How Do the Federal Regulations Define Research?

 

“A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”

 

Let's Break This Down...

 

A systematic investigation involves a methodical procedure and plan, is theoretically grounded, and specifies a focused and well-defined research problem or question, is informed by the empirical findings of others, is analytically robust, and provides a detailed and complete description of data collection methods.

Generalizable knowledge is information that is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:

  • Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
  • Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.
  • Note that publication or other dissemination of findings does not in and of itself make the activity “research”. It has been a long-standing myth that if you publish, IRB review is required.
What isn't generalizable?
  • A quality assurance/quality improvement/organizational effectiveness study where the intent is to assess, improve, or develop programs or services for an organization. Outcomes will remain specific to the organization, programs or services, although other organizations may use the results for their own programs.
  • An oral history or journalistic piece. These are published materials that are limited to only documenting or reporting on events, situations, policies, institutions, or systems without the intent to form hypotheses, draw conclusions, or generalize findings. It will not involve stories that will or may draw broad conclusions about the population, cultures, norms, and practices.
  • A note about class/educational “research” activities – Class projects and research methods classes may involve data collection activities for training purposes that do not require IRB review and oversight because the intent is to teach methods, not to contribute to generalizable knowledge. The intent of other class projects may be to provide the student with real world experiences, information gathering techniques, and report writing. However, when the primary focus and initial intent of the class activities are to collect data to be used by students or other researchers beyond the classroom thereby contributing to “generalizable knowledge,” IRB review may be needed.
  • A note about student internships – Students within many departments or schools of the University are involved in internships or practica. Some student practica/internships may include research activities that are designed to contribute to generalizable knowledge and, thus, involve research that requires IRB review.
  • It should be noted that even though a research activity may not qualify as "regulated research" now, this does not mean that you may not use these data for future "regulated research" activities. The use of data that was initially collected for non-research purposes is known as “secondary use of data not initially collected for research”.