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CITI Training Human Subjects Protection Basic Course Exam Questions with Correct Answers

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CITI Training Human Subjects Protection Basic Course Exam Questions with Correct Answers A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. - Answer-A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. - Answer-A waiver of the requirement for documentation of informed consent may be granted when: Provide potential subjects with information at the appropriate reading comprehension level. - Answer-As part of the consent process, the federal regulations require researchers to: There was neither a violation of privacy nor a breach of confidentiality. - Answer-A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? Destroying all identifiers connected to the data. - Answer-Data are made anonymous by A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified. - Answer-Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?

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CITI Training Human Subjects Protection
Basic Course Exam Questions with
Correct Answers
persons with diminished autonomy are entitled to protection - Answer-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:

Determining that the study has a maximization of benefits and a minimization of risks. -
Answer-Which of the following is an example of how the principle of beneficence can be
applied to a study employing human subjects?

Respect for Persons, Beneficence, Justice - Answer-Which of the following are the
three principles discussed in the Belmont Report?

The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. -
Answer-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?

Respect for persons. - Answer-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:

Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study - Answer-The
researcher's failure to protect research subjects from deductive disclosure is the primary
ethical violation in which of the following studies?

Justice - Answer-According to the Belmont Report, the moral requirement that there be
fair outcomes in the selection of research subjects, expresses the principle of:

Potential benefits justify the risks of harm. - Answer-The Belmont principle of
beneficence requires that:

- Protecting the rights and welfare of human subjects.
- Assuring that all applicable institutional policies and federal regulations related to
research with human subjects are followed.
- Reviewing subject recruitment materials and strategies. - Answer-What is the
Institutional Review Board (IRB) charged with? (There may be more than one correct
answer. Please be sure to select all correct answers.)

Exempt - Answer-Which type of IRB review does not require an IRB approval but does
require a determination by the IRB or an IRB designee?

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