EXAM STUDY MAT ERIALS 8/7/2024 11:29 AM
Citi Training Exam Questions With Correct Answers
Why are institutionally provisioned technology systems (in other words, systems provided through a university, hospital, or clinic) generally more secure than consumer products? - answer✔✔Because information technology professionals have vetted them with the vendor.When would an IRB consider the risks of a study to be controlled? - answer✔✔When there is an appropriate risk mitigation and management plan in place.What existing federal regulations define technology-based risk assessment? - answer✔✔None of the above Why do custom-built, homegrown, and/or investigational technologies pose the greatest risk to research participants? - answer✔✔Because researchers cannot know all the potential risks until participants have used the technology in practice.How can a Bring Your Own Device (BYOD) study approach reduce or mitigate technology- related risks? - answer✔✔The participant may already know the risks of using the device if they are familiar with it for personal use. This decision indicates a level of pre-research risk acceptance.Data lifecycle management refers to what? - answer✔✔The ongoing oversight of research data by the researchers for the study's duration Instead of "data will be stored on the researcher's computer," what should a strong data security plan state? - answer✔✔Data will be stored on an encrypted computer with a strong password that only the researcher knows.What is passive mobile data collection? - answer✔✔Data collection that occurs on the device that the researcher and participant are unaware of Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - answer✔✔Determining that the study has a maximization of benefits and a minimization of risks. 1 / 2
EXAM STUDY MAT ERIALS 8/7/2024 11:29 AM
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 - answer✔✔Persons with diminished autonomy are entitled to protection Which of the following are the three principles discussed in the Belmont Report? - answer✔✔Respect for Persons, Beneficence, Justice The two exempt research categories that always require limited IRB review as a condition of exemption are: Storage or maintenance for secondary research for which broad consent is required (Category 7) and which of the following? - answer✔✔Secondary research for which broad consent is required (Category 8) The Final Rule added a definition for three new terms, including: clinical trial, written or in
writing, and: - answer✔✔Public health authority
The Final Rule made revisions to the following definition: - answer✔✔Human subject The following category of research was added to the "Exempt Research" section at 46.104: - answer✔✔Benign behavioral interventions The compliance date for cooperative review is: - answer✔✔Three years from publishing the 2017 Final Rule in the Federal Register Broad consent for storage, maintenance, and secondary research use may be obtained: - answer✔✔In lieu of a full informed consent The definition of "research" was expanded to: - answer✔✔List activities that are specifically deemed not to be research Research approved on 1 September 2019 conducted by a regulated entity would be subject to: - answer✔✔Final Rule (2018 Requirements) The Final Rule made revisions to the following definition: - answer✔✔Human subject The Final Rule revised the definition of "written or in writing" to clarify: - answer✔✔That these terms include electronic formats A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report? - answer✔✔Justice (requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience.)
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