CRP CRP Informed Consent & Participant Rights 2 — Questions and Answers
Question 1: Which population requires additional safeguards for informed consent due to potentially diminished autonomy?
- Healthy adult volunteers
- Prisoners and pregnant women (Correct answer)
- Graduate students
- Employees of the sponsor
Correct answer: Prisoners and pregnant women
Prisoners and pregnant women are considered vulnerable populations requiring additional regulatory protections under Subparts B and C of 45 CFR Part 46.
Question 2: What is 'assent' in the context of pediatric research?
- A parent's legal consent on behalf of a child
- A child's affirmative agreement to participate alongside parental permission (Correct answer)
- An IRB's formal approval
- Sponsor sign-off on enrollment
Correct answer: A child's affirmative agreement to participate alongside parental permission
Assent is a child's affirmative agreement to participate; it is obtained in addition to—not instead of—parental permission.
Question 3: What does 'therapeutic misconception' mean in research informed consent?
- A participant incorrectly believes research procedures are designed for their personal medical benefit (Correct answer)
- A researcher misreports adverse events
- An IRB confuses exempt and expedited review categories
- A sponsor underpays participants
Correct answer: A participant incorrectly believes research procedures are designed for their personal medical benefit
Therapeutic misconception occurs when participants conflate research participation with individualized medical treatment, threatening the validity of their consent.
Question 4: In the US, who has authority to grant legally authorized representative (LAR) consent for adults who lack decision-making capacity?
- The principal investigator
- State law typically designates the LAR (e.g., spouse, adult child) (Correct answer)
- The IRB chair
- The study sponsor
Correct answer: State law typically designates the LAR (e.g., spouse, adult child)
State law generally determines who qualifies as a legally authorized representative to consent on behalf of a cognitively impaired adult.
Question 5: Which practice best supports participant comprehension during the consent process?
- Using technical scientific language to demonstrate expertise
- Providing consent forms at an 8th-grade reading level or lower (Correct answer)
- Limiting discussion to only 5 minutes
- Presenting the form only in writing without verbal explanation
Correct answer: Providing consent forms at an 8th-grade reading level or lower
Consent documents written at an 8th-grade reading level or lower improve comprehension for a broader range of participants.
Question 6: What is a 'short-form' written consent document?
- An abbreviated IRB protocol
- A written document stating key elements were orally presented and the participant agrees (Correct answer)
- A digital e-signature form
- A one-page summary of the full protocol
Correct answer: A written document stating key elements were orally presented and the participant agrees
A short-form consent document is a written statement confirming that the required consent elements were presented orally to the participant.
CRP CRP Informed Consent & Participant Rights 2
Which population requires additional safeguards for informed consent due to potentially diminished autonomy?