CITI TRAINING QUESTIONS AND ANSWERS

Census data (the final report as published by the Census Bureau) is an example of: - Answer- Public Information According to the federal regulations, which of the following studies meets the definition of research with human subjects? - Answer- 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 the federal regulations, which of the following studies meets the definition of research with human subjects? - Answer- A cognitive psychologist enrolls undergraduate students for a computer-based 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? - Answer- 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, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or: - Answer- Identifiable private information. In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? - Answer- Prisoners. According to federal regulations, the expedited review process may be used when the study procedures pose: - Answer- 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 - Answer- The research falls into one of six categories of research activity described in the regulations. Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? - Answer- officials of the institution may overrule an IRB approval. Continuing review of an approved and ongoing protocol - Answer- Must occur within 12 months of the approval date. 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 d