NIAID Funding Newsletter, November 6, 2013

November 6, 2013

Feature Articles

Step Six to a Winning Application: Outline Your Experiments

Opportunities and Resources

In The News

Advice Corner

Be Aware of Financial Conflicts of Interest
Reader Questions
- Do I need a cover letter for a corrected application?
- Can I copyright publications developed under a grant?

New Funding Opportunities

See the list

Step Six to a Winning Application: Outline Your Experiments

This article is the sixth in our Ten Steps to a Winning R01 Application series, which we are updating.

This step goes further into the iterative approach that will help you design an innovative yet feasible project in a highly significant research area.

Mapping It Out

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. Note that your experimental design is a plan whose goal is to convince your reviewers that you can reach the objectives stated in your Aims.
As you work, 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?

It will help to 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. It may also help to 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.

Research usually takes longer than people think it will, so plan your research design 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.

Use a "Wholistic" Approach

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 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, go back to Step 3 and see if there are different experiments that would meet your objectives with the expertise at your disposal.
If that doesn't work, return to Step 2 and create new aims or even to Step 1 and start over with a new project.

Set Boundaries

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.

Related Links

Strategy for NIH Funding

Sample Applications and Summary Statements

Loan Repayment Programs: Application Deadline Extended

Investigators will get about two extra weeks to submit applications for NIH's Loan Repayment Programs (LRP). Due to the recent lapse in appropriations, NIH extended the due date from November 15, 2013, to December 2.

That should provide additional breathing room for those of you who were shooting for the original deadline. It should also be enough time to start an application if, for example, you hadn't considered preparing one because you're unfamiliar with LRP.

In that case, here are a few key points you should know:

Debt relief—LRP may repay up to $35,000 of your educational debt each year if you're an eligible doctoral-level clinician or researcher who's committed to conducting qualified research for at least two years.
Career benefits—LRP participants have been shown to stay in research careers longer, apply for and receive more grants, and become independent investigators more frequently than their peers who go without LRP funding.
Various opportunities—NIH offers several repayment programs, but NIAID supports only the Clinical Research LRP and Pediatric Research LRP.

For help with writing your application, see NIH's Tips for Writing a Competitive LRP Application and LRP Overview Webinar.

If you have questions and can't find answers on NIH's LRP site or ours at Loan Repayment Programs, contact NIAID's LRP liaison Katrin Eichelberg.

Small Business Awardees: NIH Program to Kick-Start Getting Your Product to Market

Get a jump on leading your product to market with NIH’s Niche Assessment Program.

The Program is back and ready to welcome Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) phase I awardees (grants and contracts) funded in fiscal years 2013 and 2014.

The rundown. An NIH contractor, Foresight Science and Technology, will provide market insight and data that you can use to strategically position your technology in the marketplace. The contractor will create an in-depth report that addresses a number of items, including: identifying your competitive advantages, your market size and potential market share, and recommendations on a market entry strategy.

Foresight will also identify and qualify companies or funding agencies that might serve as potential commercialization partners for your business.

This Program can also:

Assess all types of technologies, such as devices, drugs, biologics, and therapeutics.
Help you find strategic alliances, investors, or immediate customers.
Help in developing a commercialization plan for your Phase II application.

Lastly, you don’t pay a dime for any of this.

form.

For complete details on the Program, see the August 28, 2013, Guide notice.

NIAID Rescheduled October Peer Reviews in Time for January Council

October's government shutdown raised the possibility that NIH would need to move Council assignments for some applications from January to May. The Center for Scientific Review is currently expecting that few, if any, applications will need revised Council dates.

Similarly, no Council assignment changes are anticipated for applications reviewed by NIAID. If we’re reviewing your application and it was assigned to January Council when you submitted it, your application will still go to January Council.

Many thanks to our scientific review officers for their hard work and diligence in rescheduling reviews in time for January Council. For more information about NIH's decisions regarding Council assignments affected by the shutdown, see the October 22, 2013, Guide notice.

New SBIR and STTR Award Certification Requirements

Whether you’re a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) applicant or grantee, pay attention to two new forms you’ll need to complete:

Applicants—If you’re applying for an SBIR or STTR award (new or renewal), you must submit a Funding Agreement Certification form before an award. This certification is a revised and renamed version of the Verification Statement that you formerly used that determines your eligibility for an award. Submit it using NIH’s Just-in-Time procedures for SBIR/STTR grants.
Grantees—If you’re an awardee (new or continuing), complete and maintain the new Life Cycle Certification form once you reach certain milestones during your project period:
- If you’re an SBIR/STTR Phase I awardee, that milestone is when you receive final payment or disbursement from the Payment Management System (PMS).
- SBIR/STTR Phase II awardees, complete it before you receive more than 50 percent of the total award amount and before your final payment or disbursement from PMS.

This new form ensures you’re complying with the assurances provided in your Funding Agreement Certification. You don’t have to submit the Life Cycle Certification directly to NIH, but you must complete it and keep it on file.

These requirements are a result of the SBIR/STTR Reauthorization Act of 2011. You can find the forms under the “SBIR and STTR Grants” section on NIH Forms and Applications.

For more details, read the September 17, 2013, Guide notice.

News Briefs

Join NIH's Rescheduled Webinar for the RPPR Phase II Pilot. Federal Demonstration Partnership members responsible for submitting progress reports to NIH through the eRA Commons should consider being a part of the Research Performance Progress Report (RPPR) Phase II Pilot to implement the RPPR module for non-SNAP awards. NIH will present a training Webinar on November 14, 2013, from 1:30 to 3:00 p.m. EDT. For more information on the pilot and to register for the Webinar, see the October 31, 2013, Guide notice.

Give Your Input on Sharing Genomic Data. NIH is looking for feedback from the public on the draft Genomic Data Sharing (GDS) Policy. Comments are due by November 20, 2013. For details on how to submit comments and to read the draft policy, see the September 27, 2013, Guide notice.

Be Aware of Financial Conflicts of Interest

Remember to tell your institution's business office about potential financial conflicts of interest related to your grant.

As a condition of your award, your institution is responsible for managing, reducing, or eliminating all conflicts for you and your collaborators, and also ensuring your subawardees comply with NIH's policy on financial conflict of interest.

Be sure to mention all financial interests, including interests in any entity that might be affected by your institutional responsibilities, even if you don't think they affect the conduct of your research.

Check with your institutional official to see what else you need to report or do.

As much as we want to avoid holding up your funding for any reason, we have done so for institutions that do not comply with NIH's financial conflict of interest policy.

Read our Financial Conflicts of Interest for Awardees SOP and visit NIH's Financial Conflict of Interest page for more information.

Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.

"Do I need a cover letter for a corrected application?"—anonymous reader

If the due date has not passed, your corrections won't require a cover letter.

If the due date has passed, your application is late. Describe the problems you fixed in the Optional Documents section of the PHS 398 Cover Letter File form. Include all relevant information from your previous cover letter since NIH doesn't keep the old version.

For more information on late applications, see Rules for Late Applications in the Strategy for NIH Funding.

"Can I copyright publications developed under a grant?"—anonymous reader

Unless your Notice of Award explicitly says otherwise, you don't need NIH approval to copyright publications developed under an NIH grant—including training and fellowship awards.

Copyright ownership is an arrangement between you and your institution, or between you and your publisher. Moreover, your institution may exercise its right of ownership over any work created during your official duties.