Amendments

Investigators are responsible for conducting human subjects research in accordance with all applicable
Federal and state regulations, and UofL IRB policies and procedures. During the conduct of the study, changes may become necessary.

If changes are required to a study, an amendment must be submitted for review utilizing the IRB Amendment Form in IRIS. The amendment and any required modifications to the protocol, consent or other study documentation are submitted at the same time.  The federal regulations specifically require the IRB to review proposed changes in a research activity, and to ensure that such changes in approved research are not initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject [45CFR46.103(b)(4)(iii) and 21CFR56.108(a)(4)]. Research activity includes all aspects of the conduct of the research study, e.g., recruitment methods, consent process, procedures used to protect privacy and confidentiality, etc.  Noncompliance with these regulations, or UofL IRB policies and procedures, during the conduct of a research study results in a protocol violation, and as such must be reported to the IRB by using the IRB Deviation/Violation/Misc. form.

If approved research is changed to eliminate an apparent immediate hazard(s) to the subject, the investigator is required to notify the IRB of the change(s) promptly (within five (5) business days). The IRB will review at the next convened meeting to determine if the change(s) instituted were consistent with the subject’s continued welfare.

Regulations permit the use of expedited procedures for review of minor changes to previously approved research during the period for which the approval is authorized. Modifications that alter the risk/benefit ratio are assigned to a primary reviewer and presented to the full committee at a convened meeting. Amendments submitted to the IRB, along with supporting correspondence, are entered into the IRIS system and stored in the study file.

Investigators are notified by e-mail and through the IRIS software of the decision of the IRB and of any changes required. Approval is not granted until all required changes have been made and submitted for review and approval. Once approved, the investigator is sent through the IRIS software an approval letter.  The IRB may only approve modifications through the current approval expiration period. Upon receipt of the approval for the amendment, the investigator may initiate the modification.

  • 1.1 of the amendment form: Please describe your amendment in lay language (what you type here will appear on your approval letter).  Example:Personnel Change: Addition of…….; Deletion of ………
  • Please list only the personnel that you will be adding or removing.  Do not add people who are already on the study. Changes in principal investigator qualify for expedited review of the proposal. When making this change in IRIS, the new PI must submit the amendment to make the change. Key study personnel (KSP) changes qualify for analyst review.
  • Attachments section –Please make sure to submit a clean and track changes copy of any revised documents. (Please be sure to update Waivers and/or Consents when you add or remove personnel). If the person you are adding needs to receive copies of all letters from the IRB, please add them as KSP and as Study contact.  If you want the person to have access to the documents, they must be added as KSP. The IRB will send all letters to the PI and all study contacts.
  • Please attach any other documents related to this amendment. Submit.
  • 1.1 of the amendment form: Please describe your amendment in lay language (what you type here will appear on your approval letter).
  • Sponsors request for temporary hold.
  • 1.1 of the amendment form: Please describe your amendment in lay language (what you type here will appear on your approval letter) – Example: Submission of Safety Report recently submitted to the FDA
  • Select External SAE, attach any necessary documents, submit.
  • 1.1 of the amendment form: Please describe your amendment in lay language (what you type here will appear on your approval letter). 
  • Submit a clean and tracked changes copy of the protocol
  • Submit any documents that need to be revised due to these protocol changes (example - Informed Consents, Partial Waivers) then submit this amendment.
  • 1.1 of the amendment form: Please describe your amendment in lay language (what you type here will appear on your approval letter).  Examples of “other”
    • Addition of other study documents
    • New recruitment flyer
      • Select Other, Attach any necessary documents, submit
  • 1.1 of the amendment form: Please describe your amendment in lay language (what you type here will appear on your approval letter).
  • Select Enrollment Closure, attach enrollment closure form, submit
  • 1.1 of the amendment form: Please describe your amendment in lay language (what you type here will appear on your approval letter) – Example: Submission of a revised Investigator’s Brochure
  • Select Safety Data/Risks Update, Attach any necessary documents, submit