Which statement best defines a human subject under federal regulations?

Which statement best defines a human subject under federal regulations?

• A. A living individual about whom an investigator obtains information through interaction or intervention, or obtains identifiable private information.
• B. A deceased person whose records are studied.
• C. An organization being researched.
• D. Non-human subjects such as cells.

Answer: (A)

Under federal regulations, a human subject is a living person about whom an investigator either intervenes or interacts to obtain data, or obtains identifiable private information. This definition centers on two ways a person becomes a human subject: the researcher engages with the person to collect data (intervention or interaction), or the researcher accesses information that could identify the person from private records. If the person is dead, or if the data involve non-identifiable or non-private information about a person, the person isn’t considered a human subject. So this statement is the best because it explicitly includes living individuals and the two paths that make someone a human subject: direct interaction or intervention to obtain data, and the collection of identifiable private information. The other options describe a deceased person, an organization, or non-human subjects, which do not meet the definition.

Under federal regulations, a human subject is a living person about whom an investigator either intervenes or interacts to obtain data, or obtains identifiable private information. This definition centers on two ways a person becomes a human subject: the researcher engages with the person to collect data (intervention or interaction), or the researcher accesses information that could identify the person from private records. If the person is dead, or if the data involve non-identifiable or non-private information about a person, the person isn’t considered a human subject.

So this statement is the best because it explicitly includes living individuals and the two paths that make someone a human subject: direct interaction or intervention to obtain data, and the collection of identifiable private information. The other options describe a deceased person, an organization, or non-human subjects, which do not meet the definition.