FRAUD, CONFLICT OF INTEREST, AND ENFORCEMENT IN CLINICAL RESEARCH

Sheehan proposed the following questions, answer, facts, and hypothesis on fraud in research.27

Ql. How is fraud defined in the courts?

Q2. How does fraud frequently manifest itself in scientific research? Q3. How is fraud defined?

A3. The knowing breach of the standard of good faith and fair dealing as understood in the community, involving deception or breach of trust, for money.

Q4. How does fraud apply to conflict-of-interest questions in medical research?

Q5. Was the bad conduct intentional?

Q6. How to determine whether to prosecute a case?

Q7. Does a case go to trial?

Q8. What if I signed up for a clinical trial?

Q9. What would I expect?

Q10. What would I rely upon?

Q11. What is the standard of good faith and fair dealing with respect to my family or me?

Q12. Are community standards met?

Q13. Who is also a treating physician?

Q14. What is responsibility to research participants of main investigator who is treating physician?

Q15. What did it motivate scientists to commit fraud?

Q16. Was good faith and fair dealing violated in a research project? Q17. Did the investigator ignore warning signs?

Q18. Did the investigator decide not to consult guidance?

Q19. Did the investigator seek advice and not follow it?

Q20. Was researcher’s conduct consistent with community standard of good faith and fair dealing?

Q21. Why was the decision made to ignore or contradict the guidance?

Q22. Who do they obtain grants and use the funds to meet other departmental goals?

Q23. How extensive is the problem of fraud in medical research?

F1. (Ranstam, 2000). 40% of researchers were aware of misconduct but

did not report it.28

F2. (Gardner, 2005). 17% of authors of clinical drug trials knew of fabrication in research.29

Q24. Who are caught cheating?

Q25. Who have much less power than the researchers and institutions have?

Q26. How best to protect research participants and patients?

Q27. How to protect the interests of research subjects?

Q28. What might potential jurors expect in terms of conduct on the part of a researcher?

HI. Lawyers’ maxim: The guilty fleeth where no manpursueth.

Q29. Has anyone been told to lie or has been threatened?

FRAUD AND MISCONDUCT IN CLINICAL RESEARCH: A CONCERN

Gupta proposed facts, questions, and answers on fraud and misconduct in clinical research.30

F1. (Ranstam, 2000). 40% of surveyed researchers were aware of misconduct but did not report it.

F2. (Gardner, 2005). 17% of authors of clinical drug trials knew of fabrication in research.

Q1. Is fraud and misconduct the same?

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

Q2. Why does anyone commit fraud/misconduct?

A2. Reasons for fraud/misconduct in clinical research could vary from personal to professional.

Q3. Are there different types of fraud/misconduct?

A3. Fraud can be fabrication, falsification and plagiarism of data, or even deception in conduct.

Q4. Can research fraud be picked up early?

A4. Red flags during the conduct of a clinical trial should prompt the monitor to be more vigilant.

Q5. What could be the impact of fraud?

A5. Costs to sponsor in tenns of additional resource for investigating fraud and cost of repeating.

Q6. How can people strengthen research misconduct and fraud detection?

A6. They should have internal control/review mechanisms for monitoring ethical/quality aspects.

Q7. Who are involved in clinical research?

Q8. What are various countries doing to manage research fraud?

A8. Despite fraud being recognized as a criminal act by all nations there are no international rules.

Q9. Can people prevent fraud from ever happening?

A9. It might not but definitely measures can be taken to reduce its incidence (cf Table 13.1).31

Q10. How to report fraud?

TABLE 13.1 Measures that Can be Taken to Reduce Fraud Incidence to a Great Extent.

Adopt zero tolerance (all suspected misconduct must be reported and all allegations must be thoroughly and fairly investigated).

Protect whistleblowers (careful attention must be paid to the creation and dissemination of measures to protect whistleblowers).

Clarify how to report (establish clear policies, procedures, and guidelines related to misconduct and responsible conduct).

Train the mentors (researchers must be educated to pay more attention to how they work with their junior team members).

Use alternative mechanisms (institutions need continuing mechanisms to review and evaluate the research and training environment of their institution, for example, internal auditing of research records).

Model ethical behavior (institutions successfully stop cheating when they have leaders who communicate what is acceptable behavior, develop fair and appropriate procedures for handling misconduct cases, develop and promote ethical behavior, and provide clear deterrents that are coimnunicated).

Source: Ref. [31].

Q11. How do researchers work with their junior team members?

Q12. What is acceptable behavior?

Q13. Can people build the culture of research?

A13. A culture of research should be developed based on integrity, openness, and honest work.

He provided the following conclusion (C).

С1. Culture of research developed in system based on integrity/openness/ honest work is critical.

 
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