17 januari: Fraud & Misconduct

Question 1

What is the difference between fraud and misconduct?

Answer 1

Malicious intent turns misconduct into fraud.
Fraud is an intentional deception made for personal gain or to damage another individual, for instance, intentionally falsifying and/or fabricating research data, and misleading reporting of the results.

Misconduct may not be an intentional action, rather an act of poor management. It also includes failure to follow established protocols if this failure results in unreasonable risk or harm to humans.

Fraud should have an element of deliberate action, which is not the case with misconduct.

Question 2

Provide examples and exemplify the difference between misconduct and poor quality research.

Answer 2

Examples of research misconduct
• Failing to get consent from an ethics committee for research on human subjects
• Failing to admit that some data are missing, ignoring outliers, and failing to include data on sides effects in a clinical trial
• Failure to publish completed research

Examples of poor quality research
• Carelessness
• Data with minor errors
• Lack of attention to detail
• Inadequate/over-complex CRFs or poor instructions on how to complete them

Question 3

How did the ICH-GCP tried to prevent misconduct?

Answer 3

Auditors, monitoring, and training in the principles of GCP.

Question 4

It is the sponsor’s responsibility to appoint a suitable investigator. How do you detect unsuitable investigators? (Dit is een Tessa vraag)

Answer 4

Looking into investigator’s history, over busy people who don’t respond to their mail fast.