Human Research Review at FSU
Depicted below is the general process for the submission and review of human research, involving 5 major steps. For steps involving OHSP and the IRB, a range of days to complete each review step (Pre-, IRB and Post-IRB) is provided; these are averages based upon current performance metrics for all human research studies regardless of study risk, scope or population. Days in review for each study will differ. Ranges within each step of review are inclusive of prior steps. Brief descriptions of these steps are provided below the General Review Requirements section.
*range of days is not provided as the time needed for this step is at the study team's discretion
General Review Requirements
For ANY study through which FSU employees (faculty or staff), students* or agents may plan to obtain information or biospecimens from or about individuals, human research regulatory review and approval is required BEFORE study activities may begin. Federal law does not permit retroactive reviews. Advance review and approval is required for new studies as well as modifications to previously approved studies, and continuing studies. To secure approval, prepare a submission in RAMP IRB. Study submissions are generally handled in order of receipt. Below is a brief description of the submission and review steps:
Pre-Submission: Study team creates and prepares a RAMP IRB submission for a new, modified or continuing study. Student-led studies undergo faculty advisor review. When submitted, the study enters the IRB queue.
Pre-Review: Submissions are evaluated by OHSP staff for readiness for IRB review; incomplete submissions are returned to the study team for correction (requests for clarification). Submissions deemed complete are assigned to the IRB for review in one of three pathways depending upon the nature, scope and risks of the research. These review pathways are determined by federal law. As a quick guidance, refer to this IRB risk-based review pathway guidance.
IRB Review: Using federal regulatory criteria, the IRB performs its ethical and regulatory review of submissions. Submissions that do not meet criteria are returned to the study team for correction (requests for clarification).
Post-Review: OHSP staff follow up on the IRB's determination; this may include preparing letters of IRB approval, requests to the study team for modifications to the study in order to secure IRB approval, or letters of disapproval or deferral of review. Deferred studies will be scheduled for subsequent IRB review.
Approved: The IRB's approval letter is sent; the study may begin.
*If you are a student planning to lead a study, refer to our Student-led Activities and Research page for customized guidance.
To learn more about the human research review process, including a description of the different IRB review pathways for new or initial study submissions, other types of reviews, and IRB performance and productivity metrics, click on one of the panels below. For information about single IRB (or "sIRB") review, visit our Single IRB (sIRB) Review page.
Need to contact OHSP? Click on the panel below.
Contact information for the IRB and OHSP are in the panel above. The garnet ribbon below is information for the FSU Office of Research or FSU generally, and does not include any information for the IRB or OHSP.