GUIDE FOR ASSIGNED REVIEWERS' PRELIMINARY COMMENTS ON EXPLORATORY/DEVELOPMENTAL GRANT MECHANISM (R21)

The R21 mechanism is designed for exploratory or developmental research. R21 grant programs are often designed to allow investigators to conduct research on innovative ideas or develop new concepts or technologies. R21 applications generally can only be submitted in response to a specific NIH initiative. Each initiative has its own unique features and often has unique review criteria. Thus reading the specific announcement is very important in reviewing R21s. Please carefully read the announcement before preparing your review. Awards vary by Institute and purpose of initiative and may be from one to five years, but generally are for 2 years in duration. Budgets can also vary enormously but they are typically from $75,000 to $150,000 per year and thus follow the modular budget requirements.Again, read the specific announcement for details. Although R21s cannot be renewed, the objective is that they would lead to regular research grant (e.g., R01, P01, U01, etc.) funding in the future. Please use the following guidelines when preparing written comments on R21 grant applications assigned to you for review. 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 applicant. DESCRIPTION: The NIH now scans the description 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 individual sections, each criterion listed in the announcement. In addition 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. If there is a criterion on Investigator, PLEASE DO NOT INCLUDE descriptive biographical information unless important to the evaluation of merit. If there is a criterion on Environment, 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 review criteria. Recommend a score reflecting the overall impact of the project on the field, weighting the review criteria of the specific announcement, as you feel appropriate for each application. An application does not need to be strong in all categories to be judged likely to achieve the goals of the initiative and, thus, deserve a high merit rating. 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. Category Gender (G) Minority (M) Children (C) Both Genders Minority & non-minority Children & adults Only Women Only minority Only children Only Men Only non-minority No children included Gender Unknown Minority representation unknown Representation of children unknown

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.

[Referral & Review]