Get Request For Modification - Auburn University

This guide provides a comprehensive approach to completing the Request For Modification form for Auburn University. Designed to assist individuals navigating the protocol modification process, it delivers clear, step-by-step instructions for each section of the form.

Follow the steps to complete your Request For Modification.

1. Press the ‘Get Form’ button to obtain the Request For Modification form and open it in an online editor.
2. Enter the protocol number in the designated field. This number is essential for identifying your original submission.
3. Fill in the IRB approval dates, specifying the start date and end date of your current approval period.
4. Provide the project title in the space provided. Ensure it accurately reflects your study for clarity.
5. Complete the section for the principal investigator by including their name, title, signature, and contact details, including mailing address and both AU and alternate email addresses. Ensure the information is up-to-date.
6. Identify the current external funding agency, if any, associated with the research project.
7. List any contractors, sub-contractors, or additional entities related to your project, ensuring that all involved parties are accounted for.
8. Briefly enumerate the activities that have occurred thus far, particularly those involving participants, in either a numbered or bulleted format.
9. Clearly describe the requested changes to your research protocol, providing a rationale for each modification. Attach additional pages if necessary.
10. Indicate whether there are changes in key research personnel and, if so, provide the names and explanations for each change. Make sure to attach CITI proof of completion for all new personnel.
11. Identify any changes in the anticipated risks and/or benefits to participants, making sure to explain the implications.
12. Note any modifications in safeguards or precautions to address these anticipated risks.
13. Attach any supporting documentation required for IRB evaluation, such as approvals or renewals from other agencies or IRBs.
14. If research involves sites beyond Auburn University, include a letter from the site or program director acknowledging acceptance of proposed changes.
15. Attach copies of all currently used IRB-approved materials (e.g., consent forms, information letters).
16. Provide a new copy of consent documents that include updated information regarding the requested changes.
17. When all sections are complete, save your changes, and prepare to submit your form as a hard copy with necessary signatures to the Office of Human Subjects Research.

Complete your Request For Modification online now for a smoother submission process.