HHS regulations define research at 45 CFR 46.102(d) as follows:
“Research means a systematic investigation, including research development, testing & evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.”
- Is your project a “systematic investigation” that features a special plan (protocol) carried out with an identified group of participants?
- Are you thinking like a researcher with the idea that you will gather data (information, interviews, observations, etc.) in order to draw (generalizable) conclusions for presentation in some “public” context?
HHS regulations define human subject & related terms at 45 CFR 46.102(f) as follows:
“Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information."
Will you be inviting people to participate in your project for the purpose of gathering and analyzing data?
“Intervention includes both physical procedures by which data are gathered (for example, venipuncture) & manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator & subject."
Are you conducting special, deliberate or out of the ordinary activities with the people you are engaging in your study?
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, & information which has been provided for specific purposes by an individual & 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.”
- Are you eliciting information a person would not typically disclose publicly in the course of a normal day?
- Will that information be recorded (and shared) in such a way that an outside observer could link it back to that individual?
Note: "Healthcare” information might first come to mind, but other demographic (age, gender) or numeric data (address) count , too!