Question: The researcher’s failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

Answer: “Tastes, Ties, and Time (T3)” study (2006-2009)

Question: 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

Question: 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

Question: The Belmont principle of beneficence requires that:

Answer: Potential benefits justify the risks of harm.

Question: 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 Study of Untreated Syphilis

Question: Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:

Answer: Must occur within 12 months of the approval date.

Question: 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.

Question: 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

Question: According to the federal regulations, research is eligible for exemption, if:

Answer: The research falls into one of eight categories of research activity described in the regulations.

Question: 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.