INTEGRATIVE AND COLLABORATIVE APPROACHES TO RESEARCH Release Date: June 3, 1999 PA NUMBER: PA-99-109 National Institute of General Medical Sciences PURPOSE The purpose of this Program Announcement (PA) is to encourage, through a new initiative, collaborative and integrative approaches to research on multifaceted biological problems. While the traditional R01 research project grant remains the backbone of NIH and NIGMS support for biomedical science, individual R01 grants may be inadequate to support larger efforts that require collaborative approaches. In some cases, individual investigators with existing R01 or R37 support, or other sources of independent funding, will need to attract and coordinate expertise in different disciplines and approaches, and may require access to specialized resources, such as computational facilities, high throughput technologies, and equipment. In order to provide a new mechanism to support such collaborative and interactive activities, this initiative will use the R24 Consortium Grant mechanism, designed for groups of currently funded investigators. This PA is one of a pair of new initiatives to increase support opportunities for collaborative ventures. It is restricted to collaborative activities that require support of up to $300,000 direct costs per year. A companion initiative, GM-99-007 (http://www.nih.gov/grants/guide/rfa-files/RFA-GM-99-007.html), was published in the guide on May 28, 1999, and is a one-time solicitation to provide a high level of resources to allow investigators to extend their research efforts and to form a research consortium to address a research problem in a comprehensive and highly integrated fashion. This PA also strongly encourages consideration of existing and previously announced mechanisms whenever appropriate, to enhance collaborative and integrative approaches to research problems. These include: administrative supplements to NIGMS-funded research grants; competitive supplements to NIGMS- funded research grants; individual R01 grants containing a consortium arrangement for a collaborative component; program project (P01) and center (P50) grants; and Interactive Research Project Grants (IRPG). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS led national activity for setting priority areas. This PA, Support of Integrative and Collaborative Approaches to Research, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Applications must be for projects in the areas of research supported by NIGMS. Applicants should visit the NIGMS website at http://www.nih.gov/nigms for detailed information on NIGMS areas of research interest. Applicants are strongly advised to contact the NIGMS staff listed below, prior to submission, to discuss the eligibility of a proposed application. Applicants also are referred to an informational page with frequently asked questions and answers at URL http://www.nih.gov/nigms/funding/gluegrants.html. Only Principal Investigators (PIs) of NIGMS-funded R01 or R37 grants with two or more years of support remaining at the time of award will be eligible to submit applications for which they will be a consortium leader for collaborative activities. One consortium leader, coordinating a minimum of two funded projects for the duration of the R24 Award, may apply for additional resources to support collaborative and integrative approaches and activities needed to better address a common biological problem. Other participating members of the consortium must have grant support from either NIGMS or another NIH Institute or Center, or have other external, peer-reviewed research grant support, and they can be located either at the same institution as the consortium leader, or at different institutions. Component projects do not have to be in phase with the grant support of the consortium leader. Component projects may end or be renewed during the R24 award as long as a minimum of two collaborative projects is maintained. Replacement or addition of participating components with access to consortium support will be considered for approval by NIGMS, as long as the overall scientific goals remain the same. Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Participation from industry is permitted and encouraged when scientifically justified. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Participating members also may be from the above organizations and institutions. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R24) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed four years. Funded consortia will be eligible for only one competitive renewal application. The R24 Consortium Grant mechanism will be used to support activities that will substantially enhance the conduct of the already funded research projects through collaborative activities. A maximum of $300,000 direct costs per year will be provided for all or some of the following: o Salaries for personnel that bridge or add to the intellectual and technological approaches of the individual consortium components o Travel expenses for collaborative activities o Specialized training of personnel in cross disciplinary concepts and approaches o Equipment o Access to resources, such as those for genomics, high throughput technologies, bioinformatics and computational services, electronic communication media to facilitate participation of off site laboratories and collaborative capabilities o Facilities for model organisms Other Available Mechanisms of Support Before pursuing the R24 mechanism of this PA, individual investigators are strongly encouraged to first consider mechanisms already in place that can be used for the support of collaborative and interactive activities. These include: administrative or competing (http://www.nih.gov/grants/guide/pa-files/PA-98-024.html) supplements to research grants, which could be used to add a collaborator or a resource to an individual funded grant; program projects and centers (http://www.nih.gov/nigms/funding/pa/prog_proj_grants.html), which could be used to provide research and core support to a group of investigators seeking new funds for collaborative activities and projects; the Interactive Research Project Grant (IRPG) mechanism (http://grants.nih.gov/grants/guide/pa-files/ PA-96-001.html), for individual R01 applicants seeking interactive resources; and a consortium component of an R01 grant, for investigators applying for a grant in which they wish support for a collaborator. Applicants should contact NIGMS staff for advice on the most appropriate mechanism to achieve their goals. RESEARCH OBJECTIVES Background and Rationale Biomedical science has entered an era in which collaboration across disciplines is essential to tackle many multifaceted biological problems. This increased need for collaborative and integrative approaches stems from the rapid progress in understanding biology at the molecular level. Although much remains to be done in defining and analyzing molecular events, a wealth of molecular details can now be used to increase our understanding of the global control and integration of many biological processes. This effort will require the involvement of groups of scientists and a diversity of resources. It is unrealistic to expect that all laboratories will have the breadth of expertise and resources to pursue problems that increasingly require the application of multiple approaches. Investigators with expertise in disciplines such as physics, engineering, mathematics, and computer science increasingly will be needed to realize the full potential of biomedical research. Furthermore, the ability to attack multifaceted problems will involve sophisticated data collection and access to rapidly evolving technologies. However, technologies and approaches such as combinatorial chemistry, DNA chips, high throughput mass spectrometric analysis, and bioinformatics are not readily available and affordable to many laboratories that could benefit from their use. Objectives The purpose of this Program Announcement (PA) is to encourage, through a new initiative, collaborative and integrative approaches to research on multifaceted biological problems .problems. The goal is to make additional resources available to groups of already funded investigators for collaborative activities, via the use of the R24 Consortium Grant mechanism. The additional funds must support activities that are likely to significantly enhance existing capabilities and introduce new approaches to the research aims. This mechanism is not intended to simply support core facilities for the purpose of access or efficiency of use. The requested resources must facilitate the collaboration and integration of the component projects and support a synthesis of information that would not take place if each grant were given its own resource facility. All areas of research traditionally supported by NIGMS will be considered as appropriate for the participating components of the R24 Consortium mechanism. Applicants are advised to visit the NIGMS website at http://www.nih.gov/nigms for detailed information on NIGMS areas of research interest. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: GrantsInfo@nih.gov. The title and number of the PA must be typed on line 2 of the face page of the application form and the YES box must be marked. The Background section must include a description of the already funded component projects that is sufficient to enable an assessment of the degree to which the R24 Consortium Grant would facilitate collaborative and integrative approaches to the research problem. This section also should contain a rationale for why the requested consortium support is likely to significantly enhance progress on the research problem, beyond what could be accomplished with the individual research grant support. The Experimental Plan should contain a description of the approaches and how they will be accomplished to further the research goals. The principal investigator should describe how the activities will be coordinated and made accessible to all participating components. Applicants also should include specific plans for sharing data and materials that may be generated through the consortium grant. The Resources section should address existing intellectual and other resources. Submit a signed, typewritten original of the application, including the Checklist, and five 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established NIH referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a favorable priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Will the integrative and collaborative studies supported by this application further research on an important problem? If the goals of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or approaches that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of component projects? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? (4) Investigator: Is the consortium leader appropriately trained and well suited to oversee this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed activities take advantage of unique features of the participating grantees or employ useful collaborative arrangements? Is there evidence of institutional support? Additional Review Criteria o Will the proposed collaborative and integrative activities and/or resources significantly enhance the ability of the investigators to address the research goals of the funded component projects? o Are the component projects suitable for a collaborative and integrative approach? In addition to the above criteria, in accordance with NIH policy, all applications also will be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects also will be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. The initial review group also will examine the provisions for the protection of human subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. For NIGMS, the following will be considered in making funding decisions: Quality of the proposed collaborative activities as determined by peer review, the degree to which the collaborative components and/or activities will significantly enhance the conduct of the research, program priority, and availability of funds. INQUIRIES Inquiries are strongly encouraged to determine the responsiveness of proposed applications to the PA. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James Cassatt, Ph.D. Division of Cell Biology and Biophysics National Institute of General Medical Sciences Building 45, Room 2AS19 Bethesda, MD 20892-6200 Telephone: (301) 594-0828 FAX: (301) 480-2004 Email: firstname.lastname@example.org Judith Greenberg, Ph.D. Division of Genetics and Developmental Biology National Institute of General Medical Sciences Building 45, Room 2AS25 Bethesda, MD 20892-6200 Telephone: (301) 594-0943 FAX: (301) 480-2228 Email: email@example.com Michael Rogers, Ph.D. Division of Pharmacology, Physiology, and Biological Chemistry National Institute of General Medical Sciences Building 45, Room 2AS49 Bethesda, MD 20892-6200 Telephone: (301) 594-3827 FAX: (301) 480-2802 Email: firstname.lastname@example.org Direct inquiries regarding fiscal matters to: Ms. Marcia Cohn Division of Genetics and Developmental Biology National Institute of General Medical Sciences Building 45, Room 2AN44 Bethesda, MD 20892-6200 Telephone: (301) 594-3918 FAX: (301) 480-2554 Email: email@example.com AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.821, 93.859, 93.862. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH Grants Policy statement (10/1/98) and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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, and portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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