CPI CPI Informed Consent & Subject Rights

Question 1

What is the primary purpose of the informed consent process in clinical research?

Accepted Answer

To ensure subjects voluntarily agree to participate with full understanding of risks and benefits

Answer

To protect the sponsor from legal liability

Answer

To satisfy IRB administrative requirements

Answer

To document that the subject has read all study materials

Question 2

Which federal regulation primarily governs informed consent requirements for FDA-regulated clinical investigations?

Accepted Answer

21 CFR Part 50

Answer

45 CFR Part 46

Answer

21 CFR Part 312

Answer

45 CFR Part 164

Question 3

Under FDA regulations, how long must a clinical investigator retain signed informed consent documents?

Accepted Answer

2 years after the study's marketing application or IND discontinuation

Answer

1 year after study completion

Answer

5 years after study completion

Answer

Indefinitely

Question 4

Which of the following is NOT a required element of informed consent under 21 CFR Part 50?

Accepted Answer

Subject's insurance coverage details

Answer

Description of reasonably foreseeable risks

Answer

Statement that participation is voluntary

Answer

Statement describing confidentiality of records

Question 5

Under what circumstance must an investigator obtain re-consent from an existing research subject?

Accepted Answer

When a protocol amendment introduces new risks or changes that may affect willingness to continue

Answer

When the study reaches its halfway enrollment milestone

Answer

Annually regardless of study changes

Answer

When the IRB membership changes

Question 6

Which population requires special additional protections for informed consent under Subpart B of 45 CFR Part 46?

Accepted Answer

Pregnant women, fetuses, and neonates

Answer

Elderly subjects over age 65

Answer

Active-duty military personnel

Answer

Employees of the sponsoring institution