According to the federal regulations (45 CFR 46 102.d),

Research means a systematic investigation (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge.

There are two significant points to consider:

1. What is a systematic investigation?
   Systematic investigations can usually be recognized by the fact that they have a question they are attempting to answer, or a hypothesis they are attempting to prove/disprove.
2. What is developing or contributing to generalizable knowledge?
   You are developing/contributing to generalizable knowledge if you intend on sharing the information you produce with others, be it within a classroom, at a poster presentation, at a conference, or in a publication.

Some examples of what is not research:

• Case reports - are not considered research in that although they contribute to generalizable knowledge, they are not systematic investigations. The clinician is simply sharing information about interesting cases for educational purposes.
  • Where people go wrong: if you attempt to answer a question, or prove/disprove a hypothesis, you are no longer dealing with a case report and instead are now dealing with research. In addition, case reports are usually limited to no more than a few patients. Once you start to exceed three subjects it appears that you are doing something systematic (attempting to prove a point or answer a question) and IRB approval is required.
    
    
• Quality Assurance - is not considered research in that although it is a systematic investigation, there is no intent to share the information with others (contribute to generalizable knowledge). For example, the pharmacy can conduct quality assurance and compare the use of a medication PO vs IV administration and not require IRB approval provided they do not publish the results. The results of QA can only be published if IRB approval is obtained prior to publication.
  • Where people go wrong: if you know you are likely to publish your work provided the results are worthwhile, then the project does not meet QA guidelines and should be submitted as research prior to initiation. To meet quality assurance criteria there must be no intent to publish at the onset of your investigation.