I work as a Clinical Research Nurse at Oxford University Clinical Research Unit- Nepal (OUCRU-NP) which is supported by Wellcome Trust major overseas programme. Currently, an open label randomized control trial of Gatifloxacin versus Ceftriaxone for the treatment of uncomplicated enteric fever is ongoing where majority of the focus is given on the care of research participants. A patient with enteric fever commonly presents with step-ladder type fever associated with nausea, vomiting, body pain, diarrhea, fatigue, bradycardia and rashes. When they come with these signs and symptoms, the first thing that we do is assess the patient and collect clinical data. We take detailed history of the patients, note the complaints including its onset and duration, take vital signs to get the objective data and provide nursing care as per the clinical indications and as required by the study. Not only we provide and coordinate clinical care, we also play a central role in assuring participant safety, maintenance of informed consent, integrity of protocol implementation, accuracy of data collection and recording, and appropriate follow up. We carefully explain to the patient about the risks and the benefits of being in the trial, follow ups that need to be done and that there would not be any discrimination in the treatment even if they choose not to participate in the study. We support them to process the information and make an informed decision about clinical trial participation.
The highest priority of clinical research is to protect human subjects from undue harm and undue burden from the research. The clinical research enterprise has special obligations to those willing to volunteer to participate in clinical studies and potentially place themselves in harm’s way for the benefit of others. The ability to conduct clinical studies depends upon individuals being willing to participate, so public trust is crucial. The public’s perception of both the safety of the studies and the integrity of the research enterprise are critical contributors to the public trust (NIH). Since Clinical research nurses are the first line of communication to participants and family members about the trial, this places us in a very important position to maintain this trust and to present the facts about the trial without being biased.
If the patient agrees to get enrolled in the trial, then additional case record form (CRF) is filled, consent is signed, specimen is collected (blood, urine and stool) and assigned drug (either Ceftriaxone or Gatifloxacin) is provided. In this study, follow-up is required on day 8, day 15, month 1, month 3 and month 6. So we educate the patient about the importance of these follow-ups and make sure that they visit the clinic by consistently reminding them at every visits and by calling them if necessary.
We communicate with Community Medical Auxiliary (CMA), who regularly visit the participants at their homes about the progress made by the participants and in every follow-up, we monitor participants for anticipated and unanticipated events, document and report the adverse events if any.
We also interpret and rephrase descriptions of study-related care for participants and family discuss about the disease, treatment process, preventive measures that is required to prevent the possible contraction of disease in the future, study progress, evolving concerns, next steps and ensure that the study objectives are attained while upholding all the principles of participant rights, patient safety and continuity of care.
After six month follow-up is completed, we enter the data on the CRF in our computer database. If there is any data missing or any refinements to be done while filling up the CRF's we communicate with physicians and other team members.
Clinical Research Nursing is a very new concept here in Nepal. There occurs a role confusion with respect to nurses who provide direct clinical care in a setting in which clinical research is conducted . When we were first recruited as clinical research nurse everyone was a bit skeptical about the title, duties that was to be performed and if it would contribute further to the nursing career. A workshop involving nursing directors, representative from nursing council and other allied health professionals needs to be conducted with introduction of clinical research nursing with discussion of the scope of practice for clinical research nurses which range from direct clinical intervention to include study management, human subject protection, care coordination within the context of research participation, to contributions to clinical science as an active research team member. It is a human nature to want to be part of a profession which has clearly defined roles and contributes to the professional development. It is a necessity for the person as well as the profession to thrive. A job description clearly delineating the role of a research nurse is a must if we want more and more nurses to be part of the research. In order to achieve the best possible outcomes for research participants and the research process, clinical research nurses must not only have expert clinical skills and well developed critical thinking skills, but must also be well versed in the complex regulatory, ethical, and scientific aspects of clinical research (NIH). So, continuing nursing education, training, workshops and seminars need to be conducted periodically in order to update the knowledge of the nurses and to keep them motivated. Here, at OUCRU-NP a workshop on "Good Clinical Research Practice" was held which helped us immensely to understand about the complex research process. Also we got an opportunity to be part of a workshop conducted by Nepal Health Research Council (NHRC) on "Field epidemiology".
Completely naïve at the start, the concept of research nurse was very new for us and for our unit as well. Despite all those constraints, our team members here at OUCRU-NP had been a continuous source of motivation for us. They constantly pushed us to strive for the recognition as a clinical research nurse and here I am on my almost second year of service as a "Clinical Research Nurse" and looking forward to being a "Nurse Scientist".
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