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 required||For 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|
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:
- 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
|Forms||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||For research involving minor participants||February 2019|
|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||For 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 Devices||For research utilizing an FDA-regulated 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|
|Information Sheet for Exempt Quantitative Studies||August 2012|
|Information Sheet for Exempt Qualitative Interview||June 2015|
|Information Sheet for Benign Behavioral Interventions||Effective 1/29/2019|
|2018 Informed Consent Template for Non-Exempt Research||November 2017|
|Parent/Guardian Permission Template for Non-Exempt Research||November 2017|
|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|
|Sample Certificate of Translation||November 2015|
|Form||When to use||Updated|
|Add, Delete or Change Personnel Form||When adding or changing research team member, principal or co-investigators||January 2015|
|Continuing Review Report||To renew approval for ongoing project, or to report completion of a protocol.||October 2017|
|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.||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 Event||To report a problem involving risks to participants or others.||May 2013|
PIs may submit applications and required supplemental materials electronically via email. Electronic submissions must be sent to firstname.lastname@example.org 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 email@example.com.