CPI CPI Informed Consent & Human Subjects Protection 1 — Questions and Answers
Question 1: Which federal regulation governs informed consent requirements for human subjects research in the United States?
- 45 CFR Part 46 (Correct answer)
- 21 CFR Part 11
- 45 CFR Part 164
- 21 CFR Part 50
Correct answer: 45 CFR Part 46
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?
- A description of the purposes, risks, and benefits of the research (Correct answer)
- The sponsor's contact information
- The PI's curriculum vitae
- The estimated duration of the entire study
Correct answer: A description of the purposes, risks, and benefits of the research
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?
- Before any research procedures are performed (Correct answer)
- Within 24 hours of study enrollment
- At the first follow-up visit
- After baseline assessments are completed
Correct answer: Before any research procedures are performed
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?
- Participation is free from coercion or undue influence (Correct answer)
- The participant signs the consent form without assistance
- The participant attends all study visits willingly
- The consent form is written in plain language
Correct answer: Participation is free from coercion or undue influence
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?
- Honor the withdrawal immediately without penalty (Correct answer)
- Ask the participant to complete the current assessment period first
- Consult the sponsor before allowing withdrawal
- Require 30 days advance notice per protocol
Correct answer: Honor the withdrawal immediately without penalty
Participants have the right to withdraw at any time without penalty or loss of benefits to which they are otherwise entitled.
Question 6: Which document must be filed with the IRB before a PI can begin recruiting research participants?
- IRB-approved protocol and consent form (Correct answer)
- Completed Case Report Forms (CRFs)
- Sponsor financial agreement
- Publication plan
Correct answer: IRB-approved protocol and consent form
The IRB must review and approve the protocol and informed consent form before any recruitment or enrollment activities begin.
CPI CPI Informed Consent & Human Subjects Protection 1
Which federal regulation governs informed consent requirements for human subjects research in the United States?