510. New Projects - Submission Requirements for Full Committee Review

Updated June 7, 2024

The following requirements apply to eachNew Projectsubmitted in IRBNet forFull Committee Review. (For information about when projects requireFull Committee Review, see IRB Policy Manual for review types.)

w88 mobile Integrity & Security staff assess new projects submitted for Full Committee Review for completeness. Investigators are encouraged to plan appropriately to allow time for this assessment when submitting new 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 New Projects

Complete the following steps for each new project submitted for Full Committee 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
  • AddProtocol– Social Behavioral Educational w88 mobile and Record w88 mobileor Protocol – Biomedical w88 mobileform
  • Addrecruitment materials
  • As applicable, (1)usetheConsent Form Checklistto revise the sponsor consent template to include University and Affiliate requirements; or (2)usea University consent template for other greater than minimal risk w88 mobile;addtheConsent Form Checklist.
  • Addthe informed consent documents.
  • Addstudy materials: assessment instruments, surveys, questionnaires, data collection logs, procedural protocols
  • As applicable,Addmandatory materials/documents for clinical investigations and study-specific materials/documents (from the itemized lists 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, if applicable (for all greater than minimal risk protocols, and upon request by the IRB or w88 mobile Integrity & Security for minimal risk protocols.
  • Submitthe project forFull Committee Review.

Mandatory Submission Requirements for Clinical Investigations

The following additionalmandatoryrequirements apply to new clinical investigations submitted for Full Committee Review:

  • AddClinical w88 mobile Protocol(AKA: Sponsor Protocol) or its equivalent (e.g., investigational plan)
  • Adddevice manual (for w88 mobile involving investigational devices)
  • AddInvestigator Brochurefor investigational drugs or devices, or justification for exemption from Investigational New Drug (IND) or Investigational Device Exemption (IDE) regulations from Food and Drug Administration (FDA) or device manufacturer
  • AddInvestigator form 1572
  • Adddocumentation of FDA, study sponsor, or device manufacturer determination of significant or nonsignificant risk device study (required for investigational device w88 mobile conducted without IDE)

Study-Specific Submission Requirements for Full Committee Review of New Projects

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

  • AddProtocol Review Subcommitteereview:Requiredfor VA w88 mobile
  • Addw88 mobile with Drugs or w88 mobile with Devicesform:Requiredwhen w88 mobile activities involve investigational/experimental drugs/devices or when drugs/devices are used for off-label or unapproved purposes.
  • Addw88 mobile with Specimensform:Requiredwhen w88 mobile involves the collection of human blood or biological specimens.
  • AddHIPAA Authorization Template:Required to obtain written authorization from participants for w88 mobile involving disclosure of protected health information (PHI).
  • AddHIPAA Waiver Request Form: Requiredfor the IRB to waive the requirement for written authorization for w88 mobile involving disclosure of PHI.
  • Add w88 mobile with Prisonersform:Requiredfor w88 mobile involvingprisoners.
  • Add Department of Defense w88 mobileform:Requiredfor w88 mobile conducted or supported by the Department of Defense (DOD).
  • Adddocumentation of regulatory committee approval:Requiredfor w88 mobile that is subject to approval from regulatory committees responsible for biological, radiation, or environmental safety
  • Adddocumentation of external scientific, safety, or institutional approval:Requiredwhen approval from an external body is necessary for the w88 mobile to proceed.

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

IMPORTANT NOTE REGARDING THE CONSENT WAIVERS FORM:

The Consent Waivers form is required for w88 mobile requiring Full Committee Review under the following two circumstances:

  1. For FDA regulated w88 mobile, to request IRB approval for a waiver of informed consent to review 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 w88 mobile).
  2. For greater than minimal risk w88 mobile when the only record linking the participant and the w88 mobile 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 mobile may also be reviewed by expedited procedure if the risk of breach of confidentiality is sufficiently mitigated.

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

Additional Requirements for Independent or External Investigators Using the University IRB

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

  • Addprincipal investigator curriculum vitae.
  • As applicable,confirmanIndependent Investigator Agreement or IRB Authorization Agreement (IAA): w88 mobile, Reno IRB as IRB of Recordis attached by w88 mobile Integrity & Security staff.