Definitions of key terms from the Code of Federal Regulations:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge. Activities that meet this definition constitute research for the purposes of this policy, 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.
It is generally accepted practice that the above is interpreted comprehensively to include as research any project in which any part of the project is to be a contribution to “generalized knowledge” and/or its results are intended to probably be made public in some way, such as in a presentation at a conference or other professional meeting or if a model is designed that will be distributed to other organizations, or if the data or strategies could be utilized in some way by another institution.
Factors to be considered:
- Is the activity a systematic investigation designed to develop or contribute to generalized knowledge?
- Does research involve obtaining information about living individuals?
- Does the research involve intervention or interaction with the individuals?
- Is the information individually identifiable?
- Is the information private? (The designation of private would include behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place or which the individual can reasonably expect will not be made public.)
Human subjects are individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under Federal regulations, human subjects are defined as living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
Other Key Terms
Intervention includes both physical procedures by which data are gathered (for example, drawing blood) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between the 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. This can include information that 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). Data is considered identifiable if the identity of the subject is associated with the information or may readily be ascertained by the investigator.