520. Project Amendments: Overview of Requirements

Updated November 29, 2021

Amendments for Non-exempt Research

Amendments (modifications) for approved non-exempt human research require prior approval by one of the following review processes:

• Full Committee or Expedited Review by the IRB or
• Administrative Review by Research Integrity staff (personnel and site changes only).

An exception to the requirement for prior approval applies when an immediate change is necessary to eliminate apparent immediate hazards to research participants or others. Such changes must be reported to the IRB in accordance with the IRB policy for reporting problems in research.

Amendments include the premature completion of a study. These may be reported as amendments or closure requests.

• Requests to amend (or modify) an existing project are submitted as subsequent packages in IRBNet.
• Protocol amendments should be incorporated into the current applications/researcher forms and recruitment and consent materials (as appropriate) to ensure that there is an historical record for each project document.
• Review Types vary for minor and substantive amendments.

(See IRB Policy Manual Definitions for more information about modifications, minor and substantive.)

Amendments Requiring Full Committee Review

The following types of amendments to approved research require review by the convened IRB:

• Substantive amendments to research approved by Full Committee Review;
• Substantive amendments to Clinical Investigations;
• Sponsor-requested amendments to investigator brochure or clinical protocol that require substantive changes to study procedures or consent documents, or that suggest an increase in participant risk or decrease in research benefits;
• Data Safety Monitoring Board (DSMB)-requested amendments that require changes to study procedures or consent documents for safety reasons;
• Substantive amendments to research initially approved by expedited procedures when the new activities do not meet the criteria for expedited review per the Department of Health and Human Services (DHHS) categories of research eligible for expedited review; or
• Substantive amendments to research initially approved by expedited procedures when the activities may increase participant risk or decrease research benefits.

For review of modifications to previously approved research by a convened IRB all members (including alternate members) receive and review all modified documents. The IRB use the criteria to approve modifications to previously approved research when the modifications affect one or more criteria or determine that any significant new findings that arise from the review process and that might relate to participants’ willingness to continue participation are provided to participants.

Amendments Eligible for Expedited Review

Minor amendments to research approved by Full Committee Review may be eligible for Expedited Review if the changes neither increase risk nor decrease research benefits. Minor amendment is any change that does not materially increase the risks, nor materially decrease the benefits of the study, nor materially decrease scientific merit. Minor modifications include changes that are editorial or administrative, do not affect criteria for IRB approval and fall within the list of categories of research eligible for expedited review.

Amendments, minor or substantive, to research approved by Expedited Review are eligible for Expedited Review if the amended research continues to meet the criteria for expedited review per the DHHS categories of research eligible for expedited review.

Amendments Eligible for Administrative Review

Two types of minor amendments to research approved by Full Committee or Expedited Review are eligible for Administrative Review:

1. changes to research personnel other than the Principal Investigator (PI) and
2. addition or removal of study sites.

Amendments to Research Using an External IRB

Amendments to research using an external IRB are approved by the Reviewing IRB and do not require submission or notification to the University IRBs unless the changes substantively alter study procedures or the University PI’s role or increase participant risk. In such situations, the University PI is advised to consult with Research Integrity.

Amendments to Projects Previously Determined to Be Not Human Research

University and affiliate investigators considering substantive changes to projects that were previously determined to not constitute human research are encouraged to discuss the proposed changes with Research Integrity by calling 775.327.2368.

Amendments to Exempt Research

Changes to exempt research that may alter the exemption status, increase participant risk, result in the involvement of children or prisoners, or trigger additional IRB policy requirements (for example, requirements related to participant recruitment or informed consent) require Research Integrity review prior to implementation.

In limited instances, prior Research Integrity review may not be required for amendments to exempt research. Investigators are required to consult with senior Research Integrity staff before implementing minor or editorial changes to exempt studies to ensure the exemption status and the protocol documentation are appropriate and compliant with federal regulations and University policy.

Addition of Federal Funding to Exempt Research

The addition of federal funding to research approved under the University’s IRB Flexibility Policy as Flex-Exempt must be immediately reported to Research Integrity.

The Review Type may change from exempt to expedited review with assignation of an expedited review category and a progress report due date. Senior Research Integrity staff will consider the requirements and categories for review by expedited procedures and inform the PI if a new application or additional information is needed.