CPI CPI Informed Consent & Subject Rights 1 — Questions and Answers
Question 1: What is the primary purpose of the informed consent process in clinical research?
- To ensure subjects voluntarily agree to participate with full understanding of risks and benefits (Correct answer)
- To protect the sponsor from legal liability
- To satisfy IRB administrative requirements
- To document that the subject has read all study materials
Correct answer: To ensure subjects voluntarily agree to participate with full understanding of risks and benefits
Informed consent ensures research subjects autonomously decide to participate after being fully informed of the study's nature, risks, benefits, and alternatives.
Question 2: Which federal regulation primarily governs informed consent requirements for FDA-regulated clinical investigations?
- 45 CFR Part 46
- 21 CFR Part 50 (Correct answer)
- 21 CFR Part 312
- 45 CFR Part 164
Correct answer: 21 CFR Part 50
21 CFR Part 50 sets the FDA's specific requirements for informed consent in clinical investigations involving human subjects.
Question 3: Under FDA regulations, how long must a clinical investigator retain signed informed consent documents?
- 1 year after study completion
- 2 years after the study's marketing application or IND discontinuation (Correct answer)
- 5 years after study completion
- Indefinitely
Correct answer: 2 years after the study's marketing application or IND discontinuation
Per 21 CFR 312.62, investigators must retain consent documents for at least 2 years following the date of marketing application approval or IND discontinuation.
Question 4: Which of the following is NOT a required element of informed consent under 21 CFR Part 50?
- Description of reasonably foreseeable risks
- Statement that participation is voluntary
- Subject's insurance coverage details (Correct answer)
- Statement describing confidentiality of records
Correct answer: Subject's insurance coverage details
Insurance coverage details are not a federally mandated element of informed consent; the required elements focus on risks, benefits, alternatives, confidentiality, and voluntary participation.
Question 5: Under what circumstance must an investigator obtain re-consent from an existing research subject?
- When the study reaches its halfway enrollment milestone
- When a protocol amendment introduces new risks or changes that may affect willingness to continue (Correct answer)
- Annually regardless of study changes
- When the IRB membership changes
Correct answer: When a protocol amendment introduces new risks or changes that may affect willingness to continue
Re-consent is required when protocol amendments introduce significant new information—such as new risks or changes to procedures—that could affect a subject's decision to continue.
Question 6: Which population requires special additional protections for informed consent under Subpart B of 45 CFR Part 46?
- Elderly subjects over age 65
- Pregnant women, fetuses, and neonates (Correct answer)
- Active-duty military personnel
- Employees of the sponsoring institution
Correct answer: Pregnant women, fetuses, and neonates
Subpart B of 45 CFR Part 46 provides additional protections specifically for pregnant women, human fetuses, and neonates involved in research.
CPI CPI Informed Consent & Subject Rights 1
What is the primary purpose of the informed consent process in clinical research?