CITI Training, Modules 1-24 (Biomedical Research) 2022
Questions and Answers With Complete Solution
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy.
While the study is on-going, a new drug becomes commercially available that may have equal or
greater benefit to the subject. The investigator should do which of the following?
A. Do not tell the subject about the new drug because physicians have the right to try out new
treatments with their patients.
B. Withhold this new information to avoid confusing the subject with other treatment options or
alternatives.
C. Give the subject comprehensive information about the new drug, including its side effects.
Discuss the pros and cons of both the investigational drug and the commercially available drug and
then allow the subject to decide whether to withdraw from the research to take the new drug.
D. Tell the subject about the new drug but discourage him from switching treatments until the
study is completed. – C. Give the subject comprehensive information about the new drug, including
its side effects. Discuss the pros and cons of both the investigational drug and the commercially
available drug and then allow the subject to decide whether to withdraw from the research to take
the new drug.
A clinician may use a HUD without IRB approval:
A. In a clinical investigation to collect data on an HDE approved indication.
B. For compassionate use where no alternative device is available for a patient’s condition.
C. If the clinician determines that approval from an IRB cannot be obtained in time to prevent
serious harm or death to a patient.
D. For clinical use only. – C. If the clinician determines that approval from an IRB cannot be obtained
in time to prevent serious harm or death to a patient.
A Data Safety Monitoring Board report for an investigator-initiated investigational drug study
indicates a significantly higher than anticipated rate of an expected adverse event. This event
required revision of the informed consent form to disclose the higher rate. A change in the
eligibility criteria of the protocol to reduce the risk was implemented. Current subjects would be
reconsented.
A. This is not an unanticipated problem because the adverse event was acknowledged in the
consent form.
B. This is an unanticipated problem.
C. Current subjects should never be reconsented.
D. This study was an investigator-initiated study. There is no need to report to the IRB or any
federal agency. – B. This is an unanticipated problem.
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:
A. No risk to the child and no further IRB review is required.
B. No more than minimal risk to the child.
C. More than minimal risk with no prospect of direct benefit to the child.
D. More than minimal risk with prospect of direct benefit to the child. – B. 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). 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?
A. Consent both of the child’s parents instead.
B. Request the child reconsider assenting to the study.
C. Honor the child’s decision.
D. Seek permission from one of the child’s parent instead. – C. Honor the child’s decision.
A general requirement for the informed consent form is that it may not include any exculpatory
language. Exculpatory language is that which waives or appears to waive any of the subject’s legal
rights or releases or appears to release those conducting the research from liability for negligence.
Which of the following statements in a consent form is an example of exculpatory language?
A. In the event of any injury you may have related to this research, you will be given medical
treatment.
B. Your participation in this research is voluntary. If you choose not to participate, or change your
mind later, your decision will not affect your relationship with your doctor or your right to health
care or other services that you may be eligible for.
C. The investigator may stop you from participating in this research without your consent if you
experience side effects that make your condition worse. If you become ill during the research, you
may have to drop out.
D. I waive any possibility of compensation for injuries that I may receive as a result of participation
in this research. – D. I waive any possibility of compensation for injuries that I may receive as a
result of participation in this research.
A HIPAA authorization has which of the following characteristics:
A. Cannot be revoked by the data subject.
B. Cannot be combined with any other document related to the research.
C. Is provided at the investigator’s discretion.
D. Uses “plain language” that the data subject can understand, similar to the requirement for an
informed consent document. – D. Uses “plain language” that the data subject can understand, similar
to the requirement for an informed consent document.
A Humanitarian Use Device (HUD) is a medical device:
A. Used to treat or diagnose a very common serious disease or condition where the likelihood of
death is high unless the device is used
B. Used to treat or diagnose a common disease or condition in individuals who do not qualify for
participation in a clinical trial.
C. Used to treat or diagnose a disease or condition that affects not more than 8,000 individuals in
the U.S. annually.
D. That is proven to be safe and effective and is provided at no cost for qualifying patients. – C. Used
to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the U.S.
annually.
A research collaboration can be enhanced by:
A. Discussing intellectual property issues while the collaboration is forming.
B. Limiting the communication between researchers and industry partners.
C. Waiting to discuss authorship issues until after data collection.
D. Avoiding the issue of which journal to target since research team members might disagree. – A.
Discussing intellectual property issues while the collaboration is forming.
A research study aims to evaluate a new experimental type of fetoscopic laser surgery to correct a
potentially life-threatening condition for the fetus prior to delivery. This research is to meet the
health needs and directly benefit the fetus only. The pregnant woman is otherwise healthy. Per
Subpart B, the investigator must obtain consent from whom?
A. The father of the fetus only.
B. The pregnant woman and the father of the fetus (except if he is unable to consent because of
unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or
incest).
C. The pregnant woman only.
D. The state court where the research is taking place – B. The pregnant woman and the father of the
fetus (except if he is unable to consent because of unavailability, incompetence, or temporary
incapacity or the pregnancy resulted from rape or incest).
A research study wants to determine the effectiveness of two prenatal care group programs as
compared to individual prenatal care in reducing the risk for HIV in young women during and after
pregnancy. The IRB determines the research is no greater than minimal risk for the pregnant
women and the fetuses. Is this research permitted under Subpart B?
A. No – this research is not permitted because it involves fetuses.
B. Yes – this research is permitted.
C. This research is only permitted if it also presents a direct benefit to the mother and the fetus.
D. No – this research is not permitted with pregnant women. – Yes – this research is permitted.
A research study will compare a new combined behavioral and pharmacologic treatment with the
standard behavioral treatment alone for individuals with severe seasonal affected disorder (SAD).
The researcher wants to include pregnant women in the study. However, the pharmacologic
treatment has not been previously studied in non-pregnant women, nor have preclinical studies on
pregnant animals been conducted. Is this research permitted under Subpart B?
A. Yes- This research is permitted if because it may benefit the pregnant women.
B. No – this research is not permitted because it involves fetuses.
C. No – this research is not permitted with pregnant women.
D. Yes – this research is permitted. – C. No – this research is not permitted with pregnant women.
A researcher is conducting a written survey about people’s attitudes toward walking as an exercise
option at the local shopping mall that supports a walking program. The survey is anonymous
(without codes, names, or other information) and subjects may complete the survey and place it in
a box at the shopping mall exits. Which of the following is the most important issue that the
researcher addressed in planning the research?
A. Possibility of emotional distress for subjects from the questions themselves
B. Data analysis from a large sample size