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Summary Social-Behavioral-Educational (SBE) Comprehensive: Citi program (all quizzes) Answered all correctly_2023

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Social-Behavioral-Educational (SBE) Comprehensive: Citi program (all quizzes) Answered all correctly_2023. Informed Consent - SBE (Answered) A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct? A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: A waiver of the requirement for documentation of informed consent may be granted when: As part of the consent process, the federal regulations require researchers to: CITI Privacy and Confidentiality SBE (answered Quiz) A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information? When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? Data are made anonymous by Assessing Risk - SBE (Quiz Answered) If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: The primary purpose of a Certificate of Confidentiality is to: Additional safeguards that may be included in a social and behavioral study may include: A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by: Identify the example of when situation and time are key to assessing risk of harm in a research study: Defining Research with Human Subjects - SBE CITI According to the federal regulations, which of the following studies meets the definition of research with human subjects? According to the federal regulations, which of the following studies meets the definition of research with human subjects? According to the federal regulations, which of the following studies meets the definition of research with human subjects? Census data is an example of: According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or: 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? Conflicts of Interest in Human Subjects Research (ID 17464) What is the term for management controls that are built in to a research study (for example, independent data analysis)? When developing conflict of interest management plans, COI committees typically examine the study design to determine whether it includes inherent controls that mitigate the researcher's opportunity to bias the research. Inherent controls may include independent data analysis, randomization, blinding, or low subject enrollment percentage at a

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CITI Social/Behavioral Research Course Summary Social -Behavioral -Educational (SBE) Comprehensive: Citi program (all quizzes) Answered all correctly_2023 1. Belmont Report: provides the ethical framework for the federal regulations designed to protect human resea rch subjects. Belmont Report and Its Principles: 2. 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. 3. The Belmont Report's principle of respect for persons incorporates at least two ethical convictions:: first, that individuals should be treated as au - tonomous 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. 4. 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. 5. The principle of beneficence: The principle of beneficence includes the oblig - ation 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. 6. Which of the following are the three principles discussed in the Belmont Report?: Respect for Persons, Beneficence, Justice CITI Social/Behavioral Research Course 7. The three principles discussed in the Belmont Report are: Respect for Persons, Beneficence, Justice. Students in Research: 8. 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?: Not Human Subjects 9. This study would qualify as not human subjects because: 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. 10. The history of ethical regulations in human subjects research began with the: Nuremberg Code 11. Nuremberg Code: 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. 12. How can faculty researchers avoid undue influence of student subjects? - : Avoid using their own students in their research 13. Avoid using their own students in their research: By recruiting students from other classes, faculty researchers can minimize the potential of undue influ - ence. 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. 14. Per federal regulations, which of the following elements must be included in an informed consent document?: All foreseeable risks and discomforts. CITI Social/Behavioral Research Course 15. The federal regulations require: all foreseeable risks and discomforts must be included in an informed consent. 16. Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?: Exempt 17. Exempt research is: 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 e xemption. Therefore, exempt studies generally are reviewed and determined by the IRB, or its representative. Expedited and Full/Con - vened Board reviews both require IRB approval. History and Ethical Principles: 18. The Belmont principle of beneficence requires that:: Potential benefits justify the risks of harm. 19. The Belmont principle of beneficence requires: that potential benefits jus- tify the risks of harm. 20. 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 (2006 -2009) 21. "Tastes, Ties, and Time (T3)" study (2006 -2009): 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. 22. According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:: Justice

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