IRB Guidelines - Amendments/Revisions to a Protocol

All revisions/changes in a project previously approved by the UMass Amherst Human Subjects Institutional Review Board (IRB) must be received and approved by the IRB before they are initiated except where necessary to eliminate apparent immediate hazard to the subject. Requests for approval of revisions/changes may be submitted at any time by an investigator.

"Major" revision requests for protocols that were approved by full IRB review must be reviewed through the full committee review process. Major revisions to protocols initially reviewed by the expedited review process may receive expedited review. However, depending on the nature of the revisions the reviewer may recommend review by the full committee. Examples of revisions considered to be major include, but are not limited to, escalation in the drug(s)/dosages; the introduction of additional drug(s); the addition of a new invasive procedure. Major revisions may impact on the risk/benefit ratio in the study. It is the investigator's responsibility to assess the degree of change in the risk/benefit ratio.

"Minor" revision  requests are reviewed administratively. If during this review it is determined that the revision  is not minor the investigator will be contacted with instructions on how to proceed. A revision  is approved only to the expiration date that was received at the protocol's most recent review.

SUBMISSION REQUIREMENTS

For eProtocol Submissions

  • From the main screen, look for the protocol you wish to revise under Approved Protocols. If you do not see your protocol, click on the circle to the right of Approved Protocols.
  • Click on the protocol number that you wish to revise.
  • A window will open with several options.
  • Click the circle beside Start Revision .
  • The protocol will open for you to edit. The first item you will see is the Revision Form. Answer questions 1-3. Go to the appropriate sections of the protocol and make your revisions. Sections that have been modified will be indicated to the IRB. You will only see the latest text on your screen. However, for IRB members the changes will automatically be highlighted, and the original text will be available.
  • Once your changes have been made, check that all information has been entered by clicking on Check for Completeness in the menu on the left. When you are ready to submit your revision, click on Submit Form in the menu on the left.
  • Once the revision is submitted, the protocol will appear in two places within your account. The originally approved protocol will appear under Approved Protocols . The revision will appear with the same protocol ID on the main page of your account, with the Protocol Event as Submitted .
  • All future correspondence regarding the revision application will have the original protocol ID number, followed by [Revision].
  • Once the revision has been reviewed by the IRB, you will receive an email stating the decision of the IRB. If changes need to be made to the protocol, you will need to login to e-Protocol and open the appropriate protocol for editing, by clicking on the item listed for that protocol under Protocol Event . Within this protocol you will find comments from the reviewers and/or the IRB staff. You must make all recommended changes and re-submit the protocol.
     
  • When the revision has been approved by the IRB, you will receive an email stating so. You may not begin any part of the research project until you have received such notification.

Further Information

For further information and/or clarification regarding revisions of a protocol please call the Human Protection Administrator at 545-3428. All completed application materials should be sent to the:

Human Research Protection Office (HRPO)
108 Research Administration Building
70 Butterfield Terrace
University Of Massachusetts
Amherst, MA 01003-9242

Phone: (413) 545-3428
FAX: (413) 577-1728
Email: humansubjects@ora.umass.edu