CITI Certification Test Questions and Answers.

CITI Certification Test Questions and Answers. 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 () The Belmont principle of beneficence requires that: Potential benefits justify the risks of harm. Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection? The Public Health Service Study of Untreated Syphilis 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 medical record is an example of: private information According to the federal regulations, which of the following studies meets the definition of research with human subjects? An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. Census data (the final report as published by the Census Bureau) is an example of: public information According to the federal regulations, which of the following studies meets the definition of research with human subjects? A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors. According to the federal regulations, research is eligible for exemption, if: No more than minimal risk and the research activities fall within regulatory categories identified as eligible Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? Officials of the institution may overrule an IRB approval. Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Must occur within 12 months of the approval date. In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?