CITI Social/Behavioral Research Course Exam Study Guide 2023 Belmont Report - Correct Answer provides the ethical framework for the federal regulations designed to protect human research subjects.Belmont Report and Its Principles - Correct Answer 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: - Correct Answer Persons with diminished autonomy are entitled to protection.The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: - Correct Answer first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.Persons with diminished autonomy should not be excluded from participating in research, because then they would be excluded from receiving the benefits of research.The Belmont Report does not limit persons with diminished autonomy with participating in greater than minimal risk research. The Belmont Report also does not limit persons involved in research from benefitting financially.Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - Correct Answer Determining that the study has a maximization of benefits and a minimization of risks.The principle of beneficence - Correct Answer The principle of beneficence includes the obligation of researchers to strive to do no harm and to maximize benefits and minimize harms. "Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being" (The National Commission 1979). The principle of beneficence can be applied to a study employing human subjects by determining that the study has a maximization of benefits and a minimization of risks. Providing detailed information during consent and ensuring persons with diminished autonomy are protected would be examples of applying the principle of respect for persons. Ensuring the selection of subjects is equitable is an example of applying the principle of justice.Which of the following are the three principles discussed in the Belmont Report? - Correct Answer Respect for Persons, Beneficence, Justice The three principles discussed in the Belmont Report are - Correct Answer Respect for Persons, Beneficence, Justice.Students in Research - Correct Answer 1 / 3
A master's degree candidate needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food the store normally stocks and which are the biggest sellers. Identifiers will not be collected.This study would fall under which of the following? - Correct Answer Not Human Subjects This study would qualify as not human subjects because - Correct Answer the data that the student is collecting does not meet the definition of human subjects research as stated by federal regulations. She is not collecting any information about the store owners, but her study mainly seeks to find information about the items in the store.The history of ethical regulations in human subjects research began with the - Correct Answer Nuremberg Code Nuremberg Code - Correct Answer Prior to the Nuremberg Code in 1949, the U.S. did not have a set of ethical regulations in human subjects research. The Nuremberg Code paved the way in creating the human subjects research guidelines and regulations we follow today.How can faculty researchers avoid undue influence of student subjects? - Correct Answer Avoid using their own students in their research Avoid using their own students in their research - Correct Answer By recruiting students from other classes, faculty researchers can minimize the potential of undue influence.Students from the faculty's own classroom may feel coerced to participate so to protect them, students who do not have any courses with the faculty should be recruited when possible.Per federal regulations, which of the following elements must be included in an informed consent document? - Correct Answer All foreseeable risks and discomforts.The federal regulations require - Correct Answer all foreseeable risks and discomforts must be included in an informed consent.Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee? - Correct Answer Exempt Exempt research is - Correct Answer research with human subjects. However, it is "exempt" from the provisions stated in Title 45, Part 46, Subpart A (the Common Rule).Federal guidance recommends that investigators not be allowed to self-determine whether a study qualifies for exemption. Therefore, exempt studies generally are reviewed and determined by the IRB, or its representative. Expedited and Full/Convened Board reviews both require IRB approval.History and Ethical Principles - Correct Answer 2 / 3
The Belmont principle of beneficence requires that: - Correct Answer Potential benefits justify the risks of harm.The Belmont principle of beneficence requires - Correct Answer that potential benefits justify the risks of harm.The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies? - Correct Answer "Tastes, Ties, and Time (T3)" study (2006-2009) "Tastes, Ties, and Time (T3)" study (2006-2009) - Correct Answer Although no students were identified by name in the T3 study, some data were specific enough to allow for re- identification of students by an outside researcher. This is an example of the failure to protect subjects from deductive disclosure of their identities. The primary ethical problems of the other studies include physical harms and unanticipated psychological harm.According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - Correct Answer Justice Justice - Correct Answer According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of justice.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? - Correct Answer The Public Health Service Study of Untreated Syphilis The Public Health Service Study of Untreated Syphilis - Correct Answer The Public Health Service Study of Untreated Syphilis 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.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: - Correct Answer Respect for persons Respect for persons - Correct Answer Humphreys collecting data for the Tearoom Trade study while posing as a lookout is an example of a violation of the principle of respect for persons. Respect for persons requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent).Defining Research with Human Subjects - Correct Answer
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