IRB Law Questions 1. 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? The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. 2. The Belmont principle of beneficence requires that: Potential benefits justify the risks of harm. 3. 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: Respect for persons. 4. According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: Justice. 5. Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? Ensuring that risks are reasonable in relationship to anticipated benefits. 1. Which of the following are the three principles discussed in the Belmont Report? Respect for Persons, Beneficence, Justice. 2. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? Determining that the study has a maximization of benefits and a minimization of risks. 3. All of the following are true regarding the Belmont Report, EXCEPT: The Belmont Report defines and delineates the differences between "Practice" and "Research". The Belmont Report describes the concept of "Respect for Persons". The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest. The Belmont Report describes the need to carefully consider how research discoveries and risks will be fairly distributed in the society. 1. 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?
Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
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- Spring '14
- Rita Marcoux
- Informed consent, Human subject research, Belmont Report