From the IRB Chair’s Desk: Summary of Changes Documents

Below, you’ll find information from the eIRB Helpdesk on how to prepare a Summary of Changes document. But before we get to that ‘How-To’, it’s important to talk about why the Institutional Review Board (IRB) needs a Summary of Changes document. There are several reasons for this, related to the following requirements placed on the IRB:

  1. Determine level of review.  Specifically, the IRB analyst must determine if the changes represent a ‘minor change in approved research’.  Why?  If the change is more than a ‘minor change’, then the submission must be reviewed by the full IRB.
  2. Identify any new risks.  Federal regulations set forth the criteria for IRB approval of research that apply to both initial review and continuing review.  The IRB must determine that among others, the following requirements are satisfied:
    1. Risks to subjects are minimized
    2. Risks to subjects are reasonable in relation to anticipated benefits, if any

A summary of changes document greatly facilitates putting the new information into perspective.

  1. In addition, the IRB must determine if there is any new and relevant information that would affect the subjects’ willingness to continue participating in the study.
  2. Ensure appropriate informed consent.  The IRB must ensure that the consent document includes accurate, up-to-date information about the study, including the requirement to include any reasonably foreseeable risks.

A Summary of Changes document is key to the IRB meeting these requirements, and doing so as quickly as possible, particularly if we need to get your submission to a meeting of the full IRB.

How to prepare a Summary of Changes document

The IRB requires detailed descriptions of proposed document revisions. For investigator’s brochures, this is usually a “summary of changes” document provided by a sponsor or coordinating center. In some cases, this document is not sufficiently detailed for IRB review.  If the summary states that “safety information has been updated,” for example, the IRB will request additional information to specifically describe what safety information has been updated and how it has been updated.

If the sponsor or coordinating center does not provide a “summary of changes” document or the document provided is insufficiently detailed, the research team must create and upload a detailed summary for IRB review. This is preferable to providing a document showing “tracked changes” because quite often the tracked document contains so many revisions it is difficult to parse out what has been changed and how.

In some cases, when changes are not complex, a “tracked changes” document will be acceptable.  In all cases, reviewers must be able to easily see exactly what changes are being proposed.

Steps to providing an adequate “Summary of Changes” document:

  1. Review the sponsor’s or coordinating center’s summary of changes.  Is it easy to tell exactly what changes are proposed?
  2. If not, prepare for your own information and for IRB review a new document titled “Summary of Changes” that describes the proposed changes in detail.
  3. If the changes are not complex, you may request a “tracked changes” version and upload this in place of a “Summary of Changes” document.