CITI Modules 9-17 Questions and Answers Already Passed

CITI Modules 9-17 Questions and Answers Already Passed prisoners Due to past abuses, which of the following groups of potential research subjects has specific Department of Health and Human Services (DHHS) regulations to ensure additional protections when this population is being considered for research. Since this research involves individual subjects who would be considered prisoners and examines the possible causes, effects, and processes of incarceration, the IRB should ensure that the additional requirements for prisoner research are met The purpose of a federally supported research study is to examine the effect of scheduled cell searches on gang violence among men confined to drug treatment facilities under court order. Which of the following best describes the IRB's duties when reviewing this research? one member who is a prisoner or prisoner representative When reviewing federally supported research involving prisoners, an IRB must have at least the following member, in addition to the standard requirements for IRBs to ensure that the prisoners' perspective is represented: research that is relevant to prisoners and their conditions or situations When researchers plan to involve a prisoner population, which best describes the type of federally supported research that may be conducted? Honor the child's decision A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of children age 8 and older is required for the study. A 10 year old firmly declined to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator? No more than minimal risk to the child A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study involves: Assent of the child and permission of both parents are required. An investigator proposes a study to determine the clinical relevance of a new assay technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer patients undergoing chemotherapy. The study requires that two additional bone marrow aspirates be performed during the course of chemotherapy. The subject's chemotherapy will not be altered based on the results of the assay technique measures. However, future patients with cancer would benefit from improved interventions based on study findings. The IRB determined that the activity was a minor increase over minimal risk. Which of the following statements best describes the IRB approval requirements for involving adolescent cancer patients in the research study?