and Human Services (HHS)
EXPIRED
MBRS SUPPORT OF CONTINUOUS RESEARCH EXCELLENCE (SCORE) RELEASE DATE: October 1, 2003 PA NUMBER: PAR-04-001 (See Modification in PAR-06-490, PAR-06-491, PAR-06-492 & PAR-06-493) EXPIRATION DATE: July 20, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.859 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Program and Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Reporting Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Post-Award Reporting Requirements o Required Federal Citations PURPOSE OF THIS PA The Minority Biomedical Research Support (MBRS) Branch of the Division of Minority Opportunities in Research (MORE), National Institute of General Medical Sciences, re-announces the Support of Continuous Research Excellence (SCORE) program. This program announcement (PA) replaces an earlier announcement, PAR-99-152, which was published in the National Institutes of Health (NIH) Guide for Grants and Contracts dated August 20, 1999, and integrates, unifies and supersedes the content of the prior SCORE PA and SCORE Supplemental Instructions for PHS 398 and for PHS 2590. All applications submitted for June 1, 2004 or later application receipt dates must be responsive to this PA. The mission of the MORE Division programs is to increase the numbers of underrepresented minority students who pursue research training for scientific careers, to increase the numbers of underrepresented minority faculty engaged in biomedical and behavioral research, and to enhance the science curricula and research capabilities of institutions with substantial minority enrollments. The purpose of the MBRS programs is to increase the numbers of underrepresented minority faculty, investigators, and students engaged in biomedical or behavioral research and to broaden the opportunities for participation in biomedical or behavioral research of underrepresented minority faculty and students. The SCORE program seeks to accomplish the above goals by supporting meritorious, investigator-initiated research projects in biomedical or behavioral sciences at minority-serving institutions. In addition to the SCORE program, the MBRS Branch also offers, for eligible institutions, the Research Initiative for Scientific Excellence (RISE) and the Initiative for Minority Student Development (IMSD) Programs. The announcements for these programs are available at http://www.nigms.nih.gov/minority/. PROGRAM and RESEARCH OBJECTIVES In the NIH Revitalization Act of 1993, NIH was encouraged to increase the number of underrepresented minorities participating in biomedical and behavioral research. In response to the Act, starting in 1996 the MBRS Branch offered institutional grants under the SCORE program. The objective of the SCORE PA is to increase the numbers of underrepresented minorities who are professionally engaged in biomedical/behavioral research. This objective will be achieved by providing support to investigator-initiated research projects and pilot research projects (see below), and to establish and/or upgrade research facilities including shared core research equipment at minority-serving institutions that satisfy both the eligibility and award criteria stipulated in the authorizing legislation (see eligibility below). It is an expectation of the SCORE program that participating faculty/investigators will increase their productivity and competitiveness and that the institutions benefiting from SCORE support will improve their research capabilities. Thus, support for faculty participating in pilot research projects is considered preparatory to seeking a SCORE regular research project, while support for a regular research project is considered preparatory to seeking more substantial funding from other extramural sources. The length of time for these transitions to occur, however, may vary depending on the characteristics of a given faculty member and the institution. MECHANISM OF SUPPORT This PA will use the NIH MBRS (S06) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PA may not exceed four years. This PA uses just-in-time concepts. This PA uses the non-modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). A non- modular budget is one in which each item listed in the budget must be clearly justified. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS As described in the authorizing legislation for the MBRS program you may submit an application if your institution is one of the following: o an accredited public or private nonprofit university, two-year or four-year college, or other institution offering undergraduate, graduate, or health-professional degrees, with a traditionally high (more than 50 percent) underrepresented minority student enrollment; or o an institution (as described above) with a student enrollment a significant proportion (but not necessarily more than 50 percent) of which is derived from underrepresented minorities provided the Secretary of the Department of Health and Human Services through the MBRS Branch Chief determines that said institution has a demonstrated commitment to the special encouragement of, and assistance to, underrepresented minority students and faculty; or o an Indian tribe that has a recognized governing body and that performs substantial governmental functions, or an Alaska Regional Corporation (ARC), as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq.); and o located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, America Samoa, or the Trust Territory of the Pacific Islands. In addition, eligible institutions should demonstrate the need for improvement of their research capability. Eligible institutions with well-developed researchers with significant extramural funding and a record of research productivity generally are not suitable applicants for SCORE grants. Underrepresented minorities are individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Historically, individuals who have been found to be underrepresented in biomedical or behavioral research include, but are not limited to, U.S. citizens who are African Americans, Hispanic Americans, Native Americans (including Alaska Natives) and natives of the U.S. Pacific Islands. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individuals with the skills, knowledge, and resources necessary to manage a SCORE program and to carry out the proposed research projects are invited to work with their institutions to develop an application for support. SCORE grants require a Principal Investigator for the application, referred to as the Program Director (PD), who is responsible for administration of the overall institutional program and serves as liaison between the grantee institution and NIH. In addition, Principal Investigators, designated as PIs, will be responsible for carrying out their proposed research projects. Typically, the PD and PIs possess a Ph.D. or M.D./Ph.D. degree. They must also have a permanent, full-time faculty appointment at the applicant institution and be eligible to apply for an NIH R01 research grant. A PD may serve concurrently as a PI. The PD should also have the experience and authority to coordinate research projects of investigators who may be affiliated with different departments. SPECIAL REQUIREMENTS SCORE grants are institutional grants that consist of an overall program component and up to a maximum of 28 individual research projects (see below). An institution may submit only one SCORE program grant application and may hold only one award. A SCORE grant application must have at least one individual research project or pilot project but no more than 20 research projects and 8 pilot research projects in addition to the overall program component. Pilot projects, which can receive a maximum of four year of support, are generally not renewable. A PI may apply for a Research or Pilot Research Project but not for both. A PI may only hold one active Research or Pilot Project. Supplemental applications to active SCORE grants may be submitted only if a two-year award can be made without extending the funding period of the parent grant. Thus, supplements may be submitted only in the first 12-15 months of a four-year SCORE grant, depending on the actual award date. It is advisable to consult with MBRS program or grant managements staff to confirm eligibility. Supplemental applications may include one or more research and/or pilot research projects but only one supplemental application may be submitted at any application receipt date. This limitation does not apply to RFA-invited supplemental applications. Current NIH policy permits a component research project of a SCORE grant application to be submitted concurrently as a traditional individual research project (R01) application. If, following review, both the research project in the SCORE application and the R01 application are found to be in the fundable range, the investigator must relinquish the SCORE subproject. The specific instructions given under 'Application Content' must be followed when submitting a new (Type 1), competing renewal (Type 2) or supplemental (Type 3) SCORE application. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: programmatic/research, peer review and financial or grant management issues: o Direct your questions about programmatic/research issues to: Hinda Zlotnik, Ph.D. Chief, MBRS Branch National Institute of General Medical Sciences, NIH 45 Center Drive, Room 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301)594-3900 FAX: (301)480-2753 E-mail: [email protected] o Direct your questions about peer review issues to: Helen R. Sunshine, Ph.D. Chief, Office of Scientific Review National Institute of General Medical Sciences, NIH 45 Center Drive, Room 3AN.12F, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301)594-2881 FAX: (301)480-8506 E-mail: [email protected] o Direct your questions about financial or grants management matters to: Antoinette Holland Grants Management Officer Grants Management Branch Division of Extramural Activities National Institute of General Medical Sciences, NIH 45 Center Drive, Room 2AN.50B, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301)594-5132 FAX: (301)480-2554 E-mail: [email protected] SUBMITTING AN APPLICATION There are three types of applications: new application (Type 1), competing renewal application (Type 2), and supplemental application (Type 3). In addition, Type 1, 2 and 3 applications may be submitted as revised applications if they were not funded on the first or second attempt. Applications of Types 1, 2 or 3 must be prepared using both the PHS 398 research grant application instructions and the organizational requirements and content instructions provided in this PA. Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the Face Page of the PHS 398 form. The PHS 398 (rev. 5/2001) is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional single-sided photocopies of the application plus appendices must also be sent to: Helen R. Sunshine, Ph.D. Chief, Office of Scientific Review National Institute of General Medical Sciences, NIH 45 Center Drive, Room 3AN.12F, MSC 6200 Bethesda, Maryland 20892-6200 Telephone: (301)594-2881 APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described above in this PA. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. APPLICATION CONTENT New applications (Type 1): These are applications from institutions that have had no previously funded SCORE grant or that had a grant that lapsed for several years. In preparing your SCORE grant application, follow the PHS 398 instructions for research project grant applications (http://grants.nih.gov/grants/funding/phs398/phs398.html), but modify the placement of Form Pages and application as described below. A SCORE grant application consists of two distinct parts: 1) Overall SCORE Program Plan and 2) Investigator-initiated research projects. The following specific instructions for the budget and narrative of these two parts supersede those in PHS 398: Presentation of Overall SCORE Program I. Budget: The budget of SCORE grant application must be presented in two parts: 1) estimated expenses for administering the institutional overall program (administrative budget with justifications) and 2) the combined projected costs of all investigator-initiated research projects as well as the administrative costs (total overall budget with justifications). Use PHS 398 FORM Pages 4 (detailed budget for initial budget period) and 5 (budget for entire proposed project period) for each one of the above required budget parts. In addition to the two sets of budget sheets discussed above, each of the investigator-initiated research projects has its own set of budget pages (Form Pages 4 and 5 along with budget justification pages). Place these budget pages at the beginning of each of the investigator- initiated research project application. II. Overall SCORE Program Plan The Overall SCORE Program Plan should include the following sections: A. SCORE Program Goals and Specific Objectives; B. Current Status of the Institutional Research Environment; C. Rationale for the Selection of SCORE Program Participants; D. Core Facilities/Renovations (if applicable); E. SCORE Program Plan; F. Program Administration; G. Program Evaluation; H. Literature Cited for the Overall SCORE Plan; I. Consortium/Contractual Arrangements with MBRS-eligible Institutions; J. Letters of Support. Do not exceed 25 pages for the SCORE program plan narrative (this page limit does not include figures, charts, or tables, but all of these should be referenced in the narrative). A. SCORE Program Goals and Specific Objectives: In this section, provide a concise description of the goals and measurable objectives of the overall SCORE program to be accomplished in the four-year period. For example, a goal might be to increase the number of minority faculty members participating in SCORE funded projects from X% to Y%. Another goal might be to increase the research competitiveness of X number of faculty so that in Y years they will be able to obtain individual extramural research support. A specific measurable objective might be an increase in the number of peer- reviewed publications from a four-year baseline of X to 2X by the time the competing renewal is submitted. Another specific measurable objective might be an increase in the number extramural grant applications submitted and funded during a grant award period. The selected goals may also be related to improvements in research infrastructure of minority-serving institutions that in turn increase competitiveness and productivity of scientists. Additionally, the applicant must provide an explanation of how the proposed goals and objectives would help achieve the SCORE program objectives of increasing the number of underrepresented minority scientists professionally engaged in basic biomedical and behavioral research and improving the institutional research capability. B. Current Status of the Institutional Research Environment: In this section, provide a description of the current capability of the participating departments to conduct biomedical research and clearly identify the investigators whose research competitiveness will be developed (from stage X to Y) and how this and other proposed improvements will impact the institution's research capabilities. Baseline data for the past four years characterizing key aspects of the research enterprise and its productivity, such as the number of total faculty and minority faculty engaged in research, number of grants and amount of extramural funding for research, number of research support staff, shared research facilities, and number of peer-reviewed publications, are required. In addition to the above, each applicant must provide in tabular form a summary of the institution's profile that provides the following information for the past four years (see suggested sample format tables 1 to 6 at http://www.nigms.nih.gov/funding/score_sample_tables.html; use only the tables applicable to your institution: o the total student enrollment at the institution and the number and percent of underrepresented minorities (e.g., Native American, African American, Hispanic American, natives of the U.S. Pacific Islands) in the total student population; o number and percent of underrepresented minority students (undergraduate and graduate) enrolled in the participating departments; o number and percent of total underrepresented minority students (undergraduates and graduate) graduating from the participating departments; o number and percent of total and underrepresented minority faculty in the participating departments and the total number of faculty and of underrepresented minority faculty from these departments participating in funded research; o number of alumni of participating departments who went on to obtain Ph.D. degrees in sciences in the past 20 years. (This information also can be obtained from WebCaspar, an NSF data base. See URL http://caspar.nsf.gov/cgi-bin/WebIC.exe?template=nsf/srs/webcasp/start.wi) C. Rationale for the Selection of SCORE Participants: In this section identify the faculty members who have been selected to participate in the SCORE-supported research projects, explain the rationale for their selection, and indicate how their participation will help achieve the MBRS objective of increasing the numbers of underrepresented minority researchers. In addition, address the level of research development of each PI and describe how participation in SCORE will increase the individual's productivity and improve his/her competitiveness for independent research funding. For each PI provide the estimated time line for anticipated SCORE participation and his/her transition to independent research support. Principal investigators who have had substantial extramural research support and a record of research productivity may submit a proposal for a research project but justification and a timeline for their participation as a PI must be given, and their role in increasing the number of minority scientists engaged in research must be described. Information helpful in establishing the level of development of PIs being considered for inclusion in the SCORE program can be found at http://www.nigms.nih.gov/news/reports/mbrs_focusreport.html#exec. D. Core Facilities/Renovations (if applicable): In this section explain the need for the proposed core or multi-user research facilities, core equipment, and/or renovations. Give the names of the PIs expected to benefit from the use of these facilities/equipment and a detailed plan on their coordinated use as well as the long-term plan for their maintenance/staffing. Please note that estimated costs of each item, including quotations for the equipment over $25,000 or remodeling, must be submitted with the application. E. SCORE Program Plan: Explain the plan for managing the SCORE program, insuring that PIs have the required administrative/clerical support and access to core facilities/specialized equipment (if applicable) or other research resources, and monitoring research progress and faculty productivity and research competence. Also provide the details and timeline for any proposed institutional activities such as scientific seminars or workshops. Give names of potential speakers and explain if any of these speakers will assist the program in any other way. Provide details of who will attend and benefit from these activities. F. Program Administration: Describe the level of involvement of the Program Director in administering the overall program in relation to the time and effort requested. Explain how the PD's involvement is relevant to the goals of the program. Describe, in addition, how the PD will relate to the institutional administrative structure needed for the appropriate functioning of the program. The PD must have knowledge of NIH policies, including those governing the use of human subjects, animals, and hazardous materials. An external advisory committee may be appointed and budgeted to assist the PD in monitoring the quality of research. G. Evaluation Plan: Evaluation of progress is a required component of every SCORE program to demonstrate overall improvement of the PIs' productivity and competitiveness and of the institutional research capability. The evaluation plan must describe the procedures and methods that will be used to collect and analyze the data needed to assess the extent to which the proposed SCORE and MBRS objectives have been achieved. In presenting the evaluation plan, restate each of the specific objectives and provide appropriate baseline data and proposed improvement relative to baseline data. Discuss anticipated intermediate and final outcomes. Provide information on the qualifications of the person(s) conducting the evaluation, the kind of data to be collected, and the data collection schedule. Note: In addition to the summary on human subjects and animals provided in the overall SCORE plan, each PI using vertebrate animals and/or human subjects in his/her research must include in his/her project plan detailed responses to the specific questions asked in PHS 398 instruction pages 18-29. H. Literature Cited: Cite any literature or supporting material referred to in the Overall SCORE Program plan (see PHS 398). I. Consortium/Contractual Arrangements with MBRS SCORE-eligible institutions. Follow instructions in PHS 398. J. Letters of Support: These include letters from collaborators, evaluators, etc. III. Investigator-initiated Research Projects A Research Project proposal, comparable to a regular NIH research project grant (R01) application, identifies a specific unsolved problem and means to obtain data pertinent to the problem. Pilot Research Projects aim to collect preliminary data necessary to develop a research project. Ordinarily, a PI may apply for only one pilot project, not a succession of pilot research projects. An exception to this is if the proposed pilot project results do not support the original research hypothesis. Investigator-initiated research project and pilot research project plans may be in any of the areas of science currently supported by the NIH. SCORE PDs are strongly encouraged to visit the NIH website, http://www.nih.gov, to search the NIH archives for all past and currently funded NIH grants and research areas. In the preparation of Research Projects and Pilot Research Projects, follow the PHS 398 instructions and use Form Pages provided with the following two exceptions: 1) Do not use the PHS 398 Face Page for these applications; instead use the investigator-initiated research project Cover Page (Sample Format 7 at http://www.nigms.nih.gov/funding/score_sample_tables.html) 2) Do not include a checklist page. The 25-page limit set for a research project plan in PHS 398 also applies to each regular research project. Pilot research project plans, however, are restricted to 10 pages each and should contain the same parts required of a regular project. In addition, a pilot research project must contain a section at the end of the narrative that explains how the results of the pilot will be used to develop a long-term research project plan. Note that each of the Research Project and Pilot Research Project plans has its own budget and requires PHS 398 Form Pages 2 to 5 and biographical and resource pages. If animal and human subjects are to be used in the research carefully follow PHS 398 instructions regarding the questions that need to be answered and the submission of the required Targeted/Planned Enrollment Tables and Inclusion Enrollment Report Tables (for additional information refer to http://grants.nih.gov/grants/funding/phs398/instructions2/p2_human _subjects_definitions.htm). IV. Arrangement and Numbering of SCORE Grant Application Pages: Order to follow: o PHS 398 Form Pages 1 to 5, which includes the budget and budget justification pages for the overall followed by biographical sketch(es) (Format Pages) of all key personnel for the overall SCORE program plan and the Resources Format page. O Overall SCORE Program Plan (sections A-M) o Research Project proposals and Pilot Research Project proposals. (Arrange all research project plans in alphabetical order of PI last names followed by pilot research project plans also arranged alphabetically by PI last name.) o Checklist o Appendix (material relevant to the overall SCORE program plan as well as to the Research Project and Pilot Research Project plans [see PHS 398 pp. 29-30] and progress reports of PIs who are not applying for competing renewal of projects). Number the PHS 398 Form Pages and the pages of overall SCORE Program plan and Research Project and Pilot Research Project plans sequentially at bottom center. Competing Renewal Applications (Type 2): In addition to all the information required for Type 1 (new) applications, the Overall SCORE Program section of Type 2 applications (competing continuation applications) must include a report on progress made in reference to the goals and objectives described in the previous application in a separate section titled Overall Progress Report. This overall progress report must be placed immediately after the section on the Current Status of the Institutional Research Environment and it is not counted in the overall 25 page limit. The overall progress report should include: 1) A list of the funded projects (with the PIs names) indicating which are being submitted as competing renewals and which are not being continued and why. 2) A description of the progress made towards the goals and objectives set for individual PIs as well as for the overall program and of how the evaluation results contributed to assessing anticipated outcomes and improving the program. 3) The contribution of the SCORE program to achieving the MBRS objective of increasing the number of underrepresented minorities engaged in biomedical or behavioral research. 4) The impact of the research accomplishments of individual PIs on the institutional research capability. 5) A concise summary (not more than 100 words) of the progress made in each previously funded research project or pilot research project even if the PI is not requesting competing renewal of the project. (Note that a detailed progress report of each previously funded research or pilot project must be included in the individual project renewal application, see below.) If a previously funded PI is not seeking SCORE support, or is proposing to change his/her field of research, include a detailed progress report on this project (limited to four pages per project). Place it in the appendix. 6) A list of all peer-reviewed and other publications by the previously-funded PIs. The Investigator-initiated Projects of Type 2 applications must include a detailed progress report (refer to PHS 398) and a list of the peer- reviewed publications resulting from SCORE support. Information on the level of funding (dollars per year) during the previous grant period and on the number of technical personnel (technicians, postdoctoral research associates, and other research associates) who participated in the project (whether or not paid from SCORE funds) must be included in the progress report. Progress on the project during the previous funded period is an important review criterion. The progress report section must be placed immediately after the section on background and significance as described in PHS 398. Competing renewal applications without an overall or individual PIs' progress reports will be returned without review. The budget reporting, arrangement and numbering of the pages of Type 2 applications are identical to that of the Type 1 applications. Supplemental Applications (Type 3): Supplemental applications to active SCORE grants to request funding for additional investigator-initiated research projects or pilot research projects may be submitted only if a two-year award can be made without extending the funding period of the parent grant. Thus, supplemental applications may be submitted only in the first 12-15 months of a four- year SCORE grant, depending on the actual award date. Such a supplemental grant application (Type 3) must include an Introduction (one page) elaborating the need for the supplement and a list of the currently funded projects. The Introduction is placed before the section on program goals and specific objectives. The supplemental applications do not require the information requested in Type 1 and Type 2 applications in the sections on the Current Status of the Institutional Research Environment, Administrative and Evaluation Plans. The Overall SCORE Plan section of the Type 3 application is limited to five pages. For the supplemental SCORE application, use and follow the instructions of PHS 398 except for the arrangement of the pages and pagination which should follow the same order as in Type 1 applications. These applications will be reviewed and will compete with new and competing renewal applications for available funding. Note that the administrative budget pages are not required unless additional administrative costs are requested. Revised SCORE applications: If Type 1, 2, or 3 applications did not receive funding, a revised application may be submitted. The revised application must include an Introduction that addresses fully the questions raised by the reviewers of the previous application. In addition, the body of the application must indicate, by changes in font or other means, the revised sections (See PHS 398 instructions). The structure of budget requests, application content and format, and arrangement and numbering of pages are as described for the Type 1, 2, or 3 applications. ALLOWABLE COSTS The costs budgeted for MBRS grants may not duplicate items already included as Facilities and Administrative (F&A) costs. The grantee institution must be prepared to provide documentation showing the direct relationship of proposed costs to the program and that costs of this type are charged in a consistent manner to all other grants and other activities at the institution regardless of the source of support. o Overall SCORE Program: Salaries: Salary support for the Program Director is allowable for that portion of time or effort required for administering the SCORE program and must be justified explicitly and in detail. The level of support typically ranges from zero to 25% and depends, in part, on the responsibilities of the PD as related to the size of the program. Limited salary support for secretarial or clerical help in direct support and according to the size of the SCORE program is also allowable and must be justified in detail. Evaluation costs are allowable and must be justified. If the evaluator is an employee of the applicant institution, the costs of his/her services must be listed under salaries. If the evaluator is not an employee of the applicant institution the charges must be budgeted under consultants. Costs of consultants who serve on an external advisory committee must be budgeted under consultants and fully justified. Multi-user Research Core Facilities: Costs for acquisition of shared equipment and its maintenance beyond the warranty period are allowable, if justified. Plans to maintain the core facility beyond the grant period should be addressed. Personnel costs to maintain and service the equipment are also allowable and must be explicitly justified in detail. Alterations and Renovation Costs: Costs for upgrading research space (up to $40,000) are allowable only when essential to conducting the proposed research and when fully justified. Scientific Seminars and Workshops: Costs to support on-campus scientific seminars and workshops that directly benefit PIs' research are allowable if justified. However, support for PI participation in off-campus workshops, meetings and specific collaborations with specialists in the field can be supported only through individual research project budgets (see below). o Research Projects: There are no preset budget limits. Costs essential to the conduct of research projects, such as technical assistance, consultants, equipment, travel, and supplies are allowable and must be adequately justified. Faculty salaries, typically based on a full-time, nine- month contract, are reimbursed according to percent time and effort dedicated to the proposed research. Summer salary support based on time and effort on the funded SCORE research project is allowable if permitted by institutional policy. The maximum summer-salary support provided by the program may not exceed the equivalent of three months at 100% effort or another length of time specified by the institution as its policy, whichever is shorter. In support of each request for a summer salary, provide evidence of the institutional policy and written assurance that the PI will forego vacation during the supported period. A statement explaining and justifying the summer salary must be provided by the PI in the budget justification. Cost of consultants, including foreign scientists, who are active researchers in the subject area of the PI, is allowable if fully justified. Foreign travel to a major scientific meeting is allowed only if the PI's participation represents a direct benefit to the project. Costs of consortium arrangements with other SCORE-eligible institutions are allowable and may include personnel costs, supplies, etc. (For more information refer to PHS 398.) Fee-for-service contract costs for research support services, such as testing of biological materials, provided by SCORE-ineligible institutions, will be considered on a case-by-case basis and must be strongly justified. For Pilot Research Projects, applicants may request support for up to a maximum of $50,000 (direct costs) per year for a maximum of four years. Purchase of essential equipment for the conduct of the research is allowable within the budgetary limit. UNALLOWABLE COSTS Unallowable costs include costs for student development (e.g., student salary, stipend or tuition), textbooks, journals, memberships, and Internet subscription costs. Employees from the applicant institution may not serve as paid consultants. Support for foreign institutions or foreign components/consortia in research projects or foreign consultants for evaluation is not allowable. Foreign travel for technical personnel is not allowable. Collaborators at a SCORE-ineligible institution are expected to have their own research funds, i.e., SCORE grant funds may not be utilized to provide salary support for technical personnel (or to purchase equipment) at a SCORE-ineligible institution. Consortium arrangements with SCORE-ineligible institutions are not allowable. PEER REVIEW PROCESS Applications submitted for this PA will be assigned to and reviewed by NIGMS on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIGMS in accordance with review criteria stated below. In evaluating the application, both the merit of the SCORE Overall Program plan and that of the Investigator-initiated Research Projects, which are assessed as independent efforts, will be considered. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score; o Receive a written critique; o Receive a second level review by the NIGMS National Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss 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. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. A. Review of the SCORE Overall Program Plan In reviewing the overall program, the initial review group will take into account: SIGNIFICANCE: Would the program goals, specific measurable objectives, and anticipated milestones, if achieved, significantly improve the research capabilities of the institution? Would the institutional goals and objectives, if achieved, contribute to MBRS mission of increasing the number of underrepresented minority scientists engaged in biomedical or behavioral research? APPROACH: Is the proposed institution's overall plan to accomplish the proposed goals and objectives, including the rationale for the selection of PIs and upgrading of core or shared research facilities, reasonable and feasible? Are the rationale for the selection of the research and pilot research project PIs and the PIs' developmental plans likely to result in their increased productivity and competitiveness? Are the proposed research projects meritorious and will they contribute to the overall success of the program? Are the plans to evaluate the effectiveness of the proposed program and measure the outcomes clearly described and are they adequate? INNOVATION: Does the proposed overall program plan take into consideration the existing knowledge or strategies for improving the competitiveness of faculty for research funding and to increase the number of underrepresented minority scientists and does it include any novel strategies? INVESTIGATOR: Does the SCORE PD possess the skills, knowledge, and abilities needed to lead the program, achieve the goals and objectives of the program, and perform the specified PD functions? Are the administrative structure and the advisory committee (if applicable) appropriate to implement the proposed program? ENVIRONMENT: Does the institution have the necessary research infrastructure? Are the research facilities adequate for the proposed research projects? Is the quality of individual research projects included in the application indicative of a supportive research environment? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: BUDGET: The reasonableness of the proposed administrative budget and the requested period of support in relation to the proposed SCORE program. MULTI-USER CORE FACILITIES/RENOVATION (if applicable): Is the justification for a multi-user core research facility or equipment and/or laboratory renovation plans appropriate and adequate? Is there a reasonable plan for shared use and maintenance of the facility and for providing technical support? Are the plans to maintain the core facility beyond the current grant period realistic? OVERALL PROGRESS REPORT (for Competing Continuation (Type 2) applications only): Is overall progress reasonable and commensurate with the previous level of research support? Is there evidence that the institutional research capabilities have improved as a result of SCORE support? Does the overall progress indicate that the PIs' research competitiveness has improved? B. Review of Investigator-initiated Research Projects 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? For Pilot Research Projects, would the planned investigations yield data that could form the basis for a regular Research Project application or a grant application for other extramural funding? APPROACH: Are the conceptual framework, design, methods, and data analyses adequately developed, well-integrated, and appropriate to the aims and timeline of the project? Does the applicant acknowledge potential problem areas and consider alternative strategies? Is the literature review critical and current, and does it identify gaps in the knowledge that will be addressed in the proposed research? 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? INVESTIGATOR: Is the investigator appropriately trained and well-suited to carry out this work? Is the proposed work appropriate to the experience level of the principal investigator and other researchers (if any)? Will the proposed scientific project allow the investigator to continue improving his/her research competence/productivity? 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? If resources such as specific technical expertise and/or equipment are not currently available at the applicant institution, are there plans to acquire, or gain access to, the necessary resources to conduct the research? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROGRESS REPORT (for competing renewal (Type 2) applications only): Has the investigator been productive in documenting his/her research findings in refereed journals? Has the investigator's productivity been commensurate with the level of previous MBRS and/or other research support? Did the research competence of the PI improve as a result of the supported work? 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 criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both sexes, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under section 'F' of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to this PA will compete for available funds with all other recommended applications from eligible institutions. The following will be considered in making funding decisions: o Availability of funds; o Scientific merit as determined by expert review; o Likelihood that the goals and objectives, if achieved, would increase the number of underrepresented minority research scientists engaged in biomedical and behavioral research and thus promote MBRS goals and objectives; o Portfolio balance; o Research development needs of the institution and the percent of underrepresented minority students; o Number of years/cycles of prior MBRS support for the PIs submitting competing renewals; o The institution's capability, from a scientific and technical standpoint, to develop a competitive research environment by engaging in biomedical research; o Other research support available to the applicant, PIs, and/or the applicant institution. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm . DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. See also Senate Appropriations Committee Report, No. 92-316, July 29, 1971, Executive Order 12900, Educational Excellence for Hispanic Americans February 22, 1994, Executive Order 12876, Historically Black Colleges and Universities, November 1, 1993, and Executive Order 13021, October 21, 1996 and Outline of Work Plan, August 18, 1998, White House Initiative on Tribal Colleges and Universities. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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