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CITI Certification, Questions with accurate answers. Latest update. 2022/2023

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CITI Certification, Questions with accurate answers. Latest update. 2022/2023 Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - Determining that the study has a maximization of benefits and a minimization of risks. Which of the following are the three principles discussed in the Belmont Report? - Respect for Persons, Beneficence, Justice The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - Persons with diminished autonomy are entitled to protection. According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four? - Physical control, coercion, undue influence, and manipulation When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: - Is there a power differential between researchers and subjects? Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of: - Medical vulnerability The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a: - Cognitive or communicative vulnerability Which is an example of a situation where deferential vulnerability might be a factor? - A physician recruiting patients to be subjects An example of an individual financial COI is: - A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. 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 The COI management plan aims to: - Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - There may be bias by the peer reviewer as to the area of research 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 Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? - Ensuring that risks are reasonable in relationship to anticipated benefits Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: - Respect for persons The researcher's failure to protect research subjects from

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CITI Certification, Questions with
accurate answers. Latest update.
2022/2023



Which of the following is an example of how the principle of beneficence can be applied to a study
employing human subjects? - ✔✔Determining that the study has a maximization of benefits and a
minimization of risks.



Which of the following are the three principles discussed in the Belmont Report? - ✔✔Respect for
Persons, Beneficence, Justice



The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first,
that individuals should be treated as autonomous agents, and second, that: - ✔✔Persons with
diminished autonomy are entitled to protection.



According to the authors, there are four common abuses that historically are described as giving rise to
vulnerability. Which response below contains the correct four? - ✔✔Physical control, coercion, undue
influence, and manipulation



When an IRB is reviewing a research study and they are considering if a potential subject population is
vulnerable, they should consider: - ✔✔Is there a power differential between researchers and subjects?



Subjects with a serious illness may be at risk for exploitation because they may be desperate for a
possible cure. This is an example of: - ✔✔Medical vulnerability



The NBAC looks at characteristics individuals might have that would prevent them from being able to
provide voluntary informed consent. The traits may be thought of as falling into six broad areas:
cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective

, research subjects who are not able to comprehend information, deliberate, and make decisions about
participation in a proposed research study have a: - ✔✔Cognitive or communicative vulnerability



Which is an example of a situation where deferential vulnerability might be a factor? - ✔✔A physician
recruiting patients to be subjects



An example of an individual financial COI is: - ✔✔A researcher's spouse holds equity in a publicly traded
pharmaceutical company that is also the sponsor of the researcher's study.



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



The COI management plan aims to: - ✔✔Provide procedures or extras steps to be taken to minimize the
risk of bias when a COI is disclosed



The peer review process can create conflicts of interest because the choice of who reviews a potentially
publishable project may show: - ✔✔There may be bias by the peer reviewer as to the area of research



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



Which of the following is an example of how the principle of beneficence is applied to a study involving
human subjects? - ✔✔Ensuring that risks are reasonable in relationship to anticipated benefits



Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an
example of a violation of the principle of: - ✔✔Respect for persons



The researcher's failure to protect research subjects from deductive disclosure is the primary ethical
violation in which of the following studies? - ✔✔"Tastes, Ties, and Time (T3)" study (2006-2009)

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