Investigators engaged in human subject research are required to obtain either an exempt determination or IRB approval before these activities can be initiated. 

To determine if your project requires review, you will need to first determine that your study meets both the federal definitions of (1) research and (2) 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.”
  • Note: Activities involving people that are conducted in conjunction with the requirements of a thesis or dissertation generally are research because the purpose of the thesis or dissertation is by definition to make a contribution to general knowledge. However, if the study activities involving people are conducted solely for the purpose of fulfilling a course requirement and not used for a thesis or dissertation, they are not considered research because they are not designed to contribute to general knowledge. 
• Does the research involve human subjects?
  • Human subject is “a living individual about whom an investigator (whether professional or student) conducting research:
    1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
    2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens 

Use our Human Subjects Research Determination Worksheet to assist you in carefully considering whether your project meets the federal definitions discussed above. If after completing that worksheet you are unsure whether your study requires review or if you need a letter formally documenting that review is not required, submit the form to our office.

If your study does meet the definition of human subject research, you will then need to complete one of two initial review applications for either an exempt determination or IRB review. Human subject research activities may not begin until an exempt determination or IRB approval is issued by RCS and/or the IRB. 

Is the UO engaged in the human subject research?

RCS and the UO IRB will review research for which the UO is engaged. The term "engaged" is based on federal guidance and there are a number of scenarios that engage an institution in research. The most common activities that engage an institution are described below. However, please refer to the federal guidance on engagement for a more complete description. 

An institution is considered engaged in human subjects research when 

1. An institution receives an award through a grant, contract, or cooperative agreement directly from HHS for the human subjects research (i.e. primary awardee institutions).
2. The employees or agents of the institution intervene for research purposes with any human subjects of the research by performing research procedures or  by manipulating the environment. 
3. The employees or agents of the institution interact for research purposes with any human subject of the research.
4. The employees or agents of the institution obtain the informed consent of human subjects for the research.
5. The employees or agents of the institution obtain for research purposes identifiable private information or identifiable biological specimens from any source for the research (e.g., by observing or recording private behavior, by using, studying, or analyzing the data or samples for research purposes).  Note: if institutions are just releasing existing identifiable private data or specimens to researchers, they may not be engaged (see federal engagement guidance for more details). 

 If you are conducting the human subject research as part of your affiliation with the University of Oregon (i.e., in your capacity as a faculty, student, staff, etc.), then the UO is engaged. For more information about engagement in research, see OHRP’s guidance on engagement of institutions in human subject research. This guidance includes scenarios and examples of when an institution is or is not engaged in human subject research.

If you have questions, please contact Research Compliance Services.