Standard Operating Procedures

Welcome to the Standard Operating Procedures for the Human Research Protections Office and the Institutional Review Board. These documents represent the standard processes, procedures, and requirements for conducting the business of the Human Research Protections Program at Utah State University. Questions or concerns can be directed to the HRP Director, or submitted through the Researcher Feedback form.

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Series 100: Mission & Scope


Series 200: Organizational Responsibilities

Series 201 The Institutional Official

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...

Series 202 Conflicts of Interest

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...

Series 203 Institutional Conflicts of Interest

USU Policy 583 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 economi...

Series 204 Privacy Board

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...

Series 205 Office of Sponsored Programs

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.

Series 207 The IRB & Undue Influence

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....

Series 208 Continuous Quality Improvement

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...

Series 300: Researcher Responsibilities

Series 300 Definitions

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 ...

Series 301 Researcher Responsibilities

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.

Series 302 The Principal Investigator

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.

Series 400: Review of Research Activities

Series 401 Institutional Review Board

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...

Series 402 IRB Review Activities

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...

Series 403 Non Human Subjects Research

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 584. It may do so in a meeting of the Convened IRB or via de...

Series 404 Exemptions and IRB Review

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...

Series 405 Expedited Review Process

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...

Series 406 Convened Review Process

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...

Series 407 Meetings of the Convened

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.

Series 408 Modifications to Approved Protocols

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...

Series 410 Study Closure

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...

Series 411 Appeal of IRB Decisions

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...

Series 412 Documentation of Review Activities

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

Series 413 Reliance Agreements

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...

Series 500: Recruitment & Informed Consent

Series 501 Recruitment of Prospective Subjects

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.

Series 502 Informed Consent

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.

Series 504 Compensation of Research Participants

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.

Series 600: Reportable Events

Series 601 Reportable Events

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.

Series 602 Notifications and Reporting

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.

Series 700: Advanced Consideration in HSR

Series 701 International Research

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

Series 702 Research and Protected Health Information

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...

Series 703 Data and Safety Monitoring

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 ...

Series 704 Differences of Laws

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.

Series 800: Noncompliance

Series 801 Noncompliance

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

Series 802 IRB Review of Noncompliance

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...

Series 803 Appeal of Noncompliance Determinations

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...

Series 900: Records & Administration


Guidance Documents

Below, you will find guidance documents related to topics that frequently appear in human subjects research at Utah State University.

Laws, Regulations, & Codes

USU Process Guidance

Protocol Closures & Expirations