General Institutional Review Board information
IRB meeting schedule and 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.
Research Integrity staff assess each submission in IRBNet for completeness and to determine the requisite level of review. 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.
Complete projects/packages contain the following:
- Completed Part I Application or Cover Sheet (for new projects only)
- Completed Part II or Exempt Application; 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)
- Completed IRB-requested changes or revisions (for follow-up, information requested, or revisions packages only)
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.
IRB review fees
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, Renown Medical Center and the VA Sierra Nevada Health Care System. These individual fees will not be charged to these entities as it would result in double billing.
External Principle 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. In most cases, the IRB authorizes the IRB Chair to make this decision, but accepting or declining review will in some cases be determined by the board. 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.
Initial Review of the Research - $2,000
Initial review encompasses the review of the research protocol, qualifications of the investigator, associated consent forms, protocol-related advertisements, questionnaires, screening scripts, and other submitted materials.
Expedited review of initial protocol submission - $300
There will be a one-time fee for the initial review of the research protocol, qualifications of the investigator and staff, and other submitted materials, for studies that meet expedite review categories.
Exempt review of initial protocol submission - $150
There will be a one-time fee for the initial review of the research protocol, qualifications of the investigator and staff, and other submitted materials, for studies that meet exempt review categories.
Continuing Review - $725
The IRB must review ongoing research at least annually and that review must be substantive and at least comparable to the initial review. The protocol is reviewed on an annual basis, or more frequently as directed by the Board.
Modifications/Amendments to Research - $400
Modifications to research such as protocol amendments, revised protocols, updates to consent forms, and new recruitment or retention materials, change of principal investigator or Co-Principal Investigator incur a fee. The change in research fee applies each time Board review and preparation of regulatory documentation is required for a research site.
Important note regarding administrative modifications
There is no charge for administrative modifications (i.e., study personnel changes, or site additions) or submission of reportable events (i.e., unanticipated problems, adverse event/serious adverse event, protocol deviation).
Levels of IRB review
- 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 9 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