2. Dr. A. Sundhararajan, Ph.D
Assistant Professor
Department of Biochemistry & IRB
Trichy SRM Medical College
Irungalur – 621105
sundhararajana@gmail.com
3. I cannot teach anybody
anything, I can only make
them think.
4. W & H
Create the strategy
Develop Concept
Proposal Writing
Work plan
Budget
Summary
5. • How to write an effective research protocol
• Action plans for fundraising for Research.
6. W & H Question’s
• Enables research
• Prestige
• Tenure/Promotion
• Travel to Professional Conferences
• Purchase Equipment Needed in Lab
• Develop New Curriculum
• Can build collaborations, increase exposure
• Measure of quality
7. Create the strategy
• Set your vision: what do you want to be known for 3
/ 5 / 10 years from now
• Assess your own capabilities and passions for research
• Identify capabilities that you can leverage here - do not
become isolated
• Create milestones needed for tenure
8. Develop Concept
Understand literature and needs
Build from your strengths
Identify/develop partners
Reaction from colleagues and peers
9. More strategy
• Assess the Market
– Identify agencies and programs that fund related
research
– Determine how your vision can be crafted to
match funding priorities
– Create a proposal writing schedule
– How critical is funding in fulfilling your vision
10. Securing Fund
Key points
1. Identify relevant funding agencies
2. Research the programs
3. Get to know the program officer
4. Write a (responsive) proposal
5. Get feedback and revise
11. Identify relevant agencies
Goal: Find the sources of funding
Search the web
Contact your peers, mentors, at local and
elsewhere
Find out where other universities get funding in
your area
Attend relevant conferences
12. Where to Approach
University Grant Commission (UGC)
Indian Council of Medical Research (ICMR)
Department of Science and Technology (DST)
Department of Biotechnology (DBT)
Council of Scientific and Industrial Research (CSIR)
Science and Engineering Research Board (SERB)
Defense Research and Development Organization (DRDO)
Indian National Science Academy (INSA)
Indian Council of Agricultural Research (ICAR)
National Institute of Health (NIH)
Ministry of Heath and Family Welfare (MOHW)
Ministry of Environment and Forests
13. Research the programs
Goal: determine priorities and selection process
Read material on the web
Program priorities, who has been funded and for what,
review process; who decides and how peer review is
conducted; total cost; size and duration of awards; success
rate
Contact program officer
What is the real story on funding; obtain suggestions on how
to structure proposal
Contact other people who have been funded
What did it take for them to get funded; get example of a
funded proposal.
14. Get to Know the Program Officer
Goal: Make your research a priority within the program
Visit and meet in person; present your ideas and get feedback;
find out what the program officer cares most about; find out &
influence what will happen in future
Volunteer to serve on a review panel
Try to connect to program officer through conferences and
professional meetings
Treat him or her like a customer
15. Write a Responsive Proposal
Goal: Be responsive, innovative and communicate well
Make sure that you have addressed all requirements
Write the proposal for the audience (understand who are the
reviewers)
Create an appropriate budget and plan
Excel in all categories
17. Proposal Writing
A good research proposal
demonstrates innovation and
significance within its field
of study.
18.
19. • Accurate, short, concise
• Descriptive: should make the main objective
clear, should mention the target population
• Key words: should contain key words for
referencing
– i.e. “Anemia in hiv infected ANC"
– Better: "prevalence of anemia among
HIV infected ANC attending tertiary care hospital”
Project Title
20. • Concise, one page (about 300 words)
• Stands on its own – no reference to protocol
content
• Summarizes central elements (rationale,
methodology, populations, time frame, expected
outcomes)
Project Summary
21. Statement of the problem
• Why
• What
…is the research needed?
…is the relevance of the results?
Logical flow ofstatements:
Magnitude, frequency,anddistribution
Probablecauses of the problem
Possiblesolutions
Unansweredquestions
22. Literature Review
• Prevents duplication of work, which has been
done
• Clarifies, what others have found addressing the
problem
• Familiarizes with potential methodologies and
methodological errors
• Should convince, that the research is needed!
23. Justification of research
• How does the research relate to the priorities of the
region and the country?
• What knowledge and information will be
obtained?
• What is the ultimate purpose that the knowledge
obtained from the study will serve?
• How will the results be disseminated?
• How will the results be used, and who will be the
beneficiaries?
Shouldbeaconvincingstatementfor the needto do thisresearch
24. Research hypothesis
• Describes the relationship between INDEPENDENT
variables (risk factors, predisposing factors) and
DEPENDENT variables (outcome)
• Determines the type of data to be collected and the type
of analysis to be conducted
Independent
variable
Dependent
variable
Intervention,
Observation,Control
variable
Make clear
statements!
26. Research objectives
Objectives should be:
• Logical and coherent
• Feasible
• Realistic, considering local conditions
• Defined in operational terms that can be
measured
• Phrased to clearly meet the purpose of the study
(relevant)
Objectives should be stated in action verbs that illustrate theirpurpose:
i.e. “To determine…, Tocompare..., Toverify..., Tocalculate...,Toreduce..., Todescribe...,
etc.
27. Methodology
Important aspect of the protocol
• Assures, that the hypothesis will be proved or
disproved, using the right tools
• Presents a detailed strategy, how the objectives are
achieved
Consider
• operational definitions
• study design
• definition of variables
• sample size
• ethical aspects
28. Ethical considerations
Important aspects to consider:
• Data safety / confidentiality
• Any possibly harm/ side effects/ consequences
• Right of discontinuation at any time
• Role of data safety and monitoring board (in trials)
• Alternative treatments/ approaches (in trials)
• Incentives/ Rewards
One of the most important aspects of biomedical
research!
Asklocalethicscommitteeforadvice!
29. Ethical considerations - Informed consent
Information form should contain:
• Justification for research
• Responsibilities (Who)
• Outline of study
• Risks
• Insurance
• Confidentiality (legal framework)
• Voluntary participation
• A separate consent form is required!
Outline how, when and where the patient will be
consented!
Simple language!
Patients mother tongue!
30. Data management and analysis
Based on objectives consider:
• Coding for variables/ type of variables
• Analysis plan depending on type of variables
• Statistical tests implicated
• (Style of presentation i.e. tables, graphs)
• Data safety and storage
31. Data quality control
• Describe measures of data quality control:
– Double data entry
– Consistancy checking
– Data monitor
– Verfication procedures of source data
– Interrater variability measurements
32. References/Bibliography
• Use of standard referencing system:
– Harvard style
• Name and publication year in text
• Alphabetical bibliography
– Vancouver style
• Numbered references
• Continous referencing in text
• Make use of software
– Reference Manager
– Endnote software
37. Funder Restrictions
What are valid expenses according to the funder ?
Are you limited to spend money on certain things ?
Do you need to report additional funding you receive ?
Can you hold multiple fellowships simultaneously?
RESTRICTIONS
38. Budget
The budget should be broken down by:
• Items
– Personnel
– Consumables, equipment, supplies,
communication, funds for patients, data
processing
• Budget justification
– Jusitify the use of each item, considering the
workplan of the study
39. Salary
Consumables
Chemicals, Glass wares, Reagents, etc.,
Computer and Printer Accessories
Stationeries
Contingencies
Communications (Telephone, postage)
Printing and Duplicating
Costs of health insurance
Domestic or International Travel Expenses
To get to where you are doing research
Flights, Train Ride, Bus
COMMON THINGS TO
INCLUDE
40. Equipments
Permanent equipments
Computer and Printer
Tech supplies (cameras, audio recording
equipment, flash drives)
Furniture and etc.,
Miscellaneous
X, Y,andZ
COMMON THINGS CONT…
41.
42. Other names
Budget detail, budget description, budget
justification
What it is:
Explains what the budget numbers represent
Shows how you arrived at the numbers
Forces you to get into the nitty -gritty details
of your research
who will accomplish what/when and how
you arrived at costs
Tells the funder how you will spend its
investment
Item by Item detail
BUDGET NARRATIVE
43.
44.
45. Annexes
• Case Record Forms (CRFs)
• Questionaires
• Patient information form (in required
languages)
• Consent form (in required languages)
• CV of investigators
46. Get Feedback and Revise
Goal: Make sure you got it right
Complete proposal at least 3 weeks before deadline
Show proposal to a peer who knows your area of work well
Show proposal to a peer who is not a specialist in your area
Show proposal to a non-researcher
47. Reality
Reviewers often do not read proposals carefully, and they
frequently look for the “big ideas”
Reviewers also look for reasons to deny proposals -- there
should be no holes
Reviewers are not always experts
Managers make the final decision, and influence the process
48. What Peers Want
Innovation and significance
Responsiveness to program
Care in writing proposal
Capability to accomplish objectives
49. What Managers Want
Proposals that fulfill
programme priorities
Complementary work (no
duplication)
Investigators who are good to
work with
No black marks (always deliver
on promises)
50. Begin with innovation and significance
Treat programs like customers -- you need
to be responsive
Get as much feedback as possible -- avoid
risks - You can raise the probability of
being picked