Now that you have assessed your Specific Aims and are confident they are up to snuff, it's time to sketch out the sets of experiments necessary to address those aims. Your experimental design is a plan whose goal is to convince your reviewers that you can reach the objectives stated in your Aims.
Be Aware of Special Rules
For some areas of science, you must follow special policies and instructions from the U.S. Department of Health and Human Services (HHS), NIH, or NIAID.
If you plan to conduct research in any of the following areas or you’re trying to determine whether the rules apply to your type of research, follow these links for more information:
- Research Using Human Subjects. Note that even some work with samples qualifies as human subjects research.
- Investigator-Initiated Clinical Trials (IICTs). You must follow NIAID’s process and apply only through IICT-specific notices of funding opportunities. See the NIAID IICT Policy Guide notice.
- Research Using Vertebrate Animals. NIH limits research using chimpanzees, dogs, and cats.
- Research Using Select Agents. You need advance approval for restricted experiments.
- Research Using Stem Cells. See NIH Stem Cell Information.
For other NIAID policies and procedures, see Research Rules and Policies.
Map Experiments and Money to Your Aims
As you work on your Aims, keep the following questions in mind:
- What are the anticipated outcomes of the experiments?
- Can they meet the objectives of the aims?
- Is the scientific scope and complexity of the proposed project a good fit with my expertise and/or the expertise of my team as demonstrated by relevant preliminary data and publications?
- Am I proposing to accomplish more than I have time and funds for?
- Have I considered potential pitfalls and alternative approaches?
- What sort of reagent, data, and technological resources do I need to support my research?
Regarding that last bullet, here’s where NIAID can help. We offer many resources to support your research, including reagents, model organisms, and tissue samples. Learn about our offerings at Resources for Researchers and use the filter options on the left. Some options are free while others have a cost you should note.
You should also document all of the resources and facilities (e.g., access to clinical samples or specialized reagents and animal models) available to you at your institution. We encourage you to include this information in your application.
As you draft your budget, start a running tab of "who, what, when, where, and how (much money)." That approach gives you a reality check as you plan and ultimately can save you time.
Research usually takes longer than people think it will, so design your research with that thought in mind.
Get help from colleagues and experts in your field if you have never planned out such a large project before or are unsure how long some of your planned experiments are likely to take.
The Feedback Loop
Your experimental design—the nitty-gritty of what you will actually do—must enable you to achieve the Specific Aims you describe and test your hypothesis. Optimally, your experimental results should be able to prove or disprove your central hypothesis.
For planning purposes, your Specific Aims and research design work in a feedback loop: your aims lead to your experiments, which determine your budget and personnel needs.
But the experiments you can design are ultimately limited by the availability of people and resources and proposed scope of the project.
Following the steps in our Iterative Approach to Application Planning Checklist on Draft Specific Aims is key to ensuring that all aspects of your application stay in sync and in scope as you plan the various parts.
For example, let's say you have an idea for a project that you believe your review committee would judge to be highly significant.
You sketch out a reasonable number of Specific Aims, but when you start designing the experiments you find you cannot gather all the expertise needed to conduct them.
- First, talk to advisors and colleagues at your institution to see if there is potential to collaborate with other experts on-site. Also, review the literature and reach out to investigators who conduct similar experiments and request an opportunity to consider a collaboration.
- See if there are different experiments that would meet your objectives with the expertise at your disposal.
- If that doesn't work, create new aims or even start over with a new project idea.
Set Boundaries To Stay in Scope
How do you know whether the scope of project is appropriate to your skill level (or, if you’ve recruited collaborators or consultants, the skill level of your team)?
If you are new to grant writing, you may want to get advice from your program officer, colleagues, or other respected sources.
If you find yourself trying to squeeze too much into your Research Plan, now is the time to step back and reassess.
Be realistic about what you can accomplish. But know that even if you are a new investigator, it's fine to ask for five years—the maximum—for an R01 as long as you can fill the time productively.
The same goes for budget planning—estimate costs realistically. If your budget exceeds $250,000 in direct costs, you will need to provide a detailed budget rather than a modular one. Your chances of getting funded are not impacted by whether your budget is modular or non-modular, although the reviewers may recommend budget cuts in either case.
Checklist
Create an initial experimental design that will achieve your Specific Aims and test your hypothesis or hypotheses.
- Use our iterative process to make sure all parts track with each other.
- Check again as you plan that the research is significant and innovative, but not too innovative.
- Create a running tab of "who, what, when, where, and how much money."
- Learn what to do for:
- Research Using Human Subjects
- Research Using Vertebrate Animals
- Research Using Select Agents
- Research using stem cells: see NIH Stem Cell Information