510. w88 online casino Projects - Submission Requirements for Full Committee Review

Updated June 7, 2024

The following requirements apply to each w88 online casino Project submitted in IRBNet for w88 online casino Committee Review. (For information about when w88 online casino require w88 online casino Committee Review, see IRB Policy Manual for w88 online casino types.)

Research Integrity & Security staff assess w88 online casino projects submitted for Full Committee Review for completeness. Investigators are encouraged to plan appropriately to allow time for this assessment when submitting w88 online casino projects for IRB review. Incomplete submissions are not assigned to a meeting agenda regardless of the submission date.

Mandatory Submission Requirements for Full Committee Review of w88 online casino Projects

Complete the following steps for each w88 online casino project submitted for Full Committee Review.

Confirm the Principal Investigator (PI) and all members of the study team have completed the w88 online casino training
Create a w88 online casino Project in IRBNet
Add Part I, Cover Sheet
Add Protocol – Social Behavioral Educational w88 online casino and Record w88 online casino or Protocol – Biomedical w88 online casino form
Add recruitment materials
As applicable, (1) use the w88 online casino Form Checklist to revise the sponsor w88 online casino template to include University and Affiliate requirements; or (2) use a University consent template for other greater than minimal risk w88 online casino; add the w88 online casino Form Checklist.
Add the informed w88 online casino documents.
Add w88 online casino materials: assessment instruments, surveys, questionnaires, data collection logs, procedural protocols
As applicable, Add mandatory materials/documents for clinical investigations and w88 online casino-specific materials/documents (from the itemized lists below)
Share IRBNet access for all w88 online casino personnel (and the Responsible Official, if applicable).
Obtain the PI’s signature electronically through IRBNet.
Obtain the Responsible Official’s signature electronically through IRBNet, if applicable (for all greater than minimal risk protocols, and upon request by the IRB or w88 online casino Integrity & Security for minimal risk protocols.
Submit the project for w88 online casino Committee Review.

Mandatory Submission Requirements for Clinical Investigations

The following additional mandatory requirements apply to w88 online casino clinical investigations submitted for Full Committee Review:

Add Clinical w88 online casino Protocol (AKA: Sponsor Protocol) or its equivalent (e.g., investigational plan)
Add device manual (for w88 online casino involving investigational devices)
Add Investigator Brochure for investigational drugs or devices, or justification for exemption from Investigational w88 online casino Drug (IND) or Investigational Device Exemption (IDE) regulations from Food and Drug Administration (FDA) or device manufacturer
Add Investigator form 1572
Add documentation of FDA, study sponsor, or device manufacturer determination of significant or nonsignificant risk device study (required for investigational device w88 online casino conducted without IDE)

Study-Specific Submission Requirements for Full Committee Review of w88 online casino Projects

For w88 online casino projects submitted for Full Committee Review, additional materials are required as follows:

Add Protocol w88 online casino Subcommittee w88 online casino: w88 online casino for VA w88 online casino
Add w88 online casino with Drugs or w88 online casino with Devices form: w88 online casino when w88 online casino activities involve investigational/experimental drugs/devices or when drugs/devices are used for off-label or unapproved purposes.
Add w88 online casino with Specimens form: w88 online casino when w88 online casino involves the collection of human blood or biological specimens.
Add HIPAA Authorization Template: Required to obtain written authorization from participants for w88 online casino involving disclosure of protected health information (PHI).
Add HIPAA Waiver Request Form: w88 online casino for the IRB to waive the requirement for written authorization for w88 online casino involving disclosure of PHI.
Add w88 online casino with Prisoners form: w88 online casino for w88 online casino involving prisoners.
Add Department of Defense w88 online casino form: w88 online casino for w88 online casino conducted or supported by the Department of Defense (DOD).
Add documentation of regulatory w88 online casino approval: w88 online casino for w88 online casino that is subject to approval from regulatory committees responsible for biological, radiation, or environmental safety
Add documentation of external scientific, safety, or institutional w88 online casino: w88 online casino when approval from an external body is necessary for the w88 online casino to proceed.

NOTE: In some cases, external bodies require w88 online casino approval before approving the w88 online casino or w88 online casino components (e.g., recruitment). Contact w88 online casino Integrity & Security with questions about obtaining approval from external institutions.

IMPORTANT NOTE REGARDING THE w88 online casino WAIVERS FORM:

The Consent Waivers form is required for research requiring w88 online casino Committee Review under the following two circumstances:

For FDA regulated w88 online casino, to request IRB approval for a waiver of informed consent to w88 online casino medical records to identify eligible patients, or for a waiver of documentation of consent to complete minimal risk components prior to enrolling a participant in the study (for example, pre-screening interview) (i.e., minimal risk components of greater than minimal risk research).
For greater than minimal risk w88 online casino when the only record linking the participant and the w88 online casino would be the consent document and the principal risk is the potential harm resulting from a breach of confidentiality, that is, to request IRB approval for a Category 1 waiver of documentation of consent. Such w88 online casino may also be reviewed by expedited procedure if the risk of breach of confidentiality is sufficiently mitigated.

For more information, see w88 online casino policy for waiver/alteration informed consent and waiver of documentation of consent.)

Additional Requirements for Independent or External Investigators Using the University w88 online casino

w88 online casino IRB policy for independent or external investigators to use the University IRB and complete the following steps:

Add principal investigator curriculum vitae.
As applicable, confirm an Independent Investigator Agreement or w88 online casino Authorization Agreement (IAA): University of Nevada, Reno w88 online casino as w88 online casino of Record is attached by w88 online casino Integrity & Security staff.