STP Ethics in Research 5 — Questions and Answers
Question 1: A scientist discovers an error in a published paper after peer review. The appropriate first step is to:
- Ignore the error if the conclusions remain valid
- Contact the journal editor to issue a correction or erratum (Correct answer)
- Retract the paper immediately without notifying collaborators
- Publish a new paper superseding the old one without disclosure
Correct answer: Contact the journal editor to issue a correction or erratum
Authors are obligated to notify the journal and issue a correction or erratum promptly when a non-fraudulent error is discovered post-publication.
Question 2: Pre-registration of a clinical trial before participant enrollment is required primarily to:
- Secure funding from NIH
- Prevent outcome switching and selective reporting bias (Correct answer)
- Allow faster IRB approval
- Enable the sponsor to patent the protocol
Correct answer: Prevent outcome switching and selective reporting bias
Pre-registration publicly records primary outcomes before data collection, making it impossible to switch endpoints post-hoc to achieve significance.
Question 3: Under HIPAA's Privacy Rule, a limited data set differs from fully de-identified data in that a limited data set:
- Contains all 18 direct identifiers
- Retains certain geographic and date information but removes direct identifiers (Correct answer)
- Requires no data use agreement
- Can be shared publicly without restriction
Correct answer: Retains certain geographic and date information but removes direct identifiers
A limited data set removes direct identifiers but may retain geographic subdivisions below state level and dates, and must be governed by a data use agreement.
Question 4: An investigator conducting a dual-use research of concern (DURC) study must:
- Publish findings immediately to prevent others from discovering them independently
- Assess potential biosecurity risks and consult institutional biosafety and biosecurity oversight bodies (Correct answer)
- Classify all results and share only with government sponsors
- Abandon the research if any dual-use potential exists
Correct answer: Assess potential biosecurity risks and consult institutional biosafety and biosecurity oversight bodies
DURC policies require researchers to conduct risk-benefit assessments and engage oversight bodies to mitigate misuse potential while enabling scientific progress.
Question 5: When an IRB waives the requirement for written documentation of informed consent, participants must still receive:
- Nothing additional—the waiver is complete
- A verbal explanation of the study with an opportunity to ask questions (Correct answer)
- Written consent from a legally authorized representative
- Full signed consent from their primary care physician
Correct answer: A verbal explanation of the study with an opportunity to ask questions
Waiving written documentation removes the signature requirement but does not eliminate the obligation to provide information and allow participants to make a voluntary, informed decision.
Question 6: A mentor who publishes a student's thesis data under the mentor's name alone is committing which form of research misconduct?
- Plagiarism and misappropriation of credit (Correct answer)
- Duplicate publication
- Selective reporting
- Protocol deviation
Correct answer: Plagiarism and misappropriation of credit
Taking another person's ideas, data, or work without attribution constitutes plagiarism and misappropriation of intellectual credit, a serious form of research misconduct.
Question 7: The concept of equipoise in randomized controlled trials means that:
- The investigator personally believes the experimental arm is superior
- There is genuine uncertainty in the expert community about which treatment is better (Correct answer)
- Both treatment arms must have equal sample sizes
- The placebo must be chemically identical to the active drug
Correct answer: There is genuine uncertainty in the expert community about which treatment is better
Clinical equipoise exists when there is honest, substantial disagreement among experts about the relative merits of interventions, ethically justifying random assignment.
STP Ethics in Research 5
A scientist discovers an error in a published paper after peer review.
The appropriate first step is to: