Standard Operating Procedures

The mission of Utah State University’s Human Research Protection Program (HRPP) is to protect the rights and welfare of participants in research that occurs under Utah State University (USU) oversight.

Utah State University maintains a Federalwide Assurance (#00003308) on file with the U.S. Department of Health and Human Services. The Federalwide Assurance (FWA) assures the federal government that Utah State University will comply with applicable provis...

The Utah State University Institutional Review Board adheres to the University’s Conflict of Interest policies, and to the procedures established by the Office of Research Integrity and Compliance, which govern all research projects at Utah State Universi...

USU Policy 4102 states that Utah State University is “committed to advancing knowledge through engagement in research and scholarship” and that USU provides “a creative and ethical environment that supports free inquiry… that will contribute to the econom...

The Utah State University Privacy Board reviews research-related data requests to use and/or disclose Protected Health Information (PHI) that is managed at Utah State University. At Utah State University, the Privacy Board is the Institutional Review Boar...

The Office of Sponsored Programs (commonly referred to as “SPO”) at Utah State University is an important contributor to the Human Research Protections Program at Utah State University.

Ancillary Reviews assist Utah State University and the Institutional Review Board with matters related to research compliance, risk, regulatory requirements, research feasibility, and engagement in a communicative and cooperative institutional structure f...

The Institutional Review Board is required to conduct its business independent of other institutional interests. This includes business interests of the university, conflicts of interest, or general pressures to conduct research absent a thorough review....

The Human Research Protection Program (HRPP) is not a static entity. Leadership within the HRPP should always strive for improvements based on feedback from research participants, feedback from researchers, best practices in the field of human research pr...

The mission of Utah State University’s Human Research Protection Program (HRPP) is to protect the rights and welfare of participants in research that occurs under Utah State University (USU) oversight.

Studies involving human subjects require the utmost care. When a living person shares their bodies or information with a researcher to advance knowledge and scientific inquiry, that person is owed a strict duty of care by the research team.

An investigator is an individual involved in the performance of human subjects research activities who performs one or more of the following activities: (i) obtaining information about or biospecimens from living individuals by intervening or interacting ...

The Institutional Review Board (IRB) at USU is a body established under the requirements of 45 C.F.R. 46 to, first and foremost, protect the rights and welfare of human participants in research. The IRB operates under USU's Federalwide Assurance #00003308...

The Institutional Review Board at Utah State University reviews research involving human participants by utilizing Limited IRB Review of exemptions, Exemption determinations, Expedited review procedures, review via the Convened IRB, review of proposed mod...

The Institutional Review Board at Utah State University is the only entity that can provide an official determination that a project is or is not human subjects research as defined in USU Policy 4103. It may do so in a meeting of the Convened IRB or via d...

The Common Rule (45 C.F.R. 46) permits the use of Exemptions and Limited IRB Review for certain categories of human subjects research. These categories of review permit some types of human subjects research to move forward without having to comply with ma...

The Common Rule (45 C.F.R. 46) permits the Secretary of the Department of Health and Human Services to designate certain types of research for Expedited review. The Office for Human Research Protections maintains this list and releases it as guidance by p...

The Common Rule (45 C.F.R. 46) tasks the Convened IRB with the review of proposed human subjects research. While many of those review processes can be delegated as outlined in SOP 402, the undelegated review processes occur via a meeting of the Convened I...

The Convened IRB will meet at least monthly during the Fall and Spring academic semesters, with greater frequency as deemed appropriate by the IRB Chair, Institutional Official, and HRP Director.

After a protocol has been approved, researchers may need to make modifications. For guidance on modifications to Exempt projects, please see SOP 404 Section III. This SOP describes modifications for protocols that have been reviewed via the Expedited or C...

All studies that are not subject to one of the items below will receive an annual administrative check in via email (including exempt studies). No investigator action is required for an Administrative Check In

Principal Investigators are responsible for ensuring the timely closure of a completed human subjects research project. Human subjects research is complete when the aims of the study have been reached, analyses are complete, and the study no longer involv...

The USU IRB has the authority to approve research activity, specify modifications required to secure IRB approval of the research activity, disapprove any research activity overseen and/or conducted by Utah State University; or establish the appropriate s...

The IRB must maintain accurate and thorough documentation of its review activities. This includes discussions (between IRB members as well as between the IRB and researchers), decisions, and findings. In the case of review conducted by the Co

When a protocol will be filed and reviewed with USU’s Institutional Review Board, prior to seeking review from the USU IRB, the investigators should collaborate with the IRB they hope will become a Relying IRB to ensure that that IRB or HRPP will be amena...

Procedure 414 is reserved for future use.

When human subjects research is sponsored or initiated by the Department of Defense (DoD) or any of its entities, the provisions in this Standard Operating Procedure apply.

Recruitment is the process and associated documentation that permits the targeted population to learn about a research study. Recruitment is considered to be the start of the informed consent process.

Informed Consent is a process that begins with the recruitment of a participant, and continues through (and sometimes beyond) that person’s involvement with the research.

Research conducted with individuals with limited, questionable, or fluctuating decision making capacity must be designed in such a way as to provide additional protections to these populations.

Compensation is any item of value given to research participants in consideration for their participation in research. Compensation is closely tied to the requirements in SOP 501 regarding recruitment.

The types of reportable events are defined and discussed in this SOP, including timeframes for reporting to the IRB based on the appropriate categorization of the event.

In processing each reportable event, the IRB shall consider whether notification to participants (or others, such as family or community members) is appropriate, regardless of the language in the informed consent documentation.

USU requires all human subjects research performed in an international setting to provide equivalent levels of protection that would be required for participants in the United States, while simultaneously complying with local laws and taking

PHI is individually identifying information relating to the past, present, or future health status of an individual that is created, collected, or transmitted, or maintained by a HIPAA-covered entity in relation to the provision of healthcare, payment for...

Investigators are in the best position ensure the safety of participants both during study procedures and once they have been completed. Adequate monitoring activities ensure that participant safety is not compromised during their active participation in ...

Investigators are in the best position to learn about, disclose to the IRB, and ensure compliance with local laws in the location where the research will be carried out.

Investigators are in the best position to learn about, disclose to the IRB, and ensure compliance with local laws in the location where the research will be carried out.

The HRPP Emergency Response Plan establishes the policy and procedures for initiating a response to an emergency impacting the HRPP or HRPP operations.

When any Utah State University employee, student, or affiliate receives information related to Noncompliance and those activities appear to be related to research being conducted by USU personnel or under USU’s purview

The convened Utah State University Institutional Review Board shall, based on the findings provided by the investigative team and materials provided by the investigator(s), make the final determination of whether the allegations of noncompliance constitut...

Investigators who wish to appeal any determinations of the IRB Chair or Convened IRB may do so. Procedures for appealing noncompliance determinations are outlined here, and supersede the provisions of the SOPs in Series 400 regarding appeals, due to the t...

The Institutional Review Board is a body established in federal regulations. Its records, including but not limited to protocol submissions, investigator correspondence, participant contacts, budgets, meeting minutes, expenditures, noncompliance records, ...