Amendments

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Requesting a change to your approved research project

An amendment to an existing approved Institutional Review Board (IRB) protocol is viewed as any change to what was previously approved during the period for which approval was given. Amendments are categorized as either major or minor and are distinguished based on the type of changes proposed.

If your protocol was previously approved via the expedited or full board review process, you must obtain IRB approval prior to implementing any changes. Exempt studies may not require additional approval, unless the amendment changes the study’s eligibility for exemption.

Learn more about amendments

Minor amendments to exempt protocols

Minor modifications to exempt studies do not generally need review by the Human Research Protection Program (HRPP). However, substantive modifications must be submitted to HRPP for review prior to implementation.

Here are some examples of minor amendments to exempt protocols that do not require HRPP review:

• Addition or removal of study personnel other than the principal investigator
• Minor revisions to recruitment materials and method such as a change to the phone number or the addition of a newspaper ad when using language similar to an already approved flyer
• Minor revisions to survey, interview, or focus group instruments that do not fall outside the scope of the original approved instruments such as wordsmithing, addition of clarifying questions, addition of very similar questions to those previously approved, or deletion of questions

Here are some examples of substantive amendments to exempt protocols that do require HRPP review:

• Change in principal investigator
• Change in funding source
• Change to study purpose or procedures such as adding a survey on a different topic than previously approved or collection of data falling outside the parameters of the data collection previously approved
• Changes to study population targeted for recruitment such as adding a new population or substantively revising the inclusion/exclusion criteria for the current population
• Changes to the identifiability of the research data you will receive or record. For example, your exempt application states that you will not collect names with the surveys, but you now want to, or you now want to record identifiable data from an existing dataset
• Changes to the risks involved in the study

To request review of a substantive modification, submit an amendment to the existing study in Kuali Protocols.

Major amendments to approved research

Major amendments to previously approved expedited and full board review projects receive the same level of review as the original project. A major change in a research protocol may involve increased risk or discomfort or decrease the potential benefit to the subjects.

Here are examples of major amendments requiring review:

• Increase in the amount of blood drawn
• Safety issues
• Extension of the study duration
• Multiple changes in the study design
• New software in devices
• Additional arm added to the study
• Additional population added to the study (including vulnerable populations)
• Increase in the medication dose
• Increase in infusion rate
• Increase in radiation exposure

Minor amendments to approved research

Minor amendments to previously approved research are reviewed using the expedited review procedure. To be considered a minor amendment, all of the following criteria must be met:

• Proposed change does not significantly alter the risk-to-benefit ratio
• Proposed change does not significantly affect the safety of subjects
• Proposed change does not involve the addition of invasive procedures (procedures not otherwise eligible for expedited review)
• Proposed change does not involve the addition of procedures, interactions, or inventions that add significant physical, social, or psychological risks
• Proposed change does not involve the addition of a vulnerable population in research initially reviewed by the full board and
• Proposed change does not significantly alter the hypotheses or research design in research initially reviewed by the full board

Here are examples of minor amendments requiring review:

• Decrease in the amount of blood drawn
• Title change
• Change in principal investigator
• Clarification of issues
• Addition of risks to the informed consent and other study documents at the IRB’s request
• Dose reduction
• Requested changes by the Radiation Safety Office
• Extended accrual period
• Addition of urine pregnancy test
• Addition of audio recording
• Addition of video recording

Standalone Investigator Brochure updates

Investigator Brochure (IB) updates which do not result in changes to other study documents (e.g. informed consent document, protocol) do not require submission to the IRB. IB updates which do not result in changes to other documents may be held by research staff and combined with a later amendment (minor or major) submission. If more immediate review is preferred by the study team or sponsor, the IRB will review standalone IBs as minor amendments if submitted in Kuali Protocols.

Filing an amendment in Kuali Protocols

To file an amendment to a previously approved research project, amend the study in Kuali Protocols:

• Complete the amendment form in Kuali Protocols
• Attach supporting documentation e.g., study forms, documents, or questionnaires affected by the amendment.
• Once you have uploaded your amendment in the Kuali Protocols system, you will be contacted by the HRPP if additional information is needed. When you receive approval, you may begin using the amended materials.

Instructions for creating an Amendment in Kuali Protocols can be found in the Kuali Protocols instructional guides.