Etiquette in Clinical Research: Some Do's and Don'ts When You Sign Up
In 2017, the Canada's governor general, Mr David Johnston, caused a diplomatic incident. His crime? While at an event in London (UK), he was observed lightly touching the Queen's elbow. Mr. Johnston was simply concerned about Her Majesty's safety as she was descending a set of stairs, but his kind gesture was an egregious breach of royal etiquette: Ladies and Gentlemen, you do not touch the Queen.
In Mr. Johnston's defence, he was not the first to break this rule (see Ex-Aussie PM John Howard, Ex-first lady Michelle Obama,... the list goes on), but the episode helps to draw attention to the topic of etiquette.
The word 'etiquette' stems from Old French, 'estiquette' which translates to "label, ticket". It refers to small cards that were written/printed with instructions for how was to behave properly at court (the royal variety that is).
Etiquette is an important - and often under-discussed - aspect of clinical research. A great deal of precious resources are involved in a clinical study, and there is a critical need for the research to be conducted in a correct and proper manner, that will withstand scrutiny at the end of the project. It would be extremely unfortunate if a seemingly thoughtful gesture by someone new to the process were to disrupt a clinical study. Thus, some basic instructions could be useful for individuals who have never been involved in clinical research before.
At the start of each study, the onus is obviously on the researchers conducting the project to explain to participants the ‘rules’ of being involved in clinical research. This is particularly important if the new recruit has never been involved with a research study before. Were a trial were to fail because a participant did not follow certain rules of etiquette, it would not necessarily be their fault. Therefore, the researcher should outline what is and is not allowed, and then provide explanations as to why each rule is necessary. There should also be an opportunity for the participant to ask questions about any aspects of ‘the etiquette’ that they may not fully understand. What is often obvious to the researcher may not be so apparent to the butcher, the baker or the candle stick maker.
In this new age of social media, however, there also needs be a wider conversation within the community about what kinds of activities are acceptable (or inappropriate) with regards to the discussion of ongoing research. Everyone is free to choose whether or not to be involved in clinical research. But those who decide not to be involved should not necessarily feel immune from making breaches of etiquette. They could still be at risk of offending the unwritten rules of what is right and wrong in research by sharing undisclosed information on an online forum for example. In this new interconnected world, the etiquette of clinical research extends well beyond the walls of the clinic.
Thus, some 'small cards'-like information regarding clinical research etiquette could be very useful for members of the community who are unfamiliar with this foreign environment of a research facility. While a larger discussion needs to be had regarding this topic, some of those 'small cards' of etiquette could include information about topics including:
Disclosure - excited as you may be to be part of a particular clinical study, you should refrain from discussing the details of what you do during said study. For example, all of the clinical tests that are used in the assessment of Parkinson's have been validated over thousands of hours, on thousands of individuals. By sharing information about such tests with people who have never been tested (for example on social media forums), the novelty of the test for those individuals is lost which could bias them by providing them with a certain level of preparedness.
Cheating - this seems like a pretty obvious one, but there is something wonderfully human about cheating. One always wants to do one's best in any endeavor, and there can also be a desire to please the assessor in a clinical test - to give them the result they want. But in the larger scheme of things, cheating in a clinical trial ultimately serves no one, least of all the overall community.
Don't practice - I once had an individual walk into a cognitive test assessment and they immediately started reciting a series of sentences that they had been asked to memorise as part of their previous assessment 12 months before. Unfortunately for the person concerned, those sentences were not part of their current assessment. Practicing brings another level of bias into the equation, which does not help with the assessment of individuals over time.
Unpublished data - this relates to #1, but it deserves to be discussed separately. If you are privy to any information from a research group/study that is not already in the public domain, you should not be sharing it with anyone else. Certainly not in an online forum, blog or social media. Such disclosures can have much wider ramifications, from affecting the funding of research to patenting of intellectual property.
Generating a list of rules or etiquette for clinical research is a difficult task, as no one wants to discourage participation in or the discussion of research. Investigators are very keen for the Parkinson's community to be involved in research (both as participants as well as active stake holders). In addition, it is important for individuals who have taken part in a study to share their experience of the process, not only to encourage others to get involved, but also to provide feedback to the research community. Research is ultimately a team effort and for the endeavor to succeed, open communication and following some pretty basic ground rules is necessary.
Therefore, it is equally critical for investigators to make sure that people who are new to research be aware of and adhere to some simple rules. While clinical research is somewhat different from meeting the queen, some etiquette is still required.
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Simon Stott, PhD is a Research Associate of the John van Geest Centre for Brain Repair at the University of Cambridge. He also maintains the Science of Parkinson’s disease website www.scienceofparkinsons.com.
Ideas and opinions expressed in this post reflect that of the author(s) solely. They do not necessarily reflect the opinions of the World Parkinson Coalition®