Procedure for Handling Cases of Suspected Serious Breach, Misconduct & Fraud

Fraud and misconduct in research are on the rise globally with more of these being discovered at all stages of research. The consequence of fraud in research is that it defeats the purpose of evidence-based practice which should be based on facts established through research. This is a course that exposes techniques used in detecting fraud in research. Included in the course are the different kinds of research frauds and the methods of identifying them. Participants also learn about the responsibility of sponsors, investigators, and regulatory agencies in curbing research fraud.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

Lesson 1: Suspected Serious Breach, Misconduct & Fraud

• Types of Fraud and Misconduct in Clinical Research
• False Data Collection
• Data Fabrication
• Plagiarism
• Fraud/Misconducted Cases

Lesson 2: Mechanisms to Identify Fraud and Misconduct

Lesson 3: Who is Responsible to Identify Fraud & Misconduct

• Responsibility of Authors and Colleagues
• Responsibility of Journals
• Responsibility of Institute or University

Lesson 4: Reporting Misconduct and Fraud

• Policies Regarding Conduct, behavior, and Reporting
• Responsibility of Employees and Management Team
• Protection For Those Reporting Misconduct and Fraud
• Cooperation with a Reporter During the Investigation

Lesson 5: Mechanisms to Prevent Misconduct

• Primary and Secondary Preventions
• Problems in the Prevention of Fraud and Misconduct

Lesson 6: Management of Misconduct and Fraud by Various Countries

Conclusion

Glossary

Quiz