How do I submit an Amendment to a Research Project?

Protocol Amendments | Can it be modified after IRB approval | How to Submit | How will I know it has been approved | Who receives the IRB Board Action Notices

Please submit all protocols to the Office of Research Compliance located in CBH Suite 160 during business hours (8 am – 5 pm).

NOTE: Protocols in which the Principal Investigator (PI) and research members are considered John Peter Smith Health Network (JPS) personnel MUST be initially submitted to the Office of Clinical Research (OCR) located at 1500 S. Main Street, Fort Worth. For additional assistance, please contact the JPS Office of Clinical Research at 817-702-3655.

 

Full Board Amendment:

Note that investigators must submit the appropriate amount of hard-copies for proper IRB review. No E-versions of research-related documents will be accepted.

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

(2) THREE (3) Copies of the following:

  • Signed Memo
  • Track changes version of the modified research documents (i.e. informed consent, protocol synopsis, etc.) reflecting proposed amendment

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

Minor Modifications to Protocol (not Full Board Amendment):

For modifications involving no more than minimal risk

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

(2) One (1) copy of the following:

  • Track changes version of the modified research documents (i.e. informed consent, protocol synopsis, etc.) reflecting proposed modifications/amendment

(3) A CLEAN Copy of the modified research document(s) reflecting proposed modifications/ amendment (This copy will later be 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. 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). This often is a faster level of review and can be processed within approximately 1-7 business days depending on the clarity as well as completeness of information provided.

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 page was last modified on December 22, 2017