CPI CPI Informed Consent & Human Subjects Protection

Question 1

Which federal regulation governs informed consent requirements for human subjects research in the United States?

Accepted Answer

45 CFR Part 46

Answer

21 CFR Part 11

Answer

45 CFR Part 164

Answer

21 CFR Part 50

Question 2

What is the minimum required element that must be included in every informed consent document?

Accepted Answer

A description of the purposes, risks, and benefits of the research

Answer

The sponsor's contact information

Answer

The PI's curriculum vitae

Answer

The estimated duration of the entire study

Question 3

When must a principal investigator obtain informed consent from a research participant?

Accepted Answer

Before any research procedures are performed

Answer

Within 24 hours of study enrollment

Answer

At the first follow-up visit

Answer

After baseline assessments are completed

Question 4

Which of the following best defines 'voluntariness' in the context of informed consent?

Accepted Answer

Participation is free from coercion or undue influence

Answer

The participant signs the consent form without assistance

Answer

The participant attends all study visits willingly

Answer

The consent form is written in plain language

Question 5

A research participant who has signed an informed consent form wants to withdraw from the study. What should the PI do?

Accepted Answer

Honor the withdrawal immediately without penalty

Answer

Ask the participant to complete the current assessment period first

Answer

Consult the sponsor before allowing withdrawal

Answer

Require 30 days advance notice per protocol

Question 6

Which document must be filed with the IRB before a PI can begin recruiting research participants?

Accepted Answer

IRB-approved protocol and consent form

Answer

Completed Case Report Forms (CRFs)

Answer

Sponsor financial agreement

Answer

Publication plan