CIP Human Subjects Protection & Safety 4 — Questions and Answers
Question 1: A researcher conducts a study exclusively with prisoners. Under Subpart C (45 CFR 46), which category of research may be approved without additional OHRP consultation?
- Research on the causes and effects of incarceration that may benefit society broadly
- Research on practices intended to improve the health and well-being of the prisoner population (Correct answer)
- Research posing more than minimal risk without direct benefit to prisoners
- Research designed to test novel psychotropic medications in prisoners
Correct answer: Research on practices intended to improve the health and well-being of the prisoner population
Subpart C permits IRB approval without OHRP consultation for research on practices likely to improve health or well-being of the prisoner population, provided other conditions are met.
Question 2: Which of the following scenarios constitutes a 'protocol deviation' rather than a 'protocol violation'?
- Enrolling a subject who did not meet all inclusion criteria, putting them at increased risk
- A subject taking the study drug two hours later than scheduled with no impact on safety or data (Correct answer)
- Omitting a required safety blood draw from a high-risk participant
- Administering the wrong dose of an investigational drug to a subject
Correct answer: A subject taking the study drug two hours later than scheduled with no impact on safety or data
Minor deviations such as a slight timing difference that has no effect on safety or data integrity are protocol deviations; violations are deviations that affect subject safety or data validity.
Question 3: Under FDA regulations (21 CFR 50.25), which of the following is NOT a required basic element of informed consent?
- A description of the procedures to be followed
- A description of any reasonably foreseeable risks or discomforts
- The name of the IRB chair who reviewed the study (Correct answer)
- A statement that participation is voluntary and refusal involves no penalty
Correct answer: The name of the IRB chair who reviewed the study
FDA regulations specify eight basic elements of informed consent; the identity of the IRB chair is not among them.
Question 4: A pediatric study involves research with greater than minimal risk and no direct benefit to individual subjects. Under Subpart D, approval requires that:
- Both parents must consent and the child must assent regardless of age
- The intervention presents only a minor increase over minimal risk and is likely to yield generalizable knowledge about the subject's disorder (Correct answer)
- A DSMB is constituted and the sponsor agrees to pediatric labeling
- The FDA grants a waiver under the pediatric exclusivity provisions
Correct answer: The intervention presents only a minor increase over minimal risk and is likely to yield generalizable knowledge about the subject's disorder
Under 45 CFR 46.406, research with greater than minimal risk and no direct benefit to subjects may be approved only if risk is a minor increase over minimal risk and the study is likely to yield vital knowledge about the subjects' disorder.
Question 5: Which of the following best illustrates the concept of 'undue influence' in research recruitment?
- A consent form written at a 12th-grade reading level for a low-literacy population
- An employer offering paid leave only to employees who enroll in a company-sponsored study (Correct answer)
- A researcher explaining expected side effects in vivid detail
- An IRB requiring translation of consent documents into multiple languages
Correct answer: An employer offering paid leave only to employees who enroll in a company-sponsored study
Undue influence occurs when an excessive, unwarranted, or improper reward induces subjects to agree to research they would otherwise decline, such as employer-contingent benefits.
Question 6: When assessing the risk-benefit ratio of a research protocol, the IRB should:
- Compare aggregate group benefits against individual subject risks
- Weigh anticipated benefits to individual subjects and to society against the probability and magnitude of harms (Correct answer)
- Defer to the principal investigator's assessment as the clinical expert
- Consider only physical risks and exclude psychological or social risks
Correct answer: Weigh anticipated benefits to individual subjects and to society against the probability and magnitude of harms
The IRB must balance potential benefits—both to subjects and to society through knowledge gained—against the probability and magnitude of all anticipated harms.
Question 7: A Certificate of Confidentiality (CoC) issued by NIH protects researchers from being compelled to disclose:
- Study results to regulatory agencies conducting inspections
- Identifying information about research participants in legal proceedings (Correct answer)
- Intellectual property developed during federally funded research
- Adverse event data from the FDA during an IND review
Correct answer: Identifying information about research participants in legal proceedings
A Certificate of Confidentiality protects researchers from being forced to disclose identifying information about participants in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding.
CIP Human Subjects Protection & Safety 4
A researcher conducts a study exclusively with prisoners.
Under Subpart C (45 CFR 46), which category of research may be approved without additional OHRP consultation?