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) regulatio
...
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?
The pregnant woman and the father of the fetus. ✔✔A research project is designed to evaluate a
new experimental type of fetal surgery to correct diaphragmatic hernia in the fetus (a potentially
life-threatening condition for the baby) prior to delivery. This research is directed toward the fetus
as subject to meet the health needs of the fetus. The pregnant woman is otherwise healthy. The
investigator must obtain consent from whom?
There is compelling evidence that inclusion would be inappropriate with respect to the health of
the subjects ✔✔According to current NIH Guidelines, which of the following is adequate
justification for exclusion of women from NIH funded research?
The pregnant woman only. ✔✔Investigators wish to evaluate a new treatment for eclampsia (a life
threatening condition in pregnant women) in women 30 - 50 years of age. The research is intended
to directly benefit the pregnant woman who is otherwise healthy and competent. The investigator
must obtain consent from whom?
A study of the genetic links between DNA samples found at a prehistoric central Asian
archeological site and west coast Native American tribes. ✔✔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 is:
- Collaborative IRB review
- Ongoing consultation
- Planning disclosure of research results
- Community consultation ✔✔Which of the following practices can be effective in minimizing
group harms?
Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer
✔✔Which of the following studies has the LEAST potential to create group harm?
Significant risk device ✔✔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?
Treat the patient with the drug based on physician's best medical judgment ✔✔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 several reports about a drug
that is approved and marketed for another indication, but has shown some benefit for ADHD. The
physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient.
Which of the following would be the most appropriate course of action?
Submit the research protocol to the IRB for review and submit an IND application to the FDA
before conducting the research ✔✔An investigator proposes to study a marketed product sold to
treat high blood pressure in individuals over age 12 using a liquid formulation for children under
age 12. The drug sponsor hopes that the information from the research can be used to change the
labeling for use of the drug in younger children. Which of the following is the investigator's most
appropriate course of action?
Allow the use of electronic documents and signatures in the regulatory process for drugs and
devices. ✔✔The FDA's regulations related to electronic records and electronic signatures (21 CFR
Part 11) is intended to:
The medical center to replace the use of paper records with electronic records for its research.
✔✔An academic medical center is selecting a new database system for clinical research. The
system needs to be "Part 11 compliant" in order to allow:
for all human subjects research that uses PHI without an authorization from the data subject, except
for limited data sets. ✔✔Under HIPAA, a "disclosure accounting" is required:
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