Requirements for Human Research

Federal regulations, FSU policy and other laws require OHSP and/or IRB review of all human research conducted by any FSU employee or agent (e.g., faculty, staff, students, contractors, volunteers). Researchers conducting human research are required to submit their studies for review using the FSU Research Administration and Management Portal (RAMP) Institution Review Board (IRB) module (RAMP IRB). For an explanation of the human research review process click on the Human Research Review tab on the left or this link.

Studies involving non-FSU institutions may require those institutions' IRB or other research reviews. Contact those institutions to obtain authoritative information about their own review requirements, and plan accordingly. For clinical collaborations with non-FSU partners, click here for more information. 

About the FSU Institutional Review Board (IRB)

The FSU IRB is a committee composed of scientists, non-scientists (e.g., professionals as well as laypersons) as well as unaffiliated (non-FSU) members that review proposed research involving human subjects to ensure the protection of their rights and welfare. The FSU IRB has authority to approve, require modifications in (to secure approval), or disapprove all research activities covered federal law and FSU policy. Research that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by FSU officials; however, these officials may not approve the research if it has not been approved by the IRB. The FSU IRB is registered with the U.S. government to conduct its reviews, and is a participating institution in SmartIRB, a consortium to both standardize reviews and reduce unnecessary duplicate reviews in studies involving multiple institutions.

Assurance and Jurisdiction of the IRB

FSU’s Assurance with the federal government (an agreement under which as a condition of receiving federal funds and support for human research FSU agrees to abide by the terms of the Assurance, with all applicable laws, and The Belmont Report) and FSU policy 7-IRB-0 require that all human research conducted by any FSU employee or agent be reviewed by the OHSP and/or IRB, regardless of funding source or sponsorship.

As a reference only, refer to this engagement guidance and the HRP-311 Worksheet Engagement Determination form in RAMP IRB, under the IRB, Library and Worksheets tabs, also available here, to see how the OHSP and IRB may determine, based upon an FSU employee or agents' involvement in research, whether the research is subject to FSU's Assurance and FSU Policy 7-IRB-0 and requires certification of IRB review and approval. Regardless of whether FSU is engaged in research for purposes of IRB certification, FSU researchers (e.g., faculty, staff, students, contractors or volunteers) conducting human research are required to submit their studies for review using the FSU Research Administration and Management Portal (RAMP) Institution Review Board (IRB) module (RAMP IRB).

About the Office for Human Subjects Protection (OHSP)

The Office for Human Subjects Protection, under the University's Office of Research, supports the IRB and maintains all human research regulatory records; provides human research protection subject matter expertise and related consultations; conducts pre-IRB reviews and regulatory reviews of research that do not require IRB oversight as well as post-approval monitoring activities; and generally carries out human research-related authorities, responsibilities and functions in accordance with applicable law and FSU policy.