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
What is the primary role of an Institutional Review Board (IRB) in human subjects research?
Answer: To protect the rights and welfare of research participants
The IRB's primary role is to protect the rights, safety, and welfare of human research participants through independent review.
Which of the following research activities qualifies as 'exempt' from full IRB review under 45 CFR 46.104?
Answer: Research involving educational tests with no identifiable information
Research involving educational tests, surveys, or observation of public behavior where subjects cannot be identified may qualify for exempt status.
A PI discovers that a unanticipated problem involving risk to participants occurred. Within what timeframe must most IRBs be notified?
Answer: Promptly, typically within 5–10 business days
Unanticipated problems involving risks to subjects or others must be reported promptly to the IRB, sponsor, and regulatory authorities as required.
What is 'continuing review' as it relates to IRB oversight of an ongoing study?
Answer: Periodic re-evaluation of the study to ensure ongoing protection of participants
Continuing review is the IRB's periodic re-evaluation of an approved study, at least annually, to confirm ongoing protection of participants.
The Belmont Report identifies three core principles for ethical research involving human subjects. Which answer lists all three correctly?
Answer: Respect for persons, beneficence, and justice
The Belmont Report's three principles are respect for persons (autonomy), beneficence (do good/minimize harm), and justice (fair distribution of burdens and benefits).
When can a PI use a waiver of documentation of informed consent (waiver of written consent)?
Answer: When the research presents no more than minimal risk and involves no procedures requiring written consent outside the research
An IRB may waive the requirement for a signed consent form if the research involves minimal risk and the main risk would be a breach of confidentiality from the signed document.