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IRB Forms

All IRB applications, appendices, post-approval submission forms and templates are listed below. Principal investigators must submit an application and required supplemental materials for research activities that meet the definition of human subjects research.


Protocol Applications

Form When to use Last Revised
IRB Protocol Form:  Exempt Categories
For research qualifying for Exemption in categories 1, 2, 3, 5, or 6.  July 2014
IRB Protocol Application:  Research Involving Existing Records/Data/SpecimensFor secondary research use of identifiable information or specimens which falls into Exemption Category 4, or Expedited Category 5. June 2016
IRB Protocol FormFor research qualifying for expedited or full review. October 2016

Request for IRB Prescreening of Sponsored Project (45 CFR 46.118 Designation)

To request approval for a project lacking definite plans for involvement of human subjects; for which funds are necessary for preliminary work to develop human subjects protocols.  July 2014

Supplemental Materials

Depending on the specific details of the proposed research, supplemental forms/appendices and/or approvals may be required.  Incomplete submissions may cause delays in processing reviews and approvals. 

Common supplemental materials include:

  • Appendices
  • Consent forms, parent permission forms, child or youth assent forms, or information sheets
  • Recruitment materials such as initial invitations (email or hard copy), flyers, advertisements and/or oral scripts
  • Survey or interview questions
  • Associated grants or contracts

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When To Use
Additional Materials AttachmentWhen utilizing additional data, documents or biological samples/specimens that have already been collected (pre-exist), or will be collected solely for non-research purposes.May 2013
Children in ResearchWhen children will be included as subjects/ participants of the researchMay 2013
Individual Investigator AgreementFor non-exempt research where NDSU is serving as the IRB of record, and the collaborating institution does not hold an FWA
Expedited Categories AttachmentTo document the appropriate expedited category.April 2013
Informed Consent Waiver or Alteration RequestWhen requesting to waive some or all of the required elements of consent, or when requesting a waiver of the signature for expedited or full board studies.April 2016
Investigational Use of Medical DevicesFor research utilizing an FDA-regulated Medical Device October 2010
Planned Emergency ResearchFor research to be conducted in emergency settingsOctober 2010
Prisoners in ResearchIf some or all of the research participants are expected to be incarceratedMay 2013

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Post-Approval Forms

When to use
Add, Delete or Change Personnel FormWhen adding or changing research team member, principal or co-investigatorsJanuary 2015
Continuing Review Report **NEW**
To renew approval for ongoing project, or to report completion of a protocol.October 2017
Exempt Recertification FormTo renew certification of exempt projects that will continue past the three-year expiration.October 2013
Protocol Amendment RequestTo make a change to a previously approved protocol.June 2015
Protocol Deviation Report To report unplanned deviations from the approved protocol.October 2016
Protocol Status Update **NEW**
For protocols eligible for expedited review which do not require annual continuing review (this cannot be used if the protocol is subject to FDA regulations).August 2018
Protocol Termination Report  **NEW**To close a protocol form which was previously approved by the IRB.October 2017
Report of Unanticipated Problem or Serious Adverse EventTo report a problem involving risks to participants or others.May 2013

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Submission Instructions

PIs may submit applications and required supplemental materials electronically via email. Electronic submissions must be sent to from the PI’s official NDSU email account, copying all co-investigator(s) and the department chair, dean, or director. Approval of the chair, dean or director is needed (via their NDSU email) for studies requiring expedited or full review.

QUESTIONS? Contact Kristy Shirley at 701.231.8995 or

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Last Updated: Friday, August 17, 2018 10:29:33 AM
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