Important updates to IRB policies and procedures

As part of the IRB’s reaccreditation process, several policies and procedures have been updated that affect study submissions and oversight. Below is a summary of the most significant changes.

• Forms and Templates: Many forms and templates found in IRBNet have been updated, including the Protocol and Consent Form templates. Please use the most current versions by downloading them from the “Forms and Templates” tab in IRBNet.
• Part I, Cover Sheet: The IRBNet Part I, Cover Sheet smart form has been updated to include additional information for external collaborators (as applicable) and displays information about additional forms that must be completed based on the characteristics of the research, as indicated by the investigator.
• Not Human Subjects Research: Formal requests for a human research determination can still be submitted to the IRB for review. Investigators may also use the Human Research Determination form to self-determine that a project is not human subjects research.
• Amendments to Exempt Studies: Policy 566 has been updated to outline several types of amendments to exempt studies that may be adopted by the study team without prior IRB review of the changes.
• Umbrella Protocols: Policy 566 has also added a new section that outlines under what circumstances umbrella protocols (a single protocol that supports multiple related sub-studies) are permissible.
• Recruitment Requirements: Policy 300 has generalized the recruitment expectations around use of emails and crowdsourced platforms and expanded the parameters for which third parties may contribute to recruitment efforts.
• Waivers/Alterations of Informed Consent/Consent Documentation: Policies 335 and 101 were revised to more clearly describe how and when waivers/alterations of informed consent or waivers of consent documentation are permissible.
• Flexibility Provisions: Policy 6 updated the flexibility provisions afforded to the conduct and review of eligible research projects.
• Humanitarian Use Devices: Policy 125 was revised to allow for HUD applications to include anticipated off-label use as part of the IRB approval.
• External IRBs, External Investigators, and Reliance Agreements: Policy 4 was rewritten to more clearly explain the process for requesting that IRB review be ceded to an external institution, requesting that the University’s IRB serve as the IRB of record for multisite research, and obtaining University IRB oversight of independent external investigators.
• Exceptions to FERPA Requirements: Policy 77 added a new exception for the disclosure of education records to school officials with legitimate educational interest.
• New Policy: Research Involving American Indian Tribes and Communities: Policy 260 supports researchers interested in conducting studies on tribal lands or with tribal communities.

Please contact the IRB office at irb@unr.edu with questions.