CRP 112 Lecture 3 Flashcards
FRAUD VS MISCONDUCT
Both: violation of standard codes of conduct & ethical behaviour in scientific research
They are NOT
- Honest error or honest differences in:
- design
- execution
- interpretation
- judgment in evaluating research methods or
results
- Misconduct unrelated to the research
process
- Poor research unless it encompasses
“intention to deceive”
FRAUD definition
-Fabrication, falsification, plagiarism or
deception in proposing, carrying out or
reporting results of research
- Deliberate, dangerous or negligent
deviations from accepted practices in
carrying out research
-Element of deliberate action
Fabricating data
-Creating a new record of data or results
-Examples: ICF, participant diaries
Falsifying data
-Altering existing records
-Deliberate distortion or omission of undesired data or results
Plagiarism
Unacknowledged presentation or exploitation
of work and ideas of others’ as one’s own
Deception
-Deliberate concealment of a conflict of interest
- Inclusion of deliberately misleading statements
in research proposals or other documents
Motivation for Fraud
- Desired result, e.g., ‘statistical -significance’
- Monetary gain
- Enhancement of prestige
- Compensate for laziness, sloppiness in data collection
- Include participants who would otherwise be excluded
- Damage another individual
Data Prone to Fraud
Eligibility criteria
Repeated measurements, e.g. BP
Adverse events
Concomitant medications
Compliance
Participant diaries
Scientific Misconduct definition
Not intentional
Act of poor management
Includes failure to follow established
protocols if this failure results in
unreasonable risk or harm to humans
No element of deliberate action
i.e.
Failure to follow an investigational plan
Inadequate and inaccurate records
Inadequate drug accountability
Inadequate completion of ICFs
Failure to report adverse drug reactions
Failure to obtain and/or document consent
Failure to notify an Ethics Board of
changes/progress reports
Failure to obtain/document ethics approval
Detection of fraud and misconduct
-Role of REBs should be strengthened ( internal control & review mechanisms for monitoring ethical and quality aspects of studies)
-Simplify existing regulations to be more effective
-All organizations should have clear
operational policies/procedures for
approach to scientific misconduct and fraud
-Whistle blowers should be safeguarded with international guidelines and legislation (US has, Canada does not)
-Monitor to be vigilant & look at data with a magnifying glass- look for red flags
-Site practices or behaviour could raise suspicion
Auditor Questions
- How was fraud detected?
- Why was fraud committed?
- What are the consequences of fraud?
- How is data handled when fraud suspected or confirmed?
- Can statistical methods detect fraud?
- How can we prevent future episodes of fraud?
Prevention
Never discard original data
Understand that missing data and outliers
are expected
Human data is often random and difficult to
duplicate with fraud
Consequences of Fraud
Tarnishes public image of clinical trials
Tarnishes reputation of innocent researchers
Negatively impacts other research
Topples research organizations
Huge cost to sponsor
additional resource to investigate fraud and
cost of possibly repeating part or all of study
Disciplinary action for researchers
- Article published might be re-reviewed /retracted
-black listed for running clinical trials, No longer allowed to be a part of advisory committees or peer review boards
-affects validity of data and impacts
core of GCP adversely
-wrong or ineffective or harmful molecules being brought
to market
For Cause Inspections
Site doing large # of studies
Site doing studies outside their field of specialization
Site reporting better efficacy, fewer AEs or
different lab results than other sites
Enrolling too many participants for location
Complaints from participant, sponsor, REB, staff
Site has significant financial interest in IP
Defining misconduct part of problem
-QRP – Questionable
Research Practices
- “gift authorship” – most common
fraud
- “ghost authorship” is common for peer reviews
-power relations deter reporting
