I received a question from a researcher this week asking whether or not eliciting grammatical judgments for syntactic research required IRB review. IRB review is only required for projects that are “research” (which this collecting elicitations is) and that include “human subjects’ defined in U.S. federal research regulations. Here is the definition of human subject:
“45CFR46.102 (f) Human subject means 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) Identifiable private information.
Intervention includes both 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 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 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). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”
Based on this, would you conclude that eliciting grammatical judgments constitutes “human subjects” research? If no, how would you convince your IRB that this type of research does not need review? And then, how about collecting speech samples for phonetic analysis?