CIP Human Subjects Protection & Safety 2 — Questions and Answers
Question 1: Under the Common Rule, which of the following activities is NOT considered 'research' requiring IRB oversight?
- A systematic investigation designed to develop generalizable knowledge
- Quality improvement projects designed solely to improve local practice (Correct answer)
- A randomized controlled trial testing a new medication
- A study collecting identifiable biospecimens for future use
Correct answer: Quality improvement projects designed solely to improve local practice
Quality improvement projects intended solely to improve local practice, not to generate generalizable knowledge, do not meet the regulatory definition of research.
Question 2: A researcher wants to conduct a secondary analysis of de-identified data from a hospital registry. Under 45 CFR 46, this would most likely be:
- Exempt under Category 4 if the data cannot be re-identified (Correct answer)
- Subject to full board review due to sensitivity of medical data
- Expedited review because data are pre-existing
- Excluded from IRB oversight entirely with no determination needed
Correct answer: Exempt under Category 4 if the data cannot be re-identified
Research involving secondary analysis of existing de-identified data commonly qualifies for exemption under Category 4 of the revised Common Rule when re-identification is not possible.
Question 3: The principle of 'respect for persons' in the Belmont Report requires that:
- All research participants receive equal benefits regardless of risk
- Individuals with diminished autonomy must be protected and autonomous agents must be treated as such (Correct answer)
- Researchers must maximize benefits while minimizing risks for every subject
- The justice principle takes precedence when allocating research burdens
Correct answer: Individuals with diminished autonomy must be protected and autonomous agents must be treated as such
Respect for persons incorporates two convictions: individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.
Question 4: A DSMB (Data Safety Monitoring Board) is most critically needed in which type of study?
- A retrospective chart review examining disease prevalence
- A phase III randomized controlled trial with a mortality endpoint (Correct answer)
- An anonymous online survey about health behaviors
- A focus group study on patient satisfaction
Correct answer: A phase III randomized controlled trial with a mortality endpoint
DSMBs are most essential in trials with serious endpoints such as mortality, where ongoing safety monitoring may require early stopping to protect participants.
Question 5: Which of the following best describes a 'waiver of documentation of informed consent' under 45 CFR 46.117(c)?
- Eliminating the requirement for subjects to read the consent form
- Allowing consent without a signed form when the only link to identity is the signature itself (Correct answer)
- Permitting verbal consent for any minimal-risk study
- Removing the requirement to provide subjects with a written summary
Correct answer: Allowing consent without a signed form when the only link to identity is the signature itself
A waiver of documentation of consent is appropriate when the signature would be the only record linking the subject to the research, creating a greater breach risk than the research itself.
Question 6: An IRB is reviewing a protocol involving deception. For approval, the IRB must determine that:
- Subjects will never learn the true nature of the study
- Deception is necessary, subjects will not be harmed, and debriefing will be provided (Correct answer)
- Full consent waivers are not required when deception is used
- The researcher has published prior studies using similar deception
Correct answer: Deception is necessary, subjects will not be harmed, and debriefing will be provided
When deception is used, the IRB must confirm it is scientifically necessary, subjects will not be harmed, and a debriefing plan is in place to disclose the true purpose afterward.
Question 7: According to 45 CFR 46, 'minimal risk' is defined as the probability and magnitude of harm not greater than:
- The risks of a standard outpatient surgical procedure
- The risks encountered in daily life or routine physical or psychological examinations (Correct answer)
- A 1% chance of serious adverse events in a healthy adult population
- Risks deemed acceptable by the principal investigator
Correct answer: The risks encountered in daily life or routine physical or psychological examinations
The regulatory definition of minimal risk benchmarks against harms ordinarily encountered in daily life or during routine physical or psychological examinations or tests.
CIP Human Subjects Protection & Safety 2
Under the Common Rule, which of the following activities is NOT considered 'research' requiring IRB oversight?