512. New Projects - Submission Requirements for Exempt Review

Updated June 7, 2024

For projects to be eligible forExempt Review, participant risk must be no greater than minimal and w88 casino games login 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 w88 casino games login protection. For more information about DHHS or Flex-Exempt review categories, see the online Human w88 casino games login Protection Program (HRPP) Policy Manual Review Types).

Projects forExempt Reviewmay be submitted at any time; meeting dates and deadlines do not apply to exempt reviews.

Mandatory Submission Requirements for Exempt w88 casino games login

The following requirements apply to eachNew Projectsubmitted forExempt Review:

• Confirmthe Principal Investigator (PI) and all members of the study team have completed the required training.
• Create a New Projectin IRBNet.
• Add Part I, Cover Sheet.
• Add Protocol – Social Behavioral Educational w88 casino games login and Record w88 casino games login
• As applicable,add study-specific materials/documentsfrom the itemized list below.
• ShareIRBNet access for all study personnel, giving PIFull Access.
• ObtainPI signature electronically through IRBNet.
• Submitthe project forExempt Review.

Study-Specific Materials/Documents for Exempt w88 casino games login

Submit the following materials/documents when relevant to an exempt w88 casino games login project:

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

Materials that May Be Requested

At the reviewer's discretion, thew88 casino games login with Prisonersform may be requested for w88 casino games login 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:

• Addprincipal investigator curriculum vitae.
• As applicable,addexternal IRB exempt determination and relevant applications and project materials.