persons with diminished autonomy are entitled to protection ✔✔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: Determining that the study has a maximization of benefits and a minimization of risks. ✔✔Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? Respect for Persons, Beneficence, Justice ✔✔Which of the following are the three principles discussed in the Belmont Report? The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. ✔✔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? Respect for persons. ✔✔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: Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study ✔✔The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies? Justice ✔✔According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: Potential benefits justify the risks of harm. ✔✔The Belmont principle of beneficence requires that: - Protecting the rights and welfare of human subjects. - Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed. - Reviewing subject recruitment materials and strategies. ✔✔What is the Institutional Review Board (IRB) charged with? (There may be more than one correct answer. Please be sure to select all correct answers.) Exempt ✔✔Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee? Studies collecting data about living individuals. ✔✔Which of the following studies need IRB approval? Full Board Review ✔✔A student working on his dissertation plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, what types of disciplinary actions were taken (including decisions they may have personally made), and their feelings or thoughts as to whether those actions were appropriate. Identifiers will be collected. This study would be categorized as which type of review? Nuremberg Code ✔✔The history of ethical regulations in human subjects research began with the All foreseeable risks and discomforts. ✔✔Per federal regulations, which of the following elements must be included in an informed consent document? Private information ✔✔A medical record is an example of: The IRB will not review this study because it is not research as defined by the federal regulations. ✔✔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? Obtains, uses, studies, analyzes, or generates identifiable private information. ✔✔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: 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. ✔✔According to the federal regulations, which of the following studies meets the definition of research with human subjects? Public information ✔✔Census data (the final report as published by the Census Bureau) is an example of: Officials of the institution may overrule an IRB approval. ✔✔Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? Must occur within 12 months of the approval date. ✔✔Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: No more than minimal risk and the research activities fall within regulatory categories identified as eligible. ✔✔According to federal regulations, the expedited review process may be used when the study procedures pose: