Human Subjects Regulation

Human Subjects Definitions

• Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research whether they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities (45 CFR 46.102)(d)).
  
  
• Pilot studies and other preliminary studies e.g. convening a focus group to help researchers develop a questionnaire or pilot testing a questionnaire fall under the definition of research.

  The human subject definition is triggered if the information and biospecimens are obtained through intervention or interaction with the living individual, regardless of whether the information or biospecimen has identifiers attached (for example, anonymous surveys or collections of samples using a swab).

  A Human Subject is a "living individual about whom an investigator (whether professional or student) conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

Any research involving human subjects should be reviewed if it is: 1) sponsored by the University, 2) conducted by or under the direction of any University employee in connection with his or her university responsibilities, 3) conducted on or with University property, or 4) involves the use of the University's nonpublic information to identify or contact subjects or prospective subjects. Note that the IRB does not require review of student projects conducted in the context of course work.

The IRB must review and approve human subjects research:

• Before any work is started.
• Ongoing research at least annually (expedited and full studies only).
• All changes to research protocols before implementation (except when necessary to eliminate any immediate hazards to subjects or others).

Instructions on how to start a protocol on Cayuse

First Step: Request an account by completing the access request form. Please note that this step is only required for Students. Faculty already have access to the Human Ethics module.

Second Step: Once you are logged into the Cayuse account, start a new protocol application and begin responding to the initial questions and drafting your protocol. The Cayuse system will tailor the required sections based on your responses. Please remember to upload PDF documents rather than hyperlinks, include a letter of support if any portion of the work is conducted outside Florida Institute of Technology, and attach the informed consent form. Submission occurs in two stages: first, the Principal Investigator (PI) must submit and certify the protocol; thereafter, the Co‑Principal Investigator (Co‑PI) must also certify the protocol before it advances to organizational approval. Job aid: Protocol Submission. 

Third Step: After the PI and Co‑PI certify the protocol, the Department Head and Dean will conduct an organizational‑level review and approve the study. This is known as securing organizational approval (org approval). Please note that this step replaces the DocuSign routing used in the older IRB submission process and does not constitute approval by the Institutional Review Board (IRB). Job Aid: Org Approval.

After Organizational Approval, the protocol proceeds to the Institutional Review Board (IRB) for regulatory determination and review. Based on the level of risk and the nature of the research activities, the IRB may classify the submission into one of the following categories:

 • Not Human Subjects Research (NHSR) — The project does not meet the federal definition of human subjects research under 45 CFR 46.Subpart A. In such cases, IRB oversight is not required, although documentation of the determination is maintained for institutional records.

 • Exempt Review — The research involves no more than minimal risk and fits within one or more of the federally defined exemption categories. Although termed “exempt,” these studies still require a formal IRB determination prior to initiation.

 • Expedited Review — The research presents no more than minimal risk and falls within the federally designated expedited review categories. Review is conducted by the IRB Chair or a designated experienced reviewer rather than the full board. 

• Full Board Review — The research involves more than minimal risk, includes vulnerable populations requiring additional protections, or does not qualify for exempt or expedited pathways. These protocols are reviewed at a convened IRB meeting with a quorum present.

The timeline for the review process varies depending on the nature of the submission. The IRB may return the protocol to the Principal Investigator (PI) for clarification or revisions, or it may issue an approval. If you have any questions, please contact cayuse@fit.edu or fit_irb@fit.edu 

When the protocol has been approved, the PI and Co‑PI will receive an email notification confirming the approval of their submission. An official approval letter will also be available for download in Cayuse. Job aid: Approval Letter.

Modifications may be submitted for any previously approved protocol. The review process for a modification follows the same procedures as a new submission. Job aid: Request Modification. 

Additional Resources: Cayuse Academy. Create an account using your FIT email address to access instructional videos and training materials on the platform.