RESEARCH CENTERS IN TRAUMA, BURN, AND PERIOPERATIVE INJURY RELEASE DATE: April 3, 2002 PA NUMBER: PAR-02-092 Update: The following update relating to this announcement has been issued: December 12, 2008 - This PA has been reissued as (PAR-09-048) LETTER OF INTENT RECEIPT DATE: Four weeks before the submission date EXPIRATION DATE: JUNE 2, 2005, unless reissued National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this 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 an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of General Medical Sciences (NIGMS) is announcing new guidelines for academic Research Centers in Trauma, Burn, and Perioperative Injury, which will supersede all previous announcements. The goals for this centers program are to provide support to: o Improve understanding of the biological processes invoked after traumatic or burn injury at all levels, including molecular and cellular, physiological, and multilevel integration of homeostatic loss and recovery o Foster translational research, bringing basic scientific observations and principles into the clinical arena and using clinical observations to generate or validate mechanistic hypotheses o Foster interactions and communications within institutions and throughout the trauma community by outreach efforts that promote trauma, burn, and perioperative research at the institutional level. Each Research Center must include patient-oriented research, be multidisciplinary in nature, and serve as a focal point, within the institution, for research on trauma, burn, and perioperative injury. We encourage the involvement of scientific expertise and approaches that have not usually been associated with this research. To facilitate communication throughout the community of trauma, burn, and perioperative injury, the Research Centers will become part of a network of researchers and institutions that will meet annually. RESEARCH OBJECTIVES Background Injury is the leading cause of death for Americans under the age of 44 years. The years of potential life lost due to trauma are significant. Based on recent data from the National Center for Health Statistics (see http://www.cdc.gov/ncipc/wisqars/), trauma related to accidents results in the death of more than 93,000 individuals per year in the United States and, as a cause of death, ranks fifth after heart disease, cancer, stroke, and lung disease. Taking into account the potential years of life lost, the estimated cost of each trauma-related death in the United States is 2.4 times more than that of cancer and cardiovascular disease combined. Based on the best available data, trauma will equal or surpass communicable diseases in 2020 as the number one cause of disability-adjusted life years worldwide. Besides mortality, the social and economic impact of morbidity after injury also constitutes a significant public health issue. Trauma victims not killed by the initial injury may have prolonged and complicated recovery periods. In addition, surgical interventions for other disease conditions constitute controlled injuries and have perioperative complications which are also a significant problem. Advances in understanding the basic physiological responses to injury have yielded improved strategies of care, but, for a multitude of clinical problems, the scientific understanding needed to create effective new treatments is still lacking. For example, scientists have developed some means to prevent early death after injury (such as aggressive fluid resuscitation after a severe burn), but victims then face various life-threatening complications well after the initial injury. Research suggests that molecular, cellular, and systemic events occurring shortly after a traumatic event may be protective AND precipitate programmed potential responses that cause complications much later. Ideally, appropriate therapeutic interventions shortly after injury would not only keep a patient alive, but also enhance repair and restoration. The future of clinical care for victims of traumatic or burn injury, including treatment of the inevitable ensuing shock, depends on having a fundamental understanding of the physiological responses that occur at the molecular, cellular, tissue, organ, and systemic levels. Scientific advances have occurred rapidly, to provide new insights into biological processes, and investigators interested in trauma are now at an opportune time to apply newly available expertise and technology (e.g., genomics, proteomics, quantitative analytical approaches, and high-throughput testing) to clinical problems. Simultaneously, scientists who understand the clinical issues faced by injured patients can offer specific direction for laboratory investigations. The body"s response to injury is a complex systemic process that is difficult to address, particularly in narrowly defined individual research projects. Moreover, funding mechanisms for independent individual investigators (the R01 award, for example) necessarily limit the scope of their research projects, making the gathering of an adequate and appropriate diversity of expertise and insight often impossible. Studies of injured humans are difficult because of medical, scientific, and ethical reasons, but they are still possible and necessary. The multi-component research center grant mechanism offers investigators the opportunity to enhance the scientific effort from multiple perspectives and to allocate and leverage resources efficiently, thus allowing optimal research progress. Scope of Research The appropriate scope of research for the proposed Research Centers broadly covers the mechanisms of immediate and/or long-term adaptive and maladaptive physiological responses to injury (which is defined as blunt, penetrating, surgical, or burn injury and including hemorrhage occurring due to tissue damage). This research includes, but is not limited to: o Whole organism, organ, tissue, cellular, and molecular responses (adaptive, compensatory, or dysfunctional), including shock (e.g., hypovolemic, cardiogenic, or septic) o Mechanisms of cellular and organ failure (alterations in cellular bioenergetics, necrosis, apoptosis, single organ failure, and acute respiratory distress syndrome or multiple organ dysfunction syndrome) o Resuscitation strategies and mechanisms o Post-injury alterations of metabolic patterns and nutritional requirements o Normal or pathophysiological changes after injury and factors or therapies influencing stabilization and recovery o Alterations in host-defense mechanisms (innate and adaptive immune mechanisms, systemic inflammatory response syndrome, compensatory anti- inflammatory response syndrome) o Wound healing, tissue repair and regeneration, or tissue engineering related to repair of traumatic injuries o Behavioral antecedents or consequences of trauma or burn injury as related to physiological responses, including effects of allostasis and allostatic load o Individual, age-related, gender-specific, or population-specific responses to trauma, burn, or perioperative injury The time frame suitable for research is from immediately post-injury through ultimate resolution (recovery or death). Research topics derived from issues faced by critically ill patients in intensive care units may be responsive to this PA. We will not consider applications responsive to the PA and will not accept them if they focus solely on traumatic brain injury or spinal cord injury or on topics related to epidemiology, prevention of injury, social or behavioral factors that may increase the probability of injury, psychological trauma, long-term rehabilitation strategies, or delivery of health care. Projects may include research on the nervous system"s involvement in the systemic response to injury or specific subprojects on brain, spinal cord, or nerve injury if the overall focus fits within the topics listed above and most of the other research proposed does not center on the nervous system. The public health issues related to trauma are far-reaching. We encourage you to leverage the scientific endeavor and infrastructure created by this centers program to seek additional funding from other appropriate Federal agencies or private sources for related activities, such as the application of research findings to patient care and public outreach and education activities. We will view your ability to obtain institutional and other support for these activities as enhancing the chances for success of your Research Center. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Specialized Center Grant (P50) award. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Your total project period may not exceed 5 years, and competing renewals are possible. You may request a budget for your Research Center in FY 2002 of up to $1.1 million in direct costs per year for continuing operations (e.g., personnel, supplies, travel and other expenses), for a total direct cost of $5.5 million for 5 years. If you request a budget for less than 5 years, you should prorate this limit and adjust for inflation. The limits for direct costs for Research Centers that would be initially funded in the following fiscal years are thus: FY 2002 $5,500,000 FY 2003 5,650,000 FY 3004 5,800,000 FY 2005 5,950,000 FY 2006 6,100,000 You may request up to $200,000 in direct costs per year, above these limits, specifically to support a Human Subjects Core that will serve the entire Research Center (see "HUMAN SUBJECTS CORE" below). With prior approval from NIGMS, you may also request funds in excess of the limits to acquire large equipment in the first year of your award. We anticipate that the size of awards will vary because the nature and scope of the research programs proposed in each application will be unique. You may find the program project (P01) mechanism more suited to the scale or scope of your effort, if so, you should consult NIGMS staff and a previous PA (PA-01-116), which is available at http://grants.nih.gov/grants/guide/pa-files/PA-01-116.html. Please note that both human-based studies and translational research may be supported by the P01 funding mechanism. ELIGIBILE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or 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 Domestic INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individuals with the skills, knowledge, and resources necessary to carry out the proposed research are 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. SPECIAL REQUIREMENTS Research Centers must have a minimum of three, and generally no more than six, subprojects and may include core facilities if appropriate. In addition, each Research Center must have an Administrative Core and other components, as detailed below. The actual structure of your Research Center will depend on the resources, expertise, and scientific and administrative goals of your organization. Your application should demonstrate significant and substantive synergy between projects. Reviewers will consider your application meritorious if it shows that the sum of your Research Center"s components is greater than the individual parts. Also, reagents, information, and ideas should flow between subprojects. Some of your proposed subprojects may have limited synergy with the rest of the Research Center, but otherwise demonstrate mutual benefits that justify their inclusion. The principal investigator and each project leader must demonstrate in your application that the research would be conducted much more effectively within a Research Center than as an individual research grant. We expect the participating scientists who lead the individual projects to be independent investigators. We do not intend Research Centers to be a vehicle for departmental support or for research support of a single senior investigator and several postdoctoral and research associates. We anticipate that Research Centers will be multidisciplinary and will draw on a variety of resources. You must demonstrate in your application and in practice that your Center is well planned and carefully organized. The Director is responsible for ensuring that scientific goals are met and for developing and managing a decision- making structure and process that allow for the allocation of resources to meet these goals. The scientifically and managerially complex projects that characterize Research Centers will require substantial effort from the Director to achieve success. Therefore, we are requiring that the Director devote a minimum of 20% effort to leadership and implementation of the Research Center. In your application, you should clearly delineate the administrative structure of your Center and include designation of a co-principal investigator or an assistant principal investigator. You also should describe any core facilities or shared resources that are needed, as well as their management and service to the research projects. The purpose of cores is to supply cost-effective and uniform laboratory practices to separate subprojects or to provide the means for applying state-of-the-art technology to the research topics being addressed. You should explain how different components of your organization, including key personnel, will interact, why they are essential to accomplishment of the research, and how the combined resources create capabilities that are more than the sum of the parts. If any components are physically separated from others (i.e., in different departments or institutions), you need to indicate in your application how you will facilitate interactions across the components. Except for requiring that your Center includes a minimum of three subprojects, we do not specify a particular organizational structure in this PA. Instead, you should develop a structure that would best accomplish your goals and objectives. Please note, however, that the effectiveness of your organizational structure is a criterion for the review of your application and that we will monitor effectiveness after an award is made. You should present a time line for the project in your application. This time line should outline how you expect to meet the project"s goals within the time frame you request for the award. The time line will also help investigators and NIGMS and our advisors to evaluate progress toward your project"s goals. We encourage you to present explicit, quantitative milestones for projects, as you deem appropriate. TRANSLATIONAL RESEARCH: An important goal for the Research Centers program is to foster two-way transfer of information, knowledge, and experience between basic science investigations and clinical studies and practice. Each Research Center must involve both laboratory and clinical research efforts. You may consider each subproject as translational research (i.e., it contains both laboratory and patient- oriented research), or you may propose a mix of separate laboratory, clinical, and translational subprojects. We anticipate that successful applications will propose a mix of scientists from different backgrounds and disciplines. We do not, however, specifically mandate a particular proportion of investigators or research projects, but require that your application include human-based research. If you only propose research on animal models, we will not consider your application to be responsive to this PA, but we could consider it appropriate for a program project (P01) award. Animal models are significantly advanced, powerful, and more controllable than research with humans, and studies using these models can offer crucial expertise and/or technology, as well as depth of understanding, in addressing issues related to trauma. Subprojects that deal exclusively with in vitro systems or animal models are appropriate if the information to be derived is relevant and applicable to the overall intent of the Research Center. ADMINISTRATIVE CORE: Your application must include an Administrative Core with a clearly articulated management plan. Although each Research Center will be unique, we encourage you to include certain features in the definable structure. Examples of these features include, but are not limited to: o Oversight of financial considerations and all pertinent issues related to animal care and usage, safety, responsible conduct of science, Institutional Review Boards, and inclusion of human subjects (which you may address in the Human Subjects Core, if included in your proposal) o Scientific management, including monitoring of the progress of subprojects and cores, mechanisms to foster interactions, and means to assure dissemination of research results o Administration of a home page (see "HOME PAGE" below), including expertise to maintain and update your home page regularly o Institutional development (as "INSTITUTIONAL DEVELOPMENT ACTIVITIES" below), including coordination of efforts, management of resources, handling and referral of inquiries, follow-up activities, and monitoring of progress o Evaluation of the success of proposed and implemented institutional outreach activities o Communication with NIGMS and other funded Research Centers (directly or through NIGMS) o Provision of ready access to statistical expertise routinely and as needed o Travel requirements (including attendance at the annual meeting of Research Center Directors and NIH staff). If any archival or database activities are included in your application, you must submit additional detail about these activities. We are very interested in ensuring that information about new methods, technologies, and computer software and data relevant to clinical practice that is developed through this program become readily available to the research community for further research and development. We expect that this sharing will eventually lead to information and products that improve the health of the public. You should develop and propose specific plans for sharing data, materials, and software generated by your Research Center (see the recent NIH guidance on this at (http://www.nih.gov/od/ott/RTguide_final.html). We strongly suggest that if relevant you describe in your application a plan for rapid deposition of data into established public databases, which have the capability for collecting and disseminating the data that will be collected by the Research Centers (see "PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT" in the section on "REQUIRED FEDERAL CITATIONS" below). The initial review group will comment on your proposed plan for sharing and release of data, although they will not include their evaluation as part of the priority score. NIH staff also will consider the adequacy of your plan as one of the criteria for award. After negotiation with you, as needed, your proposed plan for sharing will become a condition of your award. When evaluating a non-competitive renewal application (i.e., the yearly progress report), we will consider the material you provide on the effectiveness of your release of data, materials, and software developed as part of any database or archival activities. You should allocate sufficient funds in your requested budget to cover the expenses of the activities you propose for your core. INSTITUTIONAL DEVELOPMENT ACTIVITIES: Your Research Center should be a focus of activities that enhance trauma-related efforts at your institution. This focus may help to create the infrastructure needed to address the full spectrum of trauma-related issues. Ideally, your Research Center should promote a greater understanding of the scientific issues concerning the body"s response to injury, beyond the specific research projects funded. Your Center should include activities that are designed to engage other segments of the research and clinical communities at your institution and to foster a cohesive institutional approach to the basic and clinical science of physiological responses to injury. Expertise, knowledge, technology, and approaches offered by disciplines not initially involved with your Center may add exciting and important breadth and depth to ongoing research efforts. In your application, you must describe the institutional development activities that would foster interaction and communication during your award. Include how the particular activities will augment your Research Center and facilitate progress toward your goals. Most of your activities will likely be in your Administrative Core. Reviewers will evaluate and comment directly on the efforts you propose. Examples of possible activities include, but are not limited to: o A regular seminar series on trauma research that may be advertised and presented innovatively to attract a broad audience, or joint seminars with other departments o A web page that describes activities and research opportunities within your Research Center (see "HOME PAGE" below) o An open house or research day designed to attract and interest other faculty and/or students and to offer information on possible research topics and specific needs o Programs designed to attract undergraduate, graduate, and medical students, residents, or postdoctoral fellows to course work related to trauma or to actual research activities within your Research Center o A program for placing residents or postdoctoral fellows, who are interested in the research offered in your Center, into basic science laboratories on campus, to expose them to different ideas and technology o Providing access for other scientists to ideas, models, reagents, or experimental systems available within your Research Center o Linkage of your Research Center to trauma-related activities funded by other Federal agencies or private organizations o Support of joint meetings with basic science departments. Although the activities you propose will be peer reviewed and are an important component of our funding decision, we recognize that your efforts may change during the course of an award. You should discuss any significant modifications with NIGMS staff before implementing them, and you should describe them thoroughly in your annual progress report. Funds may be used for any of the activities listed above. For example, funds may support salary and research expenses for an individual in your Research Center to receive extensive training in a laboratory outside the Center, or to bring an individual who has unique expertise into your Research Center. In either case, the actual research performed must be an integral part of the research proposed for a subproject or core activity. In this way, funds can be used to bridge the activities of your Research Center to potentially valuable new collaborations with experienced and qualified investigators and thereby foster development and expansion of the science conducted in your Center. However, funds for institutional development activities may NOT be used to support pilot projects by new or established investigators. HUMAN SUBJECTS CORE (OPTIONAL): To meet the goal for translational research, you may wish to consolidate acquisition and management of human subjects within a separate Human Subjects Core, rather than keeping all aspects of these studies with the relevant subproject. Establishing a Human Subjects Core may be effective if a significant portion of your Research Center will focus on the study of injured, burned, or critically ill patients (by studies of isolated cell and tissue samples or physiological assessments of individuals and appropriate controls). The Human Subjects Core should have responsibility, for example, for development and implementation of standard operating procedures, recruitment and obtaining consent of subjects, collection and distribution of samples, keeping of all records, and coordination with subprojects. You should specify a particular individual who will directly supervise the core"s functions and activities. You may request up to $200,000 in direct costs per year above the limits specified in the section on "MECHANISM OF SUPPORT" (see above) for personnel such as research nurses or data managers and for necessary supplies, patient care, consultant fees, and other pertinent expenses. Furthermore, if opportunities arise for multi-institutional research studies involving injured humans, the Human Subjects Core may serve as a focal point and/or resource for recruitment, accrual, and coordination of patients and/or samples. ANNUAL MEETING OF RESEARCH CENTER PERSONNEL AND NIGMS STAFF: If you receive a Research Center award, you should plan on attending an annual meeting of NIGMS staff and other Research Center personnel. The goals for this meeting will be to share scientific information, assess progress, solve problems, identify new research opportunities, and establish priorities for enhancing the translation of advances to and from your Center. We will hold the meeting on or near the NIH campus. You should include travel funds in your requested budget, to cover travel expenses for the Research Center Director and one other participant, other individuals may attend, but their costs must be paid by their institutions. HOME PAGE: Each Research Center must maintain an individualized home page that describes its scope of research, lists investigators, contact information, and training opportunities, and relates other special details. We will reference and link your site to a home page for Research Centers on Trauma, Burn, and Perioperative Injury, which will be included on the NIGMS home page. In your application, you must convince reviewers that you have the necessary expertise to develop and maintain a home page. Reviewers will not consider the actual contents of your page during the review process. 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: Scott Somers, Ph.D. Division of Pharmacology, Physiology, and Biological Chemistry National Institute of General Medical Sciences Building 45, Room 2AS.43C Bethesda, MD 20892-6200 Telephone: (301) 594-5560 FAX: (301) 480-2802 Email: email@example.com o Direct your questions about peer review issues to: Helen R. Sunshine, Ph.D. Office of Scientific Review National Institute of General Medical Sciences Building 45, Room 1AS.13F Bethesda, MD 20892-6200 Telephone: (301) 594-2881 FAX: (301) 480-8506 Email: firstname.lastname@example.org o Direct your questions about financial or grants management matters to: Mr. Joe Ellis National Institute of General Medical Sciences Building 45, Room 2AN.3C Bethesda, MD 20892-6200 Telephone: (301) 594-5510 FAX: (301) 480-1969 E-mail: email@example.com SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. LETTER OF INTENT: Four weeks prior to submitting your application, prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed grant application. o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this PA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIGMS staff to estimate the potential review workload and plan the review. The letter of intent should be sent to: Scott Somers, Ph.D. Division of Pharmacology, Physiology, and Biological Chemistry National Institute of General Medical Sciences Building 45, Room 2AS.43C Bethesda, MD 20892-6200 Telephone: (301) 594-5560 FAX: (301) 480-2802 Email: firstname.lastname@example.org SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study, 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award, and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SPECIFIC INSTRUCTIONS FOR RESEARCH CENTER (P50) GRANTS: Research Center grant applications should be structured as a series of separate, but interrelated, project proposals. Use the following format: OVERALL PROPOSAL: An introductory section must contain justification for the Research Center and must describe the goals that are better met using this mechanism than other possibilities. You should identify clearly in the abstract, and more fully in the research plan, the specific biological questions to be explored and any new approaches and collaborations in place at the Center. Describe fully the synergy to be achieved by establishing multi-disciplinary teams and novel collaborations. This section should include: the face page, an abstract for the entire Center, a list of participating personnel and institutional affiliations, a biosketch, including other recent research support, for the Director of the Center, and the composite budget for the entire Center. The narrative for the general overview should include a description of the global vision, objectives, and strategy for the entire Center, a brief description of individual research projects and cores, including information on the relationship of each project and core to the Center and the unique benefits to be achieved by funding the work as a composite research program, including the synergy between separate components, a general progress report that includes a brief recent history of research conducted by the investigators and significant accomplishments of the Center (if applicable), a statement of any special institutional arrangements pertinent to the viability of the Research Center, and a brief description of the scientific leadership and overall management plan for the Center. The narrative for the introduction may not exceed 10 pages. ADMINISTRATIVE CORE: The section on the Administrative Core should contain a cover page, an abstract, a list of pertinent personnel and institutional affiliations, a detailed budget with justification, biosketches indicating other recent research support, an administrative and management plan that details the strategies and policies to be developed to assure that the Center functions optimally, a description of all institutional development activities, and details on the development and management of the Center"s home page. This narrative may not exceed 10 pages. COMPONENT PROJECTS AND CORES: You should present each subproject as an independent or, if appropriate, an interdependent research effort, prepared using the format for individual research grant (R01) applications. This format includes a cover page (with subproject title), an abstract, a list of pertinent personnel and institutional affiliations, a detailed budget with justification, biosketches indicating other recent research support, a detailed description of the research to be conducted, and appropriate justification and documentation for the use of human subjects or animals (if applicable). For each subproject, you should detail the special benefits of being associated with the Research Center, including potential synergistic efforts. The page limits for presenting each subproject are the same as for R01 applications (as specified in the PHS 398 form for sections a-d of the Research Plan). You should present core facilities, including the Human Subjects Core (if applicable), also in the format used for individual research projects. Provide the same information noted above, except for the following two points. First, instead of relating specific aims, the narrative should describe general and specific functions of each core facility within the overall Center and, in particular, the contributions of each core and the benefits of the core to other aspects of the Center. You should also provide specific details on technical and experimental aspects of the core"s functions. Second, the narrative may not exceed 10 pages per core. Please note that you are not required to submit the maximum number of pages for any section. Rather, we encourage you to submit a concise and articulate application. SENDING AN APPLICATION TO THE NIH: 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) 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. APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Upon receipt of your application, the CSR will review it for completeness, and NIGMS will review it for responsiveness to the PA. If your application is incomplete or non-responsive, it will be returned to you without further consideration. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group, convened by the Office of Scientific Review of NIGMS and in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm), will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Be discussed and assigned a priority score o Receive a second level review by the National Advisory General Medical Sciences Council You should not assume that review of your application will include a site visit or an interview of the principal investigator. Your application must be complete as submitted. Reviewers will give priority scores only to the entire Research Center and individual subprojects. Reviewers will not give priority scores to research cores or to the Administrative Core, which includes institutional development activities and (if applicable) the Human Subjects Core. However, they will provide an evaluation for each core based on the review criteria defined below. REVIEW CRITERIA The goals of NIH-supported research are to advance 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: 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 (the entire Research Center and individual components) overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. REVIEW CRITERIA FOR OVERALL RESEARCH CENTER: SIGNIFICANCE: Will the results of the Research Center have an impact on the understanding of physiological response to injury? If the aims of your application are achieved, how do they advance scientific and clinical knowledge? What will be the effect of these studies on the concepts or methods that drive this field? Will potential benefits extend beyond the injury research community? APPROACH: What are the advantages to you of the Research Center mechanism compared with support for multiple separate independent research grants (R01s)? Will the Research Center be able to perform translational research? Will the Research Center foster significant synergy among the components (i.e., be greater than the sum of its parts)? INNOVATION: Will your Research Center challenge existing paradigms or develop new methodologies, technologies, or practices? INVESTIGATOR (PROGRAM DIRECTOR): Is there adequate evidence that your Program Director has the ability to lead and coordinate activities and to develop and implement the management plan, as required for the project"s success? ENVIRONMENT: Is the degree of institutional commitment, including support for any needed expansion of facilities, improvement of infrastructure, and relief from other academic duties when necessary, clearly indicated? ADMINISTRATIVE CORE AND MANAGEMENT PLAN: Is there an appropriate management plan and adequate evidence of an effective management structure? Is the plan for deployment of equipment and human resources sufficient to attain research aims and overall Center goals? What is the quality of the plans for making critical decisions or choices about overall research direction during a project? Where appropriate, are the approaches that are being used or being developed cost-effective? Does your proposed core and plan contain the elements required to assure monitoring and oversight of financial, scientific, and administrative aspects of the Research Center? Are shared resources readily available to all qualified participants? Are resources adequate? The reviewers cannot delete an Administrative Core, but may recommend budget changes. INSTITUTIONAL DEVELOPMENT ACTIVITIES: Are your plans for bridging the Research Center to your institution described adequately? Are your proposed activities innovative and/or likely to enhance the scientific productivity of your Research Center and augment or create a larger, cohesive effort focused on the science of physiological response to injury? Do you have the capability within the Research Center, to evaluate the effectiveness of these activities? The reviewers cannot remove institutional development activities from your application, but may recommend alterations in your budget to reflect their judgment of the value and likely success of your proposed activities. REVIEW CRITERIA FOR INDIVIDUAL SUBPROJECTS AND CORES: SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: INTERACTIONS, INTERDEPENDENCE, AND INCLUSION IN THE RESEARCH CENTER: Does your proposal have significant and substantial interactions with other aspects of the Research Center? Does your component depend on other components, and visa versa? If your component does not have substantial interactions with the rest of the Research Center, are there definite benefits for including it in the Research Center (besides access to core facilities or resources)? PROTECTIONS: Is the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application, adequate? INCLUSION: Are the 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, adequately developed and described? Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on "REQUIRED FEDERAL CITATIONS" below.) BUDGET: Is the proposed budget and the requested period of support in relation to the proposed research reasonable and justified? OTHER REVIEW CRITERIA: HUMAN SUBJECTS CORE (if included): Is this core needed and essential to achieve the overall scientific goals proposed? Is there adequate oversight? Are resources allocated appropriately? This core will be evaluated and given a priority score based upon the criteria listed above. DATA SHARING OF ARCHIVAL OR DATABASE ACTIVITIES (if included): Is the proposed plan to share data and/or activities adequate? The activities you propose will be commented on by the reviewers, but their opinions will not be factored into the priority score for the pertinent subproject, core, or overall Research Center. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Appropriateness of the plan for sharing data, materials, and technology o Availability of funds o Relevance to program priorities Evidence of institutional support for the Research Center may also be important when making final funding decisions. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 is a result of the NIH Revitalization Act of 1993 (Section 492B of Public Law 103- 43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2 001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice- files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly connect to an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.859, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourages the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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