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Institutional Review Board (IRB)

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IRB Forms

 

For guidance on the process of IRB review:

Steps to Approval of Your Research: PowerPoint or pdf

Contact the IRB Office: 231-8995, or 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.

Exemption certification

pAllow at least 5 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

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 10 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

Expedited Review Categories attachment

Participant informed consent template and instructions

New 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

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.

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

Participant informed consent template and instructions

New 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.

Other Attachments:

Children in Research Attachment

Prisoners in Research Attachment

Informed Consent Waiver or Alteration Request

Additional Materials Attachment

PHI and 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)

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

Qualtiy Assurance Checklist form (for QA audits of research and IRB records)

Audit Checklist form (for directed audits of research and IRB records)

 

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