How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?Īnswer: Report the adverse drug experience in a timely manner, in keeping with the IRB’s policies and procedures, using the forms or the mechanism provided by the IRB. The Belmont Principle of beneficence requires thatĪnswer: Potential benefits justify the risks of harm.Ī subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. 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?Īnswer: The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.Īccording to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: 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: Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?Īnswer: 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?Īnswer: Harvard “Tastes, Ties, and Time (T3)” study (2006-2009)” study Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?Īnswer: Determining that the study has a maximization of benefits and a minimization of risks.Īll of the following are true regarding the Belmont Report, EXCEPT:Īnswer: The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest. The three principles discussed in the Belmont Report are Respect for Persons, Beneficence, Justice.Īnswer: Respect for Persons, Beneficence, Justice. Which of the following are the three principles discussed in the Belmont Report?Īnswer: Respect for Persons Beneficence Justic The Belmont Report also does not limit persons involved in research from benefitting financially. The Belmont Report does not limit persons with diminished autonomy with participating in greater than minimal risk research. 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’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. 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:Īnswer: Persons with diminished autonomy are entitled to protection Ensuring the selection of subjects is equitable is an example of applying the principle of justice. Providing detailed information during consent and ensuring persons with diminished autonomy are protected would be examples of applying the principle of respect for persons. 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. “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 includes the obligation of researchers to strive to do no harm and to maximize benefits and minimize harms. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?Īnswer: Determining that the study has a maximization of benefits and a minimization of risks
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