IV. Submission and Review of Applications

Home Funding for Research Types of Funding Clinical Research Center Grant [P50]Submission and Review of Applications
IV. Submission and Review of Applications A. Submission of Applications The receipt dates are the same for all new (Type 1), renewal (competing continuation/Type 2), resubmission (revised or amended) and revision (Type 3) P50 applications. Application Receipt Dates: January 25th, May 25th, September 25th Initial Review Dates: June/July, October/November, February/March National Advisory Council Dates: September, January, May Earliest Possible Start Dates: December 1, April 1, July 1 The original and three copies of the completed application must be mailed to the NIH Center for Scientific Review; the CSR address label is included in the application kit (PHS 398). In addition to the copies submitted to CSR, send two copies and all appendix CDs, in one package, to: Chief, Scientific Review Branch, NIDCD 6120 Executive Blvd, EPS – 400C, MSC 7180 Bethesda, MD 20892-7180 (U.S. Postal Service Express or regular mail) Bethesda, MD 20852 (for express/courier service; non-USPS service) 1. Appendix All appendices for the P50 shall be submitted to the NIDCD, not to the CSR. If such materials are submitted, they should be mailed to the Chief, Scientific Review Branch, NIDCD. All appendix material must be clearly identified with one subproject or core. The appendix for each subproject has a limit of 3 publications, which are not publicly available, that will be considered in the initial peer review. See the formal application instructions for more details at: http://grants.nih.gov/grants/funding/phs398/phs398.html Five identical CDs of Appendix material must be received by the NIDCD Scientific Review Branch at the time of submission of the P50 application. If Appendix materials are being submitted, this should be indicated on the Table of Contents page, by checking the appropriate box at the bottom of the page. 2. Late Material A P50 application submitted for a specific receipt date is considered complete and in final form as received. As emphasized in the Instructions for PHS 398: "Submit a complete application. An application will be returned if it is illegible, if it fails to follow the instructions, or if the material presented is insufficient to permit an adequate review. Unless specifically required by these instructions (e.g., human subjects certification, changes in other support, appendix), do not send supplementary or corrective material after the receipt date unless the scientific review officer of the initial review group (IRG) solicits or agrees to accept this information. Because there is no guarantee that late material will be considered, the application must be complete and accurate at the time of submission." Unsolicited late material, including proposal revisions, addenda, and budget modifications may not be accepted or may result in deferral of the application. B. Review of Application Upon receipt, applications will be reviewed for completeness and responsiveness. NIDCD staff will review for responsiveness to the P50 funding mechanism, based on the essential criteria listed in Section II.B. of this document. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group (Initial Review Group or IRG) convened by the NIDCD in accordance with the review criteria stated below. As part of the initial review, all applications will be discussed and receive a written critique. Applications receive a second level of review by the National Deafness and Other Communication Disorders Advisory Council. 1. Review Criteria Only the review criteria described below will be considered in the review process. 2. Review and Selection Process Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below. As part of the scientific peer review, all applications will: Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned a priority score. Receive a written critique. Received a second level of by review by the National Deafness and Other Communication Disorders Advisory Council. The following will be considered in making funding decisions: Scientific and technical merit of the proposed project as determined by peer review Availability of funds Relevance of the proposed project to program priorities The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewer will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. 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. Review Criteria for Individual Research Subprojects Significance: Does this study address an important problem? 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? Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools or technologies for this area? Are the aims original and innovative? Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate for the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Are the commitment of the investigators, and their ability to devote the required time and effort to the subproject appropriate? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there adequate evidence of institutional support? Appropriateness for the mechanism: Is the proposed research clinical? To what level is this subproject related to other subprojects and to the overall theme of the center? How well does this subproject contribute to the multidisciplinary nature and overall theme of the center? NIH considers the following in evaluating Center grant applications: The scientific and technical merit of the proposed program; The qualifications and experience of the center director and other key personnel; The statutory and program purposes to be accomplished; The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the center; The extent to which the center’s activities would be coordinated with similar efforts by other organizations; The administrative and managerial capability of the applicant; and Other factors which the awarding IC considers appropriate in light of its particular statutory mission. Additional Review Criteria: In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating: Resubmission Application (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate? Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions). Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions). Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed. Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate. Additional Review Considerations: Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget. Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed. In the case of a competing renewal (continuation) application, the progress made during the past period of funding is also an important consideration in the review of subprojects. It should be noted that each meritorious subproject will receive a priority score and that these scores will appear in the summary statement. Individual subprojects judged as "less meritorious" (because the proposed research is less significant and substantial when judged against the above criteria, or there are other significant concerns) will be deleted from the overall P50. Inclusion of a 'weak' or 'non-essential' subproject will reflect poorly on the overall program (see overall center criteria). In addition, the NIDCD retains the right to delete individual subprojects when making final funding decisions. Review Criteria for Individual Cores Utility of the core to the Clinical Research Center: Does each core provide essential facilities or service for two or more subprojects judged to have substantial scientific merit? Facilities and services: What is the quality of the facilities and services provided by this core (including procedures, techniques, quality control, and criteria for user priority)? Personnel: Are the qualifications, experience, and commitment of the personnel involved in the core appropriate and adequate? In the case of a renewal (competing continuation) application, the progress made during the past period of funding is also an important consideration in the review of cores. Overall Clinical Research Center Review Criteria Each P50 must have a well-defined central unifying theme with three or more meritorious subprojects for the duration of the project period and may contain appropriately justified cores that support two or more subprojects. Whereas subprojects are scored individually, the overall P50 score is an overall evaluation, and not an average of the individual subprojects’ scores. Program staff may consider deletion of a weak subproject when recommending award of the remaining reduced scope yet strong P50. The IRG will evaluate the relationship and contributions of the combined subprojects and cores to the overall theme of the Clinical Research Center. Additional factors include overall scientific considerations, leadership, and administration, as detailed below. However, the most important consideration will be the scientific merit of the research plans, as judged in the individual subprojects. Scientific Considerations Significance of the overall center goals. Level of scientific gain from combining the individual subprojects/cores into a center. Level of cohesiveness of the center's component parts, including the interrelationships and coordination. Past accomplishments of the center or the demonstrated ability of the core personnel in conducting similar programs. Scientific Considerations for Renewal (Competing Continuation) Applications Progress and achievements specific to this center since the previous competitive review, with consideration for the level of collaboration, integration and use of multidisciplinary approaches (e.g., publications, conferences). Evidence that the previous specific aims have been accomplished, that new research goals are logical extensions, and that the basic requirements for a clinical research center still apply. Evidence that previously funded cores, if any, were well utilized and contributed significantly to the center's performance. Justification for adding new subprojects or cores, and for deleting previously supported components. Leadership and Administration The ability of the principal investigator to manage the overall scientific effort and budget. Evidence of established leadership in scientific research and demonstrated capabilities in program administration. The utilization of internal and/or external advisory committees to assist in making scientific/administrative decisions and evaluating progress and direction. Planned meetings or other methods to facilitate the interaction of participating investigators and assure a cohesive program (sharing and evaluate results, new ideas). Academic environment and resources in which the research will be conducted, including availability of space, equipment, human subjects, or other resources as required, and the potential for interaction with scientists from other departments/disciplines. Institutional commitment to the requirements of the program, including fiscal responsibility and management capability of the institution to assist the principal investigator and his or her staff in following DHHS and NIH policy. Administrative planning and leadership capability to provide for internal quality control of ongoing research, allocation of funds, enhancement of internal communication and cooperation among the investigators involved in the program, and replacement of the principal investigator if required on an interim or permanent basis. This overall leadership and administration also should be demonstrated in the considerations for human subject protection; inclusion of women, minorities, and children, and biohazard issues as reviewed in the individual components. 3. Review by the National Advisory Council The recommendations of the initial review group are reviewed by the National Deafness and Other Communication Disorders Advisory Council. Items considered in this review include: scientific merit (as determined by peer review) availability of funds programmatic priorities Back \| Table of Contents \| Next Top