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For an overview of the FSU College of Medicine Human Subjects Review Process, see this Fact Sheet.

  • Who needs to follow the procedures outlined in these policies?
    These policies apply to all College of Medicine-affiliated human subjects research and cover the following individuals:
    • All College of Medicine Faculty, including faculty with additional affiliations outside of the College of Medicine
    • Regional Campus Deans
    • Clerkship/Community Faculty at all regional campuses or rural sites
    • Faculty mentors for M1, M2, M3, M4 and Bridge students
    • M1, M2, M3, M4 and Bridge students
    • Residency Program Directors
    • Residents or Faculty affiliated with any FSU residency program
    • Fellows of Faculty affiliated with any FSU fellowship program
    • FSU CoM Post-docs and Fellows
    • Staff
  • What qualifies as Human Subjects Research?
    Generally, three critical questions provide the federal regulatory framework for determination as to whether a project or activity constitutes human subjects research:
  1. Does the activity meet the definition of research by being a systematic investigation that is designed to contribute to generalizable knowledge?
  2. Will the activity involve gathering information or data about living individuals that is private and individually identifiable?
  3. Will the investigator (faculty, professional staff or student) obtain the information or data through intervention or interaction with living individuals?

Ultimately, the Institutional Review Boards (IRBs) providing oversight for your study determine what qualifies as human subjects research based on federal regulations. Consult all the IRBs involved in your research to determine if your study needs to be submitted for their review and approval. 

  • Are medical case reports considered human subjects research?
    Generally, medical case reports are human subjects research and will need to be submitted for RAC review UNLESS the report:
    • describes medical observations or innovative treatment rather than being presented as a systematic investigation intended to contribute to generalizable knowledge,
    • is associated with three or fewer patients who are being treated by the physician preparing the report,
    • does not analyze data or test a hypothesis.
  • Who can serve as a project Lead Investigator?
    The designation of “Lead Investigator” refers to the FSU CoM individual who is primarily responsible for the research project on behalf of the College of Medicine, whether the study is being conducted only at the College of Medicine, or is a collaborative project involving other FSU departments or outside institutions. The Lead Investigator may or may not be the Principal Investigator for the study. The following College of Medicine personnel can be Lead Investigators:
    • All College of Medicine Faculty
    • Regional Campus Deans
    • Clerkship/Community Faculty at any regional campus or rural site
    • Faculty mentors for M1, M2, M3, M4 and Bridge students
    • FSU Residency Program Directors
    • FSU Fellowship Program Directors
    • Residents or Faculty affiliated with any FSU Residency Program
    • Fellows or Faculty affiliated with any FSU Fellowship Program
    • FSU CoM Post-docs
    • Staff
  • Can a student be a Lead Investigator?
    No, students cannot serve as Lead Investigators. Students must identify a Faculty Mentor who will serve as the Lead Investigator. Students will be listed on the application as “Key Personnel”.
  • I am a resident at an FSU-affiliated residency program, but my project comes under the regulatory jurisdiction of a hospital that has its own Institutional Review Board. Do I need to submit my research proposal to the Research Advisory Committee?
    Yes. All CoM investigators must submit their research proposals to the Research Advisory Committee, regardless of the location where you will conduct the research, or the facility IRBs providing regulatory oversight.
  • I am not affiliated with the FSU College of Medicine, but will be collaborating with personnel from the College of Medicine. Do I need to submit my research proposal to the Research Advisory Committee?
    Yes. Before College of Medicine personnel, students, residents, facilities or resources can be committed to a research project, Research Advisory Committee review must occur. The College of Medicine collaborator will conduct the Research Advisory Committee submission process as the CoM Lead Investigator. Your name and project role will be included in the proposal application.