and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Human Genome Research Institute (NHGRI) (http://www.genome.gov)
Title: A Data Coordination Center for the Encyclopedia of DNA Elements (ENCODE) Project (U41)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
The purpose of this RFA is to solicit applications for a Biotechnology Resource Cooperative Agreement (U41) award to develop and implement a Data Coordination Center (DCC) as part of the Encyclopedia of DNA Elements (ENCODE) Project. The goal of the ENCODE Project is to apply high-throughput, cost-effective approaches to generate a catalog of functional elements in the human genome. The ENCODE Project is currently in a pilot phase focused on the development of efficient large-scale approaches to identify all of the sequence-based functional elements in genomic DNA by focusing on a selected 30 Mb (1%) of the human genome (see www.genome.gov/ENCODE). A companion RFA, (RFA-HG-07-030) Creating the Encyclopedia of DNA Elements (ENCODE) in the Human Genome is being issued to continue the support of pilot projects and to support production centers that will expand the ENCODE Project to the entire genome. The funded projects will participate in a Research Consortium that will be a continuation of the existing ENCODE Consortium. This RFA (HG-07-031) solicits applications for a DCC that will develop, house, and maintain databases to track, store, and provide access to the data generated as part of the ENCODE Project.
The ENCODE Research Consortium will be separate from, but affiliated with, the Research Consortium that will be organized for the modENCODE Project following the funding of applications submitted in response to RFA-HG-06-006, Identification of All Functional Elements in Selected Model Organism Genomes in spring 2007. The modENCODE Project will analyze either the Caenorhabditis elegans genome or the Drosophila melanogaster genome, or both.
Background
In April 2003, the sequence of the human genome was essentially completed. For the scientific community to make the best use of that fundamental information resource, the identity and precise location of all sequence-based functional elements in the genome must be determined. While many of the protein-coding sequences are already known, others still remain to be identified. Beyond open reading frames, most other sequence-based functional elements, such as non-protein-coding genes, transcriptional regulatory elements and determinants of chromosome structure and function, remain largely unknown. A comprehensive encyclopedia of all of these features is needed to fully utilize the sequence of the human genome to better understand human biology, to understand the biology of disease, to predict potential disease risk, and to stimulate the development of new therapies and other interventions for preventing and treating disease.
To address this need, the NHGRI initiated the Encyclopedia of DNA Elements (ENCODE) Project in 2003. The goal of the ENCODE Project is to identify sequence-based functional elements in the human genome sequence in a comprehensive manner. The ENCODE Project started with two components. The first was a pilot in which available methods for the identification of functional sequence elements were to be tested and compared in a defined one percent (30 Mb) of human genomic DNA. (For information about the selected target sequences, see http://www.genome.gov/10506161). The projects that composed this pilot addressed the comprehensive identification of coding sequences, transcriptional units, transcriptional control elements, chromatin modifications and certain chromosomal features such as origins of replication and DNase hypersensitive sites. The goals of the pilot phase were to test the ability of existing technologies to be applied at high-throughput in an efficient and cost-effective manner, to identify gaps in our ability to fully annotate the human genome and to set a clear path forward for scaling up these efforts to efficiently and effectively characterize the entire human genome in detail. The pilot project was supported through the funding of applications received in response to RFA HG-03-003. The ENCODE pilot project was an open effort and additional groups, who were not initially participants but who agreed to abide by the Consortium’s criteria for participation, have subsequently joined the Consortium.
The second original component of the ENCODE Project addressed the need for new or better technologies to identify these and other sequence-based functional elements on a genome-wide scale. Technology development has been supported through the funding of applications received in response to two RFAs in 2003 and 2004 (HG-03-004 and HG-04-001) and RFAs to solicit a third round of applications were released in August 2006 (HG-07-028 and HG-07-029). For a full list of the participants in the ENCODE pilot and technology development components, see http://www.genome.gov/12513391.
The pilot project has been successful in bringing together a set of individual groups to work together in a highly collaborative and synergistic effort. The ENCODE Consortium participants developed and agreed to abide by a common data release policy (http://www.genome.gov/encode/#3) that requires rapid data release, and they are developing common quantitative data standards for each of the technologies being used in the pilot. Consortium members have generated data using common cell lines and, where relevant, using a common set of DNA binding factors. All ENCODE data are made available in appropriate public databases (http://www.genome.gov/encode/#4). Currently, the UCSC Genome Browser (http://genome.ucsc.edu/) serves as a repository for the different sequence-based functional elements identified by each different technology. Analysis groups within the Consortium have focused on different aspects of the project to assemble and analyze the data that have been generated. These analyses, which will be published within the next year, have revealed interesting scientific discoveries, and have enabled NHGRI to identify strengths and gaps in the current knowledge about how to scale up these efforts to analyze the complete human genome.
The technology development component of ENCODE has also progressed well. New and improved methods are emerging that will allow a more precise definition of gene structures, including their boundaries, better mapping of DNA-binding sites, localization of sites of DNA methylation, identification of areas of chromatin accessible to chemical cleavage, and mapping of chromosomal regions that interact in vivo. Some of these new approaches have been developed to the point where they are now being applied to the full set of ENCODE regions.
These accomplishments have led NHGRI to continue the pursuit of the goal of the ENCODE Project to identify sequence-based functional elements in the human genome comprehensively. As the initial phase of the ENCODE Project will be completed in September 2007, the companion RFA-HG-07-030 is being issued to solicit applications for research projects to continue the ENCODE-based analysis of the human genome sequence. The continuation of the ENCODE Project will be comprised of three kinds of efforts: 1) production efforts that will scale to the entire human genome, using methods that have been clearly demonstrated to identify sequence-based functional elements efficiently, comprehensively, cost-effectively, and in a reasonable time frame; 2) continued pilot efforts that will analyze the current ENCODE target regions in new and interesting ways; and 3) new pilot projects using novel technologies, such as those developed by the first set of technology development projects, to study the current ENCODE target regions. This RFA, HG-07-031, is being issued to solicit applications for a Data Coordination Center that will track, store, and disseminate data from the ENCODE Project.
Research Scope
The ENCODE Project will need to manage both primary data from multiple experimental or computational methods and data that result from processing the primary data with a variety of computational methods to identify the functional elements in the genome. In addition, metadata that describe the experimental and computational methods will need to be managed for the Project. This RFA solicits applications to support a Data Coordination Center (DCC) for the ENCODE Project and will use the U41 Biotechnology Resource Cooperative Agreement award mechanism. Following the model established by the ENCODE pilot project, primary data will be stored in available public databases such as the Gene Expression Omnibus (GEO) at the National Center for Biotechnology Information (NCBI) or ArrayExpress at the European Bioinformatics Institute (EBI), while processed data that identify potential functional elements will be linked to the genome sequence and stored at the DCC. The DCC will be required to support the tracking of primary data submitted to public databases and the management of other data from the ENCODE Consortium. The DCC also will be required to identify and import data from research projects outside of the ENCODE Consortium that are generating data related to the goals of the Consortium. This new informatics resource will be the primary location for data on functional elements in the human genome from the ENCODE Project for access by the scientific community.
The applicant should describe plans for a DCC that is capable of working with data from all of the members of the ENCODE Consortium who will be generating data for the identification of functional elements the human genome. The DCC will compile and track data being generated by different ENCODE research projects and will implement quality assurance methods to ensure that data meet the relevant data formats for submission. The DCC should be prepared to work with data from the range of different experimental and computational projects that are expected to be funded through the companion RFA HG-07-030, Creating the Encyclopedia of DNA Elements (ENCODE) in the Human Genome . For example, the data generated by the current ENCODE pilot project include data from comparative sequencing, promoter reporter assays, microarray chip hybridization assays from a variety of different experimental approaches, and assays to identify DNase hypersensitive sites. (The project descriptions at http://www.genome.gov/12513391 provide a complete listing of experimental approaches in the current ENCODE pilot project.) RFA-HG-07-030 requests applications that propose to continue to work on the 1% of human genome selected as targets for the ENCODE pilot project as well as applications that propose to identify functional elements throughout the entire human genome. The DCC will be expected to manage data from both the pilot- and genome-scale projects.
As outlined in the companion RFA-HG-07-030, each project will be expected to generate several types of data from different experimental approaches. These approaches include high-throughput determination of functional elements, different methods to validate the biochemical authenticity of these elements, and further experiments to demonstrate the biological relevance of a class of functional elements. In addition, any metadata that describe the experimental or computational methods will need to be captured using standard formats and stored as part of the DCC. The DCC should be able to capture links to the primary data in public repositories, to the location of any identified sequence element in the reference genome sequence, and to metadata describing the experimental methods including any informatics methods.
The DCC will work with the ENCODE Consortium to facilitate analyses of the ENCODE data. The DCC will be responsible for producing defined freezes of the ENCODE data that meet bioinformatics quality control standards. The DCC will work with any analysis groups sponsored by the Consortium to transform the ENCODE data as necessary to facilitate the analyses of the data.
The DCC should provide multiple mechanisms for delivering data about functional elements in the human genome, including a genome browser view of the functional elements identified by the ENCODE Consortium with links to a description of the data (including any metadata associated with an experiment) and a method of freely downloading large datasets from the DCC so that users can acquire and analyze all or large parts of the data. This resource should provide the data in formats that will facilitate additional analysis by members of the Consortium and by the broader scientific community. The applicant should include information on how efficient and unencumbered access to the DCC will be maintained. The efforts of the DCC should be focused on collecting, tracking, and distributing relevant information for the ENCODE Project, and should not duplicate the informatics efforts of other projects that have been funded to describe the characteristics or functions of specific genes. However, it will be important for the DCC to have close interactions with the other informatics resources to facilitate the transfer of information to these informatics resources.
The DCC is expected to be a stable resource that will gather data from the ENCODE Consortium and other related genomic projects and integrate those data with genome sequence. The DCC should use robust data management tools capable of handling all of the ENCODE data that will be stored. Where possible, the applicant should use existing software modules for the DCC. The DCC is expected to be able to work with the other funded projects of the ENCODE Consortium to establish the exact types and formats of data that will be transferred to the DCC along with developing procedures to track the quality of incoming data. As the identity of these projects will not be known at the time that the applications in response to this RFA are due, the applicant should provide a general plan that addresses many types of data related to functional sequence elements, for example the data currently being produced by the ENCODE pilot project. For all of the data in the DCC, the sources of the data should be identified and links back to these sources should be provided.
The applicant should define a clear set of goals for the overall project, and milestones with metrics that will document progress towards the achievement of the ultimate goals. For example, these goals could include any planned software development activities, the anticipated level of throughput for capturing and processing data from the ENCODE data production centers, and the anticipated number of data freezes during the project period. Milestones may be revised at the time of the award as described in the terms and conditions of a Cooperative Agreement in section 2.A.2.
As a Biotechnology Resource (U41), the applicant should describe plans for training and providing technical support for users. These plans should recognize the different types of users of the DCC, both participants of the ENCODE Consortium and outside users who will have a range of bioinformatics skills. As these users will have different levels of sophistication in the use of genomic data, any training plan should accommodate these different user types.
The ENCODE Project will be run as a Research Consortium that will be open to all academic, government, and private sector scientists interested in participating in an open process to facilitate the comprehensive annotation of the human genome. The awardee funded through this RFA (HG-07-031) will participate in this Research Consortium.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the U41 Biotechnology Resource Cooperative Agreement award mechanism(s).
The NIH U41 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". This is a one-time solicitation. At the current time, plans for continuing the ENCODE project beyond the next four years are not definitive and will depend, to some extent, on the progress made during the next grant period.
2. Funds Available
The NHGRI intends to commit approximately $1.5 million dollars in FY 2007 to fund 1 new cooperative agreement in response to this RFA. An applicant may request a project period of up to 4 years. The earliest anticipated award date is September 30, 2007.
Although the financial plans of NHGRI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
Foreign institutions are allowed as collaborators with the submitting organization. The proposed research at the foreign institution should provide a unique research opportunity not available in the U.S.
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 support.
2. Cost Sharing or Matching
No cost sharing or matching is required for applications submitted in response to this RFA.
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 may submit more than one application, provided they are scientifically distinct.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
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
Letters of Intent Receipt Date(s): February 27, 2007
Application Receipt Date(s): March 29, 2007
Peer Review Date(s): June-July 2007
Council Review Date(s): September 2007
Earliest Anticipated Start Date(s): September 30, 2007
Applicant Information Meeting. There will be a meeting at the Conference Center at 5635 Fishers Lane, Rockville, Maryland 20852 from 1:00 p.m. to 3:00 p.m. EST on Monday, December 18, 2006 to answer questions about this RFA from prospective applicants. Attendance at this meeting is not a prerequisite for responding to this RFA. For information about calling into this meeting, email: [email protected]
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:
Peter Good, PhD
Program Director, Genome Informatics
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305 (U.S Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-7531
Email: [email protected]
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:
Rudy Pozzatti, PhD
Scientific Review Administrator
Scientific Review Branch
National Human Genome Research Institute
5635 Fishers Lane, Ste. 4076, MSC 9306
Bethesda, MD 20892-9306 (U.S Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 402-0838
Email: [email protected]
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 NHGRI. 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.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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
The Research Plan (sections A-D) for U41 applications should not exceed 40 pages.
Plan for Sharing Research Data
The NHGRI is committed to the principle of rapid data release to the scientific community. This principle was initially implemented during the Human Genome Project and has been recognized as leading to one of the most effective ways of promoting the use of the genome sequence data to advance scientific knowledge. At a meeting in Ft. Lauderdale, FL that was co-sponsored by the Wellcome Trust and NHGRI in January 2003, the concept of rapid data release by genomic sequence data producers was reaffirmed, and the attendees strongly recommended applying the practice to other types of data produced by community resource projects . The attendees recognized, however, that different issues, particularly with respect to data validation, would be involved in the development of appropriate release practices for different types of data. Since they also recognized that sustaining the practice of rapid, prepublication data release by community resources requires that the interests of all involved - including the data producers, data users, and funding agencies - be addressed, they emphasized the need to develop a tripartite system of responsibility. The meeting report from the Ft. Lauderdale meeting can be found on the Wellcome Trust website at: http://www.wellcome.ac.uk/doc_wtd003208.html
The NHGRI has identified the ENCODE Project as a community resource project. As such, the ENCODE Project aims to function openly by making all data available to the scientific community in a timely manner prior to publication. During the pilot phase, the ENCODE Consortium established a common Data Release Policy (see http://www.genome.gov/12513440) and all participants agreed to abide by that policy. It is expected that the general principles of this policy will continue during the next phase of the ENCODE Project. Additional specifications may be added, e.g., relating to timing of release of validated data. All applicants should provide specific plans for data release in the application and indicate their willingness to abide by the ENCODE Consortium Data Release Policy and any changes that may be made during the next funding period by the Consortium. The reasonableness of the data sharing plan 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.
After completion of the initial review, NHGRI program staff will be responsible for any additional administrative review of the plan for sharing data. The adequacy of the data 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 sharing plan with the prospective awardee before recommending funding of an application. The final negotiated version of the data sharing plan will become a condition of the award of the cooperative agreement. The effectiveness of the data sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.
Sharing Research Resources
NIH policy expects that grant 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.
As the ENCODE Project is a community resource project, NHGRI expects that not only data, but also resources generated during the course of the program should be made rapidly available to the research community and that sharing plans should follow the same principles and spirit as the rapid data release policy. The applicant should provide specific plans for resource sharing and distribution in the application. The reasonableness of the data sharing plan will be assessed by the reviewers. However, reviewers will not factor the proposed resources sharing plan into the determination of scientific merit or the priority score. The adequacy of the resources sharing plan will be considered by the funding organization when making recommendations about funding applications. The presence of a resources sharing plan will be part of the terms and conditions of the award. 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.
Section V. Application Review Information
1. Criteria
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 NHGRI 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.
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?
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?
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 (if applicable)?
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?
2.A. Additional Review Criteria:
Not Applicable
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
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 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. 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. Reviewers will be asked to consider the data sharing plan in the context of the ENCODE Consortium Data Release Policy, as described in section IV.6.
2.D. Sharing Research Resources
NIH policy expects that grant 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.
The reasonableness of the resources sharing plan will be assessed by the reviewers. However, reviewers will not factor the proposed resource sharing plan into the determination of scientific merit or the priority score.
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
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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 NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
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.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the NIH U41 Biotechnology Resource Cooperative Agreement award mechanism, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The following terms apply to the Encyclopedia of DNA Elements (ENCODE) Project and the ENCODE Research Consortium as described in RFAs HG-07-030 and HG-07-031.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator (P.I.) will have the primary responsibility for defining the details for the project within the guidelines of RFA HG-07-031 and for performing the scientific activities. The P.I. will agree to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the project as described under "NIH Responsibilities".
The P.I. of the Data Coordination Center (DCC) for the ENCODE Project will:
The Project Scientist will:
An External Consultant Panel will be established by the NHGRI to evaluate the progress of the ENCODE Research Consortium. The External Consultant Panel will provide recommendations to the Director, NHGRI about the progress and scientific direction of all components of the program. The External Consultant Panel will be composed of six to eight senior scientists with relevant expertise, although the membership may be enlarged permanently or on an ad hoc basis as needed.
The External Consultant Panel will meet at least twice a year; some meetings may be conducted by telephone conference. At least once a year, there will be a joint meeting with the Steering Committee to allow the members of the both the External Consultant Panel and the Steering Committees to interact directly with each other. Twice a year the External Consultant Panel will make recommendations regarding progress of the ENCODE Research Consortium and present advice to the Director of NHGRI about changes, if any, that may be necessary in the ENCODE Research Consortium program.
Additionally, an NHGRI program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.
2.A.3. Collaborative Responsibilities
The Steering Committee will serve as the main governing board of the ENCODE Research Consortium. It is anticipated that additional coordination mechanisms will be set up with other U.S. and international groups that may join this effort. The Steering Committee membership will include one NIH Project Scientist and the P.I. from each awarded cooperative agreement from both RFAs HG-07-030 and HG-07-031. The Steering Committee may add additional members. Other government staff may attend the Steering Committee meetings if their expertise is required for specific discussions.
The Steering Committee will be responsible for coordinating the activities being conducted by the ENCODE Consortium. To address particular issues, the Steering Committee may establish working groups as needed, which will include representatives from the Research Consortium and the NHGRI and possibly other experts. Such groups might include ones to: 1) develop a list of common reagents needed for the ENCODE Project; 2) address data management issues; 3) analyze ENCODE data; 4) develop quality standards and methods to assess data quality; and 5) handle communication issues and develop principles for reporting findings. Minutes of the Steering Committee meetings will be available to the Steering Committee members within 30 days after each meeting.
Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
2.A.4. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be required to submit periodic (at least every six months) progress reports in a standard format, as agreed upon by the Steering Committee and External Consultant Panel.
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.
Section VII. Agency Contacts
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Peter Good, PhD
Program Director
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane, Ste. 4076, MSC 9305
Rockville, MD 20852 (courier/overnight service)
Bethesda, MD 20892-9305 (regular mail)
Telephone: (301) 496-7531
Email: [email protected]
2. Peer Review Contacts:
Rudy Pozzatti, PhD
Scientific Review Administrator
Scientific Review Branch
National Human Genome Research Institute
5635 Fishers Lane, Ste. 4076, MSC 9306
Bethesda, MD 20892-9306 (U.S Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 402-0838
Email: [email protected]
3. Financial or Grants Management Contacts:
Cheryl Chick
Grants Management Officer
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane, Ste. 4076, MSC 9306
Bethesda, MD 20892-9306 (U.S Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-7858
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
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.
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://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||