Amendments and Modifications to a Research Project

How do I submit an Amendment to a Research Project?

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

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) Twenty (20) 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 initially reviewed by OReC Executive Director and staff to determine risk to subject. If the IRB Chairperson concurs with OReC staff that the modifications are "minimal risk" to subject, it is then processed in an "expedited" manner. Under an expedited review process, the review may be carried out 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 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 last updated 08th Oct 2013