Question
Answer
Explanation
A community-based organization wants to conduct a
survey to understand the health needs of a specific
population. The survey involves collecting anonymous,
non-identifiable information about health behaviors.
According to 21 CFR Part 56, does this type of activity
typically require IRB review?
a) Yes, all research involving human subjects under FDA
jurisdiction requires full IRB review.
b) Yes, but it may qualify for expedited review if it poses
minimal risk.
c) No, research involving anonymous surveys generally
falls outside the purview of IRB review.
d) It depends on the funding source of the survey; federal
funding always requires IRB review.
c) No, research involving anonymous surveys
generally falls outside the purview of IRB
review.
During an IDE study for a new surgical laser, a participant
experiences an unexpected serious adverse event that was not
explicitly listed in the original informed consent form. What is
the investigator's responsibility regarding informed consent in
this situation, according to FDA regulations?
a) To continue the study as planned, as the patient has already
provided consent.
b) To report the adverse event to the sponsor and IRB but not
necessarily re-consent the subject.
c) To promptly inform the subject (or their legally authorized
representative) about the new risk and revise the informed
consent form, seeking re-consent if the subject wishes to
continue participation.
d) To only inform future participants about the new risk during
the consent process.
c) To promptly inform the subject (or their legally
authorized representative) about the n ew risk and
revise the informed consent form, seeking re-
consent if the subject wishes to contin ue
participation.
A subject participating in an IDE study for a new diagnostic
device experiences a temporary cognitive impairment due t o a
pre-existing medical condition. The investigator n eeds to
perform a study-related procedure. Can the investigator
proceed with the procedure based on the s ubject's initial
informed consent?
a) Yes, the initial consent remains valid u nless the subject
explicitly withdraws it.
b) Yes, as long as the investigator believes the procedu re is in
the subject's best interest.
c) No, the investigator should obtain consent from the su bject's
legally authorized representative if the subject lacks the
capacity to provide ongoing informed consent.
d) It depends on the specific terms outlin ed in the original
consent form regarding temporary incapacitation.
c) No, the investigator should obtain consent from
the subject's legally authorized representative if the
subject lacks the
