CITI -Social &Behavioral Research
UPDATED ACTUAL Exam Questions and
CORRECT Answers
A criterion for waiving informed consent is that, when appropriate, subjects are provided
additional pertinent information after the study. In which of the following studies would it NOT
be appropriate to provide subjects with information about missing elements of consent: -
CORRECT ANSWER - A study in which subjects were assigned to study activities based
on an undesirable or unflattering physical characteristic as assessed by members of the research
team.
A general requirement for informed consent is that no informed consent may include any
exculpatory language. Exculpatory language is that which waives or appears to waive any of the
subject's legal rights or releases or appears to release those conducting the research from liability
for negligence. Which of the following statements in a consent form is an example of
exculpatory language? - CORRECT ANSWER - Taking part in the research is voluntary,
but if you choose to take part, you waive the right to legal redress for any research-related
injuries.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects
research study. He wants to know at what point he and his study team must submit COI
disclosures to comply with the PHS regulation. - CORRECT ANSWER - No later than the
time of proposal submission
A researcher conducting behavioral research collects individually identifiable sensitive
information about illicit drug use and other illegal behaviors by surveying college students. One
of the subjects is in an automobile accident two weeks after participating in the research study. Is
this an example of an unanticipated problem that requires reporting to the IRB? - CORRECT
ANSWER - No, this does not need to be reported because it was assessed by the
researcher as unrelated to the research study.
A researcher conducting behavioral research collects individually identifiable sensitive
information about illicit drug use and other illegal behaviors by surveying college students. The
data are stored on a laptop computer without encryption, and the laptop computer is stolen from
the researcher's car on the way home from work. This is an unanticipated problem that must be
reported because the incident was (a) unexpected (in other words, the researchers did not
, anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a
greater risk of psychological and social harm from the breach in confidentiality of the study data
than was previously known or recognized. According to OHRP, this unanticipated problem must
be reported to the IRB in which timeframe? - CORRECT ANSWER - Promptly
A researcher leaves a research file in her car while she attends a concert and her car is stolen.
The file contains charts of aggregated numerical data from a research study with human subjects,
but no other documents. The consent form said that no identifying information would be
retained, and the researcher adhered to that component. Which of the following statements best
characterizes what occurred? - CORRECT ANSWER - There was neither a violation of
privacy nor a breach of confidentiality.
A researcher proposes to conduct a study at a foreign site that has been determined to be exempt
from the federal regulations by institutional policy. According to federal regulations, is review
required at the foreign site? - CORRECT ANSWER - If a proposed study qualifies for
exemption, federal regulations do not require review at the foreign site where it will be
conducted.
A researcher wants to observe preschoolers at a local public playground to evaluate levels of
cooperation. The researcher will not interact with the children or record information in such a
manner that the identity of the subjects can be readily ascertained. Which of the following
statements is true? - CORRECT ANSWER - This research would be eligible for
exemption because the researcher is not interacting with the children and the playground is a
public setting.
A therapist at a free university clinic treats elementary school children with behavior problems
who are referred by a social service agency. She is also a doctoral candidate who proposes using
data she has and will collect about the children for a case-based research project. Which of the
following statements about parental permission is correct? - CORRECT ANSWER - The
parents of the children might feel pressure to give permission to the therapist to use their
children's data so that she will continue to provide services to their children.
A waiver of the requirement for documentation of informed consent may be granted when: -
CORRECT ANSWER - The only record linking the subject and the research is the consent
document and the principal risk is a breach of confidentiality.
UPDATED ACTUAL Exam Questions and
CORRECT Answers
A criterion for waiving informed consent is that, when appropriate, subjects are provided
additional pertinent information after the study. In which of the following studies would it NOT
be appropriate to provide subjects with information about missing elements of consent: -
CORRECT ANSWER - A study in which subjects were assigned to study activities based
on an undesirable or unflattering physical characteristic as assessed by members of the research
team.
A general requirement for informed consent is that no informed consent may include any
exculpatory language. Exculpatory language is that which waives or appears to waive any of the
subject's legal rights or releases or appears to release those conducting the research from liability
for negligence. Which of the following statements in a consent form is an example of
exculpatory language? - CORRECT ANSWER - Taking part in the research is voluntary,
but if you choose to take part, you waive the right to legal redress for any research-related
injuries.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects
research study. He wants to know at what point he and his study team must submit COI
disclosures to comply with the PHS regulation. - CORRECT ANSWER - No later than the
time of proposal submission
A researcher conducting behavioral research collects individually identifiable sensitive
information about illicit drug use and other illegal behaviors by surveying college students. One
of the subjects is in an automobile accident two weeks after participating in the research study. Is
this an example of an unanticipated problem that requires reporting to the IRB? - CORRECT
ANSWER - No, this does not need to be reported because it was assessed by the
researcher as unrelated to the research study.
A researcher conducting behavioral research collects individually identifiable sensitive
information about illicit drug use and other illegal behaviors by surveying college students. The
data are stored on a laptop computer without encryption, and the laptop computer is stolen from
the researcher's car on the way home from work. This is an unanticipated problem that must be
reported because the incident was (a) unexpected (in other words, the researchers did not
, anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a
greater risk of psychological and social harm from the breach in confidentiality of the study data
than was previously known or recognized. According to OHRP, this unanticipated problem must
be reported to the IRB in which timeframe? - CORRECT ANSWER - Promptly
A researcher leaves a research file in her car while she attends a concert and her car is stolen.
The file contains charts of aggregated numerical data from a research study with human subjects,
but no other documents. The consent form said that no identifying information would be
retained, and the researcher adhered to that component. Which of the following statements best
characterizes what occurred? - CORRECT ANSWER - There was neither a violation of
privacy nor a breach of confidentiality.
A researcher proposes to conduct a study at a foreign site that has been determined to be exempt
from the federal regulations by institutional policy. According to federal regulations, is review
required at the foreign site? - CORRECT ANSWER - If a proposed study qualifies for
exemption, federal regulations do not require review at the foreign site where it will be
conducted.
A researcher wants to observe preschoolers at a local public playground to evaluate levels of
cooperation. The researcher will not interact with the children or record information in such a
manner that the identity of the subjects can be readily ascertained. Which of the following
statements is true? - CORRECT ANSWER - This research would be eligible for
exemption because the researcher is not interacting with the children and the playground is a
public setting.
A therapist at a free university clinic treats elementary school children with behavior problems
who are referred by a social service agency. She is also a doctoral candidate who proposes using
data she has and will collect about the children for a case-based research project. Which of the
following statements about parental permission is correct? - CORRECT ANSWER - The
parents of the children might feel pressure to give permission to the therapist to use their
children's data so that she will continue to provide services to their children.
A waiver of the requirement for documentation of informed consent may be granted when: -
CORRECT ANSWER - The only record linking the subject and the research is the consent
document and the principal risk is a breach of confidentiality.
