206 Ancillary Reviews

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 for the responsible conduct of research. Not all studies require Ancillary Review. If an Ancillary Review is required, the Principal Investigator will be notified via the Kuali Protocols system, including which institutional office has received the review assignment. 

If Ancillary Review is required, final IRB approval, exemption, or reliance cannot be granted until the review process is complete. Ancillary Reviews may have requirements that the IRB must ensure are implemented within the study, or they may be approved by the partner office with no further action. The Ancillary Reviewing office is responsible for communicating the results of its review, when applicable, to the study investigators. 

II. Ancillary Review Process

During the pre-review process described in HRP SOP 402.III, certain study characteristics will trigger the Ancillary Review process (for example: the use of ionizing radiation automatically triggers a review by the Radiation Safety Office). Those reviews will be assigned by the Human Research Protections Assistant according to the office’s pre-review checklist. Other Ancillary Reviews might be assigned manually by a Human Research Protections Analyst, the IRB or IRB Manager, or the Executive Director of Human Research Protections (for example, a survey that collects data in many different countries that may include an export-controlled country may trigger a review by the Research Integrity & Compliance Office). 

The Human Research Protections Office asks Ancillary Reviewers to resolve their reviews within seven calendar days. However, some reviews may take longer, such as reviews that require an entire external committee to convene (for example: Institutional Conflict of Interest reviews, Radiation Safety Committee reviews). 

Ancillary Reviewers have three options within the Kuali Protocols System. They can approve the review, mark it as not yet resolved, or disapprove the review. An approval can mean that the issue flagged does not rise to the level of requiring additional compliance requirements, or it can mean that the review is approved pending the implementation of a compliance or management plan shared with the IRB from that office. Not yet resolved status indicates that the Ancillary Review office is actively working toward resolving the review process, and requires more time. Disapproved means that the underlying activity that triggered the review is not permitted to proceed, which may impact the IRB’s assessment of the project. 

In all cases, the Ancillary Reviewing office is responsible for communicating the results of its review to the study investigators. From time to time, the Human Research Protections Office might facilitate that communication, to assist with more efficient processing of human subjects research submissions.

III. Examples of Ancillary Review Requirements

The following is a non-exhaustive list of offices which might be assigned an Ancillary Review, and a brief description of their compliance- or responsible conduct of research-related oversight areas:

USU Office	Area of Review
Radiation Safety	Any use of ionizing radiation on a living person for a research purpose requires Radiation Safety review
University Ethics & Compliance	Institutional Conflict of Interest Review: Any time Utah State University-owned intellectual property is utilized in a research project involving human participants, the project must be screened to determine whether the institution itself has a conflict of interest with the project. Additionally, any time a private entity external to USU is funding a research project involving human research participants, that entity must be screened to see whether its financial relationship with Utah State University might constitute a conflict of interest for USU. In both cases, the concern is that the institution’s relationship to the study subject matter or sponsor might impact the conduct or reporting of the research, and measures to minimize the perceived or actual bias must be implemented. Privacy Review: Utah State University’s Privacy Officer is located in the University Ethics & Compliance Office. That office reviews research involving living people in locations where robust privacy regulations or laws exist, to ensure that USU is in compliance with those laws before research proceeds.
Research Integrity & Compliance	Conflict of Interest: Utah State University’s Research Compliance Officer over Conflicts of Interest resides in the Research Integrity & Compliance Office. Any human subjects research project involving a conflict of interest must be screened and, if appropriate, managed by that office.  Export Control: Any human subjects research involving an export-controlled locale or embargoed country must be reviewed for Export Control compliance, which is also housed in the Research Integrity & Compliance Office.  Research Integrity: Utah State University’s Human Research Protection Program includes the Research Integrity & Compliance Office. The HRP Office will comply with requests for information about human subjects research projects involving responsible conduct of research concerns from Research Integrity & Compliance.
Biosafety	Research involving human pathogens, biological toxins, human blood, and recombinant DNA requires USU’s Biological Safety Program to monitor laboratory safety practices, providing training and information, and pick up certain biomaterial for safe disposal. In some cases, a separate protocol must be filed with the Institutional Biosafety Committee before the IRB can approve the project.
Risk Management	When a project involving human participants could reasonably result in a claim on Utah State University’s general liability insurance, Risk Management has requested the ability to review the study procedures for concerns regarding participant safety and risk minimization.
Sorenson Center for Clinical Excellence	Research conducted in or using records from the Sorenson Center for Clinical Excellence at Utah State University must be reviewed by both the HIPAA Privacy Officer for the SCCE as well as the applicable Clinic Director. If the Director is proposing the research, the Director-level review shifts to the SCCE Executive Director.