512. New Projects - Submission Requirements for Exempt Review

Updated August 23, 2021

For projects to be eligible for Exempt Review, participant risk must be no greater than minimal and research activities must be in one or more Department of Health and Human Services (DHHS) exempt categories at 45 CFR 46.104 or the University's IRB-Flexibility Policy (IRB-Flex). For information about IRB-Flex, see the policy for institutional authority for human research protection. For more information about DHHS or Flex-Exempt review categories, see the online Human Research Protection Program (HRPP) Policy Manual Review Types).

Projects for Exempt Review may be submitted at any time; meeting dates and deadlines do not apply to exempt reviews.

Mandatory Submission Requirements for Exempt Research

The following requirements apply to each New Project submitted for Exempt 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
• As applicable, add study-specific materials/documents from the itemized list below.
• Share IRBNet access for all study personnel, giving PI Full Access.
• Obtain PI signature electronically through IRBNet.
• Submit the project for Exempt Review.

Study-Specific Materials/Documents for Exempt Research

Submit the following materials/documents when relevant to an exempt research project:

• Add documentation of approval from agency or department head for research involving public benefit or service programs: Required only for Exempt Category 5.
• Add materials for inviting prospective participants (e.g., SONA posting flyers, emails, scripts): Required when participants will be invited to participate.
• Add materials for informing participants about the research (e.g., information sheets/scripts): Required when participants will be told about the research.
• Add study materials (e.g., surveys, assessment materials, data collection logs): Required as applicable to the 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 when the PI is requesting a waiver of the requirement for written authorization for research involving disclosure of PHI.
• Add Department of Defense Research form: Required for research conducted or supported by the Department of Defense (DOD).
• 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 with questions about obtaining approval from external institutions.

Materials that May Be Requested

At the reviewer's discretion, the Research with Prisoners form may be requested for research involving prisoners.

Additional Requirements for Independent or External Investigators to Use the University IRB

Review IRB policy for independent or external investigators to use a University IRB and complete the following steps:

• Add principal investigator curriculum vitae.
• As applicable, add external IRB exempt determination and relevant applications and project materials.