Protocol Modifications

IRB Review Process | External IRB Review Process | Consent Process | Protocol Modifications | Reportable Events | Human Subject Educational Training Requirement | IRB Submission | IRB Submission Deadline

How do I request a change/addition to key personnel?

To change/add key personnel to the protocol, submit a signed Application for Change of Key Personnel. In addition, submit certification of CITI and conflict of interest form (for Expedited and Full Board studies) for EACH added key personnel. Protocol revision is not necessary except in the case of a change in the Principal Investigator.


What is the review process for protocol modifications of already IRB-approved study?

Review of protocol modifications can be conducted in two different ways: Expedited or Full Board.

Federal regulations allow for “expedited” review of minor changes in previously IRB approved research. Under expedited procedures, the IRB chair, or one or more experienced IRB members designated by the chair carry out the review. To qualify for this type of review process, protocol modification(s) must be deemed by the IRB chair to be no more than minimal risk or does NOT increase the current risk level of the study. Non-substantial modifications (e.g. revise PI contact number) usually fall under this type of review. However, if the list of modifications becomes extensive or complex, regardless of initial minimal risk determination, the IRB chair may consider it necessary for a Full Board review.

Protocol modification(s) or amendment(s) that are greater than minimal risk or add/remove a component which can increase subject risk are brought to a convened board for review. The IRB chair and OReC staff make this initial risk assessment and determination to bring the protocol amendment to full board review. Previously IRB-approved Expedited category study (minimal risk) can also be subject to Full Board review if a protocol modification or amendment increases risk. Some examples of Full Board amendments may include, but are not limited to: an addition of a study arm, randomizing subjects, surveying children about sensitive questions, withdrawing medication, or increasing drug dosage.

Principal Investigators must keep in mind that ALL protocol modifications must be reviewed and approved by the IRB before implementation.

For more information on protocol modifications, please visit “Protocol Amendments” link found in this website.



How do I submit protocol modifications after IRB approval?

Send in a signed memorandum by the Principal Investigator briefly explaining and listing the modifications/amendment you want to incorporate to the protocol. The memo must include protocol name and IRB number. With the memorandum, attach “track changes” of the appropriate documents (protocol synopsis, informed consent, recruitment email, etc.) reflecting those modifications/amendment being requested. In addition, include a clean version of the modified documents.

“Track changes” can be accessed in MS word 2003 by going under “Tools” and select “Track Changes”. You may also want to display the track changes toolbar by going to “View” and “Toolbars”. Once you have printed out the track changes version, you may “Accept All Changes” to print out a clean version. For those with MS word 2007, you may go under the “Review” ribbon and click “Track changes”.

For more information on protocol modifications, please visit “Protocol Amendments” link found in this website.


Do modifications to an already approved Exempt category protocol need to be reported to the IRB?

Yes…Exempt category research means that it is “exempt” from Full Board review but not necessarily from OReC or IRB review. Protocol modification(s) must be reported to the OReC as certain changes can increase risk to subject or change the type of review (Expedited or Full Board). To report a change in Exempt category research, the principal investigator needs to submit a signed memo describing the intended modification. Often times, minor changes only require a note to file and OReC acknowledgement with no IRB board action. However, if the OReC Executive Director and staff assess modifications to increase risk to subject or compromise eligibility criteria for Exempt category, the study is given to the IRB chair for review. The principal investigator may be asked to provide additional information for proper IRB review.


This page was last modified on June 10, 2015