B) Falsification
The scenario described represents falsification, which is the intentional manipulation or omission of research data to misrepresent research findings. 1, 2
Understanding Research Misconduct Categories
Research misconduct is classically defined as three distinct violations 3:
- Fabrication: Creating data or results that never existed
- Falsification: Manipulating research materials, equipment, processes, or changing/omitting data to misrepresent research findings 2, 4
- Plagiarism: Using someone else's ideas, processes, results, or words without proper attribution 1, 2
Why This Is Falsification
The key distinguishing feature in this scenario is that the researcher:
- Did not create fictional data (which would be fabrication) 2
- Actively omitted real complications that actually occurred and adjusted the dataset to exclude these events 2, 4
- Manipulated existing data by selective exclusion to misrepresent the true complication rate 5
This selective omission of unfavorable data points constitutes data falsification because it involves changing or omitting data that were actually collected, thereby misrepresenting the research findings 2, 4. The researcher is essentially manipulating the dataset to present a misleadingly favorable outcome profile.
Clinical and Scientific Implications
Falsification in clinical trials is particularly serious because:
- It can directly harm patients who may be treated based on fraudulent safety data 4, 6
- It undermines scientific and public trust in clinical trial validity 4
- It represents a significant misrepresentation of research that affects clinical decision-making 5
The evidence indicates that while severe data fraud (fabrication and falsification) is relatively rare, it carries profound consequences when it occurs in clinical research 4. In clinical trials specifically, such misconduct accounted for 13% of all scientific misconduct findings reviewed by the Office of Research Integrity between 1992-2002 6.
Intent and Consequences
For this action to constitute research misconduct rather than merely poor research practice: