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LARGE-SCALE COLLABORATIVE PROJECT AWARDS RELEASE DATE: July 20, 2004 PA NUMBER: PAR-04-128 (Reissued as PAR-07-412) EXPIRATION DATE: June 22, 2007, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.859 Application Receipt Dates: Phase I – September 20, 2004-2006 Phase II – June 21, 2005-2007 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting a Phase I Application o Supplementary Instructions 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 Submitting a Phase II Application o Supplementary Instructions for Phase II Applications o Peer Review Process for Phase II Applications o Review Criteria for Overall Phase II Project o Review Criteria for the Core Resources o Review Criteria for the Bridging Projects and the Pilot Projects o Additional Review Considerations for the Overall Project and All Components o Award Criteria for Phase II Applications o Required Federal Citations PURPOSE OF THIS PA The purpose of this PA is to re-announce the National Institute of General Medical Sciences’ (NIGMS) program of large-scale collaborative project awards (also known as glue grants), last issued as RFA GM-02-007 in February 2001. Large-scale collaborative project awards are intended to solve critically important, complex biological problems within the mission of the NIGMS by supporting a team of independently funded investigators to synergize and integrate their efforts. This new announcement includes important updates and modifications, and should be used in lieu of any previous announcements. This new announcement is being issued as a program announcement (PA). PAs are typically open for three years and are then considered for re- announcement. Using a PA with one annual deadline in each of three consecutive years allows potential principal investigators to take the time needed to develop their ideas and a core network of investigators before applying. It should be noted, however, that NIGMS anticipates making no more than one new Phase II (see below) award per year, depending on availability of funds. Another change with this announcement is that Phase I applications, as well as Phase II applications, will be reviewed by the National Advisory General Medical Sciences Council. The Institute wishes to involve community representatives at an earlier stage in providing advice on whether to allocate its resources to support a glue grant approach for a particular biomedical problem. Applicants are also strongly advised to begin consulting with NIGMS staff regarding their plans, even in advance of submitting an application. Also new is an added requirement that applicants include a diversity plan to increase the number of participating investigators who are currently underrepresented in the biomedical, clinical, behavioral, and social sciences. The maximum amount that a large-scale collaborative project award applicant may request is $25 million in direct costs over a five-year period. This high level of resources is intended 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. In the past, applications for this program have generally requested the maximum amount allowed. One goal of this announcement is to encourage submission of applications for lesser amounts as well. In all cases, the scope of a large- scale project should be limited to the scale necessary to achieve the desired synergistic effect. The NIGMS 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. For example, investigators can apply for up to $300,000 in annual direct costs to support collaborative and integrative research using the NIGMS collaborative project grant mechanism, http://www.nigms.nih.gov/funding/cpg.html. A good way to initiate collaborative interest might be to apply for an NIGMS multidisciplinary conference grant, http://grants.nih.gov/grants/guide/notice-files/NOT-GM-04-106.html. RESEARCH OBJECTIVES The goal of this program remains to enable the solution of complex biological problems that are critical to advancing biomedical science and fall within the NIGMS mission (http://www.nigms.nih.gov/about/overview.html). Solution of the scientific problem selected must be beyond the means of any single research group. The solution will likely involve technology development, but the primary focus must be the solution of a biological question. Experience has shown that large-scale collaborative project awards offer the scientific community a unique funding mechanism that serves the needs of interdisciplinary, team science: It allows independently funded investigators to self assemble into teams to provide coordination and integration of their work, to add state-of-the-art large-scale technologies, and to develop the infrastructure for high volume data collection, management, and analysis. The application of this large-scale mechanism will be reserved for the most pressing scientific problems which have reached the stage where they require this type of approach for advancement. The paramount considerations for large-scale collaborative project awards are the potential impact on biomedical science, the value added over individual grant approaches, and the likelihood of success in a ten-year time frame. 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 is imperative that the proposed consortium identify a critical problem in biomedical science that is now ready to be solved using a large-scale collaborative approach. The importance of the problem, the scope, and approaches taken to solve the problem must be very strongly justified. 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. 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 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 the resources for assembling a more fully developed proposal. Successful Phase I applicants will be awarded a $50,000 (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. The Phase II application should provide a significantly more detailed explanation of the proposed project, including specific intermediate goals (milestones) and a timeline for their accomplishment. MECHANISM(S) OF SUPPORT PHASE I APPLICATIONS: This PA will use the NIH R24 grant mechanism for Phase I applications. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. A Phase I award will be made at a level of $50,000 in direct costs to provide for costs associated with planning the large-scale collaborative project. This PA uses just-in-time concepts for Phase I applications. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. The anticipated award dates for Phase I awards are February, 2005, February 2006, and February 2007. The length of the Phase I awards may be for up to one year and does not count against the time limit for Phase II awards. PHASE II APPLICATIONS: This PA will use the NIH Specialized Centers (U54, Cooperative Agreements) awards mechanism for Phase II applications. The NIH U54 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award". 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. Phase II applications may request up to $25 million dollars in direct costs for a five-year period, with no one year exceeding seven million dollars in direct costs; this excludes Facilities and Administrative costs (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html. Applications asking for shorter time periods are limited to an average of $5 million in direct costs per year. Facilities and Administrative costs for consortium arrangements are not counted towards the maximum amounts. Experience has shown that lower amounts are needed in the first year than in subsequent years due to time needed to hire personnel and purchase and install equipment. Applicants should take this into account in planning their budgets. The total project period for an application submitted in response to this PA may not exceed five years. The anticipated award date for Phase II awards is April 2006, April 2007, and April 2008. Phase II awards will be considered for one and only one five-year renewal period following the initial award. This PA uses just-in-time concepts for Phase II awards. Follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. This PA will continue for three years. It may be re-announced at that time. All principal investigators (PIs) will be expected to budget for and attend and to send additional staff, as appropriate, to scheduled annual meetings of the NIGMS large-scale collaborative project awards. REVISED APPLICATIONS (for applications submitted in response to this PA): NIGMS will accept only one revision for a Phase I application. Phase II applications that are not funded must submit the Phase I application again prior to submitting a revised Phase II application; this requirement for resubmission of the Phase I application may be waived in exceptional circumstances on the advice of the National Advisory General Medical Sciences Council. Twice-amended applications will not be accepted for either Phase I or Phase II applications. ELIGIBLE INSTITUTIONS You may submit an application 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 o Foreign institutions are not eligible to apply 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 Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. 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 initiative (referred to in the Purpose of this PA 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 the 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. SPECIAL REQUIREMENTS Large-scale collaborative project awards must include a principal investigator, a steering committee, participating investigators, and an advisory committee. See below under terms and conditions of award for the roles and requirements for these elements. 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 an administrative structure, including an information dissemination and data coordinating core. Alternatively, the large-scale collaborative project may require additional components 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 and pilot projects, either as separate entities or combined into integrated structures. 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 may not exceed $100,000 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 goals and delineates the organization of the project to achieve the goals. It also must outline 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. In addition, timelines for ramping up to a fully operational level should be included. 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 PA 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. Computational tools that are developed for analysis, visualization, or modeling the data must be freely shared with the scientific community as well as the annotated source code; others should be free to modify the source code and share the modifications with each other; and that the code should be made available to be incorporated into commercial products. The scientific review group will comment on the adequacy and feasibility of the plans for sharing research resources and tools. Data sharing is required, and dissemination is a critical aspect and fundamental purpose of this PAR. Therefore, there should be evidence of a genuine commitment of the large-scale project leadership to the sharing or research resources. Reviewers will consider the data sharing plan, and will factor the plans into the determination of the scientific merit or the priority score, because this is critical to the purpose of this initiative. Evaluation of annual progress reports and of subsequent renewal applications will also include an assessment of the effectiveness of the sharing of research resources. The scientific review group will also comment on the adequacy and feasibility of the intellectual property plan. In a Phase I application, the intent is to judge the adequacy of the applicant institution's commitment to develop a workable intellectual property plan. In a Phase II application, the effectiveness of the management of intellectual property issues will be considered as part of the scientific merit review; accordingly, reviewers will factor the plan into the determination of the scientific merit and priority score. This will also be an important factor in the institute’s decision to make an award, and will become a term and condition of award. PLAN FOR DIVERSITY DEVELOPMENT: Each request for a large-scale collaborative project award must include a plan to increase the number of participating investigators who are underrepresented in the biomedical, clinical, behavioral, and social sciences. 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. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD: The following section 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 mechanism, the NIH’s 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 primary responsibility resides with the awardees for the project as a whole. 1. Principal Investigator Responsibilities: The PI will have prime responsibility and authority for the scientific and technical direction and the administration and overall operation of the large-scale collaborative project. The PI will select and chair the steering committee. 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. The PI will coordinate project activities scientifically and administratively. 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, and also subject to the approved sharing of research resources plan and intellectual property plan to 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). 2. 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. 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). Principal Investigators of pilot projects are also included as participating investigators. 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. They must provide a listing of organizational resources from their home institution that will be committed to the project. Participating investigators will be actively involved in the project and interactive with the other members of the project. 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 research 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. 3. NIGMS Program Director Responsibilities: The NIGMS program director will be responsible for the normal stewardship of the award. In addition, s/he will serve as a voting member of the steering committee, attending all meetings, and will have substantial programmatic involvement. 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 will 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. 4. Steering Committee Responsibilities: The steering committee will function to provide scientific and administrative advice to the PI and to assist the PI by providing oversight and strategic planning for the consortium as a whole and for the individual components. 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, deal 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. Membership will be from a select group from those investigators actively involved the functioning of the consortium. It 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. Members will be selected by the PI in consultation with the steering committee and with the approval of the NIGMS program director. 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. 5. Advisory Committee Responsibilities: The advisory committee will provide scientific and administrative advice to the PI, the steering committee, and the members of the consortium only. It will be composed of a panel of a minimum of three scientists not otherwise associated with the large-scale collaborative project. The members will be appointed by the PI in consultation with the steering committee, and with the approval of the NIGMS program director. The NIGMS program director will attend the meetings of the advisory committee 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 to provide advice to the PI and 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. 6. Milestones and Evaluations: Milestones upon which progress can be evaluated annually must be established for consortium goals. Progress should be assessed and milestones updated 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. 7. 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 by NIH. 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. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action 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 your inquiries concerning this PA 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 o 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 o Direct your questions about financial or grants management 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 SUBMITTING A PHASE I APPLICATION Applicants must submit a Phase I application that contains an overview of the proposed large-scale collaborative project. 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 listed below. Phase I applications will be evaluated by an appropriately constituted peer review group. 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). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 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. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS FOR PHASE I APPLICATIONS A Phase I response to this PA should follow the PHS 398 instructions, with the following modifications, and the parts should be assembled in the order prescribed by the PHS 398: For listing of personnel on page two, it is important that 1) all participants, including consultants and private sector alliances, 2) all the institutional and industrial affiliations for each participant, and 3) their roles on the project, be included. Include a description of the proposed budget allocation. All Phase I awards will be for up to $50,000 for up to a one-year period of support. Biographical sketches and one-page letters of commitment from each of the participating investigators who have already indicated their interest in joining the collaborative project should be included. Biographical sketches should include a listing of research 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. A suggested maximum page length is 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 and to developing a plan for increasing diversity of investigators working on the chosen scientific problem. 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. An Appendix will not be allowed as part of a Phase I application since a detailed plan is not requested at this stage. A Literature Cited section is permissible. 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. 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 must be sent to: Dr. Helen R. Sunshine Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Rm 2An.12F, MSC 6200 Bethesda, MD 20892-6200 APPLICATION PROCESSING: Applications for Phase I must be received by September 20, 2004-2006. 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 PA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. RECEIPT AND REVIEW SCHEDULE: Phase I Application Receipt Date: September 20, 2004-2006 Phase I Peer Review Date: November/December 2004-2006 Phase I Council Review Date: January 2005-2007 Phase I Award Date: February 2005-2007 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 PAR 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 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 o Receive a written critique o Receive a second level review by the National Advisory General Medical Sciences Council 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. However, the paramount considerations for large-scale collaborative project awards are the potential impact on biomedical science, the value added over individual grant approaches, and the likelihood of success in a ten-year time frame. SIGNIFICANCE: How significant is this research problem to the advancement of biomedical science? Has a compelling case been presented for pursuing the research problem at this time? Will there be significant value added over individual grants? APPROACH: For the project as a whole, are the conceptual framework, general approaches, and proposed analyses reasonable? Are all of the components necessary and sufficient to achieving the scientific aims? Is their planned integration appropriate? Is there a good balance between the application of current ideas and approaches, and the development of required new state-of- the-art ideas and tools? Are potential problems acknowledged and do alternatives exist? INNOVATION: Are the proposed aims original and innovative? Will the collaborative project challenge existing paradigms and/or develop new methodologies or technologies? Is the potential impact clearly innovative and exciting? ENVIRONMENT: Are the scientific environments where the work will be performed optimally selected to enhance the probability of success? Does necessary institutional support appear likely? Will open and free exchange of information be supported by this environment? Are the bioinformatics facilities well-positioned and supported in their planned locations? INVESTIGATORS: Principal Investigator and Steering Committee. Is there evidence that the PI and the central governing body have the vision, scientific expertise, administrative capacity and leadership skills to successfully lead the large- scale project? Is the level of commitment for the PI and consortium leaders adequate? Is the use of this collaborative team the best way to approach this problem? Is this group well-poised to solve this research problem within the next decade? Participating Investigators. Are the participating investigators already committed to the project among the best in their respective fields? Is the skill set for the participating investigators sufficient? Are there plans to apply expertise from diverse disciplines and fields to the scientific question, and if not, what specific expertise is lacking? Is the level of commitment for each investigator adequate? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, Phase I applications will be reviewed with respect to the following: o adequacy of commitment to the sharing of research resources with the broader scientific community. o adequacy of commitment to developing a diversity development plan to increase the number of participating investigators who are currently underrepresented in the biomedical, clinical, behavioral, and social sciences. o adequacy of 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 plans for sharing of research resources o plans for handling of intellectual property o uniqueness as a large-scale effort o program priorities o program balance o availability of funds SUBMITTING A PHASE II APPLICATION Phase I awardees may submit a Phase II application for peer review for the receipt date immediately following award of the Phase I application or the next subsequent receipt date. 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). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 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. SUPPLEMENTARY INSTRUCTIONS FOR PHASE II APPLICATIONS Applications in response to this PAR should consist of an application that, in addition to or in lieu of part of the items requested in the PHS 398, includes: 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 as 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 below 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. Although a substantial level of effort is expected for the PI, NIGMS has not set minimum levels of effort; 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. 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. 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 $100,000 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). 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. 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. Applications for large-scale collaborative project awards may not request more than $25 million in direct costs (exclusive of subcontract indirect costs requested as a direct cost by the applicant organization, but including all equipment) for a five-year award and no more than $7 million in direct costs for any one year. Applications must include a rationale for why the requested level of resources is critical to success of the project. Also, experience has shown that large-scale collaborative project awards require considerable time to come up to full speed (including hiring of personnel and purchase and installation of equipment). First year budgets should take that into consideration and most likely will require a lower level of resources than succeeding years. Experience has also shown that bioinformatics needs are frequently underestimated and these should be planned for appropriately. 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. Note: each participating consortium/contractual organization must submit a separate composite budget for both the initial budget period (using Form Page 4) and the entire proposed project period (using Form page 5). 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, which 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. Place the budgets for consortium components, cores, bridging projects, and pilot projects immediately prior to the description of the relevant individual component. For the 01 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 entire project period (years 01-05). Budget justifications and explanations. Describe the specific functions, including the level of effort, of all key personnel, including consultants, collaborators, and technical staff. Provide detailed justifications for requested equipment. BIOGRAPHICAL SKETCHES AND LETTERS OF COMMITMENT: Biographical sketches must be included for all participating investigators along with one-page letters of commitment indicating their role in the consortium and their willingness to follow guidelines and procedures established for the large-scale collaborative project. For all participating investigators, including the PI, heads of core resources, and principal investigators of bridging and pilot projects, provide a listing of all research support; support for other investigators such as postdoctoral students should not be listed. Highlight 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. PARTICIPANT AFFILIATIONS: Applications should include a separate cover sheet that lists 1) all participants, including consultants and private sector alliances, 2) all the institutional and industrial affiliations for each participant, 3) their roles on the project, and 4) the percent effort listed separately for each role. This added requirement will facilitate the review of applications. 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 strictly using the straightforward format that follows, or may use alternate combined formats for some parts of the application, as described below. Required components of all applications are the program summary; administrative and program management plans; a plan for data sharing and intellectual property; Cores A (administrative) and B (information dissemination and data coordinating); and responses to the bioinformatics questions listed below (see Core Resource C – Bioinformatics Core) if the optional bioinformatics core is utilized. If desired, an optional bioinformatics core may be may be combined with Core B. 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, scientific cores and bridging projects may be presented in a combined or more integrated fashion. When this, or a different alternate format from that outlined below 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. Program Summary (Required) Describe the goals and operation of the large-scale project. Explain what complex biomedical problem is being solved, why it is critical to advancing biomedical science, and how the approach of using a large-scale collaborative project is necessary. Also explain why the time is right for its solution within a ten-year period. Provide the background that has dictated your choices of approaches selected for the project. 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 a cohesive overall program. 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 a comprehensive whole. Discuss how and when information and other research resources generated by the collaborative projects will be disseminated to the participants and to the scientific public. Administrative Management Plan (Required) Describe the structure, organization, and operation of the project and explain why this plan has been selected. Describe the organizational framework and provide an organizational chart. Also describe how information will flow within the collaborative project. Explain the role of the steering committee. 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 communities that are impacted by the collaborative project will be considered. Project Management Plan (Required) Present a project management plan, including milestones, to keep the collaborative project moving forward and on track. Define yearly milestones for the first five-year period of support. Explain the planned role of the steering committee in project management. 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. The proposed members of the advisory committee should not be contacted or selected until an award has been made and the names of prospective members should not be included in the application. The program summary, administrative management plan, and project management plan 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 (Required – three-page limit) List and comment on how the sharing of research resources and intellectual property issues will be handled in the first five-year period of support; research resources include, among others, data and information, materials such as cell lines and mutant animals, and novel reagents and techniques. The PI and steering committee should (1) present their 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; (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; and (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 PA. Plan for Diversity Development (Required – two-page limit) Describe the plan to increase the number of participating investigators who are currently underrepresented in the biomedical, clinical, behavioral, and social sciences. The adequacy of this plan will serve as an award criterion. Core Resource A: Administrative Core (Required – 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 and Dissemination and Data Coordinating Core (Required – 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 and timing 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 and 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 of each for a maximum of 20 pages). The policies with respect to future dissemination of data and computational tools should be explained in the proposal and it is required that they conform to the following principles: Computational tools developed for analysis, visualization, or modeling the data must be freely shared with the scientific community as well as the annotated source code; others should be free to modify the source code and share the modifications with each other; and that the code should be made available to be incorporated into commercial products. The core description must include answers to the following queries, whether a separate core or combined with the information dissemination and data coordinating core. o What are the plans for sharing research data and the timing for release policies, and what are the associated intellectual property issues? o How will the data be made available to the scientific community? Are there browser access, formats for downloading complete data sets, on-line computational aids, etc.? o What are the nature and structure of the data? Describe the projected plans 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 projected mechanism for communication (both computational and human) between the distributed sites and the database managers? Are there data liaisons? o What are the key interacting databases? How are the data to be linked? What are the plans for modifying or enhancing those linkages? o How is progress made available to the public, e.g., are lists of the systems being analyzed made available? o What experience in bioinformatics is available in the group and what resources can the consortium draw on? Discuss the qualifications and experience of the bioinformatics team. o How will the bioinformatics plan evolve over the initial period of support? Core D: Scientific Resource Core(s) (Optional - 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 for each who possesses expertise in the area of the core. Describe the planned direction, management and use of the core(s), as well as the professional and technical staff to be involved in the core(s) and their duties. Include plans to utilize the core(s), such as services that will be provided and to whom and their bearing on productivity and quality of the collaborative research effort. Bridging Projects (Optional – five-page limit for each) Bridging projects will support work in the laboratories of the participating investigators. Describe the 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. 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 for the specific aims, background and significance, preliminary studies, and research design and methods. Also include, as applicable, the following sections, which do not count against the page limitations for the section or the overall page limit: Abstract (one paragraph), Human Subjects Research (also see special requirements in the Federal citations below), Vertebrate Animals, and Literature Cited. Pilot Projects (Optional – ten-page limit for each) 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. 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 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, which do not count against the page limitations for the section or the overall page limit, on Human Subjects Research (also see special requirements in the Federal citations below), Vertebrate Animals, and Literature Cited. There is a maximum of three pilot projects allowed per large-scale collaborative project. 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 Plan for increasing diversity – 2 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 that include consortium arrangements should refer to the NIH Grants Policy Statement appendix on consortium arrangements at http://grants.nih.gov/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. 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: Dr. Helen R. Sunshine Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Rm 3An.12F, MSC 6200 Bethesda, MD 20892-6200 RECEIPT AND REVIEW SCHEDULE: Phase II Application Receipt Date: June 21, 2005-2007 Phase II Peer Review Date: October/November 2005-2007 Phase II Council Date: January 2006-2008 Earliest Anticipated Phase II Award Date: April 2006-2008 APPLICATION PROCESSING: Applications must be mailed on or before the prescribed receipt dates above. Applications for Phase II must be received by June 21, 2005-2007. If an application is received after the due date, it will be returned to the applicant without review. CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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 I applications that are complete and responsive to the PA 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 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 o Receive a written critique, o Receive a second level review by the National Advisory General Medical Sciences Council REVIEW CRITERIA FOR THE OVERALL PHASE II 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. However, the paramount considerations for glue grants are the potential impact on biomedical science, the value added over individual grant approaches, and the likelihood of success in a ten-year time frame. SIGNIFICANCE: How significant is this research problem to the advancement of biomedical science? Has a compelling case been presented for pursuing the research problem at this time? Will there be significant value added over individual grants? APPROACH: For the project as a whole, are the conceptual framework, general approaches, and proposed analyses reasonable? Are all of the components necessary and sufficient to achieving the scientific aims? Is their planned integration appropriate? Is there a good balance between the application of current ideas and approaches, and the development of required new state-of- the-art ideas and tools? Are potential problems acknowledged and do alternatives exist? INNOVATION: Are the proposed aims original and innovative? Will the collaborative project challenge existing paradigms and/or develop new methodologies or technologies? Is the potential impact clearly innovative and exciting? ENVIRONMENT: Are the scientific environments where the work will be performed optimally selected to enhance the probability of success? Does necessary institutional support appear likely? Will open and free exchange of information be supported by this environment? Are the bioinformatics facilities well-positioned and supported in their planned locations? INVESTIGATORS: Principal Investigator and Steering Committee. Is there evidence that the PI and the central governing body have the vision, scientific expertise, administrative capacity and leadership skills to successfully lead the large- scale project? Is the level of commitment for the PI and consortium leaders adequate? Is the use of this collaborative team the best way to approach this problem? Is this group well-poised to solve this research problem within the next decade? Participating Investigators. Are the participating investigators who have committed to the project among the best in their respective fields? Is the skill set for the participating investigators sufficient? Are there plans to apply expertise from diverse disciplines and fields to the scientific question, and if not, what specific expertise is lacking? Is the level of commitment for each investigator adequate? Others. Do the professional staff without independent research funding used in critical positions have the necessary expertise and experience to successfully meet the consortium requirements? ADDITIONAL REVIEW CRITERIA FOR THE OVERALL PROJECT: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: o Commitment of the host and participating institutions 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 and record of the leadership to the sharing of research resources (including data and information, materials such as cell lines and mutant animals, and novel reagents and techniques) generated by the large- scale project with the broader scientific community. o Adequacy of the plans to effectively and realistically manage intellectual property issues for the collaborative project. o Adequacy of the diversity development plan to increase the number of participating investigators who are currently underrepresented in the biomedical, clinical, behavioral, and social sciences. REVIEW CRITERIA FOR THE 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 availability to devote the required time and effort to the program. REVIEW CRITERIA FOR BRIDGING PROJECTS AND PILOT PROJECTS Reviewers will be asked to discuss the following aspects of each bridging and pilot project. SIGNIFICANCE: Does this study address an important problem? 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? Will this bridging or pilot project serve to increase the cohesiveness of the large-scale project? 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? INNOVATION: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR(S): Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will/has been 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 CONSIDERATIONS FOR THE OVERALL PROJECT AND ALL COMPONENTS PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both 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 in the sections on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. 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 award 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 likely impact on the broader scientific community o uniqueness as a large-scale project o program priorities o program balance o availability of funds REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing . Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan and will factor the plan into the determination of the scientific merit or the priority score, because it is a critical part of the fundamental purpose of this initiative. 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). participating investigators, including the PI, heads of core resources, and principal investigators of bridging and pilot projects, provide a listing of all research support; support for other investigators such as postdoctoral students should not be listed. Highlight 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. PARTICIPANT AFFILIATIONS: Applications should include a separate cover sheet that lists 1) all participants, including consultants and private sector alliances, 2) all the institutional and industrial affiliations for each participant, 3) their roles on the project, and 4) the percent effort listed separately for each role. This added requirement will facilitate the review of applications. 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 strictly using the straightforward format that follows, or may use alternate combined formats for some parts of the application, as described below. Required components of all applications are the program summary; administrative and program management plans; a plan for data sharing and intellectual property; Cores A (administrative) and B (information dissemination and data coordinating); and responses to the bioinformatics questions listed below (see Core Resource C – Bioinformatics Core) if the optional bioinformatics core is utilized. If desired, an optional bioinformatics core may be may be combined with Core B. 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, scientific cores and bridging projects may be presented in a combined or more integrated fashion. When this, or a different alternate format from that outlined below 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. Program Summary (Required) Describe the goals and operation of the large-scale project. Explain what complex biomedical problem is being solved, why it is critical to advancing biomedical science, and how the approach of using a large-scale collaborative project is necessary. Also explain why the time is right for its solution within a ten-year period. Provide the background that has dictated your choices of approaches selected for the project. 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 a cohesive overall program. 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 a comprehensive whole. Discuss how and when information and other research resources generated by the collaborative projects will be disseminated to the participants and to the scientific public. Administrative Management Plan (Required) Describe the structure, organization, and operation of the project and explain why this plan has been selected. Describe the organizational framework and provide an organizational chart. Also describe how information will flow within the collaborative project. Explain the role of the steering committee. 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 communities that are impacted by the collaborative project will be considered. Project Management Plan (Required) Present a project management plan, including milestones, to keep the collaborative project moving forward and on track. Define yearly milestones for the first five-year period of support. Explain the planned role of the steering committee in project management. 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. The proposed members of the advisory committee should not be contacted or selected until an award has been made and the names of prospective members should not be included in the application. The program summary, administrative management plan, and project management plan 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 (Required – three-page limit) List and comment on how the sharing of research resources and intellectual property issues will be handled in the first five-year period of support; research resources include, among others, data and information, materials such as cell lines and mutant animals, and novel reagents and techniques. The PI and steering committee should (1) present their 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; (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; and (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 PA. Plan for Diversity Development (Required – two-page limit) Describe the plan to increase the number of participating investigators who are currently underrepresented in the biomedical, clinical, behavioral, and social sciences. The adequacy of this plan will serve as an award criterion. Core Resource A: Administrative Core (Required – 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 and Dissemination and Data Coordinating Core (Required – 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 and timing 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 and 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 of each for a maximum of 20 pages). The policies with respect to future dissemination of data and computational tools should be explained in the proposal and it is required that they conform to the following principles: Computational tools developed for analysis, visualization, or modeling the data must be freely shared with the scientific community as well as the annotated source code; others should be free to modify the source code and share the modifications with each other; and that the code should be made available to be incorporated into commercial products. The core description must include answers to the following queries, whether a separate core or combined with the information dissemination and data coordinating core. o What are the plans for sharing research data and the timing for release policies, and what are the associated intellectual property issues? o How will the data be made available to the scientific community? Are there browser access, formats for downloading complete data sets, on-line computational aids, etc.? o What are the nature and structure of the data? Describe the projected plans 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 projected mechanism for communication (both computational and human) between the distributed sites and the database managers? Are there data liaisons? o What are the key interacting databases? How are the data to be linked? What are the plans for modifying or enhancing those linkages? o How is progress made available to the public, e.g., are lists of the systems being analyzed made available? o What experience in bioinformatics is available in the group and what resources can the consortium draw on? Discuss the qualifications and experience of the bioinformatics team. o How will the bioinformatics plan evolve over the initial period of support? Core D: Scientific Resource Core(s) (Optional - 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 for each who possesses expertise in the area of the core. Describe the planned direction, management and use of the core(s), as well as the professional and technical staff to be involved in the core(s) and their duties. Include plans to utilize the core(s), such as services that will be provided and to whom and their bearing on productivity and quality of the collaborative research effort. Bridging Projects (Optional – five-page limit for each) Bridging projects will support work in the laboratories of the participating investigators. Describe the 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. 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 for the specific aims, background and significance, preliminary studies, and research design and methods. Also include, as applicable, the following sections, which do not count against the page limitations for the section or the overall page limit: Abstract (one paragraph), Human Subjects Research (also see special requirements in the Federal citations below), Vertebrate Animals, and Literature Cited. Pilot Projects (Optional – ten-page limit for each) 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. 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 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, which do not count against the page limitations for the section or the overall page limit, on Human Subjects Research (also see special requirements in the Federal citations below), Vertebrate Animals, and Literature Cited. There is a maximum of three pilot projects allowed per large-scale collaborative project. 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 Plan for increasing diversity – 2 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 that include consortium arrangements should refer to the NIH Grants Policy Statement appendix on consortium arrangements at http://grants.nih.gov/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. 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: Dr. Helen R. Sunshine Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Rm 3An.12F, MSC 6200 Bethesda, MD 20892-6200 RECEIPT AND REVIEW SCHEDULE: Phase II Application Receipt Date: June 21, 2005-2007 Phase II Peer Review Date: October/November 2005-2007 Phase II Council Date: January 2006-2008 Earliest Anticipated Phase II Award Date: April 2006-2008 APPLICATION PROCESSING: Applications must be mailed on or before the prescribed receipt dates above. Applications for Phase II must be received by June 21, 2005-2007. If an application is received after the due date, it will be returned to the applicant without review. CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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 I applications that are complete and responsive to the PA 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 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 o Receive a written critique, o Receive a second level review by the National Advisory General Medical Sciences Council REVIEW CRITERIA FOR THE OVERALL PHASE II 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. However, the paramount considerations for glue grants are the potential impact on biomedical science, the value added over individual grant approaches, and the likelihood of success in a ten-year time frame. SIGNIFICANCE: How significant is this research problem to the advancement of biomedical science? Has a compelling case been presented for pursuing the research problem at this time? Will there be significant value added over individual grants? APPROACH: For the project as a whole, are the conceptual framework, general approaches, and proposed analyses reasonable? Are all of the components necessary and sufficient to achieving the scientific aims? Is their planned integration appropriate? Is there a good balance between the application of current ideas and approaches, and the development of required new state-of- the-art ideas and tools? Are potential problems acknowledged and do alternatives exist? INNOVATION: Are the proposed aims original and innovative? Will the collaborative project challenge existing paradigms and/or develop new methodologies or technologies? Is the potential impact clearly innovative and exciting? ENVIRONMENT: Are the scientific environments where the work will be performed optimally selected to enhance the probability of success? Does necessary institutional support appear likely? Will open and free exchange of information be supported by this environment? Are the bioinformatics facilities well-positioned and supported in their planned locations? INVESTIGATORS: Principal Investigator and Steering Committee. Is there evidence that the PI and the central governing body have the vision, scientific expertise, administrative capacity and leadership skills to successfully lead the large- scale project? Is the level of commitment for the PI and consortium leaders adequate? Is the use of this collaborative team the best way to approach this problem? Is this group well-poised to solve this research problem within the next decade? Participating Investigators. Are the participating investigators who have committed to the project among the best in their respective fields? Is the skill set for the participating investigators sufficient? Are there plans to apply expertise from diverse disciplines and fields to the scientific question, and if not, what specific expertise is lacking? Is the level of commitment for each investigator adequate? Others. Do the professional staff without independent research funding used in critical positions have the necessary expertise and experience to successfully meet the consortium requirements? ADDITIONAL REVIEW CRITERIA FOR THE OVERALL PROJECT: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: o Commitment of the host and participating institutions 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 and record of the leadership to the sharing of research resources (including data and information, materials such as cell lines and mutant animals, and novel reagents and techniques) generated by the large- scale project with the broader scientific community. o Adequacy of the plans to effectively and realistically manage intellectual property issues for the collaborative project. o Adequacy of the diversity development plan to increase the number of participating investigators who are currently underrepresented in the biomedical, clinical, behavioral, and social sciences. REVIEW CRITERIA FOR THE 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 availability to devote the required time and effort to the program. REVIEW CRITERIA FOR BRIDGING PROJECTS AND PILOT PROJECTS Reviewers will be asked to discuss the following aspects of each bridging and pilot project. SIGNIFICANCE: Does this study address an important problem? 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? Will this bridging or pilot project serve to increase the cohesiveness of the large-scale project? 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? INNOVATION: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR(S): Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will/has been 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 CONSIDERATIONS FOR THE OVERALL PROJECT AND ALL COMPONENTS PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both 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 in the sections on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. 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 award 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 likely impact on the broader scientific community o uniqueness as a large-scale project o program priorities o program balance o availability of funds REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing . Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan and will factor the plan into the determination of the scientific merit or the priority score, because it is a critical part of the fundamental purpose of this initiative. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm . The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the “Standards for Privacy of Individually Identifiable Health Information”, the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm . The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the “Standards for Privacy of Individually Identifiable Health Information”, the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Office of Extramural Research (OER) |
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National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
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Department of Health and Human Services (HHS) |
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