What is a "systematic investigation"?
The term systematic investigation is generally thought of as a predetermined method for answering certain questions or studying a specific program or topic.
Examples include: program evaluations, program assessments, interviews, surveys, focus groups, and comparisons of groups.
What is "generalizable knowledge"?
An activity may be thought to develop or contribute to generalizable knowledge if the information collected can be applied beyond a particular program.
The following are examples of activities that would not contribute to generalizable knowledge:
If a program evaluation, program assessment, or other activity is used only for:
- internal improvements to a program or service.
- quality assurance purposes (e.g., customer satisfaction surveys).
The following are examples of activities that would contribute to generalizable knowledge:
If a program evaluation, program assessment, demonstration project or other activity is:
- conducted to examine whether the program had the desired effect on program participants, and that evaluation can inform other programs.
- conducted with the intent to replicate the program.
- designed to draw general conclusions.
- designed to inform policymakers.
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for the purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 28 C.F. R § 46.102(d).
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.
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.
28 C.F. R. § 46.102(f).