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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 FORMS & TEMPLATES

Protocol Applications (2019)

For more information on the submission process, please see the Submission Instructions (below) or the Frequently Asked Questions (FAQs) page of our website.

Protocol forms have been updated in response to upcoming regulatory changes which take effect January 21, 2019.  For more information, please visit the Resources page of our website.

Form When to use Updated
IRB Protocol Application for Exemption:  Primary Research For primary research which falls into Exemption Categories 1, 2, 3, 5, or 6.  A detailed description of each of the Exemption Categories can be found here. January 2018
 IRB Protocol Application:  Secondary Research for which Consent is not requiredFor secondary research use of identifiable information or biospecimens which falls under Exemption Category 4 or Expedited Category 5 January 2019
IRB Protocol Form For human subjects research requiring expedited or full board review. January 2018
Request for IRB Pre-Screening of Sponsored Project For “pre-approval” of funded projects where human subjects procedures are not yet finalized. July 2014

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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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Appendices

Forms
When To Use
Updated
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 ResearchFor research involving minor participantsFebruary 2019
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 RequestFor Non-Exempt Research:  To apply to waive some or all of the required elements of consent, or to apply for an exception to consent for screening, recruiting or determining eligibility.January 2019
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

Form
When to use
Updated
Add, Delete or Change Personnel FormWhen adding or changing research team member, principal or co-investigatorsJanuary 2015
Continuing Review Report
To renew approval for ongoing 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 ndsu.irb@ndsu.edu 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 non-exempt studies.

QUESTIONS? Contact Kristy Shirley at 701.231.8995 or ndsu.irb@ndsu.edu.

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Last Updated: Friday, April 26, 2019 10:38:41 AM
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