Who is a human subject?

Within the context of IRB review, a human subject is defined as a living person about whom a researcher obtains data through:

• Intervention (for example, cognitive tests) or
• Interaction (for example, interviews) with the person, or
• Identifiable Private Information (for example, observations or private records). A person may be a “human subject” when a researcher obtains data about the person from a third party as well as from the person directly.

Research that involves human subjects

Below are a few examples of research that typically involve human subjects. This is not a comprehensive list and there are often exceptions to each research.

Generalizing Findings

Activities that obtain data about individuals, systematically performed with the intent to generalize findings.

Viewing Identifiable Private Information

Identification of potential participants for a study or use of living individuals’ data for research purposes, whether or not the data will be recorded in an identifiable manner.

Survey, Interview, Observation

Collection of individuals’ data using surveys, interviews, or observation with the intent to generalize findings.

Audio or Videotaping

Taping individuals for study in situations not normally expected to be recorded or when individuals can be identified from recordings.

Research That Does Not Involve Human Subjects

Below are a few examples of research that typically does not involve human subjects. This is not a comprehensive list and there are often exceptions to each research.

Coded Data

Study or use of data that cannot be readily associated with the living individual about whom the information relates. There are some exceptions. Be sure to contact IRB for assistance.

Quality Improvement

Activities involving individuals intended solely for internal use, performed to improve services or develop new services or programs, (e.g., satisfaction surveys) without intent to generalize findings, even if results will be presented or published; audits (internal or external) performed as a part of organizational operations. There are some exceptions. Be sure to contact IRB for assistance.

Data Banking

Collection and storage of private information, if the data may be used in the future for research purposes, whether or not the data will be recorded in an identifiable manner.