Additional Requirement – 31: Research Definition

A means of systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The purpose of research is to generate or contribute to generalizable knowledge.

Once an activity is classified as research, three additional determinations must be made:

1. Is the activity research involving human participants?
2. If the activity is nonexempt research involving human participants, which institutions are engaged in research and are required to certify IRB approval?
3. If the activity is research involving human participants, does the research meet the criteria for exemption from 45 CFR part 46?

Source: Distinguishing Public Health Research and Public Health Non-research Policy, http://aops-mas-iis.cdc.gov/Policy/Doc/policy557.pdf.