CITI Training correctly answered 2023 already passed

CITI Training correctly answered 2023 already passedThe Belmont principle of beneficence requires that: Risks to subjects are reasonable in relation 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 According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: Justice An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle? Justice A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report? Justice 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. According to the federal regulations, research is eligible for exemption, if: The research falls into one of eight categories of research activity described in the regulations. In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? Prisoners 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. According to federal regulations, the expedited review process may be used when the study procedures pose: No more than minimal risk and the research activities fall within regulatory categories identified as eligible. Which of the following are the three principles discussed in the Belmont Report? Respect for Persons, Beneficence, Justice 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. 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. 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: Public information 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 behavior 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. According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or: Obtains, uses, studies, analyzes, or generates identifiable private information. According to the federal regulations, which of the following studies meets the definition of research with human subjects? 1. A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period. 2. A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. 3. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors. 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 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 PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? Researcher 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 During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: Disclose their potential COI and may answer questions, but recuse themselves from voting The FDA regulations governing disclosure of individual COIs require: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies 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