Amendments and Modifications to a Research Project

IRBNet Announcement / Update

 

For existing (already IRB-approved) projects not yet in IRBNet: To assist in a smooth transition, ALL Modifications (Amendments) will continue as PAPER-BASED submissions (NOT through IRBNet) until those projects come up for Continuing Review (Progress Reports).


Protocol Amendments

Can it be modified after IRB approval

How to Submit

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 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. back to top

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 were reviewed and approved.  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.  And 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 (via the IRB Chair).  Some examples are: 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, 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.  Any change in a project approved as Exempt category must still be reviewed beforehand by North Texas Regional IRB. 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. As usual, contact North Texas Regional IRB personnel if you have any questions. back to top

How do I submit an Amendment to a Research Project?

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. back to top

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

Once a protocol Amendment has been reviewed and approved, a formal written notice of approval will be sent to the Principal Investigator.

As with other reviews, approval for modifications to a protocol are managed by Board Action Notices signed by the IRB Chair, 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), and are usually dispatched within 48 hrs of approval (whether approved by the IRB Chair alone, or by a convened Board).

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. back to top

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, in writing, other project personnel to receive copies of such notices or correspondence, and such designation should be sent directly to the IRB for inclusion in the protocol folder. However, the principal investigator is still fully responsible for acting on such correspondence from the North Texas Regional IRB. back to top

This page was last modified on September 24, 2018