InCyt Focusing on issues impacting on biomedical scientists, cytotechnologists and cytology screeners
The role of biomedical scientists in research When discussing the role of biomedical scientists and cytotechnologists with the wider public, there is a widely held assumption that our main task is to perform research to push back the frontiers of human knowledge, but how far from that role have we digressed? Our role in the health service, and even within the private sector, is that of service provision and delivery and all that this entails. The management of quality assurance [both external quality assurance (EQA) and internal quality control (IQC)] ensures that clinical needs are met in terms of turnaround times and quality outcomes. Often our employer’s expectations are that we ensure that the laboratory operates within financial constraints and we deliver on operational targets to provide value for money. These are important functions and cannot be ignored, but we have become more corporate than scientific. Or have we? Surely the role of the biomedical scientist should include research and its application? Research is often seen as an addendum to the working day of a biomedical scientist. It is in the job descriptions of most scientists, but the level of achievement is rarely covered by annual review as it is in academia. Those biomedical scientists who undertake research often do so in their own time outside their routine roles. There are numerous opportunities for original research which can be tagged onto a routine workload. Possible research topics and hypotheses are frequently discussed, but, in reality, the pressures from an increasing routine workload and frequent workforce reviews result in the discussions going no further. All biomedical scientists appointed over the last 20 years in the UK have been graduates, all with experience at undergraduate level of undertaking research, and many undertaking postgraduate qualifications that will require elements of, if not a full, postgraduate research project. A recent
© 2015 John Wiley & Sons Ltd Cytopathology 2015, 26, 139–141
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cytotechnology survey has indicated that many other European countries have a similar graduate entry for cytotechnologists. Biomedical scientists and cytotechnologists in all laboratory disciplines support their medical colleagues in both audit and research by providing material, testing platforms and analysis. We have the tools and the ability. What is required are the resources to clear the final hurdle: ‘publishing’. Our role in research should not be diminished and, although I appreciate that trying to apply our science may seem to be a full-time job, we should all remember that, as scientists, we should be pushing back the boundaries of knowledge, even if this takes place in small incremental steps. Why undertake research? Personal development
Research requires the scientist to act independently, to work with a multidisciplinary collaborative team, to be assertive to drive the project forward and to be able to meet deadlines. All of these qualities demonstrate to our clinical colleagues how we can develop both as professional scientists and as employees. Ownership of a project means that the scientist can work outside of the structure of a department and, although most of the work may well be undertaken outside working hours, it allows personal ownership of an important piece of work, providing career advancement and job satisfaction. The research undertaken can form a part of a structured academic qualification such as a Master of Science (MSc) or a professional doctorate such as the course offered by Manchester Metropolitan University. Improves the working environment
Within each department, there will be individuals who enjoy the challenges associated with research. Encouraging a research hub to develop prevents the department stagnating, brings a new enthusiasm and
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improves the working environment, as research allows staff to operate outside the routine. Improves service and relationships with clinical colleagues
Research and development of new methods of service delivery invariably improve the laboratory service to clinicians and, ultimately, to the patients. It allows us to work alongside our clinical colleagues as equal partners. We become more involved with the patients and their journey. Laboratory staff often exist in a ‘laboratory silo’ with very limited patient contact; research clearly links laboratory service improvement with an improved patient pathway. Leading future developments
A department that is active in research will quickly develop an internal and external reputation and will be approached to become involved in related research projects. A virtuous circle where the learning and development from research is reinforced by a feedback loop leading to the development of a cycle of continuous research and improvement of clinical practice. The basis should always be to seek an evidence base for changes to clinical practice and challenge the frequently held mindset of ‘this is always how it is done here’. A department with strong scientific leadership in research will continue to develop and remain flexible to change. Improves staff skills
By undertaking research, we improve and extend the skills within the department and encourage statistical analysis, independent thinking and development of presentational skills. The laboratory team unites when a department successfully publishes and demonstrates the department ’s skills to the wider scientific community. The collective pride gained from publishing in peer-reviewed journals should not be underestimated. How to start research Ask questions: Who? What? Why? When? Discuss with colleagues; gather viewpoints; read journals, books and articles around the topic. Write a literature review to gain a deeper understanding of the question, determine who is active in the area and what other work is being and has been undertaken. The next step is to carry out a feasibility study, the aim of which is to determine the resources required in terms of staff, equipment, consumables and, most importantly, TIME to complete the study. Include all resources required.
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What are the budget requirements?
With the budgetary constraints in place in most publicly funded laboratories, research budgets are limited or non-existent, but funding can often be found from local sources, especially if the support of clinicians can be gained. Start small; look for opportunities for pump priming a study. Hospitals may have discretionary funding for R&D, professional bodies, such as the British Association for Cytopathology (BAC), offer bursaries and commercial partners may provide consumables and equipment. Local and national charities will often offer funding for related research in return for recognition and publicity. Academic centres may have research funding streams that can be accessed if the work is related to existing projects. Remember, the laboratory scientist is an asset to academic researchers. We have the ability to apply tests and methodologies to clinical specimens. We have access to clinical specimens and clinicians. Be realistic when applying for funds. Include costs for equipment, staff and consumables. Is there adequate space for your project? Can another laboratory in your building offer a bench or storage space for specimens during your study? Will this work be undertaken out of hours and, if so, what is the cost. What skill mix is required? What time from each team member will be required? It is important to include these details. There is a need to be realistic with regard to the time frame and the time needed to complete, otherwise it will become apparent very early on in the project that the resources required have been underestimated. Build your research team
Consider carefully the staff you need to support your project. Do you need pathologists to assess your results? Do you need nurses to gain consent? What team do you need? Working with academia has advantages in that academic staff are experienced in writing applications for funding and in publishing their work. Their support is vital to keep the research on track. Get the team together and involved as soon as possible. Ensure you have the support of all the staff required for the project, and that their role and time commitments have been clearly explained.
Ethical approval Ethical approval is needed for all research. Application processes will vary from centre to centre.1 Engage with local ethics and R&D committees and seek advice on local protocols. Develop a relationship with the key individuals who are there to help and
© 2015 John Wiley & Sons Ltd Cytopathology 2015, 26, 139–141
5/12/2015 4:53:01 PM
guide you in your research. National guidance is available from the National Research Ethics Service, IRAS (Integrated Research Application System). Key milestones and objectives This will usually be driven by the research sponsor who will require updates throughout the time span of the project. It is good practice to have this documented and agreed with all the research team. Milestones and objectives may change along the way, but a well-documented project plan helps to keep the study on track. Extensive data recording is vital to the success of all research projects. Consider carefully what data should be recorded and how they are to be recorded. Ensure that the data are recorded in such a way that they can be analysed to answer your research questions. Network Network with other researchers within your organization and within your professional body. Ask those who have successfully published for advice. Challenges Sir Michael Rawlins, chairman of the UK National Institute of Health & Clinical Excellence (NICE) highlighted the potential challenges facing researchers in the UK NHS.2 I suspect many of these issues are common in most western countries where bureaucracy can be a significant hurdle to clear before research projects can even begin. There are multiple layers of ethical approval to be peeled back before a study can start. These include: • National Research Ethics Service • Human Tissue Authority,
regarding how to define and claim NHS costs for undertaking the research was inconsistent. The competitive advantage of a publicly funded, open access health system for undertaking health services research and clinical trials within the UK has been outweighed in recent years by stifling bureaucratic structures and processes for governance of research. Within the UK, another challenging area is running research projects across more than one NHS organisation. Each NHS legal entity must give individual approval before the study can commence, variations in interpretation between the organisations can lead to multiple iterative approval processes.
Conclusion Although many laboratory scientists are providing a diagnostic service within the many hospital laboratories, there are ample opportunities to become involved with and even to drive and lead research. It is hard work and, without doubt, there will be many obstacles to overcome. However, the rewards on both a personal and department level far outweigh the disadvantages. I would recommend and enthuse all biomedical scientists, no matter what level and no matter what constraints, to become involved in research and to always remember we are SCIENTISTS. References 1. Fistein E, Quilligan S. In the lion’s den? Experiences of interaction with research ethics committees. J Med Ethics 2012 ;38 :224 –7. 2. Rawlins M . A new era for UK clinical research? Lancet 2011;377:190 –2. 3. Snooks H, Hutchings H, Seagrove A et al. Bureaucracy stifles medical research in Britain: a tale of three trials. BMC Med Res Methodol 2012;12 :122. doi: 10.1111/cyt.12253
• Human Fertilisation and Embryology Authority • National Information Governance Board and its Ethics and Confidentiality Committee, • Gene Therapy Advisory Committee All these bodies were introduced with the best of intentions but the cumulative effects of the idiosyncrasies of these different organizations – usually operating in series rather than parallel – leads to delays in obtaining approvals.2 Snooks et al3 concluded that the processes for gaining approvals in the UK are overly complex and differed between sites and UK countries; guidance about processes was unclear; and information
© 2015 John Wiley & Sons Ltd Cytopathology 2015, 26, 139–141
cyt_12253.indd 141
A. Wilson Lead Biomedical Scientist in Cellular Pathology and Advanced Practitioner in Cervical Cytology Pathology Department, Monklands Hospital, Monkscourt Avenue, Airdrie, UK Tel: 01236 712087 Fax: 01236 713050 Email: [email protected] J. Jamison Consultant Biomedical Scientist Cytology Department, Antrim Area Hospital, Antrim, UK
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The role of biomedical scientists in research When discussing the role of biomedical scientists and cytotechnologists with the wider public, there is a widely held assumption that our main task is to perform research to push back the frontiers of human knowledge, but how far from that role have we digressed? Our role in the health service, and even within the private sector, is that of service provision and delivery and all that this entails. The management of quality assurance [both external quality assurance (EQA) and internal quality control (IQC)] ensures that clinical needs are met in terms of turnaround times and quality outcomes. Often our employer’s expectations are that we ensure that the laboratory operates within financial constraints and we deliver on operational targets to provide value for money. These are important functions and cannot be ignored, but we have become more corporate than scientific. Or have we? Surely the role of the biomedical scientist should include research and its application? Research is often seen as an addendum to the working day of a biomedical scientist. It is in the job descriptions of most scientists, but the level of achievement is rarely covered by annual review as it is in academia. Those biomedical scientists who undertake research often do so in their own time outside their routine roles. There are numerous opportunities for original research which can be tagged onto a routine workload. Possible research topics and hypotheses are frequently discussed, but, in reality, the pressures from an increasing routine workload and frequent workforce reviews result in the discussions going no further. All biomedical scientists appointed over the last 20 years in the UK have been graduates, all with experience at undergraduate level of undertaking research, and many undertaking postgraduate qualifications that will require elements of, if not a full, postgraduate research project. A recent
© 2015 John Wiley & Sons Ltd Cytopathology 2015, 26, 139–141
cyt_12253.indd 139
cytotechnology survey has indicated that many other European countries have a similar graduate entry for cytotechnologists. Biomedical scientists and cytotechnologists in all laboratory disciplines support their medical colleagues in both audit and research by providing material, testing platforms and analysis. We have the tools and the ability. What is required are the resources to clear the final hurdle: ‘publishing’. Our role in research should not be diminished and, although I appreciate that trying to apply our science may seem to be a full-time job, we should all remember that, as scientists, we should be pushing back the boundaries of knowledge, even if this takes place in small incremental steps. Why undertake research? Personal development
Research requires the scientist to act independently, to work with a multidisciplinary collaborative team, to be assertive to drive the project forward and to be able to meet deadlines. All of these qualities demonstrate to our clinical colleagues how we can develop both as professional scientists and as employees. Ownership of a project means that the scientist can work outside of the structure of a department and, although most of the work may well be undertaken outside working hours, it allows personal ownership of an important piece of work, providing career advancement and job satisfaction. The research undertaken can form a part of a structured academic qualification such as a Master of Science (MSc) or a professional doctorate such as the course offered by Manchester Metropolitan University. Improves the working environment
Within each department, there will be individuals who enjoy the challenges associated with research. Encouraging a research hub to develop prevents the department stagnating, brings a new enthusiasm and
139
5/12/2015 4:53:01 PM
improves the working environment, as research allows staff to operate outside the routine. Improves service and relationships with clinical colleagues
Research and development of new methods of service delivery invariably improve the laboratory service to clinicians and, ultimately, to the patients. It allows us to work alongside our clinical colleagues as equal partners. We become more involved with the patients and their journey. Laboratory staff often exist in a ‘laboratory silo’ with very limited patient contact; research clearly links laboratory service improvement with an improved patient pathway. Leading future developments
A department that is active in research will quickly develop an internal and external reputation and will be approached to become involved in related research projects. A virtuous circle where the learning and development from research is reinforced by a feedback loop leading to the development of a cycle of continuous research and improvement of clinical practice. The basis should always be to seek an evidence base for changes to clinical practice and challenge the frequently held mindset of ‘this is always how it is done here’. A department with strong scientific leadership in research will continue to develop and remain flexible to change. Improves staff skills
By undertaking research, we improve and extend the skills within the department and encourage statistical analysis, independent thinking and development of presentational skills. The laboratory team unites when a department successfully publishes and demonstrates the department ’s skills to the wider scientific community. The collective pride gained from publishing in peer-reviewed journals should not be underestimated. How to start research Ask questions: Who? What? Why? When? Discuss with colleagues; gather viewpoints; read journals, books and articles around the topic. Write a literature review to gain a deeper understanding of the question, determine who is active in the area and what other work is being and has been undertaken. The next step is to carry out a feasibility study, the aim of which is to determine the resources required in terms of staff, equipment, consumables and, most importantly, TIME to complete the study. Include all resources required.
140
cyt_12253.indd 140
What are the budget requirements?
With the budgetary constraints in place in most publicly funded laboratories, research budgets are limited or non-existent, but funding can often be found from local sources, especially if the support of clinicians can be gained. Start small; look for opportunities for pump priming a study. Hospitals may have discretionary funding for R&D, professional bodies, such as the British Association for Cytopathology (BAC), offer bursaries and commercial partners may provide consumables and equipment. Local and national charities will often offer funding for related research in return for recognition and publicity. Academic centres may have research funding streams that can be accessed if the work is related to existing projects. Remember, the laboratory scientist is an asset to academic researchers. We have the ability to apply tests and methodologies to clinical specimens. We have access to clinical specimens and clinicians. Be realistic when applying for funds. Include costs for equipment, staff and consumables. Is there adequate space for your project? Can another laboratory in your building offer a bench or storage space for specimens during your study? Will this work be undertaken out of hours and, if so, what is the cost. What skill mix is required? What time from each team member will be required? It is important to include these details. There is a need to be realistic with regard to the time frame and the time needed to complete, otherwise it will become apparent very early on in the project that the resources required have been underestimated. Build your research team
Consider carefully the staff you need to support your project. Do you need pathologists to assess your results? Do you need nurses to gain consent? What team do you need? Working with academia has advantages in that academic staff are experienced in writing applications for funding and in publishing their work. Their support is vital to keep the research on track. Get the team together and involved as soon as possible. Ensure you have the support of all the staff required for the project, and that their role and time commitments have been clearly explained.
Ethical approval Ethical approval is needed for all research. Application processes will vary from centre to centre.1 Engage with local ethics and R&D committees and seek advice on local protocols. Develop a relationship with the key individuals who are there to help and
© 2015 John Wiley & Sons Ltd Cytopathology 2015, 26, 139–141
5/12/2015 4:53:01 PM
guide you in your research. National guidance is available from the National Research Ethics Service, IRAS (Integrated Research Application System). Key milestones and objectives This will usually be driven by the research sponsor who will require updates throughout the time span of the project. It is good practice to have this documented and agreed with all the research team. Milestones and objectives may change along the way, but a well-documented project plan helps to keep the study on track. Extensive data recording is vital to the success of all research projects. Consider carefully what data should be recorded and how they are to be recorded. Ensure that the data are recorded in such a way that they can be analysed to answer your research questions. Network Network with other researchers within your organization and within your professional body. Ask those who have successfully published for advice. Challenges Sir Michael Rawlins, chairman of the UK National Institute of Health & Clinical Excellence (NICE) highlighted the potential challenges facing researchers in the UK NHS.2 I suspect many of these issues are common in most western countries where bureaucracy can be a significant hurdle to clear before research projects can even begin. There are multiple layers of ethical approval to be peeled back before a study can start. These include: • National Research Ethics Service • Human Tissue Authority,
regarding how to define and claim NHS costs for undertaking the research was inconsistent. The competitive advantage of a publicly funded, open access health system for undertaking health services research and clinical trials within the UK has been outweighed in recent years by stifling bureaucratic structures and processes for governance of research. Within the UK, another challenging area is running research projects across more than one NHS organisation. Each NHS legal entity must give individual approval before the study can commence, variations in interpretation between the organisations can lead to multiple iterative approval processes.
Conclusion Although many laboratory scientists are providing a diagnostic service within the many hospital laboratories, there are ample opportunities to become involved with and even to drive and lead research. It is hard work and, without doubt, there will be many obstacles to overcome. However, the rewards on both a personal and department level far outweigh the disadvantages. I would recommend and enthuse all biomedical scientists, no matter what level and no matter what constraints, to become involved in research and to always remember we are SCIENTISTS. References 1. Fistein E, Quilligan S. In the lion’s den? Experiences of interaction with research ethics committees. J Med Ethics 2012 ;38 :224 –7. 2. Rawlins M . A new era for UK clinical research? Lancet 2011;377:190 –2. 3. Snooks H, Hutchings H, Seagrove A et al. Bureaucracy stifles medical research in Britain: a tale of three trials. BMC Med Res Methodol 2012;12 :122. doi: 10.1111/cyt.12253
• Human Fertilisation and Embryology Authority • National Information Governance Board and its Ethics and Confidentiality Committee, • Gene Therapy Advisory Committee All these bodies were introduced with the best of intentions but the cumulative effects of the idiosyncrasies of these different organizations – usually operating in series rather than parallel – leads to delays in obtaining approvals.2 Snooks et al3 concluded that the processes for gaining approvals in the UK are overly complex and differed between sites and UK countries; guidance about processes was unclear; and information
© 2015 John Wiley & Sons Ltd Cytopathology 2015, 26, 139–141
cyt_12253.indd 141
A. Wilson Lead Biomedical Scientist in Cellular Pathology and Advanced Practitioner in Cervical Cytology Pathology Department, Monklands Hospital, Monkscourt Avenue, Airdrie, UK Tel: 01236 712087 Fax: 01236 713050 Email: [email protected] J. Jamison Consultant Biomedical Scientist Cytology Department, Antrim Area Hospital, Antrim, UK
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