Trees

Institutional Review Board

Modifications to Approved IRB Proposals

Changes to your original approved IRB proposal must first be discussed with your principal investigator. Modification applications must be submitted for all proposed modifications/changes to exempt and currently approved research protocols. The IRB must approve the modification(s) before you can begin, or resume your research study.

Examples of modifications include but are not limited to: research data collection methods, consent forms, assent form, permission forms, verbal scripts, advertisements, changes in testing instruments, change in risk level, change in participant population, investigators, etc.

What if my research is exempt and with the modifications it will still be exempt ?
Even if your research is exempt, you must notify the IRB as the IRB is responsible for the final determination of whether the research continues to be exempt, or if the category has changed due to the modification.

If you need to make changes to your approved IRB research proposal, the first step is to review the changes with the principal investigator (your faculty research advisor). Fill out the Research Modification FormPDF and submit it to the principal investigator who will submit it to the chair of the IRB, Dr. Kim Tolley, ktolley@ndnu.edu. Exempt modifications will be reviewed by the chair of the IRB or designee within five business days.

What if the modifications change my research from exempt to expedited or full review?
If your original research protocol was exempt, and with the modifications is determined to be non-exempt, you will need to complete the Research Modification FormPDF and submit a new IRB proposal under the expedited or full category (please see non-exempt guidelines).

What if my research was approved as expedited or full review and I want to modify my original proposal?

If you would like to make modifications to your approved expedited or non-exempt IRB Proposal, first review the changes with your principal investigator (your faculty research advisor). Complete the Research Modification FormPDF and submit it to the principal investigator, who will submit it to the chair of the IRB, Dr. Kim Tolley, ktolley@ndnu.edu. Modifications will be reviewed by the chair of the IRB or designee within five business days.

Include a copy of your approved IRB proposal, highlighting the content that you would like to change, and label it “CURRENT IRB.” Next, add the new pages with the proposed modifications; highlight the new proposed changes and label it “PROPOSED CHANGES.” You can also use the “track changes” feature to show the proposed changes (if it is easy to follow).

Sign the proposal form and also have your principal investigator (PI) sign it. If the proposal was expedited and the research will continue to be expedited, the PI may submit it to the chair of the IRB for expedited review. Either the chair, or the chair’s designee, will review the proposal. If there is any question about the proposal and the chair or designee will not approve it as expedited, the proposal will be submitted for review by the full IRB committee at the next committee meeting (see IRB dates).

Modifications to an approved expedited review that change the category to full review will be submitted for review by the full IRB committee at the next committee meeting (see IRB dates).

Modifications to proposals that were approved as full review will be submitted for review by the full IRB committee at the next committee meeting (see IRB dates).

Submit modification forms and accompanying material to the chair of the IRB, Dr. Kim Tolley, ktolley@ndnu.edu.