CIP Ethical & Regulatory Compliance 3 — Questions and Answers
Question 1: Under the Common Rule, continuing review by the IRB is required at intervals appropriate to the degree of risk, but no less than:
- Every 6 months
- Every 12 months (Correct answer)
- Every 18 months
- Every 24 months
Correct answer: Every 12 months
45 CFR 46.109(e) requires that IRBs conduct continuing review at intervals appropriate to the degree of risk, but not less than once per year.
Question 2: Which of the following best defines 'minimal risk' as used in federal research regulations?
- No possibility of harm to participants
- The probability and magnitude of harm anticipated are not greater than those ordinarily encountered in daily life (Correct answer)
- Risk that is less than 5% probability of adverse events
- Any risk that is outweighed by the benefits of the research
Correct answer: The probability and magnitude of harm anticipated are not greater than those ordinarily encountered in daily life
45 CFR 46.102(j) defines minimal risk as the probability and magnitude of harm or discomfort anticipated in the research not being greater than those ordinarily encountered in daily life or routine physical/psychological examinations.
Question 3: In the context of IRB review, 'assent' differs from 'consent' in that assent:
- Applies only to adult participants with diminished autonomy
- Is the agreement of a minor or cognitively impaired individual who cannot legally consent (Correct answer)
- Requires written documentation in all cases
- Replaces parental permission when children are 15 or older
Correct answer: Is the agreement of a minor or cognitively impaired individual who cannot legally consent
Assent is the affirmative agreement of a minor or cognitively impaired individual to participate, while legal informed consent must still be obtained from a legally authorized representative.
Question 4: A researcher discovers that a participant has experienced an unexpected serious adverse event (SAE) possibly related to the study intervention. What is the researcher's primary obligation?
- Report the SAE to the sponsor only and await instructions
- Report the SAE promptly to the IRB, sponsor, and applicable regulatory authorities per protocol requirements (Correct answer)
- Continue the study and document the SAE in the final report
- Remove the participant from the study without notifying the IRB
Correct answer: Report the SAE promptly to the IRB, sponsor, and applicable regulatory authorities per protocol requirements
Unanticipated problems involving risks to subjects or others must be reported promptly to the IRB, and SAEs must also be reported to the sponsor and relevant regulatory bodies per applicable regulations.
Question 5: Which of the following IRB review categories allows for approval by one or more experienced IRB members rather than requiring full board review?
- Exempt research
- Expedited review (Correct answer)
- Full board review
- Continuing review
Correct answer: Expedited review
Expedited review under 45 CFR 46.110 allows a single experienced IRB member or small subset of the board to review and approve studies that present no more than minimal risk and fit listed categories.
Question 6: The concept of 'therapeutic misconception' in research ethics refers to:
- Researchers misrepresenting the risks of treatment to enrollees
- Participants mistakenly believing that research procedures are designed to benefit them personally rather than generate generalizable knowledge (Correct answer)
- IRBs incorrectly classifying therapeutic studies as minimal risk
- Sponsors conflating regulatory approval with IRB approval
Correct answer: Participants mistakenly believing that research procedures are designed to benefit them personally rather than generate generalizable knowledge
Therapeutic misconception occurs when research participants confuse the purpose of research (generating knowledge) with individual medical care, which can impair true informed consent.
Question 7: Under HIPAA, which of the following is NOT considered Protected Health Information (PHI)?
- A patient's diagnosis documented in a medical record
- De-identified health information that meets Safe Harbor or Expert Determination standards (Correct answer)
- A patient's date of birth combined with their medical condition
- An individual's geographic data at the ZIP code level (fewer than 20,000 people)
Correct answer: De-identified health information that meets Safe Harbor or Expert Determination standards
Information that has been de-identified using either the Safe Harbor method (removing 18 identifiers) or Expert Determination method is no longer PHI and is not subject to HIPAA Privacy Rule protections.
CIP Ethical & Regulatory Compliance 3
Under the Common Rule, continuing review by the IRB is required at intervals appropriate to the degree of risk, but no less than: