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Research Governance

Research is governed by a broad range of regulations, principles and standards, Razia Meer-Baloch shares her knowledge and experiences.
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Research is governed by a broad range of regulations, principles and standards of good practise that exist to achieve and continuously improve research quality. Yes, as researchers, we have some very important questions to answer. But we must do this in such a way that we safeguard participants and ensure that our researchers have ethical and of scientific quality. We’ve learnt some important lessons from the past in nineteen forty six in Germany at the end of the Second World War, a number of doctors went on trial for their research on prisoners of war without their consent.
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The outcome of these trials led to the first international guideline for human experimentation, the Nuremberg Code, a set of ethical principles for the protection of human subjects in medical research. The first and most important point of this code states that the voluntary consent of the human subject is absolutely essential and integral and heavily scrutinised process in all currently approved research. In nineteen sixty four, the World Medical Association provided specific ethical guidance for the conduct of research involving human subjects. The Declaration of Helsinki is a set of ethical principles which govern research, and its introduction contains a binding statement for clinicians. The health of my patients will be my first consideration.
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Standards of practise and research are continuously evolving, and good clinical practise, or GCP, which has its origins in the Declaration of Helsinki, is now an internationally recognised ethical and scientific quality standard for the design, conduct and reporting of research involving humans. Conducting research and compliance with this well recognised and data standard is also a legal requirement for certain types of research in certain countries. But why is it a legal requirement for some types of research and not for others? Understanding the history behind the development of GCP will help to explain this. In the 1990s, a series of conferences took place aimed at harmonising some of the research processes for the pharmaceutical industry.
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These conferences, known as ICH, brought together the regions of Europe, America and Japan with a mission to overcome GCP inconsistencies. Creating an agreed standard of practise for the conduct of research would help the pharmaceutical industry, because if they conducted their research in compliance with that agreed standard in one ICH country, the research would be of a standard that could then be mutually acceptable in the other ICH countries. This would eliminate the unnecessary delay in the global development and availability of new medicines and decrease the immense costs of research and development.
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The pharmaceutical industry adopted this standard as they had a vested interest in doing so, but for other types of research on drugs being conducted outside of this industry, in universities, in hospitals where the interest was not in the global development of new medicines, the incentives were different. And this led in some instances to dual standards in research conduct.
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Within the European Union, directives were published in two thousand and one and two thousand and five, which would make GCP a legal requirement for all trials of an investigation on medicinal products, whether they were conducted in the pharmaceutical industry or in academic institutions and hospitals, thus creating one standard of GCP that needed to be complied with for all trials involving an investigation on medicinal product. Similar laws exist in countries outside of the European Union. But what about standards for all the other research that is conducted, not involving an investigational medicinal products?
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What standards exist for trials involving surgery, public health and behavioural interventions for research into devices and investigating the best clinical management of different diseases in the UK All research falls under the Department of Health Standard, the U.K. Policy Framework for Health and Social Care Research. This policy framework sets out the principles of good practise in the management and conduct of health and social care research in the UK. You should check the laws and guidelines which govern research in the country in which your research is being conducted. These principles and standards of good clinical practise, along with a broad range of regulations which govern research, are defined as research governance.
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Research Governance includes the process for obtaining approvals to run a research project. It defines responsibilities and the roles of the people involved. Each country will have its own set of laws, regulations, policy documents and standards of GCP, which must be complied with, and it is important that you understand how these documents apply to you and your role in the research process. It is crucial that research is planned, regulated and conducted in such a way that is ethical, scientific and safeguards participants. We have learnt from the lessons of the past and continuously strive to promote good practise and improve research. Quality research governance sets out the standards to achieve this.

In this step, Razia Meer-Baloch elaborates on the broad range of regulations, principles and standards of ethical practice that exist to achieve and continuously improve research quality.

“The health of my patient will be my first consideration” – The Physician’s Oath, 1968
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