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Human Subjects Division (HSD)

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Human Research Subjects

What is a human research subject?

An individual about whom a researcher obtains:

  1. data through intervention or interaction with the individual, or
  2. identifiable private information.

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Federal regulations state that a human research subject is a "living individual." However, in Washington State, in some cases research with deceased individuals requires IRB review even though they are not explicitly identified as human research subjects.

"Third party" subjects

If subjects are providing researchers with individually identifiable and private information about other individuals, then those other individuals are also subjects in the research. They must be included as such in the IRB application and addressed in the consent process.

Hints to help decide if there are "third party" subjects:

  • Federal guidance states that information about individuals who are identified only by their association with the subject (e.g., "father", "friend", "sister") is not usually considered to be readily identifiable.
  • Federal guidance indicates that many types of health information are generally considered private, but there are many exceptions such as age, body build, and ethnic or cultural background that may have a bearing on health. Information about family relationships and structure, marital status, social networks, and occupation is also generally not considered private. In most cases, a researcher will ask a subject for information about a third party that is necessary to understand the health, medical history, life experiences, or behavior of the subject and which is relevant to the research question. Drawing on his/her own observations and experience, the subject reports his/her knowledge, perceptions, or beliefs about the third party. Information about a third party that is obtained from a subject as background information about the subject is not generally considered private. This type of information is considered "contextual" and not private, since it is usually unverified information and is used to provide background information important to the condition and/or circumstances of the subject.