“Formulae” do not exist for calculating an individual reviewer's score on an application. In considering the scientific and technical merit of each application, the following criteria will be used:

All SBIR/STTR Applications

1.     Significance

a.   Does the proposed project have commercial potential to lead to a marketable product or process? Does this study address an important problem?

b.   What may be the anticipated commercial and societal benefits that may be derived from the proposed research?

c.   If the aims of the application are achieved, how will scientific knowledge be advanced?

d.   Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries?

e.   Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs?

2.     Approach

a.   Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project?

b.   Is the proposed plan a sound approach for establishing technical and commercial feasibility?

c.   Does the applicant acknowledge potential problem areas and consider alternative strategies?

d.   Are the milestones and evaluation procedures appropriate?

3.     Innovation

a.   Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies?

b.   Are the aims original and innovative?

4.     Investigators

a.   Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR?

b.   Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)?

c.   Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed?

5.     Environment

a.   Is there sufficient access to resources (e.g., equipment, facilities)?

b.   Does the scientific and technological environment in which the work will be done contribute to the probability of success?

c.   Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements?

Human Subjects.  In conducting peer review for scientific and technical merit, SRGs will also evaluate the involvement of human/animal subjects and proposed protections from research risk relating to their participation in the proposed 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.

When human subjects are involved in the proposed clinical research, the SRG will also evaluate the proposed plans for inclusion of minorities and members of both sexes/genders, as part of the scientific assessment of Approach criterion.

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. See section in Research Plan on Vertebrate Animals.

These evaluations will be factored into the overall score for scientific and technical merit of the application.

In accordance with NIH policy, the following criteria will be applied to ALL applications:

Human Subjects

1.     Protection of Human Subjects from Research Risks — for all studies involving human subjects. See instructions in the Omnibus SBIR/STTR Solicitation and also see “Guidance for Preparing the Human Subjects Research Section”.

a.   If an exemption is claimed, is it appropriate for the work proposed? If no exemption is claimed, are the applicant's responses to the six required points appropriate?

b.   Are human subjects placed at risk by the proposed study? If so, are the risks reasonable in relation to the anticipated benefits to the subjects and others? Are the risks reasonable in relation to the importance of the knowledge that reasonably may be expected to be gained?

c.   Are the plans proposed for the protection of human subjects adequate?

2.     Inclusion of Women Plan — for clinical research only.

a.   Does the applicant propose a plan for the inclusion of both genders that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent?

b.   Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants?

3.     Inclusion of Minorities Plan — for clinical research only

a.   Does the applicant propose a plan for the inclusion of minorities that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent?

b.   Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants?

4.       Inclusion of Children Plan- for all studies involving human subjects

a.   Does the applicant describe an acceptable plan in which the representation of children of all ages (under the age of 21) is scientifically appropriate and recruitment/retention is addressed realistically?

b.   If not, does the applicant provide an appropriate justification for their exclusion?

5.     Data and Safety Monitoring Plan – for clinical trials only

a.   Does the applicant describe a Data and Safety Monitoring Plan that defines the general structure of the monitoring entity and mechanisms for reporting Adverse Events to the NIH and the IRB?

Animal Welfare

1.     If vertebrate animals are involved, are adequate plans proposed for their care and use?

2.     Are the applicant's responses to the five required points complete and appropriate?

3.     Will the procedures be limited to those that are unavoidable in the conduct of scientifically sound research?

Budget

1.     For all applications, is the percent effort listed for the PI appropriate for the work proposed?

2.     On applications requesting up to $100,000 total costs, is the overall budget realistic and justified in terms of the aims and methods proposed?

3.     On applications requesting over $100,000 in total costs, is each budget category realistic and justified in terms of the aims and methods?

Biohazards

1.     Is the use of materials or procedures that are potentially hazardous to research personnel and/or the environment proposed?

2.     Is the proposed protection adequate?

Phase II Application Review Criteria

In addition to the above criteria:

1.     How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?

2.     Did the applicant submit a concise Commercialization Plan (formerly Product Development Plan [PDP]) that adequately addresses the specific areas described in Item j of the Phase II Research Plan?

3.     Does the project carry a high degree of commercial potential, as described in the Commercialization Plan?

Amended Applications

In addition to the above criteria, the following criteria will be applied to revised applications.

1.     Are the responses to comments from the previous SRG review adequate?

2.     Are the improvements in the revised application appropriate?

Phase I/Phase II Fast-Track Application Review Criteria

For Phase I/Phase II Fast-Track applications, the following criteria also will be applied:

1.     Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

2.     Did the applicant submit a concise Commercialization Plan (formerly Product Development Plan [PDP]) that adequately addresses the specific areas described in Item j of the Phase II Research Plan?

3.     To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization?

4.     Does the project carry a high degree of commercial potential, as described in the Commercialization Plan?

Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating. Failure to provide clear, measurable goals may be sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review.