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Design of the research proposal

There are key elements when designing a research proposal. A suggestedtemplate, written by the Hull and East Yorkshire Hospitals NHS Trust isoutlined below.

1. TitleClearly identifying the study and may contain a description of the studydesign as well as the objectives.2. InvestigatorsThe named investigators on the research proposals, ie.all those withvaluable contribution to the work.3. BackgroundThe background of the project including a critical review of the currentknowledge, published and unpublished work, gaps in the evidence and thepotential value of furthering knowledge in this field. The research

hypothesis should also be included in this section, with the explanation ofreasons for undertaking the work.4. AimsExpressed as a small number, i.e. 1-4. Concise and precise objectives thatshould follow logically, from the rationale hypothesis for a quantitativestudy and toward the hypothesis for a qualitative study.5. Study DesignDescription of the important elements of the methodology. It may includesome or all of the following:

o The process by which subjects will be sampled

o

The number of groups studiedo Whether subjects/investigators will be aware of which intervention is

being administeredo Whether patients will receive all or only one intervention

o Whether past or current data are collected

o Methods to reduce bias

o The tools used for sampling

6. Subjects/PatientsAll the following information about the study groups should be included:

o A description of the study population, including a rationale

o The methods by which they will be found and recruited

o Inclusion/exclusion criteria

o Sample size

7. InterventionsA full description of the study intervention should be provided:

o Treatment or investigation; the dose, timing, method of

providing, administering and receiving the treatment should bedetailed.Questionnaire or interview; reasons for method and possiblecontamination should be discussed.

o Necessary safeguards and potential risks should be made

apparent, including the methods by which intervention will bemonitored.

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8. End-PointsMeasurement outcomes used to confirm/reject or generate the hypothesis.They should be separated into primary and secondary:

o Primary end-points: those most important to the hypothesis,

there should only be 1 or 2.

o Secondary end-points: provide some support to the hypothesis,but without the expected primary outcome would not prove thetheory.

o The number of end-points should be kept to a minimum, the

inclusion of many variables may hinder the interpretation of thefindings.

o The expected effect of the end-points should be described.

9. MeasurementsAll relevant measurements, investigations and techniques should beclearly and fully described. When there are a variety of acceptedtechniques possible for use, the exact procedure should be defined. Adetailed list of any equipment used should also be included and thereliability of the measurements must be taken into account.10.Study PlanDetails of the order, site and timing of all study procedures. Anyinformation, equipment, treatment and documentation to be given to thepatient or to be collected by the investigator, must be detailed.11. AnalysisThe method of the data analysis should be specified within the protocoland should include:

o timing of data collection, entry and statistical analysis

o method of data entryo data analysis package

o presentation of demographic and outcome data summaries

o the arithmetic, graphical and statistical manipulation of the data

o criteria for statistical and clinical significance of data

12. Ethical IssuesThese are matters relevant to and the methods by which thepatient/subjects interests will be safeguarded. They include risk limitation,patient study information and confidentiality, methods of monitoring andpossible adverse side effects. (for more detail see section on EthicalApproval)13.Resource RequirementsThe resource implications to the host organisation and any other involveddepartments should be defined in this section. If the study involves co-operation by individuals other than the researchers, or use of equipment orany other resource, then permission for the use of these services must beobtained form the relevant person.In addition the following must be displayed if not stated explicitly on theResources form:

o Timetable/schedule of the research

o Names of the staff

o Staff involved peripherally, such as outpatient/ward staffo All costs (both fixed and semi-fixed)

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14. SupervisionThe proposal should name the individual(s) who will supervise theresearch project and the intended arrangements for the supervision. Alsoany details of a steering group, for example, the role, frequency ofmeetings, monitoring arrangements and the membership of the group.

15.Dissemination and OutcomeThe intended route for internal and external publication should bespecified. Any implications for future practice and patient care should alsobe suggested.

Hull and East Yorkshire Hospitals NHS Trust Research Study Pack