Create a Modification

Modifications to Previously Approved Research

After obtaining initial approval from the Institutional Review Board (IRB) for a study, any subsequent alterations to the study procedures, personnel, recruitment materials, or consent form are categorized as modifications, necessitating submission to the IRB for review. It is your responsibility to ensure that all modifications are promptly submitted to the IRB. Any adjustments in study procedures or personnel must undergo IRB review and approval before implementation. The modification application serves as the platform for proposing these changes. Initiating a modification reopens your previously approved IRB application for editing, enabling you to amend, remove, or append information within the application and its attachments.

Investigators are required to submit proposed changes to IRB-approved or exempt certified studies prior to implementing any changes. The Modification Submission electronic form in Cayuse Human Ethics is used to propose changes to an existing study.

The only exception to this requirement is when a change is necessary to eliminate apparent immediate hazards to subjects. In such a case, a Modification Submission should be submitted promptly following its implementation and so that the change can be reviewed by the IRB/ORC to determine that it is consistent with ensuring the subjects’ continued welfare. In such instances, immediate contact with an IRB Chair or Research Compliance Manager is advised to address the safety concerns effectively. Please call (817) 257-5070 or email Research@tcu.edu.

The Texas Christian University Institutional Review Board (TCU IRB) Chair and/or IRB Chair’s designee(s) is responsible for reviewing and determining whether the proposed changes are minor or substantive in nature. This determination will dictate the level of review required. When a change is substantive – that is, it increases risks to subjects beyond minimal risk, or is a significant change in the study design – the change may need to be reviewed by the full IRB. Otherwise, minor changes of administrative nature can be submitted and approved by the IRB Chair’s designee.

What are considered changes that need review?

The regulations and TCU IRB policies require that anything outside of typographical errors or reordering of questions be reviewed and approved by the IRB/ORC as a modification. This includes, but is not limited to, the addition of study team members, changes to study procedures or instruments (questionnaires, consent documents, recruitment materials, etc.), changes to subject populations or study locations, changes in recruitment/consenting procedures, changes in funding support, etc.

Creating a Modification Submission

• Log in to Cayuse Human Ethics
• From the Product drop-down menu, select Human Ethics

 

 

 

• Find your study on the dashboard in “Approved Studies” and select it.
• In the top right corner select the “+ New Submission” button.
• Choose “Modification.”
  • If “Modification” is not shown as an option, contact ORC
• Select the “Complete Submission” link and follow the instructions to fill out the submission.
• When completing the submission:
  • Use language that could be understood by a layperson. Avoid jargon, and when unavoidable provide explanations.
  • Be sure the descriptions of human subjects research activities are consistent with the information provided in any related grant or contract applications.
• When the submission is complete, follow the instructions for submitting.
• The PI and the Co-I (if applicable) will be sent emails with instructions for certifying the submission in Cayuse. Once all certifications are entered, the submission will be routed to ORC.
• Once ORC has received the submission, you will receive an acknowledgment email.