AMENDMENTS AND MODIFICATIONS TO A RESEARCH PROJECT
At UNTHSC ALL research projects involving human subjects require a priori review by the Office for the Protection of Human Subjects (OPHS), and if required, by the 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?
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 be reviewed beforehand by OPHS staff.
This OPHS review is essential to determine if the change has altered the level of review and whether or not IRB review might be involved as a result of the modification. As usual, contact OPHS personnel if you have any questions.
How do I submit an Amendment to a Research Project?
Please submit all protocols to the Office for the Protection of Human Subjects located in CBH Suite 160 during business hours (8 am - 5 pm).
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 OPHS Director and staff to determine risk to subject. If the IRB Chairperson concurs with OPHS 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.
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 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 OPHS and/or the 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 OPHS and/or the IRB.