CIP Ethical & Regulatory Compliance 4 — Questions and Answers
Question 1: A researcher proposes a study involving deception where participants are not told the true purpose of the research. The IRB may approve this only if:
- The deception is never revealed to participants
- The study cannot be conducted without deception, the risks are minimal, and subjects are debriefed as soon as possible (Correct answer)
- The researcher obtains verbal consent for the deception itself
- The funding agency has approved the use of deception
Correct answer: The study cannot be conducted without deception, the risks are minimal, and subjects are debriefed as soon as possible
Under 45 CFR 46.116(c), the IRB may waive or alter informed consent elements for deceptive research only if the study cannot practicably be conducted otherwise, risks are minimal, and subjects are debriefed after participation.
Question 2: Which of the following scenarios represents a conflict of interest that an IRB member must disclose?
- The IRB member works at the same institution as the PI
- The IRB member holds stock in the company sponsoring the study under review (Correct answer)
- The IRB member has previously reviewed a different study by the same PI
- The IRB member is the same gender as the PI
Correct answer: The IRB member holds stock in the company sponsoring the study under review
A financial relationship with the sponsor, such as holding company stock, creates a conflict of interest requiring disclosure and recusal from IRB deliberation and voting on that study.
Question 3: The principle of 'respect for persons' in the Belmont Report encompasses which two moral requirements?
- Risk minimization and equitable subject selection
- Autonomy of individuals and protection of those with diminished autonomy (Correct answer)
- Beneficence and non-maleficence
- Scientific validity and social value
Correct answer: Autonomy of individuals and protection of those with diminished autonomy
Respect for Persons requires acknowledging individual autonomy and providing additional protections for those with diminished autonomy, forming the ethical basis for informed consent requirements.
Question 4: A Certificate of Confidentiality (CoC) protects researchers from being compelled to disclose which type of information?
- Financial records of the research study
- Identifiable, sensitive research data that could harm subjects if disclosed (Correct answer)
- The identity of the IRB members who reviewed the study
- Proprietary methods used in the research protocol
Correct answer: Identifiable, sensitive research data that could harm subjects if disclosed
A CoC, authorized under 42 USC 241(d), protects researchers from compelled disclosure of identifiable, sensitive research data through legal demands such as subpoenas or court orders.
Question 5: When research involves greater than minimal risk to children but offers the prospect of direct benefit, the IRB must determine that:
- The risk is justified by the anticipated benefit to the subjects and the relation of risk to benefit is at least as favorable as alternative approaches (Correct answer)
- The research presents no more than a minor increase over minimal risk
- Parental permission is waived due to the potential benefit
- The FDA has independently approved the study design
Correct answer: The risk is justified by the anticipated benefit to the subjects and the relation of risk to benefit is at least as favorable as alternative approaches
Under 45 CFR 46.405 (Subpart D), research with greater than minimal risk that offers direct benefit to child subjects may be approved if the risk-benefit ratio is at least as favorable as available alternatives.
Question 6: Which document formally defines an IRB's operating procedures, membership requirements, and review processes?
- Institutional Assurance (FWA)
- IRB Written Procedures and Standard Operating Procedures (SOPs) (Correct answer)
- Principal Investigator's Protocol
- OHRP Compliance Determination Letter
Correct answer: IRB Written Procedures and Standard Operating Procedures (SOPs)
Written procedures and SOPs document how the IRB operates, including membership composition, meeting quorum requirements, review categories, and reporting procedures, as required by 45 CFR 46.108(a).
Question 7: In research, 'equipoise' refers to:
- Equal distribution of risks and benefits across study arms
- Genuine uncertainty in the scientific community about which treatment arm is superior (Correct answer)
- The requirement that placebo and active arms have equal sample sizes
- Balancing financial incentives against research risks
Correct answer: Genuine uncertainty in the scientific community about which treatment arm is superior
Clinical equipoise is the genuine uncertainty that exists in the expert medical community about the comparative merits of the treatments being tested, which ethically justifies randomization in clinical trials.
CIP Ethical & Regulatory Compliance 4
A researcher proposes a study involving deception where participants are not told the true purpose of the research.
The IRB may approve this only if: