Amendments and Modifications to a Research Project

How (and When) will I know it has been approved

Who receives the IRB Board Action Notices

Protocol Amendments

ALL research projects involving human subjects, including modifications to those projects, require review by the North Texas Regional Institutional Review Board (IRB). Note that this review process may involve several stages or levels of review, depending on the various features of the research project and the potential risk to the subjects.

Can a Protocol be modified after IRB approval?

North Texas Regional IRB review and approval only applies to those specific project documents and procedures that received review and a determination/approval. Any change in any document or procedure must have IRB review and approval before that change can be implemented. The exception: when a change is immediately essential for the safety of subjects. However, even in those cases, the modification must still be reported as soon as possible afterwards to the IRB for a needed change in protocol and/or consent form.

Many modifications entail minimal risk adjustments to a protocol and/or consent form and can be made on an Expedited basis (approval via the IRB Chair) even for projects deemed to be Full Board Category of Review. Some examples include format changes, correcting spelling errors, adding key personnel, minor changes to questionnaires, recruiting ad changes, and so forth. Other, more substantive changes, especially those that may alter the risk-benefit ratio (e.g., additional eligibility criteria, changes to study medication dosage, additional intervention, etc.), may require Full Board review and approval. In all cases, except where noted above regarding subject safety, any changes to any protocol document or procedure must first be approved by the IRB before they can be implemented.

Note that these modification requirements also apply to EXEMPT category projects. North Texas Regional IRB must still review any change in a project approved as Exempt category beforehand. This review is essential to determine if the change has altered the level of review and whether or not further IRB review and surveillance might be needed as a result of the modification.

Similarly, researchers should consult with the North Texas Regional IRB regarding any major or significant modifications made to a Not Human Subject Determination, as the changes might alter said determination.

As usual, contact North Texas Regional IRB personnel if you have any questions.

How do I submit an Amendment to a Research Project?

Please submit all amendments/modifications to the NTR IRB within IRBNet.

NOTE: Principal Investigator (PI) and research members who are considered John Peter Smith Health Network (JPS) personnel should initially consult with the Office of Clinical Research (OCR) at 817-702-3655 prior to submission and for additional assistance.

Full Board Amendment:

Note that investigators must submit the appropriate documentation within IRBNet by the IRB Meeting submission deadline. You can find the IRB Meeting schedule by visiting the NTR IRB webpage titled, “IRB Review Schedule.”

(1) SIGNED original memo from the PI requesting protocol amendment. The memo should include the elements or modifications found within the proposed amendment (preferably, including the location of the change) and provide a brief justification for each change.

(2) Track changes (redline) version of the modified research documents (i.e. informed consent, protocol synopsis, etc.) reflecting proposed amendment. NOTE: Researchers should be using the most recent IRB approved version of the research documents when making changes.

(3) A CLEAN version the modified research document(s) reflecting proposed amendment. (This version will later be electronically stamped- “IRB Approved”).

NOTE: Protocol modifications, just as in a protocol review, are reviewed by the convened Board to determine risk to subject. Depending on the complexity of the amendment, the PI may be invited to the IRB meeting to discuss the amendment, and address any possible questions the Board may have regarding the changes.

Minor Modifications to Protocol (not Full Board Amendment):

For modifications involving no more than minimal risk, they can be requested at any time (no submission deadline to adhere) and must include the following items within the submission package:

(3) A CLEAN version the modified research document(s) reflecting proposed amendment. (This version will later be electronically stamped- “IRB Approved”).

NOTE: Protocol modifications, just as in a protocol review, are reviewed by the North Texas Regional IRB to determine risk to subject. If the IRB Chairperson (or designated Board member) finds the modifications are “minimal risk” to subject, it is then processed in an “expedited” manner. This applies to changes made to a Full Board project. Under an expedited review process, the final approval is granted by the IRB Chairperson (or by one or more experienced IRB members designated by the Chairperson).

Recall that even modifications deemed as “minimal risk” can be sent for Full Board Review if the protocol requires additional consideration and review as indicated by federal regulations, or if the IRB Chair finds it necessary for full Board review. This applies to projects deemed as Expedited Category of Review.

How (and When) Will I know that a Protocol Amendment has been Approved?

Once a protocol Amendment has been reviewed and approved, a formal notice of approval will be sent to the Principal Investigator/Research team through the NTR IRB electronic system (IRBNet).

As with other reviews, approval for modifications to a protocol are managed by Board Action Notices specifying the current terms and conditions for any changes to the protocol or documents associated with the research protocol. These notices are sent for all categories of projects (Exempt, Expedited and Full Board) through IRBNet.

Recall that a modification to a protocol cannot be implemented until after North Texas Regional IRB approval. Thus, investigators should build in sufficient time for review and approval before a change needs to be implemented.

Who receives these IRB Board Action Notices / Letters of Approval?

The Principal Investigator of record is responsible for all aspects of a research protocol involving human subjects, and is the person who will receive formal correspondence from the North Texas Regional IRB.

The Principal Investigator may designate within IRBNet other project personnel to receive IRB notifications or correspondence. However, the Principal Investigator is still fully responsible for acting on such correspondence from the North Texas Regional IRB.

This page was last modified on March 14, 2024