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 Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)
Title: Centers
for Membrane Protein Structure Determination (U54)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Key Dates
Release Date: July 24, 2009
Letters of
Intent Receipt Date: September
9, 2009 (Changed to September 28, 2009 per NOT-GM-09-026)
Application Receipt Date: October 9, 2009 (Changed to October 28, 2009 per NOT-GM-09-026)
Peer Review
Date(s): February/March, 2010
Council Review
Date: May, 2010
Earliest
Anticipated Start Date: July 1, 2010
Additional Information To Be Available Date (Url
Activation Date): May 1, 2009
Additional information about the PSI:Biology
initiative will be available at http://www.nigms.nih.gov/Initiatives/PSI/Biology. A briefing
for potential applicants will be held some time in late June, 2009.
Further information will be posted when the date is determined.
Expiration Date:(New Expiration Date October 29, 2009 per NOT-GM-09-026) Orginal Date: October
10, 2009
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, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
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. Resource Sharing Plan(s)
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
This FOA solicits applications to establish Centers for Membrane Protein Structure Determination that will become a vital component in fulfilling the expanded goals of the NIGMS PSI:Biology network for high-throughput-enabled structural biology. It is recognized that as the Protein Structure Initiative (PSI) moves toward the solution of biological problems beyond the relationship between sequence and structure, it is imperative that it be able to address membrane proteins that play critical roles in cell transport, metabolism, and regulatory processes. The Project Director/Principal Investigator for each center will be a member of the PSI:Biology Network Steering Committee. This committee will provide the organizational structure for overall coordination and governance of network activities. Individual centers will set their own priorities, but will be significantly bound by decisions of the Steering Committee on behalf of the network as a whole.
Background
This FOA is part of a new NIGMS initiative, PSI:Biology (http://www.nigms.nih.gov/Initiatives/PSI/Biology/) that will be established through a series of five RFAs (Request for Applications) and three PARs (program announcements with on-going receipt dates and special review considerations but with no set-aside funds) over the course of the next several years. PSI:Biology represents a significant shift in focus for the PSI. The PSI was initiated in FY2000, after extensive dialog with the scientific community, with the ultimate goal of significantly increasing understanding of the protein folding problem (i.e., the relationship between the sequence of a protein and its three-dimensional structure). The first phase (PSI-1), FY2000-2004, tested whether the concept of high-throughput structure determination was viable and resulted in the development of new methods and technologies as well as high-throughput pipelines for all steps along the pathway from targeted sequence to deposition of the solved structure in the Protein Databank (PDB). The second phase (PSI-2), FY2005-2009, applied high-throughput methods, such as those developed in PSI-1, to solve large numbers of proteins of novel structure, revealing new folds and illuminating families of proteins that had no previous representation in the PDB. The goal of PSI-2 was to cover sequence/structure space at a sufficient density that the structure of most proteins could be modeled reliably from their sequences and the known structures of their nearest neighbors in the database. See: http://www.nigms.nih.gov/Initiatives/PSI/ and http://grants.nih.gov/grants/guide/rfa-files/RFA-GM-05-001.html for extensive discussion of the initial goals of the PSI and of structural genomics in general.
A mid-course Assessment of the PSI was conducted on September 24, 2007. Among the main conclusions were: 1) that the PSI had been highly successful in establishing pipelines for protein production and structure determination and had successfully solved large numbers of structures; 2) that the PSI had made significant contributions to improve methodology and technology that had benefited structural biologists in general. However, there were concerns as well: 3) that the dissemination of results and materials had not been effective; 4) that the effort aimed at full coverage of sequence space was becoming an unattainable goal due to the rapidly accelerating pace of determining new sequences; and 5) that the focus on novel folds meant that structures were by and large divorced from known biological function. Thus, the impact of the PSI on the biological community at large was not as great as it could and should be.
Since the Assessment, the then recently established PSI-Structural Genomics Knowledgebase and PSI-Materials Repository have become more firmly established and efforts have been put in place to improve annotation of structures, improve the access to modeling capabilities, more clearly articulate the target selection strategy, and establish a centralized process for community nomination of targets. The goals and metrics of success have been carefully documented and as of February, 2009, more than 3,000 distinct structures have been solved by PSI centers. Efforts to improve dissemination have included over 1,200 publications. A centralized repository and set of processes have been established for reporting, validating, storage, and distribution of plasmids generated by the PSI centers.
As the end of PSI-2 on June 30, 2010 approaches, it has become clear that the goal of covering sequence space may not be achievable in the short term. However, it does not appear that fold-space or the number of single-domain family structures is unbounded and indeed, the PSI has gone a very substantial way toward coverage of these more restricted goals. The subject of sequence space coverage and of the leverage of solved structures (i.e., ability to provide models of sequences of unknown structure) has been reexamined and discussed at length. It appears useful to continue this effort, but at a reduced level of intensity and with focus on the more restricted biomedically significant regions of sequence space. The need to remarry structure and function has been recognized and increasingly plays a role in the current PSI through biological theme projects and collaborations. These changes in direction and emphasis will be accelerated as PSI:Biology comes into existence.
In anticipation of the end of PSI-2, NIGMS held a meeting to discuss Future Structural Genomics Initiatives on October 30-31, 2008. This meeting included a review of progress since the 2007 Assessment with a view to understanding the capabilities of high-throughput structure determination and the potential application of those capabilities to additional problems beyond the protein folding problem. The meeting included a balance between currently funded investigators of the PSI, other structural genomics investigators, and scientists from the structural biology and cell biology community at large. Among the recurring themes were: i) evolution of the intellectual drivers for structural genomics; ii) engagement of a broad scientific community in the selection of protein structural targets; iii) improvements in experimental and computational functional annotation; and iv) enhancing the utilization of the intellectual and material products of structural genomics through improved access, education, and dissemination. As captured in the chairperson's summary, "The panel was in uniform agreement that PSI-1 and PSI-2 have met many of the initial goals. In particular, new methods and technologies have been developed; high throughput structural pipelines have been set up in a number of centers; it has been demonstrated that macromolecular structures can be determined on the scale of many hundreds of structures per year, with both X-ray and NMR methods contributing; the cost per structure has fallen continuously; the range of previously unknown folds and protein families has been vastly enlarged; and several joint projects with biomedical communities have been established." The question then became how best to utilize this capacity in a way that will provide the greatest impact on biomedical science. The report included several specific topic suggestions as covered below. The report also emphasized the need for continuing technology development, increased outreach to the biomedical community, and the establishment of mechanisms that support PSI activities and interface with the wider biological community.
The report of the Future Structural Genomics Initiatives meeting, along with progress reported at the PSI Annual Meeting on December 10-11, 2008, were considered by the PSI Advisory Committee (PSIAC), and reported to the National Advisory General Medical Sciences Council, at its meeting on January 22-23, 2009, along with the report of the Meeting of the PSI Steering Committee. The Report of the PSI Advisory Committee and its Recommendations for the Future of the PSI set the stage for the new PSI:Biology initiative.
The PSIAC emphasized the value that had been created through PSI-1 and PSI-2 "The PSIAC has followed the evolution of PSI-1 and PSI-2 closely and observed the impressive development of a new type of science: large teams working in a cooperative fashion, with clearly articulated goals, and with close management by NIGMS staff. The capacity of the resulting large PSI centers to carry out high-throughput structure determination is truly stunning, and the accomplishments from eight years of effort are outstanding in terms of numbers of new structures. Particularly impressive are the number of novel folds and the resulting impact on fold space, as well as the technological enhancements that enable high-throughput structure determination and consequently touch the entire field of structural biology. Moreover, the existing large-scale centers established as a result of PSI-1 and PSI-2 represent a new resource, unknown before the PSI, and one that changes what our scientific enterprise is capable of from 2009 forward."
The PSIAC made a number of recommendations about how the PSI might be restructured and refocused, including realigning the mission of any large-scale centers to focus on biologically important questions that would be pursued in partnership with the broader community of scientists. They felt that a number of components of the current PSI could be satisfactorily competed and supported through program announcements, rather than FOAs; specifically, technology developments for specific stages in the determination of protein structures and methods for improving homology modeling could be supported using program announcements. They emphasized the overwhelming importance of membrane proteins and the continuing huge lag in the number of structures solved relative to soluble proteins. However, opinion on the most effective approaches to solving membrane protein structures and the scope of activities that should be undertaken by any one group of investigators varied. Some advisors felt that the solution of membrane protein structures requires an intimate knowledge of the physical and functional properties of specific targeted membrane protein families and that they are not amenable to high-throughput approaches. Others felt that high-throughput approaches to membrane proteins would ultimately be successful and that additional resources may be needed to achieve breakthroughs. Accordingly, a wide range of possible budgets is suggested below under Section II.2 Funds Available. Finally, they recommended continued support for the PSI-Structural Genomics Knowledgebase and PSI-Materials Repository, coupled with increased outreach and dissemination efforts by all components of the PSI. Based on the above recommendations, NIGMS staff presented a Concept Clearance document to the Council, and the Council approved those plans, which are being implemented as outlined below.
Organization of the PSI:Biology Initiative for High-Throughput Structural Biology
The goal of the PSI:Biology initiative will be to test whether the new paradigm of high-throughput structure determination via highly organized networks of investigators can be applied to a broad range of biological problems. It will consist of five main components, established through RFAs with set-aside funds soliciting applications for Cooperative Agreements: 1) Centers for High-Throughput Structure Determination; 2) Centers for Membrane Protein Structure Determination; 3) Consortia for High-Throughput-Enabled Structural Biology Partnerships; 4) the PSI-Structural Genomics Knowledgebase; and 5) the PSI-Materials Repository; plus three additional components supported through on-going PARs: a) Technology Development for High-Throughput Structural Biology Research; b) Technology Development for Protein Modeling; and c) High-Throughput-Enabled Structural Biology Research. These components will function as follows.
Requests for Applications
The core of the PSI:Biology network will be created through five FOAs that will establish cooperative agreements. These will be managed collectively through a steering committee that will include representatives of each of the components and NIH staff.
Applications for the first four above components are all being solicited for start dates in the summer, 2010. Because the existing PSI Materials Repository is funded through FY2010, that component of the network is not being competed until next year.
Program Announcements
Recognizing that not all of the best ideas may be ready for submission on a single RFA receipt date or conceived only in large-scale centers, and recognizing the need for continued support of some projects evolving from the current specialized centers, it is planned to issue a series of PARs (program announcements with on-going receipt dates and special review considerations but no set-aside funds) to allow for the fluid addition of new projects and investigators to the network as opportunities emerge. These PARs will provide for on-going peer review of applications using traditional (R21, R01, and P01) grant mechanisms for investigators who wish to conduct research in association with the network. The applications might or might not build on existing collaborations in the network. Independent projects will be welcomed in response to these PARs, but investigators will be expected to participate in network activities.
The first two of the above PARs will be competed in parallel with the above RFAs. The first competition under High-Throughput-Enabled Structural Biology Research will be delayed by several months after RFA-GM-10-007 so that applications for the RFA and for the PAR will not be in competition.
The estimated budget for each component of the PSI:Biology initiative is included in each of the RFAs and in the Concept Clearance. The overall budget for PSI:Biology is expected to be at least $37.7 Million and may be as high as the current PSI budget of $69.9 Million, depending on the number, quality, and size of the applications, under current budget predictions. The overall budget for awards through the three PARs will be open-ended as applications in response to these FOAs will be in competition with all other applications assigned to NIGMS.
Objectives of this FOA
This FOA (RFA-GM-10-006) specifically solicits applications to establish the Centers for Membrane Protein Structure Determination. Membrane proteins comprise approximately 35% of all predicted protein sequences. They play a crucial role in many cellular and physiological processes. They are essential mediators of material and information transfer between cells and their environment, between compartments within cells, and between compartments comprising the organ systems. Functionally normal membrane proteins are vital to health and specific defects are associated with many known disease states. Membrane proteins are the targets of a large number of pharmacologically and toxicologically active substances and are responsible, in part, for their uptake, metabolism, and clearance. Despite the importance of membrane proteins, knowledge of their structures still lags behind that of soluble proteins.
The Centers for Membrane Protein Structure Determination will have the five main goals enumerated under the above overview. These goals are intertwined with the overall goals of the PSI:Biology initiative. The centers will pursue membrane protein structures required to solve biological problems of interest to the center investigators. They will also work on targets that are to be determined through interactions with the PSI:Biology partners, collaborators, and an open community nomination process. Because relatively few membrane protein structures have been solved, these targets will likely also be of value to extending the PSI-2 goal of providing increased of coverage of protein sequence and structure space.
Awards resulting from this FOA will provide support for the core activities of the centers. These include center infrastructure; support for technology development, continuation of sequence and structure coverage goals, and biological theme project(s); and support for determination of community-nominated targets and partial support of collaborative research activities. The centers will receive additional support through the remaining programs of the initiative that will enable them to scale up specific activities to meet the needs of their collaborators. The centers are expected to devote approximately 70% of their effort to protein targets proposed by the center investigators. This is a reflection of the consensus that successful determination of membrane protein structures requires considerable familiarity with physical and functional properties of the particular protein family of interest. The centers will devote 30% of their effort to research in conjunction with awards issued through RFA-GM-10-007, subsequently issued program announcements for additional partnerships, and community-nominated targets.
The Centers for Membrane Protein Structure Determination should be able to carry out all of the constituent tasks of structural genomics and apply them to the specialized case of membrane proteins and their complexes with other proteins. Constituent tasks of structural genomics include, in brief:
The centers should include both prokaryotic and eukaryotic targets and be prepared to work on targets of both types that come from the PSI:Biology partnerships, collaborators, and community nomination process. They should include the necessary expertise and/or technology development to accomplish each of the phases necessary to study membrane protein structures, i.e., expression, solubilization, stabilization, purification, crystallization, and other forms of sample preparation that in general will involve manipulation and characterization of detergents and lipids as well as protein. Approaches should also be included for handling hetero-oligomeric membrane proteins and for complexes formed between membrane proteins and their biological protein partners. Approaches should be included to assure that the proteins produced for structure determination are in functionally relevant states. The centers will concentrate on particular protein families but will also work to develop methods and technology that can be applied at high throughput. Attention should be focused on the costs, success rates, and efficiency of operations.
Investigators of the PSI:Biology Centers for Membrane Protein Structure Determination should be aware of work supported by the NIH Structural Biology Roadmap (http://nihroadmap.nih.gov/) and in some cases may be supported by both programs. While the goals of these programs overlap in part, specific work in any given laboratory should not be part of both programs. Interaction between membrane protein investigators funded by the PSI:Biology initiative, the Roadmap, and by other means is desirable and may be included in the community outreach and dissemination plans for the centers proposed in response to this FOA.
It is expected that the PSI:Biology Centers for Membrane Protein Structure Determination will involve collaborative efforts between chemists, biochemists, molecular biologists, and biophysicists with expertise in the synthesis of probes, novel solubilizing and stabilizing reagents; in cloning and expression; in the isolation and characterization of integral membrane proteins; and in x-ray crystallography, NMR, and other structural methods. A goal of this FOA is to stimulate such multidisciplinary collaborations.
Although partners may be most interested in the structure of a particular protein from a specific organism, it will be recognized by all PSI:Biology participants that determination of the structure of such exactly specified targets may prove to be intractable. Centers will be expected to expand the list of targets around any single specified protein target, taking into account both the potential utility of solved structure information and the feasibility of determining the structure of the specified protein or of any closely related protein family member. Centers will be expected to deliver the requested structure when possible or the structure of as close a homolog as possible and a model of the requested structure based on this homolog. Centers will negotiate with partners, collaborators, and community target nominators through the PSI:Biology Steering Committee to arrive at a reasonable set of targets, goals, and milestones.
Intermediate products of the structure determination pipeline (clones, proteins, procedures) between gene sequence and structure solution may be of value, even if the structure is not solved. These intermediate products must be deposited in the PSI-Materials Repository and the PSI-Structural Genomics Knowledgebase, and otherwise shared with the broad scientific community. In addition to solving specific protein targets, the centers are expected to collaborate intellectually with partners, collaborators, and the community at large to establish linkages between solved structures and the functions of target proteins. In most cases, these efforts will involve functional characterization experiments conducted outside of the centers. However, some limited activities may be conducted within the centers and using center funding when suitable partners are not available to conduct the appropriate experiments.
As partners, the centers and all other components of the PSI:Biology network should have a stake in the outcome of the research. The PSI:Biology centers are not intended to provide simply a structure determination service. Centers will work through the PSI:Biology Network Steering Committee to establish meaningful collaborative interactions with other PSI:Biology researchers, equitably distribute targets among all centers, set community and individual goals and milestones, and appropriately share credit for accomplishments.
The following specific areas of scientific opportunity were identified during the Future Structural Genomics Initiatives meeting as sources of potential protein targets. In many cases, these targets will include membrane proteins. Please see the meeting report for additional description:
The above list should not be considered to be comprehensive. Applications proposing research outside the above areas but still appropriate to the goals of PSI:Biology are welcome.
The PSI:Biology Centers for Membrane Protein Structure Determination may also be called upon to serve as facilities capable of providing structural information in response to other imperative NIGMS program needs and in response to urgent biological or medical problems.
Since its inception in 1999, Protein Structure Initiative target selection has focused on representatives of protein sequence families for which there are no known structures. The NIGMS staff determined in consultation with various advisory groups that the best strategy for target selection in the PSI-2 was to concentrate on large protein families in order to provide the broadest possible structure coverage of sequenced genes. However, the PSI:Biology initiative puts a higher emphasis on the biomedical impact of the structures to be determined. Thus, the target selection policy of the center should reflect a balance between structural coverage of sequenced genes and the elucidation of biomedically important systems and pathways.
With several components that are interdependent, management and administration of the center are crucial. In addition to the usual administrative requirements, the leadership of each research center must direct the research and make a wide range of decisions about subcontracts, equipment purchases, staffing, protocols, pipeline priorities, etc. Administration and management of the center must also take into account the following specific areas of concern: network operations and governance; external input to the network; research training; commitment to diversity; and the sharing of data and material resources.
PSI:Biology Network Operations and Governance
All awarded components of the PSI:Biology initiative will become part of a network of researchers that will be governed by the "Cooperative Agreement Terms and Conditions of Award" that are discussed in Section VI.2.A "Award Administration Information". A single overall PSI:Biology Network Steering Committee (Steering Committee) will be responsible for overall governance. A PSI Investigators Intranet website to be maintained by the Knowledgebase will facilitate communications among PSI:Biology network investigators.
After initiation of the PSI:Biology network, the Steering Committee and the PSI Advisory Committee (see immediately below) will meet jointly with NIH staff to determine how to best carry out the overall distribution of targets throughout the network. Further refinement of target distribution plans will be carried out by these same groups on a regular basis throughout the lifetime of the initiative. Each center will participate in all discussions of target distribution and network capacity allocation. Each center will be expected to abide by the decisions of the Steering Committee and to provide due diligence in the pursuit of their assigned targets.
External Input to the Network
The PSI Advisory Committee will provide external input to the PSI:Biology Network Steering Committee and to NIH staff on the performance of the overall network and its various components. Each of the Centers for Membrane Protein Structure Determination is also expected to have its own External Advisory Committee to provide more specific advice to the center investigators.
Research Training
In addition to conducting research, centers will provide training to graduate students and/or postdoctoral associates as part of the research staff. Although many center activities may involve extensive data collection and repetitious tasks that are not appropriate research training projects, other activities will be at the cutting edge of research and thus would be suitable as graduate thesis research or postdoctoral training projects. The centers will also provide other forms of research training in methods and technology, such as workshops, that may benefit the scientific community at large.
Commitment to Diversity
The NIH and the NIGMS are committed to promoting and advancing the diversity of the scientific workforce. See: http://www.nigms.nih.gov/News/Reports/workforcediversity_100307.htm. Applicants responding to this initiative must propose creative ways to enhance and/or successful ways to ensure the continued diversity on their research teams. Reports from the National Science Foundation and the National Academy of Sciences emphasize the need for a well-trained diverse scientific workforce.
The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans or Blacks, Hispanic Americans or Latinos, American Indians or Alaska Natives, Native Hawaiians or other Pacific Islanders. In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be included in the recruitment and retention plan.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates (a) have qualified for Federal disadvantaged assistance; or (b) have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program; or have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.
The PSI:Biology research groups should reflect the resolve of the NIH and NIGMS to enhance the diversity of the scientific workforce and should include plans for increasing workforce diversity.
Sharing of Data and Material Resources under this Initiative
A central feature of the PSI:Biology initiative is the timely deposition and sharing of data through the PSI-Structural Genomics Knowledgebase, and timely sharing of research resources through depositions to the PSI-Materials Repository and by other mechanisms. Details of these requirements are described under the "Cooperative Agreement Terms and Conditions of Award" that are discussed in Section VI.2.A "Award Administration Information".
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding
opportunity will use the U54 cooperative agreement award mechanism(s).
The Project
Director/Principal Investigator (PD/PI) will have primary responsibility for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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". Projects funded as cooperative agreement projects may be continued beyond the initial award period through application for a grant award in response to any appropriate FOA. Plans to reissue this FOA in the future are indefinite.
2. Funds Available
The
National Institute of General Medical Sciences expects to award at least $8
million through this announcement; and anticipates making 4-10
awards. The expected budget range is from $1.5 - $5 million total
costs (direct costs, plus Facilities and Administrative costs) per year for
project periods of up to 5 years. The maximum allowable request is $5
million in any year. The budget cap must include all costs, such as
equipment and Facilities and Administrative costs for subcontracts.
Annual cost-of-living increases must not exceed 3%. Future
year amounts will depend on annual appropriations.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
During the course of the grant period, both computational and experimental technologies are expected to improve, and the rate of progress and focus of the work supported by the cooperative agreement may change. It is expected that the Principal Investigator will make any necessary adjustment in scientific direction to accommodate to changing environment. However, NIGMS staff must be kept informed of significant changes and prior approval may be appropriate before major changes the in utilization of awarded funds begins.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. However, such institutions may be included as part of consortium applications submitted by any other type of eligible institution.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Investigators funded through the NIH Structural Biology Roadmap may apply for this RFA. In that case, a very careful explanation of the relationship between any on-going activities supported by the Roadmap and the proposed activities of the PSI:Biology center must be presented.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of
Applications. Applicants may submit more than one application, provided they are
scientifically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
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 in item (box) 2 only of the
face page of the application form and the YES box must be checked.
RFA-GM-10-006
Centers for Membrane Protein Structure Determination (U54)
Foreign
Organizations (Non-domestic
(non-U.S.) Entity)
Foreign Organizations are NOT eligible to apply. However, applications from domestic organizations may include a foreign component through a consortium arrangement. Policies governing awards to domestic organizations with a foreign component will apply to such consortium arrangements.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
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: September
9, 2009
Application Receipt Date: October 9, 2009
Peer Review Date(s): February/March,
2010
Council Review Date: May, 2010
Earliest
Anticipated Start Date: July
1, 2010
3.A.1.
Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent
should be sent to:
Peter C. Preusch,
Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Building 45, Room Number 2AS.13C
Bethesda, MD 20892
Telephone: (301) 594-1158
FAX: 301-480-2004
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Helen R. Sunshine,
Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Building 45, Room Number 3AN.12F
Bethesda, MD 20892
Telephone: (301) 594-2881
FAX: 301-480-8506
Email: [email protected]
3.C. Application
Processing
Applications must be received on or before the
application receipt date) described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute Incomplete and/or 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 NIH Grants
Policy Statement.
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new award if such costs: 1)
are necessary to conduct the project, and 2) would be allowable under the
grant, if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a new
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
For cooperative agreements, awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."
Participant Affiliations:
The applications should include a separate page that lists: 1) all participants, including consultants, collaborators, and private sector alliances; 2) all the institutional affiliations for each participant; 3) their roles in the project and the person-months of effort listed separately for each role; and 4) all other research networks/consortia of which each participant is a member. This requirement will facilitate the review of applications. Applications for centers should not explicitly reference groups of investigators that are expected to apply to RFA-GM-10-007, Consortia for High-Throughput-Enabled Structural Biology Partnerships, unless there are on-going collaborations and significant preliminary data involving these investigators. It is intended that the scientific merit of center applications and partnership applications will be evaluated independently. It may be impossible and undesirable to mask previously established and on-going collaborations; however, collaborations to be established in the future should not be included as part of the center grant application.
Research Plan Page Limitations
The overall application should not exceed 50 pages for the Research Plan Sections, Items 2-5 (Specific Aims, Background, Preliminary Results, and Research Plan including the specifically mentioned sections described below). This includes the overall summary of the center and any subprojects. The application should describe an integrated, coordinated project, with various subprojects and collaborative or consortium arrangements as necessary to accomplish the goals of the center and the PSI:Biology initiative. The application should describe plans for a center that is more than the sum of its parts.
The application should include in order: Face Page (Form Page 1); Summary Page (Form Page 2); Participant Affiliations page mentioned above; Table of Contents (Form Page 3); Consolidated Detailed Budget for the Initial Budget Period (Form Page 4) and Consolidated Budget for the Entire Proposed Project Period (Form Page 5), followed by subproject and consortium budget details for the initial year and the entire project period; biographical sketches for all key personnel; institutional support, resources and facilities; the research plan as described below; followed by other components as needed according to the directions provided in the PHS 398 application, including details of consortium arrangements and letters of collaboration. The resources and environment section of the application should explain the relationship between the proposed center and any other center grant support (including pending applications) or relevant administrative structures. Any institutional commitments to the program should be documented.
The application should include an overall summary of the center, its aims, background, preliminary results and/or progress, and general experimental plan, including the Management Plan, the Research Training Plan, the Plan for Increasing Researcher Diversity, the Plan for Data Sharing and Dissemination, the Plan for Sharing Material Resources, and the Intellectual Property Plan. This should be followed by subprojects for specific activities, such as technology developments and biological theme projects that need to be elaborated in greater detail. Each subproject should contain its own Research Plan Section, Items 2-5, but may also cross reference material in the overall summary. A given center investigator may serve as the subproject investigator for more than one component of the center; however, the center as a whole should provide opportunities for synergy deriving from the interactions among multiple investigators.
The overall summary of the center should take the following form:
Section A. Specific Aims. Applicants should succinctly state the scientific objectives of the center under each of the main activity areas: i) determination of membrane protein structures; ii) development of technology to improve membrane protein structure determination and to increasingly solve such proteins at high throughput; iii) bioinformatics analysis of potential targets, solved structures, and the creation of models based on solved structures; iv) dissemination of information and materials via the Materials Repository, Knowledgebase, and by other appropriate means; and v) collaborative research with other members of the network to be established through this and the other RFAs and PARs that are part of this initiative. The specific aims should address any unique biomedical theme projects that the center will pursue and should also address how the center will contribute to the continuing goal of novel protein sequence and structure coverage.
Section B. Background. Applicants should provide sufficient background information to convey their acquaintance the state of the art in membrane protein structure determination. They should also demonstrate their familiarity with the Protein Structure Initiative; structural genomics, in general; the opportunities and challenges of high-throughput structure determination methods as they may be applied during the proposed project period; and their understanding of how their application will contribute to the overall PSI:Biology initiative. This should include background information on high-throughput structure determination, the state of the art with respect to modeling unknown protein structures based on known protein structures and/or other information, and the necessary background to understand any proposed biological theme project. The relationship between protein targets and activities to be carried out under this center and those to be carried out under any other centers or other forms of support should be explained.
Section C. Preliminary Results. Applicants should include under preliminary results data that demonstrate their ability to carry out the solution of membrane protein structures and their potential to develop high-throughput approaches to this problem. Applicants should include under preliminary results any analysis that they have carried out with respect to the sequence and structure space coverage/leverage goals for the project period. Applicants should provide relevant preliminary results for any proposed biological theme project, including analysis of the likely contribution of such work to sequence and structure space coverage, and discussion of any other types of work that has been conducted. This section should include information about the solved structures of the nearest known family or superfamily members (percent homology of proposed targets to nearest neighbors). It should include information about the likely leverage that a solved structure would provide for the modeling of other proteins of unknown structure. This type of information is available through the PSI-Structural Genomics Knowledgebase, and it is highly recommended that applicants subject their proposed target sequences to the analysis available there through the Submit Targets module (http://kb.psi-structuralgenomics.org/KB/SubmitTargets). The results should be presented in an appendix to the application. Similarly, applicants should search the PSI-Materials Repository to determine which plasmids relevant to their project have already been deposited and include plans to make use of such materials. This material should also be included in the appendix. Applicants for PSI:Biology Centers for Membrane Protein Structure Determination are expected to be thoroughly familiar with these concepts and resources; thus, additional discussion and analysis should be presented to demonstrate the expertise of the centers.
Additional relevant preliminary results/progress should include data on unique, non-redundant (and other) membrane protein structures that have been solved by the participating investigators during the past five years. These data should include the following information:
These data, which may be voluminous, should be included in the appendix, not in the body of the application. However, useful summary statistics and discussion should be included in the body of the application.
Other preliminary results may be included as the investigators wish. However, since it is not known which investigators will be funded as part of the PSI:Biology initiative, the center application should not rely on any specific collaborations to demonstrate its viability. Thus, preliminary results related to current collaborative efforts should not be a major component of the application. On the other hand, the application should indicate the willingness of the investigators to collaborate with biologists.
The application should include information about the estimated cost per structure determination for various types of target proteins reported in the preliminary results.
Section D. Experimental Plan. Applicants should describe in detail how the work is to be conducted. These plans should address all steps necessary to the solution of membrane protein structures and all steps to be taken toward development of a membrane protein structural genomics pipeline, including:
Work to be conducted by as-yet-unidentified collaborators as part of the PSI:Biology network may be anticipated and described in schematic form. The application should indicate the expected ways that collaborators can both contribute to and utilize the capabilities of the center.
Applications must also include the following specifically identified components: Management Plan, Research Training Plan, Plan for Increasing Researcher Diversity, Plan for Data Sharing and Dissemination, Plan for Sharing Material Resources, and Intellectual Property Plan.
Management Plan: Applications must include a project management plan, which may include the Multiple PD/PI Leadership Plan as a subheading (if the application is designated a Multiple PD/PI application). Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" that are discussed in Section VI.2.A "Award Administration Information" and should explain how they plan to meet these terms and conditions. Applicants must indicate their willingness to participate in the PSI:Biology Network Steering Committee and how they anticipate managing the interactions between the center and other components of the PSI:Biology network. The center should plan for an External Advisory Committee to provide at least annual feedback to the center investigators. Although the plan should be set forth, names of potential members should not be included. Potential members should NOT be contacted, named, or appointed until after an award is made. If the investigators are now or have been involved in previous projects with advisory structures, however, the names of present and recent past advisors should be identified in the Participant Affiliations page described above. Centers should plan for a meeting that brings all participating investigators together at least annually and provides an opportunity for External Advisory Committee review. Other means for more frequent communication should also be described. The management plan should address how the center will go about priority setting, redistribution of resources, personnel, and space, and other management issues. The centers may request center development funds and the process for deciding how these funds will be used should be described.
In the case of investigators with support from the NIH Structural Biology Roadmap or other significant sources of support for their work on membrane proteins, the management plan should indicate how the interactions between these projects will be managed.
Research Training Plan: Applicants must explain how activities of the center will contribute to the training of graduate students, postdoctoral researchers, and other scientists and how these activities will be supervised.
Plan for Increasing Researcher Diversity: Plan for Increasing Researcher Diversity: Applicants must propose ways to reflect the NIH and NIGMS commitment to enhancing the diversity of the scientific workforce. Applicants should provide information on the diversity of the proposed research teams and plans to enhance and/or ensure the continued diversity of their research teams.
Plan for Data Sharing and Dissemination: Applicants should describe how they will contribute to data sharing and dissemination in addition to the activities described under the Cooperative Agreement Terms and Conditions.
Plan for Sharing Material Resources: Describe plans for research resource sharing in addition to the activities described under the Cooperative Agreement Terms and Conditions of Award.
Intellectual Property Plan: An institution's stance must be consistent with the goals of advancing and not hindering future research.
Budgetary Instructions: The budget should be in the range of $1.5 - $5 million per year total costs for the first year and should not exceed $5 million in any year. Annual cost-of-living increases should not to exceed 3%. The budget should be proportional to the scale of activity proposed and should be fully justified. The budget to be awarded through this RFA is expected to support the core activities and infrastructure of the center that enable membrane protein structure determination; the technology development objectives of the center; activities to conduct bioinformatics analysis and modeling; dissemination of information and materials; and part of the costs of collaborative research to be established through RFA-GM-10-007, as well as costs for work on community-nominated targets. Approximately 70% of the effort and the budget of the center should be to research on targets specified by the center investigators in their response to this RFA (RFA-GM-10-006). About 30% of the effort should be planed for work on targets adopted as a result of awards issued through RFA-GM-10-007 and community-nominated targets. For planning purposes, additional budgetary support for the centers will be provided through the awards resulting from RFA-GM-10-007 and this source may be considered in the management plan. However, these funds should not be included in the center budget. Applicants for RFA-GM-10-007 have been informed that the current cost for solution of soluble protein targets by PSI-2 is close to $50,000. However, since a large part of the costs for structure determination will be awarded to the centers through this RFA, applicants for partnerships have been instructed to request funds on the order of $10,000 per structure. Costs for more difficult protein targets, such as complexes and membrane proteins, will be higher. Estimates of expected costs to collaborating partners should be discussed.
Applicants may request up to 5% of the total budget annually as center development funds that are not specifically assigned to any proposed project and not explicitly justified by the proposed studies. This budget item will provide budgetary flexibility in the development and operation of the centers. It will permit centers to make budget changes within a budget year and to explore innovative ideas and new technologies. Since reallocation during any budget year between subprojects (which may be at different institutions) is difficult, the center development funds may be needed to allow the center to make major changes and move in new directions. They may also be used to support pilot studies in new areas interest that can efficiently utilize the capabilities of the center. Use of center development funds is subject to approval of the NIGMS program official assigned to the center.
Applicants should plan for and request funds to support the travel of the principal investigators and one or more other scientific staff members to attend at least two PSI:Biology initiative meetings of up to two days each year. This is in addition to requesting travel funds for normal attendance at scientific meetings.
Applicants should request funds to support an annual meeting of all center investigators with the External Advisory Committee and the necessary funds to support travel and consultant fees.
Applicants should request funds to support any activities proposed under the Research Training, Plan for Data Sharing and Dissemination, and Plan for Sharing Material Resources.
Funds for administrative assistance in managing the center and it interactions with other components of the PSI:Biology network may be requested but must be strongly justified.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html. Include five identical CDs in the same package with the copies of the application that are submitted to NIGMS.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
For this FOA, the following materials must be included in the appendix in addition to those specified in the general NIH guidelines. 1) Output from searching the PSI-Structural Genomics Knowledgebase Submit Targets module for data on the relationship of proposed targets to already proposed targets and known structures. 2) Output from searching the PSI-Materials Repository for previously deposited plasmids relevant to the proposed research. 3) Data documenting in detail structures solved by the applicants as described under preliminary results.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Resource sharing requirements of the PSI:Biology initiative go beyond the NIH policies described above and are included in the Cooperative Agreement Terms and Conditions described below.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIGMS and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
NIH considers the following in evaluating Center grant applications:
The following will be considered in making funding decisions:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Will the proposed center contribute in an important way to the solution of significant biological problems? Will the proposed center contribute to the secondary goal of determining novel protein structures and increasing the coverage of sequence/structure space? Do the proposed biological theme targets address significant biological problems? Will the technology development activities of the center be significant?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the investigators demonstrate the potential to be interactive and effective members of the PSI:Biology network? Is there evidence of synergy among the investigators of the center or the potential for such synergy to develop? Do(es) the PD/PIs have the administrative skills, experience, and/or potential to manage a center of the proposed scope?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Will the proposed technology developments enhance the ability of the center to solve the structures of many more membrane proteins and their complexes with partner proteins? Will they contribute to the eventual development of a high-throughput approach to membrane protein structures? Do these technological innovations also have the potential to significantly facilitate structure determination by the greater structural biology community?
Approach. Are the overall strategy, methodology, and analyses well-reasoned
and appropriate to accomplish the specific aims of the project? Are potential
problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed? Is feasibility
demonstrated for most aspects of the research plan and will particularly risky
aspects be managed? Are plans for organization of the center
appropriate? Are the goals and milestones appropriate?
Do the plans for and/or previously demonstrated success in protein family classification and target selection, with an emphasis on membrane protein families, indicate the potential of the center to make a strong contribution to the multiple goals of the PSI:Biology initiative? Do the plans and/or previously demonstrated success at producing and determining structures of membrane proteins indicate the potential of the center to solve many membrane protein structures and to eventually achieve a high-throughput operation for membrane proteins? Do the plans and/or previously demonstrated success indicate the potential of the center for increasing throughput, efficiency, success rates, and decreasing costs for producing and determining structures of membrane proteins?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of the overall scientific merit and the impact/priority score.
Management Plan: Is an adequate plan presented to assure the productive and collaborative functioning of the center and its interactions with other components of the PSI:Biology network? Are there adequate plans and assurances that the center will carry out the work assigned by the Steering Committee and meet production goals of the PSI:Biology network?
Research Training Plan: Is an adequate plan presented to assure that graduate students and postdoctoral researchers associated with the center receive appropriate scientific training? Are adequate plans presented to provide additional training and outreach activities to the scientific community at large?
Subprojects, consortia, and cores will not be individually scored. However, reviewers will be asked to comment on whether each such specifically identified unit should be included as part of the center.
Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Commitment to Diversity. Reviewers will comment on the center's commitment to enhancing the diversity of the scientific workforce and how well the scientific teams of the proposed center reflect that commitment. The reviewers will also comment on the value and likelihood of success of the center's proposed plans to enhance the diversity of the scientific workforce.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
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.
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 cooperative agreement 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.
2.
A.1. Project Director/Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for:
Awardees
will retain custody of and have primary rights to the data and software
developed under these awards, subject to Government rights of access consistent
with current HHS, PHS, and NIH policies.
2.
A.2. NIH Responsibilities
NIH project scientists
will have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below.
The PSI:Biology Network Director
The PSI:Biology Network Director will be the NIH extramural staff member with leadership responsibilities for the management and coordination of the overall PSI:Biology initiative. The PSI:Biology Network Director will serve as a Scientific Liaison to the overall PSI:Biology Network and all of its components and will be a voting member of the PSI:Biology Network Steering Committee (Steering Committee), but will not direct the scientific activities of any PSI:Biology awarded component (whose direction is the responsibility of the Project Director/Principal Investigator).
The PSI Network Director will:
The PSI Network Director will not also serve as the NH program official for any component of the PSI:Biology network.
NIH Scientific Liaisons
The NIH Scientific Liaisons will be members of the NIH extramural staff who will serve on the PSI:Biology Network Steering Committee (Steering Committee) and have substantial scientific/programmatic involvement in the project that is above and beyond normal program stewardship. Each of the NIH institutes and centers supporting the PSI:Biology network will have one Scientific Liaison. Additional Scientific Liaisons may be assigned as necessary to work with specific components of the PSI:Biology network. Each of the Centers for Membrane Protein Structure Determination will be assigned an NIH Scientific Liaison who may or may not be the same individual for all centers and may or may not be identical with the PSI:Biology Network Director.
The Scientific Liaisons will:
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. A Scientific Liaison to any component of the PSI:Biology network may not also serve as the NIH Program Director for another component.
NIH Program Directors
The NIH Program Directors are the extramural staff individuals who provide normal program stewardship for the PSI:Biology network awards. The NIH Program Directors are not members of the Steering Committee and do not direct the scientific activities of the PSI:Biology network awards (whose direction is the responsibility of the Project Director/Principal Investigator).
The NIH Program Directors will:
The
assigned program director for a component of the PSI:Biology network may not
also serve as a scientific liaison for another component.
2.A.3. Collaborative Responsibilities
PSI:Biology Network Steering Committee
The PSI:Biology Network Steering Committee (Steering Committee) will be the main governing body of the PSI:Biology network. Membership will include the Project Directors/Principal Investigators of the Centers for High-Throughput Structure Determination, the Centers for Membrane Protein Structure Determination, the Consortia for High-Throughput-Enabled Structural Biology Partnerships, the PSI-Structural Genomics Knowledgebase, and the Materials Repository, the NIH Scientific Liaisons, and others as nominated by the PSI:Biology Network Director. In the case of awards involving Multiple PD(s)/PI(s), each PSI:Biology component will be entitled to one voting member. The NIGMS/NIH Scientific Liaisons and the PSI:Biology Network Director will serve as voting members of the Steering Committee and attend its meetings. Total NIH representation on the Steering Committee will make up no more than 40% of the voting members. Other members of the NIH staff may also attend the Steering Committee meetings. The leaders of other national and international structural genomics projects may be added to the Steering Committee as non-voting members, as determined appropriate by the PSI:Biology Network Director.
The Steering Committee will:
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.
PSI Advisory Committee
The PSI Advisory Committee is a working group of the NIGMS Advisory Council. It will advise NIH staff and the Council on the management, progress, and plans for the PSI:Biology initiative. The membership will be appointed by the PSI:Biology Network Director, following consultation with the Director of NIGMS. Members will include at least one NIGMS Advisory Council member, plus additional consultants as deemed necessary to provide appropriate guidance to the NIGMS Advisory Council.
This PSI Advisory Committee will:
Goals and Milestones
Appropriate goals and annual milestones for each of the components of the PSI:Biology network will be set to ensure that the overall goals of the initiative are met. Initial milestones will be determined by negotiation between the applicant and the NIH Program Director assigned to the center during the award process and will be included in the Terms and Conditions of Award. Scientific Liaisons may assist the PD(s)/PI(s) in setting milestones, but do not have authority to approve them. This authority rests with the NIH Program Director. Milestones will be further refined as the PSI:Biology initiative evolves with input from the Steering Committee and PSI Advisory Committee and renegotiated annually as part of the non-competing continuation award process. The NIH may reduce or withhold funds for failure to meet milestones agreed upon by the investigators and NIH staff.
Reports
The PSI:Biology Network Steering Committee will produce an annual report on the progress made toward the annual goals and milestones. The report will be delivered to the NIGMS staff and PSI Advisory Committee within one month of the annual meeting.
Data Sharing Policies
The PSI:Biology network will be governed by the Data Sharing Policies that have governed PSI-1 and PSI-2. Coordinates of solved structures, along with structure factors, MUST be deposited in the Protein Databank within four weeks of completing the refinement of the structure. Data must be released by the PDB to the public immediately, unless the dataset is designated as a "technology development data set" to be used in CASP-like tests of software development. In any event, ALL structural data must be made public within eight weeks. In addition, protein targets adopted by the Centers for Membrane Protein Structure Determination must be entered in the TargetDB, including those arising from the Consortia for High-Throughput-Enabled Structural Biology Partnerships and those submitted through the community nominations process. Furthermore, progress on these targets must be updated on a monthly basis. As work progresses, appropriate data must be entered in the PepcDB regarding the methods and success or failure of various steps in the structure determination pipeline in a timely fashion. Finally, all components of the PSI must abide by all NIH policies for sharing of published information through PubMedCentral and must also abide by policies of the PSI:Biology network requiring the deposition of information about publications and other activities in the PSI-Structural Genomics Knowledgebase. Participants must also contribute appropriate information to the PSI-Investigators intranet website as necessary to facilitate communication between the various components of the PSI.
PSI:Biology Resource Sharing Policies
All funded components of the PSI:Biology network are expected to deposit vectors and clones developed with PSI:Biology funding or used in PSI:Biology research into the PSI-Materials Repository.
Intellectual Property Policies
Normal NIH guidelines regarding intellectual property will apply to these grants. However, it is expected that the above data sharing and experimental resource sharing activities will take place in a timely fashion, even if IP protection activities are delayed.
2.A.4.
Dispute Resolution
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. A Dispute Resolution
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 dispute resolution
procedure does not alter the awardee's rights 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 the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
In addition to the Non-Competing Continuation
Grant Progress Report (PHS 2590) and reports on the operation of the overall
PSI:Biology network to be produced by the PSI:Biology Network Steering
Committee and the PSI Advisory Committee, each Contact Principal Investigator
will be required to submit quarterly reports of progress that will be shared
with other members of the PSI:Biology network via the Knowledgebase.
These reports will be in the form of text documents (or PDF files) with figures
and tables to be determined by the PD(s)/PI(s). These reports will focus
on progress toward the determination of structures and are intended to
facilitate coordination of effort and sharing of methodological advances.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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 C. Preusch, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Building 45, Room Number 2AS.13C
Bethesda, MD 20892
Telephone: (301) 594-1158
FAX: 301-480-2004
Email: [email protected]
2. Peer Review Contacts:
Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Building 45, Room Number 3AN.12F
Bethesda, MD 20892
Telephone: (301) 594-2881
FAX: 301-480-8506
Email: [email protected]
3. Financial or Grants Management Contacts:
Earl C. Melvin
Grants
Administration Branch
Division
of Extramural Research
National
Institute of General Medical Sciences
45 Center Drive, MSC 6200
Building 45, Room Number 2AN.32E
Bethesda, MD 20892
Telephone: (301) 594-3912
FAX: 301-480-2554
Email: [email protected]
Section VIII. Other Information
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.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
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.
NIH Public Access Policy Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
Standards
for Privacy of Individually Identifiable Health Information:
The Department
of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH
Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy
People 2010:
The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is
described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service
Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and
45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy Statement. The
NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan
Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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