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Guidelines for Defining Systematic Investigation and Generalizable Knowledge

The definition of research as defined by the Department of Health and Human Services (DHHS) regulations: “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” 45 CFR 46.102 (d)

To be considered a “systematic investigation”, the concept of a research project must meet all of the following:

  • Attempt to answer research questions (in some research, this would be a hypothesis).
  • Is methodologically driven, that is, it collects data or information in an organized and consistent way. 
  • The data or information is analyzed in some way, be it quantitative or qualitative data.
  • Conclusions are drawn from the results.

“Generalizable Knowledge” would include one or more of the following concepts:

  • The knowledge contributes to a theoretical framework of an established body of knowledge.
  • The primary beneficiaries of the research are other researchers, scholars and practitioners in the field of study.
  • Publication, presentation or other distribution of the results is intended to inform the field of study.
  • The results are expected to be generalized to a larger population beyond the site of data collection.
  • The results are intended to be replicated in other settings.
  • Web based publication for professional purposes.