FDA: Informed Consent For Clinical Trials! Trivia Questions Quiz
.
Questions and Answers
- 1.
Informed consent involves all of the following except:
- A.
Providing a potential subject with inadequate information to all for all informed consent decision about participation in the clinical investigation
- B.
Facilitating the potential subject's comprehension of the information
- C.
Providing an adequate opportunity for the potential subject to ask questions and consider whether to participate
- D.
Obtaining the potential subject's voluntary agreement to participate
- E.
Continuing to provide information as the clinical investigation progresses or as the subject or situation requires
Correct Answer
A. Providing a potential subject with inadequate information to all for all informed consent decision about participation in the clinical investigationExplanation
Informed consent involves providing a potential subject with adequate information to make an informed decision about participation in a clinical investigation. This includes facilitating their comprehension of the information, giving them an opportunity to ask questions and consider whether to participate, and obtaining their voluntary agreement. Additionally, informed consent requires continuing to provide information as the investigation progresses or as the subject or situation requires. Therefore, the statement that contradicts the concept of informed consent is providing a potential subject with inadequate information to allow for an informed decision.Rate this question:
-
- 2.
The consent form serves several purposes, including
- A.
Helping to ensure that the subject receives the required information
- B.
Providing a "take home" reminder of the elements of the clinical investigation
- C.
Providing contact information in case additional questions or concerns arise
- D.
Documenting the subjeect's voluntary agreement to participate
- E.
All of the above
Correct Answer
E. All of the aboveExplanation
The consent form serves several purposes, including ensuring that the subject receives the required information about the clinical investigation, providing a reminder of the elements of the study that the subject can take home, providing contact information in case of any additional questions or concerns, and documenting the subject's voluntary agreement to participate. Therefore, the correct answer is "all of the above."Rate this question:
-
- 3.
For all FDA-regulated clinical investigations (except as provided in 21 CFR 50.23 and 50.245), legally effective informed consent must be obtained from the subject or the subject's legally authorized representative.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The statement is true because according to FDA regulations, informed consent must be obtained from the subject or their legally authorized representative for all FDA-regulated clinical investigations, except in specific situations outlined in 21 CFR 50.23 and 50.245. This ensures that individuals participating in clinical trials are fully informed about the purpose, risks, and benefits of the study, and have the autonomy to make an informed decision about their participation.Rate this question:
-
- 4.
According to the Belmont Report, "Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain noncompliance."
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The explanation for the given answer, which is False, is that the statement provided in the Belmont Report is not accurate. Coercion is not defined as an overt threat of harm to obtain noncompliance, but rather as the use of force or threats to compel someone to act against their will. The statement in the Belmont Report does not mention force or compulsion, therefore it is not a correct definition of coercion.Rate this question:
-
- 5.
_____________is not a basic element of informed consent .
- A.
Description of clinical investigations
- B.
Voluntary participation
- C.
Contacts
- D.
Number of participation
Correct Answer
D. Number of participationExplanation
Informed consent is a process in which individuals are provided with information about a clinical investigation and voluntarily agree to participate. The basic elements of informed consent include a description of the clinical investigation, voluntary participation, and contacts for further information. The number of participation is not considered a basic element of informed consent as it does not directly relate to the individual's understanding of the study or their ability to make an informed decision about participating.Rate this question:
-
- 6.
The FDA believes that treatment options lacking evidence of therapeutic value do need to be discussed.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The FDA does not believe that treatment options lacking evidence of therapeutic value need to be discussed.Rate this question:
-
- 7.
The description of _________________should be clear, balanced, and based on reliable information to the extent such information is available.
- A.
Benefits
- B.
Confidentiality
Correct Answer
A. BenefitsExplanation
The description of benefits should be clear, balanced, and based on reliable information to the extent such information is available. This means that when explaining the benefits of something, it is important to provide a clear and unbiased view, using reliable and trustworthy information as much as possible. This ensures that the information provided is accurate and helpful for the audience.Rate this question:
-
- 8.
The consent process must note the possibility that FDA may inspect records and should state or imply that FDA needs permission from the subject for access to the records.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The explanation for the answer "False" is that the consent process does not need to note the possibility of FDA inspecting records or imply that FDA needs permission from the subject for access to the records. While FDA may indeed inspect records, it is not necessary to include this information in the consent process. The consent process primarily focuses on obtaining the subject's informed consent for participating in the study and disclosing any potential risks or benefits associated with the study.Rate this question:
-
- 9.
______________requires that subjects be informed that they may decline to take part in the clinical investigation or may stop participation at any time without penalty or loss of benefits to which subjects are entitled.
- A.
Alternative procedures or treatment
- B.
Benefits
- C.
Voluntary participation
- D.
Confidentiality
Correct Answer
C. Voluntary participationExplanation
Voluntary participation refers to the ethical principle that individuals have the right to choose whether or not to participate in a clinical investigation. This principle ensures that subjects are fully informed about the study and have the freedom to decline participation or withdraw from the study at any time without facing any negative consequences or losing any benefits they are entitled to. It emphasizes the importance of respecting individual autonomy and protecting the rights and well-being of research participants.Rate this question:
-
- 10.
The FDA considers exculpatory language to be language that has the general effect of freeing or appearing to free an individual or an entity from all the following except:
- A.
Malpractice
- B.
Negligence
- C.
Blame
- D.
Beneficence
Correct Answer
D. BeneficenceExplanation
Exculpatory language is considered by the FDA as language that releases or appears to release someone or something from responsibility or blame. It is used to protect individuals or entities from being held accountable for malpractice, negligence, or blame. However, it does not exempt them from the principle of beneficence, which is the obligation to act in the best interest of others and promote their well-being. Therefore, the correct answer is beneficence.Rate this question:
-
Quiz Review Timeline +
Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.
-
Current Version
-
Apr 18, 2024Quiz Edited by
ProProfs Editorial Team -
Feb 24, 2018Quiz Created by
London Sanders
Which One of These Weirdly Named U.S. Towns Should You Live In?
Which One of These Weirdly Named U.S. Towns Should You Live In?
Which Manhattan Neighborhood Should I Live In Quiz
Which Manhattan Neighborhood Should I Live In Quiz
Back to top