Monitoring and audit

In 1995 in response to an editorial18 written in the BMJ by Stephen Lock concerning the fraudulent publications in the British Journal of Obstetrics and Gynaecology, Iain Chalmers and Muir Gray, both members of the NHS Research and Development Directorate, and Trevor Sheldon of the NHS Centre for Reviews and Development26 agreed that national mechanisms must be in place to reassure the public that activities of the research community can, when necessary, be audited.

Box 17.1 Research governance framework for health and social care: the governance framework's recommendations

• The rights, safety, and well-being of participants must be the primary consideration in any research study.

• All research involving patients, users, and carers, or volunteers, or their data or material, must be reviewed independently to ensure it meets ethical standards.

• Patient's data must be protected.

• Research should reflect the diversity of the population.

• Research that duplicates other work unnecessarily or that is not of sufficient quality to contribute something useful to existing knowledge is unethical.

• All health and social care research should be subjected to rigorous review by recognised experts.

• Information

• There should be free access to information on research and on its findings, once these have been subjected to appropriate scientific review.

• Researchers should aim to publish their work and open it to critical review in the scientific press.

• Studies involving direct contact with patients, users, and carers, or the public, should provide accessible accounts of the research.

• Health and safety

• The safety of research participants and staff must be given priority at all times.

• Financial probity and compliance with the law and with the rules laid down by the Treasury for the use of public funds are as important in research as in any other area.

Dews and Vandenburg,27 as long ago as 1991, in a letter to the BMJ entitled "Preventing fraud", drew attention to the part that good practice has played within the pharmaceutical industry.28 The main thrust of good clinical practice is to protect the research subject and confirm the veracity of the research data. The elements of good clinical and research practice (GCP) have been enshrined within the many documents and legalities of the Food and Drug Administration (FDA), in the USA,29 which were brought to Europe by the guidelines issued by the Committee for Proprietary Medical Products.30

Within the pharmaceutical and medical devices industries the responsibility for the veracity of the research data lies with the investigator(s) and the monitors. Monitors must validate by comparing the research data written in case report form with the clinical patient records and raw laboratory data. In time pharmaceutical companies operating within the GCP framework must have at least one tier of auditors to audit the performance of investigators and monitors. In the USA the FDA has a team of compliance officers who check data validity.31 As Dews and Vandenberg wrote, "It is this typically American attitude of checks and balances that maximises the chance of detecting fraud in American pharmaceutical research." Furthermore, the FDA publishes a "blacklist" of researchers who have not met audit standards but, unlike the situation in Europe, it also has the power to institute change. We must also believe that the more recent advent of GCP in the UK and the rest of Europe will increase both detection and prevention of misconduct in research.

In the UK at present the only recourse is to the GMC, which of course has no jurisdiction over non-medically qualified scientific research workers. Europe still does not have any specific laws and, as Dews and Vandenburg wrote in 1991,27 "no government undertook audit, with the exception of Greece, which has two auditors, and the only other country intending to audit was France, although no definitive audit had occurred". Today in the new millennium, ten years later, despite all the publicity, the situation is not much different. At this time in many countries in Europe, excluding the Nordic countries, there is no external audit body to monitor, and local efforts within individual research institutions is patchy.

Along with others,31 it is difficult not to conclude that the pharmaceutical industry was doing much more to prevent misconduct and fraud in medical research than the many academic institutions and the NHS. Many researchers within the latter organisations can be scathing at worst or suspicious at best about the veracity of research sponsored by the industry compared with research sponsored by the traditional grant-giving bodies within academic institutions and the NHS. Maybe we should all be much more humble and learn their lessons, a view also expressed by others.32

Since then, things have indeed moved on and, in October 1996, the UK Medicines Control Agency formed a division to ensure GCP and to monitor compliance inspections and enforcement.

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