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)
National Cancer Institute (NCI), (http://www.cancer.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute on Deafness & Other
Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute of Diabetes, Endocrinology, and
Metabolic Diseases (NIDDK), (http://www.niddk.nih.gov)
National Institute on
Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of
Environmental Health Sciences (NIEHS), (http://niehs.nih.gov)
National Heart, Lung, and
Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
Title: Structural Biology of Membrane Proteins (R01)
Announcement
Type
This is a reissue of PA-07-253.
Update: The following update relating to this announcement has been issued:
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).
Program Announcement (PA) Number: PA-10-228
Catalog of Federal Domestic
Assistance Number(s)
93.396,
93.866, 93.173, 93.847, 93.279, 93.113, 93.859, 93.837,
Key Dates
Release Date: July 9, 2010
Opening Date: September 5, 2010 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application Submission Dates(s): Standard
dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
AIDS Application
Submission Dates(s): Standard dates
apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review
Date(s): Standard dates
apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date: Standard dates
apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Url
Activation Date): Not Applicable
Expiration Date: September
8, 2013
Due Dates for E.O.
12372
Not Applicable
Additional Overview
Content
Executive Summary
Purpose. This
FOA issued by NIGMS, as well as NCI, NIA, NIDCD, NIDDK, NIDA, NIEHS and NHLBI,
National institutes of Health, encourages grant applications from
institutions/organizations that propose to develop research and methods to
enhance the rate of membrane protein structure determination and to determine
specific membrane protein structures. Innovative methods for expression,
oligomerization, solubilization, stabilization, purification, characterization,
crystallization, isotopic labeling, and structure determination of unique and
biologically significant membrane proteins by x-ray diffraction, nuclear
magnetic resonance (NMR), electron microscopy, mass spectrometry, and other
biophysical techniques are encouraged. Projects that will lead in the
near term to determining the structures of biologically important membrane
proteins are also encouraged. Responding to this FOA, rather than the
regular investigator-initiated Research Project Grant (R01) FOA, will help NIH
staff track interest and progress of research in this scientific area.
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 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
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
This Funding Opportunity Announcement
(FOA) encourages grant applications for research that will lead to the
determination of membrane protein structures at high resolution. In addition
to the structures of integral membrane proteins, the structures of the
complexes formed between these proteins and their biological partners are of
interest. Despite increases in the number of solved structures, the
knowledge of membrane protein structures still lags far behind that of soluble
proteins.
Applications are sought both for the development of new methods to approach the problem and for the application of current methods to the solution of specific membrane protein structures. Areas of interest and appropriate topics include but are not limited to those listed below: innovative methods for production of membrane proteins in sufficient quantities for characterization and structural studies of membrane proteins. Novel approaches to cloning, expression, oligomeric assembly, solubilization, stabilization and purification of membrane proteins are needed to advance the production of structurally and functionally intact membrane proteins suitable for structural studies. Innovative methods are also needed for structure determination, including crystallization, phasing, isotopic labeling, and collecting x-ray crystallographic, nuclear magnetic resonance (NMR), and other relevant data.
It is recognized that novel solutions may arise during the course of efforts to solve the structures of specific membrane proteins as well as through focused efforts stressing methods development. Investigators with different perspectives and backgrounds and with significant interests in the determination of membrane protein structures are particularly encouraged to apply. Responding to this PA, rather than the regular investigator-initiated Research Project Grant (R01) FOA, will help NIH staff track interest and progress of research in this scientific area.
Background
Membrane proteins and their complexes play crucial roles in many cellular and physiological processes. They are essential mediators of material, information, and energy 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.
Considerable research is ongoing in the area of membrane protein structure and function, and significant advances have been made in the techniques of x-ray crystallography, electron diffraction, or NMR spectroscopy to solve the high resolution structures of membrane proteins. Since 1985, approximately 200 unique membrane protein structures have been solved, and each structure has made a major contribution in its area of science. (See http://blanco.biomol.uci.edu/Membrane_Proteins_xtal.html.) However, during this same period, the rate of soluble protein structure determination has accelerated greatly, and there remains a huge gap between the understanding of membrane proteins and their soluble protein counterparts (1). The much slower progress demonstrates that solving membrane protein structures is feasible albeit difficult, so innovative approaches are clearly still needed.
This FOA continues NIH efforts to stimulate work on membrane protein structures. Responses to previous program announcements in this area have resulted in 165 competing awards over the period FY2005-FY2010 (2). Other efforts by NIH to stimulate research in this area have included the NIH Roadmap and the NIGMS funded Protein Structure Initiative (PSI). In 2004, two Roadmap Centers for Innovation in Membrane Protein Production were awarded (3). A second NIH Roadmap effort focused on individual researchers and smaller collaborative groups. Since 2005, a total of 24, R01 and R21 grants, as well as one program project grant, were awarded through the NIH Roadmap for the development of innovative methods for membrane protein production and structure determination (4). Despite great progress, innovative approaches for membrane proteins are still needed so the Roadmap effort has been continued, albeit at a reduced level. Roadmap center applications were again solicited and three awards were made in 2009 (5). Applications for R01s focused on novel approaches have been solicited again and it is anticipated that 13-16 Roadmap awards will be made in 2010 (6). During the period 2005-2010, the PSI has included several Specialized Centers that focused on membrane proteins (7). The new PSI:Biology program initiative has solicited applications for dedicated Centers for Membrane Protein Structure Determination to be awarded in 2010 (8).
A significant number of meritorious applications have been received in response to the the above RFAs that may not be funded due to the limited amount of money available. Other applications may not be competitive in the context of the RFAs because they focus on the solution of specific protein structures instead of the development of new methods or lack a sufficient concentration of research to compete successfully as centers. Such projects may be appropriate for the current funding opportunity. Investigators who submitted applications for these RFAs may wish to rework their ideas into a new application in response to this FOA. Any projects that were previously submitted in response to RFAs should be submitted as NEW, rather than as RESUBMISSION, applications by the appropriate submission dates. See NIH Policy at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html .
It is expected that many of the projects will be collaborative efforts between and among 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 membrane-bound proteins; and in x-ray crystallography, NMR, and other structural methods. An objective of this FOA is to stimulate such multidisciplinary and new collaborations. A further objective is to encourage additional investigators to begin work on the structure and function of membrane proteins. Investigators may wish to consider how their work can benefit from or complement the work that is supported through the Roadmap expression centers, the PSI:Biology centers, and are encouraged to participate in meetings that may be organized by these centers from time to time.
An increase in the number of known membrane protein structures will contribute to an enhanced understanding of many basic phenomena underlying cellular functions essential to human health. Specific membrane proteins may be of interest to one or more of the participating Institutes and Centers (ICs) of the NIH. Rather than listing suggested areas of interest here, potential applicants are encouraged to consider the disease relevance or general interest value of the proteins that they intend to study and to consult with appropriate IC staff regarding IC interest in their projects. See IC Program Contacts below In Section VII, Agency Contacts.
References:
(1) The progress of membrane protein structure determination. Stephen H. White, Protein Science (2004), 13:1948 1949 and Biophysical dissection of membrane proteins. Stephen H. White, Nature (2009), May 21;459(7245):344-6.
(2) Structural Biology of Membrane Proteins Program Announcements (PA-95-035, PA-99-004, PA-02-060, PA-06-119, PA-07-253) and Structural Biology of Membrane Proteins SBIR/STTR Announcement (PA-02-108). See NIH Guide: http://grants.nih.gov/grants/guide/pa-files/.
(3) Centers for Innovation in Membrane Protein Production (RFA-RM-04-009). See: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-009.html. See awards at: http://nihroadmap.nih.gov/structuralbiology/fundedresearch.asp
(4) Membrane Protein Production and Structure Determination (RFA-RM-04-026 and RFA-RM-07-003). See: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-026.html. See awards at: http://nihroadmap.nih.gov/structuralbiology/fundedresearch.asp.
(5) Centers for Innovation in Membrane Protein Production for Structure Determination (RFA-RM-08-019). See: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-019.html. See awards at: http://nihroadmap.nih.gov/structuralbiology/fundedresearch.asp.
(6) Membrane Protein Production for Structure Determination (RFA-RM-09-12). See: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-09-012.html
(7) Protein Structure Initiative. See: http://www.nigms.nih.gov/psi/.
(8) Centers for Membrane Protein Structure Determination (RFA-GM-10-005). See: http://grants.nih.gov/grants/guide/rfa-files/RFA-GM-10-006.html
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding
opportunity announcement (FOA) will use the R01 award mechanism. The
applicant will be solely responsible 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) Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component. U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
2. Funds Available
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.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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.
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.
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 that each application is scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Applicants may submit a renewal application.
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the
Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions
provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1. Request Application
Information
Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further
assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm)..
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover
component)
Research & Related
Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget,
as appropriate (See Section IV.6. regarding
appropriate required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign
Organizations [Non-domestic (non-U.S.) Entity]
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
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 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.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the 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 (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review and Anticipated Start Dates
Opening
Date: September 5, 2010 (Earliest date an application may be submitted to
Grants.gov)
Application
Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS
Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer
Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council
Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A
letter of intent is not required for the funding opportunity.
3.B.
Submitting an Application Electronically to the NIH
To submit an application in response to this
FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must
only be submitted electronically. PAPER APPLICATIONS WILL NOT BE
ACCEPTED. All attachments must be provided to NIH in PDF format,
filenames must be included with no spaces or special characters, and a .pdf
extension must be used.
3.C.
Application Processing
3.C.1
Submitting On-Time
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
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.
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 renewal 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 or renewal 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
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
All application instructions outlined in the PHS 398 Application Guide are to be followed, with the following additional requirements:
Budget Component
U.S. organizations submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component. U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
Specific Instructions for Applications Requesting $500,000
(direct costs) or More per Year
Applicants requesting
$500,000 or more in direct costs for any year (excluding consortium F&A
costs) must carry out the following steps:
1) Contact the
IC program staff at least 6 weeks before submitting the application, i.e., as
plans are being developed for the study;
2) Obtain agreement
from the IC staff that the IC will accept the application for consideration for
award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the application.
This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.
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 should 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/.
Foreign Applications (Non-domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States
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
Review Process
Applications
submitted for this funding opportunity will be assigned on the basis of
established PHS referral guidelines to the ICs for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) 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:
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 scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored 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?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
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?
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?
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?
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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Additional Review Considerations
As applicable for the project proposed, reviewers will 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.
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agents 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).
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.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
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.
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.
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.
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
When multiple years are
involved, 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.
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:
Jean Chin, Ph.D.
Division
of Cell Biology and Biophysics
National
Institute of General Medical Sciences
Building
45, Room 2AS.19A
45
Center Drive, MSC 6200
Bethesda,
MD 20892-6200
Telephone:
(301) 594-0828
Email: chinj@nigms.nih.gov
Peter C. Preusch, Ph.D.
Division of Cell Biology and Biophysics
National
Institute of General Medical Sciences
Building
45, 2AS.13C
45
Center Drive, MSC 6200
Bethesda,
MD 20892-6200
Telephone:
(301) 594-0828
Email: preuschp@nigms.nih.gov
John
R. Knowlton, Ph.D.
Structural
Biology and Molecular Applications Branch
National
Cancer Institute
Executive
Plaza North, Room 5006
6130
Executive Blvd, MSC 7385
Bethesda,
MD 20892-7385
Telephone:
(301) 435-5226
Email: jk339o@nih.gov
Bradley
C. Wise, Ph.D.
Neuroscience
and Neuropsychology of Aging Program
National
Institute on Aging
Gateway
Bldg, Room 350
7201
Wisconsin Ave, MSC 9205
Bethesda,
MD 20892-9205
Telephone:
(301) 496-9350
Email: wiseb@nia.nih.gov
Nancy
L. Freeman, PH.D.
Hearing
and Balance/Vastibular Branch
National
Institute on Deafness and Other Communication Disorders
Executive
Plaza South, Room 400
6120
Executive Blvd, MSC 7180
Bethesda,
MD 20892-7180
Telephone:
(301) 402-3458
Email: freemann@mail.nih.gov
Salvatore
Sechi, Ph.D.
Division
of Diabetes, Endocrinology, and Metabolic Diseases
National
Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy
Plaza, Room 611
6707
Democracy Blvd, MSC 5460
Bethesda,
MD 20892-5460
Telephone:
(301) 594-8814
Email: Salvatore_Sechi@nih.gov
Rao S. Rapaka, Ph.D.
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
NCS Building, Room 4275
6001 Executive Blvd., MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 435-1304
E-mail: rrapaka@nida.nih.gov
David
Balshaw, Ph.D.
Center
for Risk and Integrated Sciences
National
Institute of Environmental Health Sciences
4401
Bldg (East Campus), Room 3447
79 TW
Alexander Drive
Research
Triangle Park, NC 27709
Telephone:
(919) 541-2448
Email: balshaw@niehs.nih.gov
Bishow B. Adhikari, Ph.D.
Division of Cardiovascular Sciences
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 8186, MSC 7956
Bethesda,
MD 20892-7956
Telephone:
(301)-435-0504
FAX:
(301)-480-1335
Email: adhikarb@mail.nih.gov
2. Peer Review Contacts:
Not Applicable
3. Financial or Grants Management Contacts:
Earl C. Melvin
Grants
Administration Branch
National
Institute of General Medical Sciences
Building
45, Room 2AN.32E
45
Center Drive, MSC 6200
Bethesda,
MD 20892-6200
Telephone:
(301) 594-3912
FAX:
(301) 480-2554
Email: melvine@nigms.nih.gov
Leo
Buscher
Office
of Grants Administration
National
Cancer Institute
Executive
Plaza South, Room 234
6120
Executive Blvd, MSC 7148
Bethesda,
MD 20892-7148
Telephone:
(301) 496-7753
Email: buscherel@gab.nci.nih.gov
Linda
Whipp
Grants
Management Branch
National
Institute on Aging
Gateway
Bldg, Room 2N212
7201
Wisconsin Ave, MSC 9205
Bethesda,
MD 20892-9205
Telephone:
(301) 496-1472
Email: whippl@gw.nia.nih.gov
Christopher
P. Myers
Grants
Management Branch
National
Institute on Deafness and Other Communication Disorders
Executive
Plaza South, Room 400B
6120
Executive Blvd, MSC 7180
Bethesda,
MD 20892-7180
Telephone:
(301) 402-0908
Email: cm143g@nih.gov
Craig E. Bagdon
Grants
Management Branch
National
Institute of Diabetes and Digestive and Kidney Diseases
Two
Democracy Plaza, Room 721
6707
Democracy Blvd, MSC 5460
Bethesda,
MD 20892-5460
Telephone:
(301) 594-2115
Email: BagdonC@mail.nih.gov
Dorothy
G. Duke
Grants
Management Branch
National
Institute of Environmental Health Sciences
4401
Bldg (East Campus), Room 3403
79 TW
Alexander Dr
Research
Triangle Park, NC 27709
Telephone:
(919) 541-2749
Email: duke3@niehs.nih.gov
Ryan C. Lombardi
Office of Grants Management
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 7172, MSC 7940
Bethesda,
MD 20892-7940
Telephone:
(301)-435-0177
FAX:
(301)-541-5462
Email: lombardr@mail.nih.gov
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.
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/.
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.
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.
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-09-116.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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Department of Health and Human Services (HHS) |
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NIH... Turning Discovery Into Health® |
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