and Human Services (HHS)
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Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)
Title: Disease Investigation through Specialized Clinically-Oriented Ventures in Environmental Research (DISCOVER) [P50]
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) 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
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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
1. Research Objectives
Purpose
The National Institute of Environmental Health Sciences (NIEHS) invites qualified investigators from academic institutions or non-profit research institutions to submit an application for a Disease Investigation through Specialized Clinically-Oriented Ventures in Environmental Research (DISCOVER) Center. Each DISCOVER Center will develop an over-arching theme that is based on a specific environmentally-influenced disease or dysfunction and will craft an interdisciplinary research approach that integrates patient-oriented or public health research with basic mechanistic studies to address disease etiology, pathogenesis, susceptibility and/or progression. An extraordinary level of synergy, integration, and potential for advancement of environmental health sciences is expected. By fostering collaborative research these centers will (1) increase the relevance of basic scientific discoveries in environmental health sciences to human disease; and (2) move this knowledge into clinical and public health application to ultimately improve human health.
NIEHS recognizes that to accomplish this research agenda, two types of activities need to converge. First, the research team must focus on a particular human disease or dysfunction that is likely to be caused or influenced by environmental exposure(s). Second, a team of physician scientists, research scientists trained in the basic biomedical disciplines, and public health researchers will work collaboratively to use toxicant exposures or environmental perturbations to understand human disease. Thus, the research conducted by a DISCOVER Center will capitalize on multiple aspects of environmental health sciences research including exposure biology, environmental genetics and genomics, patient-oriented clinical research and public health sciences, such as epidemiology, as well as computational and engineering approaches to define the functional contributions of environmental and genetic determinants in (1) assessing the risk of developing disease, (2) identifying the underlying physiological mechanisms in disease pathogenesis and progression, (3) characterizing disease phenotype, (4) understanding the environmental and endogenous factors that affect the distribution of disease in populations, and (5) applying the knowledge gained to develop therapeutic, diagnostic, prognostic, and preventative strategies.
Background
The mission of the NIEHS is to promote research that will reduce the harmful effects of environmental exposures on human health and disease. The link between environmental agents and disease risk has been recognized for over a century. It has also been recognized that there is considerable variability in an individual’s response and ultimately an individual’s risk to developing disease as a consequence of exposure to environmental or lifestyle factors. The completion of the Human Genome Project has been heralded as the beginning of a new age of science where the resultant genetic advances will imminently lead to improvements in human health. However, our understanding of environmental health and the development of disease suggests a multi-factorial process involving a complex interplay between genetic variability, external exposures (i.e., the environment), temporal vulnerability (i.e., age), and other unique host factors such as pre-existing conditions, nutritional status, lifestyle choices and social status. This leads to a daunting challenge for the environmental health sciences community to assess the risk of developing disease from exposures to toxicants/stressors and to apply this knowledge for improving human health.
Most common chronic diseases such as cancer, cardiovascular disease, asthma, diabetes, reproductive diseases/disorders, autoimmune diseases, and neurobehavioral and neurodegenerative disorders are believed to have multiple genetic and environmental factors contributing to their observed phenotype. For example, more than 35 genes have been identified that are likely to contribute to asthma susceptibility, indicating the complex etiology and biology of this disease. Additionally, early life exposures to factors such as microbial toxins, pet dander, and environmental tobacco smoke influence the risk for asthma and related phenotypes in a genotype-specific manner, suggesting that environmental exposures are critical to understanding the underlying pathogenesis of asthma. Similarly, there is mounting evidence that neurodegenerative diseases such as Parkinson s, Alzheimer s, and dementia, not only are strongly influenced by genetic variables, but that environmental exposures during vulnerable periods of early life may contribute to disease etiology. Likewise, there is increasing evidence that early life exposures to environmental factors predispose individuals to developing obesity as adults. Obesity, along with insulin resistance, dyslipidemia, and hypertension are key clinical features of metabolic syndrome, a common disease associated with an increased risk of type 2 diabetes mellitus and cardiovascular disease. While a direct linkage between environmental exposures beyond lifestyle factors such as diet and nutrition has not been made to date, environmental exposures are likely contributing to the increasing prevalence of metabolic syndrome. In aggregate, these observations demonstrate the importance of environmental exposures in understanding the etiology, pathogenesis, and prognosis of many complex human diseases.
The contribution of the environmental component in the gene-environment paradigm to the etiology of human disease has been difficult to ascertain. This is due, in part, to the lack of precision in the methods to integrate exposure over time, the inability to characterize the attributable risk from multiple exposures (i.e., environmental toxicants, nutrition, and lifestyle choices) experienced through one’s lifetime and the lack of statistical and computational approaches to measure complex gene-environment, or gene-environment-comorbidity interactions. Ultimately this imprecision in the exposure measurement may underestimate the involvement of environmental factors in disease causation. The advent of the omics transcriptomics, genomics, proteomics, and metabolomics - as well as nanotechnology and molecular imaging are creating new sets of tools that hold promise to better quantify environmental exposures and assess early indicators of biological responsiveness. The incorporation of these approaches offer opportunities to better understand the underlying biology that confers variability in disease response as a consequence of exposure.
Historically, the preponderance of research conducted by the NIEHS community has emphasized an assessment of the toxicological effects of environmental agents on biological processes using animal models; in many instances these studies have not made direct linkages to human disease. Consequently, the translation of research supported by the NIEHS into improving human health has not been as rapid as desired. In the past few years, NIEHS has developed and supported new programs such as the Centers for Children's Environmental Health and Disease Prevention Research (http://www.niehs.nih.gov/translat/children/children.htm), the Centers for Population Health and Health Disparities (http://obssr.od.nih.gov/CPHHD/Index.htm), the Collaborative Centers for Parkinson's Disease Environmental Research (http://www.niehs.nih.gov/ccpder/), and the Breast Cancer and the Environment Research Centers (http://www.bcerc.org/) that are intended to provide a human disease focus for the NIEHS.
The DISCOVER Centers program is designed to further broaden the NIEHS research portfolio in a clinically focused direction, by encouraging the extramural community to identify and define the basic and applied research opportunities likely to have the most profound impact on the understanding and management of environmentally-influenced disease. The NIEHS continues to be committed to supporting research through investigator-initiated, single laboratory project grants that focus on the adverse effects that environmental toxicants/stressors have on cellular and biological processes. However, the resources required to conduct the multi-faceted, interdisciplinary projects necessary to achieve significant advances in the characterization of human disease, and accelerate research findings into clinical and public practices that impact disease outcome are beyond the scope of a typical R01 grant. Therefore, the DISCOVER Center program is being initiated to create an integrated research approach involving teams of scientists that represent clinical research, basic biomedical research disciplines, and public health sciences. These teams will focus on complex human diseases or disorders where there is evidence or a strong rationale for the involvement of environmental factors in its etiology, phenotypic expression, or population distribution. As part of the design for these centers, the research should lead to improved clinical and public health practices through advances in prevention, diagnosis and treatment.
Scope of Research:
Each DISCOVER Center will develop an over-arching theme that is based on a specific environmentally-influenced disease or dysfunction and will craft an interdisciplinary research approach that incorporates clinical and basic mechanistic studies to address disease etiology, pathogenesis, susceptibility, progression, and/or prognosis. An extraordinary level of synergy and potential for advancement of environmental health sciences is expected through the creation of research projects that individually are scientifically meritorious but together display a high degree of complementariness and integration. Ultimately, these centers are expected to accelerate the application of knowledge derived from basic research into the clinical or public health setting with the goal of improving human health. The DISCOVER program is expected to create opportunities to develop and apply novel approaches for the diagnosis, prognosis, prevention, and treatment/intervention of environmentally-influenced diseases or disorders.
The general characteristics of a DISCOVER Center to promote the goals of this initiative include:
Suggested Research Themes
As has been stated, a DISCOVER Center must reflect an integrated research enterprise that will advance our understanding of how environmental stimuli interact with biological processes to either preserve health or cause disease. Applicants may focus their center on any human disease or dysfunction provided there is adequate justification for the role of primary environmental stressors in influencing disease etiology, progression, prognosis, or population distribution. The NIEHS defines environment quite broadly, and for the purposes of this initiative considers chemical, physical or biological toxicants as primary stressors. In addition to a focus on primary stressors, it is encouraged that applicants investigate the effects of secondary modifiers such as co-morbid disease/conditions, aging, diet, infectious disease, and/or idiosyncratic drug reactions that have the possibility to influence the susceptibility to physical or environmental toxicant exposures and thereby alter disease processes. For the purposes of this initiative proposals focusing solely on secondary modifiers, including but not limited to, smoking, alcohol, infectious agents or diet, in the absence of primary exposures, will not be considered responsive.
The scientific theme developed for a DISCOVER Center should reflect an interdisciplinary research approach that incorporates multiple levels of scientific endeavors. Examples of general themes and approaches that may be considered appropriate for inclusion within a DISCOVER Center include but are not limited to the following suggestions.
Disease Processes. Characterize disease occurrence in terms of etiologic heterogeneity, disease pathogenesis, or by identifying biological targets for understanding gene-environment interactions and novel approaches to therapeutic intervention.
Disease Susceptibility. Clarify the contribution of environmental and genetic variables in the risk of developing disease and the risk of disease progression.
Disease Intervention. Stratify disease risk and target intervention to promote improved health at the individual or population level.
Translational Research Outcomes. A DISCOVER Center must also have a strong focus on translational research which has been defined by NIH as studies at the interface of the bench and bedside and/or community. Information flow at these interfaces is bi-directional, requiring close interaction between clinical and bench scientists to study human diseases. It is expected that the structure of the center will facilitate the acceleration of basic research findings into practical applications that benefits clinical and public health practice to improve human health. Examples include:
General Description of a DISCOVER Center and Center Components
The DISCOVER Center supports a full range of basic, developmental, clinical, public health, and/or applied research components; and is intended to result in novel scientific concepts about the etiology and pathogenesis, and distribution of human diseases. The ultimate goal of the DISCOVER Centers is to use scientific methods that are unique to environmental health sciences to further understand human health and disease.
The DISCOVER Center must have an identifiable organizational unit within a university, medical school, non-profit research institute, or a consortium of cooperating institutions with a university affiliation. The applicant institution must include a minimum of 50% of the research effort. Partnerships may consist of investigators at a single institution or at multiple sites and may include collaborative arrangements as appropriate with organizations, domestic or foreign, public or private (such as universities, colleges, hospitals, laboratories, for-profit and non-profit, units of State and local governments, and eligible agencies of the Federal government), as necessary to conduct portions of the research. Teams that are geographically distributed must be well-justified and steps to minimize the effects of geography should be clearly stated.
The DISCOVER P50 grant mechanism fosters collaborative and integrated basic, clinical and public health research and provides funds to support personnel, stipends and tuition for trainees, equipment, supplies and services for research projects, facility cores, and an administrative core.
1. The Director for the DISCOVER Center is the designated leader and provides the leadership for the administrative, scientific and programmatic direction. It is expected that the director will commit a minimum of 15% effort to the administration of the Center. Likewise, the Center must reflect an emphasis on clinical research and integration by the identification of a lead physician-scientist whose role is to ensure communication and translation across the research projects by devoting a minimum of 15% effort to Center administration. The physician-scientist can serve as either Director or Associate-director of the Center.
2. The research projects provide the intellectual and scientific direction for the program. These projects should be well integrated and relate to the theme of the center. A minimum of four research projects are required and must include at least two patient-oriented clinical/public health research projects and two mechanistically-driven basic research project. Additional projects are encouraged. Project Leaders are expected to devote at least 20% effort to these projects.
3. A required Administrative Core oversees the organizational, budgeting and reporting aspects of the DISCOVER center and provides the environment and infrastructure to promote cross-discipline interactions among all projects and cores. To aid the Center Director in achieving the goals of the program, the establishment of an external advisory committee is required. The composition of the external advisory committee should reflect the scientific expertise of the Center and must include physician-scientists. The Administrative Core will also include a plan to support product development to facilitate the translation of knowledge, resources and tools resulting from the research effort to improve human health.
4. Facility Cores are principally designed as a service or resource component to the research projects within the Center. Core facilities may include clinical research support, biostatistics and/or bioinformatics support, and basic molecular/cellular capabilities. These cores serve to enhance or make more cost-effective the services, techniques or instrumentation used by the Center and also promotes interdisciplinary activities. The DISCOVER Center should include facility cores that serve at least two research projects if resources are not available through other Institutional infrastructure such as P30 Core Centers or other resources such as GCRCs or Clinical and Translational Science Award Centers (CTSAs). The number of facility/service cores may not exceed the total number of research projects and are not a requirement of the Discover Centers. Applicants must include a discussion of the cost savings and other efficiencies provided by the inclusion of such core facilities.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the P50 award mechanism.
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
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.
2. Funds Available
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application if your organization has any of the following characteristics:
Applications from foreign institutions and for-profit organizations will not be accepted. However, grantees are encouraged by NIEHS, to develop consortia arrangements as appropriate with organizations, domestic or foreign, public or private (such as universities, colleges, hospitals, laboratories, for-profit and non-profit, units of State and local governments, and eligible agencies of the Federal government), as necessary to conduct portions of the research.
The proposed DISCOVER Center must be affiliated with an institution, such as a university, medical center, or research center that has the resources to sustain a long-term, coordinated research program. An applicant institution must demonstrate the ability to attract high-quality scientists from biomedical, clinical and/or public health disciplines that are willing to make a long-term commitment to research.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
2. Cost Sharing or Matching
Cost sharing is not required.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Applicants must propose an interdisciplinary approach that targets a specific disease or dysfunction where environmental factors are known or expected to influence the development or progression of human disease. This interdisciplinary effort should bring together investigators from different scientific disciplines to direct discrete Research Projects, each of which is to be related to the central theme developed for the applicant’s Center. It is expected that the research team will include the expertise required to perform the research proposed and include both biomedical researchers and physician scientists.
The applicant must name a Director as the designated leader of the DISCOVER Center to provide scientific and administrative leadership to the Center. The Center Director must commit a minimum of 15% effort to the administration of the Center. The applicant must also identify a lead physician-scientist whose role is to ensure communication and translation across the research projects by devoting a minimum of 15% effort to Center Administration. The Project Leaders of the individual research projects should devote a minimum of 20% effort to that project.
In order to be considered for funding, each applicant must successfully meet the following requirements:
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) 710-0267, 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 line 2 of the face page of the application form and the YES box must be checked.
3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: October 17, 2006
Application Receipt Date(s): November 17, 2006
Peer Review Date: February 2007
Council Review Date: May 2007
Earliest Anticipated Start Date: July 1, 2007
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 at the beginning of this document.
The letter of intent should be sent to:
Janice Allen, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233, EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-7556
FAX: (919) 541-2503
Email: allen9@niehs.nih.gov
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant applications 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 material must be sent to:
Janice Allen, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233, EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-7556
FAX: (919) 541-2503
Email: allen9@niehs.nih.gov
Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application Processing
Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Institute of Environmental Health Sciences. Incomplete and non-responsive 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 review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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
Guidance for Applicants Submitting a P50 DISCOVER Center Grant
Applicants should use the following guidance, in addition to the instructions accompanying the PHS 398 form. The DISCOVER Center grant proposal consists of three general sections of information:
Section I. This section includes PHS 398 Form Pages 1-3, PHS 398 Form Page 4 - Detailed Composite Budget for the First 12-month Period Description and Form Page 5 Composite Budget for All Years, All Projects as well as the corresponding budgets for each individual project and core supported by the DISCOVER Center application. In addition, a table that indicates the percentage use of each facility core relative to the individual projects should be included to assist the reviewers in determining the relationship between Facility Cores and Research Projects. Biographical Sketches should be provided for all KEY investigators using the PHS 398 Biographical Sketch Format Page. List the Center Director first followed by all other key personnel in alphabetical order. Use duplicate copies of the Biographical Sketch Format page for each investigator. Include only one copy of each biosketch in the application. Lastly, Section I should include Institutional Environment and Resources using the PHS 398 Resources Format Page. Include a brief description of the environment where the overall program and other activities will be conducted. If more than one campus or location will be involved, briefly describe each setting. If unique resources are available, briefly describe these and their relevance to the proposed program.
Section II. This section is unique to the P50 application. The information covered in this section for the most part, is not covered in the PHS 398. The page limit for this section is 15 pages. This Section includes:
Program Introduction and Statement of Objectives.
Organizational and Administrative Structure
Section III - V. These sections contain the research plans of the individual research projects, facility cores, and administrative core.
General Instructions for all Projects and Cores.
All Projects and Cores.
Section III Individual Research Projects.
Follow the instructions in the PHS 398 for the Research Plan (a-i) for describing each research project. Each project should clearly state its overall objective and explain its relevance to the central theme of the DISCOVER program. In addition, an explanation should be included describing how the project relates to and both complements and enhances the other research projects and cores of the program. Specify the overall biomedical significance of the work proposed.
The research plan (a-d; 25 page limit per project) includes:
The instructions in the PHS 398 form should be used to complete sections e-i for the individual research projects.
SECTION IV Facility Cores.
Follow the instructions in the PHS 398 Research Plan (a-i) as is appropriate for describing a Facility Core. A facility core is defined as a resource for the DISCOVER Center that provides centralized services to two or more research projects. Information that should be included is as follows:
SECTION V Administrative Core
Follow the instructions in the PHS 398 Research Plan (a-i) as is appropriate for describing the Administrative Core.
A successful DISCOVER application will include a well-integrated project plan. Within the Administrative Core, the specific administrative and organizational structure that is needed to support the research and the synergies enabled by the Center needed to be clearly articulated. DISCOVER projects will be multi-disciplinary and will draw from a variety of resources. Thus a well thought out and carefully described organizational structure will be required.
A narrative description should be provided that includes the planning and coordination of research activities; the integration of cross-disciplinary research; the oversight of fiscal and resource management; and the maintenance of ongoing communication with NIEHS. Indicate who will be responsible for each of these activities. Describe the role(s) of advisory groups and consultants.
The process for identifying product development/technology transfer projects should be fully described. Additional funds to support these activities should be available in funding years 3-5 and should not be included in the initial proposal. Projects are intended to result in products, tools, and or resources (for example validation of biomarker panels or clinical interventions, or development of in vitro diagnostics) that are directly applicable to improving clinical/public health practice.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
1. Criteria
Only the review criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
2. Review and Selection Process
Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
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, weighting them 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 high 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.
The initial review for scientific and technical merit of applications will emphasize two major aspects: (1) review of the DISCOVER Center as an integrated research effort focused on a central theme, including the administrative core, Center Director and Lead Physician-scientist; and (2) the review of each research and facility core component independently.
Review Criteria for the Overall P50 Center
The overall Center will be evaluated based on the following criteria:
Significance
Coordination and Cohesiveness
Resources and Environment
Center Director
The Center Director will be evaluated based on the following criteria:
Lead Physician-Scientist
The lead physician-scientist will be evaluated based on the following criteria:
Administrative Core
The Administrative Core will be assessed based on the following criteria:
Research Projects
The review of the individual research projects is similar to the review of investigator-initiated research projects (R01).
Research Projects will be assessed based on the following criteria:
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the study is successful, would it lead to an incremental advance, or would it provide a substantial step forward that would likely not be achieved through mechanisms other than this DISCOVER Center? If successful, will the project result in knowledge or resources that could be utilized to improve human health or disease.
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there strong synergy among the combined efforts of various investigators within the DISCOVER Center? Is there evidence that environmental health sciences research is well-integrated into the research design?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Facility/Service Cores:
The Facility/Service Cores will be assessed based on the following criteria:
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. For DISCOVER grants, the presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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.
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.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. 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).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
3. Reporting
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
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:
David M. Balshaw, Ph.D.
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233, EC-27
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
(919) 541-2448
FAX: (919) 541-4937
Email: Balshaw@niehs.nih.gov
Kimberly Gray, Ph.D.
Susceptibility and Population Health Branch
Division on Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233, EC-21
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
(919) 541-0293
FAX: (919) 316-4606
Email: gray6@niehs.nih.gov
Jerry Heindel, Ph.D.
Cellular, Organ and Systems Pathobiology Branch
Division on Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233, EC-23
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
(919) 541-0781
FAX: (919) 541-5064
Email: heindelj@niehs.nih.gov
2. Peer Review Contacts:
Janice Allen, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233, EC-30
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-7556
FAX: (919) 541-2503
Email: allen9@niehs.nih.gov
3. Financial or Grants Management Contacts:
Lisa Archer
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233, EC-20
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-0751
FAX: (19) 541-2860
Email: archer@niehs.nih.gov
Required Federal Citations
Use of Animals in Research:
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 priority score.
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.
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.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (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-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).
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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.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 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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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