CITI CERTIFICATION 2025 FALL TERM CURRENTLY TESTING STUDY TEST GUIDE- 100%
ACCURATE SOLUTIONS
A census is a regularly-occurring and official count of a particular population. Census data
available at the United States Census Bureau website are an example of:
Public information
Identify the following groups that are protected in the federal regulations (45 CFR 46),
specifically in Subparts B, C, and D with additional protections:
Pregnant women, prisoners, children
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill
might be considered at especially high risk of harm for:
Situational cognitive vulnerability
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting patients to be subjects
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
Subjects with a serious illness may be at risk for exploitation because they may be
desperate for a possible cure. This is an example of:
,Medical vulnerability
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?
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).
According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study
involves:
No more than minimal risk to the child.
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?
Assent of the child and permission of both parents are required.
, The results from research have been known to produce harms to members of the sampled
population who do not actually participate in the research study. An example of the type of
research that could result in group harms by stigmatizing members of the group (even for
individuals who do not participate in the research) is:
A study of the types and prevalence of sexually transmitted infections (STIs) in small rural
towns in a midwestern state.
Which of the following practices can be effective in minimizing group harms?
- Collaborative IRB review- Ongoing consultation- Planning disclosure of research results-
Community consultation
Which of the following studies has the LEAST potential to create group harm?
A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with
breast cancer.
A sponsor proposes research to evaluate reengineering a commercially available
pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when
compared to the current commercially available product. How should this device be
classified?
Significant risk device
An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To
date, no behavioral or drug interventions have proven useful. The physician has just read
ACCURATE SOLUTIONS
A census is a regularly-occurring and official count of a particular population. Census data
available at the United States Census Bureau website are an example of:
Public information
Identify the following groups that are protected in the federal regulations (45 CFR 46),
specifically in Subparts B, C, and D with additional protections:
Pregnant women, prisoners, children
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill
might be considered at especially high risk of harm for:
Situational cognitive vulnerability
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting patients to be subjects
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
Subjects with a serious illness may be at risk for exploitation because they may be
desperate for a possible cure. This is an example of:
,Medical vulnerability
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?
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).
According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study
involves:
No more than minimal risk to the child.
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?
Assent of the child and permission of both parents are required.
, The results from research have been known to produce harms to members of the sampled
population who do not actually participate in the research study. An example of the type of
research that could result in group harms by stigmatizing members of the group (even for
individuals who do not participate in the research) is:
A study of the types and prevalence of sexually transmitted infections (STIs) in small rural
towns in a midwestern state.
Which of the following practices can be effective in minimizing group harms?
- Collaborative IRB review- Ongoing consultation- Planning disclosure of research results-
Community consultation
Which of the following studies has the LEAST potential to create group harm?
A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with
breast cancer.
A sponsor proposes research to evaluate reengineering a commercially available
pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when
compared to the current commercially available product. How should this device be
classified?
Significant risk device
An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To
date, no behavioral or drug interventions have proven useful. The physician has just read
