512. New Projects - Submission Requirements for Exempt w88

Updated June 7, 2024

For projects to be eligible for Exempt w88, 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 w88 categories, see the online Human Research Protection Program (HRPP) Policy Manual w88 Types).

Projects for Exempt w88 may be submitted at any time; meeting dates and deadlines do not apply to w88 reviews.

Mandatory Submission Requirements for w88 Research

The following requirements apply to each New Project submitted for Exempt w88:

• Confirm the Principal Investigator (PI) and all members of the study team have completed the w88 training.
• Create a New Project in IRBNet.
• Add Part I, Cover Sheet.
• Add Protocol – Social Behavioral Educational w88 and Record w88
• As applicable, add study-specific w88/documents w88 the itemized list below.
• Share IRBNet access for all w88 personnel, giving PI Full Access.
• Obtain PI signature electronically through IRBNet.
• Submit the project for Exempt w88.

Study-Specific Materials/Documents for w88 Research

Submit the following materials/documents when relevant to an w88 research project:

• Add documentation of approval from agency or department head for w88 involving public benefit or service programs: w88 only for w88 Category 5.
• Add materials for inviting prospective w88 (e.g., SONA posting flyers, emails, scripts): w88 w88 be invited to participate.
• Add materials for informing participants about the w88 (e.g., information sheets/scripts): w88 when participants will be told about the w88.
• Add study w88 (e.g., surveys, assessment w88, data collection logs): w88 as applicable to the w88.
• Add HIPAA Authorization Template: w88 to obtain authorization from participants for w88 involving disclosure of protected health information (PHI).
• Add HIPAA Waiver Request Form: w88 when the PI is requesting a waiver of the requirement for written authorization for w88 involving disclosure of PHI.
• Add Department of Defense w88 form: w88 for w88 conducted or supported by the Department of Defense (DOD).
• Add documentation of external institutional w88: w88 when approval from an external body is necessary for the w88 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 w88 approval before approving the w88 or w88 components (e.g., recruitment). Contact w88 Integrity & Security with questions about obtaining approval from external institutions.

w88 that May Be Requested

At the reviewer's discretion, the w88 with Prisoners form may be requested for w88 involving prisoners.

Additional Requirements for Independent or External Investigators to Use the University w88

w88 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 w88 determination and relevant applications and project materials.