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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

For more information on the submission process, please see the Submission Instructions (below), the Frequently Asked Questions (FAQs), or review the Steps to Approval of Your Research (PowerPoint or PDF).

 

Form When to use Updated
IRB Protocol Form:  Exempt Categories For human subjects research expected to fall into one of the six categories of Exemptions. July 2014
IRB Protocol Form For human subjects research requiring expedited or full board review. October 2016

IRB Application:  Research Involving Existing Records/Data/Specimens

For studies utilizing existing data/records/specimens OR data/records/specimens which will be collected solely for non-research purposes October 2016
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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REVISED COMMON RULE - NEW Forms for use in 2018

Form When to use Effective Date
IRB Protocol Application for Exemption:  Primary Research
For primary research which falls into Exemption category 1, 2, 3, 5, or 6. 1/19/2018
IRB Protocol Application:  Secondary Research for Which Consent is not required
For secondary research use of identifiable information or specimens which falls into Exemption Category 4, or Expedited Category 5. 1/19/2018

Informed Consent Waiver, Alteration or Exception Request

To request a waiver or alteration of informed consent, or to request an exception to consent for screening or recruitment procedures. 1/19/2018

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 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 2013
Investigational Use of Medical DevicesFor FDA-regulated research investigating a 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 **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 ongoing projects for which continuing review is no longer required after 1/19/2018.  Protocols eligible for expedited review or protocols reviewed via full board procedures which are now open only for long term follow up or data analysis require an update every three (3) years.Effective January 19, 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 studies requiring expedited or full review.

Hard copy submissions are also accepted. These must be signed by the PI, co-investigator(s), and department chair, dean, or director and either deliver to:

Research 1
1735 NDSU Research Park Drive
Fargo, ND 58102

or mail to:

NDSU Human Research Protection Program
Dept. 4000, PO Box 6050
Fargo, ND 58108-6050

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

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RCA
Phone: 701.231.8045
Physical/delivery address:  1735 NDSU Research Park Drive/Fargo, ND 58102
Mailing address:  P.O. Box 6050—Dept. 4000/Fargo, ND 58108-6050
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Last Updated: Monday, November 20, 2017 11:20:46 AM
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