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 subjects requires consent from a Legally Authorized Representative (LAR) rather than the subject themselves?
Answer: A minor child enrolled in a pediatric trial
Minor children lack legal capacity to provide independent informed consent, so an LAR (parent or guardian) must consent on their behalf.
Under 21 CFR 50.55, when must a child's assent be obtained in addition to parental permission?
Answer: When the IRB determines the child is capable of providing assent
The IRB determines on a case-by-case basis whether children are capable of providing assent, and if so, assent must be obtained.
An investigator wants to waive the requirement for signed informed consent documentation. Which regulation governs this waiver?
Answer: 45 CFR 46.117(c)
45 CFR 46.117(c) permits the IRB to waive the requirement for a signed consent form under specific conditions.
When enrolling prisoners in research, which additional federal regulation applies beyond standard informed consent requirements?
Answer: 45 CFR 46 Subpart C
45 CFR 46 Subpart C specifically addresses additional protections for prisoners as a vulnerable population in research.
A subject with fluctuating decision-making capacity signs consent during a lucid interval. What is the most appropriate next step?
Answer: Obtain concurrent LAR consent and reassess capacity regularly
Best practice for subjects with fluctuating capacity is to obtain both LAR consent and subject assent, with ongoing capacity reassessment.
Which element of informed consent must be disclosed when a study involves more than minimal risk?
Answer: Compensation available for research-related injury
21 CFR 50.25(a)(6) requires disclosure of compensation and medical treatment available if injury occurs in studies involving more than minimal risk.
A subject who does not speak English must be consented using a 'short form' consent document. What additional requirement applies?
Answer: A witness to the oral presentation must sign both the short form and the summary
When using a short form, FDA requires a witness to the oral presentation who signs both the short form and the written summary of the consent.