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: NIGMS Center for the Determination of Structures of HIV/Host
Complexes (P50)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-GM-07-001
Catalog of Federal Domestic Assistance Number(s)
93.859
Key Dates
Release Date: April 13, 2006
Letters of Intent
Receipt Date(s): December 13, 2006
Application Receipt
Date(s): January
12, 2007
Peer Review Date(s): April 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date:
July 1, 2007
Expiration Date: January 13, 2007
Due Dates for E.O. 12372
Not
Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
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
The National Institute of
General Medical Sciences invites applications for Centers that will support the
determination of the structures of macromolecular components of the human
immunodeficiency virus (HIV) complexed with macromolecular components of host
cells.
From the time of entry into the host to final release, viral-host complexes play an integral role in the reproduction and proliferation of the virus. These complexes range from binary protein-protein and protein-nucleic acid complexes to much larger multicomponent complexes. A number of these interactions are documented in the HIV-1, Human Protein Interaction Database (http://www.ncbi.nlm.nih.gov/RefSeq/HIVInteractions/). Although these structures offer the potential of providing intervention strategies for the treatment of AIDS, the first step towards the exploitation of these targets, the determination of their high resolution structures, has been accomplished in only a few cases. Thus the goal of this Request for Applications (RFA) is the creation of Centers dedicated to the determination of the high-resolution structures of these complexes. In order to succeed, these Centers must collaborate with the biological community doing research aimed at identifying and validating the presence of these complexes. The latter will be funded by existing mechanisms and a related Program Announcement (PA-06-388) published by the National Institute of Allergy and Infectious Diseases (NIAID).
The goal of this announcement is to attract the best scientists in relevant fields to attack the problem of the structure determination of HIV/host macromolecular complexes. Hence the application should focus on the specific problems to be solved, approaches to be used, identification of potential bottlenecks, a workable management plan along with milestones, and the commitment and past experience of the investigators. The research being proposed is expected to push the boundaries of what is feasible. As such, it is recognized that aspects of the plan necessarily will be highly risky.
Characteristics of each Center:
1. Each Center must have the demonstrated capabilities for the high resolution structure determination of macromolecular complexes.
2. Each Center must have a focus of investigation within the broader biology of HIV/host cell interactions. This focus will help to guide selection of structure determination targets.
3. Each Center must actively collaborate with the biological community engaged in research on HIV/host complexes.
4. Each Center is strongly encouraged to have a technology component designed to push the state-of-the-art in the cloning, expression and structure determination of HIV/host complexes.
5. Alternatively or in addition to 4 above, a Center may propose to study the role and/or activity of certain complexes in vivo using state-of-the-art biophysical techniques.
Details on each of the above characteristics are given below:
1. Structure determination: X-ray crystallography is generally the method of choice for determining the structures of macromolecular complexes. However, it often may be useful to employ other methods either alone or in conjunction with x-ray crystallography. For example, nuclear magnetic resonance may be the method of choice for structure determination in certain instances or may be used to determine interfaces between subunits whose individual structures have been determined by x-ray crystallography. Likewise, electron microscopy may be used to determine moderate resolution structures of complexes or may be used to provide envelopes into which higher resolution models of subunits can be docked. Small angle x-ray scattering and other methods also may play important roles. Given the scope of the research to be undertaken, each Center must have available a range of structure determination methods, from routine to more advanced. It is expected that methods unique to a Center will be made available to the other Center(s) on a collaborative basis.
The determination of the structures of macromolecular complexes requires control over all aspects of sample preparation, including cloning, expression or synthesis, purification, and for crystallography, crystallization. Success in these steps often is determined by trial and error methods in which many experimental conditions are systematically varied. As has been shown by various structural genomics efforts throughout the world, there is tremendous advantage to automating many of the procedures. For some aspects of sample preparation, it may make sense to carry out the procedures in house. For other aspects, it may make more sense to tap into an existing structural genomics pipeline through a collaborative agreement. Applicants are strongly encouraged to establish such collaborations.
2. Biological focus: The proposed research should aspire to achieve a comprehensive structural analysis of a particular aspect in the biology of HIV-host cell interactions. A judiciously selected set of structures will provide a sufficiently extensive and detailed framework for interpreting, integrating, and guiding functional research related to that aspect of HIV biology. Through such a focused approach, a deep and definitive understanding of that aspect of HIV biology should emerge that then may be capitalized effectively for therapeutic strategies. Since in certain cases related systems, such as other lentiviruses, may be more tractable for structure determination, work on such is acceptable. In these cases, the work must contribute demonstrably to our understanding of HIV biology and provide lessons that can be applied to the development of anti-HIV therapeutics.
3. Collaboration: The set of possible targets for structure determination is very large. Thus, it is unreasonable to expect the Centers, even when considered together, to possess the biological expertise to explore and develop all such targets. It, therefore, is essential that each Center have a mechanism and infrastructure for establishing and maintaining collaborations with outside scientists studying HIV/host interactions. These collaborators should be able to enter the structure determination pipeline at several points, from the provision of clones to actual purified complexes. The collaborators expertise in the biological aspects may also be important as the Centers attempt to bring the particular biological system under the control needed for structure determination. Conversely, investigators pursuing functional studies of HIV host cell interactions are being encouraged to collaborate in structural studies with the Centers through a Program Announcement published by NIAID (PA-06-388). Through these multiple avenues for collaboration, the goal is to mesh structural and functional studies of HIV host interactions such that they inform and build on each other in pursuit of effective anti-HIV therapeutics. Thus, it is expected that potential competitors will collaborate to the benefit of the project as a whole.
4. Technological Component: The determination of the structure of macromolecular complexes pushes the current state of the art, both in terms of the technology needed for structure determination and the biology needed to produce sufficient material for analysis. Hence each Center is encouraged strongly to have a component devoted to advancing the state of the art of the determination of structures of macromolecular complexes. While well-behaved non-HIV related macromolecular complexes may be appropriate to develop and validate new methods, the methods developed must be clearly applicable to the determination of the structures of HIV/host complexes.
5. In vivo role: Modern single-particle methods are being used increasingly to examine biological processes in vivo. A Center may include a component to study role of HIV/host complexes in the lifecycle of the virus in real time using such imaging methods. For this component, collaboration with scientists with demonstrated expertise in these methods is recommended strongly.
Management and Oversight
Because of the complex nature of these Centers, the Principal Investigator must devote at least 25% of his/her effort to the project. It is also essential that significant effort and enthusiasm be exhibited by other key personnel. Because of the complex nature of these Centers, support of a Center coordinator, who will attend to the day-to-day operation of the Center, is strongly encouraged. If Collaboration Development Funds (see Section IV.6-Other Submission Requirements) are requested as part of the budget, then an explanation of the process by which fund use will be decided must be provided.
Overall success of this program depends critically on the success of each Center, the accomplishments of collaborating investigators and on the ability of the entire program to work in concert.
Therefore:
Each Center will appoint an advisory committee in consultation with and subject to the approval of the NIGMS Program Official. This advisory committee will meet at least once a year and give advice directly to the Center. The NIGMS Program Official will attend each meeting of the advisory committee as an observer. Candidates for the advisory board should not be named in the application or solicited prior to award.
In addition, NIGMS and the Division of AIDS, NIAID will appoint an advisory committee to oversee the operation of the entire network. That committee will be a subcommittee of the National Advisory General Medical Sciences Council. Members of this committee will be appointed directly by the Program Officials of NIAID and NIGMS and will give advice directly to NIH. The committee will meet at least annually. Representatives from each Center are required to attend.
To ensure coordination and cooperation among the funded Centers and the other members of the scientific research community working in areas germane to the mission of the Centers, an annual scientific meeting will be held. Attendance of the principal investigator and key participants from each Center is required. Attendance of key collaborating investigators is highly encouraged. Sufficient funds should be included in the budget for travel to these meetings.
The collaborative aspects of the overall program are essential for its success. Given the dynamic nature of collaborations, this aspect is expected to change from year to year. Therefore, each Center must update its plans for collaboration each year. These updated plans for collaborations will be reviewed by the Advisory Committee and approved by the NIGMS Program official. This approval will be a condition of the award. In the event additional funds become available, support could be provided for innovative approaches that are conceived after the onset of the Center grant.
See Section VIII, Other Information - Required Federal Citations,
for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the P50
Center award
mechanism.
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses the just-in-time budget concepts. It also uses the non-modular budget
format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
2. Funds Available
NIGMS intends to commit up to 10,000,000 dollars total costs in FY 07 to fund two or three applications in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to 2.7 million dollars per year and for total costs up to four million dollars per year. Although the financial plans of the NIGMS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
Only one
application may be submitted from an applicant organization.
1.B. Eligible Individuals
Any individual with the
skills, knowledge, and resources necessary to carry out the proposed research
is invited to work with their institution to develop an application for
support. Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH support.
2. Cost Sharing or Matching
Cost sharing is not
required.
The most current Grants
Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
Not applicable
Section
IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
The instructions for the Research Plan section of the
application should be modified as follows: The
overall page limit for the Research Plan section (excluding the Bibliography)
of the application is 60 pages. This overall limit must be adhered to strictly.
The page limits given below for each subsection are recommendations. Given the
page limits, experimental details should be provided to the extent it is felt
necessary to provide confidence that the research plan is reasonable and that
likely hurdles and potential solutions have been considered carefully.
Section 1--Center in its entirety using the following sections:
Specific Aims: In one page, the specific aims should be presented for the Center as a whole.
Background and Significance: In up to five pages, the proposal should present relevant background information, biological problems and technological problems that need to be solved to push the field forward.
Preliminary Results and Progress Report: In up to three pages, describe the expertise of the key participants and provide references to their significant relevant publications.
Approach: In up to seven pages, present the rationale for the organization of the Center, the rationale for the inclusion of each investigator, a management plan and milestones for each year of research proposed. Justify the length of award sought. If Collaboration Development Funds (see Section IV.6-Other Submission Requirements) are requested in the budget, then a plan for potential uses and the process by which fund use decisions will be made must be included.
Section 2--Biological Theme:
Specific Aims: In one page, outline what you wish to accomplish over the term of the grant.
Background and Significance: In up to three pages, the application should place the proposed studies in the context of the field and the Center.
Preliminary Results: In up to five pages, outline the experience of the group in the area of the biological theme. Cite relevant key publications. Any unpublished preliminary results should be presented briefly.
Approach: In up to seven pages, outline the approach to be taken to further knowledge on the biological theme. Included should be milestones and a delineation of the likely major bottlenecks to be encountered. Possible approaches to be taken should be given and at a level of detail sufficient to provide reasonable confidence that the bottlenecks can be overcome.
Section 3--Collaborations:
In up to four pages describe the mechanisms and infrastructure that will be used to establish and maintain collaborations with the scientific community engaged in the identification, validation and study of HIV/host complexes. This section should document existing collaborations. Letters of collaboration and collaborators biosketches should be included in the appendix material. It is essential that sufficient travel funds be allocated in the budget for the collaborations envisaged.
Next Section(s)--Technological component(s) and/or single particle in vivo imaging:
Specific Aims: Use one page. For a technological component, outline the technological barriers to be overcome. For in vivo imaging, outline the goals of the in vivo imaging approach.
Background and Significance: Use up to three pages. For a technological component, describe the problem or barrier the technological advances will solve or overcome and the advantage of the technological advances will have over existing technology. For in vivo imaging, place the proposed studies in the context of the field and the Center.
Preliminary results: Use up to five pages. Outline the experience of the group in the area of the biological theme. Cite relevant key publications. Any unpublished preliminary results should be presented briefly.
Approach: Use up to seven pages. Outline the approach to be taken. Included should be milestones, a delineation of the bottlenecks to be encountered, the kinds of expertise required and the steps taken to acquire that expertise, either by direct participation or collaboration. Possible approaches to circumvent potential bottlenecks should be described.
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: December 13, 2006
Application
Receipt Date(s): January 12,
2007
Peer Review Date: April 2007
Council Review
Date: May 2007
Earliest
Anticipated Start Date: July 1, 2007
3.A.1. Letter of Intent
Prospective applicants
are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is
to be sent by the date listed at the beginning of this document.
The letter of intent
should be sent to:
Ravi Basavappa, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive
Building 45, Room 2As.19E
Bethesda, MD 20892
Telephone: (301) 594-0828
FAX: 301-480-2004
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five 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).
Using the RFA Label: The RFA label available in
the PHS 398 application instructions must be affixed to the bottom of the face
page of the application. Type the RFA number on the label. Failure to use this
label could result in delayed processing of the application such that it may
not reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications must be received on or before the
application receipt date(s) described above (Section IV.3.A.).
If an application is received after that date, it will be returned to the
applicant without review. Upon receipt, applications will be evaluated for
completeness by the CSR and responsiveness by the NIGMS. Incomplete and non-responsive
applications will not be reviewed.
The NIH will not accept
any application in response to this funding opportunity that is essentially the
same as one currently pending initial review, unless the applicant withdraws
the pending application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be submitted
in response to a funding opportunity, it is to be prepared as a NEW
application. That is, the application for the funding opportunity must not
include an Introduction describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.
Information on the
status of an application should be checked by the Principal Investigator in the
eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Annual
Meeting. Applications should include travel funds for the appropriate personnel
to attend an annual meeting and the annual advisors meeting
Letters of collaboration and collaborator biosketches must be provided as appropriate. The letters of collaboration must document the extent of the collaboration.
Collaboration Development Fund: To provide flexibility in establishing new or strengthening existing collaborations, applicants may request part of their budget be allocated to a Collaboration Development Fund. Such a fund will allow within a fiscal year rapid funding changes that may be necessary to keep pace with the dynamics of new and existing collaborations. The fund should be used primarily to support staff and purchase equipment or supplies. All expenditures from the Collaboration Development Fund must be approved by NIH staff. Applicants may request up to 5% of the total annual budget be allocated to this fund.
Plan for Sharing Research
Data
All
data must be made available to the public in a timely manner. All
coordinates and structure factors or NMR resonance assignments and restraints
resulting from research supported by funds from this RFA, whether the project
originated in the Center or in the laboratory of a collaborator, must be available
from the Protein Data Bank or BioMagResBank on publication. Structures of
protein complexes solved by electron microscopy using funds from this RFA must
be submitted to the EMDB database.
Sharing Research Resources
NIH policy requires that
grant awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related
data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
The following will be
considered in making funding decisions:
Program
priorities and balance will be an especially important selection
criterion. That is it may be the case that a more highly ranked
application may passed over in favor of a less highly ranked one to achieve a
balance in targets, methods and approach.
2. Review and Selection Process
Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the Center for Scientific Review
(CSR) in
accordance with the review criteria stated below.
As part of the initial
merit review, all applications will:
The goals of NIH
supported research are to advance our understanding of biological systems, to
improve the control of disease, and to enhance health. In their written
critiques, reviewers will be asked to comment on each of the following criteria
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score. For example, an investigator
may propose to carry out important work that by its nature is not innovative
but is essential to move a field forward.
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the scientific methods and approaches proposed appropriate? Are the plans for project coordination and collaboration adequate?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area? Does
the project strike an appropriate balance between using established methods and
developing innovative approaches? Will the innovative approaches proposed
benefit the field of HIV-related research?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)? What is the record of the investigators
in developing innovative approaches to similar projects? What is the level of
enthusiasm and commitment of the participants for the project?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support? Is the environment conducive to
the establishment of collaborations with the larger participating scientific
community? Is the organization of the Center sufficient to meet the goals of
this RFA?
2.A. Additional Review
Criteria:
In addition to the above
criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and subgroups),
and children as appropriate for the scientific goals of the research will be
assessed. Plans for the recruitment and retention of subjects will also be
evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing Research
Resources
NIH policy requires that
grant awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding organization
when making recommendations about funding applications. Program staff may
negotiate modifications of the data and resource sharing plans with the awardee
before recommending funding of an application. The final version of the data
and resource sharing plans negotiated by both will become a condition of the
award of the grant. The effectiveness of the resource sharing will be evaluated
as part of the administrative review of each non-competing Grant Progress
Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
N/A
Section
VI. Award Administration Information
1. Award Notices
After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees
will be required to submit the PHS Non-Competing Grant Progress Report, Form
2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section
VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
Ravi Basavappa, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive
Building 45, Room 2As.19E
Bethesda, MD 20892
Telephone: (301) 594-0828
FAX: 301-480-2004
Email: [email protected]
2. Peer Review Contacts:
Ranga
V. Srinivas, Ph.D.
Chief, AIDS & Related Research IRG
Center for Scientific Review, N.I.H.
6701 Rockledge Drive
Room 5222, MSC 7852
Bethesda, MD 20892-7852
(Use 20817 for FedEx)
Phone: 301-435-1167
FAX: 301-480-2241
3. Financial or Grants Management Contacts:
Grace Olascoaga
Chief Grants Management Officer
National Institute of General Medical Sciences
Building 45, Room 2An.32C
45 Center Drive
Bethesda, MD 20892
Telephone: (301) 594-5135
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.
Access to Research
Data through the Freedom of Information Act:
The Office of Management
and Budget (OMB) Circular A-110 has been revised to provide access to research
data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in
part with Federal funds and (2) cited publicly and officially by a Federal
agency in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources including
the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children
as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on
the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
NIH Public Access
Policy:
NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central
(PMC) an electronic version of the author's final manuscript upon acceptance
for publication, resulting from research supported in whole or in part with
direct costs from NIH. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications from
the publishing peer review process.
NIH is requesting that
authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more information
about the Policy or the submission process please visit the NIH Public Access
Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
Standards for Privacy
of Individually Identifiable Health Information:
The Department of Health
and Human Services (DHHS) issued final modification to the "Standards for
Privacy of Individually Identifiable Health Information", the
"Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable health
information, and is administered and enforced by the DHHS Office for Civil
Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant
Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to the
review because reviewers are under no obligation to view the Internet sites.
Furthermore, we caution reviewers that their anonymity may be compromised when
they directly access an Internet site.
Healthy People 2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This PA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is described in
the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy Statement. The
NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages
all grant recipients to provide a smoke-free workplace and discourage the use
of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act
of 1994, prohibits smoking in certain facilities (or in some cases, any portion
of a facility) in which regular or routine education, library, day care, health
care, or early childhood development services are provided to children. This is
consistent with the PHS mission to protect and advance the physical and mental
health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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