Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

Research Centers in Injury and Peri-operative Sciences (P50)

Activity Code
P50 Specialized Center
Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-13-291

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859

Funding Opportunity Purpose

The National Institute of General Medical Sciences (NIGMS) encourages grant applications from institutions/organizations for Research Centers in Injury and Peri-operative Sciences (RCIPS).  The program is meant to provide support to 1) improve understanding at all levels of the biological processes invoked after traumatic or burn injury, or in critically ill patients, including molecular and cellular, physiological, and multilevel integration of homeostatic loss and recovery, including pertinent aspects of wound healing; and 2) foster translational research, bringing basic scientific observations and principles into the clinical arena and using clinical observations to generate or validate mechanistic hypotheses.  Applications should be built around a common theme for investigation.  RCIPS applications may include interventional studies only if there is connection, harmonization and synergy with the biological and physiological processes under investigation. An application that solely proposes an interventional clinical trial would not be appropriate for this funding mechanism.  Contact with the NIGMS program official at initial stages of program planning is strongly encouraged.  

Key Dates
Posted Date

 August 2, 2013

Open Date (Earliest Submission Date)

August 25, 2013

Letter of Intent Due Date(s)

6 weeks before the standard due date

Application Due Date(s)

Standard dates apply

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

July 1, 2014

Expiration Date

September 8, 2016

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

The purpose of this FOA is announce the National Institute of General Medical Sciences (NIGMS) "Research Centers in Injury and Peri-operative Sciences” program (RCIPS). This FOA was originally issued as PAR-09-048. The overall mission of the RCIPS 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 body’s response to the acute illness as 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 RCIPS application must feature collaborations and team approaches that could otherwise not be easily established, including individuals from multiple medical and scientific fields. NIGMS expects that these collaborations be central to the RCIPS, 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 RCIPS within this program is that an emphasis must be placed on translational research, which is understood to span a bi-directional bench-bedside approach.  Thus, 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.  Successful applications will most likely include aspects of both directions of translational research.  Moreover, successful RCIPS applications will most likely emphasize T1 translational research (as defined in http://jama.jamanetwork.com/article.aspx?articleid=1149350).

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 (for either internal use only or open source for a wider scientific community). Discovery-based/high-throughput studies may be proposed as an integral part but not the sole purpose of the RCIPS application.

A RCIPS application may include interventional studies, or may 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 consistent with the intent of this FOA. Any interventional study proposed must be within a research 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 RCIPS 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 2010, unintentional injury resulted in the death of more than 120,000 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 traumatic injury 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 similar 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 approaches 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 likely 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 methodologies) to clinical problems should make it possible to discover 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 would be optimal.

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 perceived barriers that have prevented scientific collaboration. At this time, long-term research efforts by the wound-healing community have produced a knowledge base about many of the individual molecular and cellular processes involved in wound healing.  Breakthrough findings in wound healing will likely result from understanding the interdependencies of the individual wound-healing processes.  Research efforts that target these kinds of questions will require the collaborative efforts of scientists with diverse skills and expertise.

The body’s response to injury is a complex systemic process that is difficult to address, particularly through narrowly defined individual research projects. Studies of injured humans can be challenging for medical, scientific, and ethical reasons, but they are possible and necessary. The multi-component RCIPS program offers investigators the opportunity to enhance the scientific effort from multiple perspectives and to allocate and leverage resources efficiently, thus accelerating research progress.

Scope of Research

The scope of research for RCIPS broadly covers the mechanisms of immediate and/or long-term adaptive and maladaptive physiological responses to injury (defined as blunt, penetrating, surgical, or burn injury and including hemorrhage occurring due to tissue damage).  Research topics derived from complications faced by critically ill patients in intensive care units may be appropriate for this FOA if conditions are common following injury (sepsis or multiple organ failure).  This research includes but is not limited to:

The time frame for research occurs immediately post-injury through ultimate resolution (recovery or death), but an application need not cover the entire span.  In general, applications should address systemic responses to injury and acute critical illness. Applications should not focus on a single organ system, but rather multi-system perspectives are required. 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 projects on brain, spinal cord, or nerve injury if the overall focus fits within the topics listed above and the majority of research proposed is not exclusively centered on the nervous system. Similarly, some epidemiological effort may fit well within the general theme of a RCIPS, but it may not be the predominant element of study.

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.

RCIPS applications may include interventional studies if and only if there is connection, harmonization and synergy with the biological and physiological processes under investigation. An application that only proposes an interventional clinical trial would not be appropriate for this funding mechanism.  

Components and Organization of a RCIPS

Each center must be an integrated, coordinated effort, featuring collaborations and team approaches that accomplish significantly more than a collection of largely independent R01 projects. Project integration may be reflected in the scientific interdependence of the projects and/or shared leadership of the projects. It also should be clearly evident in the governance of the Center. The benefits to be achieved through the establishment of multidisciplinary teams and novel collaborations must be described fully in the application. The minimum requirements for a RCIPS will be three independent research projects led by faculty-level participants, a Human Subjects Core, and an Administrative Core. Additional cores and/or shared resources may be proposed as appropriate to each center. The Human Subjects Core is intended 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 projects, and is not the appropriate place in the application for clinical trials. It is important however that this Human Subjects Core or any other core not contain hypothesis-driven or discovery studies, which must be placed within the projects in the RCIPS. 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 RCIPS structure will be assessed in peer-review.

Proposed projects should have the research scope and depth typical for research grant projects. Applicants should describe collaborative and interdependent research projects as well as mechanisms for promoting scientific interactions among the participants. Plans must also be presented for effective team communication and coordination of effort that cover 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 projects is desirable; a particular project must benefit from inclusion in the overall center and ideally the center benefits as well.  All component parts of the RCIPS must be interactive. RCIPS applications that are multidisciplinary in nature are highly encouraged.

Cores are defined as research resources providing essential services, techniques, or instrumentation to the RCIPS projects, 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 projects or elsewhere in the institution.  At a minimum, a core must be used by at least 2 projects. Ideally cores should facilitate interactions between the center participants. Whereas cores may also have developmental aspects, specific hypothesis- or discovery-based research questions must be contained within projects.

Administration and Management

Due to the inherent complexity of research centers, including collaborative and/or interdependent research projects as well as shared resources, a carefully described management plan that ensures progress and that the interests of all participants are represented will be required and should be addressed within the mandatory Administrative Core.  

The PD/PI of the Center 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 projects, as well as the measures to ensure that progress is strong, steady and timely.  While it is anticipated that RCIPS applications will include participants from a single institution, those that involve participants from more than one department or institution are welcome under this FOA. In all cases, the applicant should describe how interactions between investigators, projects and cores will be facilitated.

Projects of the anticipated degree of complexity, both scientific and managerial, will require a substantial investment of the PD’s/ PI's effort. It is expected that the overall RCIPS Director should commit at least 10% effort to the administration of the center.  The Lead for each project 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 can be used to provide independent assessment and advice to the RCIPS PD/PI and other participants. The boards will be appointed by the RCIPS PD/PI and confer as often as required in the manner most efficient for the given situation. Such advisory boards are strongly suggested as a useful resource for the RCIPS leadership.

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

Human Subjects Core

To meet the goal for translational research, acquisition and management of human subjects should be consolidated within a separate Human Subjects Core, rather than keeping all aspects of these studies with the relevant project(s). Establishing a Human Subjects Core can effectively provide isolated cell and tissue samples or physiological assessments of individuals and appropriate controls. The Human Subjects Core should have responsibility 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 projects. A particular individual who will directly supervise the core functions and activities should be specified. Furthermore, if opportunities arise for multi-institutional research studies involving injured humans, the Human Subjects Core should serve as a focal point and/or resource for recruitment, accrual, and coordination of patients and samples. 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 research projects. The Human Subjects Core is mandatory for an RCIPS application.

Annual Meeting of RICPS Personnel and NIGMS Staff

A meeting of all RICPS PDs/PIs and NIGMS staff will be held annually.  Other RICPS personnel and staff may attend as appropriate.  Other participants from the Federal government and/or other institutions and organizations may be invited by NIGMS. 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 RICPS. 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.

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 include 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 Nation’s capacity to address and eliminate health disparities.

Accordingly, NIGMS encourages RCIPS 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.

Section II. Award Information
Funding Instrument

Grant:  A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIH intends to fund an estimate of 3 awards, corresponding to a total of $8,100,000 for fiscal year 2014. Future year amounts will depend on annual appropriations.

Award Budget

An applicant may request a budget in direct costs up to $1.8 million per year.  Applicant budgets need to reflect the actual needs of the proposed project.  Funds for initial large equipment may be requested in excess of the $1.8 million limit if prior approval is obtained from the Scientific/Research Contact  listed in Section VII. 

Award Project Period

 An applicant may request a project period of up to five years. 

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

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) and component Project Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

  1. To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  2. Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  3. Of an application with a changed grant activity code.
Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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 as well as to potentially provide feedback to the applicants

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Scott Somers, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
NIGMS, NIH
45 Center Drive
Building 45, 2As.43K
Bethesda, MD 20892-6200
Telephone: 301-594-3827
Email: somerss@nigms.nih.gov

Application Submission

Applications submitted to this FOA will be made up of a collection of application components. All applications will include an ‘Overall’ component that provides information regarding the application as a whole, as well as a combination of additional component types. Applicants should select the appropriate application component types in ASSIST when preparing applications. Note, eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

6

Human Subject Core

6

Core (use for all other Cores)

6

Project

12


Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed unless otherwise specified in the text of this announcement.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Note: Cores will be listed in the final application in the order in which they were entered in ASSIST.

Note: Projects will be listed in the final application in the order in which they were entered into ASSIST.

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Provide a succinct summary of the proposed work for the entire RCIPS.

Project Narrative: In 1-3 sentences describe the relevance on public health for the research to be conducted by the RCIPS.

Facilities and Other Resources: Provide a description of resources for all cores and projects in the Facilities and Other Resources attachment.   Information from this attachment will be used to evaluate the quality of the scientific environment for the research proposed.

Equipment: Do not include. Equipment should be identified in the appropriate components. Equipment that is shared across components should be described in the Administrative Core.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan          (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the aims of the overall center and outline how each component will contribute to these aims.

Research Strategy:

Significance: The applicant should describe the overall theme of the RCIPS and how translational research will be advanced.  Focusing on the center as a whole address (i) the importance of the problem or critical barrier to progress in the field that the proposed center is focused on, (ii) how the resources of the proposed center will improve scientific knowledge, technical capability, and/or clinical practice; (iii) how the concepts methods, technologies, treatments, services, or preventive interventions that drive this field will be improved if the proposed aims are achieved.  The integration of the proposed research projects and cores as well as the entire research team is a key factor that will be assessed in peer review.  A clear explanation of the benefits of inclusion of all components must be provided.      

Renewal Applications: Describe any changes in research emphasis.

Innovation: Considering the center as a whole, show how the proposed research seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Does the proposed work refine, or improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed?

Approach: The RCIPS application must specify the administrative and organizational structure(s) that will be used to support the research, and the interactions and/or synergies enabled by those structures as well as how each component part contributes to the overall cohesion of the effort. Include the major approaches and studies in the application showing how the approaches of cores complement each other or are inter-dependent.  Describe the mechanisms that will ensure the coherence of the center and maintain a multidisciplinary focus. A timeline should be presented for each project and core. This timeline should outline the expected accomplishments within the time frame requested for the award. The timeline will help NIGMS evaluate progress toward the centers goals. Explicit, quantitative milestones are highly recommended for all aspects of the RCIPS. 

Center Organizational Structure:  Applicants should include a diagram of the organizational structure of the Center.  This diagram should demonstrate how the interactions among the Center components will achieve the stated goals of the Center. 

Table of Research Core Utilization:  In order to assist the reviewers in determining the relationship between the Research Cores and the Research Projects, a table should be provided that indicates the percentage use of each core relative to the individual projects.

Renewal Applications: Provide an Overall Progress Report that addresses the major scientific achievements.

In lieu of a progress report, new applications will be evaluated based on preliminary organizational work, experience, potential for developing new and exciting research, and specific plans for implementation of the new program.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Letters of Support: Include signed letters of support from all collaborating institutions.

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Equipment: Describe any equipment that is shared across components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Administrative Core)

The Program Director/Principal Investigator of the proposed Center should also be the Administrative Core Lead. In the Project Director/Principal Investigator section, use Project Role of ‘Other’ with Category of ‘Center Director’ and provide a valid eRA Commons ID in the Credential field. The biographical sketch should present evidence of scientific expertise relevant to the themes of the Center and demonstrate the capacity for the leadership of the Center.  

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.  

An Associate Director may be named who will be involved in the administrative and scientific efforts of the Center. If named, specify Project Role of ‘Other’ with Category of ‘Associate Director’.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient. If more than 30 subawardees, then include details for additional subawardees in the budget justification. Any questions about budget development may be directed to the Financial and Grants Management Contact listed below (Section VII).

PHS 398 Research Plan    (Administrative Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  Describe the aims of the Administrative Core.

Research Strategy:  Within the Research Strategy, the application should describe how the Administrative Core will take a leadership role in ensuring the synthesis of findings and activities from research projects and cores towards solving the central problem proposed by the RCIPS.  Clearly state how the Administrative Core will contribute to the goals of the RCIPS and outline interactions of the Administrative Core with each of the other cores and projects. Provide an overview of how the Administrative Core will set the overall direction of the RCIPS and ensure optimal utilization of resources, including plans for the strategic and day-to-day management of the center.  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 RCIPS participants. Potential members for advisory boards (particularly external members) should not be contacted prior to an award, specific members should not be named in the application, and letters should not be supplied at the time of application as this complicates the peer review process; only the expertise that will be included should be described.  If however there are existing internal or external advisory boards (e.g., for a renewal application), the members should be listed in the application.  

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.

The Administrative Core should delineate means for ongoing evaluation of each component part of the RCIPS and describe the framework through which problems (such as under-performing projects 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.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Human Subjects Core

When preparing your application in ASSIST, use Component Type ‘Human Subjects Core’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Human Subjects Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Human Subjects Core Name)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Human Subjects Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Human Subjects Core Name)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Human Subjects Core)

In the Project Director/Principal Investigator section, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Human Subjects Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient. If more than 30 subawardees, then include details for additional subawardees in the budget justification. Any questions about budget development may be directed to the Financial and Grants Management Contact listed below (Section VII).

PHS 398 Research Plan   (Human Subjects Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the aims of the Human Subjects Core.

Research Strategy:  Within the Research Strategy, the applicant should describe the acquisition and management of cells, tissues, and/or patients including physiological, clinical, demographic, and outcomes data as dictated by the RCIPS and detailed in Section 1 above. To support these activities, funds may be requested for personnel such as research nurses or data managers and for necessary supplies, patient care, consultant fees, and other pertinent expenses.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Cores

When preparing your application in ASSIST, use Component Type ‘Core’ (with appropriate descriptive titles).

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Core)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Core)

In the Project Director/Principal Investigator section, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient. If more than 30 subawardees, then include details for additional subawardees in the budget justification. Any questions about budget development may be directed to the Financial and Grants Management Contact listed below (Section VII).

PHS 398 Research Plan  (Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  Describe the aims of the particular core.

Research Strategy:  Within the Research Strategy, the application should describe the function of the core and how the activities will interact with and enhance the other RCIPS components. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Projects

When preparing your application in ASSIST, use Component Type ‘Project’ (with appropriate descriptive titles).

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project)

Complete only the following fields:

PHS 398 Cover Page Supplement (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Project)

In the Project Director/Principal Investigator section, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan   (Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  Describe the aims of the research projects.

Research Strategy:  Within the Research Strategy, the application should provide descriptions of how the individual project fits within the overall RCIPS including interactions, interdependency and possible synergy with other components. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the NIGMS Referral Office by email at Sheehyp@nigms.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post-Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

It is expected that most applications will be discussed and assigned an overall impact  score based on the following criteria. If however all reviewers agree that an overall RCIPS application lacks significant merit or has fundamental weaknesses, they may vote to not discuss the application although written comments for the overall application, individual projects and all cores will be provided to the applicant.  Unless the overall RCIPS is not discussed, individual projects and all cores will be scored as well, also using the following criteria. If the overall RCIPS is not discussed, then no individual project or core will be scored.  Except for the Administrative and Human Subjects Cores (which must be included) inclusion or exclusion of each individual project and core will be considered although the overall impact score for the entire RCIPS shall be based on the application as presented. 

Overall Impact - Overall

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

Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit. Individual criteria will not be scored for the overall application.  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

In total, how does the RCIPS address an important problem? Does the RCIPS propose translational research?  How will the RCIPS likely be effective in performing the proposed translational research efforts?   What will be the effect of the overall RCIPS effort and results on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)

Does the PD/PI(s) of the RCIPS have the appropriate management and administrative skills to lead and coordinate the activities, and to develop and implement the management plan, as optimally required for the center’s success?  Do the project 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 sufficient for the research proposed?

Innovation

How  is originality and innovation demonstrated by the overall center?  For example: How does the RCIPS challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  How does the RCIPS develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Approach

How does the overall RCIPS 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)?  How will the RCIPS 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 RCIPS, is there a strong advantage for inclusion, such as added cohesion or providing an innovative direction?  How much interaction exists among all the components?  How critical are the interactions among the key 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 RCIPS, and if so, how will the efforts achieve the stated goals?  Is there an attempt to engage appropriate outside organizations, efforts or activities into the goals and/or activities of the RCIPS?   

Environment

How 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?   

Overall Impact - Projects

Reviewers will provide an overall impact score for each project 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 review criteria and additional review criteria (as applicable for the project proposed).  Reviewers will further recommend whether a project should be included or excluded.

Scored Review Criteria - Projects

Reviewers will consider each of the review criteria below in the determination of scientific 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(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

Innovation

Does the project 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

How 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?  To what extent does the project interact with/depend on other projects and components of the RCIPS?  Note that synergy between projects is desirable but not absolutely necessary if a case may be made that there are definite benefits for including it in the overall effort (and beyond simple access to core facilities or resources). 

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

How 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?   

Overall Impact - Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the cores to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the core proposed). Reviewers will determine whether the Administrative Core and the Human Subjects Core are acceptable or unacceptable.

Scored Review Criteria - Cores

Reviewers will consider each of the review criteria below in the determination of scientific 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.  Reviewers should assess a support core’s ability in providing essential services, techniques, or instrumentation to the research projects, thus enabling more efficient and effective conduct of the research.  

Administrative Core

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 RCIPS?  What is the quality of the plans for making critical decisions or choices about overall research direction for projects and utilization of core functions?  Is the plan for deployment of equipment and human resources sufficient to attain research aims and overall RCIPS 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?  Is the timeline and are the milestones the most appropriate and efficient?

All Other Cores including Human Subjects Core

Significance

How does the core address an important problem or a critical barrier to progress in the RCIPS? If the aims of the core 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 of the projects and RCIPS?  Will the core be used by two or more 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(s) and other participants? Does the core team bring complementary and integrated expertise to the projects and overall RCIPS (if applicable)?  Are the leadership approach, governance and organizational structure appropriate for the project?   

Innovation

How 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 conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well-reasoned, and appropriate to the aims of the projects and overall RCIPS? Does the applicant acknowledge potential problem areas and consider alternative tactics?  Can the core deliver the proposed activities/services required by the project(s) and RCIPS?  Will the core help promote interactions among the RCIPS participants?

Environment

How 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 core proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements offered through the core?   

Additional Review Criteria – All Components

As applicable for the RCIPS, projects and cores proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score (where applicable), 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

For Resubmissions, 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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, 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.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent 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).

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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIGMS in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to The National Institute of General Medical Sciences. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National General Medical Sciences Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Scott Somers, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
National Institutes of Health
Telephone: 301-594-3827
Email: somerss@nigms.nih.gov

Peer Review Contact(s)

Helen Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
National Institutes of Health
Telephone: 301-594-2881
Email: sunshine@nigms.nih.gov

Financial/Grants Management Contact(s)

Lisa Moeller
Division of Extramural Activities
National Institute of General Medical Sciences
National Institutes of Health
Telephone: 301-594-3914
Email: moellerl@nigms.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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