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Proposal Amendments

Many minor proposal amendments may be submitted by email and approved by the expedited review process.  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.

Minor substantive changes can also be approved by the expedited process,provided that they meet the criteria for 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 Chair with the new questions highlighted.  The IRB Chair would likely respond in a timely manner that the amended survey is approved.

When a proposal is resubmitted for annual continuing review, all previously approved amendments should be incorporated into a revised proposal.

Amendments must be made and approved in writing, usually by email.

If proposal amendments are substantial, the IRB Chair may determine that the entire proposal needs to be revised and resubmitted for either full or expedited review.

The IRB Chair reports in writing all amendments approved using the expedited review process on the monthly Expedited Report to the full board at its next regular meeting.