When is IRB approval required?
IRB approval is required when conducting “research” with “human subjects”
Human Subject Definition
A human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research (a) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (b) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes
- Interaction includes communication or interpersonal contact between investigator and subject
- Private information includes 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
- Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- Identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Systematic investigation is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
- Generalizable knowledge relates to drawing general conclusions, informing policy, or generalizing findings beyond a single individual or an internal program (e.g., publications or presentations.)
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.
Scholarly and Journalistic Activities (as of January 21, 2019):
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) will not be considered as research, so long as the activity focuses directly on the specific individuals about whom the information is collected and used without extending that information to draw generalizations about other individuals or groups.
- Note: It is not the particular field that removes the activity from the definition of research, but rather that the purpose and design of the particular activity is to focus on specific individuals only.
Obtaining IRB Approval or IRB Exemption:
If your proposed project meets the definitions of “research” and “human subjects” then you will need to proceed with the steps outlined on the Obtaining IRB Approval web page.
Human Subject Research (HSR) Determination Process
If you are not sure if your proposed project meets the definitions of “research” and “human subjects” then you can submit the “IRB HSR Determination Form” to get an official written determination from the FIU Office of Research Integrity to find out if IRB approval is necessary for your study. In some cases, a funding agency or the FIU University Graduate School may also request for a written determination to be made (when it is not clear if IRB approval is necessary). The “IRB HSR Determination Form” can be accessed in the online TOPAZ Electronic Protocol Application System.