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According to the U.S. Public Health Service, the definition of the term "investigator": - Includes anyone involved in the conduct or reporting of research. An investigator received $4,000 of consulting income from a publicly traded drug company over the past 12 months. The investigator also own...

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of A. Institutional vulnerability B. Communicative vulnerability C. Economic vulnerability D. Social vulnerability - C. Economic vulnerability A...

Why are institutionally provisioned technology systems (in other words, systems provided through a university, hospital, or clinic) generally more secure than consumer products? - Because information technology professionals have vetted them with the vendor. When would an IRB consider the risks o...

What must you file before conducting human clinical trials with an experimental drug? - IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? - Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA wit...

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. Which of the following are the three principles discussed in the Belmont Report? - ...

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four? - Physical control, coercion, undue influence, and manipulation In considering NBAC's analytic approach, an otherwise competent ...

What is the term for management controls that are built in to a research study (for example, independent data analysis)? - Inherent controls An example of an individual financial COI is: - A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of th...

Which of the following studies would need IRB approval? - Studies collecting identifiable information about living individuals. Identify one way faculty researchers can possibly avoid undue influence of student subjects? - Avoid recruiting their own students in the research Under the U.S. Depart...

he 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: - Persons with diminished autonomy are entitled to protection. Which of the following are the three principles dis...

A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. The student will not collect identifiable information. This study would be subject to which type...

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: A. Persons with diminished autonomy should only participate in no more than minimal risk research. B. Persons wit...

1. Which of the following are the three principles discussed in the Belmont Report? - Respect for Persons, Beneficence, Justice 2. The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, ...

Three principles of Belmont Report - Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - TRUE The Belmont Report Res...