511. New Projects - Submission Requirements for Expedited Review

Updated June 7, 2024

The following requirements apply to eachNew Projectsubmitted in IRBNet forExpedited Review(i.e., review by one or more IRB members, outside of a committee meeting).

For projects to be eligible forExpedited Review, participant risk must be no greater than minimal and w88 online casino betting activities must be listed among the DHHS categories of w88 online casino betting eligible for expedited review.

New projects forExpedited Reviewmay 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 forExpedited Review:

Confirmthe Principal Investigator (PI) and all members of the study team have completed the required training.
Create a New Projectin IRBNet.
AddPart I, Cover Sheet.
Add Protocol – Social Behavioral Educational w88 online casino betting and Record w88 online casino bettingor Protocol – Biomedical w88 online casino betting.
Addrecruitment materials.
Addconsent materials (e.g., information scripts or sheets;rarelyconsent or permission forms).
Addstudy materials: assessment instruments, surveys, questionnaires, data collection logs.
As applicable,Addstudy-specific materials/documents from the itemized list below.
ShareIRBNet access for all study personnel (and the Responsible Official, if applicable).
Obtainthe PI’s signature electronically through IRBNet.
Obtainthe Responsible Official’s signature electronically through IRBNet (upon request by the IRB or w88 online casino betting Integrity & Security for minimal risk protocols).
Submitthe project forExpedited Review.

Study-Specific Submission Requirements for Expedited Review of New Projects

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

AddProtocol Review Subcommitteereview:Requiredfor VA w88 online casino betting.
Addw88 online casino betting with Drugs or w88 online casino betting with Devicesform:Requiredfor w88 online casino betting involving drugs, dietary supplements, or devices when these donotrequire IND (drug) or IDE (device) per Expedited Review Category 1. (w88 online casino betting involving IND or IDE requires Full Committee Review; see submission requirements for Full Committee Review.)
Addw88 online casino betting with Specimensform:Requiredwhen w88 online casino betting involves the collection of human blood or biological specimens per Expedited Review Category 2 or 3.
AddConsent Waivers Request Form: Requiredfor the IRB to waive or alter DHHS requirements for informed consent or documentation of consent for minimal risk w88 online casino betting projects ONLY when these are conducted/supported by a federal agency or involve deception or incomplete disclosure or prisoners. All other minimal risk w88 online casino betting may beexcludedfrom 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 w88 online casino betting and for exempt and minimal risk w88 online casino betting.
AddHIPAA Authorization Template: Requiredto obtain authorization from participants for w88 online casino betting involving disclosure of protected health information (PHI).
AddHIPAA Waiver Request Form: Requiredfor the IRB to waive the requirement for written authorization for w88 online casino betting involving disclosure of PHI.
Add w88 online casino betting with Prisonersform:Requiredfor w88 online casino betting involving prisoners.
Add Department of Defense w88 online casino bettingform:Requiredfor w88 online casino betting 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 online casino betting 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 online casino betting or w88 online casino betting components (e.g., recruitment). Contact w88 online casino betting Integrity & Security with questions about obtaining approval from external institutions.

Additional Requirements for Independent or External Investigators Using 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,confirmanIndependent Investigator Agreement or IRB Authorization Agreement (IAA): w88 online casino betting, Reno IRB as IRB of Recordis attached by w88 online casino betting Integrity & Security staff.