General Institutional Review Board information
The University Institutional Review Board (IRB) meets twice monthly to review human subject research that presents greater than minimal risk to participants: on the 2nd and 4th Thursdays. Researchers are advised to submit projects for full board (above minimal risk study activity) review at least three weeks in advance of the meeting date for preliminary review to ensure clear and complete submissions to facilitate review at the meeting. Please see schedule for submission deadlines and IRB full board meeting dates.
|Submission deadline||IRB meeting date|
Research Integrity staff assess each submission in IRBNet for completeness and to determine the requisite level of review.
Complete projects/packages contain the following:
- Completed Part I Application or Cover Sheet (for new projects only)
- Completed Protocol – Social Behavioral Educational Research and Records Research or Protocol – Biomedical Research; application to request a determination for human subject research, continuing review, amendments to approved projects, or to use an external IRB; application for emergency or expanded use drug/device or HUD; or problem report form
- Completed supplemental applications as applicable to the research (e.g., for research involving vulnerable populations, federal agency support or funding, blood/biological specimens, drugs, or devices)
- All applicable recruitment/consent documents
- All research instruments, data collection logs, or other materials relevant to the research
- Applicable committee approvals (e.g., biosafety or radiation safety committees, PRS Committee for VA research, Renown Clinical Research Department)
- Completed IRB-requested changes or revisions (for follow-up, information requested, or revisions packages only)
- Completed signatures in IRBNet from the Principal Investigator and other signatory officials that may be needed (i.e., Responsible Official, Renown Clinical Research Department, Saint Mary’s Signatory Official).
Projects/packages requiring Full Committee Review must be determined to be complete before these are placed on the agenda for review at a scheduled IRB meeting. Project/packages requiring Administrative, Exempt, or Expedited Review must be determined to be complete before these are forwarded for review. See IRB policy for information about submission types in IRBNet.
The University of Nevada, Reno IRB will conduct reviews of appropriate, external, human subjects research proposals on a fee-based schedule. The infrastructure that supports the IRB is funded by the indirect (F&A) return on expenditures. That cost is not captured when the funding is run outside of the University. The fees are charged to help offset the costs of such operations, including expertise-based protocol reviews, administrative support, technological infrastructure (electronic-based submission systems), educational and training requirements, and other activities of the Human Research Protection Program (HRPP). Note: The University has an agreement for an annual fee for IRB review from Saint Mary's Medical Center and Renown Medical Center.
External Principal Investigator and IRB review
When an investigator is not engaged with the University as an employee or student for the purpose of conducting a research project involving human subjects, that project will be considered external and charged a fee regardless of the for-profit or non-profit nature of the project, investigator, or investigator's company or agency.
The IRB will only conduct external reviews of proposals for which it is qualified in terms of adequate experience and subject expertise. Specifically, the IRB reserves the right to accept or decline a request for review on a case-by-case basis. The IRB will review proposals at the full-board, expedited, and exempt levels of review as is appropriate to the complexity and risk level of the proposal.
The fees are assessments of costs associated with study reviews conducted by the IRB and are charges for services rendered. Fees are due and payable upon submission to the IRB for initial, continued, amendment or closure review. Checks are payable to the Board of Regents. Send to University of Nevada, Reno. 1664 N Virginia Street, Mail Code 0331, Reno NV 89577.
Fees are non-negotiable and non-refundable. Because the IRB office commits its resources appropriate to each level of review, fees are due in full from the applicant regardless of subsequent conduct of the study, including disapproval by the IRB or early termination by the investigator or sponsor.
Review type & fees
|Reliance Agreement Single Administrative Fee||$1500|
|Amendments (NO CHANGES TO INFORMED CONSENT)||Fee|
|Protocol Amendment with Consent form||Fee|
|Review of Revised Product Information (i.e. Clinical Investigator Brochure, Package Insert, DSMB reports)||$500|
|Reliance Agreement Single Aministrative Fee||$1500|
|Non-Human Subjects Determination||$150|
|Convened Review Response Follow Up||$150|
|Local Review & Oversite Fee (a one-time fee for local administrative review and oversight pre-review to a commercial IRB)||$1300|
- More than minimal risk to participants
- Not covered under other review categories
Example: Interventions involving physical or emotional discomfort or sensitive data
- Not greater than minimal risk
- Fits one of the 7 expedited review categories
Example: Collection of biospecimens by noninvasive means, research with existing documents or records collected for non-research purposes where participants are identifiable
- Less than minimal risk
- Fits one of the 6 exempt categories
- Fits additional Flex Policy* exemption
Example: Research with de-identified records, anonymous surveys
- For studies that are no greater than minimal risk
- For studies with no federal funding
- Provide equivalent protections to subjects commensurate with risk level