Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)

Title: Research Centers in Trauma, Burn, and Peri-Operative Injury (P50)

Announcement Type
This is a reissue of PAR-02-092.

Update: The following update relating to this announcement has been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-09-048

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: December 12, 2008
Letters of Intent Receipt Date(s): Letters of intent should arrive at NIGMS at least 30 days prior to the intended submission date. http://grants1.nih.gov/grants/funding/submissionschedule.htm
Application Submission Dates(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: (Extended to May 7, 2012 per NOT-GM-11-118), Original Date January 8, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
       1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose of this FOA

The purpose of this FOA is to re-announce the National Institute of General Medical Sciences (NIGMS) "Research Centers in Trauma, Burn, and Peri-operative Injury program (RCTBPI). This FOA was originally issued as PAR-02-092. Both new and competing renewal applications will be accepted under this FOA. The overall mission of the RCTBPI program is to foster hypothesis-based and translational research around a theme related to the human physiological response to injury and/or processes of acute/critical illness. Specifically, these research centers are multi-disciplinary efforts that employ state-of-the-art technology and procedures to further the goal of understanding and better controlling the bodys response to the acute illness as is invoked by severe trauma or burn injury. Relevant research could cover the immediate post-trauma period through ultimate resolution and is inclusive of conditions and complications commonly referred to as critical illness such as systemic inflammatory response syndrome (SIRS), sepsis, and multiple organ dysfunction syndrome (MODS) as well as the process through which wounds caused by injury are repaired and/or healed. A RCTBPI application must feature collaborations and team approaches that would otherwise not be established, including individuals from multiple medical and scientific fields. NIGMS expects that these collaborations be central to the RCTBPI, elevating a successful program beyond a collection of independent R01-type projects, meaning that there must be demonstrable evidence of significant value-added to grouping the research efforts together in a unified effort beyond a simple economy of resources.

A vital foundation for all RCTBPI within this program is that an emphasis must be placed on translational research. Appropriate RCTBPIs will adhere to the vision promoted as part of the NIH Roadmap:

Scientists are increasingly aware that this bench-to-bedside approach to translational research is really a two-way street. Basic scientists provide clinicians with new tools for use in patients and for assessment of their impact, and clinical researchers make novel observations about the nature and progression of disease that often stimulate basic investigations.

In particular, RCTBPI programs must focus on what is now considered to be T1 translational research. In light of the requirement for two-way communication between laboratory/clinical science and the bedside, it is expected that the successful centers will include research on human subjects, and most likely be patient-oriented. The entire research effort need not be solely based on human studies however, and a mix of in vitro or experimental model systems may be appropriate given the overall theme of the center. Applications should propose some human and/or patient oriented research beyond creation and maintenance of a database containing clinical and/or biological/physiological information. Discovery-based/high-throughput studies may be proposed as an integral part but not the sole purpose of the RCTBPI application.

A RCTBPI application may include interventional studies, or may in fact be based around trials if and only if there are complementary studies proposed that will further the understanding of the fundamental biological and physiological mechanisms underlying the human response to injury or acute critical illness. Accordingly, an interventional study with only associated discovery science activities would not be considered responsive to this FOA. Any interventional study proposed must be within a project and not as a core activity.

There should be evidence that the presence of a center structure is essential for the accomplishment of the research activities. It is expected that a RCTBPI will transform knowledge in the sciences it is studying. Incremental work should not be the sole focus of center activities; rather, new and creative directions are required.

Background

Injury is the leading cause of death for Americans under the age of 44 years. In 2005, unintentional injury resulted in the death of more than 117,000 individuals per year in the United States (National Center for Health Statistics, http://www.cdc.gov/ncipc/wisqars/), ranking fifth behind heart disease, cancer, stroke, and lung disease as a cause of death. The years of potential life lost due to trauma are significant. 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. Similarly, surgical interventions for other disease conditions constitute a class of controlled injuries and have peri-operative 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 immediately or 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. Applying newly available expertise and technology (e.g., genomics, proteomics, metabolomics, quantitative analytical approaches, and high-throughput testing) to clinical problems makes it possible to discover new interactions and physiological mechanisms. Simultaneously, scientists who understand the clinical issues faced by injured patients can offer specific direction for mechanistic laboratory investigations. Approaching problems from multiple directions is necessary.

The bodys 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 RCTBPI program offers investigators the opportunity to enhance the scientific effort from multiple perspectives and to allocate and leverage resources efficiently, thus allowing optimal research progress.

Successful wound healing requires a complex and integrated interplay of different cell types, pathways, and processes. Over the years, basic and clinical research has revealed much about the individual molecular and cellular processes involved in wound healing, but attempts to accelerate and/or improve wound healing by enhancing, inhibiting, or modifying isolated aspects of the wound-healing process have met with only limited success. Previous progress was hampered by the limitations of animal model systems in mimicking human wound healing, gaps in the understanding of how the molecular and cellular processes of wound healing are interconnected and interdependent, and perceived barriers that have prevented scientific collaboration. At this point in time, long-term research efforts by the wound healing community have produced a large and detailed knowledge base about many of the individual molecular and cellar processes involved in wound healing. There is also a realization that break-through findings in wound healing will likely result from understanding the interdependencies of the individual wound-healing processes and that research efforts that target these kinds of questions will require the collaborative efforts of different scientists with diverse skills and expertise.

Scope of Research

The appropriate scope of research for RCTBPI from NIGMS 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:

The time frame suitable for research is from immediately post-injury through ultimate resolution (recovery or death). Research topics derived from complications faced by critically ill patients in intensive care units may be responsive to this FOA. In general, applications should address systemic responses to injury and acute critical illness. Applications should not focus on a single organ system, rather multi-system perspectives are encouraged. In particular, applications that focus only 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 are outside the mission of NIGMS. Projects may include research on the nervous systems 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. Similarly, some epidemiological effort may fit well within the general theme of a RCTBPI, but it may not be the predominant element of study.

The public health issues related to trauma are far-reaching. Applicants are encouraged 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. The ability to obtain institutional and other support for these activities would be viewed as enhancing the chances for success of the RCTBPI application.

Elements and Organization of a RCTBPI

As stated above, each center must be an integrated, coordinated effort, featuring collaborations and team approaches that render it more than a collection of largely independent R01 projects. Project integration may be reflected in the scientific interdependence of the subprojects and/or shared leadership of the subprojects. It also should be evident in the governance of the Center. The integration of the proposed research projects and of the research team is a key factor that will be assessed in peer review.

The benefits to be achieved through the establishment of multidisciplinary teams and novel collaborations, as opposed to working independently, must be described fully. The applicant should identify clearly in the abstract, and more fully in the research plan, the overall theme of the RCTBPI and how translational research will be achieved.

The minimum requirements for a RCTBPI will be three independent research subprojects led by faculty-level participants, and an Administration Core. Additional cores or shared resources may be proposed as appropriate to each center. A separate Human Subjects Core is possible to maximize efficiency and quality for patient-oriented research, generation and maintenance of a clinical database, and/or generation and distribution of biological samples to subprojects. It is important however that this Human Subjects Core or any other core not contain hypothesis-driven or discovery studies, which need to be placed within the subprojects in the RCTBPI. NIGMS is not specifying a maximum number of projects, cores or participants; rather, the size of a center should be a function of the science as well as the available funds (see below). The anticipated effectiveness of the proposed RCTBPI structure will be a criterion of the peer-review evaluation prior to an award and will be monitored after an award is made.

Proposed subprojects should have the research scope and depth typical for R01 applications. Applicants should describe collaborative and interdependent research subprojects as well as mechanisms for promoting scientific interactions among the participants. Plans must be presented for effective team communication and coordination of effort that covers the development, implementation, and conduct of all aspects of the research program. It is essential to justify the proposed center in terms of the "value added" beyond what would be expected from a set of independent R01-style projects. Synergy between subprojects is desirable but not absolutely necessary if a case may be made that a particular subproject benefits from inclusion into the RCTBPI or that the overall center benefits from a non-synergistic subproject. Regardless of the synergy however, all component parts of the RCTBPI must be interactive. Subprojects and overall RCTBPI applications that are multidisciplinary in nature are encouraged.

Cores are defined as research resources providing essential services, techniques, or instrumentation to the RCTBPI subprojects, thus enabling more efficient and effective conduct of the research. Cores must be well-justified central components of the center and clearly non-redundant with support provided within the subprojects or elsewhere in the institution. At a minimum, a core must be used by at least 2 subprojects. Ideally, although not required, cores also should attempt to increase interactions between the center participants. Whereas cores may also have developmental aspects as part of their overall function, specific hypothesis- or discovery-based research questions must be contained within subprojects.

A time line should be presented for each subproject and core. This time line should outline the expected goals within the time frame requested for the award. The time line will help NIGMS evaluate progress toward the centers goals. Explicit, quantitative milestones for projects are also recommended for all aspects of the RCTBPI.

Administration and Management

Due to the inherent complexity of research centers, including collaborative and/or interdependent research projects as well as shared resources, a well thought out and carefully described management plan that ensures that the interests of all participants are represented will be required. Within the context of the Administrative Core, plans must be presented for the proper strategic and day-to-day handling of the center. The RCTBPI application must specify the administrative and organizational structure(s) that will be used to support the research, and the synergies enabled by those structures as well as how each component part contributes to the centers overall cohesion. Or, for those situations where a subproject may not be synergistic with the others, a clear explanation of the benefits of inclusion must be provided.

The PD/PI of the RCTBPR will be responsible for ensuring that scientific goals are met and for developing and managing a decision-making structure and process that will allow resources to be allocated equitably in order to meet those scientific goals. To that end, the PD/PI must describe how the scientific focus will be maintained in the overall project and in each of the subprojects, as well as the measures to ensure that progress is strong and steady. It is expected that the overall RCTBPI Director should commit at least 10% effort to the administration of the center; research effort would be in excess of this level of effort. One or more associate directors should be named as well, with a clearly defined administrative hierarchy presented. A plan covering succession of leadership should be provided.

While it is anticipated that most RCTBPI applications will include participants from one institution, those that involve participants from more than one physical site are welcome under this FOA. If any of the components is physically separated from the others (e.g., different departments or institutions), the applicant should describe how interactions will be facilitated. The signature of the authorized organizational official on the Face Page signifies that the applicant and all proposed consortium participants understand and agree to the following statement: The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the NIH consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy. A separate statement is no longer required.

Projects of the anticipated degree of complexity, both scientific and managerial, will require a substantial investment of the PI's effort. The PD/PI for each subproject and core will be required to devote sufficient effort to ensure successful leadership and implementation of the goals of his/her individual part as well as the overall center.

Internal and/or external advisory boards of research scientists who are not involved in the center may be used to provide independent assessment and advice to the RCTBPI PD/PI and other participants. The boards would be appointed by the RCTBPI PD/PI and confer as often as required in the manner most efficient for the given situation. Such advisory boards are not a requirement of this PAR but are suggested as a useful resource for the RCTBPI leadership. If either internal or external advisory boards are to be used, the Administrative Core should provide clear descriptions of how members will be selected; how, when, and where meetings will be held; and how information and suggestions/recommendations flow between the board(s) and RCTBPI participants. Specific membership for advisory boards should not be named in the application.

The Administrative Core should delineate means for ongoing evaluation of each component part of the RCTBPI and describe the framework through which problems (such as under-performing subprojects or cores; scientific changes created through the normal process of progress within or outside the center; internal conflicts over resources, concepts, or publications; etc.) are handled.

Examples of Administrative Core functions include but are not limited to:

Any archival or database activities included in the application must be detailed.

Institutional Outreach Activities

The Administrative Core will be responsible for outreach activities to both further the overall aims and objectives of the RCTBPI and help define the RCTBPI as a focal point for trauma, burn, and peri-operative injury activities within the home institution. Outreach activities might include a seminar series, guest lectures, research day, workshops, mentor-training courses, symposia, learning experiences (for RCTBPI participants or individuals in the home institution or surrounding community), mini-sabbaticals, or other educational activities. Travel funds may be used by RCTBPI participants to learn new laboratory techniques at different sites or to bring experts into the RCTBPI for a short period of time, as well as to develop new collaborations or engage in scientific information exchange. While there is neither a minimal nor maximal amount of institutional outreach activities allowable, each application should propose what will best enhance achieving the overall goals and objectives of the RCTBPI.

Human Subjects Core

To meet the goal for translational research, acquisition and management of human subjects may be consolidated within a separate Human Subjects Core, rather than keeping all aspects of these studies with the relevant subproject(s). Establishing a Human Subjects Core may be effective if a significant portion of the RCTBPI 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 could 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. A particular individual who will directly supervise the cores functions and activities should be specified. To support these activities, up to $250,000 in direct costs per year above the limits specified in the section on "MECHANISM OF SUPPORT" (see below) may be requested 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. Please note that the Human Subjects Core is meant for consolidation and efficient handling of patient-oriented research and is not to be used for proposing or running of actual research protocols. Rather, all experiments, either hypothesis- or discovery-based or interventional, must be proposed and managed within the subprojects. All subprojects will receive an impact/priority score within the peer review process while the Human Subject Core (like other cores) will simply be rated as acceptable/unacceptable. Thus, to assure that all experiments on human subjects receive the full benefit of peer review, it is inappropriate to include such experiments in cores.

Annual Meeting of RCTBPI Personnel and NIGMS Staff

All awarded RCTBPIs will attend an annual meeting of NIGMS staff and other RCTBPI personnel. Other participants from the Federal government and/or other institutions and organizations may be invited as appropriate. 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 each RCTBPI. The meeting will likely be held on or near the NIH campus or at an alternative location if coordinating with the timing of a national scientific meeting. At is discretion, NIGMS may consider the award of supplemental funds to support this planning activity if the expense for hosting the meeting becomes the responsibility of one or more RCTBPI; however, all requests for supplemental funds must included verification that funds are currently unavailable to cover these costs, including re-budgeting from other cost categories.

Enhancing Diversity

The NIH recognizes a compelling need to promote diversity in the biomedical, behavioral, clinical, and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment to balance and broaden the perspectives in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nations capacity to address and eliminate health disparities.

Accordingly, NIGMS encourages RCTBPI applicants to diversify their investigator populations and thus increase participation of individuals currently under-represented in the biomedical, behavioral, clinical, and social sciences such as: individuals from under-represented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity announcement (FOA) will use the P50 Research Center grant award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIGMS provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions are not eligible.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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 support.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2).  For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Applicants may submit a renewal application.

Applicants may submit more than one application, provided that each application is scientifically distinct.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on item box 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): Letters of Intent should arrive at NIGMS at least 1 month before the intended application receipt date listed in the following Application Receipt Date(s) section.
Application Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

Scott Somers, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, Room 2As.49H, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
FAX: (301) 480-2802
Email: somerss@nigms.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html). At the time of submission, two additional copies of the application and all copies of the appendix materials must be sent to:

Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Room 3AN.12F, MSC 6200
National Institutes of Health
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: sunshinh@nigms.nih.gov

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

Research Plan Page Limitations

The application should include: (a) a single face page for the entire application; (b) description; (c) key personnel listing; (d) table of contents; (e) the consolidated budget for the entire RCTBPI grant [summarizing budgets for the component projects and core(s)]; (f) individual project and core budgets; (g) biographical sketches for all key personnel; (h) resources and facilities (including major instruments and special program resources); (i) institutional support; (j) project overview/Overall Research Strategy (including a description of the overall scope and objectives; (k) justification of the P50 Center mechanism, including a description of the synergy among the participants, the research projects, and the other components of the RCTBPI and a discussion of how the scientific goals will be furthered via the P50 Center grant mechanism in ways that would not be readily attainable through individual research project grants; (l) plans for administrative management; (m) plans for project management; (n) plans for handling intellectual property issues; (o) project descriptions/Research Strategies); (p) description(s)/Research Strategies of core(s); and (q) letters of collaboration. Section (h) must also detail the relationship of other support to the proposed Center and describe anticipated modifications to that support in the event of funding (e.g., folding in support for related, already funded research).

Each project narrative should include (in the following order) a cover page (with title and PDs/PIs), description (abstract), budget pages, and a detailed research plan. The research plan should be organized as specified in the PHS 398 application form and will include specific aims, research strategy. The research strategy for each project and core will be 12-pages. The special benefits (to the project) of being associated with the Center must also be addressed.

Each core facility should be described in no more than 12 pages, in addition to the budget pages for that particular core. Separate sections describing and justifying the core resource(s) should be included. Sections (j) through (o) of the application (see above) should be presented in no more than 12 pages. For renewal applications, section (l) should include a discussion of progress to date, in addition to the topics that are specified above.

Note that there is no requirement to submit the maximum number of pages; to the contrary, concise, articulate applications are strongly encouraged.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application, as described above.

Annual meeting: Applicants should plan to attend an annual meeting of RCTBPI awardees, in order to present results and to discuss issues of common interest or concern. For the purpose of preparing an appropriate budget, it should be presumed that at least two representatives of each center will attend this annual meeting. Participating faculty, graduate students, postdoctoral associates, center staff, and external advisory board members are encouraged to attend the scientific sessions of the RCTBPI annual meeting.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;

2) Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application.  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIGMS and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious impact/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.

For subprojects:

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance:  Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition to the above review criteria, the following will be addressed and may be considered in the determination of scientific merit and the rating.

Interactions, interdependence, and inclusion in the RCTBPI: Does the subproject have significant and substantial interactions with other aspects of the RCTBPI? Does the subproject depend on other components, and visa versa? If the subproject does not have substantial synergy with the rest of the RCTBPI, are there definite benefits for including it in the overall effort beyond access to core facilities or resources?

For cores:

Significance: Does the core address an important need within the RCTBPI? If the aims of the core are achieved, how will scientific or clinical knowledge of the sub-projects be advanced? What will be the effect of the core functions on the concepts, methods, technologies, treatments, services, or preventative interventions of the sub-projects?

Investigator(s): Are the core director(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the core director and other participants? Does the core team bring complementary and integrated expertise to the sub-projects and overall RCTBPI (if applicable)?

Innovation: Are the core activities original and innovative? Does the core develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Can the core deliver the proposed activities/services required by the subproject(s) and RCTBPI?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Administration Core and Management Plan: Is there an appropriate management plan and adequate evidence of an effective management structure? Do the proposed administration core and management plan contain the elements required to assure monitoring, oversight, and ongoing evaluation of financial, scientific, and administrative aspects of the RCTBPI? What is the quality of the plans for making critical decisions or choices about overall research direction for subprojects and utilization of core functions? Is the plan for deployment of equipment and human resources sufficient to attain research aims and overall RCTBPI goals? Where appropriate, are the approaches that are being used or being developed cost-effective? Are shared resources readily available to all qualified participants? Are resources adequate? Are the proposed institutional outreach activities reasonable and likely to be effective?

For the overall RCTBPI:

Significance: In total, does the RCTBPI address an important problem? Does the RCTBPI propose translational research? Will the RCTBPI likely be effective in performing the proposed translational research efforts? What will be the effect of the overall RCTBPI effort and results on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the outcomes result in incremental advances or potentially transform the field? Will potential benefits extend beyond the injury and critical illness community?

Investigator(s): Does the Principal Investigator of the RCTBPI have the appropriate management and administrative skills to lead and coordinate the activities, and to develop and implement the management plan, as required for the project's success? Do the subproject and core leaders have appropriate scientific and managerial skills, as well as a commitment to team-oriented science? Are the levels of effort of the key personnel adequate?

Innovation: Is the overall RCTBPI original and innovative? For example: Does the RCTBPI challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the RCTBPI develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Approach: Can the overall RCTBPI achieve the proposed aims, goals, and objectives with the research proposed? What are the advantages of the proposed center mechanism compared with support for multiple separate independent research grants (R01s)? Will the RCTBPI foster significant synergy among the components (i.e., be greater than the sum of its parts)? If there are components purposefully not synergistic with the rest of the RCTBPI, is there a strong advantage for inclusion, such as added cohesion or providing an innovative direction? How much interplay and synergy are there among the projects and among the key personnel? Are the interactions among the key personnel critical to achieving the stated goals? Is there an attempt to engage other aspects of the parent institution(s) into the goals and/or activities of the RCTBPI? Is there an attempt to engage appropriate outside organizations, efforts or activities into the goals and/or activities of the RCTBPI?

Environment: Is there evidence of institutional support, including any needed expansion of facilities, improvement of infrastructure, and relief from other academic duties, where necessary?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

For all components seeking renewal, was progress in the prior funding period adequate and did it satisfactorily achieve the stated goals and objectives?

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

Scott Somers, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, Room 2As.49H, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
FAX: (301) 480-2802
Email: somerss@nigms.nih.gov

2. Peer Review Contacts:

Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Room 3AN.12F, MSC 6200
National Institutes of Health
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: mailto:sunshinh@nigms.nih.gov

3. Financial or Grants Management Contacts:

Ms. Lisa Moeller
Grants Management Officer
National Institute of General Medical Sciences
National Institutes of Health
45 Center Drive, Room 2AN.50C, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3914
FAX: (301) 480-5601
Email: moellerl@nigms.nih.gov

Section VIII. Other Information


Required Federal Citations

Vertebrate Animals:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, 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 and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 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 funding opportunity 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.

Inclusion of Women, Minorities, and Children:
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical 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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigators NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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