Federal regulations require that proposed changes in a protocol may not be initiated prior to IRB review and approval except in very limited circumstances. As of January 31, 2018, all modification requests must be submitted through Cayuse IRB. Do not create a new study for a modification. Open the appropriate study (including Legacy studies) and then choose Modification from the New Submission drop down. Complete the Modification Form and certify it as you would a new study submission. Any pertinent supporting documents (such as new instruments or informed consent documents) should be attached to the submission as well.
Minor modifications that do not change the overall nature of the approved research protocol and do not subject the participants to additional risk may be reviewed and approved by a member of the REC staff who has been authorized to do so by the Chair.
Examples of minor modifications might include: expanding the subject pool size (due to a low initial participation rate), changing a data collection form to make it easier for subjects to read, changes in personnel other than the PI for Expedited or Full Review studies, or adding an additional field site similar to those already being used. REC staff may also choose to refer minor modifications to the IRB Chair for review on a case-by-case basis.
Significant changes may include, but are not limited to, changes in the objective of the study as originally submitted and approved by the IRB, changes which increase risk to the subjects such as those resulting in greater discomfort or in a greater degree of invasive-ness, and a change in PI.
The IRB Chair is authorized to approve modifications for protocols originally designated as Expedited Review, provided that the proposed changes do not increase the risks to participants thereby triggering a higher level or review. For protocols originally designated as Full Board Review, the IRB Chair is authorized to approve minor modifications, but modification requests for significant changes must be reviewed by the IRB Executive Committee and are subject to the same submission deadlines as new studies.
As with an initial review, the requested modification may be approved, withheld pending minor revisions, or denied. If approved, the revised protocol will carry the same approval period as the original approval unless a continuation has also been requested by the PI (see the prior section for continuation review procedures).
If the modification request is denied, the originally approved research may still continue for the approval period.