Design of the research proposal

There are key elements when designing a research proposal. A suggested

template, written by the Hull and East Yorkshire Hospitals NHS Trust is
outlined below.

1. Title
Clearly identifying the study and may contain a description of the study
design as well as the objectives.
2. Investigators
The named investigators on the research proposals, ie.all those with
valuable contribution to the work.
3. Background
The background of the project including a critical review of the current
knowledge, published and unpublished work, gaps in the evidence and the
potential value of furthering knowledge in this field. The research
hypothesis should also be included in this section, with the explanation of
reasons for undertaking the work.
4. Aims
Expressed as a small number, i.e. 1-4. Concise and precise objectives that
should follow logically, from the rationale hypothesis for a quantitative
study and toward the hypothesis for a qualitative study.
5. Study Design
Description of the important elements of the methodology. It may include
some or all of the following:
o The process by which subjects will be sampled
o The number of groups studied
o Whether subjects/investigators will be aware of which intervention is
being administered
o 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/Patients
All 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. Interventions
A 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 be
detailed.
Questionnaire or interview; reasons for method and possible
contamination should be discussed.
o Necessary safeguards and potential risks should be made
apparent, including the methods by which intervention will be
monitored.
8. End-Points
Measurement 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 the
theory.
o The number of end-points should be kept to a minimum, the
inclusion of many variables may hinder the interpretation of the
findings.
o The expected effect of the end-points should be described.
9. Measurements
All relevant measurements, investigations and techniques should be
clearly and fully described. When there are a variety of accepted
techniques possible for use, the exact procedure should be defined. A
detailed list of any equipment used should also be included and the
reliability of the measurements must be taken into account.
10. Study Plan
Details of the order, site and timing of all study procedures. Any
information, equipment, treatment and documentation to be given to the
patient or to be collected by the investigator, must be detailed.
11. Analysis
The method of the data analysis should be specified within the protocol
and should include:
o timing of data collection, entry and statistical analysis
o method of data entry
o 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 Issues
These are matters relevant to and the methods by which the
patient/subject’s interests will be safeguarded. They include risk limitation,
patient study information and confidentiality, methods of monitoring and
possible adverse side effects. (for more detail see section on Ethical
Approval)
13. Resource Requirements
The resource implications to the host organisation and any other involved
departments should be defined in this section. If the study involves co-
operation by individuals other than the researchers, or use of equipment or
any other resource, then permission for the use of these services must be
obtained form the relevant person.
In addition the following must be displayed if not stated explicitly on the
Resources form:
o Timetable/schedule of the research
o Names of the staff
o Staff involved peripherally, such as outpatient/ward staff
o All costs (both fixed and semi-fixed)
14. Supervision
The proposal should name the individual(s) who will supervise the
research project and the intended arrangements for the supervision. Also
any details of a steering group, for example, the role, frequency of
meetings, monitoring arrangements and the membership of the group.
15. Dissemination and Outcome
The intended route for internal and external publication should be
specified. Any implications for future practice and patient care should also
be suggested.

Hull and East Yorkshire Hospitals NHS Trust Research Study Pack