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CITI TRAINING. Questions with 100% Correct Answers | Verified | Latest Update 2024
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CITI TRAINING. Questions with 100% Correct Answers | Verified | Latest Update 2024
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CITI TRAININGA 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the
study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the
subject. The investigator should do which of the following? - ✔✔Give the subject comprehensive information
about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and
the commercially available drug and then allow the subject to decide whether to withdraw from the research to
take the new drug.
A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy. While the
study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the
subject. The investigator should do which of the following? - ✔✔Discuss the pros and cons of both the
investigational drug and the commercially available drug and then allow the subject to decide whether to
withdraw from the research to take the new drug.
A 510(k) Premarket Notification is submitted: - ✔✔When the new device to be marketed is substantially
similar (equivalent) to one already on the market
A 510(k) Premarket Notification is submitted when a manufacturer wishes to market a qualified medical device
in the U.S. without conducting clinical trials. To do so, the manufacturer must demonstrate to FDA that the
device is equivalent to one already marketed. An IDE must be submitted when clinical trials of investigational
devices are needed to determine the safety and effectiveness of a new device or when studying substantial
modifications to or new intended uses for devices already on the market. A Premarket Approval (PMA) might
be submitted for the FDA to evaluate the results of a completed clinical trial of a Class III device.
A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an
alteration of authorization, for all of the following EXCEPT: - ✔✔Data that does not cross state lines when
disclosed by the covered entity.
A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an
alteration of authorization, for all of the following EXCEPT: - ✔✔Data that does not cross state lines when
disclosed by the covered entity.
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 or unflattering physical characteristic as assessed by members of the
research team.
A double-blinded trial for a new indication is conducted under an IND comparing two (2) marketed drugs, at
twice the approved prescribed doses. On Day 2, subject 603 had difficulty breathing. Although it was
,life-threatening initially, subject 603 was treated and discharged directly from the emergency department after
complete recovery. On Day 5, subject 20 had a headache, which led to hospitalization and required blood
pressure lowering medications. These episodes cannot be explained on the basis of the pharmacological
property of either drug or the subjects' medical histories. The investigator would submit an SAE report for: -
✔✔Both of the subjects
A film badge is useful for monitoring x-ray, gamma, and moderate to high energy beta emissions. - ✔✔True
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? - ✔✔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 general requirement for the informed consent form is that it may not 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? - ✔✔I waive any possibility of
compensation for injuries that I may receive as a result of participation in this research.
A HIPAA authorization has which of the following characteristics: - ✔✔Uses "plain language" that the data
subject can understand, similar to the requirement for an informed consent document.
A medical record is an example of: - ✔✔Private information
A primary purpose of the ICH is to: - ✔✔Minimize the need for redundant research.
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 regulations.
A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile
surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order
to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big
State University IRB? - ✔✔Will the researchers have collaborators at the research site abroad?
A publication restriction, such as DFARS 252.204-7000, is most likely to cause which of the following to occur:
- ✔✔The project will no longer fall under the Fundamental Research Exclusion (FRE)
A radioactive package wipe that exceeds ______ dpm should be reported to the Radiation Safety Office. -
✔✔200
,A research collaboration can be enhanced by: - ✔✔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 research must pose no more than minimal risk.
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. - ✔✔No later than the time of proposal submission
A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at
the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or
other information) and subjects may complete the survey and place it in a box at the shopping mall exits.
Which of the following is the most important issue that the researcher addressed in planning the research? -
✔✔Confidentiality of the individual subject's responses
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 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.
A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey
will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects
about the availably of the research, but will not consent the subjects nor perform any research procedures
(even screening procedures). Are the nurses engaged in the research according to federal regulations? -
✔✔No, they are not engaged because they are only informing the subjects and not consenting or performing
any research procedures, or receiving or sharing any private, identifiable information.
A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt
from the federal regulations by institutional policy. According to federal regulations, is review required at the
foreign site? - ✔✔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 conduct a secondary analysis using a Centers for Disease Control and Prevention
(CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The
researcher did not participate in the initial collection of the data. The database is publicly available. The
, database does not include any identifiers. The IRB makes a determination that the individuals whose records
will be reviewed do not meet the federal definition of human subjects.
Which of the following considerations was relevant to the IRB's determination that this activity does not
constitute research with human subjects? - ✔✔The researcher will not be interacting/intervening with subjects
and the data has no identifiers.
A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of
obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor
crimes. She needs to: - ✔✔Do nothing in regards the Subpart C because the research does not meet the
criteria for prison research -- individuals on parole are not considered prisoners. The definition applies to both
minors and adults.
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: - ✔✔Both the magnitude (or severity) and the probability (or
likelihood) of harm.
A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions
regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the
therapists will not be discussed. Which of the following will be the most important issue for the researcher to
consider when planning the research? - ✔✔Breach of confidentiality from the focus group subjects
(therapists)
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? - ✔✔This research would be
eligible for exemption because the researcher is not interacting with the children and the playground is a public
setting.
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: - ✔✔Experience emotional
or psychological distress.
A researcher's membership on an advisory board with an organization sponsoring research can create a COI
because: - ✔✔It may be difficult for the researcher to appear neutral, as the researcher may have an interest
in the research's success
A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal
history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no
interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB
review. This decision: - ✔✔Is wrong because 46.104 states that research conducted in prisons is not exempt
if the subject population is only prisoners.
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