The Informed Consent Process Flashcards
7 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 The Informed Consent Process flashcards as text
Which of the following accurately describes the concept of 'voluntariness' in informed consent?
Answer: Participation must be free from coercion or undue influence
Voluntariness means the subject's decision to participate is made freely, without coercion, undue influence, or manipulation.
What is the primary purpose of the 'comprehension' element in the Belmont Report's informed consent framework?
Answer: To ensure information is presented in a way subjects can actually understand
Comprehension requires that information be presented in a manner appropriate to the subject's capacity, using language they understand.
Electronic informed consent (eIC) must comply with which FDA guidance?
Answer: FDA Guidance on Use of Electronic Informed Consent
FDA issued specific guidance on Use of Electronic Informed Consent in Clinical Investigations, which eIC processes must follow.
A subject wants to withdraw from a study but is concerned their medical records will be erased. What must the investigator explain?
Answer: Data already collected may still be used, but no new data will be collected
Subjects may withdraw at any time without penalty, but data collected prior to withdrawal may be retained and used per regulatory requirements.
Under ICH E6(R2), the informed consent process must be documented in which trial master document?
Answer: The Investigator Site File / Trial Master File
ICH E6(R2) requires that documentation of the informed consent process, including signed consent forms, be maintained in the Investigator Site File/Trial Master File.
Which scenario would most likely require the IRB to suspend or terminate a study under 21 CFR 56.113?
Answer: Unexpected serious harm is occurring to subjects
The IRB has authority to suspend or terminate research when unexpected serious harm to subjects is identified, as required under 21 CFR 56.113.
What does 'capacity to consent' specifically refer to in clinical research?
Answer: The subject's cognitive ability to understand, appreciate, reason, and express a choice about participation
Capacity to consent involves four components: understanding information, appreciating its relevance, reasoning about options, and communicating a choice.