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What is a research nurse and what do they do?

Posted on by Kelly Gleason in Professional Development, Research

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.

Protocol Development

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.

Informed Consent

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.

Study Approvals

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

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?

Clinfield offers courses on Informed Consent, Applying for Ethical Opinion in the NHS and a more general introduction to managing clinical trials Clinical Research: Getting Started!

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14 Responses to What is a research nurse and what do they do?

  1. The research is very interesting. Not only it generates new knowledge, but it also allows to predict the future for the people involved (researchers and others). Here I am referring to correlative studies preachers.
    Research is also interactive. Especially, if you are in a multidisciplinary team. It generates more learning curiosity. We actually keep searching. Because good research generates a new one. A sort of perpetual questioning following the continuous responses. The research permit to take rational decisions. Well done research responds to the real issue and thus solves the real problem and its root causes.

  2. ne khumalo says:

    Lovely rich & highly informative infomation. I’ve learnt something from this. I’m a student doing PHC reseach thank you so much. South Africa

  3. Shubhjot kaur sandhu says:

    Hi i am a fresh bsc nursing new graduate . I want to work as nurse researcher. But i dont know the pathway. Should i do masters or should i go for clinical experience. What is the requirement to become nurse researcher ?

    • Kelly Gleason says:

      Hi Shub,

      You do not have to do a Masters, some people work as research nurses without a Masters but it is an option. If you want to see if you really like research nursing, try to shadow someone to get a better idea what the role is about. You can also take a GCP course (Good Clinical Practice course) which shows you the guidance and law that governs setting up and managing clinical trials. If you are in travelling distance to London, Clinical Research: Getting Started! is a good place to begin as it gives you a good overview of the process for setting up and managing clinical trials and what GCP looks like in your every day role.

      I hope this helps!

      Kelly

  4. ANTHONIA OSUJI says:

    Thanks for this write up. It has opened my eyes to all the roles a research nurse should take.

  5. JENNIFER says:

    I am a newly registered nurse, after graduation I jumped into clinical research field and its totally NEW things for me. I need to start from zero in order to be a good Research Nurse. After reading this site, its an opening eyes for me and I able to understand more about what am I doing now.

    • Rowan says:

      Hi Jennifer, I am also a new nurse like you. Right now I am working as a Psychiatric nurse but I am interesting in taking a second job as a clinical Research nurse but I am told you must have experience at least 2 years in clinical research before you can maybe get a job in research. So how did you just jump in after graduation. I just need advice on how to get into the research field. I have a BSN here in the USA. I am currently looking to apply for an MSN in clnical trials research. Would appreciate some insight about the best starting point or strategies to get in. Thanks.

  6. Nurse says:

    It’s interesting to know about a research nurse’s job. Hope I’ll have a chance to become one in the future.

  7. Asisipho Davedi says:

    Thank you very much , I am still a student at University of Forthare doing Bachelor and I am still struggling to find which specialty do I want…I
    am falling in love with this one…

  8. Diana says:

    I am also interested in clinical research, could you tell what credentials are needed to participate in the clinical trials as a nurse? I recently graduated with A BSN degree.

    • Kelly Gleason says:

      Hi Diana, your nursing degree is a good start, it would be good to try to shadow a research and if you are interested in learning more about the field, then I would recommend doing a GCP or Good Clinical Practice course that is needed when working with clinical trials. It is guidance we follow to ensure we are keeping patients safe and collecting complete and accurate information and samples for the study. If you want to learn more about how clinical trials are set up and managed (what GCP looks like in practice) I would recommend attending Clinical Research: Getting Started! This course is a one day course that gives you a good overview of a clinical trial from set up to close down. I hope this helps!

  9. Kabelo Molosi says:

    Hi! I have developed more of an interest in being a research nurse because one can learn about new drugs, establishing of relationship and innovation.

  10. simbiso maswera says:

    Thank you for the information
    where can I do research course

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