STP Ethics in Research 3 — Questions and Answers
Question 1: A scientist publishes the same dataset in two separate journals without disclosure. This practice is called:
- Salami slicing
- Duplicate publication (Correct answer)
- Data dredging
- Selective reporting
Correct answer: Duplicate publication
Duplicate publication involves submitting or publishing the same data in multiple outlets without disclosure, misleading the scientific record.
Question 2: Assent in pediatric research differs from informed consent in that assent:
- Is legally binding and replaces parental consent
- Seeks the child's agreement while legal authority rests with the parent or guardian (Correct answer)
- Is only required for studies above minimal risk
- Applies exclusively to adolescents aged 15 and older
Correct answer: Seeks the child's agreement while legal authority rests with the parent or guardian
Assent is the child's affirmative agreement to participate, but legal authority to enroll the child remains with the parent or guardian.
Question 3: When a researcher has a financial stake in the company whose product they are studying, this is classified as:
- Research misconduct
- A conflict of interest (Correct answer)
- A protocol deviation
- A breach of confidentiality
Correct answer: A conflict of interest
A financial relationship with a sponsor or product manufacturer constitutes a conflict of interest that must be disclosed and managed.
Question 4: The principle of justice in research ethics most directly requires that:
- All participants receive the experimental treatment
- Benefits and burdens of research are distributed fairly across populations (Correct answer)
- Vulnerable populations are excluded from all studies
- Researchers disclose all funding sources
Correct answer: Benefits and burdens of research are distributed fairly across populations
Justice demands equitable selection of research subjects so that no single group bears a disproportionate burden or is unfairly excluded from benefits.
Question 5: An IRB conducts continuing review of an ongoing study primarily to:
- Approve publication of results
- Ensure that risks remain acceptable and the protocol is followed as approved (Correct answer)
- Determine final authorship order
- Audit the sponsor's financial records
Correct answer: Ensure that risks remain acceptable and the protocol is followed as approved
Continuing review allows the IRB to monitor ongoing studies, reassess risk-benefit ratios, and verify protocol compliance over time.
Question 6: Which of the following is NOT a required element of informed consent under federal regulations (21 CFR 50)?
- A statement that participation is voluntary
- The expected duration of participation
- The researcher's personal home address (Correct answer)
- A description of foreseeable risks
Correct answer: The researcher's personal home address
Federal regulations require disclosure of risks, duration, voluntary nature, and other elements, but do not require the researcher's personal home address.
Question 7: Whistleblower protections in research misconduct cases are important primarily because they:
- Guarantee the whistleblower authorship on corrected papers
- Encourage reporting without fear of retaliation (Correct answer)
- Automatically trigger federal criminal prosecution
- Transfer liability from the institution to the accused
Correct answer: Encourage reporting without fear of retaliation
Whistleblower protections are designed to foster a culture of accountability by shielding those who report misconduct from professional retaliation.
STP Ethics in Research 3
A scientist publishes the same dataset in two separate journals without disclosure.
This practice is called: