Please use the following guidelines when preparing written comments on research grant applications assigned to you for review. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In your written review, you should comment on the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.  NOTE: Your written reviews should not bear personal identifiers because unaltered comments will be sent to the investigator.

DESCRIPTION:  The NIH now scans the abstract on page 2 of an application for use in the Description section of the summary statement. However, as a reviewer you must be prepared to present the application to the Study Section so that all members can follow the critiques and discussion. Thus, any description you write (in prose or in bullet form) is for your use in making this presentation.

CRITIQUE: Include as little descriptive information in this section as possible. Please address, in five individual sections, each criterion listed below. In addition: for competing continuation (renewal) applications, include an evaluation of progress over the past project period; for amended applications, address progress, changes, and responses to the critiques in the summary statement from the previous review, indicating whether the application is improved, the same as, or worse than the previous submission. Comments on progress and response to the previous review should be provided in a separate paragraph and/or under the appropriate criteria.

1. Significance Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

2. Approach Are the conceptual framework, design (including composition of study population), methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

4. Investigator Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? PLEASE DO NOT INCLUDE descriptive biographical information unless important to the evaluation of merit.

5. Environment Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? PLEASE DO NOT INCLUDE description of available facilities or equipment unless important to the evaluation of merit.

OVERALL EVALUATION: In one paragraph, briefly summarize the most important points of the Critique, addressing the strengths and weaknesses of the application in terms of the five review criteria. Recommend a score reflecting the overall impact of the project on the field, weighting the review criteria, as you feel appropriate for each application. An application does not need to be strong in all categories to be judged likely to have a major scientific impact and, thus, deserve a high merit rating. For example, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward.

GENDER, MINORITY AND CHILDREN SUBJECTS: Examine whether the minority and gender characteristics of the sample are scientifically acceptable and consistent with the aims of the project, using the categories of "1" to "4" as follows. Also examine whether there is appropriate inclusion of children (individuals under the age of 21). Also determine whether the research is a Phase III clinical trial.

Evaluate acceptability as "A" (acceptable) or "U" (unacceptable). If you rate the sample as "U", consider this feature a weakness or deficiency in the design of the project and reflect it in the overall score.

NOTE: To the degree that acceptability or unacceptability affects the investigator's approach to the proposed research, such comments should appear under "Approach" in the five major review criteria above, and should be factored into the score as appropriate.

HUMAN SUBJECTS: If Exemptions are claimed, express any comments or concerns about the appropriateness of the exemption(s) claimed (e.g., for Exemption 4, is it clear that the information will be recorded by the investigator so that subjects cannot be identified directly or indirectly?). If No Exemptions are claimed, express any comments or concerns about the appropriateness of the applicant's responses to the six required points. Discuss whether the risks to the subjects are reasonable in relation to the anticipated benefits to the subjects and/or in relation to the importance of the knowledge that may reasonably be expected to result from the research.

ANIMAL WELFARE: Express any comments or concerns about the appropriateness of the responses to the five required points, especially whether the procedures will be limited to those that are unavoidable in the conduct of scientifically sound research.

BIOHAZARDS: Note any materials or procedures that are potentially hazardous to research personnel and indicate whether the protection proposed will be adequate.

BUDGET: Evaluate the direct costs only. Do not focus on detail. Determine whether the total budget is appropriate for the project proposed. Provide a rationale for suggested modification in amount or duration of support.

OTHER CONSIDERATIONS (for Administrative Notes in the Summary Statement): These comments are useful to NIH but should not influence your overall score.

FOREIGN: If the applicant organization is foreign, comment on any special talents, resources, populations, or environmental conditions that are not readily available in the United States or that provide augmentation of existing U.S. resources. In addition, indicate whether similar research is being performed in the U.S. and whether there is a need for such additional research. These aspects do not apply to applications from U.S. organizations for projects containing a significant foreign component.