500. Submission Types in IRBNet

Updated August 23, 2021

This policy identifies the Submission Types available in IRBNet and describes when each type is used.

Researchers and Research Integrity staff apply the following general guidelines and descriptions when selecting Submission Types. Selecting the appropriate submission type helps to ensure documentation of reviews accurately reflect the review process.

General Guidelines

• Each Submission Type is unique to a particular review process.
• Researchers may submit only one type of request in a single package.
• Different submission types may not be combined.
• All packages require the electronic signature of the Principal Investigator (PI).
• Renewals and amendments are different submission types and must be submitted as separate packages. Ideally, researchers wait for IRB approval for one submission before submitting the other.
• A single amendment request may involve multiple changes but all changes must be listed/described on the amendment researcher form.

Submission Types Defined (Listed in Alphabetical Order)

Adverse Event (non-UP)

For submission of a problem report involving an adverse device effect or a serious adverse event (SAE) or serious problem. May be updated by the Research Compliance Officer following initial assessment of the submission.

Amendment/Modification

For all submissions involving changes to an approved project.

Closure/Final Report

For reporting closures to the IRB.

Continuing Review/Progress Report

For submitting Continuing Review (Renewal) Request or Progress Report for Expedited or Full Committee Review project.

Funding/Grant

No prescribed use. Grant proposals/funding documents are included with New Project submissions or as an Amendment/Modification if informing the IRB of a change in funding or sponsorship.

New Project

For submitting new projects including:

• Request for Human Research Determination
• Request to Use External IRB
• New application for Exempt Review
• New application for Expedited or Full Committee Review

Other

Used by the Research Integrity Research Compliance Officer for creating packages to document quality improvement and other reviews.

For submissions that do not fit into one of the defined types (use should be limited).

Other Reportable Event

For submission of an Outside Audit Report by a compliance officer from an affiliated institution, federal agency, or other external regulatory body (as specified in the problem reporting form).

Protocol Deviation/Violation

For submission of a problem report involving an unapproved Protocol change or Protocol Deviation/Violation; May be updated by the Research Integrity Research Compliance Officer following initial assessment of the submission.

Publication

No prescribed use.

Response/Follow-Up

For submission of IRB-requested changes, following IRB Action: Approved with Conditions and Information Required

Revision

For submission of IRB-requested changes, following IRB Action: Deferred.

Unanticipated Problem

For submission of a problem report involving a Death; Immediate harm; New or additional risks; Changes to expected harms; Changes to expected benefits; Privacy; Confidentiality; Serious Research Information Security Problem (for VA research); Complaints; Sponsor determination of Unanticipated Problem; or FDA changes (as specified in the problem reporting form). May be updated by the Research Integrity Research Compliance Officer following initial assessment of the submission.