Requesting Approval of a Change in an Approved Study

Investigators must sometimes modify their study protocols as the project develops. In some cases, too, new collaborators may join the study staff, so that the list of personnel changes over time. In some cases, too, significant changes must be made to an investigation for both practical and scientific reasons.

All amendments to an approved study's protocol must be submitted by email and approved by the IRB. For example, if a faculty researcher adds several students to an ongoing research project, these students could be named in an email to the IRB Chair or to irb@richmond.edu After verifying that the students have completed CITI training, the IRB Chair will send the principal investigator an email stating that the amended list of co-investigators has been approved. (One exception to this policy: Changes to reduce risk or harm to participants should be made immediately and then communicated to the IRB.)

Minor changes can also be approved by this process, provided that they meet the criteria for limited or expedited review. The addition of several "minimal risk" questions to a survey, for example, would qualify for expedited review. In this case, the principal researcher would submit the revised survey to the IRB with the new questions highlighted for review.

• When a proposal is resubmitted for annual continuing review, all previously approved amendments should be incorporated into a revised proposal.
• Amendments must be requested and approved in writing only, via email.
• If proposal amendments are substantial, the IRB office may determine that the entire proposal needs to be revised and resubmitted for either full or expedited review (see below).
• The IRB Office reports all amendments approved through limited or expedited review to the convened IRB at at its regular meetings.
• If the proposal is near the required renewal date (one year from the previous IRB approval), the researcher should submit the proposal for renewal instead of amendment.

If a researcher is making substantial revisions to an approved proposal, investigators should contact the IRB office to discuss the need for a new submission. It is possible that the revisions will require reconsideration of the proposal, either by the expedited process or the full review process. Sometimes a change in the subject population will necessitate reconsideration of the proposal. For example, if a researcher decided to add minors to the subject population of an already-approved proposal, the proposal would require review by the convened IRB, even if the original proposal had been approved using the expedited process.

When submitting a revised proposal, the researcher should take care to update any sections of the proposal that are date sensitive. For example, recruiting materials or consent forms may have dates in them that need to be refreshed.