CPI CPI Informed Consent & Human Subjects Protection 2 — Questions and Answers
Question 1: What is the primary role of an Institutional Review Board (IRB) in human subjects research?
- To protect the rights and welfare of research participants (Correct answer)
- To ensure the scientific validity of the study design
- To manage the study budget and funding
- To train research staff on GCP guidelines
Correct 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.
Question 2: Which of the following research activities qualifies as 'exempt' from full IRB review under 45 CFR 46.104?
- Research involving educational tests with no identifiable information (Correct answer)
- Clinical trials testing an investigational drug
- Research involving prisoners
- Observational studies of illegal behavior
Correct 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.
Question 3: A PI discovers that a unanticipated problem involving risk to participants occurred. Within what timeframe must most IRBs be notified?
- Promptly, typically within 5–10 business days (Correct answer)
- Within 30 calendar days
- At the next annual review
- Only if the participant files a complaint
Correct 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.
Question 4: What is 'continuing review' as it relates to IRB oversight of an ongoing study?
- Periodic re-evaluation of the study to ensure ongoing protection of participants (Correct answer)
- Monthly data audits by the sponsor
- Quarterly financial reporting to the funding agency
- Re-consenting all participants each year
Correct 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.
Question 5: The Belmont Report identifies three core principles for ethical research involving human subjects. Which answer lists all three correctly?
- Respect for persons, beneficence, and justice (Correct answer)
- Autonomy, nonmaleficence, and fidelity
- Confidentiality, beneficence, and equity
- Informed consent, safety, and transparency
Correct 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).
Question 6: When can a PI use a waiver of documentation of informed consent (waiver of written consent)?
- When the research presents no more than minimal risk and involves no procedures requiring written consent outside the research (Correct answer)
- When the participant is unable to read
- When the sponsor approves the waiver in writing
- When the study is federally funded
Correct 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.
CPI CPI Informed Consent & Human Subjects Protection 2
What is the primary role of an Institutional Review Board (IRB) in human subjects research?