Question 1 Question Which of the following are the three principles discussed in the Belmont Report? Your Answer Respect for Persons, Beneficence, Justice Result Correct Comment The three principles discussed in the Belmont Report are Respect for Persons, Beneficence, Justice. Question 2 Question 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: Your Answer Persons with diminished autonomy are entitled to protection. Result Correct Comment 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. 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. Question 3 Question Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? Your Answer Determining that the study has a maximization of benefits and a minimization of risks. Result Correct Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research Comment 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. Question 1 Question An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk. Your Answer This is an unanticipated problem requiring notification to the IRB and FDA. Result Correct Comment This is an unanticipated problem because the screening procedure problem was not anticipated; both the subject and others were exposed to risk and could have been infected with Hepatitis B or HIV. A Phase II clinical trial involving a biologic falls under the jurisdiction of the FDA