Belmont Report and Human Subjects Research – U.S. Federal
Regulations and Ethical Principles Quiz Review – Complete
Answer Key
Which of the following are the three principles discussed in the Belmont Report?
A. IRB review, Federal regulations, Declaration of Helsinki.
B. Informed Consent, Institutional Assurance, Researcher responsibility.
C. Privacy, Confidentiality, Equitable selection of subjects.
D. Respect for Persons, Beneficence, Justice. ✔✔D. Respect for Persons, Beneficence, Justice.
Which of the following is an example of how the Principle of Beneficence can be applied to a
study employing human subjects?
A. Providing detailed information about the study and obtaining the subject's consent to
participate.
B. Determining that the study has a maximization of benefits and a minimization of risks.
C. Ensuring that the selection of subjects includes people from all segments of the population.
D. Ensuring that persons with diminished autonomy are protected. ✔✔B. Determining that the
study has a maximization of benefits and a minimization of risks.
All of the following are true regarding the Belmont Report, EXCEPT:
A. The Belmont Report describes the need to carefully consider how research discoveries and
risks will be fairly distributed in the society.
B. The Belmont Report describes the concept of "Respect for Persons".
C. The Belmont Report defines and delineates the differences between "Practice" and
"Research".
D. The Belmont Report indicates that it is necessary to rigorously avoid conflicts ✔✔D. The
Belmont Report indicates that it is necessary to rigorously avoid conflicts
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?
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
B. Stanford Prison Experiment (Zimbardo).
, C. The Harvard T3 study.
D. Tearoom Trade Study (Humphreys). ✔✔A. The Public Health Service Tuskegee Study of
Untreated Syphilis in the Negro Male.
The Belmont principle of beneficence requires that:
A. Subjects derive individual benefit from study participation.
B. Potential benefits justify the risks of harm.
C. The study makes a significant contribution to generalizable knowledge.
D. Risks are managed so that they are no more than minimal. ✔✔B. Potential benefits justify
the risks of harm.
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:
A. Respect for persons.
B. Justice.
C. Beneficence. ✔✔A. Respect for persons.
According to the Belmont Report, the moral requirement that there be fair outcomes in the
selection of research subjects, expresses the principle of:
A. Beneficence.
B. Respect for persons.
C. Justice. ✔✔C. Justice.
Which of the following is an example of how the principle of beneficence is applied to a study
involving human subjects?
A. Ensuring that subjects understand that participation is voluntary.
B. Ensuring that the selection of subjects is fair.
C. Providing detailed information about the study to potential subjects.
D. Ensuring that risks are reasonable in relationship to anticipated benefits. ✔✔D. Ensuring
that risks are reasonable in relationship to anticipated benefits.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the discovery of
the adverse event occurrence?
Regulations and Ethical Principles Quiz Review – Complete
Answer Key
Which of the following are the three principles discussed in the Belmont Report?
A. IRB review, Federal regulations, Declaration of Helsinki.
B. Informed Consent, Institutional Assurance, Researcher responsibility.
C. Privacy, Confidentiality, Equitable selection of subjects.
D. Respect for Persons, Beneficence, Justice. ✔✔D. Respect for Persons, Beneficence, Justice.
Which of the following is an example of how the Principle of Beneficence can be applied to a
study employing human subjects?
A. Providing detailed information about the study and obtaining the subject's consent to
participate.
B. Determining that the study has a maximization of benefits and a minimization of risks.
C. Ensuring that the selection of subjects includes people from all segments of the population.
D. Ensuring that persons with diminished autonomy are protected. ✔✔B. Determining that the
study has a maximization of benefits and a minimization of risks.
All of the following are true regarding the Belmont Report, EXCEPT:
A. The Belmont Report describes the need to carefully consider how research discoveries and
risks will be fairly distributed in the society.
B. The Belmont Report describes the concept of "Respect for Persons".
C. The Belmont Report defines and delineates the differences between "Practice" and
"Research".
D. The Belmont Report indicates that it is necessary to rigorously avoid conflicts ✔✔D. The
Belmont Report indicates that it is necessary to rigorously avoid conflicts
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?
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
B. Stanford Prison Experiment (Zimbardo).
, C. The Harvard T3 study.
D. Tearoom Trade Study (Humphreys). ✔✔A. The Public Health Service Tuskegee Study of
Untreated Syphilis in the Negro Male.
The Belmont principle of beneficence requires that:
A. Subjects derive individual benefit from study participation.
B. Potential benefits justify the risks of harm.
C. The study makes a significant contribution to generalizable knowledge.
D. Risks are managed so that they are no more than minimal. ✔✔B. Potential benefits justify
the risks of harm.
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:
A. Respect for persons.
B. Justice.
C. Beneficence. ✔✔A. Respect for persons.
According to the Belmont Report, the moral requirement that there be fair outcomes in the
selection of research subjects, expresses the principle of:
A. Beneficence.
B. Respect for persons.
C. Justice. ✔✔C. Justice.
Which of the following is an example of how the principle of beneficence is applied to a study
involving human subjects?
A. Ensuring that subjects understand that participation is voluntary.
B. Ensuring that the selection of subjects is fair.
C. Providing detailed information about the study to potential subjects.
D. Ensuring that risks are reasonable in relationship to anticipated benefits. ✔✔D. Ensuring
that risks are reasonable in relationship to anticipated benefits.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the discovery of
the adverse event occurrence?
