Investigators engaged in human subject research are required to obtain either a Determination of Registration, Exempt Determination, or IRB approval before research activities begin. To determine if your project requires IRB review, you will need to first determine that your project meets both the federal definitions of research and human subjects.
Are you doing research?
Research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
Does the research involve human subjects?
The human subject is “a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
OR
- Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.
Tools to Help You Determine
Use our Human Subjects Research Determination Worksheet and the IRB Guidance: Projects Not Meeting the Definition of Research to assist you in carefully considering whether your project meets the federal definitions discussed above.
If after completing the worksheet and reading the guide, you are unsure whether your project requires review contact the IRB Office.
If your study does meet the definition of human subject research, you will most likely need IRB approval to conduct your research project. Human subject research activities may not begin until determination or IRB approval is issued by the IRB.
Is Campbell University engaged in human subjects research?
The IRB will review research for which Campbell University is engaged. An institution is considered engaged in human subjects research when its employees or agents for the purpose of the research project obtain:
- Data about the subjects of the research through intervention or interaction with them;
- Identifiable private information about the subjects of the research; or
- The informed consent of human subjects for the research.
If you are conducting the human subject research as part of your affiliation with Campbell University (i.e., in your capacity as a faculty, student, staff, etc.), then Campbell University is engaged. When you collaborate with institutions outside of Campbell University, Campbell’s engagement as well as the other institution’s engagement needs to be determined by the IRB. For more information about engagement of research, see OHRP’s guidance on the engagement of institutions in human subjects research or Guidance: Determining Engagement in Research. These guidance documents include scenarios and examples of when an institution is or is not engage in human subjects research.