Citi Training
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: - ANS - Both the magnitude (or severity) and the probability (or
likelihood) of harm.
A researcher wishes to study generational differences in coping mechanisms among
adults who experienced abuse as children. Adequate measures will be instituted to
obtain informed consent and ensure that there is no breach of confidentiality. The most
likely additional risk is that some subjects may: - ANS - Experience emotional or
psychological distress.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the
discovery of the adverse event occurrence? - ANS - Report the adverse drug
experience in a timely manner, in keeping with the IRB's policies and procedures, using
the forms or the mechanism provided by the IRB.
According to federal regulations, the expedited review process may be used when the
study procedures pose: - ANS - No more than minimal risk and the research activities
fall within regulatory categories identified as eligible.
According to federal regulations, which of the following best describes when expedited
review of a new, proposed study may be used by the IRB? - ANS - The study involves
no more than minimal risk and meets one of the allowable categories of expedited
review specified in federal regulations
According to the federal regulations, human subjects are living human beings about
whom an investigator obtains data through interaction or intervention with the individual
or: - ANS - Identifiable private information.
According to the federal regulations, research is eligible for exemption, if - ANS - The
research falls into one of six categories of research activity described in the regulations.
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: - ANS - Both the magnitude (or severity) and the probability (or
likelihood) of harm.
A researcher wishes to study generational differences in coping mechanisms among
adults who experienced abuse as children. Adequate measures will be instituted to
obtain informed consent and ensure that there is no breach of confidentiality. The most
likely additional risk is that some subjects may: - ANS - Experience emotional or
psychological distress.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the
discovery of the adverse event occurrence? - ANS - Report the adverse drug
experience in a timely manner, in keeping with the IRB's policies and procedures, using
the forms or the mechanism provided by the IRB.
According to federal regulations, the expedited review process may be used when the
study procedures pose: - ANS - No more than minimal risk and the research activities
fall within regulatory categories identified as eligible.
According to federal regulations, which of the following best describes when expedited
review of a new, proposed study may be used by the IRB? - ANS - The study involves
no more than minimal risk and meets one of the allowable categories of expedited
review specified in federal regulations
According to the federal regulations, human subjects are living human beings about
whom an investigator obtains data through interaction or intervention with the individual
or: - ANS - Identifiable private information.
According to the federal regulations, research is eligible for exemption, if - ANS - The
research falls into one of six categories of research activity described in the regulations.
