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 condition must be met for an IRB to approve a waiver of informed consent for research under 45 CFR 46.116(f)?
Answer: The research could not practicably be carried out without the waiver
One key criterion for a consent waiver is that the research could not practicably be carried out without the waiver of informed consent.
What is 'therapeutic misconception' in the context of informed consent?
Answer: When subjects confuse research participation with receiving individualized medical care
Therapeutic misconception occurs when subjects fail to understand that the goal of research is to generate generalizable knowledge, not to optimize their individual care.
Under FDA regulations, how long must signed informed consent documents be retained?
Answer: At least 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued
21 CFR 312.62 requires retention of consent documents for at least 2 years after approval of a marketing application or 2 years after the investigation is discontinued.
A CRC discovers that an enrolled subject did not fully understand the risks when signing consent. What is the most appropriate immediate action?
Answer: Re-consent the subject with a thorough explanation of all risks before any further study procedures
The ethical obligation requires re-consenting the subject and ensuring full comprehension before any further study-related procedures are conducted.
Which of the following is an example of undue influence in the consent process?
Answer: A physician-investigator implying poorer care will result if the patient refuses to enroll
Undue influence occurs when a person in authority implies negative consequences for non-participation, compromising truly voluntary consent.
In emergency research under 21 CFR 50.24, what must occur within how many days after enrollment without consent?
Answer: The subject or LAR must be asked for consent as soon as feasible
Under 21 CFR 50.24, consent from the subject or LAR must be sought as soon as feasible once the emergency situation allows.
When must an investigator obtain re-consent from a study subject?
Answer: When there is a protocol amendment that materially affects subject risk or willingness to participate
Re-consent is required when protocol changes or new information significantly impact subject risk or could affect a subject's decision to continue participating.