CITI Modules Latest Update 2024-2025 Exam 180 Questions and 100% Verified Correct Answers Guaranteed A+
A census is a regularly-occurring and official count of a particular population. Census
data available at the United States Census Bureau website are an example of: -
CORRECT ANSWER: public information
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:
- A study in which subjects were assigned to study activities based on an undesirable
- A study in which subjects were told that they performed in the third quartile on an
- A study in which researchers told students that they would be given a quiz after
or unflattering physical characteristic as assessed by members of the research team.
anagram task when in reality students were randomly assigned scores that were not related to their actual performance.
reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects' attention on the material.
D) A study involving decision-making games in w - 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?
- The researcher may stop you from taking part in this research without your consent if
- Your participation in this research is voluntary. If you choose not to participate, or
- In the event of any distress you may have re - CORRECT ANSWER: Taking part in
you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.
change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for.
the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.
A literature review by Freedman, Cockburn, and Simcoe in 2015 estimates that in the
U.S., the failure of research to replicate is associated with a cost of:
- / 4
- Trillions of dollars per year
- Thousands of dollars per
- Billions of dollars per year
D) Million dollars per year - CORRECT ANSWER: Billions of dollars per year
A medical record is an example of:
- Public behavior
- Public information
- Private behavior
D) Private information - CORRECT ANSWER: private information
A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members, and business acquaintances. The researcher submits the research proposal to the institution's IRB.What action can he expect by the IRB?
- The IRB will not review this study because it is not research as defined by the federal
- The IRB will not review this study because it does not include human subjects as
- The IRB will review this study because it includes human subjects and is considered
- The IRB will not review this study because it does not involve an investigational new
regulations.
defined by the federal regulations.
research.
device. - CORRECT ANSWER: The IRB will not review this study because it is not
research as defined by the federal regulations.
A research collaboration can be enhanced by:
- Discussing intellectual property issues while the collaboration is forming.
- Limiting the communication between researchers and industry partners.
- Waiting to discuss authorship issues until after data collection.
- Avoiding the issue of which journal to target since research team members might
disagree. - CORRECT ANSWER: Discussing intellectual property issues while the
collaboration is forming.
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?
- The students must be offered an optional classroom activity.
- Parents must be notified that the study is taking place.
- The research must pose no more than minimal risk. 2 / 4
D) An independent consultant must approve the waiver. - CORRECT ANSWER: The
research must pose no more than minimal risk.
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?
- Yes, this must be reported because it was not listed as a risk of study participation in
- Yes, this must be reported because it involved a subject in a research study and it is
- No, this does not need to be reported to the IRB since the researcher reported it to
- No, this does not need to be reported because it was assessed by the researcher as
the consent form (was unexpected) and the subject experienced harm.
up to the IRB to determine if it was related to participation.
the sponsor of the study.
unrelated to the research study. - 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?
- Within 24 hours
- Promptly
- Within two weeks
D) Within 48 hours - CORRECT ANSWER: promptly
A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery.Based on HHS regulations, should the researcher report this event to the IRB?
- No, this does not need to be reported because the subject recovered.
- No, this does not need to be reported because the subject had the heart attack when
- No, this does not need to be reported because it is unrelated to participation in the
they were home, not at the focus group.
study. 3 / 4
- No, this does not need to be reported because two weeks have passed. - CORRECT
ANSWER: No, this does not need to be reported because it is unrelated to participation in the study.
A researcher is examining the quality of life for prisoners who are HIV-positive using
surveys followed by interview. The IRB must ensure that:
- Confidentiality of the prisoners' health status is maintained.
- A medical doctor serves as co-investigator.
- All prisoners receive HIV testing.
- The survey instrument is standardized. - CORRECT ANSWER: Confidentiality of the
prisoners' health status is maintained.
A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This
collection of information is an example of:
- Public information
- Public behavior
- Private information
D) Private behavior - CORRECT ANSWER: Public behavior
A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In
assessing this proposal, the IRB needs to determine that the toys are:
- Educational
- Not an excessive incentive.
- Of high quality
D)Age appropriate. - CORRECT ANSWER: Not an excessive incentive.
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?
- There was neither a violation of privacy nor a breach of confidentiality.
- The subjects' privacy has been violated.
- Confidentiality of the data has been breached.
- There was both a violation of privacy and a breach of confidentiality. - CORRECT
- / 4
ANSWER: There was neither a violation of privacy nor a breach of confidentiality.