Reflecting on what I do and what my responsibilities are as a Research Nurse is quite complex and one single role cannot encompass all the activities associated with clinical research trials.
Protocol development is the first phase of the project where a team is involved in developing the protocol. From my perspective, knowledge and experience of a research nurse is indispensable in creating a good balance between the needs of the research and the patients involved.
Taking into account the individual perspective of the patients, we take into consideration what patients would be happy to endure if they decide to participate. If the demands are too high, it may be difficult to recruit patients. Similarly, if the patient wants to abandon the study before it finishes, the nurse has to establish a balance between the needs of the research and the individual patients involved, so everyone can benefit from the results.
Another very important role and responsibility in conducting the trial is consent and recruitment process. At SAPS this task is undertaken by a Research Nurse and recruitment success and retention depends heavily on the research nurses and their ability to network within the care teams, attend multi-disciplinary team meetings to select patients suitable for each specific study.
In addition to team work and clinical resources, patients are the most valuable part of the chain that requires verbal explanation of the study. Responsibilities of the participants, the foreseen benefits and potential risks are vital discussions carried out to accommodate an informed decision as to whether or not potential participants choose to participate.
This information presented to a patient is part of the patient information sheet (PIS) which contains all the information required by law to be provided to potential study participant.
Following consent I identify where on a care pathway it is best to approach potential patients for recruitment, this may seem straight forward but often isn’t, as research can sometime be seen as non-essential. The knowledge and confidence to handle these challenges efficiently and safely is essential. I believe in using every challenge as an opportunity to dissolve the barrier between care and research so that we will one day integrate the two, in order to deliver excellence in healthcare. In essence, I believe I’m primarily a Nurse and the clinical care takes the prevalence, what obliged me to use my clinical skills to identify and address potentials issues, as they arise during the study, involving relevant clinician in the process.
This is where ‘Safety Reporting’, plays a vital part in the trial. This involves collecting data on adverse reactions patient may experience to the drug being investigating or any other events not associate with trial medication, and depending on the severity, fast reporting to our collaborative body (PACSSC) Palliative Care Clinical Studies Collaborative or Human Research Ethics Committee (HRECs) if more serious is very important. Maintaining participants’ safety and wellbeing as the top priority in clinical trials. Accurate and complete data collection is vital in research, paralleling the best clinical practice.
I find research very interesting and interactive, and the above is not an exhaustive list of the responsibilities faced on day to day bases, but rather it is an outline of the role. It is a role that requires having initiative and drive to keep all aspects of a study applicable throughout the process from the start to completion.
Vera Margitanovic is a Research CN in Palliative Care. She has worked on a number of
research projects and clinical trials across Southern Adelaide Clinical Network. She actively
participates in over 20 national and International clinical trials being run by Southern
Adelaide Palliative Services (SAPS) Research and is specifically responsible for clinical trials
investigating management of refractory dyspnoea in patients with COPD, Pulmonary
Arterial Hypertension and heart failure.
Vera is an author of two publications (http://researchonline.nd.edu.au/nursing_article/51/; https://www.ncbi.nlm.nih.gov/pubmed/23597092) and has presented preliminary study findings at many conferences and seminars.