“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:

1. Significance

1. Does the proposed project have commercial potential to lead to a marketable product, process or service? Does this study address an important problem?
2. What may be the anticipated commercial and societal benefits that may be derived from the proposed research?
3. If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
4. Does the application lead to enabling technologies (e.g., instrumentation, software) for further discoveries?
5. Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs?

2. Approach

1. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project?
2. Is the proposed plan a sound approach for establishing technical and commercial feasibility?
3. Does the applicant acknowledge potential problem areas and consider alternative strategies?
4. Are the milestones and evaluation procedures appropriate?

3. Innovation

1. Are the aims original and innovative?
2. Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?
3. Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators

1. Is the principal investigator appropriately trained and capable of coordinating and managing the proposed SBIR/STTR?
2. Are the investigators and well suited to carry out this work? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
3. Is the work proposed appropriate to the experience level of the principal investigator and other researchers, including consultants and subcontractors (if any)?
4. Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed?

5. Environment

1. Is there sufficient access to resources (e.g., equipment, facilities)?
2. Does the scientific and technological environment in which the work will be done contribute to the probability of success?
3. Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Protection of 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, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.

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 well as the inclusion of children in clinical research, as part of the scientific assessment of Approach criterion. The evaluation will be factored into the overall score for scientific and technical merit of the application.

When human subjects are involved in research that involves one of the six categories of research that are exempt under 45 C.F.R. 46, the SRG will evaluate the justification for the exemption and (1) Human Subjects Involvement and Characteristics, and (2) Sources of Materials.

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

1. Protection of Human Subjects — for all studies involving human subjects. See instructions and Decision Table for Human Subjects Research, Protection and the Inclusion of Women, Minorities, and Children.

1. 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?
2. 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?
3. Are the plans proposed for the protection of human subjects adequate?

2. Inclusion of Women Plan – for clinical research only

1. 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?
2. 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

1. 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?
2. 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

1. 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?
2. If not, does the applicant provide an appropriate justification for their exclusion?

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

1. 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?

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:

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 principal investigator appropriate for the work proposed?
2. On applications, is the overall budget realistic and justified in terms of the aims and methods proposed?

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?

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 that adequately addresses the specific areas described in Item K 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?

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 that adequately addresses the specific areas described in Item K 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.

In addition to the review criteria stated above for “All SBIR/STTR applications," the following items will be applied to ALL Competing Continuation Phase II applications in the determination of scientific merit and the priority score.

1. Does the activity as proposed address issues related to Federal regulatory approval processes?
2. Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in Item K of the Phase II Research Plan?
3. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan?

In cases where an IC has issued a competing continuation announcement in the NIH Guide, applicants should read the RFA or PA carefully for special instructions or additional review criteria. The Topics section (http://grants.nih.gov/grants/funding/sbirsttr1/2006-2_sbir-sttr-topics.doc) includes the relevant announcement links to the NIH Guide for Grants and Contracts.