LARGE-SCALE COLLABORATIVE PROJECT AWARDS RELEASE DATE: March 21, 2002 RFA: GM-02-007 National Institute of General Medical Sciences (NIGMS) (www.nigms.nih.gov) APPLICATION RECEIPT DATE: Phase I Applications, June 18, 2002 Phase II Applications, January 15, 2003 THIS APPLICATION CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements for Cooperative Agreements o Where to Send Inquiries o Submission Procedures for Phase I Applications o Peer Review Process for Phase I Applications o Review Criteria for Phase I Applications o Award Criteria for Phase I Applications o Submission Procedures for Phase II Applications o Peer Review Process for Phase II Applications o Review Criteria for Phase II Applications o Award Criteria for Phase II Applications o Required Federal Citations PURPOSE OF THIS RFA The purpose of this RFA is to re-announce the National Institute of General Medical Sciences (NIGMS) program of "Large-Scale Collaborative Project Awards," (commonly called Large Glue Grants) last issued as GM-01-004 in February 2001. This new announcement includes updates and modifications, and should be used in lieu of any previous announcements. The goal of this program is to enable the solution of major problems in biomedical research and to facilitate the next evolutionary stage of integrative biomedical science. The intention is to make resources available for independently funded scientists to form research teams to solve a complex biological problem that is of central importance to biomedical science and to the mission of the NIGMS, and that would be beyond the means of any one research group. It is expected that the participating investigators will already hold externally peer-reviewed and funded research grants in the area of the proposal. In general, support of new individual research projects will not be a part of these large-scale project awards. A high level of resources may be requested to allow participating investigators to extend their research efforts to form a consortium to approach a research problem of overarching importance in a comprehensive and highly integrated fashion. Grants for this initiative will be awarded in two phases. Phase I applicants will submit an overview of the proposed large-scale project for peer review. The purpose of the Phase I award is to provide resources for assembling a more fully developed proposal to applicants who have demonstrated the selection of an appropriate complex biological problem, an innovative approach to its solution, and appropriate commitments from participating investigators and institutions. Successful Phase I applicants will receive a $25,000 (direct costs) planning grant. Those applicants, and only those applicants, who receive awards will be eligible to submit a more extensively planned and detailed application for a Phase II award to support the large- scale project itself. This RFA is one of a pair of initiatives to increase support opportunities for collaborative ventures. A companion program, "Integrative and Collaborative Approaches to Research," (http://grants.nih.gov/grants/guide/pa-files/PA-00-099.html and http://grants.nih.gov/grants/guide/notice-files/NOT-GM-01-001.html), commonly called Small Glue Grants, is intended to support collaborative activities that are smaller in scale and scope than those requested in response to this RFA. Small Glue Grants are for applications requesting up to $300,000 in direct costs per year. Large Glue Grants are for applications requesting from $300,000 up to $5,000,000 in direct costs per year. The NIGMS also advises that collaborations can be supported by most of the institute"s existing support mechanisms and strongly encourages potential applicants to talk with program directors in NIGMS to determine the most appropriate support mechanism for their collaborative work. RESEARCH OBJECTIVES Background: NIGMS" external advisors, who met in May and November 1998, urged the Institute to support new mechanisms for collaboration on complex systems in biomedical science. The first Large-Scale Collaborative Award announcement appeared in May 1999 and has been reissued in each subsequent year. One award was made in FY 2000 and three awards were made in FY 2001 (http://www.nigms.nih.gov/funding/gluegrants.html). For most of the last 30 years the main approach used in biomedical science has been to focus attention on understanding the individual steps in biological processes at the subcellular and molecular level. Although much still needs to be done in defining and analyzing molecular events, it appears that enough of the pieces have been characterized to begin to put them together to solve problems of the global control and integration of biological processes. These efforts will require the cooperation of many groups of scientists and many types of science. The mainstay for support of biomedical science has been the traditional research project grant, the NIH R01 grant. While this grant mechanism remains the backbone of NIH support for biomedical science, it may not be sufficient in and of itself to support the solution of complex problems of the type described above. Many scientists are now expressing a strong need for a type of support that will encourage scientific collaboration and provide for a higher level of coordination to solve problems requiring multifaceted approaches. These scientists are able to secure research support for their own efforts, but they also seek a means to encourage and facilitate the development of an interactive research network around a complex biological problem. The purpose of this RFA is to address the need to coalesce and coordinate efforts on a larger central problem in biomedical science and to make collaborations and resources available to a group of independently funded investigators. Biomedical science has entered a new era where these collaborations have become critical to rapid progress. This is the result of several factors. First, not every laboratory has the breadth to pursue problems which increasingly must be solved through the application of a multitude of approaches. These include the involvement of fields, such as physics, engineering, mathematics, and computer science, that were previously considered peripheral to mainstream biomedical science. Second, the ability to attack large projects that involve considerable data collection and technology development requires the collaboration of many groups and laboratories. Finally, large-scale, expensive technologies such as combinatorial chemistry, DNA microarrays, high throughput mass spectrometric analysis, etc., are not readily available to all laboratories that could benefit from their use. These technologies require specialized expertise but could lend themselves to management by specialists who collaborate or offer services to others. Research Objectives: The primary research objectives are to solve complex biological problems of great significance through large-scale collaborative projects that integrate broad and diverse areas of science by bringing together independently funded investigators who share a connection to a central problem and to facilitate the development of integrative biomedical science. The intention is to provide the framework and incentives to foster the development of integrative research teams and to provide considerable flexibility for participants to request and employ the specific resources necessary to accomplish the job. Part of the challenge of each large-scale collaborative project will be to devise the organizational structure that best facilitates accomplishment of the specific scientific goals of that collaborative project. The main outcome expected is the solution of a complex, multifaceted research problem of overarching significance, where such a solution could not be achieved in a reasonable time frame by separate efforts. An additional expected outcome is that collaboration and integration in the biomedical sciences will be enhanced. The research scope for this RFA includes all areas of science that are of direct relevance to the National Institute of General Medical Sciences (http://www.nigms.nih.gov/about_nigms/overview.html). Participation by investigators doing mechanistic clinical science, as well as by investigators doing basic laboratory science, is welcomed. It is also recognized that data collection and technology development may be logical and necessary parts for some or all large-scale collaborative projects. Whether projects are sufficiently important to be funded as large-scale collaborative project awards will be determined by peer review and relevance to current areas of interest to the Institute. For examples of successful applications and results of previous competitions, visit the NIGMS glue grant website at http://www.nigms.nih.gov/funding/gluegrants.html. It will not be sufficient to organize a research network simply to promote access of individual investigators to research resources. There must be intense and meaningful interaction proposed around a central biological problem among the participating scientists, so that progress achieved would be substantially greater than the sum of the participants" individual achievements. Each large-scale collaborative project could require considerable new resources, such as for a centralized core facility, but would also require a synthesis of information from participating laboratories in order to solve the biological problem being addressed. The Phase I application should provide an overview of the proposed collaborative project, including the goals for the project, the reasons for using this mechanism, and the approach to the expected elements of a Phase II application. The Phase II application should provide a more detailed explanation of the proposed project, including specific intermediate goals (milestones) and a timeline for their accomplishment. Elements and Organization of a Large-Scale Collaborative Project PRINCIPAL INVESTIGATOR: Each collaborative project will be headed by a principal investigator (PI) who will chair and be assisted in governing the project by a steering committee. Although a substantial level of effort is expected for the PI, minimum levels of effort have not been set for the PI, however, the appropriateness of the level of effort of the PI will be a factor in the assessment of scientific merit and in the Institute"s funding selections. STEERING COMMITTEE: The steering committee is responsible for governance of the large-scale collaborative project. The members should be chosen from participating investigators and project staff, and the membership should be representative of the scope of the proposed collaborative project. The level of effort and commitment to the collaborative project of the members of the steering committee will also factor into the assessment of scientific merit as well as the Institute"s funding decision. It is expected that the PI, the steering committee, and the participating investigators will work together to develop reasonable and sound goals and operating procedures for the collaborative project. An NIGMS program director will serve as a voting member of the steering committee and attend its meetings. The steering committee will meet annually with the Advisory Committee, as described below. PARTICIPATING INVESTIGATORS: In addition to the PI and members of the steering committee, each collaborative project will include a team of investigators who will contribute to and benefit from participation in the project. The members of the collaborative project will be referred to collectively as participating investigators. It is expected that each of the participating investigators will hold an externally peer-reviewed and funded research grant in the area of the project. It is expected that the majority will be funded through research grants supported by NIGMS, other NIH institutes and centers, and other governmental and private agencies. Exceptions to the rule of external funding may include participating investigators from industry, foreign institutions, or allied fields not traditionally supported by the NIH (e.g., physics and mathematics). However, they must provide evidence of their commitment to the project and a listing of organizational resources that will be committed to the project. Principal investigators of pilot projects (see below under COLLABORATIVE PROJECT RESOURCES) will also be considered participating investigators. Participating investigators will work with the other members of the team to develop workable guidelines for the collaborative project. Participating investigators must agree to abide by the policies and rules set up for the collaborative project and to the terms and conditions herein to be eligible to participate. During the period of the award, a participating investigator, whose independent research support terminates, may continue as a participating investigator at the discretion of the steering committee and with the approval of the NIGMS program director. However, funds from this award are not to be used to support the independent project of such an investigator. It is expected that new participating investigators will be added to the collaborative project over the period of the award as deemed appropriate by the PI and steering committee and with the approval of the NIGMS program director, these additions will be reported in the annual progress report. ADVISORY COMMITTEE: Each large-scale collaborative project will include an external advisory committee, of at least three members, whose purpose is to meet annually with the PI and the steering committee to assess progress and provide feedback on proposed goals for the next year of support. The members will be appointed by the PI in consultation with the steering committee, and with the approval of the NIGMS program director, after the Phase II award has been made, and will be drawn from research scientists not involved in the project. The members of the advisory committee should not be selected until an award has been made and the names of prospective members should not be included in the application. The NIGMS program director, responsible for the award, will attend the advisory committee meeting as a member of the steering committee but will not actually be a member of the advisory committee. The advisory committee will meet at least once a year immediately prior to the submission of the annual progress report. COLLABORATIVE PROJECT ORGANIZATION AND RESOURCES: The organizational structure of the collaborative project may have a variety of forms depending on the needs of the research problem being addressed. For example, the large-scale collaborative project could consist entirely of a research and administrative structure, including an information dissemination and data coordinating core. Alternatively, the large-scale collaborative project may involve additional activities and may request the following types of resources, either as distinct entities or in integrated combinations. Support to Individual Laboratories Investigators are expected to bring their own support for their individual laboratories to the collaborative project. The large-scale collaborative project award mechanism is not meant to support R01-type projects. It is recognized, however, that in some cases, there may be a need for special efforts in the individual laboratories of the participating investigators to enhance the efforts of the consortium or to integrate the individual work of a participating investigator with the consortium. Two mechanisms have been designated for this purpose: Bridging projects may be used to support work in the laboratories of the individual participating investigators when that work is intended to provide either a bridging function to more fully integrate the individual work with the collaborative project or a service function to develop data or resources or technology to benefit the overall glue project. For example, support to allow a participating investigator to employ a standardized model system so that his/her results can be compared with results from other project members is appropriate. Another example is exchanging personnel among laboratories of different investigators to transfer technology between glue grant laboratories or for other purposes that would help in coordinating and integrating programmatic goals. Another might be to develop an assay to be used by consortium members. These bridging projects to the laboratories of individual participating investigators should add to or bridge the intellectual and technological approaches of the collaborative project. They are not meant to be stand-alone research efforts but are to be subprojects that tie, or enhance the contribution of, the independent work and expertise of the participating investigator to the large-scale collaborative project. A bridging project should extend the participating investigator"s independent work in a new direction(s). A bridging project to do more of what the investigator is already doing should be considered only if there are extraordinary circumstances that make it essential for the effective functioning of the large-scale project. If the participating investigator"s work is already closely tied to the large-scale project, a bridging project should not be needed. Stand-alone new research projects should not be submitted for bridging projects. If a bridging project could be submitted as a regular R01 application, it should not be requested as a bridging project, even if it adds value to the large-scale project. Judgment will be required on the part of applicants and reviewers alike to distinguish between projects that are appropriate for support by consortium resources and those that should be submitted and reviewed as regular research grants (R01s). Pilot projects may be requested in this application for investigators without current independent support in the area of the collaborative project in order to add elements where gaps exist, or to add investigators with critical knowledge or expertise but who do not have a research background in the area of the collaborative project. These pilot projects must not exceed $75,000 in annual direct costs and must be limited to no more than three pilot projects per year per large-scale collaborative project. The pilot project should be of sufficient scope to qualify as a stand-alone research effort. It is primarily intended to allow the collaborative project to add investigators outside the scientific mainstream of the project area in a mode that will allow them to develop independent research in the area of the collaborative project. Applicants must explain why the principal investigator"s expertise is needed for the large-scale project and how the pilot project will contribute directly to accomplishing the aims of the large-scale project. While funding for a pilot project may run for five years, at the discretion of the steering committee, it is expected that the PI of a pilot project will seek R01 funding during the period of the collaborative project, based on the results obtained from the pilot project. Cores Core resources may be requested to speed progress on the scientific goals of the project or add additional capability to the collaborative project by adding new or improved technology or by standardizing data among different research teams. An example of new technology might be gene chip microarray technology, an example of standardizing results might be establishment of a model organism core. It is expected that each large-scale collaborative project will request core resources for information collection, coordination, and dissemination. A bioinformatics core to include assemblage and organization of data for querying, developing tools for its querying, computation, and modeling may be requested as a separate core or be combined with the information dissemination core. Other types of resources might be for instrumentation, genomics, proteomics, or high-throughput assay cores. Requests for core resources must be strongly justified in terms of value to achieve the goals of the project, value to increase the synergy of the collaborative project, and cost effectiveness. ADMINISTRATIVE MANAGEMENT PLAN: Each large-scale collaborative project award must include an administrative management plan that describes the organization of the project and outlines the policies and procedures whereby participating and non-participating investigators can have access to the collaborative project resources. The application should address the flow of information within the project and plans as to how the information will be integrated into the solution of the biological problem being addressed. The application should address the mechanism that will be followed to add new participating investigators and delete members whose association with the project has not been productive. The plan should also include proposed methods for information dissemination both within the collaborative project and to the scientific community. Furthermore, each large-scale collaborative project should discuss the mechanism whereby concerns of the scientific community directly affected by the project will be considered and responded to. A discussion of scientific community views will be part of the agenda for annual meetings of the steering committee with the advisory committee. PROJECT MANAGEMENT PLAN: Each large-scale collaborative project application must include a project management plan, including an ongoing evaluation plan, to ensure consistent forward progress of the project. Each collaborative project will define, at a minimum, yearly milestones, and those receiving awards will have the opportunity to modify these milestones at the time of their awards, with the concurrence of NIGMS. It is expected that the milestones will be adjusted annually at the award anniversary dates, both to incorporate a team"s scientific accomplishments and progress in the field in general and to reflect the recommendations of the advisory committee. The NIGMS program director responsible for the large-scale collaborative project may include outside consultants in the annual progress review and may recommend reducing or withholding funds, or termination of the award, for failure to meet milestones. A report by the NIGMS program director of the collaborative project"s progress and any recommendations to modify funding will be made annually to the National Advisory General Medical Sciences Council. PLAN FOR HANDLING INTELLECTUAL PROPERTY AND SHARING OF RESEARCH RESOURCES: The nature of large-scale collaborative projects is to move entire fields forward. NIGMS intends that, to the extent possible, all investigators within a field have equal access to research resources generated by these collaborative projects. To address this interest in assuring that research resources are accessible, NIH requires applicants who respond to this RFA to (1) submit a plan for sharing the research resources generated through the award, and (2) address how they will exercise intellectual property rights, should any be generated through this award, while making such research resources available to the broader scientific community. It is expected that resources to be shared will include, among others, data and information, materials such as cell lines and mutant animals, and novel reagents and techniques. The sharing of research resources plan and intellectual property plan must make unique research resources readily available for research purposes to qualified individuals within the scientific community in accordance with the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/) and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html and http://ott.od.nih.gov/NewPages/64FR72090.pdf). These documents also define terms, parties, responsibilities, prescribe the order of disposition of rights, prescribe a chronology of reporting requirements, and delineate the basis for and extent of government actions to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page, http://www.iedison.gov. As noted below (see Peer Review Process and Review Criteria), the scientific review group will comment, as appropriate, on the adequacy and feasibility of the sharing of research resources plan and the intellectual property plan. The review group will describe the adequacy of the plans in an administrative note and the evaluation of the plans per se will not affect the priority score. However, because dissemination is a critical aspect and fundamental purpose of this RFA, evidence of the commitment of the large-scale project leadership to the sharing or research resources and to effective management of intellectual property issues will be part of the scientific merit review. The adequacy of the proposed sharing plans will be an important factor in the institute"s decision to make an award. Furthermore, the proposed sharing plans, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual progress reports and of subsequent renewal applications will include an assessment of the effectiveness of the sharing of research resources. DISCLOSURES: It is suggested that the members of the large-scale collaborative project disclose to the steering committee their ties to profit-making organizations to aid the project in avoiding conflict-of- interest situations. Applicants are also reminded that the grantee institution is required to disclose each subject invention to the Federal Agency providing research funds within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters. MECHANISMS OF SUPPORT Phase I Applications For Phase I applications, this RFA will use the National Institutes of Health (NIH) R24 grant mechanism. A Phase I award will be made at a level of $25,000 in direct costs to provide for costs associated with planning the large-scale collaborative project. Appropriate expenses for a planning award include, but are not limited to, salary for release time for the PI to commit a significant percentage of effort to planning the Phase II application, meetings of the steering committee and participating investigators, and consultant costs for initial design and cost estimates for proposed core resources. The anticipated award date for Phase I awards is September, 2002. The length of the Phase I awards may be for up to one year and do not count against the time limit for Phase II awards. Phase II Applications Only applicants who receive a Phase I award will be eligible to submit a Phase II application, which will be a new (Type 1) award. For Phase II applications, this RFA will use the NIH Specialized Center (Cooperative Agreements) mechanism, U54. The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date for Phase II awards is September 2003. Phase II awards will be considered for one five-year renewal period following the initial award. The NIH U54 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with the NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Special Requirements for Cooperative Agreements, Terms and Conditions of Award." This RFA is a one-time solicitation. In addition to new applications, both revised Phase I applications and revised Phase II applications from the previous two announcements (RFA GM-01-004 and Notice GM-00-001) will be accepted. However, NIGMS will accept for consideration only one revision of a previously submitted, unfunded Phase I or Phase II application. Twice- amended applications will not be accepted. If the solicitation is re- announced within a two-year period of this announcement, revised Phase I and Phase II applications from this announcement will again be accepted. FUNDS AVAILABLE NIGMS intends to commit approximately $10-15 million in total costs in FY2003 to fund Phase II awards. NIGMS anticipates making up to ten Phase I awards from FY2002 funds, Phase I awards will be for $25,000 in direct costs. Because the nature and scope of the proposed research will vary, it is anticipated that the size of the Phase II awards also will vary, and the upper limit for a Phase II award from NIGMS funds will be $5 million in annual direct costs in any given year. Applications of different scales and scope are encouraged. Applications requesting direct costs between $300,000 and $5,000,000 per year will be considered responsive to this announcement. Although the financial plans of NIGMS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. NIGMS anticipates re-announcing the solicitation for the next fiscal year, depending on the availability of funds. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o Non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government For-profit and foreign institutions are not eligible to submit an application as the lead institution. However, a collaborative project may include participating investigators from foreign and/or for-profit organizations. Multi-institutional applications are encouraged. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Applications must fall directly into the areas of research supported by the National Institute of General Medical Sciences. Applicants may visit the Institute website at http://www.nigms.nih.gov for information on NIGMS areas of interest. Applicants may also wish to visit the NIGMS website created for this RFA and the PA (referred to in the Purpose of this RFA section) at http://www.nigms.nih.gov/funding/gluegrants.html. Applicants are strongly advised to contact the NIGMS staff listed below to discuss NIGMS areas of interest and the eligibility of a proposed project. The major research activity of the PI must be in the research area of the collaborative project application, and the PI is expected to make an appropriate level of commitment of effort to directing and managing the operation of the project, a substantial level of effort will be necessary to manage projects of largest magnitude. While NIGMS expects that the applications will be multi-institutional with more than one participating investigator, minimum and maximum numbers of participating investigators or institutions have not been set. Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are encouraged to apply for NIH programs. SPECIAL REQUIREMENTS FOR COOPERATIVE AGREEMENTS TERMS AND CONDITIONS OF AWARD: The following section is repetitive of previous sections but represents Terms and Conditions that will be incorporated into the award statement and will be provided to the PI, as well as to the appropriate institutional official, at the time of award. The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies: The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients" activities by involvement in and otherwise working jointly with the award recipients in a partnership role, it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole. Principal Investigator Responsibilities: The PI is the scientist who assembles the large-scale collaborative project and is responsible for submitting the application in response to this RFA and for performance of the project. The PI will coordinate project activities scientifically and administratively at the awardee institution. The PI will have the overall responsibility for the scientific and technical direction and the administration and overall operation of the large-scale collaborative project. To assist the PI with the governing of the project, a steering committee will be established from among the participating investigators and project staff. The PI will chair the steering committee. The membership will be representative of the scope of the project. As for all participating investigators, the PI must abide by the operating rules and guidelines developed by the steering committee. The PI will agree to accept participation of NIGMS staff in those aspects of management of the project described under "NIGMS Program Director Responsibilities." He/she will also ensure the timely dissemination of information generated by the large-scale collaborative project to both the project members and the scientific public. Participating Investigator Responsibilities: The participating investigators are those scientists holding externally peer reviewed grant support in the area of the project and who are involved with and committed to the goals of the project. Exceptions to the rule of external funding may include participating investigators from industry, foreign institutions or allied fields not traditionally supported by the NIH (e.g., physics and mathematics), PIs of pilot projects are also included. Participating investigators will work with the PI, the steering committee, and the other members of the large-scale collaborative project to set goals and develop working procedures, they must agree to support the goals of the project and to abide by the operating guidelines and procedures established for the project. Participating investigators will be actively involved in the project and interactive with the other members of the project. NIGMS Program Director Responsibilities: The NIGMS program director will serve as a voting member of the steering committee and will attend all meetings. In addition to having all of the duties and responsibilities of a steering committee member, the NIGMS program director will facilitate interactions among the steering committee and the advisory committee and NIGMS and provide advice and guidance to assure that the large-scale-collaborative project adheres to the NIH and NIGMS rules and regulations. The NIGMS program director will facilitate communication with the scientific community directly affected by the collaborative project and will assure that the steering committee and the advisory committee address issues and concerns raised by the community. Additional responsibilities may be negotiated at the time of award depending on the individual characteristics of the awards to be made. Steering Committee Responsibilities: A steering committee will serve as the governing board of each large-scale collaborative project and will participate in setting direction, policies, and operating procedures. Membership will include the PI, as well as other scientists and administrators drawn from the staff and participating investigators of the project, sufficient in breadth and balance to be representative of the overall project. The NIGMS program director will serve as a member of the steering committee. The original members will be selected by the PI from among the participating investigators and staff to be representative of the scope of the project. Additional or replacement members will be selected by the steering committee. The steering committee will work with the PI to establish the scientific and technical direction of the project, develop common guidelines and procedures, establish rules for access to resources of the project, and for dealing with intellectual property issues, and participate in the process of developing a cohesive group. The steering committee will develop a policy regarding disclosure of ties between scientists and for-profit organizations to aid the project in avoiding conflict-of-interest situations. The steering committee will monitor bridging projects, core resources, and pilot projects for progress and efficiency and recommend modification of support and addition/deletion of these activities as needed to facilitate progress on the goals of the large- scale collaborative project. Advisory Committee Responsibilities: The advisory committee will be composed of a panel of a minimum of three scientists not otherwise associated with the large-scale collaborative project. The NIGMS program director will attend the meetings of the advisory committee as a member of the steering committee. The advisory committee will meet at least yearly to provide advice to the steering committee of the large-scale collaborative project about meeting its goals and to comment on plans for future directions. The advisory committee will raise issues for consideration by the PI and the steering committee and will comment on the appropriateness of the level of NIGMS support to achieve the goals of the project. The advisory committee will also comment on the impact of the collaborative project on the relevant scientific communities. Milestones and Evaluations: It is expected that milestones will be adjusted annually at the award anniversary dates, both to incorporate a group"s scientific accomplishments and progress in the field in general, as well as to reflect the recommendations of the advisory committee. In accordance with the procedure described above, the NIGMS program director may recommend to the Director, NIGMS, augmenting any subproject or core facility or reducing or withholding funds for any subproject or core facility that substantially fails to meet its milestones or to remain state of the art. The Director, NIGMS, retains the right to call a meeting of advisors, most likely members of the National Advisory General Medical Sciences Council or their designee(s), at any time to provide advice on the scientific progress of a large-scale collaborative project. It is anticipated that such a group of advisors may want to attend a meeting of the project advisory committee as part of its fact-finding mission. Handling Intellectual Property and Sharing of Research Resources: Awardees will retain custody of and have primary rights to the research resources developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. Awardees should comply with their institutional intellectual property policies and practices as described in the application and approved in this award. Consistent with the objectives of this award, awardees will be expected to share (make available) these research resources openly with the scientific community. Arbitration Process: Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIGMS may be brought to arbitration. An arbitration panel will be convened. It will be composed of three members: a designee of the steering committee without NIH staff voting, one NIGMS designee, and a third designee with expertise in the relevant area who is chosen by the other two, in the case of an individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee"s right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Michael E. Rogers Division of Pharmacology, Physiology and Biological Chemistry National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3827 FAX: (301) 480-2802 Email: rogersm@nigms.nih.gov Dr. James C. Cassatt Division of Cell Biology and Biophysics National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-0828 FAX: (301) 480-2004 Email: cassattj@nigms.nih.gov Dr. Judith H. Greenberg Division of Genetics and Developmental Biology National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-0943 FAX: (301) 480-2228 Email: greenbej@nigms.nih.gov Direct your questions about peer review issues to: Dr. Helen R. Sunshine Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-2881 FAX: (301) 480-8506 Email: sunshinh@nigms.nih.gov Direct inquiries regarding fiscal matters to: Mr. Joseph Ellis Chief, Grants Management Office National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5510 FAX: (301) 480-1969 Email: ellisj@nigms.nih.gov SUBMISSION PROCEDURES FOR A PHASE I APPLICATION Phase I awards are intended to support planning activities in order to structure and organize the large-scale collaborative project for submission as a Phase II application. In general, the Phase I application will be used to gauge the merit of the basic idea and the conceptual framework for the collaborative project, specific review criteria are discussed below. Prospective applicants must submit, by June 18, 2002, a Phase I application that contains an overview of the proposed large-scale collaborative project. Phase I applications will be evaluated by an appropriately constituted peer review group. Phase I applicants will be advised by September 2002 whether their applications will be funded. Only Phase I awardees may submit Phase II applications for scientific merit review. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: A Phase I response to this RFA should follow the PHS 398 instructions, with the following modifications, and the parts should be assembled in the order prescribed by the PHS 398: Application face page. Complete all items. This is page one, number succeeding pages consecutively. For listing of personnel on page two, it is important that 1) all participants, including consultants and private sector alliances, 2) all the institutional affiliations for each participant, and 3) their roles on the project, be included. Include a description of the proposed budget allocation (one page, in lieu of the PHS 398 budget section). All Phase I awards will be for up to $25,000 for a six-month period of support. Biographical sketches and letters of commitment from each of the participating investigators who indicate their interest in joining the collaborative project should be included. Biographical sketches should include a listing of other support that includes only the grants of each participating investigator that are in the area of the large-scale collaborative project. The statement of institutional and other resources available to the consortium should be limited to three pages. The Research Plan should be replaced with the following: A statement (two-page limit) by the PI describing his/her commitment to the large-scale collaborative project and identifying the members and the commitment of the steering committee. This section should also include a statement of commitment to developing a plan for handling intellectual property and the sharing of research resources. A project summary (ten page limit) describing the scientific goals and operation of the large-scale collaborative project. Explain what complex biological problem will be solved. Describe in adequate detail and explain the scientific approach to this problem. Explain why a large-scale collaborative project is critical to its solution. Describe the range of scientific expertise to be brought to bear on the problem. It is important to make clear the significance of the biological problem chosen and what the value-added benefit will be from pursuing the problem with a collaborative project rather than individual grants. Approaches envisioned to the key elements of a large-scale collaborative project should be described. The roles that bridging projects, pilot projects, and/or core resources will play in the collaborative project should be described. The project summary will serve as the research plan for the Phase I application. A references section is permissible, but appendices will not be allowed as part of a Phase I application since a detailed plan is not requested at this stage. Letters signed by the authorized business official of each of the participating investigators" institutions committing support to the collaborative project should be included. Arrangements for the participation of investigators from industry and foreign sites and resources they may bring to the collaborative project should be documented. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 copies of the Phase I application and all five sets of any appendix material must be sent to: Helen R. Sunshine, Ph.D. Office of Scientific Review National Institute of General Medical Sciences Building 45, Room Number 1As.13 Bethesda, MD 20892 Applications for Phase I must be received by June 18, 2002. If an application is received after the due date, it will be returned to the applicant without review. The CSR will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. RECEIPT AND REVIEW SCHEDULE: Phase I Application Receipt Date: June 18, 2002 Phase I Peer Review Date: August 2002 Phase I Award Date: September 2002 Phase II Application Receipt Date: January 15, 2003 Phase II Peer Review Date: March/April 2003 Advisory Council Date: May 2003 Earliest Anticipated Phase II Award Date: September 2003 PEER REVIEW PROCESS FOR PHASE I APPLICATIONS Upon receipt, Phase I applications will be reviewed for completeness by the Center for Scientific Review (CSR) and responsiveness by the NIGMS. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Phase I applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the NIGMS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique, and may: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score. REVIEW CRITERIA FOR PHASE I APPLICATIONS 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. (1) SIGNIFICANCE: Does this project address a complex biological problem of overarching significance to biomedical science that would be difficult to address by separate grants? If the aims of the application are achieved, will the field of biomedical science be advanced? (2) APPROACH: Is the conceptual framework appropriate to achieve the scientific aims of the large-scale collaborative project? (3) INNOVATION: Are the project"s structure and goals novel? Are the aims original and innovative? Will the project attack a problem in a significantly new way? What will be the value added over individual grants? (4) INVESTIGATORS: Is the PI"s major research activity within the research area of the collaborative project? Is the PI well suited to the scientific and administrative leadership required to carry out this work? Are the research grants of the participating investigators within the area of the project? Are the participating investigators well chosen for their roles in the project? Do the commitments of the PI, steering committee members, and participating investigators appear reasonable for the scope of the planned activities? (5) ENVIRONMENT: Do the scientific environments in which the work will be done contribute to the probability of success? Is the level of institutional support adequate? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, Phase I applications will be reviewed with respect to the following: o commitment to the project by the PI, the members of the steering committee, and the participating investigators. o commitment to the sharing of research resources with the broader scientific community. o commitment of the host university to supporting the consortium, reflected, for example, in the willingness to work out potential intellectual property issues prior to submission of the Phase II application and to remove any institutional barriers to the establishment and healthy maintenance of the large-scale collaborative project. AWARD CRITERIA FOR PHASE I APPLICATIONS Award criteria that will be used to make funding decisions include: o scientific merit (as determined by peer review) o adequacy of plans for handling of intellectual property and sharing of research resources o program priorities o program balance o availability of funds SUBMISSION PROCEDURES FOR A PHASE II APPLICATION Phase I awardees may submit a Phase II application by January 15, 2003 for peer review. The Phase II application should include detailed plans for the large-scale collaborative project. In addition to an assessment of the merit of the basic idea and the conceptual framework, an assessment of the specific plans will be conducted. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Phase II response to this RFA should consist of an application that, in addition to or in lieu of part of the items requested in the PHS 398, includes: Application face page. Complete all items. This is page 1, number succeeding pages consecutively. Abstract of Research Plan. On page 2, describe briefly the proposed large- scale-collaborative research project. List all key personnel involved in the collaborative project, use a continuation page if needed. Table of Contents. Prepare a detailed Table of Contents that includes all elements of the application. Use numeric pagination only. The major areas to be listed in the Table of Contents appear here in capital letters. Units should be presented in the order in which they appear in the application. Under Research Plan, identify each component core with a capital letter (A, B, C), as well as title, and provide the name of the core director. BUDGET ESTIMATES: Specific examples of allowable costs that may be requested include: Salaries for the PI, members of the steering committee, participating investigators, and technical and support personnel commensurate with their level of effort in the large-scale collaborative project. Bridging projects to the laboratories of participating investigators. Pilot projects to investigators without current independent research support in the area. These subprojects must not exceed $75,000 in annual direct costs and must be limited to no more than three such projects per application. Travel of personnel, which may include technicians, predoctoral students, postdoctoral fellows, and investigators, to different laboratories to gain specialized expertise. Travel to and conduct of regular meetings of the steering committee and regular meetings of the participating investigators. Core facilities (examples: instrumentation, genomics, proteomics, model organism, or high-throughput assay cores). Electronic media cores to allow participation of off-site laboratories and/or the means necessary to establish collaboratory capabilities and to disseminate information. Travel to and conduct of regular meetings of an advisory committee. In addition to the overall budget, include a separate budget for each bridging project and pilot project and each core resource. Phase II applications for large-scale collaborative project awards may not request more than $5 million in annual direct costs (exclusive of subcontract indirect costs requested as a direct cost by the applicant organization, but including all equipment) for any year of the award. Salaries for support personnel required for coordination and maintenance of the project, such as secretaries, may also be included as necessary in an administrative core. Composite budget. Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of Form PHS 398 to present the total budget for all requested support for the first year. For each category such as "Personnel," Equipment," etc., give the amount requested for each core unit and each component project, with subtotals. For consortium arrangements involving other institutions or organizations, include total (direct and facilities and administration) costs associated with such third-party participation in the "Consortium/Contractual Costs" category. Costs for purchased services should be itemized under "Other Expenses." Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of Form PHS 398 to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual component subprojects (bridging projects and pilot projects) and core unit budgets. Individual component core and research budgets. For the first-year budgets of each of the cores and projects, use Form Page 4 of the PHS 398. Use Form Page 5 of the PHS 398 to report the budgets of each of the projects and cores for total project period (years 01-05). Budget justifications and explanations. Describe the specific functions of all key personnel, including consultants, collaborators, and technical staff. Provide justifications for requested equipment. For years 02-05 of the application, justify any significant increases or decreases in any category over the first-year budget. BIOGRAPHICAL SKETCHES AND LETTERS OF COMMITMENT: Biographical sketches must be included from all participating investigators along with one page letters of commitment indicating their willingness to follow guidelines and procedures established for the large-scale collaborative project. For all participating investigators, including the PI, and heads of core resources, provide a listing of all other support, support for other investigators such as postdoctoral students should not be listed. Include the relevant grant support that allows participating investigators to be part of the large-scale collaborative project. Provide the specific aims of the project and describe in sufficient detail for evaluation of the relationship of the funded grant to the goals of the proposed large-scale project. RESEARCH ENVIRONMENT: Complete the "Resources" page of PHS 398 for the overall large-scale collaborative project, including both the host institution and any participating institutions. Briefly describe the features of the institutional environment(s) that are relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. ANIMAL AND HUMAN SUBJECT ASSURANCES: Because of the relatively short turnaround time for review of Phase II applications, IACUC assurances must be completed (and not pending) at the time of submission of the Phase II application. However, IRB approval is no longer required prior to review, but only prior to funding (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-00-031.html). PARTICIPANT AFFILIATIONS: Applications should include a separate cover sheet that lists 1) all participants, including consultants and private sector alliances, 3) all the institutional affiliations for each participant, 3) their roles on the project, and 4) the percent effort for each role. This added requirement will facilitate the review of applications. Research Plan Instructions for organization of the large-scale project research plan: The NIGMS wishes to provide applicants with the flexibility to organize large-scale collaborative projects in the manner which best facilitates progress on the project being pursued. Therefore, applicants may organize and present their large-scale collaborative project applications using the straightforward format that follows, or alternate formats for some parts of the application. Required components of all applications are the program summary, including administrative and program management plans, a plan for data sharing and intellectual property, and Cores A (administrative) and B (information dissemination and data coordinating). If desired, Core B may be may be combined with an optional bioinformatics core (the page limit for the combined unit will be 20 pages). The remainder of the Research Plan may be organized as deemed appropriate, keeping in mind that the major purpose of a large-scale collaborative project award is to provide resources to enable collaboration rather than primary research support. For example, the scientific cores and bridging projects may be presented in a combined or more integrated fashion. When this, or a different alternate format is used, applicants should explain, in the program summary, why a different organizational structure is proposed. Any combined unit may not exceed the sum of the page limits that would have been allowed for the individual pieces of the unit. For example, if two bridging projects were submitted as a combined unit, the page limit for the combined unit would be twice that for one bridging project. In all cases, the Research Plan, including the required components, may not exceed 160 pages. The Research Plan includes the program summary, the administrative management plan, the project management plan, the plan for handling intellectual property and sharing of research resources, the administrative and information dissemination cores, as well as any optional cores, bridging projects, and pilot projects. PROGRAM SUMMARY: Describe the goals and operation of the large-scale project. Explain what complex biological problem will be solved and how the approach of using a large-scale collaborative agreement is critical to its solution. Discuss the range of scientific expertise to be used to address the research problem. Explain the interactions that will occur between investigators at the host site and at the participating sites. Explain how each element of the large-scale collaborative project will contribute to successful attainment of its goals. Explain the programmatic value of the core resources, bridging projects, and pilot projects. Explain how the information coming from the collaborative project and the laboratories of the participating investigators will be integrated into comprehensive whole. Discuss how information generated by the collaborative project will be disseminated to the scientific public. ADMINISTRATIVE MANAGEMENT PLAN: Describe the structure, organization, and operation of the project. Describe the organizational framework and provide an organizational chart. Also describe how information will flow within the collaborative project. Discuss arrangements between the collaborating institutions that are important to effective operation of the large-scale collaborative project. Detail the usage of the core resources by the participating investigators. Include any outreach efforts to provide access to the core resources to investigators outside the collaborative project. Explain how decisions will be made to add/delete participating investigators and to respond to changes in short term goals necessitated by research findings. Discuss how the views of the scientific community that are impacted by the collaborative project will be considered. PROJECT MANAGEMENT PLAN: Define, at a minimum, yearly milestones. Present a project management plan, including milestones, to keep the collaborative project moving forward and on track. Explain how progress in the bridging projects and pilot projects and efficiency of the core resources will be tracked. Include an evaluation plan to determine how the collaborative project is progressing. Discuss the plan for evolving milestones. Explain how the advisory committee will be used in updating the project management plan. PAGE LIMITS: The program summary, administrative management plan and the project management plan sections when combined have an aggregate page limit of 30 pages. Page limits for other sections are given within each section and a summary follows at the end. Investigators should endeavor to be clear and concise. PLAN FOR HANDLING INTELLECTUAL PROPERTY AND SHARING OF RESEARCH RESOURCES (three-page limit): The PI and steering committee should (1) propose a plan for providing access to the research resources generated by the large-scale collaborative project to the members of the project and the scientific public, research resources include, among others, data and information, materials such as cell lines and mutant animals, and novel reagents and techniques, (2) address if or how intellectual property rights will be exercised, (3) discuss guidelines for licensing of joint inventions, (4) discuss procedures for settling of intellectual property disputes, (5) discuss the existence of any pre-existing intellectual property rights, including options to for-profit research sponsors, and (6) propose a plan for disseminating the research resources developed under this RFA. Core Resource Descriptions CORE RESOURCE A. ADMINISTRATIVE CORE (five-page limit): This core must be directed by the PI. Include the objectives of the core, a description of its staffing, and services to be provided to other core resources and to the participating investigators. Communicating the objectives of the collaborative project and fostering opportunities for collaboration are encouraged. Expenses associated with the operation of the steering committee, meetings of all or subgroups of the participating investigators, and meetings and operation of the advisory committee would fall under the administrative core. CORE RESOURCE B. INFORMATION DISSEMINATION AND DATA COORDINATING CORE (five- page limit): Dissemination of information on techniques, scientific findings, and methodologies is a vital component of each large-scale collaborative project. Computer technology, print media, and telecommunications are relevant. Describe the staffing (including a Core Director, as well as any professional or technical personnel and their duties), facilities, and resources that will be devoted to this goal. Indicate plans to make results of research or other unique features of the collaborative project available to as wide an audience as possible. Describe how data generated by the core resources and the participating investigators will be processed into the information to be disseminated. Discuss plans for dissemination of published and unpublished data. CORE RESOURCE C. BIOINFORMATICS CORE (OPTIONAL AND MAY BE COMBINED WITH CORE B.) (15 page limit): A bioinformatics core to include assembly and organization of data for querying, developing tools for its querying, computation, and modeling may be requested as a separate core or be combined with the information dissemination core (combining the page limits). The core description must include answers to the following bioinformatics queries, whether a separate core or combined with the information dissemination and data coordinating core. The answers to the questions should both facilitate the planning for bioinformatics needs as well as provide important information for the peer review of the application. o What are the data release policies and what are the associated intellectual property issues? o How will the data be available to the scientific community? Will there be browser access, formats for downloading complete data sets, on-line computational aids, etc.? o What is the nature and structure of the data? Present the plans to date for ontologies, schema, or other data models. o What is the underlying structure of the database, e.g., relational, object- oriented, etc.? o What is the mechanism for communication (both computational and human) between the distributed sites and the database managers? Will there be data liaisons? o What are the key interacting databases? How will the data be linked? o How will progress be available to the public, e.g., will lists of the systems being analyzed be available? o What experience in bioinformatics is available in the group, and what resources can the consortium draw on? CORE D. SCIENTIFIC RESOURCE CORE (S) (ten-page limit per core): Provide specific titles for any proposed scientific resource cores (e.g., instrumentation, genomics, proteomics, model organism, or high-throughput assay), along with a designated Core Director who possesses expertise in the area of each core. Describe the professional and technical staff to be involved in the core(s) and their duties. Include plans to utilize the core(s), including services that will be provided and to whom and their bearing on productivity and quality of the collaborative research effort. Projects BRIDGING PROJECTS (five-page limit for each bridging project for the research plan, i.e., specific aims, background and significance, preliminary studies, and research design and methods): Bridging projects will support work in the laboratories of the participating investigators. Describe the new research proposed in the bridging project and explain how this work more fully integrates the participating investigator"s independently-supported work into the large-scale collaborative project or provides a necessary service function or technology to the collaborative project. For all proposed projects, the underlying rationale and potential impact of the studies should be specifically addressed. Projects must be described in sufficient detail to permit evaluation through the competitive peer-review process. For each bridging project undertaken as part of the collaborative project, include a combined summary of the specific aims, background and significance, preliminary results, and research design and methods. Also include, as applicable, the following sections, which do not count against the page limitations: Abstract (one paragraph), Human Subjects Research (also see special requirements in the Federal citations below), Vertebrate Animals, and Literature Cited. PILOT PROJECTS (ten page limit for each pilot project for the research plan, i.e., specific aims, background and significance, preliminary studies, and research design and methods, maximum of three pilot projects per large-scale collaborative project): Pilot projects will support the work of investigators not already supported in the area of the collaborative project who have unique skills or expertise to add to the collaborative project effort. For all proposed projects, the underlying rationale and potential impact of the studies should be specifically addressed. How the pilot project will add new elements essential to achieving the goals of the collaborative project must be described. Projects must be described in sufficient detail to permit evaluation through the competitive peer-review process. For each pilot project undertaken as part of the collaborative project, include the following sections: Abstract (one paragraph), Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods. As applicable, include sections on Human Subjects Research (also see special requirements in the Federal citations below), Vertebrate Animals, and Literature Cited. SUMMARY OF PAGE LIMITS: o Combined length of the project summary, administrative management plan, and the project management plan – 30 pages o Plan for handling intellectual property and sharing research resources – 3 pages o Administrative core – 5 pages o Information dissemination and data coordinating core – 5 pages o Bioinformatics core (optional) – 15 pages o Scientific cores (optional) – 10 pages each o Bridging projects (optional) – 5 pages each o Pilot projects (optional) – 10 pages each o Combined units (optional) – pages equal to combined total for individual elements o Overall limit for the Research Plan – 160 pages INSTITUTIONAL COMMITMENTS: Letters, signed by authorized business officials of each of the participating investigators" institutions committing support to the large-scale collaborative project, must be included. Applicants for Phase II applications that include consortium arrangements should refer to the NIH Grants Policy Statement appendix on consortium arrangements at http://grants.nih.gov/archive/grants/policy/nihgps/part_iii_5.htm#Consortium. APPENDICES: Appendices are allowed for the Phase II applications, but they should follow the rules for appendices in the PHS 398 instructions. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 copies of the Phase II application and all five sets of any appendix material must be sent to: Helen R. Sunshine, Ph.D. Office of Scientific Review National Institute of General Medical Sciences Building 45, Room Number 1As.13 Bethesda, MD 20892 Applications for Phase II applications must be received by January 15, 2003. If an application is received after the due date, it will be returned to the applicant without review. The CSR will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. RECEIPT AND REVIEW SCHEDULE: Phase I Application Receipt Date: June 18, 2002 Phase I Peer Review Date: August 2002 Phase I Award Date: September 2002 Phase II Application Receipt Date: January 15, 2003 Phase II Peer Review Date: March/April 2003 Advisory Council Date: May 2003 Earliest Anticipated Phase II Award Date: September 2003 PEER REVIEW PROCESS FOR PHASE II APPLICATIONS Upon receipt, Phase II applications will be reviewed for completeness by the Center for Scientific Review (CSR) and responsiveness by the NIGMS. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Phase II applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the NIGMS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique, o Receive a second level review by the National Advisory General Medical Sciences Council, and may: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score. REVIEW CRITERIA FOR PHASE II APPLICATIONS Review Criteria for the Overall Large-Scale Collaborative Project 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your 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. (1) SIGNIFICANCE: Does this large-scale collaborative project address a complex biological problem of overarching significance to biomedical science that would be difficult to address by separate grants? If the aims of the application are achieved, will the field of biomedical science be advanced? Will these studies affect, in a meaningful and important way, the concepts or methods that drive this field? Is there a commitment to maximize the impact of the collaborative project through the sharing of research resources generated by the large-scale project? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the scientific aims of the collaborative project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the project management plan adequate? Is the administrative framework appropriate? Do milestones articulate key indicators set for appropriate times that will demonstrate significant forward progress for the collaborative project? Are the plans to monitor and evaluate progress of the collaborative project adequate? Will the research resources generated by the large-scale project be shared with the larger community? Will the group take the views of the scientific community impacted by the large-scale collaborative project into consideration? (3) INNOVATION: Are the large-scale collaborative project"s structure and goals novel? Are the aims original and innovative? Will the collaborative project challenge existing paradigms or develop new methodologies or technologies? Will the collaborative project attack a problem in a significantly new way? Will there be value added over individual grants? (4) INVESTIGATORS: Is the PI"s major research activity within the research area of the collaborative project? Is the PI well suited to the scientific and administrative leadership required to carry out this work? Is the level of effort proposed for the PI and the members of the steering committee appropriate? Is the work proposed appropriate to the experience level of the collaborative project"s research and technical staff? Are the research grants of the participating investigators within the area of the collaborative project? Are the participating investigators well chosen for their roles in the collaborative project? Is the plan to add and delete participating investigators to and from the collaborative project satisfactory? (5) ENVIRONMENT: Do the scientific environments in which the work will be done contribute to the probability of success? Are support personnel and resources in place to advance the work? Will the proposed collaborative project take advantage of unique features of the scientific environments of the component projects? Is the level of institutional support adequate? Are the requested core facilities critical to achieving the scientific goals of the collaborative project and are they cost effective? Is access to the core facilities appropriate? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. The adequacy of the data and safety monitoring plans (required for clinical trials). o INCLUSION: 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. In addition, the following criteria will be considered: o Commitment to the project by the PI and the members of the steering committee. o Commitment of the host and participating universities to supporting the large-scale collaborative project, e.g., this would be reflected in efforts to work out ahead of time potential intellectual property issues and to remove any institutional barriers to the establishment and healthy maintenance of the collaborative project. o Commitment of the leadership to the sharing of research resources generated by the large-scale project with the broader scientific community. In an administrative note, the reviewers will comment on the adequacy of the proposed plans to deal with intellectual property issues for the collaborative project and the adequacy of the plans to share research resources (including data and information, materials such as cell lines and mutant animals, and novel reagents and techniques). Review Criteria for Core Resources Consideration of the technical merit of the core units will include: (1) Facilities within the core compared to the state of the art. The contributions of the cores to fulfilling the goals of collaborative project. (2) The extent to which core units promote greater collaboration and cohesiveness among the participating investigators. (3) Qualifications, experience, and commitment to the large-scale collaborative project mission of the investigators responsible for the core resources and their abilities to devote the required time and effort to the program. (4) Appropriateness of the budgetary requests. Review Criteria for Bridging Projects and Pilot Projects 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your 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. (1) SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? Will these studies be effective in the achieving the goals of the collaborative project? Will the bridging project tie or enhance the independent work of the participating investigator to the collaborative project, or will the pilot project add an essential missing aspect to the collaborative project? (2) APPROACH: Are the conceptual framework, design, 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? Is the proposed work appropriate for support by the large-scale collaborative project or would it be more appropriate for support by a regular research grant? (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) INVESTIGATORS: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PI and other researchers (if any)? (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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA FOR PHASE II APPLICATIONS Award criteria that will be used to make funding decisions include: o scientific merit (as determined by peer review) o adequacy of plans for handling of intellectual property and sharing of research resources o program priorities o program balance o availability of funds REQUIRED FEDERAL CITATIONS 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 AMENDMENT "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.ht m. 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://grants.nih.gov/grants/stem_cells.htm 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 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. 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 RFA 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 No. 93.821, 93.859, and 93.862 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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