What is a research nurse and what do they do?
I am often asked, by nurses not working in research, “what is a research nurse and what do they do” “what are the responsibilities of a research nurse”? When I start to think about all of the steps involved in developing research projects and how research nurses get involved in a research project, the list of what a research nurse could be doing is quite extensive. It is not often that a single research role would encompass all the possible responsibilities of a research nurse but I believe most research nurse roles share some common elements.
The first phase of a research project, whether it be a study or a clinical trial (a clinical trial meaning it is a study which involves an unlicensed drug which is being tested), is the development of a study protocol: what are we trying to determine, how will we measure this, what tests will need to be undertaken by patients and at what time points, what clinical data will need to be collected, will blood tests be required, how often and will this coincide with regular patient visits or will these be extra visits to the hospital. There is usually a team involved in developing the protocol but it is really very important that research nurses be included at this stage as they know patients, they know the care pathway. They have invaluable knowledge and experience to help researchers gather the information they will need to draw conclusions from the study, while taking into consideration what a patient would be happy to undergo if they decide to participate. If the demands are too great or the criteria for inclusion too strict, it may be difficult to recruit patients or they may want to abandon the study before it finishes. If there is a good balance between the needs of the research and the patients involved, everyone will be much happier with both the process and the outcomes.
Once a protocol is developed a Patient Information Sheet (PIS) and consent form must be written. This PIS contains all the information required by law to be shared with a potential study participant by the research team. Often research nurses will write the PIS and consent form as they have a good understanding of the study, the regulations and legislation that govern what constitutes an informed consent process and they know how to speak to patients in a way that allows patients to understand complex scientific and medical information. Written information is part of the informed consent process but verbal discussion around the study, the responsibilities of participants, the foreseen benefits and potential risks and data protection and on-going sharing of information regarding the study also plays a big part of the informed consent process and again is often a significant responsibility of the research nurse.
Approvals by Ethics Committees and NHS R & D, and for clinical trials the Medicines and Healthcare Products Regulatory Agency (MHRA), are required before any study can begin to recruit patients. Some research nurses have the responsibility of completing these application forms and submitting them to the appropriate authorities for review and approval.
Patient recruitment is also often the responsibility of the research nurse, and where nurses spend a good deal of their time. Studies vary but mostly, research nurses identify where on a care pathway it is best to approach potential patients for a study or a clinical trial. They may screen hospital notes or attend Multi Disciplinary Team (MDT) meetings to highlight which patients are suitable for which study so that the care team seeing the patients in clinics can offer a study or clinical trial as a care option to suitable patients. This may seem straight forward but often isn’t. Success in offering a study to all suitable patients requires research nurses to network within the care teams, to make sure the study or studies they are working on remain(s) visible at the MDT and that the patients, once they attend their visit, do receive the offer and necessary information to make an informed decision as to whether or not they choose to participate. This is also where research nurses use their innovation to develop tools and ways to keep their study fresh in the mind of the care team and to ease the team’s effort in approaching all patients who may be suitable. In busy clinics and wards, research can sometimes be seen as non-essential. A good research nurse uses every challenge as an opportunity to dissolve the barrier between care and research so that we will one day integrate the two, so as to deliver excellence in healthcare.
Data Collection and Safety Reporting
The research nurse then follows the patients recruited to a clinical trial or study through their treatment making sure they attend all necessary visits as per protocol and that all necessary data is collected at each visit. Accurate and complete data is as important in research as the care of the patients as it is the information collected at each time point that will be used to determine the study outcome. Without accurate compliance to a protocol and accurate data collection, a study is not worth the efforts of all included – least of all the patients who gave of their time and themselves to a study.
Another important aspect of data collecting is ‘Safety Reporting’, this involves collecting data on untoward reactions patient may experience to the drug being investigating. Sometimes these untoward reactions can be expected meaning they have already been reported by other study participants but sometimes reactions can be new and not yet seen in anyone taking the study drug. Fast and clear reporting of adverse reactions are very important especially when they are more serious. Researchers are constantly looking at the balance between effectiveness of a drug and its side effects. The benefits must outweigh the risks. When testing a new drug that we are still learning about, it requires skill to identify all adverse reactions and knowledge of how these reactions must be dealt with to maintain participants’ safety and well being which is always the top priority in clinical trials. Research nurses develop strong communication and history taking skills to deliver deliver robust safety data and maintain patient safety.
Tissue and Sample Collection and Processing
In many research roles, lab skills are often acquired by research nurses. Blood samples are processed using a centrifuge; serum and plasma are batched into aliquots and frozen for later analysis. Some studies collect other types of specimens which are also stored for later analysis. Sometimes biopsy tissue is collected which requires nurses to attend surgical procedures or radiologically guided procedure under local anaesthetic. Again collection of samples at specific time points and proper care of these samples during processing and storing are equally as important as the data collected. These samples will be analysed and used to determine the outcome of the study; integrity of samples is crucial for drawing conclusions with confidence.
There are many different people, departments and external agencies involved in clinical research and the research nurse is often the “central hub” for a study. The research nurse is often the point of contact for patients. He or she is there to answer any questions the patient may have regarding the study – from their initial introduction to the study until they finish the trial. The research nurse often has to triage phone calls from patients who call with complaints, and must have the knowledge and confidence to handle these calls efficiently and safely while understanding his/her limitations and referring patients to other members of the care team when necessary. There is also a great deal of communication with the pharmaceutical company if the study is commercially sponsored as well as the various departments involved in the study such as imaging, pathology and labs.
The above is not an exhaustive list of the responsibilities of the research nurse, but rather it is an overview of the role. It is a role that requires a person to have initiative and drive to keep all aspects of a study relevant every step of the way. Often nurses are drawn to research because they feel it is exciting to be at the cutting edge of new developments and they like being part of making things better and they are attracted to the autonomy that research roles offer.
Is research nursing for you? Well if you like working autonomously within a team, if you are happy to roll your sleeves up and give it your best, if you have a good sense of Ethics in action and you like the idea of being part of change …maybe research nursing is for you! Why not give it a try?