How to Write a Grant Application E-Book

Allan Hackshaw

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 223

Veröffentlichungsjahr: 2010

Beschreibung

This concise guide covers the important angles of your grant application, whether for a health research project or personal training programme, and will help you be among the successful applicants. The author, a reviewer for grant funding organisations and internationally respected research scientist, gives you the benefit of his experience from both sides of the process in this easy-to-use, readable guide. The book takes you through the grant application process, explaining how to: * Present the justification for the proposed project * Describe the study design clearly * Estimate the financial costs * Understand a typical review process, and how this can influence the contents of the grant application The author provides practical advice on a range of project types (observational studies, clinical trials, laboratory experiments, and systematic reviews) to increase the chance that your application will be successful. There are also tips on what to avoid throughout the application. With generic information about application requirements, How to Write a Grant Application is ideal for healthcare professionals seeking a health services or scientific grant.

Leseprobe

Contents

Foreword

Preface

Acknowledgements

About the author

Chapter 1: Overview

1.1 Types of grants

1.2 Types of funding organisations

1.3 Choosing an appropriate funding body

1.4 Contents of the grant application

1.5 Including several studies in one application (project grants)

1.6 Translational research sub-studies

1.7 The application process

1.8 Estimating timelines and a planned work schedule

1.9 Intellectual property

1.10 Text, grammar and format

Summary points

Chapter 2: People involved in the study

2.1 Who should be part of the Study Team?

2.2 Other investigators, collaborators and consultants

2.3 The host institution and Sponsor

2.4 Commercial companies

2.5 Oversight committees

Summary points

Chapter 3: Justification for the study

3.1 Finding background information

3.2 Previous evidence and similar research (why the study is needed now)

3.3 Biological plausibility

3.4 Safety of new interventions in clinical trials

3.5 Feasibility

3.6 What will the study contribute?

3.7 Summary of the justification for a proposed study

Summary points

Chapter 4: Describing the study design

4.1 Abstract

4.2 Appendices

4.3 Study objectives and outcome measures

4.4 Types of studies

4.5 Observational studies in humans

4.6 Clinical trials in humans

4.7 Laboratory experiments

4.8 Describing sample size

4.9 Describing the main statistical analyses

4.10 Systematic reviews

Summary points

Chapter 5: Associated documents with the grant application

5.1 Study protocol

5.2 Participant Information Sheet

5.3 Curricula vitae of the Chief Investigator and all co-applicants

5.4 Letters of support from co-applicants, centre investigators, collaborators, or other advisors

5.5 Letters of support from commercial companies

5.6 Other documents specific to the field of research

Summary points

Chapter 6: Financial costs

6.1 Overview of items to include in the financial costs

6.2 Indirect costs or overheads (full economic costs)

6.3 Per patient (or per subject) payments

6.4 Staff costs

6.5 Access to core funds and resources

6.6 Consideration of costs not to be met by the funding body

6.7 Grant applications associated with calls for proposals

6.8 Observational studies in humans (see also Section 4.5, page 44)

6.9 Clinical trials in humans (see also Section 4.6, page 49)

6.10 Laboratory experiments (see also Section 4.7, page 57)

6.11 Systematic reviews (see also Section 4.10, page 69)

Summary points

Chapter 7: Funding body review process

7.1 Submitting the application

7.2 Processing the application within the funding body

7.3 Initial reviews (external reviewers)

7.4 Funding committee meeting

7.5 Funding committee evaluation

7.6 Feedback to applicants after the meeting

7.7 Responding to the funding committee feedback

Summary points

Chapter 8: Annual reports and applying for a grant extension

8.1 Annual reports

8.2 Applying for a grant extension

Summary points

Bibliography

Index

How to Write a Grant Application

This edition first published 2011, © 2011 by Allan Hackshaw

BMJ Books is an imprint of BMJ Publishing Group Limited, used under licence by Blackwell Publishing which was acquired by John Wiley & Sons in February 2007. Blackwell’s publishing programme has been merged with Wiley’s global Scientific, Technical and Medical business to form Wiley-Blackwell.

Registered office: John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK

Editorial offices:

9600 Garsington Road, Oxford, OX4 2DQ, UK

111 River Street, Hoboken, NJ 07030-5774, USA”

The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK

For details of our global editorial offices, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/wiley-blackwell

The right of the author to be identified as the author of this work has been asserted in accordance with the Copyright, Designs and Patents Act 1988.

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher.

Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is sold on the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought.

The contents of this work are intended to further general scientific research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method, diagnosis, or treatment by physicians for any particular patient. The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of fitness for a particular purpose. In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. Readers should consult with a specialist where appropriate. The fact that an organization or Website is referred to in this work as a citation and/or a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make. Further, readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read. No warranty may be created or extended by any promotional statements for this work. Neither the publisher nor the author shall be liable for any damages arising herefrom.

Library of Congress Cataloging-in-Publication Data

Hackshaw, Allan K.

How to write a grant application / Allan Hackshaw.

p.; cm.

Includes bibliographical references and index.

ISBN 978-1-4051-9755-7 (alk. paper)

1. Proposal writing in medicine. 2. Medicine—Research grants. 3. Proposal writing for grants. I. Title.

[DNLM: 1. Research Support as Topic. 2. Biomedical Research. 3. Writing—standards. W 20.5]

R853.P75H33 2011

610.79—dc22

2010036482

A catalogue record for this book is available from the British Library.

This book is published in the following electronic formats: ePDF 9781444329667; Wiley Online Library 9781444329650; ePub 9781444329674

Foreword

Writing a grant is often a painstaking process. However, if one is fortunate it can be aided by an experienced mentor who has learnt over many years how to navigate through the complex process of taking a scientific hypothesis from an idea to a formal proposal that leads to a financially viable set of experiments or studies. For most aspiring academic clinicians or scientists, career development depends on publishing their scientific work. Obtaining grant funding even in a buoyant economy is never easy. As financial pressure on government, industries and charities increases, the chance of successful funding diminishes.

In How to write a Grant Application the author brings together many years experience of obtaining grants for clinical and scientific projects. Allan Hackshaw provides an invaluable resource to guide the reader through each step in the preparation, writing and management of a grant.

Regulations concerning the conduct of clinical trials in humans are complex and have created a new terminology that needs to be understood and incorporated into grant applications. The book describes the important components that need to be considered in formulating a grant application that will lead to a study that is scientifically sound, realistic and feasible.

Each section of the book will help the reader formulate a logical and clear application covering the scientific, financial and administrative components needed to run a modern series of experiments or a clinical study. By reading this book the applicant should be able to avoid the common pitfalls involved in writing a grant so that more time can be spent crafting a mature scientific application that is internationally competitive.

Professor Jonathan A Ledermann

Director, Cancer Research and UCL Cancer Trials Centre, University College London

Preface

All researchers are familiar with how most projects, and the people who work on them, are funded. A large majority of projects need to be funded from specific study grants that must be applied for in a competitive fashion, including training fellowships and doctoral studentships. Many applications are not successful due to a variety of problems, some of which could have been avoided in the submitted application or by having a better understanding of the review process and what is usually expected by the funding committee and their external reviewers. Funding organisations want value for money, and because there are many researchers applying for a limited pool of funds, applicants need to develop and write a strong and well-written application, so that it is likely to be ranked above most of the others, and therefore successfully funded.

This book aims to provide a clear account of how to develop a grant application that hopefully will have a better chance of success. It will cover the key aspects of writing a grant application, namely describing the justification, feasibility and value of the proposed study; the design, and being clear about objectives, hypotheses and outcomes; estimating financial costs; and a description of a typical funding committee review process. The book also distinguishes between the different types of studies (observational studies, clinical trials and laboratory experiments).

Allan Hackshaw

Deputy Director, Cancer Research UK & UCL Cancer Trials Centre

Acknowledgements

I would like to express many thanks to those who commented on draft chapters: Kerry Chester, Cheryl Mason Rosalind Raine and Jane Wooders. I am most grateful to Jan Mackie for her careful and thorough editing. Final thanks go to Harald Bauer.

About the author

Allan Hackshaw has been working in academic clinical research since 1991, with experience in a variety of areas including smoking and health, antenatal and cancer screening, and treatments for several disorders including cancer and migraine. He has been co-investigator on many successful grant applications to public sector bodies, charities or commercial organisations; with a total funding amount of over £24.7 million associated with observational studies, clinical trials and systematic reviews. Just as importantly, he has also been involved in unsuccessful applications and learnt key lessons from the experience. He has acted as an external reviewer for grant funding bodies, and been a member of one of the main funding committees at Cancer Research UK (Clinical Trials Advisory Awards Committee, CTAAC) since 2007.

Chapter 1 Overview

Many researchers in health sciences need to obtain funding in order to establish or continue with their work. This is a common activity in the non-commercial (academic or public) sector, such as universities and hospital research departments. The process of obtaining financial support is usually very competitive, particularly when there are limited resources. Funding bodies also need to ensure that their grants will be put to the best use, maximising the effect on clinical practice, public health, scientific knowledge or future research.

It can easily take 1–2 years (often more) from inception of a research proposal until the first subject is recruited to the study. This may sometimes feel daunting to researchers, especially those new to the field. However, as more people become involved and time is spent on developing the idea and study design, the likelihood of it being successfully funded should increase. If it has been thought through properly, major potential problems and design issues will have been considered and addressed in the application, rather than being raised for the first time by the funding committee or its external reviewers. It can be easy for experienced reviewers to distinguish a polished and cogent application that may have taken perhaps several months to develop and write, from one that has been written hastily in 3 weeks and only seen by one or two colleagues.

There is no such thing as a perfect grant application. The external reviewers and funding committee will usually have criticisms, and the applicants themselves often see ways of improving their application with hindsight. What largely matters is making the proposed project look important enough to be funded, that it is well designed, and that the financial costs are reasonable.

1.1 Types of grants

Grants are used to investigate a multitude of study objectives:

Examining risk factors for or causes of disease or early death.Examining the characteristics, attitudes, experiences or behaviour of defined groups of people.Evaluating methods for preventing, detecting or treating disease, or preventing early death.Laboratory experiments on biological samples, animals or simple organisms, in order to investigate the effects of a stimulus or exposure, identify associations, or as part of drug development.Correlating biological measurements with each other, or with patient outcomes, such as examining genetic, protein or other biomarkers associated with a disorder or early death.

The types of grants available to researchers include the following.

1.1.1 Project grants

These are the most common and are the type of grants with which researchers are familiar. The idea for a specific project is first thought of by one or two people in the field, who then establish a small group of colleagues to develop the idea further before applying for a grant. Alternatively, a project title can be first developed by a funding organisation, perhaps through an advisory committee, which has identified a need for a particular piece of research. The organisation advertises this (sometimes referred to as a call for proposals), and interested applicants then compete over who can address the research idea with the best study design and most acceptable resource requirements.

Project grants can cover any length of time, depending on the objectives, how common the disorder is and the number of expected participating centres. For example, a systematic review of a set of 10 published clinical trials, that involves obtaining raw data from each trial group, could take 12–18 months to complete, whereas a screening trial to identify people at a high risk of stomach cancer and to prevent it through adequate treatment could take over 10 years. An early phase clinical treatment trial of 50 patients could run for 2 years, compared with a late phase randomised trial of 500 patients that could take around 5 years.

1.1.2 Fellowships and doctoral (research) postgraduate degrees

These usually fund either a specific person who has formulated a research idea as part of his/her professional development, or a project proposal that has been advertised by a research department. Fellowships, which are competitive, are a sign of personal professional achievement if the grant application is successful. They can be awarded to those who are already employed and the grant will allow the recipient to focus their research on a particular area for a fixed time period. Doctoral research degrees are common, particularly among people who are early in their career. The study objectives for these two types of grants are similar to those for project grants but are often smaller-scale studies, limited to laboratory experiments, or involving only a few centres for studies of humans, because funding is for a fixed length of time, for example 3–5 years.

1.1.3 Programme grants

Programme grants apply to a set of related projects in a particular field of research. These could fund a group of people with a common general research goal, or may support the formation of a core unit, either on its own or as part of a larger department, for example, establishing a clinical trials unit to design and conduct treatment trials in particular disorder. A programme grant can also be used to fund a set of new related studies to examine aspects of a disorder, for example, looking at different risk factors for heart disease, such as lifestyle characteristics, genetic and biological markers in blood or urine. These types of grants involve significant amounts of money and are associated with a duration of several years, for example 5 or 10 years, sometimes with the expectation that the grant will be renewed at the end of the period. Those who lead the units supported by these grants usually have prior experience with securing project grants and are established in their field of research.

Each of these three types of grants requires different levels of effort spent in the application process; the input is approximately in proportion to the funding requested. Programme grants are the most intensive to prepare because they are expensive, they will employ several people and last for many years. Project grants are perhaps the most competitive because they are usually open to any level of researcher, ie. those new to the field or already established. Grants for fellowships and research degrees tend to be offered by relatively few organisations, such as governmental research councils or charitable bodies, and are for short periods of time (up to about 3–5 years). These grants may be relatively easier to obtain, but elements of the grant application are similar to project grants.

1.2 Types of funding organisations

Several types of organisations provide funding for research projects:

Governmental bodies or research councilsDepartment of Health/National Health Service (UK)Medical Research Council (UK)National Institutes of Health (USA) (see Yang 2005 for specific details about applying for NIH grants)National Cancer Institute (USA)Biotechnology and Biological Sciences Research Council (UK)Regional or international funding organisationsEuropean Research CouncilEuropean CommissionAssociation for International Cancer ResearchWorld Health OrganizationCharities, disease-specific associations or foundationsBritish Heart Foundation (UK)Cancer Research UK (UK)March of Dimes (USA)Bill and Melinda Gates FoundationDeutsche Forschungsgemeinschaft (DFG, German Research Foundation)Local trustees within an organisation: Some hospitals have a trustees’ fund, which has accumulated from donations made by former or current employees, or by patients. Such funds are usually available to conduct relatively small-scale studies within that organisation (i.e. local or single centre studies), and not usually with national or international centres.Commercial companies: Some pharmaceutical companies and those that manufacture medical devices often provide funds to researchers in the non-commercial sector (e.g. a university), to conduct a clinical trial using one of their products. The drug or medical device may or may not already be licensed for use in humans, but it is almost always provided to the researchers without any cost. In some instances, the company also gives financial support to set up and conduct the trial in the form of a study-specific grant or an educational grant.Private benefactors: A researcher or research unit may have developed a professional relationship with a single, relatively wealthy individual who is willing to support them for a specific project. It is often the case that the benefactor (or his/her family member) has suffered from an illness related to the work of the researcher.

There is also a website called researchresearch.com that lists a wide range of funding organisations, including many of the smaller ones. The website is http://new.researchresearch.com.

Almost all grant applications will be considered by a funding committee, a group of experts with various backgrounds who are internal or external to the funding organisation. They will make the decision to fund a study or not.

Each funding organisation has its own process for grant applications. It is not the purpose of this book to cover specific agencies, nor to compare and contrast between them. However, the information required from prospective researchers and many elements of the review process tend to be very similar, particularly for the larger well-known funding bodies. Details of the application process for a particular organisation should be available from their website, the application form or other documentation sent on request. Many regularly update their terms and conditions and requirements, so it is important to check these for each application as they may have changed since the last time the researcher submitted to the funding body. The organisation will usually have administrative staff available to provide advice on the application process by email or telephone.

Many application forms can be downloaded from the funding body’s website (often in Microsoft Word), to be completed electronically and emailed or posted with the relevant signatures. Sometimes, there is an online submission form which is transferred directly to the funding body without the need for a hard copy (this is becoming increasingly common), though original signatures may still be expected to be posted.

1.3 Choosing an appropriate funding body

It will often be obvious which organisations are appropriate for funding a specific project, and large organisations sometimes have separate funding streams for different types of studies (such as laboratory experiments, observational studies or clinical trials). Colleagues with prior experience may recommend an appropriate funding body, or applicants could obtain information from websites or other documentation. When there are several potential funding organisations, the researcher needs to decide which might be the most appropriate after discussion with the Study Team (the group of people responsible for developing the study and who will usually be co-applicants; see Chapter 2). An application on the same topic should not be sent to more than one funding body at the same time with the expectation that this increases the chance of success. This is not usually allowed, and it avoids an unsatisfactory situation where two funding organisations approve the same study and applicants have to reject one.

Deciding which funding organisation to apply to may depend on the following factors:

Whether there is a limit to the amount that can be requested, either each year or in total, or for single items of equipment.How wealthy the funding body is (small organisations are highly unlikely to fund large expensive studies).Whether or not the funding body will include institutional overheads (indirect costs) as part of the grant (see Section 6.2, page 82).Whether the application success rate for a funding body is low (usually because there are so many applications).

If the application is unsuccessful, it is always possible to submit a revised version elsewhere. However, the reviewers’ comments should always be taken into account unless they are entirely inappropriate, because the next funding body may use one or more of the same reviewers. This may often be by chance, but is far more likely if the field of research is relatively narrow with a limited pool of appropriate experts.

1.4 Contents of the grant application

What is required from the applicants will usually be clear, either from the section headings in the application form itself or the guidelines from the funding organisation. Figure 1.1 provides an overview of the key features that are expected to be addressed in a typical grant application. Background, biological plausibility and justification, feasibility, and how the study results and conclusions will be used are covered in more detail in Chapter 3, while study design (which often forms most of the application) is discussed in Chapter 4. When there is no guidance from the funding body on the structure of the application (e.g. a commercial company or private benefactor), the main headings from Figure 1.1 could be used.

Figure 1.1 Key features of a typical grant application.

All projects should have a simple and concise title (one sentence). It is also worth creating an acronym for the study using letters from the title (sometimes the first letter from key words), or some word that encompasses the study aim, but check whether the same acronym is already in use for similar studies.

1.5 Including several studies in one application (project grants)

Most applications are associated with a single project, but there are occasions when several related projects are specified, though it is not meant to be a programme grant (see page 3). Sometimes, this approach is an efficient way to examine two or more objectives without having completely separate studies. For example, evaluating several treatments for a rare disorder as patients proceed through the clinical pathway from initial diagnosis to improvement, stable disease or progression, where different subsequent treatments are used according to level of recovery. Alternatively, there could be several related laboratory experiments, with specific but distinct stages.

Having too many sub-studies and objectives can make the application difficult to follow, or the overall project too complex. Occasionally, the funding committee may like parts of the project, but not others, and therefore need to decide whether to fund only these parts or decline the entire study. Applicants should, therefore, generally aim to avoid having too many sub-studies within a single application. If this approach is judged to be appropriate, applicants must provide a clear scientific justification, and show that there really is a central theme between the constituent studies. They will need to demonstrate that these are not different studies simply cobbled together. The applicants also need to ensure that one sub-study does not have an adverse impact on another, and that the results of any sub-study can be interpreted easily. A (simple) diagram showing how they all fit together would be helpful (see pages 38–39).

1.6 Translational research sub-studies

Many studies on humans, particularly case–control and cohort studies and clinical trials, will have clear objectives regarding a specific disorder or prevention of early death. However, it is becoming more common to collect biological samples as part of the main study, to be stored centrally in a laboratory for future, sometimes unspecified, analyses (i.e. the creation and maintenance of a biobank). This secondary analysis is sometimes referred to as a translational research study. The samples are usually blood, saliva or urine, but may also include tissue samples (e.g. cancerous tissue removed from affected patients). The analyses involve measuring biomarkers which could be chemical, biological (eg. genomic or proteomic markers) or radiological, that are to be correlated with clinical outcomes from the main study, such as response to a treatment, disease incidence, disease severity or mortality. Examples of this could be to examine the prognostic value of a biomarker (i.e. how well it correlates with a clinical outcome), its predictive value (i.e. whether the marker can be used to identify subgroups of individuals that are, for example, more likely to benefit from a certain treatment), or whether a biomarker can be used as a surrogate measure.

Adding a translational research sub-study could strengthen an application for the main study; the funding body may feel that they are getting more value for their money. Applicants may not need to describe in detail what the actual laboratory analyses will entail, because funding for the particular sub-study is sometimes applied for at a later date, or even from a different funding organisation. The application could briefly indicate the type of samples to be collected, when this will be undertaken, and whether there are any markers of current interest that would be measured. However, not all studies would benefit from having a translational study component, and indeed the collection and storage of biological samples could sometimes be a hindrance to the main study. The Study Team should decide together whether such a sub-study might be useful.

1.7 The application process

Figure 1.2 shows an overview of a typical grant application process (the funding committee evaluation is described in Chapter 7). Some funding bodies have an initial screening process for project grants, where an