Fraud investigation

There has been much published on the incidence, detection and prosecution of publication fraud, rather less on fraud and misconduct in clinical research, but we should be equally concerned about research fraud. The Consensus Conference on Misconduct in Biomedical Research convened by the Faculty of Pharmaceutical Medicine and the Royal College of Physicians of Edinburgh in 1999 defined research misconduct as behavior by a researcher, intentional or not, that falls short of good ethical and scientific standards . Frank Wells, co-founder of MedicoLegal Investigations Ltd., the only specialist research fraud investigation company in Europe, prefers the generation of false data with the intention to deceive . 

Analogous procedures have been proposed for the identifica-tiott of butcher s meats (Jess and Uhlenhuth), for the identification of bones, for the determination of commercial albumins in fraud investigations, etc. 

Quebracho bark was first examined by Fraude, who isolated aspidospermine, and later by Hesse, who obtained quebrachine (yohimbine) and four other bases, aspidosamine, aspidospermatine, m.p. 162°, [a]n — 72-3°, hypoquebrachine and quebrachamine, of which the last has been confirmed by other workers the first and third, according to Ewins, are possibly decomposition products of aspidospermine. In the course of an investigation of this alkaloid Ewins isolated two unnamed bases. One of these, m.p. 149-150°, is probably quebrachamine the other crystallises from ethjd acetate in octahedra, m.p. 176-7°. 

Fraud is not limited to the investigator and his or her staff. Staff of pharmaceutical companies and institutions may alter CRTs, modify data sets, alter tables, suppress reported side effects or bias written reports. The detection of such activities, inside or outside an institution, by investigators or company staff relies on others in the same team recognising that something is suspicious. Double checking of data by colleagues and authentication of those data is the best deterrent to misconduct. 

The introduction of GCP has accelerated the need for quality control and quality assurance, particularly in the field of clinical research. Quality control is carried out by the staff who are responsible for the particular activity, working to SOPs that cover all the tasks under scrutiny. SOPs not only need to be written but must also be updated regularly. Quality assurance is the process which seeks to confirm that SOPs have been observed this is accomplished by the process of auditing. Internal audit departments should be under a separate management from the medical department. Regular audits can not only assure external bodies, such as regulatory authorities, that proper procedures have been followed, but also serve to deter those rare attempts at fraud on the part of clinical investigators, which occasionally become evident. ... 

One question that is frequently asked is what do you do with patients who get given the wrong treatment by mistake It must be said that this does not happen very frequently, but when it does it is necessary to dig a little and try to find out why this has happened. If it is an isolated case and is clearly an administrative error then it seems most reasonable to include that patient in the group according to treatment received. If, however, it is not an isolated case, maybe there are several such mistakes in the same centre, then this draws into question the validity of what is happening at that centre and one starts to think in terms of fraud, has the investigator correctly followed the randomisation scheme In such situations... 

The nature of tort litigation precludes systematic empirical investigation of the effect of legal rules on behavior. Not all accidents result in litigation. In addition, not all litigation actually stems from accidents some cases stem from nonaccidents (i.e., fraud). Finally, not all litigation results in a court decision. 

Berkeley group reported their inability to reproduce the original observation (Gregorich et al., Eur. J. Phys. A IS, 633 (2003)). A subsequent investigation (Gilchriese et al., 2003) revealed the original data had been fabricated by one individual, who was later connected to similar instances of fraud at Darmstadt in the work with elements 110 and 112 mentioned above. From these episodes, one learns that science works, fraud will be found, and the traditional method of independent confirmation of important findings is reaffirmed. 

Complete Patient Records (case forms) should be included, with any gaps clearly indicated and discussed. The natural FDA assumption is that any missing case record form represents either (a) an adverse reaction, (b) sloppy procedures, or (c) an attempt at fraud. Clearly document the reason for any missing case form, including the results of a Quality Assurance follow-up investigation. 

An excellent review on the subject has been recently published by Agrawal et al. (5) not only reporting technical issues and solutions around proteomics investigations but also extending the context to food security throughout reducing pathogen risk and food traceability to prevent frauds. Unfortunately,... 

Rep. Richard Tomy was convicted of vote fraud in the Louisiana Democratic primary following a federal grand jury investigation. Tomy was removed from the congressional seat that he won in the subsequent November general election. 

This part provides details on the reward scheme that allows pharmacists (pharmacies) to claim a financial reward where they have identified a fraudulent prescription form and thereby either prevented fraud or contributed with valuable information to the investigation of fraud. 

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