Investigators engaged in human subject research are required to obtain either a Determination of Registration, Exempt Determination, or IRB approval before research activities begin.听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 鈥渁 systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.鈥�
Does the research involve human subjects?
The human subject is 鈥渁 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 and the 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.听
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 橙子影院 engaged in human subjects research?
The IRB will review research for which 橙子影院 is engaged.听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 橙子影院 (i.e., in your capacity as a faculty, student, staff, etc.), then 橙子影院 is engaged.听 When you collaborate with institutions outside of 橙子影院, 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 辞谤听 . These guidance documents include scenarios and examples of when an institution is or is not engage in human subjects research.