Human Subjects Regulation
Florida Tech is committed to full compliance with federal rules for the protection of human subjects in research. In accordance with federal regulations (45 CFR 46), all research involving human subjects must be reviewed, or determined exempt, by an institutional review board (IRB), to assure certain protections for human participants.
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 or not 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)).
- A Human Subject is a living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual or 2) identifiable private information (45 CFR 46.102(f)).
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).
- Download and fill out one of two protocol submission forms (Exempt or Expedited/Full), depending on the nature of the study. Obtain all required signatures.
- Prepare accompanying materials as appropriate. Email completed forms and required accompanying materials to FIT_IRB@fit.edu
- Allow 1-2 weeks for Exempt review and 2-3 weeks for Expedited/Full review.
Which Form to Choose
- The Expedited/Full Protocol Submission Form should be submitted if there is more than minimal risk associated with the research (none of the exempt conditions below apply) or if the research utilizes a special population (children, prisoners, institutionalized individuals etc.).
- The Exempt IRB Submission Form should be submitted if there is little to no risk to human subjects and one or more of the conditions below apply.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- Research on regular and special education instruction strategies, or
- Research on the effectiveness of or the comparison among instruction techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior unless:
- The subjects can be identified, directly or through identifiers linked to the subjects and
- Any disclosure of subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
Note: This exemption does not apply to survey procedures or interviews involving minors.
- Research involving the use of educational tests, survey or interview procedures, or observation of public behavior if:
- The subjects are elected or appointed public officials or candidates for public office or
- The confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, or specimens if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, indirectly or through identifiers linked to the subjects.
- Research and demonstration projects that are conducted by or subject to the approval of Department or Agency heads and that are designed to study, evaluate, or otherwise examine:
- Public benefit or service programs,
- Procedures for obtaining benefits or services under those programs,
- Possible changes in or alternatives to those programs or procedures, or
- Possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies if:
- Wholesome foods without additives are consumed or
- Food is consumed that contains food ingredients found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.