How to Detect Fraud and Research Misconduct

Fraud and research misconduct is any intentional and serious deviation from acceptable practices such as fabrication, falsification, and plagiarism. When looking for misconduct, you must be able to distinguish between 1) innocent ignorance and lack of knowledge, 2) sloppiness and 3) malicious intent. Investigating fraud can become complicated, but for simplification, an example of innocent ignorance would be “backdating documents” such as the subject’s informed consent form because the subject forgot to date it when they signed. An example of sloppiness is completing the visit dates for each visit before it occurs and forgetting to correct the date when the visit doesn’t happen. Most importantly, an example of malicious intent is creating patients and/or creating data. This article will tell you how to approach the process and determine if fraud is happening at your principal investigator research center.

Difficulty: Moderately Challenging

Instructions

Things You'll Need:

• Basic Good Clinical Practices knowledge
• Clinical Research Center

1. 

   Interview the staff before, during and after your inspection. I have investigated at least 3 cases of investigator site fraud within the past 5 years. Each time, the fraud was initially discovered by the Clinical Research Associate and generally through discussion with clinical research staff and reviewing documents. When fraud is occurring, there is always a person who is not happy about it but scared for their jobs and keeps quiet or somebody who can’t wait to brag about their smartness. Use your intuition and observation skills to find this person.

2. Compare the data in the Case Report Form (CRF), medical records and source documents to each other. Look for consistent discrepancies are consistent similarities. For example, one of my fraud cases had 80 patients enrolled. Out of the 80 patients, more than 60 had the same blood pressure (BP) and heart rate (HR) for practically every visit. Did the same person take each BP and HR reading? Was the data documented by the same person? If so, interview them and ask how these results are obtained. Document the explanation and if it sounds “unreal or impossible”, press on with your interview. If they are spinning a tale, they tend to trip themselves up. Sometimes, people make innocent mistakes. I had one site with 148 subjects with the same ECG reading for each of 3 visits. I was concerned because overall the Clinical Research Coordinator seemed very good at her job and honest. During the interview, we found out she was manually calculating the results. She realized after the interview and consulting with a technician that for the past 5 years she had been using the wrong formula. That was an innocent mistake that looked like fraud; but you see how it could also be costly, to the subjects and the sponsor. This is why it is important to distinguish honest mistakes from fraud.

3. 

   Compare the signature on the Informed Consent Form, CRF, and other source documents to the clinical research site signature log (a required document for clinical trials) for accuracy and correctness. Compare the subject’s signature to those on medical records and other documents in the files to confirm that it is the subject’s true signature.

4. Confirm that there are historical medical records for each subject. If there are no historical medical records, look for an affidavit signed by the subject stating why such records are not available at the clinical research site.

5. Verify visit dates, birth dates, and other demographic information to ensure the subjects are real and involved with the site.

Tips & Warnings

• Trust is earned so expect fraud and let the documentation prove you wrong.
• Read and evaluate ECGs, laboratory results, and other required results. Don't just inventory and verify records' s existence.
• Look for completeness in the documentation. Observe page numbers. Question documents with missing pages.
• Question missing and incomplete information such as dates and times.
• Be polite but firm and do not let them evade your answers with intimidation techniques.
• Document your observations, finding and conversations. Obtain copies of suspicious documents.
• Immediately report to the sponsor.
• Fraud affects everyone. It delays getting new therapy to the public but more importantly it violates the people who was brave enough to participate. Not reporting fraud and research misconduct makes you just as guilty as the person doing it.

Resources

• The
• Office of Research Integrity

[rjs0714]

on 7/17/2008 Thanks for the information on detecting fraud and misconduct.