STP Ethics in Research 4 — Questions and Answers
Question 1: A researcher conducting a community-based study in a developing country must obtain consent from village elders before approaching individuals. This requirement reflects:
- Waiver of individual informed consent
- Community consent as a supplement to individual autonomy-based consent (Correct answer)
- That collective consent replaces individual consent entirely
- A violation of the Declaration of Helsinki
Correct answer: Community consent as a supplement to individual autonomy-based consent
In some cultural contexts, community or group consent is sought as a prerequisite, but individual informed consent remains necessary alongside it.
Question 2: Data fabrication differs from data falsification in that fabrication involves:
- Manipulating existing data to change results
- Inventing data that were never actually collected (Correct answer)
- Removing outliers without justification
- Misrepresenting statistical methods
Correct answer: Inventing data that were never actually collected
Fabrication means creating fictitious data records, while falsification involves manipulating or misrepresenting data that actually exist.
Question 3: An expedited IRB review (rather than full board review) is appropriate when research involves:
- More than minimal risk to a vulnerable population
- No more than minimal risk using procedures already performed for diagnostic purposes (Correct answer)
- A new investigational drug with unknown risks
- Research on prisoners
Correct answer: No more than minimal risk using procedures already performed for diagnostic purposes
Expedited review applies to research involving no more than minimal risk and fitting specific categories, such as routine procedures done for diagnostic purposes.
Question 4: The concept of 'minimal risk' in human subjects research is defined relative to:
- The risk level the IRB finds acceptable for the specific population
- The risks of daily life or routine physical or psychological examinations (Correct answer)
- Zero harm to any participant under any circumstances
- The risk acceptable to a reasonable researcher
Correct answer: The risks of daily life or routine physical or psychological examinations
Under 45 CFR 46, minimal risk means probability and magnitude of harm not greater than those ordinarily encountered in daily life or routine examinations.
Question 5: Which body is responsible for investigating allegations of research misconduct at US federally funded institutions?
- The FDA's Office of Scientific Integrity
- The Office of Research Integrity (ORI) within HHS (Correct answer)
- The National Institutes of Health grants office
- The institution's IRB
Correct answer: The Office of Research Integrity (ORI) within HHS
The Office of Research Integrity (ORI) oversees research misconduct in PHS-funded research and reviews institutional investigations.
Question 6: A researcher selectively reports only statistically significant results from a battery of 20 tests without disclosing the full analysis. This is known as:
- Plagiarism
- P-hacking or selective outcome reporting (Correct answer)
- Salami publication
- Protocol deviation
Correct answer: P-hacking or selective outcome reporting
Selectively reporting significant results from multiple untested hypotheses inflates false-positive rates and constitutes a form of research misconduct called p-hacking or selective outcome reporting.
Question 7: A vulnerable population in research is best characterized as a group that:
- Consists entirely of minors under age 12
- May have diminished capacity to protect their own interests in a research context (Correct answer)
- Is excluded from all federally funded research
- Requires a waiver of informed consent automatically
Correct answer: May have diminished capacity to protect their own interests in a research context
Vulnerable populations—including prisoners, pregnant women, cognitively impaired individuals, and economically disadvantaged groups—require additional protections because their ability to safeguard their own interests may be compromised.
STP Ethics in Research 4
A researcher conducting a community-based study in a developing country must obtain consent from village elders before approaching individuals.
This requirement reflects: