Features of study design

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Research Grant Proposal
Writing
Margaret Devitt
Research Management Unit
Know your Funder
 Look at the website (www.hrb.ie)
 Read the HRB Corporate Strategy ( 2007-2011)
 Mission and Objectives
 Vision and Values
 Targets, outcomes, performance indicators
 “Improving People’s Health through Research and Information”
Background to the Health Research Board
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Statutory body established by the Minister for Health under the Health
(Corporate Bodies) Act 1961
Amalgamation of the Medico-Social Research Board and the Medical
Research Council of Ireland
The statutory obligations of the Board include :
– to promote, assist, commission or conduct health research to improve
health and increase the effectiveness of the health services
– to maintain, develop or support health information systems for the
purposes of research and to provide the evidence for health policy and
services
– to liaise and co-operate with other research bodies in the State and
outside the State in the promotion, commissioning or conduct of relevant
research
– to liaise with other health information bodies in the State and where
appropriate outside the State in the development and support of health
information systems
HRB Board and Organisational Structure
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Amendment to the Statutory Instrument in July 2007
Chair and 9 Board members nominated by Minister for Health
Term of office 5 years
Staff compliment currently 70
Organisational review in 2006 - reorganisation of Divisions into
Directorates
• Research & Information Systems Directorate
• Research Strategy & Funding Directorate
- Research Management Unit (combined R&D and RFPD)
- Research Infrastructure and Special Initiatives Unit
- Policy, Evaluation and External Relations Unit
Overview of HRB grant schemes
Training/Career Development
Projects & Programmes
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Project Grants
Translational Awards
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Partnership Awards
Health Services R&D Awards
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HRB/MRCG Awards
Global Health Research Awards
Networking Grant for Global Health
Research
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Summer Studentships
Scientific Writing Workshop
Nursing and Midwifery Fellowships
Clinical Therapies Fellowships
Health Services Research
Fellowships
Clinical Research Training
Fellowships
Postdoctoral Fellowships
Nursing & Midwifery Junior Clinician
Scientist Awards
Clinician Scientist Awards
Cochrane Training
Cochrane Fellowships
Cancer Prevention Fellowships
HRB Scientific Writing Workshops 2007
Objective : to provide training for young researchers in writing
grant applications and papers for publication in medical and life
science journals
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Call now closed
Next call in 2008
Applications made using the HRB eGrants system
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Two courses per year
Cork: 22 - 24 May 2007
Dublin: 10 - 12 October 2007
HRB Cochrane Training 2007
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Objective : to provide training in accessing and using the
Cochrane Library
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Half-day introductory course if little or no previous experience
Provides overview of evidence-based healthcare & principles
and practice of Cochrane systematic reviews
Two day training course covers systematic review
methodologies and critical appraisal skills
Suitable for those who require a more detailed knowledge of
systematic reviews and if thinking of conducting a systematic
review
Courses are provided free of charge
Application based
Next call in 2008
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Building Partnerships for a Healthier Society
Research Awards
Scope: To provide funding for research projects and pilot studies in health
and social care
Objective: promotion of partnerships to address research questions with
strong relevance and impact on health policy and practice
Funding available: €40,000 pa for up to 2 years
– Cover salary-related support (full time, part time, protected time)/
consumables/dissemination costs and overheads (up to 30%)
Eligibility:
– Lead applicant working in a recognised research institution/ health
& social care agency ( HSE, hospital, voluntary service provider,
GP)
– Co-applicants from Northern Ireland and abroad welcomed
– Proposal relevant in the context of the National Health Strategy
and/or other health policy documents
– Demonstrates a genuine multidisciplinary partnership approach
(research experience and the necessary insights)
– Contribution of funding secured from one or more partners
Building Partnerships for a Healthier Society
Research Awards
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Key points for partnership awards
– Provides opportunities for individuals who do not have an extensive
research track record
– Scoring assessed on applicant team as a whole
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Demonstration of Partnership is crucial
– Individuals/ organisations in a meaningful synergistic collaboration
where each partner brings added value to the team
– Co-applicants (active) ensuring adequate relevant research skills
– Balance between academia and practice
– Inclusion of patients/clients/ service users
– Charities, support groups, voluntary bodies
– Policy/practice: those whom the results will inform
– Inclusion of any other stakeholders in the application (e.g.
advisory group or a group to disseminate to regularly)
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NOT a training/career development scheme
Next call early 2008
Research Project Grants
Objective: to support health related research, including biomedical
and clinical sciences, public health, epidemiology, health
services research, practice based research and translational
research.
Eligibility:
- Open to all researchers working in an established academic
research centre (i.e. a university/ teaching hospital/ institute of
technology)
- Also post-doctoral researcher without a post but have support
of a Head of Dept/school.
Funding: Maximum awarded is €100,000 pa up to 3 years
- €75,000 p.a. with a post-graduate student.
• 69 awards made in 2006
• Call closes on 02 November 2007
Health Service Research Fellowships
• Objective : to provide an opportunity for graduates in a health
related disciplines to conduct research leading to a postgraduate
degree at masters or doctoral level.
• Eligibility:
- hold a primary or masters degree in a health related
discipline
- Have relevant post grad research/ relevant professional
experience at least (3 yrs Masters & 5yrs PhD )
- have support from an approved Irish academic Dept
• Up to three years duration
• Covers salary, consumables and travel grant up to €7,000
• Call closes on Friday 12 October 2007
Nursing & Midwifery Research Fellowships
• Objective : provide nurses/midwives with and opportunity to
conduct research & develop expertise as clinical specialists in
their chosen field leading to a postgraduate degree at masters
or doctoral level.
• Eligibility:
- Registered as a nurse or midwife
- Relevant professional experience at least (3 yrs
Masters & 5yrs PhD
- Support from an approved Irish academic Dept
• Up to three years duration
• Covers set salary, consumables and travel grant up to €7,000
• Call closed on June 11 2007
Clinical Research Training Fellowships
• Objective : to provide medical doctors & dentists with an
opportunity to conduct research & gain specialised research
training leading to a postgraduate degree at PhD level and
support their development as independent academic
investigators.
• Eligibility:
- Registered as a doctor/dentist up to and including Senior
Registrar/ Lecturer level
- have support from an approved Irish Academic Dept
• Up to three years duration
• Provides registrars salary scale with consumables and travel
grant up to €7,000
• Call closes on 19 October 2007
HRB Post Doctoral Fellowships
• Objective : To enable researchers with a PhD to develop their
research career in a health related discipline
• Eligibility:
- Applicant must hold a PhD
- Be actively involved in research
- Have between 2-6 yrs post-doctoral experience
- Support from an approved Irish academic Dept
• Up to three years duration
• Covers salary, consumables and travel grant up to €7,000
• 8 Fellowships awarded in 2006
• Call closed on 05 Oct 2007
Research Fellowships for the Therapy Professions
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Scope: provide an opportunity for experienced therapy professionals to
conduct research leading to a postgraduate degree at masters or
doctoral level.
Objective : to build/strengthen research capacity in the therapy
professions and foster research which impacts on therapy practice
Eligibility:
- Hold a recognised qualification (or equivalent) in one of six
therapy professions
- Practice background 5yrs PhD & 3 yrsMasters;
- Working in or related to therapy practice in the Irish health
services or an appropriate Irish academic department
- Registered with an appropriate Irish academic institution
- Supported by an academic sponsor and a suitably
qualified therapy practitioner.
6 Fellowships awarded in 2006
Call closes on 26 October 2007
Assessment Procedure
Invite Application Form
HRB
Eligibility check
&/or shortlisting
Peer
review
Minimum of 2
Specialist expertise
Vast research experience
Novelty
Contribution to knowledge
Feasibility
Design and methodology
External Referees
HRB
Collation
Ranking of average scores
Short-listing
Grant Committee
Lead and primary reviewers
Debate and discussion
Consensus ranking of scores
Applicant(s)
Partners
Project
10-15 people
Cover range of disciplines
Abreast of current medical, social
and political developments
Recommendations to HRB Board
What reviewers look for
 An important research question –
(1)
needs to be apparent from even a
quick read of the application
 Timeliness of the topic – e.g. key article in a journal editorial, recent
guidelines produced, a target in a policy document. Show that it is an
opportunity, that if not taken now, may be lost
 A well presented application – suggests attention to detail. Poorly laid
out or cluttered information will result in an important point being mislaid or
misunderstood
 An appropriate research method -
clinical trial, case series, cross
sectional surveys, cohort studies, case control studies, qualitative
methodologies. All have their place but the one chosen must be most suitable
for the stated research question
 Methodological rigour*
– always assume that the reviewers are
appraising the application looking for a flaw. Search for them yourself by
asking “where could it go wrong?”
* Methodological rigour (1)
Features of study design
 Designing surveys
The following questions should be addressed in the protocol:
Is there a description of the population which will be sampled?
Is the method of sampling described? random, cluster, stratified.
Is the method of recruiting subjects described?
Is the issue of representativeness addressed?
Is there a strategy to minimise non-response?
Is the method of collecting data described? Interview, postal
questionnaire etc
 Is an outline given of the data to be collected?
 Is the sample size justified?
 Is there a description of the statistical methods to be used?
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* Methodological rigour (2)
Features of study design
 Designing Cohort Studies
The following questions should be addressed in the protocol:
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Is the study group clearly defined?
Is the method of identifying and recruiting subjects described?
Is the method of follow up described?
Is the length of follow up justified?
Is there a strategy to minimise losses to follow up?
Is the outcome measure clearly defined, clinically relevant and likely to
be accurately measured?
Is account taken of factors which could influence the outcome?
Is the sample size justified?
Is there evidence that the desired number of subjects can be obtained?
Is there a description of the statistical methods to be used?
* Methodological rigour (3)
Features of study design
 Designing Case Control Studies
The following questions should be addressed in the protocol:
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Are the cases clearly defined?
Do the controls come from the same general population as the cases?
Is the method of recruiting cases and controls described?
Is the method of collecting data described? i.e. interview or postal
questionnaire.
Will data be collected in the same way for cases and controls?
Is the sample size justified?
Is there evidence that the desired number of cases and controls can be
obtained?
Is there a description of the statistical methods to be used?
* Methodological rigour (4)
Features of study design
 Designing Qualitative Studies
The following questions should be addressed in the protocol:
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Is the theoretical basis of the study described?
Is the method of data collection described?
Is the role of the researcher discussed?
Is it clear how the analysis will be performed?
Does the person who will conduct the analysis have sufficient
experience?
* Methodological rigour (5)
Features of study design
 Designing Economic Evaluation
The following questions should be addressed in the protocol:
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Is
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an economist mentioned in the proposal?
the relevant economic theory described?
the method of costing described?
the source of the costing data identified?
the health outcome measure described?
* Methodological rigour (6)
Features of study design
 Designing Clinical Trials
The following questions should be addressed in the protocol:
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Is the patient group described?
Is the method of recruiting study subjects described?
Is there evidence that the required number of subjects can be obtained?
Are there procedures for obtaining informed consent?
Is the method of randomisation described?
Is the intervention clearly described?
Is there a good argument why the intervention should work?
Is the control treatment clearly described?
Is the study double blind?
Is the primary outcome measure clearly defined, clinically relevant?
Is account taken of factors which could influence the outcome?
Is there a strategy to minimise losses to follow up?
Is the sample size justified?
Is there a description of the statistical methods to be used?
What reviewers look for
(2)
 Feasibility –
even if the method is perfectly worked out, this will not
guarantee that the project will work in practice. Some additional questions:
 Can enough patients be recruited?
 Will I get cooperation from the professional groups involved?
 Can accurate data be collected?
 Can I achieve the study in the time stated with these resources?
Mention any pilot work that has demonstrated feasibility of parts of the study.
 Researchers –
 CVs of the applicant(s) should be brief but carefully written.
 Get experienced researchers in as collaborators.
 Unsupported junior staff will find it difficult to get funding.
What reviewers look for
(3)
Implications of findings –
often the part of the application form which receives
the least attention. Even if all other parts are excellent, it is unlikely to be funded if
implications are not clearly spelt out. Try to answer some of these questions:
Who will be directly affected by these findings (patient groups, health
professionals)?
What changes in health care delivery or service might follow from a successful
study?
How might improvement of health be obtained?
How does the research fit in with national priorities?
What contribution to fundamental knowledge comes from the study?
Are there general principles underlying this study that have implications for
other groups/patients?
Could findings have implications for postgraduate medical/health education?
Which professional groups might benefit from the findings?
What reviewers look for
(4)
Dissemination
Address this even if not specifically asked for it. It is not enough to say that findings
will be presented at meetings or published in journals. This is expected anyway.
Identify key organisations, stakeholders and/or professional groups who should be
informed of the findings.
Are local or regional workshops a good idea?
Can local groups or newsletters play a role?
Include all associated costs for this within the application.
Common Failings
(1)
Despite the diversity, there is a relatively small number of reasons why applications
are not funded
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Uninspiring Project  those projects most inspiring are often those with national or international
implications. If a local study, still address the more far reaching
consequences and learning.
 Studies which gather masses of data but unclear of what new knowledge is
being gained.
 Studies in which answers to the research question are largely known
(usually a poor literature review)
 Don’t make reviewer search for reasons to fund your project.
 Avoid invoking the “so what” response.
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Rambling descriptions  A concise but clear description – this is difficult!
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Cobbled together work  Looks like it has been thrown together in a few days.
Common Failings
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Over Ambitious project 
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(2)
Project can have too many aims
Projects can promise too many major changes
Understand the differences between AIM and HYPOTHESIS
Never assume your hypotheses are correct
Do you have the necessary experience and/or resources to do the study?
Select a project which combines modest aims with clever ideas
Insufficient expertise  Not enough or not the right coapplicants
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Inadequate resources  Support staff, laboratories, equipment, restricted access to patients
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Ethics  Lack of awareness of the issues or not addressed at all in the application
Strategies for Success (1)
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Allow enough time
 “Written in haste, rejected at leisure”
 Set yourself own deadlines for first and second drafts
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Follow the instructions
 Answer all sections
 Do not over run the stated length – do not decrease the font size or mess
with the margins to fit the text in!
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Begin writing!
 Get ideas on paper at an early stage, especially for collaborative ventures
 Start with the main features of the study design
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Write clearly
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Avoid long sentences with many subclauses
Avoid complex or convoluted phrases – translate into simple english
Explain technical terms
Avoid jargon
Avoid acronyms and abbreviations
Spell and grammar check
Strategies for Success (2)
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Write with reviewers in mind
 Think of funders – eligibility, aim of the scheme, deadlines
 Think of expert reviewers and make sure it is methodologically rigorous
and the literature review is well done
 Think about the grant committee –some of these will not be familiar with
your area so write in a way that can be understood by non experts. Make
sure to stress the policy and implications of your results.
 Think of reviewers as intelligent specialists but who are from a different
discipline
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Explain why the study will succeed
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Theoretical basis is sound
Important question to be answered
Research design chosen is the best fit
Study subjects can be adequately identified and recruited
Data collection process is sound and you have statistical support
Strategies for Success (3)
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Seek advice
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From the funding body
From colleagues
Explaining your ideas can help you clarify things in your own mind
Get someone who is unfamiliar with the project and area to review it
Review the Layout
 Remember that your application will be among many others
 Use headings and subheadings wisely
 If a series of points being made or a set of data items beinbg listed, use
bullet points
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Keep trying!
 Use the feedback wisely
The Detailed Application
(1)
Title
should be short (12-15 words)
requires more effort per word than any other section
Summary or Abstract
should be the last section you write
should provide a map of the whole application so needs to be carefully
composed
generally no more than 100-400 words
methodological detail should be avoided
introduce topic and explain why research is needed
state main aim(s), expanding on information given in the title
give brief detail of study method, nature and number of subjects and broad
categories of data
indicate main findings expected and the implications which should flow from
them
The Detailed Application
(2)
Background to the study
This is not about the personal odyssey which led to the application
It is the scientific background and rationale to the research study
Often starts with a statement such as “The number of people suffering from
disease X is” or “ the cost to the health system per annum is”
Should include a brief review of landmark studies and recent ones
Refer to supportive and conflicting evidence relevant to the project
Should make the case for the need for research into this area by establishing
the importance of this topic and highlighting the gaps in our present
knowledge
Aims of the study
Succinct statement of what research project intends to find out
Deals with the purpose of the study, not the means
Reviewer will assume that if the applicant is in any way unsure of what they
are looking for, they are unlikely to find anything
The Detailed Application
(3)
Methodology and Design
This is the longest section of any application
The challenge is to provide sufficient information to be convincing without
drowning the reader in an excess of technical detail
Even if not asked, split in into a number of subsections:
Overview
Prepare the reader for what is to come
“If a grant applicant wrote murder novels, few bookstores would stock
them because they’d give away the ending in the opening paragraph”
What are you going to do?
How will you do it and when?
Statement of the results you expect
The Detailed Application
(4)
Methodology and Design (contd.)
Study Subjects
Patients or health professionals
Criteria used to select them (age, gender etc)
Any diagnostic criteria
Any exclusion criteria
Subject recruitment process
Data to be collected
List data and how each item will be measured
Do not want entire proforma if there is a questionnaire involved but also
not enough to say that one will be developed
Any equipment needed for physical measurements, analytical
techniques needed for biochemical measurements
Cite methodolological papers if appropriate
The Detailed Application
(5)
Methodology and Design (contd.)
Study Procedures
Deals with the logistics of the study
How will subjects be identified, accessed and recruited
Sampling methodologies
Interviews
Follow up procedures
Data Analysis
Only limited detail of the statistical techniques needed (chi squared, non
parametric, cox proportional hazards, Nudist, SPSS)
Should flow from the study design and the specification of the data to
be collected
If statistical analysis is extensive in the study, get a statistician as a coapplicant
Sample size calculation vital – seek advice
The Detailed Application
(6)
Methodology and Design (contd.)
References
Summarise the references succinctly as reviewers will NOT have the
time to retrieve and read all of them
Cite in a consistent and standard format e.g. Vancouver style is the
most common – references are cited in the text using sequential
numbers and listed in numerical order in a reference list – this minimises
space, which is at a premium in this section
Timetable of Work
Information on timings and milestones can be summarised as a table or
as a flow diagram, indicating the activity and the time in months
Don’t forget the time until decision – when can the project team start, if
the grant is awarded? When can you free up research staff, recruit staff,
begin a part-time arrangement etc?
The Detailed Application
(7)
Methodology and Design (contd.)
Existing facilities
Expected that office space and furniture will be supplied
Specialised equipment?
Computer, printer, hardware, software
Does host institution have supports such as clerical support to offer?
Supervision
Need to state how many hours per week principal applicant intends to
spend supervising or supporting the project, if not the researcher
themselves
Only requires a number on the form BUT will be very carefully assessed
The Detailed Application
(8)
Methodology and Design (contd.)
Justification of costs
Personal support
Research staff
Equipment
Patient related expenses
Materials and consumables
Access charges and overheads
For each person to be employed, a brief but explicit statement of their
tasks should be included
Describe appropriate salary scales
If going for a more experienced researcher, state why this is needed
Highlight what you and other partners are contributing ( in-kind?)
Detail why part time or full time arrangements and how this will happen
The Detailed Application
(9)
Methodology and Design (contd.)
CVs
Should include name, qualifications, current post (seniority and area of
expertise) and any relevant publications
Reviewers expect new applicants to have less preliminary data,
resources and publications. They are looking more at potential than
achievement. You should balance this by increasing the biographical
information in the application
Show that the application has the right combination of necessary
experience (clinical, research, statistical, health economist or other)
Ask yourself the questions:
Do I come across as being independent and able to lead?
Do I appear to have the support of my institution?
Have I got a range of collaborators to fill the gaps in my
experience?
The Detailed Application
(10)
Methodology and Design (contd.)
Impact
What are the impacts of the findings on health and social care
If there is no heading for this, make sure to add it in
Will it carry across much wider areas of health care and beyond the
confines of this project?
Have I approached any of the stakeholders it might have an impact on
down the line? Are they willing to endorse this study? Have they said
they would act on it? If so, can I fit this in somewhere in the application?
Research Governance Framework
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Ethical Issues
Good Research Practice
Intellectual Property
Data Protection and confidentiality
Indemnity issues
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Progress Reports and Final Reports
Database of funded research and progress
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Rules around publications and acknowledgements
Auditing arrangements, where appropriate
Get writing……and good luck!
mdevitt@hrb.ie
01-2345185
www.hrb.ie
Improving people’s health through research and information
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