CITI Assessing Risk - SBE Practice Test

An individual is classified as a 'human subject' in research primarily when identifiable private information is obtained. This classification is crucial because it emphasizes the ethical considerations and regulatory requirements that researchers must follow to protect the rights and welfare of participants. When identifiable information is collected, it raises concerns about privacy, confidentiality, and the potential for harm, thereby necessitating additional safeguards and oversight as outlined in regulations such as the Common Rule.

While other options may involve data related to individuals, they do not necessarily involve direct interaction or identifiable private information, which is integral to the definition of a human subject. Using historical medical records may not always pertain to obtaining identifiable private information if those records are de-identified. Collecting samples from public sources does not typically involve human subjects as it often does not contain identifiable information or private data from individuals. Observational studies without interaction might not meet the threshold for being considered human subjects research, particularly if no private identifiable information is collected or linked to the individuals observed.