CPI CPI Informed Consent & Human Subjects Protection 1

Question 1

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

Accepted Answer

45 CFR Part 46

Answer

45 CFR Part 46, the Common Rule, establishes the federal standards for protecting human subjects including informed consent requirements.

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

Every informed consent document must include a description of the research purpose, foreseeable risks and discomforts, and reasonably expected benefits.

Question 3

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

Accepted Answer

Before any research procedures are performed

Answer

Informed consent must be obtained and documented before any research-related procedures are performed on a participant.

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

Voluntariness means the prospective subject's decision to participate must be free from coercion and undue influence.

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

Participants have the right to withdraw at any time without penalty or loss of benefits to which they are otherwise entitled.

(CPI) Certified Principal Investigator Practice Test

(CPI) Certified Principal Investigator Practice Test

CPI CPI Informed Consent & Human Subjects Protection 1