CITI CERTIFICATION
HUMAN SUBJECTS
RESEARCH PRACTICE
EXAM 40Q
Question 1: Which three ethical principles are identi�ed in the Belmont Report?
Choices:
1) Respect for Persons, Bene�cence, and Justice 2) Autonomy, Fidelity, and Nonmale�cence 3) Privacy, Con�dentiality, and Security 4) Scienti�c Merit, Equipoise, and Transparency
Correct Answer: Respect for Persons, Bene�cence, and Justice
Explanation: The Belmont Report identi�es Respect for Persons, Bene�cence, and Justice as the three fundamental ethical principles for research involving human subjects.Page 1
Question 2: A potential participant has impaired decision-making capacity. Which action best re�ects the Belmont principle of Respect for Persons?
Choices:
1) Exclude the person from every research study 2) Allow enrollment without consent if the study is important 3) Provide additional protections and use an appropriate legally authorized representative when required 4) Ask the investigator to decide whether participation is in the person's best interest Correct Answer: Provide additional protections and use an appropriate legally authorized representative when required Explanation: Respect for Persons requires respect for autonomy and additional protection for people with diminished autonomy. When appropriate, consent must be obtained from a legally authorized representative while preserving the subject's rights and welfare.
Question 3: An IRB evaluates whether a study's foreseeable risks have been
minimized and are reasonable in relation to anticipated bene�ts and the importance of the knowledge expected. Which Belmont principle is most directly being applied?
Choices:
1) Justice 2) Bene�cence 3) Respect for Persons 4) Scienti�c independence
Correct Answer: Bene�cence
Explanation: Bene�cence requires investigators and IRBs to minimize possible harms and maximize possible bene�ts. Risk-bene�t assessment is a central application of this principle.Page 2
Question 4: A study recruits only economically disadvantaged patients for a risky intervention even though the condition a�ects all income groups and there is no scienti�c reason for the restriction. Which ethical concern is most direct?
Choices:
1) Justice 2) Con�dentiality 3) Scienti�c validity 4) Investigator credentialing
Correct Answer: Justice
Explanation: Justice concerns the fair distribution of the burdens and bene�ts of research.Selecting a disadvantaged group for convenience when others could fairly share the burdens raises a justice concern.Question 5: Which U.S. law created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research?
Choices:
1) The Health Insurance Portability and Accountability Act 2) The National Research Act of 1974 3) The Food, Drug, and Cosmetic Act of 1938 4) The Privacy Act of 1974
Correct Answer: The National Research Act of 1974
Explanation: The National Research Act of 1974 created the National Commission, which later issued the Belmont Report and helped shape modern federal human-subject protections.Page 3