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, 2016, all modification requests must be submitted through IRBNet using the instructions provided on the Modification Request job aid. Any pertinent supporting documents (such as new instruments or informed consent documents) should be sent as well.
Please also note that only the PI has the authority to submit modification requests.
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, 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 Exempt or 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, modification requests for significant changes must be reviewed by the IRB Executive Committee and are subject to the same submission deadlines as new protocols.
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.