This page is provided to research investigators as a guide to the process of submitting a UCF IRB application.

All Human Research conducted by UCF faculty, staff, and students must be reviewed by the IRB and approved for compliance with regulatory and ethical requirements before it may be undertaken (unless the IRB determines that the activity is exempt from IRB review). “Human Research” is defined as any activity that either a) is “Research” as defined by DHHS and involves “Human Subjects” as defined by DHHS or b) is “Research” as defined by FDA and involves “Human Subjects” as defined by FDA. These terms are further defined below:

Human Subject as Defined by DHHS: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through Intervention or Interaction with the individual, or (2) information that is both Private Information and Identifiable Information. For the purpose of this definition:

  • Intervention means physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
  • Interaction mean communication or interpersonal contact between investigator and subject.
  • Private Information means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
  • Identifiable Information means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

Human Subject as Defined by FDA: An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used.

Investigator: The person responsible for the conduct of the Human Research at one or more sites. If the Human Research” is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Research as Defined by DHHS: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Research as Defined by FDA: Any experiment that involves a test article and one or more human subjects, and that meets any one of the following:

  • Must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice;
  • Must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR
  • Any activity the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.

Human Research activities may include a wide variety of procedures such as, but not limited to surveys, interviews and focus groups to the collection of biological samples and clinical trials (visit the FDA website a www.fda.gov for more information).  Virtual reality simulation research and program evaluation research are also reviewed by the IRB.  Depending on the degree of personal identifying information involved, research utilizing secondary data, i.e. databases, may also require IRB review and approval when human subjects are involved.

Contact the IRB Office with any questions about whether your activity meets the definition of Human Research subject to IRB oversight. For additional guidance, see the IRB Office’s “Human Research Determination” checklist on the IRB Policies and Procedures page.