Research Ethics & Compliance Flashcards
7 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 7 Research Ethics & Compliance flashcards as text
Under HIPAA, which of the following is required for researchers to access protected health information (PHI) without individual authorization?
Answer: An IRB or Privacy Board waiver of authorization
HIPAA allows waiver of authorization for research when an IRB or Privacy Board determines that specific criteria under 45 CFR 164.512(i) are met.
The concept of 'therapeutic misconception' in research ethics refers to:
Answer: Participants confusing the goals of research with the goals of clinical care
Therapeutic misconception occurs when participants mistakenly believe research procedures are designed for their personal medical benefit rather than to generate generalizable knowledge.
A researcher conducting a study in a low-income community overseas must apply which ethical standard for consent?
Answer: The most protective standard between US regulations and host country law
International research must meet the higher of applicable US standards and host country requirements to ensure equivalent protection for participants.
What is required when a PI transfers an ongoing federally funded study to a new institution?
Answer: A new IRB review and approval at the receiving institution, plus notification of the funding agency
Institutional transfer of a study requires new IRB registration and approval at the receiving institution and notification to the federal funding agency.
Which of the following best describes 'assent' in pediatric research?
Answer: An affirmative agreement by a child who is not old enough to legally consent
Assent is a child's affirmative agreement to participate in research and is required along with parental permission when the child is capable of providing it.
A single-center pilot study unexpectedly produces compelling preliminary results. The PI decides to publish without notifying the IRB. The main ethical concern is:
Answer: Potential breach of the protocol if publication triggers study changes without oversight
Significant findings may prompt protocol modifications or early termination decisions that require IRB oversight before or alongside publication.
According to 21 CFR Part 312, what is the investigator's obligation regarding an Investigational New Drug (IND) annual report?
Answer: Investigators must provide the sponsor with information needed to prepare and submit the annual report
Under 21 CFR 312.55, investigators must provide sponsors with the information needed to prepare the required annual IND progress report submitted to FDA.