IRB Forms
 

Announcements!

Guidance on the IRB Review process is available!
Steps to Approval of Your Research: PowerPoint or pdf, or you may contact the IRB Office: Kristy at 231-8995, or Teri at 231-8908, or ndsu.irb@ndsu.edu.

Please note: The IRB has final authority in determining the appropriate level of review. In making this determination, it may err on the side of caution to require a higher level of review to ensure protection of subjects and compliance with federal regulations.

Exempt Status
 

Allow at least 7–9 working days after submission of a complete application; requests for additional information or revisions are not uncommon. Projects may not be initiated prior to receiving a formal notice of final approval from the IRB office.

IRB Protocol Form: Exempt Categories

Participant informed consent/info sheet template and instructions—additional examples are available on the Resources Page

Protocol Submission Checklist (optional)—The IRB Office uses this document to screen exempt status protocols. May also be used to ensure your protocol submission has all of the required details.

Expedited Review
 

Allow at least 12 working days (excludes weekends and holidays) after submission of a complete application; requests for additional information or revisions are not uncommon. Projects may not be initiated prior to receiving a formal notice of final approval from the IRB office.

IRB Protocol Form

Expedited Review Categories attachment

Participant informed consent template and instructions for Social/Behavioral Research—additional examples are available on the Resources Page

Participant informed consent template and instructions for Biomedical Research or research involving physical risks

Protocol Submission Checklist (optional)—This form is used to review your submission. To ensure more efficient processing, this may be used to ensure the IRB office receives all of the necessary information.

Full Board Review
 

Projects must be received two weeks prior to the meeting date. Requests for additional information or revisions are not uncommon; sometimes approval will require review over several meetings. Projects may not be initiated prior to receiving a formal notice of final approval from the IRB office.

IRB Protocol Form—This form is the same as for expedited review.

Participant informed consent template and instructions for Social/Behavioral Research—additional examples are available on the Resources Page

Participant informed consent template and instructions for Biomedical Research or research involving physical risks

Protocol Submission Checklist (optional)—This form is used by the IRB Office to review your submission. To ensure more efficient processing, this may be used to ensure the IRB office receives all of the necessary information.

Other Attachments and Forms

Informed Consent Waiver or Alteration Request

Children in Research Attachment

Additional Materials Attachment

Use of Drugs and Biological Products

Investigational Use of Medical Devices

Prisoners in Research Attachment

Collaborative and Off-Site Worksheet

  • Individual Investigator's Agreement—for collaborative projects with institutions that do not maintain a FederalWide Assurance, this agreement should be signed by each non-NDSU person engaged in research (for expedited and full board projects)
  • Template letter of cooperation from collaborating entity—this letter should come from each collaborating institution outlining their role in the research and agreeing to abide by the approved NDSU IRB protocol (for exempt, expedited or full board projects).

Request for IRB Pre-screening of Sponsored Project—for pre-review of grant awards

Planned Emergency Research

Permission/Assent Templates and Instructions

Parent(s) or Guardian(s) Permission Form template

Child Assent Form (7–12 yrs) template

Youth Assent Form (13–17 yrs) template

Post-Approval Forms

Protocol Amendment Request Form—to make a change to a previously approved protocol

Continuing Review or Completion Report Form—to renew approval for ongoing projects (Full Board or Expedited project), or to report completion of projects—(Full board, expedited or exempt projects)

Exempt Recertification Form—to renew certification of exempt projects that will continue past the 3-year expiration date

Report of Unanticipated Problem or Serious Adverse Event—to report a problem involving risks to participants or others

Quality Assurance Checklist form—for QA audits of research and IRB records

Audit Checklist form—for directed audits of research and IRB records

Last updated: January 11, 2014 4:59 PM


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