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Institutional Review Board (IRB)

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IRB Forms

IRB Forms are updated periodically; please use the current version for your application. If you are unsure of the appropriate review category, guidance can be found on the exemption protocol form (ie, screening questions and category descriptions), as well as the Expedited categories attachment. Projects not eligible for either exemption or expedited review are reviewed by the full board. Contact the IRB Office if you need assistance or have questions: 231-8908, or 231-8995, 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.

Exemption certification

pAllow at least 5 working days for a response once submitted; 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.

Exemption Protocol Form

Participant informed consent/info sheet and instructions

NEW Participant informed consent/info sheet template and instructions

New Protocol Submission Checklist (optional)

Expedited review

Allow at least 10 working days for a response once submitted; 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.

Protocol Form

Participant informed consent form and instructions

NEW Participant informed consent template and instructions

Expedited categories attachment

New Protocol Submission Checklist (optional)

Full board review

Allow at least 15 working days if submitted by the due date listed on the meeting schedule. 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.

Protocol Form (this form is the same as for expedited review)

Participant informed consent form and instructions

NEW Participant informed consent template and instructions

New Protocol Submission Checklist (optional)

Other Attachments:

Children in Research Attachment

Prisoners in Research Attachment

Informed Consent Waiver or Alteration Request

Additional Materials Attachment

NEW HIPAA Attachment

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, or to report completion of projects - full board or expedited categories)

Unanticipated Event Report Form (to report a problem involving risks to participants or others)

 

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