511. New Projects - Submission Requirements for Expedited Review

Updated May 20, 2026

The following requirements apply to each New Project submitted in IRBNet for Expedited Review (i.e., review by one or more IRB members, outside of a committee meeting).

For projects to be eligible for Expedited Review, participant risk must be no greater than minimal and research activities must be listed among the DHHS categories of research eligible for expedited review.

New projects for Expedited Review may be submitted at any time; meeting dates and deadlines do not apply to expedited reviews. New Projects are assessed for completeness; incomplete projects will not be forwarded for review until all required materials have been submitted.

Mandatory Submission Requirements for Expedited Review of New Projects

Complete the following steps for each new project submitted for Expedited Review:

• Confirm the Principal Investigator (PI) and all members of the study team have completed the required training
• Create a New Project in IRBNet.
• Add Part I, Cover Sheet.
• Add Protocol – Social Behavioral Educational Research and Record Research or Protocol – Biomedical Research
• Add recruitment materials.
• Add consent materials (e.g., information scripts or sheets; rarely consent or permission forms).
• Add study materials: assessment instruments, surveys, questionnaires, data collection logs.
• As applicable, add study-specific materials/documents from the itemized list below.
• Share IRBNet access for all study personnel (and the Responsible Official, if applicable).
• Obtain the PI’s signature electronically through IRBNet.
• Obtain the Responsible Official’s signature electronically through IRBNet (upon request by the IRB or Research Integrity & Security for minimal risk protocols)
• Submit the project for Expedited Review

Study-Specific Submission Requirements for Expedited Review of New Projects

For new projects submitted for Expedited Review, additional materials are required as follows:

• Add Research with Drugs or Research with Devices form: Required for research involving drugs, dietary supplements, or devices when these do not require IND (drug) or IDE (device) per Expedited Review Category 1. (Research involving IND or IDE requires Full Committee Review; see submission requirements for Full Committee Review.)
• Add Research with Specimens form: Required when research involves the collection of human blood or biological specimens per Expedited Review Category 2 or 3.
• Add Research: International form: Required for international research.
• Add Consent Waivers Request Form: Required for the IRB to waive or alter DHHS requirements for informed consent or documentation of consent for minimal risk research projects ONLY when these are conducted/supported by a federal agency or involve deception or incomplete disclosure or prisoners. All other minimal risk research may be excluded from DHHS requirements for informed consent under the University’s IRB Flexibility Policy. See IRB policies for informed consent for federally funded and select minimal risk research and for exempt and minimal risk research.
• Add HIPAA Authorization Template: Required to obtain authorization from participants for research involving disclosure of protected health information (PHI).
• Add HIPAA Waiver Request Form: Required for the IRB to waive the requirement for written authorization for research involving disclosure of PHI.
• Add Research with Prisoners form: Required for research involving prisoners.
• Add Population: Children as Research Participants form: Required for research involving children.
• Add Population: Pregnant Women, Fetuses, and Neonates form: Required for applicable research involving pregnant women, fetuses, or neonates.
• Add Population: Adult Participants with Impaired Decision-Making Capacity form: Required for research involving adults with impaired decision-making capacity.
• Add Department of Defense Research form: Required for research conducted or supported by the Department of Defense (DoD).
• Add Department of Energy Research form: Required for research conducted or supported by the Department of Energy (DoE).
• Add Research involving FERPA/PPRA Regulations form: Required for research conducted or supported by the Department of Education (DoEd).
• Add Department of Justice Research form: Required for research conducted or supported by the Department of Justice (DoJ) or the National Institute of Justice (NIJ).
• Add Environmental Protection Agency Requirements for Research form: Required for research conducted or supported by the Environmental Protection Agency (EPA).
• Add Research: International form: Required for research conducted in international locations.
• Add documentation of external institutional approval: Required when approval from an external body is necessary for the research to proceed (e.g., school district approval; approval to recruit Truckee Meadows Community College (TMCC) students or employees)

NOTE: In some cases, external bodies require IRB approval before approving the research or research components (e.g., recruitment). Contact Research Integrity & Security with questions about obtaining approval from external institutions.