CITI Training Exam Questions and Answers 100% Correct
6 views 0 purchase
Course
CITI Training
Institution
CITI Training
CITI Training Exam Questions and Answers 100% Correct
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 ...
CITI Training Exam Questions and Answers
100% Correct
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? - ANSWER-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 convened IRB Committee approved a protocol as a more than minimal risk study on February 15, 2019. In
2020, the study remains open to enrollment with 14 subjects currently enrolled and receiving the intervention.
Which of the following best describes IRB continuation review requirements for this study? - ANSWER-The
research must be re-reviewed by the convened IRB on or before February 14, 2020.
.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: - ANSWER-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? - ANSWER-Honor the child's
decision
.A full IRB committee meeting is convened and one agenda item is a new research proposal to evaluate how
mothers interact with their children with learning disabilities. The inclusion criteria require the children to be a
minimum of five years of age. The protocol requires the mother of the child to look at the child without any
expression and not to talk to the child for three minutes.
The committee considers that the risks to the children could be more than minimal, but the proposal does not
include adequate information to make a final determination regarding the risks. Which of the following best
describes how the IRB should proceed? - ANSWER-Table the protocol and ask the investigator to provide the
needed information for review by the full board at the next convened meeting.
, .A full IRB committee meeting is convened and one agenda item is a new research proposal to evaluate how
mothers interact with their learning-disabled child. The inclusion criteria require the children to be a minimum
of five years of age. The protocol requires the mother of the child to look at the child without any expression
and not to talk to the child for three minutes. The committee determined that the mother's required task may
upset the child. The IRB approved the study with appropriate language in the parental permission form
regarding the possibility that children might become upset.
After the start of the study, the Principal Investigator reports to the IRB that, as expected, one of the children
became upset. The incident was handled according to the protocol and the child is fine. What should the IRB do
with regard to this report? - ANSWER-Nothing
.A full IRB committee meeting is convened. The IRB committee roster consists of 15 members. However, only 8
members are in attendance for today's meeting. One of the IRB members is Principal Investigator for one of the
studies being reviewed and receives a portion of her salary from the supporting grant.
The IRB member who is the Principal Investigator, must recuse herself from the room during both the final
deliberations and the vote on the study. Which of the following best describes the committee's action after the
member leaves the IRB meeting? - ANSWER-Defer the proposal to the next meeting because of a loss if
quorum.
.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? - ANSWER-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: - ANSWER-uses "plain language" that the
data subject can understand, similar to the requirement for an informed consent document
.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? - ANSWER-A pregnant woman and the father of the
fetus
.A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller stuviaunmatched. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $14.49. You're not tied to anything after your purchase.
