In healthcare, research matters to everyone. Even if your practice has never been actively involved in a research study, you are, on a daily basis, consuming the fruits of other people’s research. Modern medical practice is built on decades of carefully conducted research from around the world that tells us, in any clinical situation, what to do and how to do it. And the more we are all involved in research, the faster we can push back the current limits of healthcare.
Many general practices in the UK are accredited as ‘Research Ready’ and are actively involved in research, but many more would like to be. Sometimes, though, it can seem a daunting prospect to make the staff and the facilities ready. Sometimes, the complex regulatory maze we have to navigate to get involved may seem more trouble that it’s worth. But, often it comes down to a simple matter of attitude. How should we approach research, how important is it to have the right mindset and what are the principles that underpin it?
As soon as you contemplate being a research active practice, you will meet a set of standards called GCP or more fully, Good Clinical Practice. What is that all about?
What is GCP?
Unfortunately, the term ‘Good Clinical Practice’ is just about the worst possible name for what we are talking about. You see, it has nothing to do with clinical practice—good or otherwise. Rather, it is a set of principles that we apply to the conduct of clinical research. Although these principles had their origins in the pharmaceutical industry back in the 1990s, they are now internationally recognized and have come to be regarded as the gold standard for the conduct of, not just drug trials but all research studies involving people.
All those involved in designing and conducting clinical trials are expected to be familiar with these principles and to work in accordance with them. There are many opportunities to attend courses or participate in online training for GCP, but in many ways these principles represent a way of thinking about research that everyone should acquire. And that state of mind revolves around three main concepts—safety, quality and respect.
Safety, quality and respect
Above all, when conducting any form of clinical research we must have the safety and well-being of our patients or healthy volunteers at the forefront of our mind. We should design our studies and carry them out with the participant in mind, always asking the question: is what we are doing as safe as it can be?
The end result of any research project is of course a set of results that we hope will help us change clinical practice for the better. We will only be able to do that though if we have taken all the care necessary to ensure that our results are accurate. The quality of our work is therefore of great importance, and GCP has a lot to say about how we should go about gathering and assessing our data. At the core of this is the call for good documentation. Of course, this is important in healthcare generally, but it is even more so in research, where the basic motto of the various regulatory agencies who govern research is: ‘if it isn’t documented, it didn’t happen.’
And we should never forget that we are working with people. Our research participants are not nameless numbers, but people with rights and dignity, and everything we do in research should be done with respect. That respect will be evident when we involve our participants fully in the study process and view them, not as research subjects, but as the most important members of our research team. When we take the time to explain our projects to prospective participants and seek their truly informed consent we are putting that respect into practice.
So, if we are involved in research we should always ask ourselves three questions: is what I plan to do as safe as possible, will it produce the highest quality results, and is it respectful? If the answer to all three questions is yes, then we can be sure that we are working very much to the spirit of GCP and the other regulatory frameworks that govern the conduct of research in the UK. However, if there is any doubt in our minds, we should pause for thought and think how we might do it better.
Getting involved in clinical research for the first time can be challenging, but the rewards can be considerable both for the practice and its patients. We are expected to understand and follow the principles of GCP, but often this amounts to everyone in the practice having the right attitude to research and never to forget the importance of safety, quality and above all respect.
© Allan Gaw 2015
This article was published in Practice Matters Summer 2015 and can be accessed here.
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