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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: - ANSWER persons ... with diminished autonomy are entitled to protection Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER Determining that the study has a maximization of benefits and a minimization of risks. Which of the following are the three principles discussed in the Belmont Report? - ANSWER Respect for Persons, Beneficence, Justice Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? - ANSWER Ensuring that risks are reasonable in relationship to anticipated benefits. The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies? - ANSWER Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - ANSWER justice 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: - ANSWER Respect for persons. The Belmont principle of beneficence requires that: - ANSWER Potential benefits justify the risks of harm. 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? - ANSWER The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. Continuing review of an approved and ongoing protocol - ANSWER Must occur within 12 months of the approval date. According to the federal regulations, research is eligible for exemption, if - ANSWER The research falls into one of six 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? - ANSWER Officials of the institution may overrule an IRB approval. In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? - ANSWER Prisoners. According to federal regulations, the expedited review process may be used when the study procedures pose: - ANSWER No more than minimal risk and the research activities fall within regulatory categories identified as eligible. What statement about risks in social and behavioral sciences research is most accurate: - ANSWER Risks are specific to time, situation, and culture. Risk of harm in social and behavioral sciences generally fall in three categories, which are: - ANSWER Invasion of privacy, breach of confidentiality, and study procedures 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: - ANSWER Experience emotional or psychological distress. 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: - ANSWER Both the magnitude (or severity) and the probability (or likelihood) of harm. Identify the example of when situation and time are key to assessing risk of harm in a research study: - ANSWER Asking women if they have had an abortion 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? - ANSWER The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children. 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? - ANSWER Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries. 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: - ANSWER A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. A waiver of the requirement for documentation of informed consent may be granted when: - ANSWER The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. As part of the consent process, the federal regulations require researchers to: - ANSWER Provide potenti [Show More]

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