After IRB Approval

If you need to make a change to a study that has been approved, the Principal Investigator must submit an amendment application to the IRB. 

Any deviation from the approved research protocol must be reviewed by the IRB prior to implementation of those changes. This applies to Exempt, Expedited, and Full Board studies.

If the proposed revisions modify the protocol a great deal, the IRB may request that a new protocol application be submitted. Contact the IRB Office with any questions.

Examples of changes that warrant an amendment:

• Adding or removing study personnel 
• Adding or removing a research site
• Updating contact information on a flyer
• Changing wording on the previously approved consent form
• Revising the study procedures
• Revising the study title
• Changing the Principal Investigator
• Adding or removing a question in your survey/interview
• Adding translated versions of study documents (recruitment materials, consent forms)
• Adding Letters of Support/Approval from schools, research sites, or community partners

Please note that this is not an exhaustive list. If you are not sure whether a change requires an amendment, please reach out to the IRB Office.

Please note: For projects with expiration dates, the approval of an Amendment Request will not change the expiration date of the protocol. The expiration of IRB Approval will remain the same as determined at the previous Initial IRB Approval or Continuing Review. 

To submit an amendment, you will need to complete: a) the Amendment Application and b) prepare any materials that have been revised since the initial submission or any new materials that have yet to be approved by the IRB. Submit these materials to the IRB in a new package.

• If amending the Consent Form, please update the package number in the footer of the Consent Form to reflect the package number under which this Amendment will be submitted. 
• If new investigators/researchers will be added to the protocol and will be engaged in human subject research (HSR) activities (interaction with participants and/or identifiable data from participants), IRB Approval is required prior to these members engaging in any HSR activities. All HSR-engaged investigators/researchers must complete appropriate human subjects research training - CITI Basic Human Subjects Training. 
  • For UMD investigators/researchers, their CITI training should be linked to their User Profile and to the package in IRBNet (see the IRB Training page).
  • For external investigators (e.g. people who are not faculty, student, or staff at UMD), the PI may upload a copy of their CITI training (or equivalent) as a Supporting Document. 

Exempt Review: IRB protocols that have received an Exempt Determination after 2022 do not require Continuing Review.

Expedited Review: Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review. However, if it is deemed necessary, the IRB Member Reviewer may require a Continuing Review for a protocol undergoing Expedited review (up to one year approval).

Many protocols do not require continuing review. To determine if your project requires a continuing review, there will be an expiration date on the approval letter. If there is no expiration date, your project does not require continuing review. Instructions for locating the approval letter are available here.

Full Board Review: Protocols deemed greater than minimal risk and some deemed minimal risk but reviewed by the Full Board will be approved for up to one year. If you plan to continue obtaining data from human subjects or collecting or analyzing identifiable private information for your research project, a Continuing Review application must be reviewed and approved by the IRB prior to the Expiration Date. Please check the Full Board Review meeting dates that are posted on the IRB website to ensure the Continuing Review is submitted by the application deadline.

• Approximately 30-45 days before the expiration date
  • IRBNet will alert you when your project is near expiration. 
• If the application is submitted shortly before the expiration date, this does not guarantee the application will receive IRB Approval before the protocol expires.
• If the protocol does expire after a Continuing Review Application has been submitted, all research activities involving human subjects must cease until approval is granted. 
• If a Continuing Review Application is not received by the IRB prior to the Expiration Date, the protocol will expire and a new Initial Protocol Application must be submitted and approved in order to continue human subject research activities.

• To submit a Continuing Review Application, you will need to complete the appropriate Continuing Review Application. 
• Additionally, if the study will remain open to enrollment, please update the package number to the footer of the Consent Form to reflect the package number under which this Continuing Review will be submitted.
• Create a new package and submit the Continuing Review Application and the updated Consent Form with the new package number in the footer to the IRB (if applicable).

The IRB does not recommend submitting amendment requests during the continuing review process as this will increase the turnaround time for these applications. However, if the requested modifications are minor (for example: editorial or research staff changes) please make the changes to the appropriate section of the protocol and clearly identify the changes in the Continuing Review Application. In certain cases the IRB will make an exception to this policy, please contact the IRB with questions.