Activities Under IRB
Research at the University of Notre Dame which involves human subjects must be reviewed and approved before any interaction with human subjects or data collection can begin. The Institutional Review Board (IRB) is the group which is required to review all human subjects research activities. While the scope of the phrase “human subjects research” may seem obvious, the federal regulations that govern IRB review define it more narrowly than many assume. Not every interaction with a person constitutes human subjects research, and comparing your proposed research with the actual definition of "human subject" and "research" should be one of the first steps you take.
Human Subject
A “human subject” is a living individual, about whom an investigator:
- 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 biospecimens.
Note that a human subject is not any person with whom an investigator interacts- the interaction must result in data about the person, themselves. Intervention and interaction can include procedures done actively in person (interviews), passively (observation), as well as electronically (phone calls, emails, and electronic surveys). Intervention may also include manipulation of a subject’s environment.
Private data is information about characteristics or behavior in a context in which a person can reasonably expect no observation or recording is taking place. Examples may include a medical record, bank account information, and similar types of information. However, it may also include personal beliefs or responses, which a subject would not otherwise publicize.
Identifiable information allows an observer to determine the identity of the source, whether that is through identifiers like name, date of birth, address, phone number, and more, or it may be through the use of a code or other data maintained to linking research information to the source.
Research
“Research” is a systematic investigation which is designed to develop or contribute to generalizable knowledge.
Systematic investigation means the researcher has identified a plan to collect data in order to answer a research question. This can include both data collection through communication with subjects, or secondary analysis of already-collected data.
Generalizable knowledge is when an investigation is designed to provide general conclusions which can be applied beyond a single individual, population, internal program or organization. Publication of results alone is not determinative when considering whether a project has been designed to contribute to generalizable knowledge. You should consider carefully who will be informed by the results to your investigation.
The following activities are not human subjects research:
- Biography
- Oral history designed only to create a record of events
- Service or course evaluations
- Case reports
- Literary criticism
- Services, courses, or concepts not intended to be shared outside of a particular class, school, organization, or the immediate University of Notre Dame community
- Some classroom exercises, if they are not intended to result in information which will inform populations outside the University
- Quality improvement or assurance methods
A student thesis, dissertation, or academic research project may or may not constitute research, depending on the application of the definitions above. While some institutions determine status as “human subjects research” based on these designations, this is not an appropriate method of classification.
Human Subjects Research Decision Tree
A decision tree created by the Office of Human Research Protections may help with determining whether your activities meet the definition of “human subjects research.”
If you need any assistance in applying the definitions above to your work, please contact our office. Providing a description of the following will expedite our review:
- The purpose of your activities
- The population about whom you plan to collect information
- The methods you plan to use
- The data points you plan to collect