CITI Training question & answer 2023

CITI Training question & answer 2023According 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 In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: Situational cognitive vulnerability 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? Which is true of inducements in research? Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research. Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections: Pregnant women, prisoners, children DSMBs are typically needed: For all randomized trials when interim efficacy and/or safety comparisons are planned Confidentiality of the interim results of a randomized trial is important because: Revealing interim results may affect the conduct of the study and lead to biased results Which of the following statements about IRBs and DSMBs is true? They have overlapping responsibilities for trial oversight DSMB members should have No significant conflicts of interest The type of member expertise needed on almost all DSMBs includes: Statistics DSMB meetings should be held It depends A risk mitigation plan might include Criteria for reducing a subject's medication dose : A DSMP includes a safety monitoring plan and what other component? Data management plan Confidentiality of the interim results of a randomized trial is important because: Revealing interim results may affect the conduct of the study and lead to biased results The only type of trial for which FDA regulations mandate a DMC is: A trial of emergency research using an exception from the informed consent requirement 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. 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 principle of beneficence requires that: Risks to subjects are reasonable in relation to anticipated benefits. 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 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 A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont 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 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 According to the federal regulations, which of the following studies meets the definition of research with human subjects? 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. 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 medical record is an example of: 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 regulations. 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 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. 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 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. 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. 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.