Data falsification

Generally, there are even further sources of risk within software s, which cannot be covered by this approach. Routines can he called within software s, which operate outside of the covered hardware areas and can cause runtime errors and data falsification. Consequently the degree of independence is difficult to determine. 

There is a fundamental difference between such scientific controversies and what simply can be called scientific fraud, i.e., deliberate falsification or fudging of data. Sloppy experimental work or data keeping can also lead to questionable or incorrect conclusions, and, although these violate established scientific standards and must be corrected (as they will), they do not necessarily represent deliberate fraud. In all this, the professor has a strict personal responsibility. As he/she is getting most of the recognition for the accomplishment of the research, it is only natural that he/she must also shoulder the responsibility for any mistakes, errors, or even falsifications. It is not accepta-... 

Collusion might take place between laboratories so that independent data are not submitted. Proficiency testing schemes should be designed to ensure that there is as little collusion and falsification as possible. For example, alternative samples could be distributed within a round. Also instructions should make it clear that collusion is contrary to professional scientific conduct and serves only to nullity the benefits of proficiency testing. 

The fraudulent investigator may add data where the original are missing, possibly not wanting to admit that they forgot to obtain or record them or that they lost them (for instance, broken blood sample tube). Serious cases involve falsification of subject data where study subjects do not exist or were not actually recruited. Fthical approval and consent documentation are created at the site. ... 

At the conclusion of each inspection, FDA investigators prepare a report summarizing any deficiencies. In cases where they observe numerous or serious deviations, such as falsification of data, DSI classifies the inspection as official action indicated and sends a warning letter or Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) to the clinical investigator, specifying the deviations that were found. 

The intention of the GLP s is good, but must be tempered with the practical reality of academic research and education. Several scenarios could be advanced such as tampering., theft and falsification of data which would support the need for more regulation. Falsification of data has occurred as in the much publicized and extremely damaging IBT case. The university climate, however, must be such that innovation and creativity are fostered in a collegial atmosphere increasing limitations by way of regulations are detrimental to this atmosphere. 

The current good manufacturing practices (GMP) state that Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards [5]. This includes all electronic and hard copies of raw data, laboratory notebooks, and/or worksheets and reports. Additionally, the regulations require that records shall be readily available for authorized inspection [6]. Consequently, the organization must have a well-defined audit trail for the generation, storage, and retrieval of reports and raw data. It must also be shown that there is adequate document management and security of all raw data and reports in terms of both disaster recovery and prevention of falsification of results. 

Falsification of data. Data fabrication (creating data that never existed). Selective reporting of findings. Omission of data that conflicts with other data (leaving out information in order to make one s story seem better). Willful suppression of data (not revealing relevant information) and/or distortion of data (exaggeration, for example). 

One of the most commonly used methods of diversion in 2007 was the falsification of import permits. The Islamic Republic of Iran, for instance, suspended a consignment of 6 tons of pseudoephedrine that was being sent to Somalia in 2007. The import permit accompanying the order purportedly authorized the importation of 15 tons each of ephedrine and pseudoephedrine. According to data from exporting countries, however, the legitimate needs of Somalia do not exceed 100 kg per year. At the time the present report was issued, Somalia had not yet replied to the enquiries about the shipment. The Board notes with concern that several African States are not in a position to respond in a timely manner to pre-export... 

Each company should have a policy that strictly prohibits the deliberate falsification, mutilation, obliteration, or destruction of raw data and associated GMP documentation. Companies must insist on strict adherence to such policies and should take aggressive disciplinary action when lapses are detected. Failure to do so may subject the company and its corporate officers to severe regulatory sanctions, including criminal prosecution under the Federal Food, Drug, and Cosmetic Act, or the general criminal laws of the United States (Title 18, U.S. Code). Even inadvertent (non-deliberate) acts that result in loss of data or records should be prevented, and, if they occur, they should be promptly and thoroughly investigated. 

Falsification the deliberate distortion or omission of undesired data/results, including the dishonest misinterpretation of results... 

This part of the laboratory performance study is probably the most sensitive to the participants. The responsible of the evaluation may have to draw consequences from the achieved performance for the various participants. To assume this responsibility he needs to be scientifically competent. The organiser should also ensure that the data have been produced without any collusion of participants or falsification. Depending on the number of participants, the objective and the consequences of the study and the frequency of the trials, preservative measures against collusion may be taken (e.g. different and coded sets of test samples, etc). Whatever, it must remain clear to the participants that laboratory performance studies are first of all organised to help them to reach and maintain quality for the benefit of ail. 

Another, wider look at the scene is Robert Bell s Impure Science Fraud, Compromise and Political Influence in Scientific Research (1992). The major part of BeU s book is concerned with the falsification or distortion of data and results that had occurred within the academic biochemical and pharmaceutical community, and were investigated by Michigan s Congressman John DingeU and his Subcommittee on Oversights and Investigations. The most notorious was what became known as the David Baltimore case. The remainder of the book is concerned with government... 

In the context of the historical development of our knowledge of the structure of the 2-norbornyl cation since Winstein and Trifan s postulate in 1949, this comparison with the 1,2-dimethyl derivative is very important for aspects provided by the theory of scientific discoveries. As discussed in our book on aromatic diazo compounds (Zollinger, 1994, Chap. 9), verifications are never definitive, in science proofs are not possible (the term proof should only be used in mathematics) falsifications, however, can be definitive. It was shown that molecular orbital calculations and their application to experimental data on the IR and NMR spectra for the 2-norbornyl cation are consistent with a symmetrical, nonclassical cationic intermediate, but not with a rapid equilibrium between two classical intermediates. The... 

Obviously, theory does not support the existence of a-TaON. If it existed, it would lie higher in energy by 314 kj/mol when compared with the well-established j6-TaON. In fact, the successful literature search for the original X-ray data of a-TaON eventually supports the theoretical falsification of a-TaON existence [365]. We note that the falsity of this structure has not been spotted in the crystallographic databases for almost four decades, but electronic-structure calculations from first principles easily detect the problem. Independent structural checks, without having to re-do the synthesis, are now possible. Let us move on to another example. 

For an interesting case of data fabrication and falsification in macro-engineering product development, see Vandivier (1972). 

Prospective methods Several new techniques for the detection of fruit juice adulteration are still vmder development. These include pyrolysis mass spectrometry, size-exclusion chromatography, NIR spectrometry, and an expert system for data interpretation. With the methods of falsifying juices being so numerous and diverse, however, it is vm-likely that any single method will ever be capable of detecting all forms of falsification. 

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