Human Research Protections Program Office

About the USU Institutional Review Board (IRB)

USU IRB Jurisdiction and Statement of Compliance

The USU IRB(s) reviews all research submitted by USU investigators, faculty, students and staff. The IRB ensures that all research involving human subjects conducted or supported by the Department of Defense shall comply with all applicable Federal statutes, regulations and Department of Defense Directives (DoDD) and Instructions (DoDI) including Part 219 of Title 32, Code of Federal Regulations (CFR), which incorporates the ethical principles of respect for persons, beneficence, and justice, as codified in the Federal Register also known as "The Belmont Report".

The IRB has the authority to hold in abeyance, suspend, or terminate approval of research that is not being conducted in accordance with the requirements or that has been associated with unexpected harm to subjects or unanticipated problems. The Chairs may act immediately on behalf of the IRB to hold in abeyance, suspend, or terminate approval of research. These actions will be reviewed at the next meeting of the IRB and affirmed or modified by the convened IRB. If the IRB suspends or terminates approval for regulatory noncompliance, it will notify and provide the rationale for the action to the investigator, the USU Institutional Official (IO) or designee, the Component Designated Official, oversight agencies, and other federal officials as required.

Composition of the Convened IRB Committee

The IRB conducts initial and continuing reviews of human subjects research during convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in non-scientific areas. In order to effectively evaluate a wide range of research, diversity in IRB membership includes expertise in socio-behavioral and medical research areas. Approval of research is by a majority vote.

IRB Review

The IRB meets monthly. IRB members have access to IRBNet which is the electronic IRB submission system for all protocol related documents including the proposed informed consent document (ICD), and any recruitment materials such as advertisements directed at potential subjects. Information entered by investigators in the IRBNet must be in sufficient detail for the IRB members to make determinations required under the regulations governing human subjects research. An in-depth review of all the submission documents is done during the initial review, continuing review, review of protocol changes, and/or review of reports of serious unanticipated problems involving risks to subjects or others or of serious or continuing noncompliance. Investigators will be notified regarding the day/time for their protocol review and are expected to appear at the IRB Review meeting to provide a brief explanation of the study and to answer questions.

IRB Approval

IRB approval and IO concurrence is required before research may begin. The criteria by which the IRB can approve research are, among other things, determinations regarding risks, potential benefits, informed consent, and safeguards for human subjects. The possible actions taken by the IRB for protocols undergoing initial or continuing review and protocol changes undergoing review are:

  1. Full approval - Approved as submitted without any conditions
  2. Contingent/conditional (pending) approval – Modifications or additional information required to secure approval. The IRB may require review of the investigator response materials by a convened meeting or may designate the IRB chairperson (or other appropriate individual(s)) to review responsive materials from the investigator and determine that the conditions have been satisfied, and further review by the IRB at a subsequent convened meeting may or may not be necessary. The convened IRB may set the conditions under which the investigator response to the IRB stipulations can be approved by the IRB designee through expedited/administrative procedures.
  3. Deferral - The protocol cannot be approved 1.) without additional information; or 2.) because major modifications are required.
  4. Disapproval - Research study or proposed changes disapproved

Communicating to investigators IRB stipulations to be accomplished as a condition for IRB approval

The HRPPO staff will do their best to ensure that the stipulations for IRB approval will be communicated to the investigator in a timely manner following IRB review of the study protocol. Communication is through correspondence in IRBNet. The investigator must respond to the stipulations in writing, providing both a cover letter and a “track changes” version of the protocol, as applicable. These (and other required changes) are uploaded into IRBnet.

Reviewing and acting upon investigators' responses

Upon receipt of the PI’s response to stipulations, the HRPPO staff will review the documents to ensure that all issues have been addressed. For expedited review of responses, the response is first reviewed by the HRPPO staff for completeness and forwarded to the Chair or designee for final approval. If the response is deemed incomplete or inadequate, this must be resolved prior to moving the study forward. The same applies if the response is for full committee review, or removed from the next meeting’s agenda if the PI response is not completed after the submission deadline.

Notifying the PI, Institutional office(s) and official(s) of IRB findings and actions

Results of the IRB review will be announced by formal memorandum in IRBNet. Investigators should anticipate receipt of such notification within a 15 working day period following the date of review by the convened IRB. Please incorporate this post-meeting processing period into study execution timelines. The IRB approval is effective on the date the final approval was given after all conditions and stipulations have been met. The IRB may decide if the study requires review more often than annually for high-risk protocols or protocols with a high risk: potential benefit ratio.

The HRPPO reports all IRB actions to the IO monthly. It is the responsibility of the PI to provide the IRB approval or IRB determination memo to the appropriate institutional office(s) and official(s) as required.