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.

Applications

New applications must be submitted and approved prior to conducting research. Depending on the specific details of the proposed research, supplemental forms/appendices, and/or approvals may be required. For more information on the submission process, please see the Submission Instructions (below), the 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. May 2014
Request for IRB Pre-Screening of Sponsored Project For “pre-approval” of funded projects where human subjects procedures are not yet finalized. July 2014

Supplemental Materials

Depending on the specific details of the proposed research, supplemental forms/appendices and/or approvals may be required. Failure to submit all required materials may delay review and/or approval. 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

Appendices

Form When to use Updated
Additional Materials Attachment When 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 Research When children will be included as subjects/ participants of the research May 2013
Individual Investigator Agreement For non-exempt research where NDSU is serving as the IRB of record, and the collaborating institution does not hold an FWA  
Expedited Categories Attachment To document the appropriate expedited category. April 2013
Informed Consent Waiver or Alteration Request When 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 Devices For FDA-regulated research investigating a Medical Device October 2010
Planned Emergency Research For research to be conducted in emergency settings October 2010
Prisoners in Research If some or all of the research participants are expected to be incarcerated May 2013

Templates

Template Updated
Information Sheet for Exempt Studies August 2012
Informed Consent Template for Social/Behavioral Research November 2012
Informed Consent Template for Biomedical Research (or research involving primarily physical risks) November 2012
Parent/Guardian Permission Template July 2014
Child Assent Template (7–12 years of age) June 2014
Youth Assent Template (13–17 years of age) April 2013
Template letter of cooperation from collaborating entity November 2011

Post-Approval Forms

Form When to use Updated
Continuing Review or Completion Report To renew approval for ongoing project, or to report completion of a protocol. May 2013
Exempt Recertification Form To renew certification of exempt projects that will continue past the three-year expiration. October 2013
Protocol Amendment Request To make a change to a previously approved protocol. May 2013
Report of Unanticipated Problem or Serious Adverse Event To report a problem involving risks to participants or others. May 2013

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 acceptable. 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? Please contact Kristy Shirley (701.231.8995) or Teri Grosz (701.231.8908) or ndsu.irb@ndsu.edu.

Last updated: September 11, 2014 8:05 PM


Student Focused. Land Grant. Research Institution.

Follow NDSU
  • Facebook
  • Twitter
  • RSS
  • Google Maps

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
Page manager: RCA