How to Write a Grant Application How to Write a Grant Application Allan Hackshaw © 2011 Allan Hackshaw. ISBN: 978-1-405-19755-7 How to Write a Grant Application Allan Hackshaw Deputy Director Cancer Research UK & UCL Cancer Trials Centre University College London London, UK This edition fi rst 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 Scientifi c, Technical and Medical business to form Wiley-Blackwell. 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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 Set in 9.5/12pt Minion by MPS Limited, a Macmillan Company, Chennai, India 1 2011 Contents Foreword, ix Preface, xi Acknowledgements, xiii About the author, xv Chapter 1: Overview, 1 1.1 Types of grants, 2 1.2 Types of funding organisations, 3 1.3 Choosing an appropriate funding body, 5 1.4 Contents of the grant application, 6 1.5 Including several studies in one application (project grants), 6 1.6 Translational research sub-studies, 8 1.7 The application process, 8 1.8 Estimating timelines and a planned work schedule, 10 1.9 Intellectual property, 12 1.10 Text, grammar and format, 13 Chapter 2: People involved in the study, 15 2.1 Who should be part of the Study Team? 15 2.2 Other investigators, collaborators and consultants, 19 2.3 The host institution and Sponsor, 20 2.4 Commercial companies, 21 2.5 Oversight committees, 21 Chapter 3: Justifi cation for the study, 24 3.1 Finding background information, 24 3.2 Previous evidence and similar research (why the study is needed now), 26 v vi Contents 3.3 Biological plausibility, 28 3.4 Safety of new interventions in clinical trials, 29 3.5 Feasibility, 29 3.6 What will the study contribute? 31 3.7 Summary of the justifi cation for a proposed study, 32 Chapter 4: Describing the study design, 35 4.1 Abstract, 35 4.2 Appendices, 40 4.3 Study objectives and outcome measures, 40 4.4 Types of studies, 44 4.5 Observational studies in humans, 44 4.6 Clinical trials in humans, 49 4.7 Laboratory experiments, 57 4.8 Describing sample size, 60 4.9 Describing the main statistical analyses, 64 4.10 Systematic reviews, 69 Chapter 5: Associated documents with the grant application, 72 5.1 Study protocol, 72 5.2 Participant Information Sheet, 73 5.3 Curricula vitae of the Chief Investigator and all co-applicants, 75 5.4 Letters of support from co-applicants, centre investigators, collaborators, or other advisors, 76 5.5 Letters of support from commercial companies, 76 5.6 Other documents specifi c to the fi eld of research, 77 Chapter 6: Financial costs, 78 6.1 Overview of items to include in the fi nancial costs, 78 6.2 Indirect costs or overheads (full economic costs), 82 6.3 Per patient (or per subject) payments, 83 6.4 Staff costs, 84 6.5 Access to core funds and resources, 86 Contents vii 6.6 Consideration of costs not to be met by the funding body, 87 6.7 Grant applications associated with calls for proposals, 88 6.8 Observational studies in humans, 88 6.9 Clinical trials in humans, 93 6.10 Laboratory experiments, 97 6.11 Systematic reviews, 98 Chapter 7: Funding body review process, 100 7.1 Submitting the application, 100 7.2 Processing the application within the funding body, 102 7.3 Initial reviews (external reviewers), 102 7.4 Funding committee meeting, 105 7.5 Funding committee evaluation, 106 7.6 Feedback to applicants after the meeting, 111 7.7 Responding to the funding committee feedback, 112 Chapter 8: Annual reports and applying for a grant extension, 115 8.1 Annual reports, 115 8.2 Applying for a grant extension, 117 Bibliography, 120 Index, 123 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 scientifi c hypoth- esis from an idea to a formal proposal that leads to a fi nancially viable set of experiments or studies. For most aspiring academic clinicians or scientists, career development depends on publishing their scientifi c work. Obtaining grant funding even in a buoyant economy is never easy. As fi nancial 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 scientifi c 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 com- plex 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 scientifi cally sound, realistic and feasible. Each section of the book will help the reader formulate a logical and clear application covering the scientifi c, fi nancial 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 scientifi c application that is internationally competitive. Professor Jonathan A Ledermann Director, Cancer Research and UCL Cancer Trials Centre, University College London ix 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 specifi c study grants that must be applied for in a competitive fash- ion, including training fellowships and doctoral studentships. Many applica- tions 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 under- standing 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 appli- cation that hopefully will have a better chance of success. It will cover the key aspects of writing a grant application, namely describing the justifi ca- tion, feasibility and value of the proposed study; the design, and being clear about objectives, hypotheses and outcomes; estimating fi nancial 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 xi 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. xiii 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 includ- ing cancer and migraine. He has been co-investigator on many successful grant applications to public sector bodies, charities or commercial organi- sations; with a total funding amount of over £24.7 million associated with observational studies, clinical trials and systematic reviews. Just as impor- tantly, 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 commit- tees at Cancer Research UK (Clinical Trials Advisory Awards Committee, CTAAC) since 2007. xv