|
GENERAL ISSUES
- Keep it simple and remember the goal is science - not advocacy, program evaluation, or responding to the needs of managed care. You will need to assure the review committee that your goal is to expand our understanding of the scientific issues, not advance a particular program, clinical practice, or management strategy.
- Write your application for an educated nontechnician - someone who is not an expert in your field. Physicians, psychologists, economists, epidemiologists, sociologists, and statisticians will read it. You cannot assume they know your area.
- Be kind to your reviewers. Make your application easy to read and appealing to look at. Write clear, easy to read sentences - check spelling, typos, grammar, syntax, and agreement. Make the application easy to read and look at. Obey type size and margin restrictions or NIH will return it.
- Don't propose to develop an instrument or method and then use it in the same research. Use the Small Grant and R01 mechanisms to develop methods and instruments.
- Do not propose an approach or method for which you do not have appropriate on-site expertise who can contribute a scientifically justifiable proportion of time. Best example: cost analyses.
- As you are choosing collaborators, consider people who have different professional training and scientific perspectives. These people can help you see new and perhaps important and creative ways to look at a problem or issue.
- NIMH does support research other than randomized clinical trials. If little is known about an area, descriptive studies - with comparison groups - are appropriate.
- DO NOT put in the appendix information that is critical for the reviewers to read. They are not likely to read appendices. Also carefully read the rules in the PHS 398 form about the appendices.
- Put separate subject headings in your application for human subjects issues and for your plans on the inclusion of women and minorities. Read the NIH Guidelines on Inclusion of Woman and Minorities as Subjects in Clinical Research and the accompanying documents, Questions and Answers Concerning the 1994 NIH Guidelines and Outreach Notebook for the NIH Guidelines. These documents can be obtained from NIH via email: jqj~cu.nih.gov
- IMPORTANT: Your chances of receiving funding the first time you submit are low. But don't give up. Use program staff input and keep trying.
- Don't forget to consider: Pl experience ~ project complexity ~ project budget
TITLE AND ABSTRACT
- The title and abstract are the sources of information for referring your application to a particular program and review committee - contact staff.
- Construct a carefully worded statement describing the main purpose of the research, hypotheses/goals, methods of data collection and analysis, and significance.
BUDGET
- Make the budget realistic and appropriate for the scientific goals. Don't pad(e.g., microwaves and refrigerators) Don't propose cutting too many corners (makes you look naive)
- Itemize the budget for each year. Hold increases in continuation costs to 4% (NIH cost containment policy).
- Justify each item. Make it possible for reviewers to determine what costs are associated with what aspects of the project.
- If the study involves multiple components, specify which costs are associated with which components.
- Insure that specific tasks are clearly related to personnel, time, and budget.
- Avoid small allocations of time among a large number of investigators; insure an adequate time commitment of the Pl, project director, and biostatistician* - in ALL years of the project. The importance of having a biostatistician from day 1 of the project planning and application preparation cannot be overemphasized.
SPECIFIC AIMS
Purpose: To sell your research idea
- Propose 3-5 aims - not a dozen - all related to 1 overall goal. That goal must address an issue in science. In other words, you must convince the review committee that your question is the next best step in science. It is not sufficient to have a convenient data set or sample.
- A useful format for the page is:
Briefly describe the problem
Describe what we know and don't know
Describe the niche your research will fill in the theoretical and/or empirical literature
- It is helpful to set aims in bullets so they are easy to find.
BACKGROUND AND SIGNIFICANCE
Purpose: To convince your reviewers you understand the research questions in the larger scientific context
- Let the reviewers know that you understand the problem. Don't make this a bibliographic lecture or describe individual studies in detail.
- Set up a theoretical and conceptual framework for your research. You must show that you have a very good scientific reason for proposing the research. It must have a thorough grounding in the literature, whether the project involves instrument development, is descriptive, or uses a randomized clinical trial methodology. This section provides the rationale and justification for the research.
- Provide information to assure the reviewers that this study is part of a larger context and that it has implications for other settings and populations.
PROGRESS REPORT/PRELIMINARY STUDIES
Purpose: To show your reviewers you and your team have experience doing research and can be good stewards of public research funds
- Previous (published) secondary analyses and/or pilot work in the area are critical. They help the IRG determine: - feasibility of proposed work - substantive/practical significance -ability of research team to carry out work.
- List most salient related work by all members of research team.
- Explicitly relate prior work to goals and objectives of proposed study.
- Append essential reprints or publications-particularly if they provide useful background information (but not information critical to understanding or evaluating the proposal). Again see the rules about appendices in the revised PHS 398 form.
EXPERIMENTAL DESIGN AND METHODS
Purpose: To convince your reviewers you have completely thought through: (1) how to answer the questions posed in the Specific Aims section; and (2) the potential problems in your design and how you will deal with those problems
This is the most important section
- Begin with a brief overview of the research design.
- Justify all instruments, incentives, etc. Provide information on validity and reliability of instruments likely to be unfamiliar to the reviewers (staff can help you to identify which those might be). Include published articles on unfamiliar instruments in an appendix.
- Justify the sample size through a power analysis. Discuss how you will take into account attrition; how will it affect the power? How will you track difficult to find subjects?
- Thoroughly discuss the effect of sampling weaknesses. How will attrition affect conclusions?
- Justify the sample composition of each group. Take into account the strengths and weaknesses of a heterogeneous or homogeneous sample.
- Provide a step-by-step explanation of any intervention. Tell the reviewers exactly what will happen to subjects in the control and experimental groups. Discuss in detail the training plans for those who will provide the intervention and for those who will perform the data collection.
- If descriptive, provide similar detail on the survey methods. If longitudinal, provide considerable detail on retention of subjects (i.e., tracking, incentives).
- Specifically discuss the weaknesses of your design. If you don't acknowledge the limits of the study and how you will deal with them, they will be pointed out to you in the summary statement.
- Discuss plans for editing and cleaning data.
- Provide a step-by-step analysis plan. Tie each hypothesis or specific aim to an analytic strategy. Discuss plans for dealing with missing data.
- Don't use analytic methods, just because they are in vogue, that are more powerful than the data or are inappropriate for the data
- Don't propose methods that you don't have the expertise to use, e.g., LISREL or costeffectiveness analysis. For particularly complex methods, the person with the expertise should either be on-site or easily accessible.
- Don't use methods just because you are comfortable with them. Choose methods that are appropriate to answer the questions you are asking with the data you will have available to you. Consider how much missing data you are likely to have, how the analytic methods you have chosen will deal with those missing data points, and what effect your choice will have on the conclusions you can reach.
- Include and discuss an implementation timeline (such as a Grant chart).
|
