1. Writing a Research Proposal for Funding Purposes Workshop Presentation

2. Proposal A proposal is a document written for the purpose of obtaining funds from grant sources and or approval for IRB (Institutional Review Boards).

3. Protocol The protocol is the detailed written plan of the study. The protocol is necessary for guiding a study whether it is required by a funding source or not. Why write the protocol if not required? Writing the protocol focuses the investigator to organize, clarify, and refine all of the elements of the study, which enhances the scientific rigor and the efficiency of the project.

4. Writing Proposals What are the 7 steps to preparing a research proposal for funding purposes?

5. Writing Proposals Step One: Decide where the proposal will be submitted. Use the Internet to locate detailed funding requirements, including: date submission due amounts of money available methods to craft the proposal

6. Writing Proposals Step Two: Organize a team and designate a leader Most proposals are written by a team of several people who will eventually carry out the study. This team may be small, including just the investigator and a mentor, or large, including a study coordinator, biostatistician, data manager, administrator, and several medical specialists.

7. Writing Proposals Most generally the Principle Investigator is the team leader, and assumes the responsibility for leading the effort. There may be a Project Director who serves as the day to day manager of the study and who coordinates the proposal writing.

8. Follow the Guidelines of the Funding Agency Step Three: Locate and follow the written guidelines for writing the proposal from the funding agency. Locate this information and use as a strict guideline to writing and construction.

9. Follow the Guidelines of the Funding Agency Make a checklist of details that are required for proposals for this specific grant, and carefully review the checklist before sending the proposal.

10. Develop an Outline Step Four: Develop an outline. Begin by writing out the proposal in outline form. This provides a starting point for writing and organizing the tasks that need to be accomplished. The outline facilitates working in a group, by having natural divisions in the tasks.

11. Follow the Guidelines of the Funding Agency Step Five: Contact the agency responsible for the grant. Make the initial contact by letter or email, then follow up with a phone call or office visit if possible. Ask if they are interested in your proposal, and if they have any ideas that might allow your project to meet all requirements.

12. Follow the Guidelines of the Funding Agency It is possible that the funding agency will offer valuable information, tips or contacts that will assist you in your grant search or request. Be sure to make this contact early, so that you might be able to adjust your proposal to meet their needs or suggestions.

13. Establish A Timetable and Meet Regularly Step Six: Develop a timetable for completing the writing tasks. The time table should take into account the administrative requirements of the institution that will sponsor the research. Include specific deadlines that are imposed by the funding agency, or your team.

14. Establish A Timetable and Meet Regularly It is maybe necessary to get local IRB approval prior to submission of a proposal. Specify the deadlines for written products. Review the time schedule at each meeting.

15. Locate a Model Proposal Step Seven: Locate and read a model proposal. Ask a colleague, mentor, or fellow resident, for a copy of a successful recent proposal to the agency from which funding is being sought.

16. Study the Model Proposal Adapt ideas from the model. Use the model to design and write your proposal that is clearer, more logical, and more persuasive.

17. Study the Model Proposal Read any written comments about the model. This will illustrate the kinds of issues that are important to the scientist who will be reviewing the proposal.

18. Elements of a Proposal Organize the proposal according to the guidelines that you are applying to.

19. The Beginning Title Abstract Table of Contents

20. Title The Title should be descriptive and concise. It provides the first impression and a lasting reminder of the content and the design of the study. The title should summarize the elements of the study. Avoid phrases like “a study to determine the…”

21. Abstract The abstract is a concise summary of the protocol that should begin with the research question, then set out the design and methods, and conclude with a statement of the importance of potential findings of the study. There is normally a word limit on the abstract. The abstract is written last, when the other protocol elements are settled.

22. Table of Contents The Table of Contents is an essential aid to the reader. It may be useful to include a more detailed table of contents than the summary version. This is especially true of large proposal or those that have complex sections. The items in the Table, should correspond to labeled headings or subheadings in the text.

23. Administrative Section of a Proposal Budget Resumes of Investigator or Investigators Resources provided

24. Study Budget This section is generally organized according to the guidelines from the funding institution. In particular, budgets may need to be developed for the first 12 month period, and a summary budget for the entire proposed project period. Pay particular attention to the amount of time budgeted for the key members of a project. Their time should be substantial.

25. Study Budget There are usually limits to the budget, and who can be paid. In many cases, the PI can not be paid to conduct the study, nor can time be claimed to write the proposal

26. Bio-sketches or CV’s of Investigators Bio-sketches are are two page resumes, or vitas, that include academic degrees, administrative and research positions, honors, committee work, and publications.

27. Resources These include those resources that are available for use by the study and exist prior to the study such as computers, technical equipment, office and lab space.

28. Goals and Rationale Objectives Significance Preliminary Studies Competence of Investigators

29. Objectives The specific objectives are a statement of the research questions using a format that specifies the desired outcome. Each objective is stated in one or two sentences. Objectives are presented in a logical sequence.

30. Objectives The objective answers the question What is the purpose of this study? Example Objectives: 1. To describe the prevalence of coffee consumption in 40-50 year old women with fibrocystic breast disease in the US. 2. To determine if the reduction of coffee consumption among 40-50 year old women with fibrocystic breast disease, changes the number of flare-ups they experience.

31. Introduction The Introduction or Review of Literature section sets the proposal in context, describing the background in the field under which the study was developed. Write this section so that it would be comprehensible for non-experts. Show information making it clear what the researcher intends to accomplish by the study and why it is important.

32. Introduction The Introduction demonstrates that the investigator understands: what has been accomplished, what the problems now are, and what needs to be accomplished. The appropriate detail of the review depends on the scope of the specific aims, the complexity of the field, and the expectations of the review panel.

33. Introduction A review of all the most recent references will suffice in many cases. Keep in mind changes in methods related to the topic. This section my be entitled Review of Literature depending on the funding agency.

34. Preliminary Studies Include Preliminary Study results that describe previous relevant work, making reference to detailed reports and preprints in the appendices. Emphasis should be placed on the importance of the previous work, and the reasons why it should be continued if that is your goal.

35. Preliminary Studies Pilot studies that support your research question and the feasibility of the study are important to many types of proposals, especially when: the researcher lacks experience in the area of the study, when the question is novel, and when there may be doubts about the feasibility of the proposed procedures or recruitment of subjects.

36. Methods Study methods describe in detail how the study will be performed, including all materials needed to conduct the study, and the proposed number of study subjects. Timelines that or detailed directions are part of this study. Methods also include the instruments of measurement or analysis that will lead to the study results. This include

37. Methods The components of the Methods Section require sufficient detail so that sophisticated reviewers will understand exactly how the study will be performed, and why the design choices were made. Long descriptions of some techniques, such as detailed descriptions of biochemical assays or of questionnaires, maybe important and can be located in an appendix for reference.

38. Methods For most studies related to medicine, it is best to contact a biostatistician, or data statistician in the inception of the study, to provide guidance in developing the study methods.

39. Methods The Biostats person is also key in writing the Analysis of the results, and possibly in future articles or presentations.

40. Protocol and Timeline This section if required, provides a realistic work plan and timetable, which includes: dates of major phase launches and completions timetables of staffing patterns and other components of the project an organizational chart describing the research team indicating levels of authority

41. Ethical Considerations Ethical issues are issues surrounding: Safety Privacy Confidentiality Ethical issues are normally addressed in the methods.

42. Ethical Considerations Some ethical considerations indicate the specific plans to inform potential subjects of the risks and benefits, and methods to obtain consent to participate.

43. Characteristics of Good Proposals A good proposal has three main attributes: The scientific quality of the research plan is based on a good research question, Uses a design and methods that are rigorous and feasible, and Has a research team with sufficient commitment to carry out the study.

44. Characteristics of Good Proposals The second attribute: clarity of presentation. The research proposal should be concise and engaging, and not lose the attention of the reviewer with writing that wanders vaguely though superficial topics.

45. Characteristics of Good Proposals Hints for Clarity: Clear outlines Short sections Meaningful subheadings Brief point by point summaries Concise tables Simple diagrams to guide understanding

46. Characteristics of Good Proposals Keep in mind that the goal is to assure the reviewer that the investigator has anticipated the potential problems and has a realistic and thoughtful approach to dealing with them.

47. Characteristics of Good Proposals 1. Scientific quality of study  Good research question  Appropriate and efficient design  Rigorous and feasible methods  Qualified research team 2. Quality of the Presentation  Clear, concise, and well-organized  Informative abstract and clear specific aims  Scholarly and pertinent background and rationale  Good schematic diagrams and tables  Neat and free of errors

48. Writing a Research Proposal for Funding Purposes The End