Designing your study

Contents

General advice
Lay involvement
Composition of your research team
Primary care collaborators
Costing out your proposal
Cost of archiving and data storage

General advice

There are many things to consider when designing your study: not least is that you must make sure that the methods you choose to use are appropriate to answer the question that you have set, and that you really can measure or assess the things you want to. You should also think about how you plan to analyse and interpret the data that you are going to collect. For further useful information about designing your study, you can look here.

Lay involvement

Getting lay involvement in your research project as early as possible will also help you to make it stronger, and most finding organisations now expect researchers to demonstrate that they have included the public in the development of their research. The Public and Patient Involvement in Research (PPIRes) group which is coordinated from the NHS Norfolk R&D office, can help and advise you.

Further useful contacts for designing your study are the Research Design Service for Norfolk and Suffolk which is based at UEA. You can also contact the Research Facilitator at the R&D Office for advice and support.

Composition of your research team

You will need to ensure that your research team has the appropriate experience and expertise to enable you to deliver on your study. Funding bodies will look at this and may reject your proposal if they do not consider your research team to have the right mix of skills and experience. Most proposals would be expected to have a mix of academic and NHS partners.

Particular considerations are statistical expertise, Health Economics expertise, methodological expertise. The Research Design Service can offer help with this area, but you would be expected to be preparing for a grant application to a recognised funding body for adoption onto the national portfolio.

Primary Care Collaborators

If you are designing your study to run or recruit from primary care then

it is recommended that you have a primary care partner on board from the clinical setting you are recruiting or delivering you study in (for example a practicing GP / Speech and Language Therapist / Physiotherapist). They can offer practical advice on areas such as fit with clinical pathways; how best to recruit your target participants; how easy it will be to identify participants from a database search & mailshot etc, and may be able to pilot your planned recruitment methods.

The PCRN may be able to help find an appropriate collaborator for you – for further detail please click speak to the local PCRN facilitator.

Costing out your proposal

You need to be clear what the difference is between Research Costs, Support Costs and Treatment Costs and how each of these are funded (see box 1).

Your local R&D office can assist with costing out your proposal. You will need to contact them at the earliest opportunity but no less that 4 weeks prior to your submission deadline as they will need to get costs signed off and agreed within their Trust / Organisation, and may also have to liaise with support departments over resources and capacity.

You need to make sure you have thought of all recruitment angles (see Recruitment page for more information as costs associated with this (such as postage, envelopes, patient travel etc) will need to be included in your funding bid: see this example .

Cost of archiving and data storage

You need to also ensure that you have included any costs associated with disseminationof your results as well as storage and archiving of your study documentation and data at the end of the study. This should include any costs of archiving at your individual research sites. See also section on archiving and data storage

Box 1

Research costs – these are the costs related to doing the piece of research and are funded from the grant. You need to ensure that all research costs are included in the bid – this includes items such as postage for mailshots and replies, training for practice staff, travel costs for participants including where staff are participants, study archiving, dissemination of results etc.

Support costs – these are the costs to the NHS of supporting research (e.g. NHS staff time in taking bloods, conducting database searches). If your study is adopted onto the national portfolio (15) these costs are covered by the CLRN (10), however early discussion with the CLRN is needed to ensure the funds are available, particularly where the support costs are large. The R&D Office at NHS Norfolk can assist with this. If your study is not eligible for adoption onto the national portfolio these costs will need to be covered by your grant funder.

Treatment Costs – these are the costs of the treatment – where these are greater than normal care for these patients these are termed excess treatment costs. Treatment costs are funded through normal commissioning arrangements for patient care. Where treatment costs (especially excess treatment costs) are to be incurred as part of a study, early discussion with the PCT/Trust is needed to agreed to these costs.

Further Guidance is available from DH to help distinguish between Research, Support and Treatment Costs, please also contact the R&D Office at NHS Norfolk for advice.

The DH ARCO guidance provides guidance on what is a research cost, support cost and treatment cost.

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