Records-Based Research (ID 5) Practice Exam Questions With Complete Solutions

Records-Based Research (ID 5) Practice Exam Questions With Complete Solutions An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes: - ANSWER A breach of confidentiality Privacy is about people and their expectations. Privacy risk pertains primarily to the methods used to obtain information about subjects. Confidentiality pertains to the actual treatment of the personal information once it is obtained. In other words, now that the researcher has obtained private information, how will it be used, stored, and reported. Clearly, this event represents a breach of confidentiality. A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from . The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects? - ANSWER The researcher will not be interacting/intervening with subjects and the data has no identifiers. Records-based research activities may not meet the federal definition of "human subjects" research. A human subject is "a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (Protection of Human Subjects 2017). In this case, the investigator did not collect the data directly from the human subject and the investigator cannot readily ascertain the identity of the subject; therefore, this would not qualify as human subject research.