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Information for Medical Students in the FSU College of Medicine

Generally, submission of an IRB application for advance IRB review and approval is required of any College of Medicine (COM) medical student-led activity that may, for a research purpose, involve individuals as respondents or study participants when the activity will include (1) interaction or intervention with individuals to collect their information or biospecimens, or (2) collection or use of individuals' information or biospecimens (e.g., secondary use of previously collected information, even when students will have no interaction or intervention with the individuals). An exception may be made for COM medical student activities conducted solely for purposes of their clerkships; use the "Exceptions" panel below to learn more. In all other cases, COM medical student-led activities may not begin until completion of review and approval or clearance by the FSU Office for Human Subjects Protection (OHSP) and/or Institutional Review Board (IRB); refer to the Submission Requirements panel below.

This page is intended to provide FSU COM medical students with instructions, guidance, FAQs and links to templates and other resources for submitting their medical student-led activities for review. The image below depicts an algorithm about when a COM medical student-led activity may require review; click on the image for the complete algorithm, including explanatory notes and instructions.

Click on a panel below to learn more about submission requirements for COM medical student-led research, including exceptions for certain activities that may not require OHSP or IRB review, as well as to access other important information about student-led activities and research.

Any FSU COM medical student who plans to undertake activities that may involve individuals who may serve as respondents or study participants or about whom information or biospecimens may be collected or used is required, before initiating or beginning their activity, to have the study submitted for federal regulatory OHSP/IRB review using the FSU Research Administration and Management Portal (RAMP) Institution Review Board (IRB) module (RAMP IRB). Paper, email or telephonic submissions or requests for OHSP/IRB review are not accepted.

See our RAMP IRB video tutorials to see how to use RAMP IRB and navigate a study submission workspace. Tutorials last just a few minutes and include video captures of RAMP IRB workspaces.

To find out how long it MAY generally take to complete OHSP/IRB review of a student-led activity, refer to our student-led research FAQs, FAQ#9.

VERY IMPORTANT NOTICE TO ALL STUDENTS, including COM medical students: FSU dissertation, theses, graduation as well as study sponsor, journal publication, and conference presentation requirements may include the need to provide official documentation of OHSP/IRB approval or clearance (including documentation that further IRB review was not required). Approval or clearance is not granted retroactively (i.e., after or while you are conducting your study). Plan carefully, timely and accordingly so that you have this official documentation.

If for purposes of your COM clerkship or summer work (1) you will not be conducting research, or (2) you will only be involved as a study team member in a study that is under the direction of a non-FSU Principal Investigator (PI) or clinician, then your involvement would generally not require FSU IRB review.

Note however that for (2) above, your clerkship or summer work may be subject to the non-FSU institution IRB’s requirement for clearance or approval. In some cases (e.g., when the PI serves as FSU clerkship faculty and the PI's organization does not have an IRB), these non-FSU studies will be or may have already been approved by the FSU IRB. In either case, you must be listed as a study team member for the study and the IRB must have approved of your involvement in the study. If you have authoritative documentation or official communication indicating that the IRB has granted clearance or approval of the study or will other exercise review jurisdiction over the study—including your involvement as a member of the study team—then a FSU regulatory review or IRB review may not be required. Refer to footnote 4 by clicking on the algorithm above.

For additional information and instructions, return to our Student-led Activities and Research web page; once there, under the Need More Information? section, click on one or more of the panels to obtain more specific information such as a list of Frequently Asked Questions, other guidance, key tips for success, and links to other useful resources.

Office for Human Subjects Protection (OHSP)
2010 Levy Avenue, Bldg. B Suite 276 (FSU Innovation Park Campus)
Tallahassee FL, 32306-2742 (mailing) or 32310 (physical or courier)
Telephone: (850) 644-7900 (automated call answering with voice menu system allowing callers to be routed quickly and efficiently to needed points of contact)
Facsimile: (850) 644-4392
Email: humansubjects@fsu.edu

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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.

Questions? Click for FAQs!