CPI Regulatory Compliance & Ethical Standards 3 — Questions and Answers
Question 1: An investigator is also a treating physician for a potential study participant. Which conflict of interest concern is MOST relevant to informed consent?
- The investigator may underestimate the participant's medical literacy
- The dual role may impair the participant's ability to freely decline or withdraw without fearing impact on their clinical care (Correct answer)
- The investigator may disclose proprietary sponsor information during the consent process
- The IRB will automatically disqualify the investigator from obtaining consent
Correct answer: The dual role may impair the participant's ability to freely decline or withdraw without fearing impact on their clinical care
The therapeutic misconception and fear of jeopardizing ongoing care can compromise voluntariness when the treating physician is also the investigator.
Question 2: Under 45 CFR Part 46, research that qualifies for exemption under Category 1 involves which type of participants?
- Prisoners and incarcerated individuals only
- Normal educational practices in established educational settings (Correct answer)
- Cognitively impaired adults in residential facilities
- Pregnant women in third-trimester studies
Correct answer: Normal educational practices in established educational settings
Category 1 exemption applies to research involving normal educational practices in established educational settings.
Question 3: When a clinical trial requires a HIPAA Authorization, which of the following is a required element that distinguishes it from a general informed consent form?
- A description of the study's primary endpoint
- A list of the types of protected health information to be used or disclosed (Correct answer)
- The investigator's professional license number
- A summary of competing sponsor interests
Correct answer: A list of the types of protected health information to be used or disclosed
HIPAA Authorization must specifically describe the protected health information (PHI) to be used or disclosed, which is distinct from general informed consent requirements.
Question 4: A clinical trial site receives a sponsor audit. The auditor finds that source documents are missing for 3 participants. What is the regulatory implication?
- The study must be terminated immediately by FDA mandate
- Missing source documents constitute a data integrity failure that may trigger FDA inspection and clinical hold (Correct answer)
- Participants must be re-consented to replace missing documentation
- The sponsor must reimburse the site for document recovery costs
Correct answer: Missing source documents constitute a data integrity failure that may trigger FDA inspection and clinical hold
Missing source documents undermine data integrity and verifiability, and can result in sponsor corrective actions, FDA inspection, or rejection of submitted data.
Question 5: The principle of justice in the Belmont Report specifically addresses which of the following research ethics concerns?
- Ensuring the research design is scientifically rigorous
- Fair distribution of the burdens and benefits of research across population groups (Correct answer)
- Protecting participant autonomy through informed consent
- Minimizing physical risks to research participants
Correct answer: Fair distribution of the burdens and benefits of research across population groups
Justice requires equitable selection of research subjects so that no group bears a disproportionate burden or is systematically excluded from benefits.
Question 6: Under 21 CFR 50.25, which of the following is classified as an ADDITIONAL element of informed consent (rather than a basic required element)?
- A description of foreseeable risks or discomforts to the participant
- A statement that records may be inspected by FDA
- Disclosure that a particular treatment or procedure may involve currently unforeseeable risks to a participant or embryo if pregnant (Correct answer)
- An explanation of the purpose of the research
Correct answer: Disclosure that a particular treatment or procedure may involve currently unforeseeable risks to a participant or embryo if pregnant
The disclosure of unforeseeable risks to participants or embryos is listed under 21 CFR 50.25(b) as an additional element, not a basic required one.
Question 7: Which action is considered a SERIOUS GCP violation that would most likely trigger an FDA Warning Letter to an investigator?
- Using an unapproved form version for 2 participants before correction
- Enrolling participants who did not meet eligibility criteria and falsifying screening data (Correct answer)
- Filing an IRB annual renewal 3 days late due to administrative error
- Storing investigational product at 2°C instead of the protocol-required 4°C for a single day
Correct answer: Enrolling participants who did not meet eligibility criteria and falsifying screening data
Falsifying screening data and enrolling ineligible participants constitutes research fraud and data integrity failure, the most serious GCP violation triggering FDA enforcement action.
CPI Regulatory Compliance & Ethical Standards 3
An investigator is also a treating physician for a potential study participant.
Which conflict of interest concern is MOST relevant to informed consent?