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
Office of Research on Women's Health (ORWH), (http://www4.od.nih.gov/orwh/)
National
Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (www3.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
(http://www.niams.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.ncrr.nih.gov/)
National Institute of Child Health and Human Development
(NICHD), (http://www.nichd.nih.gov/)
National Institute of Dental and Craniofacial Research
(NIDCR), (http://www.nidcr.nih.gov/)
Office of Dietary Supplements (ODS), (http://ods.od.nih.gov/index.aspx)
National Institute of Environmental Health Sciences NIEHS), (http://www.niehs.nih.gov/)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
National Institute of Neurological Disorders and Stroke
(NINDS), (http://www.ninds.nih.gov/)
Title: Chronic Fatigue Syndrome: Pathophysiology and Treatment (R21)
Announcement
Type
This is a reissue of PA-07-265.
Update: The following updates relating to this announcement have been issued:
Program
Announcement (PA) Number: PA-08-247
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog
of Federal Domestic Assistance Number(s)
93.389, 93.233, 93.837, 93.838, 98.839, 93.847,
93.866, 93.273, 93.855, 93.856, 93.846, 93.865, 93.121, 93.113, 93.114, 93.115,
93.853, 93.361
Key Dates
Release/Posted Date: August
21, 2008
Opening Date: September 16, 2008 (Earliest date an application may be
submitted to Grants.gov).
Letters of Intent Receipt Date(s): N/A.
NOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due
Date(s): 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(s http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: (New Date January 8, 2012 per NOT-OD-11-083), Original Date: September 8, 2011
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 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. Request
Application Information
2. Content
and Form of Application Submission
3. Submission
Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4.
Intergovernmental Review
5. Funding
Restrictions
6.
Other Submission Requirements and Information
Section V. Application Review Information
1.
Criteria
2. Review
and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3.
Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2.
Administrative and National Policy Requirements
3.
Reporting
Section VII. Agency Contacts
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) issued by the Office of Research on Women's
Health (ORWH) and co-sponsoring Institutes and Centers (ICs) of the National
Institutes of Health (NIH) encourages investigator(s)-initiated applications
that propose to examine the etiology, diagnosis, pathophysiology, and treatment
of chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis
(ME/CFS), in diverse groups and across the lifespan. Applications that address
gaps in the understanding of the environmental and biological risk factors, the
determinants of heterogeneity among patient populations, the common mechanisms
influencing the multiple body systems that are affected in CFS are encouraged.
The NIH is particularly interested in funding interdisciplinary research that
will enhance our knowledge of the disease process and provide evidence based
solutions to improve the diagnosis, treatment, and quality of life of all
persons with CFS. This interdisciplinary research may include the building of
scientific teams to study and develop biomarkers, innovative treatment modalities, and/or the
modifiable risk and protective processes specifically targeted by preventive
and/or treatment interventions.
CFS (CFS/ME) is a debilitating and complex syndrome that involves multiple body systems. It is characterized by profound fatigue that is not improved by bed rest and may be exacerbated or re-kindled by physical or mental activity. Persons with CFS most often function at substantially lower levels of activity from their pre-onset capacities. In addition to these defining characteristics, a diverse array of other symptoms is associated with CFS. These symptoms include cognitive deficits, impaired sleep, myalgia, arthralgia, headache, gastrointestinal symptoms, and tender lymph nodes. Neither a specific cause(s) nor any specific diagnostic test(s) have been identified for this illness. The range of symptoms, however, suggests that there may be subtle perturbations in at least two systems of the body that are important for homeostatic regulation and in the multiple physiological pathways through which these systems communicate. These dysregulations may be triggered by diverse causes such as infection, stress, brain structure abnormalities, hormone levels, proinflammatory cytokines, etc. Evidence is needed to detail the immune mechanisms and/or mechanisms of microbial pathogenesis involved in CFS.
Epidemiological evidence also requires further study. Existing data suggest that approximately one million people in the United States are afflicted. CFS is said to occur more frequently among women than men and among white Americans than in Americans of other racial/ethnic groups. More recent studies narrow the gap between the sexes, as well as among racial/ethnic population subgroups. In addition, the prevalence of CFS in children remains in dispute.
The role of dietary factors, background diets, and body compositions in study participants and persons with CFS also remains to be studied, along with differences according to race and gender across the lifespan.
Recent epidemiological data reveal CFS, as well as other disorders that share pain as a common symptom, is often associated with chronic urologic pelvic pain syndromes. This relationship remains to be further elucidated through epidemiological and basic-science research.
Detection and treatment of CSF also merit further study. Promising research to date has focused on identification of biomarkers for diagnosis of CSF; nonetheless, more work is needed for a clinically applicable detection method. Studies of innovative treatment modalities and their relationship(s) to pathophysiology of CFS and to co-morbid conditions are also needed.
Innovative, well designed studies are needed to provide a better understanding of CFS, prevalence, pathogenesis, and pathophysiology, with the goal of developing improved diagnostic and intervention strategies The heterogeneity of the CFS population should be recognized in both basic, translational and clinical research; thus, sex, age/developmental stage, racial and ethnic variations should be considered along with any sub typing of CFS in the study designs. In addition studies using girls and women of reproductive age should control for phase of the menstrual cycle. This FOA encourages the integration of basic research with clinical observations in forming study hypotheses. The multisystemic nature of the disorder will benefit from a collaborative multidisciplinary (across scientific disciplines) team approach that will lead to the interdisciplinary solutions necessary to provide a foundation for understanding, diagnosing and treating this complex illness.
Applicants are encouraged to review the information on the CFSWG Web site (http://orwh.od.nih.gov/cfs.html) as well as recommendations from an NIH-sponsored CFS science summit held in October 2000 at Arlington, VA. This document may be found at http://orwh.od.nih.gov/cfs/cfsWkshopSummary_6-03.pdf. They also are encouraged to review the summary of the scientific workshop: Neuroimmune mechanisms and chronic fatigue syndrome: understanding central mechanisms, which may be found at http://www4.od.nih.gov/orwh/cfs-newhome.html. Applicants also are referred to the Agenda for Research on Women's Health for the 21st Century, volume 2" (NIH Publication No 99-4386, http://orwh.od.nih.gov/pubs/agenda_book_2.pdf), as well as Exploring the Biological Contributions to Human Health. Does Sex Matter" (National Academy Press, Washington DC, http://www.nap.edu/), to ensure responsiveness to all aims of this FOA.
The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view.These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data.By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.
The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area.These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.
Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism.For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel.These studies should break new ground or extend previous discoveries toward new directions or applications.Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism.Information on the R03 program can be found at http://grants.nih.gov/grants/funding/r03.htm.
See Section
VIII, Other Information - Required Federal Citations, for policies
related to this announcement.
Section
II. Award Information
1.
Mechanism of Support
This FOA
will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. The
Project Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3.4, Modular Budget Component, of the Application Guide).
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 Institutes and
Centers (ICs) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the submission of
a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. 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.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
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(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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 (i.e., 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 and 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 electronic Research Administration (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 grant 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 the multiple PD/PI option, 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
Exploratory/developmental grant support is for new projects only; competing
renewal (formerly competing continuation) applications will not be accepted.
Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
Applicants may submit more than one application, provided each application is scientifically distinct.
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.
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/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
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 in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants
must download the SF424 (R&R) application forms and 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 Grants Info -- Telephone 301-710-0267, Email: [email protected].
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 and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, 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/PIs 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 is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include 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
Modular Budget PHS398 Modular Budget or Research & Related
Budget, as
appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget
component.)
PHS398 Cover
Page Supplement
PHS398
Research Plan
PHS398
Checklist
Optional
Components:
PHS398
Cover Letter File
Research
& Related Subaward Budget Attachment(s) Form
Foreign
Organizations (Non-domestic [non-U.S.]
Entities)
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:
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 (U.S.) or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (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 3.4 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 16, 2008 (Earliest
date an application may be submitted to Grants.gov)
Letter of Intent
Receipt Date(s): Not Applicable
Application Due Date(s): Standard dates apply, please
see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(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(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
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/Apply and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
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.
Once an application package has been successfully submitted through Grants.gov, any 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 application image to determine if any further action is necessary.
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/PI 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. 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 Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
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
While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:
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). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
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.
Research Sharing Plan
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the 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 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 (e.g., 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 (go to 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 (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.
2. Review and
Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established Public Health Service (PHS) referral guidelines.
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 initial merit review, all applications will:
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:
The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research.
Because the Research Strategy is limited to 6 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
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 meritorious impact/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.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
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: Do(es) the scientific environment(s) 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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2. A. Additional Review Criteria:
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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).
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.
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).2.
B. Additional Review Considerations
As applicable for the
project proposed, reviewers will address each of the following items, but will
not give scores for these items and should not consider them in providing an
overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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).
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.
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).
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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/her Summary Statement (written critique) via the NIH eRA Commons.
If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal
notification in the form of a Notice of Award (NoA) will be provided to the
applicant organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official.
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 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 and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3.
Reporting
When
multiple years are involved, awardees will be required to submit the Non-Competing 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 (program), peer review, and financial or grants management issues:
1.
Scientific/Research Contacts:
Office of Research on Women's Health
(ORWH)
Dr. Eleanor Hanna
Associate Director for Special Projects and Centers
Office for Research on Women's Health
National Institutes of Health
6120 Executive Plaza South, Room 150A
Bethesda, MD 20892-7116
Phone: (301) 402-1770
Email: [email protected]
National Institute on Aging (NIA)
The National Institute on Aging (NIA) invites applications on chronic fatigue syndrome pertaining to older populations and to special issues related to aging. While fatigue is common among older individuals, it is often under-evaluated in this population. This may be due in part to the common view of fatigue as a normal part of aging. More research is needed to understand the particular role of chronic fatigue syndrome in aging. Applicants interested in studying fatigue in aging are also encouraged to see the program announcements entitled, Transdisciplinary Research on Fatigue and Fatigability in Aging (R01 and R21) at http://grants.nih.gov/grants/guide/pa-files/PA-08-161.html and http://grants.nih.gov/grants/guide/pa-files/PA-08-162.html.
Basil Eldadah, M.D., Ph.D.
Program
Officer
Geriatrics Branch
Geriatrics and Clinical Gerentology Program
National Institute on Aging
Gateway Building, Suite 3C-307
7201 Wisconsin Avenue
Bethesda MD 20892
Phone: (301)
496-5761
Email: [email protected]
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The Alcohol Abuse and Alcoholism (NIAAA) accepts applications on alcohol health effects that are co-morbid with chronic fatigue syndrome. The NIAAA accepts applications if they have explicit relevance to Alcohol as reflected in the title, abstract, theoretical framework, specific aims, measures and analyses. For more information and pre-application technical assistance, please contact:
Katherine Jung, Ph.D.,
Program
Director, Division of Metabolism and Health
Effects
National Institute on Alcohol
Abuse and Alcoholism, NIH
5635
Fishers Lane, Room 2021
Bethesda, MD
20892-9304
Phone: 301-443-8744
Fax :
301-594-0673
Email: [email protected]
National Institute of Allergy and Infectious Diseases (NIAID)
Dr. Eun-Chung Park,
Health Scientist
Administrator
National Institute of Allergy and Infectious Diseases
6610 Rockledge Drive
Bethesda, MD 20892-7630
Phone: 301-402-0071
Email: [email protected]
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The National Institute of Arthritis and Musculoskeletal and Skin Diseases accepts applications on chronic fatigue syndrome that is co morbid with fibromyalgia syndrome (FMS), applications comparing CFS patients with FMS patients, or other CFS applications with explicit relevance to FMS or other rheumatic disorders.
Dr. Yan Wang,
National
Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892-4872
Phone: 301-594-4952
Email: [email protected]
National Institute of Child Health and Development (NICHD)
Dr. Lynne M. Haverkos
National Institute of Child Health and Development/NIH
6100 Executive Blvd, Room 4B05B
Bethesda, MD 20892-7510
Phone: (301) 435-6881
Email: [email protected]
National Center for Complementary and Alternative Medicine
Dr. Carol Pontzer
Senior Advisor for Scientific Coordination and Research
National Center for Complementary and Alternative Medicine
Two Democracy/Suite 401 6707 Democracy Blvd
Phone: (301) 435-6286
Fax: (301) 435-6549
Email: [email protected]
National Institute of Dental and Craniofacial Research (NIDCR)
The National Institute of Dental and Craniofacial Research (NIDCR) supports research on Chronic Fatigue Syndrome (CFS) to the extent that many of the symptoms of CFS overlap with temporomandibular joint disorder (TMJD). For example, patients with TMJD often present with pain in areas other than the TMJ, and in common with pain exhibited in CFS patients. Research aimed at uncovering and elucidating the biological mechanisms underlying the overlapping symptoms found in TMJ and of CFS is of particular interest.
Dr. John W. Kusiak, Director
Molecular and Cellular Neurobiology Program
Natcher Building, 4AN-18A
45 Center Drive
Bethesda, MD 20892-6403
Phone: (301) 594-7984
National Institute of Environmental Health Science (NIEHS)
Dr. Annette Kirshner
National Institute of Environmental Health Science
Box 12233, MD EC-2
Research Triangle Park, NC 27709
Phone: (919) 541-0488
Email: [email protected]
National Institute of Neurological Disorders and Stroke (NINDS)
The National Institute of Neurological Disorders and Stroke (NINDS) supports research on Chronic Fatigue Syndrome as it relates to nervous system involvement in the etiology, pathophysiology, and symptoms of CFS. The Institute also supports research on neurological mechanisms that may link CFS with co-morbid conditions such as headache. The NINDS will not accept unsolicited R21 applications that include clinical trials or other clinical studies of potential therapies. NINDS places a high priority on the development and evaluation of such clinical interventions and has established specific mechanisms for supporting these types of proposals, including the unsolicited R01 (see http://www.ninds.nih.gov/funding/all_opps.htm?cluster_sort=2).
Applications that involve human subjects may be submitted to NINDS if the proposal does not include any clinical intervention AND the proposed research includes safety monitoring of study participants that can be performed appropriately within the budgetary and time constraints of the R21 mechanism. Any R21 proposal that does not meet the above criteria or does not provide adequate plans for the protection of the safety, privacy and confidentiality of study participants will not be funded.
Dr. Linda Porter
Systems and Cognitive Science
6001 Executive Blvd., Room 2113
Bethesda, MD 20892-9521
Phone: (301) 496-9964
Email: [email protected]
National Institute of Nursing Research (NINR)
Dr. Linda S. Weglicki, PhD, RN, MSN
Program Director, Office of Extramural Activities
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-6908
Fax: (301) 480-8260
Email: [email protected]
Office of Dietary Supplements (ODS)
The Office of Dietary Supplements (ODS) supports studies that further understanding of the biochemical and cellular effects of dietary supplements and their physiological impact across the life cycle. Specifically how dietary supplements moderate, alter, or enhance metabolic, physiological, and psychological processes associated with maintenance or lack of optimal health and performance.
Dr. Rebecca B. Costello Deputy
Director
Office of Dietary Supplements
National Institutes of Health
31 Center Drive, Room 1B29
Bethesda, MD 20892-2086
Phone: (301) 435-2920
Email: [email protected]
2. Peer Review Contacts:
Not Applicable
3.
Financial or Grants Management Contacts:
National Institute on Aging
Pamela Adewunmi
Grants and Contracts Management Office
National Institute on Aging
7201
Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205
Phone: 301-402-7731
Fax: 301-402-3672
Email: [email protected]
National Institute on Alcohol Abuse and Alcoholism
Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
FOR EXPRESS MAIL: Rockville, MD 20852-1705
Phone: (301) 443-4704
Fax: (301) 443-3891
Email: [email protected]
National Institute of Allergy and Infectious Diseases (NIAID)
Ms. Ann Devine
6700B Rockledge Drive, Room 2114
Bethesda, MD 20892
Phone: 301-402-5601
Fax: 301-480-3780
Email: [email protected]
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Michael Morse
Deputy Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5As49
Bethesda, MD 20892-6500
Phone: (301) 594-3535
Fax: (301) 480-4543
National Institute of Dental and Craniofacial Research (NIDCR)
Mary Daley
Rm. 658, Democracy 1
MSC 4878
6701 Democracy Blvd
Bethesda, MD 20892-4878
Phone: 301-594-4808
Email: [email protected]
National Institute of Environmental Health Science
Laura Williams-Boyd
Grants Management Specialist
National Institute of Environmental Health Science
Box 12233, MD EC-22
Research Triangle Park, NC 27709
Phone: (919) 541-7629
Email: [email protected]
National Institute of Nursing Research
Mr. Ron Wertz
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD 20892-4870
Phone: (301) 594-2807
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
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 (45 CFR 46) 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 institutional review board (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 impact/priority score.
Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/
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. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal 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, Minorities, and Children:
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 SF424 (R&R) application; 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, investigators funded by the NIH
must submit or have submitted for them to the National Library of Medicines
PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their
final, peer-reviewed manuscripts upon acceptance for publication, to be made
publicly available no later than 12 months after the official date of
publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS
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) or PubMed Central (PMC) submission
identification numbers must be used for publicly accessible on-line journal
articles.Publicly accessible on-line journal articles or PMC
articles/manuscripts accepted for publication that are directly relevant to the
project may be included only as URLs or PMC submission
identification numbers accompanying the full reference in either the
Bibliography & References Cited section, the Progress Report Publication
List section, or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in each
of these sections as appropriate. There is no limit to the number of URLs or
PMC submission identification numbers that can be cited.
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 Part 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 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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