CPI Informed Consent & Human Subjects Protection Flashcards
6 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CPI Informed Consent & Human Subjects Protection flashcards as text
Which federal regulation governs informed consent requirements for human subjects research in the United States?
Answer: 45 CFR Part 46
45 CFR Part 46, the Common Rule, establishes the federal standards for protecting human subjects including informed consent requirements.
What is the minimum required element that must be included in every informed consent document?
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.
When must a principal investigator obtain informed consent from a research participant?
Answer: Before any research procedures are performed
Informed consent must be obtained and documented before any research-related procedures are performed on a participant.
Which of the following best defines 'voluntariness' in the context of informed consent?
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.
A research participant who has signed an informed consent form wants to withdraw from the study. What should the PI do?
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.
Which document must be filed with the IRB before a PI can begin recruiting research participants?
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.