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Writing a Protocol

Writing a Protocol

You have developed a question/idea for a project and have completed the planning and decided on the design of a study. 

So what next?

The next step in the process is to write the Research Protocol/Proposal.  The best way to start writing a protocol is to use the following headings as a template:

A) Background 
B) Aims 
C) Objectives 
D) Hypothesis 
E) Methods 
F) Statistical Analysis 
G) Ethical Consideration 
H) Confidentiality 
I) ICH GCP 
J) Bibliography 
K) Appendices and Supporting documents (not exhaustive of):  

  • Patient Information Sheet and Consent Form 
  • GP Letter 
  • Questionnaires
Obviously the more complicated the study, the more you will build on the headings and will perhaps have to incorporate more appendices.  The R&D Directorate have produced template documents to help you create your protocol and ensure that all the topics are covered. 


It is always a good idea to start off a protocol with a written description of the previous research that you found out about when doing your literature searches.  Make the background succinct and relevant and use references.  This should lead you on to the reasons why you are doing the research.

This should be as brief as possible and should be determined when planning the study.  The aim is the question which you want to answer.

Again, the objectives should be determined when planning the study.  The objective is the way in which you are going to achieve your aim. 

The hypothesis is again based on the question that you want to answer.  If there is more than one objective, you may need more than one hypothesis.

It is a little more than an educated guess about the nature of the relationship between two or more variables.  There are mainly three kinds of hypotheses:

  • There is no relationship between variables,
  • The direction of the relationship is known,
  • There is a relationship but the direction is unknown.

H1 (Alternative hypothesis) is also known as the Research hypothesis (RH) and states what you think the answer will be to your question.

H0 (Null hypothesis) is the Opposite hypothesis which nullifies the Research hypothesis, (i.e. RH is void).

Firstly describe the type of study you are going to use.

Describe the sample of the population you are going to use in your research.  This should include the inclusion and exclusion criteria.

Describe in detail how you are planning to perform the research – what tests/questionnaires will be used?  Who will be doing these tests?  How often will the subject (e.g. patient) be tested?  If a particular test is complex or novel you need to describe exactly how you will do this.

If drugs are to be used as part of the research you must describe the dosages/frequency of dispensing and any procedures the Pharmacy department will be using for your study.

You may need to contact support services in order to carry out your protocol.  A support service is a department that will assist in providing a service.  It is advisable to write in your protocol, what support services will be needed.

There is generally a standard way of writing the statistical analysis.  You must decide the on the numbers of subjects needed for your research and why you think these numbers will provide significant statistical results (the power of the study).  You need to explain which statistical tests you will use and why.

Statistics Required:

  • Sample size (power of study),
  • How you will analyse data,
  • Descriptive statistics,
  • Specific forms of analysis,
  • Any subgroups,
  • Analysis of subgroup data,
  • How data will be presented.

If your research involves certain subjects (e.g. patients, carers or patient records) then you will need to submit your research protocol to the Research Ethics Committee and get their approval of the study before starting your research.

You must explain how you will maintain confidentiality of information during the research project.

ICH GCP stands for “International Conference on Harmonisation Tripartite Guidelines for Good Clinical Practice” and was introduced 1997.  ICH GCP is the international, ethical and scientific quality standard for designing, conducting, recording and reporting drug trials that involve the participation of human subjects.

It is part of the Trust’s policy for all research to be conducted to ICH GCP standards.  ICH GCP covers many aspects of studies including, patient informed consent, data collection.

Remember to include all references in the order that they appear in your protocol.

Don’t forget to add all appendices, and provide supporting documentation such as including a Patient Information Sheet and Consent Form.  

Funding for research can come in many forms. Grants are made available to individual researchers, networks of researchers, and those working in research collaborations whether within the UK or internationally. Research students can benefit through support for advanced courses and PhDs, and fellowships are available to support post-doctoral researchers on an independent programme of research.

Independent funding is available for the support of the research infrastructure - the equipment and buildings required for research to take place. Funding is also available to support key research resources such as research facilities.

Due to the diverse bodies supporting research within the UK, you need to direct your applications for funding carefully.

Who Funds Research? 
A range of organisations, from the public and not-for-profit sector bodies, to private companies and international organisations funds research within the UK.

The many sources of public funding are the research councils, higher education funding councils and a number of UK government departments. In addition, much research is funded by charities, learned and professional societies, and universities and research institutes themselves. International sources of funding include the European Union, NATO and a number of other European and international public bodies.

The scope of these funding organisations differ dramatically. Some fund research across a range of areas, whilst others only provide funding within specific sciences or humanities subjects. Research funding organisations run schemes tailored to their particular objectives. Each type of grant, fellowship or other award will have associated information about the type of funds available, who is eligible and how to apply.

The DoH aims to improve the health and well-being of the people of England. In addition to providing a comprehensive, high quality health care service, the Department hugely invests money per annum in Research and Development to support government objectives for public health, health services and social care.

 

The goal of the National Institute for Health Research (NIHR) is to create a health research system in which the NHS supports outstanding individuals, working in world class facilities, conducting leading edge research focused on the needs of patients and the public. The NIHR commissions and funds health, public health and social care research that is essential for improving the health and wealth of the nation. A key objective is to improve the quality, relevance and focus of the research they commission by distributing funds in a transparent and accountable way through open competition and peer review. The NIHR also funds career development for researchers whose work focuses on people and patient-based applied health research.  The NIHR funds a range of research programmes to produce evidence that enables professionals, policy makers and patients to make informed decisions and provide the means to turn new interventions into better care. Research applications are rigorously evaluated, by independent peer review, to ensure that only the most outstanding proposals are funded.

Alternatively, the National Institute for Health Research provides a wealth of information on the funding opportunities and how to apply. 

Other well-known Funding bodies include:

For Advice, information and support with your research, there is the Research Design Service.  Research Design Service West Midlands provides help on research design to researchers in the West Midlands who are developing proposals for open, national, peer-reviewed funding competitions for applied health or social care research.

They are funded by the National Institute for Health Research (NIHR) and their advice is provided free of charge.  It is available through the use of online resources and consultations with experts. 

Click here to go to the Research Design Service website 

In order for research projects to take place in the Trust, Trust Approval must be sought alongside other activities/ approval requirements.  The flow diagram below gives an overview of the process for setting up research.

All research projects are registered with the R&D Directorate by sending us the research project protocol along with other documents and using the R&D Application Form.  Details on documents needed and how to complete the R&D Application Form are found on the Integrated Research Application System (IRAS) at www.myresearchproject.org.uk.  You will be required to create an account on IRAS before proceeding.

 

On receipt of the research project documentation, the R&D Directorate will check the feasibility of conducting the study in the Trust.  If it is agreed that the study can go ahead in the Trust, a Trust Approval letter will be sent to the Principal Investigator or the Chief Investigator if the research is only to be conducted in this Trust. 

Conditions on what R&D / Trust Approval is granted is dependent upon the type of research but can consist of the following:

  1. Radiology Requirements,
  2. The Research Personnel Approved to Work on Project,
  3. Research Specific Training,
  4. Study Equipment details,
  5. Patient Data Sharing – details about risk assessment and what data and how data is to be transferred to sponsor,
  6. Amendments requirements,
  7. Recruitment and Project Timelines updates,
  8. Safety Reporting requirements,
  9. Monitoring Report requirements,
  10. Provision of Insurance Certificates,
  11. Notification of Research Findings.

The R&D Directorate is responsible for all company sponsored research and will ensure that adequate contractual and indemnity arrangements are in place for all such research.

If you are a pharmaceutical or medical devices company wishing to carrying out research at this Trust, please contact the R&D Directorate for advice.

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