SOCRA The Informed Consent Process 2 — Questions and Answers
Question 1: Which of the following subjects requires consent from a Legally Authorized Representative (LAR) rather than the subject themselves?
- A healthy adult with a language barrier
- A minor child enrolled in a pediatric trial (Correct answer)
- A prisoner in a federal facility
- An elderly subject with mild hypertension
Correct 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.
Question 2: Under 21 CFR 50.55, when must a child's assent be obtained in addition to parental permission?
- Only when the child is over 18
- When the IRB determines the child is capable of providing assent (Correct answer)
- Assent is never required if a parent consents
- Only when the study involves more than minimal risk
Correct 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.
Question 3: An investigator wants to waive the requirement for signed informed consent documentation. Which regulation governs this waiver?
- 21 CFR 50.27(c)
- 21 CFR 50.25(a)
- 45 CFR 46.117(c) (Correct answer)
- 45 CFR 46.111(a)
Correct 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.
Question 4: When enrolling prisoners in research, which additional federal regulation applies beyond standard informed consent requirements?
- 21 CFR 312
- 45 CFR 46 Subpart C (Correct answer)
- 45 CFR 46 Subpart D
- 21 CFR 50.25
Correct answer: 45 CFR 46 Subpart C
45 CFR 46 Subpart C specifically addresses additional protections for prisoners as a vulnerable population in research.
Question 5: A subject with fluctuating decision-making capacity signs consent during a lucid interval. What is the most appropriate next step?
- Proceed without further action since consent was obtained
- Obtain concurrent LAR consent and reassess capacity regularly (Correct answer)
- Exclude the subject from the study
- Obtain only LAR consent and discard the subject's consent
Correct 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.
Question 6: Which element of informed consent must be disclosed when a study involves more than minimal risk?
- The investigator's publication record
- Compensation available for research-related injury (Correct answer)
- Names of all IRB members
- The sponsor's financial projections
Correct 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.
Question 7: A subject who does not speak English must be consented using a 'short form' consent document. What additional requirement applies?
- The study must be halted until a full translation is available
- A witness to the oral presentation must sign both the short form and the summary (Correct answer)
- Only the LAR needs to be present
- The sponsor must approve the short form consent
Correct 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.
SOCRA The Informed Consent Process 2
Which of the following subjects requires consent from a Legally Authorized Representative (LAR) rather than the subject themselves?