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Dr. A. Sundhararajan, Ph.D
Assistant Professor
Department of Biochemistry & IRB
Trichy SRM Medical College
Irungalur – 621105
sundhararajana@gmail.com
I cannot teach anybody
anything, I can only make
them think.
 W & H
 Create the strategy
 Develop Concept
 Proposal Writing
 Work plan
 Budget
 Summary
• How to write an effective research protocol
• Action plans for fundraising for Research.
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
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
Develop Concept
 Understand literature and needs
 Build from your strengths
 Identify/develop partners
 Reaction from colleagues and peers
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
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
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
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
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.
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
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
FORMAT FOR SUBMISSION OF
PROPOSAL FOR GRANT
Proposal Writing
A good research proposal
demonstrates innovation and
significance within its field
of study.
• 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
• 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
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
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!
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
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!
• Simple
• Specific
• Stated in advance.
Research objectives
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.
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
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!
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!
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
Data quality control
• Describe measures of data quality control:
– Double data entry
– Consistancy checking
– Data monitor
– Verfication procedures of source data
– Interrater variability measurements
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
Work plan
0
1
2
3
4
5
6
Months
Activity
Work plan
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
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
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
Equipments
 Permanent equipments
 Computer and Printer
 Tech supplies (cameras, audio recording
equipment, flash drives)
 Furniture and etc.,
Miscellaneous
 X, Y,andZ
COMMON THINGS CONT…
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
Annexes
• Case Record Forms (CRFs)
• Questionaires
• Patient information form (in required
languages)
• Consent form (in required languages)
• CV of investigators
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
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
What Peers Want
 Innovation and significance
 Responsiveness to program
 Care in writing proposal
 Capability to accomplish objectives
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)
 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
Dr. Sundhararajan

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Dr. Sundhararajan

  • 1.
  • 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
  • 16. FORMAT FOR SUBMISSION OF PROPOSAL FOR GRANT
  • 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!
  • 25. • Simple • Specific • Stated in advance. Research objectives
  • 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
  • 33.
  • 36.
  • 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