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Records-Based Research

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Submitted By mtarver
Words 733
Pages 3
Question 1
Question :
An investigator obtains consent 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 patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:
Your answer : An invasion of privacy.
Correct Answer : A breach of confidentiality.
Comment :
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.
Points Earned : 0
Question 2
Question :
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 1996-2006. 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?
Your answer : The researcher will not be interacting/intervening with subjects and the data has no identifiers.
Correct Answer : The researcher will not be interacting/intervening with subjects and the data has no identifiers.
Comment :
Record-based research activities may not meet the federal definition of “human subjects” research. A human subject is “a

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