Citi Training

Citi Training Complete 2023 What is the term for management controls that are built in to a research study (for example, independent data analysis)? Ans- Inherent controls An example of an individual financial COI is: Ans- A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: Ans- There may be bias by the peer reviewer as to the area of research The FDA regulations governing disclosure of individual COIs require: Ans- Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies The COI management plan aims to: Ans- Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed An example of an institutional COI is: Ans- An industry sponsor pays for the construction of a new research laboratory at the organization An example of an individual financial COI is: Ans- A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. Ans- No later than the time of proposal submission The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? Ans- Researcher A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: Ans- It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success AnsHumphreys 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: Ans- Respect for persons. 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? Ans- The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies? Ans- Harvard "Tastes, Ties, and Time (T3)" study (2006- 2009)" study According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: Ans- Justice Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? Ans- Ensuring that risks are reasonable in relationship to anticipated benefits. AnsAccording to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or: Ans- Identifiable private information. A medical record is an example of: Ans- Private information. According to the federal regulations, which of the following studies meets the definition of research with human subjects? Ans- A cognitive psychologist enrolls undergraduate students for a computerbased study about the effect of mood on problem solving behaviors. According to the federal regulations, which of the following studies meets the definition of research with human subjects? Ans- A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression. According to the federal regulations, which of the following studies meets the definition of research with human subjects? Ans- A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period. According to federal regulations, the expedited review process may be used when the study procedures pose: Ans- No more than minimal risk and the research activities fall within regulatory categories identified as eligible. According to the federal regulations, research is eligible for exemption, if Ans- The research falls into one of six categories of research activity described in the regulations. Continuing review of an approved and ongoing protocol Ans- Must occur within 12 months of the approval date. Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? Ans- Officials of the institution may overrule an IRB approval. In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? Ans- Prisoners. The primary purpose of a Certificate of Confidentiality is to: Ans- Protect identifiable research information from compelled disclosure. Additional safeguards that may be included in a social and behavioral study may include: Ans- Remove all direct identifiers from the data as soon as possible. If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: Ans- Obtain a waiver of documentation of informed consent. Risk of harm in social and behavioral sciences generally fall in three categories, which are: Ans- Invasion of privacy, breach of confidentiality, and study proce