1. Masterclass in Writing RfPB Grant Applications
Carole Fogg
Sophie Hyndman
Helen Lloyd
28th January 2011
Presented January 2011; updated and adapted for web, January 2012

2. Welcome! Introductions Aim and Objectives of the Day2

3. Who are we and what can we do for you?
RDS South Central: Research Design Support for NHS and Social Care Researchers
Who are we and what can we do for you?

4. Some of our A-Team: Multi-disciplinary team: Statisticians
Clinical Trialists
Epidemiologists
Qualitative Researchers
Health Economists
Patient/Public Experts
Health Psychologists

5. What can the RDS SC do to help you?
For all aspects of grant preparation, advice on:
Sources of funding
Literature search and review
Developing and refining research objectives
Study design, including health economics & statistics
Planning teams and budgets
Patient and Public Involvement (PPI)
Research Advisor, with access to specific experts as required
Research Design Advisory Panels
Potential for collaboration
Communications: , newsletter, website
Training: research master classes

6. Question: In what way is a research grant application like a general election campaign?

7. They both require the right balance between
Answer:
They both require the right balance between

8. Aim
To support researchers in developing successful research grant proposals, specifically, Research for Patient Benefit applications

9. Objectives To provide:
An overview of funding applications, and how they relate to research governance and ethics applications
An overview of NIHR funding schemes and the purpose and scope of RfPB
An understanding of what reviewers expect to see in an RfPB grant application
Some guidance on identifying what makes ‘good’ and ‘bad’ grant applications
An introduction to the structure and content of the RfPB form
An understanding of the importance of patient and public involvement in RfPB research
An understanding of methodological issues important to reviewers
An understanding of the resources and time required to undertake a research project
An introduction to other sources of research support

10. Part 1 Research in the NHS: Funding Applications in Context

11. Important initiatives
Good Clinical Practice (GCP) and the UK Medicines for Human Use (Clinical Trials) Regulations 2004
Responsibilities and accountabilities for clinical trials of investigational medicinal products
Research Governance Framework for Health and Social Care (2005)
Informed by above, but for research more generally
Best Research for Best Health (2006)
Infrastructure and systems
Salvatore Vuono.

12. The purpose of these initiatives
Research Governance
To protect the safety, dignity, rights and wellbeing of research participants
To promote useful, ethical, valid, safe and affordable research
To prevent futile, unethical, invalid, dangerous and extravagant research
To provide research standards
To define responsibilities and accountabilities
To set out delivery and monitoring systems to ensure standards
Best Research for Best Health
To make the UK a recognized centre of healthcare research excellence by providing a good research infrastructure
To build research capacity
To fund research to improve health and social care
To improve and manage knowledge and information systems to simplify research processes and maximise usefulness of research

13. The result of these initiatives
Among other things…
A range of funding schemes for health research
A system of research approvals to ensure that research is well regulated and ethical

14. What are the main ‘hoops’ to jump through?
All research carried out in the NHS requires:
A sponsor
Ethics approval
R&D approvals
Most research will require:
Funding
Some research will require
Other approvals (e.g. Clinical Trial Authorisation)
Honorary contracts or research passports
1 ) Hula hoop moment from Circus Smirkus performance provided courtesy of Wikipedia. Permission is granted to copy, distribute and/or modify this document under the terms of the GNU Free Documentation License, Version 1.2

15. Where do I start? Sayan Samana

16. Steps to take1.... 2. Find a sponsor 3. Apply for research funding
1. Write proposal/ protocol
4. Apply for ethics approval*
7. If required, attend to research passports/ honorary contracts
6. If required, attend to other approvals*
* IRAS
5. Apply for R+D approval*
1. May not always be in this order!
Image from Office Online

17. Steps (1) Write a research protocol and (3) Apply for funding
Q. What is the difference between a research protocol and a research grant application?
A research protocol is the definitive document that will inform the process of the research. Some R&D offices will insist on a GCP approved protocol, and provide templates for this (regardless of whether the project is a Clinical Trial of an Investigational Medical Product (CTIMP) or not)
The research protocol can be used as the basis for applying for ethics and funding, and there will be an overlap, but these latter documents will have different emphases, so it is not simply a matter of cutting and pasting
See
Downloads 16 & 17 for GCP approved templates
Image from Office Online

18. Step (2) Find a sponsor i.e.:
Q. Why do you need a sponsor?
A. You need an organisation to be accountable for the research
i.e.:
Responsibility for the initiation and overall management, including quality assurance (research protocol, team, research environment)
Responsibility for the finances associated with the study
Ensure all approvals obtained, e.g. ethics, clinical trial authorisation
Arrangements for handling of any Investigational Medicinal Products (IMP)
Ensure Good Clinical Practice (GCP), monitoring and reporting (including safety reporting)
Image from Office Online

19. Q. Who can be a sponsor?
Usually:
Chief Investigator’s employing institution, e.g. a university or NHS trust
A funding organisation
Where research is for training purposes, the research supervisor (on behalf of their employer)
Private sector e.g. pharmaceutical industry

20. Step (4) National Research Ethics Committee (NRES) approval http://www
Role:
Protect rights, safety, dignity and well-being of research participants
Facilitate and promote ethical research of potential benefit to participants, science and society. 
Advice on: information sheets and consent forms, GCP, procedures, use of personal data etc.
Apply: online via Integrated Research Application System (IRAS)
Image from Office Online

21. Step (5) Local trust research and development office (R&D) approval
Role:
To give permission to conduct research in the site
If sponsor, to undertake that role; if hosting research (sponsored by others), to undertake audit of a proportion of studies
To ensure all relevant research-related contracts are in place
Advice available:
Variable and dependent on personnel/ time: NRES applications, financial aspects of study from trust perspective, more general research advice
Image from Office Online

22. Directly to R&D Office for all non portfolio research.
When do you meet them?
Variable and dependent on personnel/ time: for high risk/ drug related/ device related studies, as soon as you have a protocol; some offices may be interested in these and other studies at the development stage.
Apply:
Via IRAS Coordinated System for gaining NHS Permission (CSP) for research qualifying for the NIHR Clinical Research Network Portfolio
Directly to R&D Office for all non portfolio research.

23. Step (6) Other approvals
IRAS captures the information needed by:
Administration of Radioactive Substances Advisory Committee (ARSAC)
Gene Therapy Advisory Committee (GTAC)
Medicines and Healthcare products Regulatory Agency (MHRA)
Ministry of Justice (National Offender Management Service) 
HSC research offices
NRES / NHS / HSC Research Ethics Committees 
National Information Governance Board for Health and Social Care (NIGB).
Social Care Research Ethics Committee
Image from Office Online

24. Step (7) Research Passports and Honorary Contracts
Q. What is a research passport?
A set of signatures and checks from your employing organisation required prior to issuing an honorary contract or letter of access.
Q. What is an honorary contract?
A contract with an NHS trust for a researcher whose employer is not that NHS trust.
What is a letter of access?
A letter permitting a researcher whose employer is not that NHS trust into the trust
Image from Office Online

25. Always check with trusts what level of access they consider you need
Q. When are honorary contracts needed?
When: (a) the research is hosted in the NHS and (b) the researcher has no contract with the NHS and (c) the researcher’s activities in the NHS site will involve interacting with individual patients in a way that has a direct bearing on the quality of their care.
Q. When are letters of access needed?
When (a) and (b) above are present, but not (c)
Always check with trusts what level of access they consider you need

26. Why are honorary contracts needed?
Patients in receipt of research procedures come under the NHS duty of care and the NHS indemnity scheme applies to the researchers and their activities.
The researcher is accountable to the NHS organisation for their activities, explicit supervision arrangements are in place, and the researcher is made aware of the relevant NHS policies with which they must comply in their activities.
The researcher’s substantive employer understands the research activities and has undertaken all the necessary checks in relation to the researcher’s suitability to carry out those activities.
Where do I apply to get an honorary contract?
A. Usually Human Resources Department of NHS Trust where you wish to do the work.

27. (1) Involving a Comprehensive Local Research Network (CLRN)
Steps you MIGHT have to take:
Can work with investigators to:
Provide NHS Support Costs for research projects
Facilitate permissions
Help with recruitment of sites and patients
Help with data collection
General advice on the research process in their area of expertise.
Image from Office Online

28. (2) Involving a Clinical Trials Unit (CTU)
Can work with investigators to:
Develop new trials (design, collaboration, funding, communication with Clinical Research Network, regulatory and governance issues)
Manage funded trials (questionnaire design, set-up, recruitment, pharmacovigilance, data management, monitoring, analyses, report preparation)
Image from Office Online

29. Part 2 – Research for Patient Benefit (RfPB) & The Importance of Sc pe
Image courtesy of Wikimedia commons (Public Domain)

30. NIHR Research Programmes
Research for Patient Benefit (RfPB)
Programme Grants for Applied Research (PGfAR)
Invention for Innovation (i4i)
Health Technology Assessment (HTA)
Efficacy and Mechanism Evaluation (EME)
Public Health Research (PHR)
Health Services and Delivery Research (NIHR HS&DR)
- formerly 2 programmes: Health Services Research (HSR) & Service Delivery and Organisation (SDO)

31. Research for Patient Benefit offers…
The opportunity to conduct research that:
arises from daily practice in the NHS
is developed between NHS and other partners
is open to topic and method
shows tangible health and health care benefits for patients
amplifies the patient voice
that encourages collaboration
closes the loop between research and practice – will be implemented or drive change

32. Aims / sc pe
To support projects in health services and public health research
Qualitative, quantitative or mixed method research that will:
study the way NHS services are provided and used
evaluate whether interventions are effective and provide value for money
examine whether alternative means for providing healthcare would be more effective

33. Aims / sc pe RfPB will also fund research that will:
pilot or assess the feasibility of projects requiring major applications to other funding bodies
formally assess innovations and developments in healthcare
Proposals which have emerged from interaction with patients/service users and public are particularly welcome
Systematic reviews may be funded as part of a larger project or as stand alone studies. For more details, see the RfPB FAQ on systematic reviews.

34. OUT of sc pe:
Lab-based or basic science research, including research based on animals
Setting up or maintaining research units
Proposals which are solely service developments
Proposals which are solely audit, surveys, needs assessment, technology development (although may be included as part of an integrated research study)
Images from Office Online

35. Read the guidance...
Each RfPB competition has associated Guidance for Applicants that covers:
aims
scope
eligibility etc
For general enquires
call Or
Or visit
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36. Selection Criteria and Eligibility
Applications judged on:
the quality of the research proposed
the significance and potential benefit of the research to the NHS
All NHS organisations and other providers of NHS services in England can apply (For joint NHS/university applications funding is awarded to the NHS partner)
Probably with academic partners
Potentially with strong component of service user involvement.
Applications with collaborations in social care and third sector providers of health and social care are also encouraged
If strong case, can include academic partner outside England.
Image from Office Online

37. The Application Process
Full application deadline
Preliminary scrutiny and is it in scope?
External peer and lay review
Full committee assessment
Final ratification
Notification of outcome
Images from Office Online

38. Overall, a wide range of RfPB projects funded
Based in a diversity of settings and care groups
Concerned with clinical and non-clinical topics
Using a diversity of methods and research techniques
See the detailed report on the first three competitions –
Prioritising Patients

39. Part 3 RfPB APPLICATIONS

40. A grant application, like a picture, should be:
Clear
Unambiguous
Easy on the eye ☺
Easy on the brain
Photo by Remy Steinegger; Copyright : World Economic Forum. Licensed under the Creative Commons Attribution-Share Alike 2.0 Generic license (
Source: Wikipedia

41. It should not be :
Jumbled up
Unclear
Difficult to decipher
Confusing

42. Or indeed something you didn’t intend it to be
Original Author: David Angell (adapted by Odder). Licensed under Creative Commons Attribution 2.0 Generic Licence ( Source: Wikipedia

43. Part 3 RfPB APPLICATIONS
(a) What would you expect to see in an RfPB grant application?

44. Part 3 RfPB APPLICATIONS (b) Examples of ‘good’ and ‘bad’ grant application sections
Group/interactive work
For examples of good & bad grant application sections, see [weblink]
Simon Howden

45. Part 3 RfPB APPLICATIONS
(c) What a reviewer expects to see in an RfPB application form

46. Overall style Limit use of overly technical language, buzzwords and acronyms
Tech Speak (defined by Edward Tenner) “Post colloquial discourse modulation protocol for user status enhancement. It's a referential system for functional-structural, microscopically specific macroscopic-object redesignation. It's a universal semantic transformation procedure. It's a holophrastic technocratic sociolect. It's a meta-semiotic mode for task specific nomenclature." Get the idea?
Buzzword An important-sounding word or phrase connected with a specialized field or group that is used primarily to impress laypersons: “‘Sensitivity’ is the buzzword in the beauty industry this fall.”
Alphabet soup Language laced with acronyms. "An RFP was issued by DOE; ORNL responded for the ORR."
Reference:
‘Tech Speak’ as defined by Edward Tenner (1986) Tech Speak, Random House, in above website.

47. Research details
Lead Applicant Details
Lead Applicant CV
Joint Lead Applicant(s)
Co-applicant(s) details
Research & Development Office
History of the Application
Patient and public involvement
Case For Support – Part 1
Case for Support – Part 2
11. Case For Support – Part 3
12. Management and Governance
13. Intellectual Property and Innovation
14. NIHR Infrastructure
15. Finances
16. Monitoring information
17. Suggested reviewers
18. Supporting Documentation
19. Declarations and signatures

48. (1) Research details Title Host organisation Region Duration
Proposed start date
(Application type) – Pilot, Feasibility, or Main Study*
(Theme Call Name) – Only fill this in if you are applying for a specific theme call, e.g. dementia
*For definitions, see:

49. Research Title Descriptive, yet concise
Contains keywords relevant to the research
Study question and main outcome measure to be included
If a trial, also include intervention and population
State if pilot/ feasibility
Clear from title that study is in scope – e.g. for RfPB, has short-medium term patient benefit

50. Title: What can go wrong
Whilst you may think some titles are genuinely funny:
Parasites as weapons of mouse destruction.
Journal Animal Ecology Mar;77(2):201-4.
They may be viewed by some as inappropriate:
Targeting promiscuous signaling pathways in cancer: another notch in the bedpost
Trends in Molecular Medicine Dec;10 (12):

51. Title: What can go wrong
And some can appear very strange indeed:
Who Moved My Cheese by Dr Spencer Morgan
Putnam Adult (1998)
A bestseller!
Image from Office Online

52. (2-5) Applicants Lead applicant
Current Research Commitments and how this application will fit within current research activities
Lead applicant’s C.V.
Joint lead, Co-applicants. N.B. There is now a system for co-applicants to formally confirm involvement, add C.V.s, and approve the final application. The latter must be done before submission.
Consider:
Kudos associated with being lead
Not necessarily a big-wig but need proper support if junior
Tends to be person initiating the research
Contract duration (especially universities), i.e. if your contract expires before project, can you be lead?
Q. What is the difference between ‘co-applicants’ and ‘research team’?
A. A research team may consist of more people than simply the applicants, but N.B. the application will be judged primarily by those appearing on the form

53. (6) Research and Development Office
Host must be an NHS organisation
Host R&D office contact details
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54. (7) History of This Application
If previous RfPB, NIHR may well look to see what the initial feedback was and how the current application has changed, BUT always viewed as a NEW application (no resubmission policy)
If previously submitted elsewhere, just for their information
Details of related applications
Details of concurrent applications are not asked for, but RfPB would obviously want to know if a submitted project gets funded from another source

55. (8) Patient and Public Involvement
Image courtesy of healthcaregovernancereview.wordpress.com

56. What is Patient and Public
Involvement?
An active partnership between the patient/public and researchers, NOT the use of patients/public as ‘subjects’ to be studied (e.g. to be interviewed or assessed) by researchers
For example:
Working together with patients to develop a good research proposal
Commenting on the methods or processes of the
research, being actively involved in the research process
Image from Office Online

57. More power in the decision making process of the research
Examples of PPI
Being part of the research team
Helping design the research
Being a member of project reference group
Writing lay summaries and patient information sheets
Carrying out questionnaires with the participants
More power in the decision making process of the research
Image from Office Online

58. Nature of PPI in Research
Consultation:
Asking people who use your services for their views on your research to help inform decision making
E.g. Commenting on the ability to understand lay summaries
Collaboration:
Ongoing partnership with members of the public throughout the course of the research project.
E.g. A member of public on the project steering group.
User-Led/ User Controlled:
Members of the public lead the research and are in control of the research. This is often, through a community or voluntary organisation
E.g. Service users may decide on the research question; or manage the research itself

59. Proper PPI in Research IS NOT:
Asking the patient or the public to answer research questions and provide data, i.e. asking them to be a ‘guinea pig’ in your research – enrolling them into the study
Listening to patients to design your service better – to elicit service design suggestions
Asking for feedback about a web based intervention – to evaluate an intervention X
Image from Office Online

60. Why Involvement?
To prevent researchers making mistakes that are obvious to patients
To guide finances
For greater transparency, making research with patients,
for patients, that is more relevant to patients.
Obligation to the tax payer
To meet the requirements of the NHS Constitution
To meets the requirements of funders

61. Can you spot Involvement?
The following are all extracts taken from National Institute of Health Research grant proposals
Which are Involvement and which are not?
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62. "We plan a steering group for the project with four patient representatives as equal members of the research team."
Involvement
Participation
None of these
Unsure

63. "Individual service users who have been referred
"Individual service users who have been referred ... via this and other routes will be interviewed regarding their experiences."
Involvement
Participation
None of these
Unsure

64. "Our patients agreed with us that the study would deliver important information and that the research was timely and important."
Involvement
Participation
None of these
Unsure

65. What can the RDS Offer?
We provide a lay review service as part of our pre-submission review panel and as a separate activity
We can advertise your project through our PPI network and help to identify patients to work with you
We can provide financial support to patients or members of the public working on projects supported by the RDS up until the point of submission.
We can provide PPI advice from our staff on the PPI team.

66. David Castillo Dominici
What can the RDS do?
Give guidance on payment structures.
Provide assistance in writing lay summaries usually by getting lay members to write them either with you or for you.
We have useful guidance helping you consider what involvement to use to get the best out of involvement in your project.
David Castillo Dominici

67. How can we work together?
Maybe you are part of, or know of, a group that wants to get involved in research, if so register the group via the RDS website
Researchers can advertise their projects through our systems
If you would like to get involved individually as a patient or a member of the public register with us via the RDS website
Image from Office Online

68. What reviewers expect to see: Patient & Public Involvement (PPI)
Have the needs of the service users been considered?
Have you made any assumptions about service users or the co-operation of other involved parties which may not actually be met?
Are there lay co-applicants?
Are there lay people on the project steering group?
Have the relevant national / local organisations been contacted for their input? Are there plans to involve them in the study design / study management / in dissemination of the results?
Is there evidence of consulting the INVOLVE guidelines on PPI?
State if PPI input at study design stage was not undertaken and say why this was the case (N.B. all efforts must be made...)
Is the PPI element ‘tokenistic’, or has real thought and planning been put into it?

69. (9) Case for Support - Part 1
Aims and objectives
Plain English (Lay) and Scientific Summaries
Background and rationale
Why research is needed now

70. Aims and Objectives
Need absolute clarity of objectives / primary outcome / secondary outcomes, and ensure that these relate to RfPB scope and are not contradicting the title
Is this definitive / exploratory / preliminary work? What would the upshot be if it is successful in the case of the latter?
If there is a null hypothesis, is it clear and appropriate?
Do any qualitative aspects of the research have clearly stated objectives / questions / intentions?
If a pilot or feasibility study, make this clear, and also how it would lead on to full trial

71. Q. What is the difference between a feasibility study and a pilot study?
Feasibility Studies “Can this study be done?” Used to estimate important parameters needed to design the main study, e.g. standard deviation of the outcome measure; willingness of participants to be randomised and clinicians to recruit them; number of eligible patients; characteristics / design of proposed outcome measure; follow-up rates, response rates, adherence/compliance rates
Pilot studies are a version of the main study that is run in miniature to test whether the components of the main study can all work together, e.g. to test recruitment, randomisation, treatment, and follow-up assessments (

72. Abstract in plain English (Lay Summary)
Concise, convincing summary of:
Problem (e.g. disease burden)
Research question and rationale
Design and method
Expected outcomes
Expected impact
BUT absolutely understandable to the lay person:
No clinical or research jargon
No difficult words
Involve a PPI representative!

73. (Scientific) Summary Concise, convincing summary of:
Problem (e.g. disease burden)
Research question and rationale
Design and method
Expected outcomes
Expected impact 
A ‘Mini-Me’ of the main protocol!

74. Background / Rationale
This section needs to
PACK a PUNCH
!!!
Using the literature:
Define the research issue
Justify WHY the research is necessary – clear case for clinical importance and impact - E.g. Disease / condition burden (local / national figures)
Back up logic of aims and objectives
Provide evidence of best design approach
Highlight if study fits into a desired but under-represented area in the funding stream - E.g. social care, minority groups
Image from Wikimedia Commons (Public Domain).

75. Relevance of proposal to RfPB
Look at RfPB scope in Guidance
Think of the:
Likely benefits to patients
Implications for health services
Potential impact on policy / service delivery
Make sure you are showing how your work fits in with
the RfPB remit
Image from Office Online

76. Why is this research needed now?
What evidence is available to justify the study at this time: make a case
Is the research addressing the right questions in the subject area at the right time in relation to, for example, the availability of knowledge, or the development of technology, Government priorities?
Are you presenting a convincing argument?
Don’t forget this is a competitive process!

77. (10) Case for Support Part 2: Research Plan & Methodology
Image: NASA

78. You should include:
Study design – appropriate to meet aims and objectives
Setting (location, population)
Sample – sampling frame, eligibility criteria
Sample size
Intervention (if relevant)
Details of randomisation if RCT
Appropriate data types and sources
Outcomes/ other measures – validated/appropriate for the population
Procedures
Data analysis methods
Consider:
How will potential sources of bias be avoided/ taken care of? Who is blinded and how will this be achieved?
Feasibility
Bear in mind what will be reported (e.g. CONSORT, STARD etc)

79. Image by Xedos4, freedigital photos.net
Study population
Clearly defined and consistent with study title/objectives
Eligibility criteria – how generalisable are the results to the NHS?
?gender
?disease severity
?comorbidities
?location
?new diagnosis
?previous treatment
?concomitant medications
?exposure
?age
Image by Xedos4, freedigital photos.net

80. Intervention (i) Clear description of intervention
?product / technology/therapy ?timing
?dose ?length of exposure
?number of sessions/treatments
?staff administering treatment (training, quality assurance, experience, preferences)
Allocation - randomisation method – blocks / stratification / matching
Blinding – who, how and why?
Balance between standardisation and tailoring to the patient
Will it be affected by patient/ carer adherence?

81. Intervention (ii) Why was it chosen?
Evidence of piloting / testing or feasibility/ effectiveness from the literature
Clear description and evidence-base for control / comparison group(s)
For Example,
Why placebo / alternative treatment chosen?
Why 3 weeks treatment rather than 6?

82. Intervention (iii) Feasibility and other benefits
Provision for gathering information on the patients / staff view of the research, whether it works or not
Patient benefit of intervention
Recovery
Empowerment
Independence
Increased confidence in their outlook
Benefits added on existing standard of care

83. Outcomes
Measurements must accurately reflect the impact of the intervention
If surrogate / proxy measures are used, give evidence that these can accurately predict long-term outcomes
WHO?
HOW?
WHEN?
WHY?
Follow-up:
Appropriate length of follow-up to see the
effect on outcome measures
Motivation of patients to complete study!
Image in Public domain, courtesy of Wikimedia

84. Statistical Considerations
Statisticians are useful for much more than just a sample size calculation!!!
Prof. David Spiegelhalter playing with Arco Iris samba band, by Tamara K.
This file is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported license (

85. Defining study objective
Defining a study design
Defining the primary outcome
Sample size calculation
Statistical analysis
Cohort study
Cross sectional study
Case-control study
Randomised controlled trial
Type of outcome
Continuous
Binary
Clinically relevant and relevant to patients
Measurable
Accurate
Effect size
Clinically significant
Results in a change in practice
Based on pilot study/previous evidence
Correct and appropriate for the study design chosen
Account for loss to follow-up
Which patients to include in the analysis
E.g. principle of intention to treat in randomised controlled trials
Account for confounding
Missing data
Subgroup analysis
Multiplicity
Sensitivity analysis

86. Sample size State null hypothesis and choice of statistical test
Is the detectable effect size likely to be clinically significant and result in a change in practice?
Is the sample size based on previous evidence / pilot results?
Are the sample size calculations correct and appropriate for the study design chosen?
Has loss to follow-up been accounted for in the sample size?

87. Common statistical errors in applications
Statistical analysis does not meet objectives or type of data collected
Section is too ‘general’ ‘continuous data will be analysed using t-tests’
Copied from other/ previous grant application without tailoring
No costing for statistical support

88. Outcomes / Analysis
Measurements accurately reflect the impact of the intervention or are surrogate / proxy measures (and if so, evidence that these can accurately predict long-term outcomes)
Appropriate length of follow-up to see the effect on outcome measures
If there is a long period of follow-up, how will the patients be motivated to complete the study?
Protection of outcome measurement from bias
Sub-analysis clear and documented – rationale and design
Listing of confounding factors – measured / factors for stratification with rationale
Set out analysis plan logically – descriptive tabulations, approach to analyzing associations among variables, qualitative analytic methods

89. What is Health Economics?
The NHS operates in a world of scarce resources (e.g. MONEY, labour, medicines, hospital beds)
Health economics informs how scarce resources may be allocated among treatment, prevention & diagnosis of different diseases. At the extreme:
Karl Marx: State allocates resources
Adam Smith (man in £20 note): Free market
Images in Public Domain. Courtesy of Wikimedia.

90. How do we prioritise resources to treat & prevent disease?
Need (how do you measure it / competing needs)
Discrimination (e.g. by age, smokers …)
Personal merit and social esteem
Lottery
Ability to pay (free market approach)
Do you think any of these methods would work in the NHS consistently?

91. In the NHS, new interventions prioritised if:
they can be shown to be effective and fit for purpose
AND GOOD VALUE FOR MONEY – i.e. the intervention is likely to be cost-effective (mainly through NICE)
Image from Office Online

92. Health economics can help us understand the costs and benefits of different interventions:
For example:
If the health benefit generated by a new intervention is worth the additional cost
If an intervention is more effective than its alternative, but its related costs are exorbitant, this intervention will represent poor value for money and not a good use of NHS resources
If one intervention provides more health outcomes for the same level of cost this intervention should be adopted
UK research funders increasingly value applications that answer health economic questions

93. Planning a project
“Beagle 2 could have crashed into Mars because the atmosphere on the planet was less dense than expected”, explained Professor Pillinger. “The probe may have been going too fast for its parachute and airbags to bring about a soft landing.”
But contrary to belief, the mission was not a failure. The technology used for the project could play a major part in managing the tuberculosis pandemic.
(Open University WebSite, March 2010)
Photograph: ESA

94. The materials, equipment and space you need The time you need
The people you need
The materials, equipment and space you need
The time you need
How you organise the above
Who?
What?
When?
Where?
For how long?
Think about what will need to be done on a day to day basis
Think about maximising benefits to all involved

95. The people you need
Photograph: NASA

96. Various roles, for example:
Collaborators
Steering committee
Day to day project manager/ co-ordinator
Research assistants
Administrative staff
Support staff
Consultants
Data Safety Monitoring Board
Patients/ public

97. Collaborators
Bring the right skill mix to the research team
Varying degrees of involvement
Steering committee
Overseeing the work, ensuring that the study happens as
intended
Day to day project manager/ co-ordinator
Managing the study on a day to day basis
Research assistants
Data collection
Collection and processing of samples
Administrative staff
Administrative support

98. Support staff
People external to the study, but whose help may be needed.
E.g. staff on wards, library, ethics committee, local data protection officer
Consultants
For specialist help and advice
E.g. statisticians, economists, computing
Data Safety Monitoring Board
Independent ; periodically check on data being collected for patient safety purposes; broad-ranging monitoring of data quality and integrity
Patients/ public
Different levels of involvement
E.g. Consultation, collaboration, user control

99. Staff management: very important
Organising the personnel
Who is in charge of what?
Must be clearly designated at the start
Everyone involved must be committed in terms of interest and time
Staff management: very important

100. Logistical issues in recruitment
Photograph: NASA

101. Staff Sites Participants Liaison with personnel
Development of job descriptions
Advertisements
Interviewing
Getting proper references
Sites
Liaison with management
Liaison with health professionals
Information about the study, what it will entail for the study site,
the information being collected etc.
Participants
Look at throughput/ numbers to give you an idea about how long it will take
First contact, informed consent
Give yourself
time!

102. Recruiting Participants
Clear recruitment plan and sampling strategy (note any key groups of patients likely to be excluded)
Realistic timing - use local data and apply eligibility criteria, refusals, variation in caseload etc
Make effort to ensure inclusion of minority / disadvantaged groups / range of patients across all socioeconomic
groups
– describe provision for overcoming
poor literacy and language barriers
Image: ddpavumba
freedigitalphotos.net
Image from Office Online

103. The importance of communication
Photograph: NASA

104. Before the start of the study
Who should know about the study?
Who should be involved?
Formal agreements (e.g. sponsorship, financial arrangements, data ownership and authorship)
External communication (e.g. Websites, Press Office)
Examples of who needs to know:
Trust R&D offices
Other senior managers
Ethics committee(s)
Clinicians caring for patients involved
Nursing staff if wards involved
Comprehensive Local Research Networks
Medical records officer
Clinic/ward clerks
GPs

105. On-going communication
Clearly defined roles between researchers – ‘chain of command’, appropriate support
To ensure data quality, reaching of project milestones
With ethics committee (any change in protocol, methods, dilemmas etc.)
With participants: contact person for everyone, whenever required (e.g. everyday, or ‘on-call’, as necessary)
Back-up information
With study sites and personnel: politics and facilitation
Clearly identified researchers on wards etc.
General information exchange
Query-answering
Trouble-shooting
Feedback and acknowledgement

106. The other resources you need
Photograph: NASA

107. Miscellaneous, e.g. staff training
Stationery
Postage
Tests
Equipment
Telephones
Travel
Printing
Miscellaneous, e.g. staff training
Photos: Wikimedia

108. Logistical considerations in study design
Photograph: NASA

109. Assigning responsibility and ensuring time for these
Can your protocol be operationalised as a guidance document for staff?
Sample selection and monitoring recruitment
If applicable:
Randomisation
Arranging an intervention
Assigning responsibility and ensuring time for these

110. Logistical considerations in data collection & data management
Data collection on Mars
Photograph: NASA

111. Types of tools Logistics
Measuring outcomes – tools need finding (N.B. permissions) or developing (N.B. validity, reliability)
Lay and Non-English speaking issues
Collecting other information, e.g. process, administrative, contextual
Coding for the computer, development of database
Only collect what you need to answer the question
Logistics
How will the data be collected: By whom? Where? When?
Holidays, bank holidays (postage)
Data checking and quality control
Confidentiality/ data protection issues
Procedures for reporting adverse events
Data management and storage (e.g. double blind entry, restricted access, back-up, encryption etc)
Computing – coding and data entry
Data cleaning

112. Piloting
Photograph: NASA

113. The importance of piloting
Always pilot!
It checks that everything works:
Management and personnel
Methods
Feasibility – technically, politically, logistically, methodologically
Training of fieldworkers
Sample
Timing and content of questionnaires/ interviews
Validity of tools and data sources (feedback from participants)
Overall time-scale
Data entry, cleaning and analysis

114. Logistical issues in data analysis
Cray 2 Supercomputer, NASA
Photograph: NASA

115. Planned before the study has started:
Equipment (hardware, software)
Statistical methods
Statistics and computing support
Other analysis issues (e.g. qualitative, health economic)
TIME

116. (11) Case for Support – Part 3 Dissemination, Outputs & Expertise
Pigeon post
Source: Wikipedia (Public Domain)

117. Routes for Outputs/ Dissemination
Via:
Involved patients / lay members & local interest groups
Research network meetings
Targeted conferences for presentations / posters
Targeted peer-reviewed journals - maximum readership within field
Other media, as appropriate
Use of workshops / training packages
Guidelines which could be altered by the results
Targeted groups of specialist / professional bodies
Inclusion of results in existing meta-analyses / Cochrane reviews
Members of the team involved in teaching

118. Not forgetting… And logistically… And importantly…
Participant patients and staff
Report for funding body
Any reports for Ethics Committee
And logistically…
Time
Personnel
And importantly…
How will findings be translated into health care to produce patient benefits

119. Expertise: have you got your A-team?3 4 1 2
Hypatia (Ὑπατία)
1 ) Mad Scientist drawn by JJ, Image provided courtesy of Wikipedia. Permission is granted to copy, distribute and/or modify this document under the terms of the GNU Free Documentation License, Version 1.2
2) The School of Athens - fresco by Raffaello Sanzio. Image in the public domain supplied courtesy of Wikipedia.
3) Marie Currie ca Image in the public domain supplied courtesy of Wikipedia.
4) This image is available from the United States Library of Congress's Prints and Photographs Division under the digital ID cph.3b Image in the public domain supplied courtesy of Wikipedia.

120. Questions a funder will ask:
What are the specific roles of members of the research team?
Does the team:
Have appropriate track records in research?
Demonstrate appropriate skills mix - clinical and research experience?
Include, where appropriate, a statistician, health economist?
Include a PPI representative?
Have genuine interest and time to commit to your research
Overall, why is this group of people best placed to do the work?

121. (12) Management and Governance
Research timetable: milestones and deliverables
Management arrangements
Previous relevant work
Measures of success, risks and how to manage them
Ethical issues

122. Ethics
Image from Office Online
Does the research involve specific areas with particular ethical implications?
Ethics committee approval required?
Has the proposal already been granted a favourable opinion from relevant regulatory authorities?

123. (13) Intellectual Property and Innovation
Current IPR held by applicants and relevance to current application
Has a search for existing IPR been undertaken?
Related/ similar IPR which may affect freedom to operate?
Will IPR be produced or improved through the research?
Management of any IPR
Competitive devices, practices and technologies and advantages over these of any likely to be produced through the research?
Benefits of any likely IPR
Regulatory considerations and risks to be considered for any new technology to reach the market?

124. (14) NIHR Infrastructure
Links to NIHR networks - look at
RDS input
Involvement with other NIHR partners
Image from Office Online

125. Source: nuttakit, freedigitalphotos.net
(15) Finances
Source: nuttakit, freedigitalphotos.net

126. Value for money
Justification for major sources of expenditure, e.g. staff
Justification for how research costs have been allocated
Justification for how NHS Support and Treatment costs will be allocated.

127. The people you will need to involve
The local NHS R&D Finance Officer of your employer
If you are collaborating with other organisations, the appropriate Finance Officer in each one
Your local Comprehensive Local Research Network (for any NHS Support Costs required)
Photo: renjith krishnan,

128. The RfPB Finance Form
Always: Consult your Finance Office at an early stage
Be aware:
That costs are broken down by project year
Of timings for university/ trust/ CLRN approval
Of which organisation is taking responsibility for the project – their authorised signatory will have to sign off the form.
That if the study is a collaboration between organisations, a ‘system’ will not necessarily exist to sort out respective costs
That the participation/ costs of other collaborators will also have to be signed off by them
That, if successful, formal collaboration agreements will need to be in place before funds are distributed
Photo: renjith krishnan,

129. Directly Incurred Costs
Q. What is a directly incurred cost?
Costs of people/ other things that are being employed/ used exclusively for the project
Research, technical and other staff
Travel and subsistence
Equipment
Consumables
PPI
Other, e.g: Conference fees, room hire, publication, training
Photo: renjith krishnan,

130. HEI Indirect Costs –Estates Charges
What are HEI Indirect Costs – Estates Charges?
For universities only, the estate costs for staff, i.e. physical environment required for general staff support.
E.g. For Oxford University, for 2010/11, the estate charges, per full time member of staff per year, regardless of grade, are £3,367 (£12,020 for lab. (scientific) departments)
Photo: renjith krishnan,

131. HEI Indirect Costs – Other Indirect Costs
What are HEI indirect Costs –Other Indirect Costs?
For universities only, (i) the overheads associated with employing someone, (ii) the costs of people already employed taking ‘time out’ for the purposes of the study (e.g. supervision), & (iii) university-based technical support (e.g. laboratory costs)
E.g. For Oxford University, for 2010/11, the additional costs (or ‘overheads’) associated with employing a full time member of staff, regardless of grade, is £44,124.
Photo: renjith krishnan,

132. Commercial/ Other Partner Organisation Indirect Costs
Q. What are ‘Commercial/ Other partner Organisation Indirect Costs’?
The costs of resources used by the research that are shared by other activities.
Seek advice from Finance Department
Photo: renjith krishnan,

133. NHS Overheads E.g. Estates charges Telephone rental etc.
Q. What are ‘NHS Overheads’?
Costs of resources used by a project, but shared by other activities
E.g.
Estates charges
Telephone rental etc.
Photo: renjith krishnan,

134. NHS Support Costs Extra patient tests Extra in-patient days
Q. What are ‘NHS support costs’?
The additional patient care costs that result from the research being run in an NHS organisation. These costs would end when the project ends.
Extra patient tests
Extra in-patient days
Extra staff time, e.g. consultants or nurses taking consent, extra attention due to the research
This funding would usually come via the Comprehensive Local Research Network, and is not included in the total of the grant application figure
Photo: renjith krishnan,

135. NHS Estimated Treatment Costs
Q. What are ‘estimated treatment costs’?
The treatment costs that relate to the research intervention.
You are asked for information on the research treatment (intervention), and the normal standard treatment, so the additional costs for running the research intervention can be calculated.
These costs would normally come from the NHS as part of normal patient care commissioning
Different treatment, or treatment administered in a new way, or a new place.
Photo: renjith krishnan,

136. Costing people
Researchers involved with the study (but already in post)
Researchers employed exclusively for the study, e.g. experienced day to day study/ clinical trial manager/ co-ordinator/ primary researcher, research assistants
Collaborators
Steering committee
Administrative staff
Support staff
Consultants
Data Safety Monitoring Board (DSMB)
Patients and public involved with research (PPI)
Photo: renjith krishnan,

137. Regular staff (internal) Consultancy (external)
Salaries:
Regular staff (internal)
Consultancy (external)
Basic salary (check scales)
National insurance
Superannuation
Increments/ pay rises
Indirect costs (including
Estate costs)
Daily rate
Rate per sample etc
Have you considered dates for each major phase of the study, with staff responsible
Photo: renjith krishnan,

138. Costing other resources
Stationery
E.g. How many questionnaires, how long, how many times; invitations; letters, information sheets, how to represent study to public/ patients
Printing
E.g. How many questionnaires, how long, how many times; invitations; letters, information sheets
Postage
E.g. How many mailings, follow-ups and reminders
Travel
E.g. researcher to participant, participant to researcher, meetings to sites to set up and run project, dissemination, PPI, Steering Committee meetings
Photo: renjith krishnan,

139. E.g. Clinical tests, laboratory tests Equipment
E.g. monitoring instruments, computing equipment (including software), desks, chairs
Telephones
E.g. Office and mobile; standard rates for institutions?
Miscellaneous
E.g. Staff training, running costs of equipment, advertisements for staff, incentives (within ethics guidance)
Photo: renjith krishnan,

140. Give yourself some leeway
Overall budget
Have you considered:
How the resources requested will be used
How realistic and accurate the costings are
Whether the ‘best price’ has been found for tests etc?
Whether anything appears ‘over-budgeted’?
Whether the requested resources are justified?
Does the proposal represent the most efficient use of resources?
Is the research good value for money?
Give yourself some leeway
Photo: renjith krishnan,

141. (16) Monitoring information
Information used by DoH and NIHR to monitor and categorise applications
RDS use and satisfaction with service
Carbon guidelines
(17) Suggested Reviewers
Suggest three potential peer reviewers who have relevant expertise
May or may not be used

142. (18) Supporting Documentation
E.g.
Flow diagram
Gantt Chart
Bibliography - ensure that all papers cited are listed clearly and logically
Letters of support

143. The inclusion of a Gantt Chart is mandatory
31st FW Balkan Operations Gantt chart. United States Air Force, 2000
Image in public domain courtesy of Wikimedia

144. (19) Declarations and Signatures
Lead Applicant
Host Organisation (finances)
Host Organisation (Head of Department/ Senior Manager)
Give yourself TIME to get these!
renjith krishnan, freedigitalphotos.net

145. Part 4 Top Tips: Optimising your chances of success (Inspired by RfPB feedback)

146. Make sure: Your study is in scope You submit your proposal on time
It is complete!
It is a ‘well-crafted’ proposal
Your proposal is understandable to a diverse audience
You have shown the relevance of the study to the NHS
You have had adequate lay involvement
You have the right skill mix
You have made the necessary research partnerships

147. Make sure:
You have demonstrated a need for the study, and your knowledge of the area
Any necessary pilot work is undertaken or planned appropriately
Interventions (e.g. for RCTs) are clearly described
You have an appropriate study design
Other aspects of the methods and procedures are clear
You have consulted appropriate experts and incorporated their suggestions
You have given yourself a realistic timetable
Your study is sensibly funded
Don’t be over-ambitious!

148. Any questions? MANY THANKS!
Evaluation
Photo: Simon Howden, FreeDigitalPhotos.net
FreeDigitalPhotos.net staff
FreeDigitalPhotos.net