March 11, 2004

I know that many of you are working hard to prepare an application for the upcoming April 1 submission date, so I thought I would pass along some guidance and advice to help you get through the next few weeks.  Specifically, I wanted to focus on what I believe to be the essential ingredient to a successful application: Communication.

(One of those essential ingredients in life-but we'll stick to SBIR/STTR applications!)

It is very important to communicate with the NIH Program staff in the relevant awarding component (Institute/Center, or IC) prior to submitting an application for the following reasons:

• To determine whether your proposed application topic would fit into the awarding component's programmatic area - or possibly fit more than one IC
• To learn about programmatic areas of interest to the IC or other non-NIH agencies
• To find out about research grant mechanisms
• To find out about requesting assignment to an IC or Scientific Review Group (SRG)
• To receive advice on preparing an application (e.g., format, structure)
• To discuss whether you should respond to an RFA

Contacts in the awarding components (ICs) can be found in Part II of the SBIR/STTR Grant Solicitation http://grants1.nih.gov/grants/funding/sbirsttr1/2004-2_SBIR-STTR-topics.doc. A list of the various ICs is also provided at the end of this email.

As you write your application, think about your audience in terms of  "who, what, where and how". Know your audience-this is the "who". Know what to communicate, where to say it, and how to say it.

WHO are your reviewers?

Let's start with a clarification: NIH Institute/Center (IC) staff are NOT the reviewers-in fact, the Program staff in the ICs are not able to affect the outcome of your review. You (and about 2000 other applicants) will be communicating your idea to an EXTERNAL peer review group. This is not unlike my son who is going through the college application process-It is essential that you know how to communicate well to capture their attention and make them want to read your application. The reviewers of your grant application are composed primarily of non-Federal scientists, physicians, and engineers (from academia and industry) selected for their expertise and stature in particular scientific fields. You may even request in a cover letter that a particular area of expertise be represented on your review panel. Don't list names of reviewers, just the area of expertise.

The real "meat" of your application in terms of what to communicate to reviewers and where to say it will be in the Research Plan. The Research Plan consists of the following sections: Specific Aims, Significance and Related R&D; Preliminary Studies (not required for Phase I, but may be included if you have convincing data)/Phase I Final Report (for Phase II applications); Experimental/Research Design and Methods; Human Subjects; Vertebrate Animals; Literature Cited; Consortium/Contractual Arrangements; Consultants; and Commercialization Plan (Phase II and Fast-Track).

Organize Items a-d to answer these questions: (1) What do you intend to do? (2) What are the anticipated commercial products, processes, services and societal benefits? Why is the work important? (3) What has already been done? (4) How are you going to do the work?

Reviewers assess the scientific and technical merit of each application using 5 major review criteria (Significance, Approach, Innovation, Investigators, and Environment). Unlike in contracts, these criteria are not "weighted."  But don't stop with there. Carefully read the questions under each of the criteria (see below and the Solicitation), and prepare your Research Plan in such a way that you communicate the answers to the questions.

1.      Significance

2.      Approach

3.      Innovation

4.      Investigators

5.      Environment

Human Subjects.  In conducting peer review for scientific and technical merit, SRGs will also evaluate the involvement of human subjects and proposed protections from research risk relating to their participation in the proposed non-exempt Research Plan according to the following four review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits of the proposed research to the subjects and others, and (4) importance of the knowledge to be gained.

Vertebrate Animals. The proposed involvement of vertebrate animals will be evaluated by SRGs as part of the scientific assessment of Approach and Environment criteria and according to the following five points: (1) detailed description of the proposed use of the animals; (2) justification for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of proposed veterinary care; (4) procedures for limiting pain and distress to that which is unavoidable; and (5) methods of euthanasia.

The best way to answer this question is to turn it around and list the most common reasons cited by reviewers for an application's failure to gain their enthusiasm. Review this list and make sure none of these items apply to your idea.

•  Unconvincing case for commercial potential or societal impact.
•  Poorly defined test of feasibility (Phase I).
  
•  Methods unsuited to the objective.
  
•  Problem more complex than investigator appears to realize.
  
•  Not significant to health-related research.
  
•  Too little detail in the research plan to convince reviewers the investigator knows what he or she is doing, i.e., no recognition of potential problems and pitfalls.

•  Over-ambitious research plan with an unrealistically large amount of work.
  
• Direction or sense of priority not clearly defined, i.e., experiments do not follow from one another and lack a clear starting or finishing point.

•  Lack of focus in hypotheses, aims, and or research plan.
  
•  Lack of innovation.
  
•  Investigator too inexperienced with the proposed techniques (and failed to enlist collaborators with complementary expertise).

•  Proposal driven by technology, i.e., a method in search of a problem.
  
•  Rationale for experiments not provided, i.e., why they are important or how they are relevant to the objective?

•  Lack of alternative methods in case the primary approach does not work out.
  
•  Proposed model system not appropriate to address the proposed questions.
  
•  Relevant controls not included.
  
•  Insufficient consideration of statistical needs.
  
•  Not clear which data were obtained by the investigator and which reported by others.

Feedback to applicants is very important. Once the principal investigator receives the Summary Statement, contact the appropriate awarding component program official (noted on the Summary Statement) for the following reasons:

• To discuss the review outcome of the application and obtain guidance 
• To get feedback and answers to any questions about the Summary Statement
• To find out the meaning of a numerical designation pertaining to human subjects or vertebrate animals on the Summary Statement
• To find out the funding status of an application

Some of you will not be successful in getting funded on your first submission. The SBIR/STTR Program is very competitive, and many will need to revise and resubmit. NIH allows the submission of 2 amended applications. Even if your application is unscored (as designated by a "**"), you should discuss the strengths and weaknesses of the application with your Program Director and revise/resubmit if it is believed that the weaknesses can be improved.