Assessing Risk – SBE

21 June 2023
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question
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:
answer
Obtain a waiver of documentation of informed consent.
question
The primary purpose of a Certificate of Confidentiality is to:
answer
Protect identifiable research information from compelled disclosure.
question
Additional safeguards that may be included in a social and behavioral study may include:
answer
Remove all direct identifiers from the data as soon as possible.
question
A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:
answer
Both the magnitude (or severity) and the probability (or likelihood) of harm.
question
Identify the example of when situation and time are key to assessing risk of harm in a research study:
answer
Asking women if they have had an abortion