be effective as of the date on the notification, and the certificate of approval will include notification to the investigator of reporting and continuing review responsibilities. Expedited level projects can be approved for up to one year. At the end of that year, investigators must either formally terminate their study or request continuing review.

Immediately following approval, PDF consent forms will be generated within the Axiom Mentor online protocol management system with the stamped approval date. Principal investigators can find their approved/stamped PDF consent forms on their protocol page and should use the approved stamped form to obtain written consent prior to data collection.

Should an IRB application protocol be submitted that does not meet the requirements to be expedited, a full committee review will be scheduled.

Research that requires a full committee review is judged to involve more than minimal risk, and/or involves protected populations such as children, prisoners, or individuals with impaired decision making.

Application deadlines for full board reviews are different from exempt and expedited. Applications for full board review are accepted during fall and spring semesters only and are due six weeks prior to the next scheduled IRB Committee meeting. Since these reviews are time and labor intensive, we suggest that principal investigators (PIs) contact the IRB chair when they are writing the protocol so the committee can be alerted to any upcoming full board reviews. Additionally, it is recommended that full board applications should be submitted the semester prior to the anticipated start date to allow sufficient time for protocol development and review. 

Principal investigators should check the IRB calendar at www.belmont.edu/irb/calendar.html for specific submission deadlines.

Once a full board application is submitted, the IRB chair will assign two lead reviewers who will work with the PI. All IRB committee members review full board protocol applications and provide feedback to the lead reviewers who will work with the PI on any revisions. Below is the timeline for full board reviews:

The PI notifies the IRB chair that an application protocol that requires a full board review is being prepared along with the anticipated submission date.

Once the application protocol is submitted to the Axiom Mentor website, the IRB chair will assign two lead reviewers based on their areas of expertise.

• Weeks 1 – 2

The IRB chair will notify the committee of the full board submission and the initial review timeline. The committee will have two weeks to review the application protocol and send their feedback to the lead reviewers. Additional review input is required if the research involves any federally recognized vulnerable populations. 

• Week 3

The lead reviewers and IRB chair will compile the feedback within a week of receiving it from the committee and provide the PI with a written review, requesting clarification and revisions as needed.

• Week 4

The PI will have one week to revise and upload updated documents (e.g., protocol, consent forms) into the Mentor system.

• Weeks 5 – 6

The IRB chair and lead reviewers will reevaluate the revised protocol and related materials, continuing to work with the PI as needed for any additional revisions. IRB board members will be notified when the final revised protocol and associated documents have been submitted to the Mentor system so that they can review the updated protocol prior to the committee meeting.

During the above review process, the IRB shall determine that the following requirements are satisfied:

-risks to subjects are minimized;

-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;

-selection of subjects is equitable, taking into account the purposes of the research and the setting in which it will be conducted;

-that informed consent will be sought from each prospective subject or subject’s legally authorized representative;

-informed consent will be appropriately documented;

-the research plan appropriately monitors the data collected to ensure the safety of subjects;

-subjects’ privacy is appropriately protected and confidentiality of subject related data maintained; and

-appropriate additional safeguards are included to protect the rights and welfare of subjects who are likely to be vulnerable to coercion.

The IRB chair may request that the PI be present at the meeting to clarify issues/concerns.

A quorum of the voting IRB membership must be present. For the Belmont IRB, a quorum is defined as one more than half of the roster members and must include at least one member whose primary concerns are in non-scientific areas.

Following the presentation of the study by the lead reviewers and discussion of the study by the committee, any voting member may make one of the motions below given the authority that IRBs have under federal regulations. The convened IRB will approve or disapprove an application by majority vote of those members present.

(1) Approval:

The research study is approved as submitted without any conditions given that all of the requirements have been satisfied.

(2) Approval Pending

The research study is approved pending non-substantial revisions. This means that the study otherwise meets the above criteria for approval, but minor changes are still required. These changes can include anything from minor alterations to the study design to requests for the PI to re-write or re-word certain study documents (e.g., the consent form). If the motion is passed, review of the PI's response to these requested changes may be undertaken by a designated reviewer, expediting the process.

 (3) Deferred

This motion is for research proposals which require substantive or complex changes before they meet “approval” or “approval pending” criteria. The IRB may vote to defer a final decision of approval or disapproval until the PI has adequately respond to the IRB's concerns. Once the Investigator has responded, the study will again be reviewed by a fully convened IRB.

(4) Disapproval

When determinations required for approval of research cannot be made, even with substantive clarifications or modifications to the protocol and/or informed consent process/document, the IRB can vote to disapprove a proposed study.

Per the Office of Human Research Protections (see https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-irb-approval-of-research-with-conditions-2010/index.html#section-c), the IRB must not approve a proposed research project undergoing initial review when the IRB (a) is unable to make the required determinations about research risks and benefits, the adequacy of privacy and confidentiality protections, or the adequacy of the informed consent process because the research protocol provides insufficient information related to these aspects of the research, and (b) is unable to specify changes to the research protocol that if made would allow the IRB to make these required determinations. 

If disapproved, no proposed study procedures may take place, and the study may not be re-submitted for review.

(5) Tabled

If the IRB committee is unable to provide adequate review of a study due to lack of time, expertise or quorum, then the review may be postponed until another full IRB meeting.

After the committee meets, the PI will receive electronic notification of the results of the IRB review.

For any full review research protocol that is approved, the IRB will state the duration of approval, which shall not exceed one year. Following approval, PDF consent forms will be generated within the Axiom Mentor online protocol management system with the stamped approval date. The PI can find the approved/stamped PDF consent forms on their protocol page and should use the approved stamped form to obtain written consent prior to data collection.

The duration of approval will be stated in the certificate of approval (i.e., electronic notification) from the IRB to the responsible investigator. IRB approval of research is always for a limited period of time not to exceed one year from the date at which the research was approved. Principal investigators will receive electronic notification of pending expiration of IRB approval approximately one month before approval ends. This notification requires the investigator to submit a study termination report. The IRB chairperson reviews that report and sends electronic notification that the report has been accepted and the study has been closed for IRB purposes, specifying the date of closure.

The IRB will need a study termination report to be submitted in the Mentor system.