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IRB Support Through the Lifecycle of a Study

IRB support services provide consultation at different stages of human subjects research. From preparing an initial submission through conducting, maintaining, and closing an approved study. Consultation is available to help research teams understand requirements, prepare IRB materials, and address questions that arise during the conduct of a study.

IRB Consult Overview

Pre-Submission Consultation

IRB Submission Form

Pre-Submission Consultation provides support to student and faculty investigators as they prepare for IRB review and navigate the submission process. Consultation may include assistance with initial IRB applications, modifications, continuing reviews, submission questions and revisions, RAMP IRB, and other administrative requirements.

Services:

  • Consultation - Comprehensive support in one or more sessions to prepare for and navigate the IRB submission process, including initial submissions, modifications, continuing reviews, clarification requests, and other submission-related questions.
  • Study Document Review - comprehensive document review which may include protocol and consent forms
  • One-time Meeting - 1:1 zoom meeting to discuss questions you may have regarding policies and regulations, the pre-submission process, or your study
  • Education Session - training sessions or workshops for faculty, students, and other university research constituents (provided during normal working hours

Common pre-submission requests:

  • “I am a first-time researcher needing assistance with using RAMP IRB.”
  • “I am developing a survey and am unsure what to submit to the IRB.”
  • “I am developing a funded study and need support navigating applicable documents and regulations.”
  • “I need help preparing a modification or continuing review submission.”
  • “I received questions about my submission and need help determining how to respond.”

Post-Approval Consultation

Research Files Binder

Post-Approval Consultation provides support to student and faculty investigators and research teams as they conduct IRB-approved research and navigate ongoing study requirements. Consultation may include assistance with study documentation, protocol and consent adherence, monitoring preparation, post-approval review activities, corrective or improvement efforts, and questions that arise during study conduct.

Services:

  • Consultation – Support in one or more sessions to address questions about conducting an IRB-approved study, maintaining compliance, or navigating post-approval requirements.
  • Study Documentation Review – Review of study documentation and records to help research teams assess organization, completeness, and alignment with IRB-approved requirements.
  • One-time Meeting – 1:1 Zoom meeting to discuss questions about study conduct, IRB requirements, compliance concerns, or other post-approval issues.
  • Education Session - training sessions or workshops for faculty, students, and other university research constituents (provided during normal working hours
  • Monitoring and Review Preparation – Support in preparing for post-approval monitoring, sponsor audits, review activities, or requests for study information.
  • Corrective and Improvement Support – Consultation to help research teams understand and address identified compliance concerns and develop strategies for improving study processes.

Common post-approval requests:

  • “I have questions about whether a change to my study needs to be submitted to the IRB.”
  • “I want to make sure my study documentation is complete and organized.”
  • “I am preparing for a monitoring review and would like help understanding what to expect.”
  • “I have identified a compliance concern and need help determining how to address it.”
  • “I have questions about whether our study procedures are consistent with the IRB-approved protocol or consent form.”

 


Ready to Connect with OHSP?

Use the booking page to select either Pre-Submission Consultation or Post-Approval Consultation, then schedule a time that works for you.

 

Schedule a Consultation

 

Questions about these services? Contact:

  • Pre-Submission Consultation: Marcia Forbes, Compliance Specialist, mforbes@fsu.edu
  • Post-Approval Consultation: Dr. Nicole Sage, Post-Approval Compliance Specialist, nsage@fsu.edu