Amendment: This refers to a modification of a currently IRB-approved protocol. Any changes to an IRB-approved protocol (Exempt, Expedited, or Full Board) must be submitted to and approved by the IRB prior to implementation.
Once an IRB package is accepted, Principal Investigators (PIs) cannot make any changes to any official IRB-approved documents. For instance, if a PI wishes to modify recruitment procedures or any other aspect of an approved IRB protocol, an Amendment must be submitted. Any deviation from the approved research protocol must be reviewed by the IRB before implementation.
If the proposed revisions significantly alter the protocol, the IRB may request the submission of a new protocol application. Please contact the IRB Office with any questions.
Note: IRB Liaison review and signature are NOT required for amendment submissions
Submit an Amendment
When is an amendment needed?
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.
Important Points Regarding Amendment(s):
(1) Federal Regulations require that all revisions be approved by the IRB prior to their implementation.
(2) Amendments that increase the risk of research participation must be approved by the fully convened IRB committee.
(3) If the proposed revisions heavily modify the protocol, the IRB may request that a new protocol application be submitted. Contact the IRB Office if you have questions.
Risk Classification:
The protocol application presents minimal risk or greater than minimal risk
(1) Minimal Risk is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of a routine physical or psychological examinations or tests” [45 CFR 46.102(i)].
(2) Greater than Minimal Risk is defined as research that does not meet the above definition.
Approval 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. For example, if the protocol expires on 6/14/24 and the Amendment Request is approved on 2/10/24, the Amendment Approval Letter will reflect the following approval period: 2/10/24– 6/14/24.
Amendment During Continuing Review
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 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.
Amendments must be submitted when changes are being made – even if your protocol does not require submission of a Continuing Review. This is a UMD Policy and Federal Regulatory requirement.
Revised Documents
If revised versions of documents (consent documents, flyers, etc) previously approved by the IRB are submitted with changes, please note this in the footer of the document. For example: Revised-3/10/21. This helps maintain a proper protocol review history.
What to submit
To submit an amendment to an IRB-approved IRB Protocol, you must create a new version of the IRB Protocol and complete the Amendment Application that will open in the new version. The Amendment Application is a section within the IRB Protocol in which you can describe the changes and their purpose.
Guide to Submitting an IRB Protocol Amendment
Scribe: How to Submit an Amendment on Kuali IRB
Please note:
- If amending Consent Forms, 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.
Contact the IRB
Institutional Review Board ∙ irb@umd.edu ∙ 301-405-4212 ∙ 1204 Marie Mount Hall ∙ Hours: 8:30 AM – 4:30 PM