Human Subject Research
What is Human Subject Research?
A “human subject” is defined as a living individual about whom an investigator conducting research obtains (a) Data (of any kind) through intervention or interaction with the individual, or (b) Private identifiable information, even in the absence of intervention or interaction with the individual.
“Research,” in this context, is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
The Department must approve any Human Subject Research that involves Department employees or persons being served by the Department or by one or more of its contractors, whose relevance to the research is based on his or her connection with the Department or who is otherwise within the Department’s area of responsibility and authority.
Please visit each of the links below to understand your federal and state responsibilities regarding conducting a human subject research study.
If your query or project does not meet the definition of Human Subject Research listed above, please visit each of the links below for current Department sources of publicly accessible data:
Historical Human Subject Research
We encourage you to click here to browse historical research projects.
Once you have reviewed the federal and state human subject research requirements and have perused the historical human subject research for similar or same research questions, if you still wish to propose a Human Subjects Research project to the Department, please complete the following documentation:
- A completed Proposed Research Project Summary;
- A signed Individual Investigator Agreement;
- Your Institutional Review Board (IRB) application; and
- Your Institutional Review Board (IRB) approval letter.
The above documents can be sent via email to the Human Protections Administrator or by mail to:
Human Protections Administrator
1317 Winewood Boulevard
Building 1, Floor 3
Tallahassee, Florida 32399-0700
The Human Protections Administrator will make a determination if your proposal meets the definition of a Human Subjects Research project, and reserves the right to not approve a research proposal even if the proposal is granted Institutional Review Board (IRB) approval.
Once all of the documents are received, your proposal will be reviewed by a Human Protections Review Committee. Committee meetings are scheduled monthly. All applications received by the 15th of each month will be reviewed by the Committee at the following monthly committee meeting. All applications received after the 15th of the month will be reviewed the month following. You may be contacted by a Committee representative if the Committee has any questions regarding your application or your proposed project. You will receive a letter advising you whether your research was approved or disapproved.
Helpful Hints on Human Subjects Research Proposals
- It is your responsibility to obtain a complete and signed Data Sharing Agreement (DSA) if required by your proposal.
- Please verify that the dates of IRB approval are consistent with the dates of your proposed project.
- Please notify the Human Protections Administrator if you wish to withdraw your research proposal.