520. Project Amendments: Overview of Requirements
Updated Oct. 4, 2019
Amendments for Non-exempt Research
Amendments (modifications) for approved, non-exempt human research require prior approval by one of the following review processes (see below for exception* to requirement for prior approval):
- Full Committee or Expedited Review by the IRB or
- Administrative Review by RI 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 ( see IRB policy for reporting problems to the IRB).
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;
- 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 DHHS categories of research eligible for expedited review; or
- Substantive amendments to research initially approved by expedited procedures when the new activities may increase participant risk or decrease research benefits.
Amendments Eligible for Expedited Review
Minor amendments to research approved by Full Committee Review may be eligible for Expedited Review if the amendments meet the criteria for expedited review per the DHHS categories of research eligible for expedited review and 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 editor 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:
- changes to research personnel (not the PI) and
- 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 the RI.
Amendments to Projects Previously Determined to Be Not Human Subjects Research
University and affiliate investigators considering substantive changes to projects that were previously determined to not constitute human subject research are encouraged to discuss the proposed changes with the RI by calling 775.327.2368.
Amendments to Exempt Research
Minor Changes to Exempt Research
Minor changes to exempt research do not require review or approval.
Substantive Changes to Exempt Research
Investigators are advised to consult with senior RI staff (775.327.2368) before implementing substantive changes to study procedures for exempt research; or changes that may alter exempt status, increase participant risk, or result in the involvement of children or prisoners.
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 the RI.
The Review Type may change from exempt to expedited review with assignation of an expedited review category. Senior RI 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.
The following considerations apply:
- If the PI receives federal funding less than one year into the three-year approval period, the IRB will review the amendment, and provide written documentation to the PI with an expedited review category and new expiration date that will be 364 days from date the exempt research was initially approved.
- If the PI receives federal funding after the first year of a three-year approval period, the IRB will review the amendment, and provide written documentation to the PI with an expedited review category and a request to submit a request for expedited continuing review within 10 days.
NOTE: The additional review under expedited procedures will result in new approval and expiration dates that will affect subsequent continuing reviews.