To meet the definition of research with human subjects, one or both of the following must be true:

1. You are conducting a pilot study, a preliminary study, or other preliminary research.
2. You have designed a study to collect information in a systematic way with the intention of contributing to a field of knowledge.  (This does not mean that your study needs to be replicable, but rather that you intend to develop or contribute to a field of knowledge in a manner consistent with your discipline.)

And you must be:

1. Interacting with living human beings in order to gather data about them, using methods such as interviews, focus groups, questionnaires, and participant observation, or
2. Conducting interventions with living human beings such as experiments and manipulations of subjects or subjects' environments, or
3. Observing or recording private behavior (behavior that individuals have a reasonable expectation will not be observed and recorded), or
4. Obtaining private identifiable information that has been collected about or provided by individuals, such as a school record or identifiable information collected by another researcher or organization.

To meet the definition of research with human subjects, you must be conducting research AND obtain information from human subjects in the research.  For example, if you receive data with no identifiers from a colleague who interviewed subjects, you are not conducing research with human subjects. You have a research question, but you have no human subjects in your study because you are not interacting with living individuals or collecting identifiable data from or about them.  (Your colleague did conduct research with human subjects, but you are not.)

Other Examples of Studies That May Not Meet the Definition

• Analysis of de-identified data

• Expert consultation
  Key words in the definition of a human subject are "a living individual about whom" a researcher obtains information. Some interactions with people for the purpose of collecting information do not any collect information about that person.  For example, a researcher may contact a non-governmental organization to ask about its sources of funding.

• Program evaluations and quality improvement studies
  Not every study is designed to contribute to a field of knowledge. For example, if data are being collected to improve a program within an institution and will be used only for that purpose, the collection of that information would not constitute research with human subjects.

• Classroom research
  In classes teaching research methods such as field work, statistical analysis, or interview techniques, students may be assigned to conduct interviews, distribute questionnaires, or engage in participant observation. If the purpose of these activities is solely pedagogical and they are not designed to contribute to a body of knowledge, the activities do not meet the definition of research with human subjects.