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
Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)
National
Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)
National
Cancer Institute (NCI), (http://www.cancer.gov/)
Office of
Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov/)
Title: Exploratory/Developmental Clinical Research Grants in Obesity
(R21)
Announcement Type
This is a reissue of PAR-04-082,
which was previously released April 1, 2004.
Update: The following updates relating to this announcement have been issued:
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 SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines provided 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 weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date(s) (see Key Dates below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
Program Announcement (PA) Number: PA-06-256
Catalog of Federal Domestic Assistance Number(s)
93.848, 93.837, 93.393
Key Dates
Release/Posted Date: March
17, 2006
Opening
Date: May 2, 2006 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent
Receipt Date(s): Not Applicable
Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer
Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council
Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional
Information To Be Available Date (URL Activation Date): Not Applicable
Expiration
Date: March 2, 2009 (now May 8, 2009 per NOT-OD-07-093)
(see NOT-DK-06-009)
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
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Background
The goal of this initiative is to encourage exploratory/developmental clinical research that will accelerate the development of effective interventions for prevention or treatment of overweight or obesity in either adults or children. The goal of this mechanism is to provide flexibility for initiating exploratory, short-term studies, thus allowing new ideas to be investigated in a more expeditious manner without stringent requirements for preliminary data. Such support is needed to encourage experienced investigators as well as new investigators to pursue new approaches, underdeveloped topics, or more creative avenues of research including new partnerships. If successful, these awards should lead to significant scientific advances in the prevention or treatment of overweight or obesity in either adults or children. Encouraged are exploratory studies that emphasize practical intervention approaches that have the potential for widespread dissemination and sustainability. Epidemiological research with a goal of informing translational/clinical research on prevention or treatment of obesity or overweight in adults or children is encouraged. The emphasis is thus on the development of exploratory clinical studies, pilot and feasibility studies, or small randomized clinical trials that will provide preliminary data for larger trials and epidemiological studies that will inform translational/clinical research.
This initiative specifically encourages the submission of applications for pilot and feasibility studies related to obesity. These pilot and feasibility studies should focus on research that is particularly innovative and/or potentially of high impact. Innovative research includes feasibility studies in which the technological, methodological, or theoretical approach to a problem lacks an historical precedent or sufficient preliminary data but is highly promising. High impact research involves studies where successful outcomes would have a major effect on the area of obesity. These pilot and feasibility studies could serve as a basis for collecting data to support future full-scale multi-center clinical trials designed to provide evidence for or against changes in the current standard of care or current intervention approaches. Such trials may use pharmacological, dietary supplement, dietary, surgical, medical device, physical activity, or behavioral interventions aimed at prevention or treatment of obesity or overweight in adults or children.
Because obesity has been observed to be associated with increased incidence and mortality of certain cancers, including breast and colon cancer, among others, the National Cancer Institute (NCI) will participate in this initiative. The NCI believes it is particularly important to foster research to identify effective interventions for prevention and treatment of obesity, including novel energy intake and expenditure modalities that alter body weight and/or composition in certain subpopulations of cancer patients and those at high risk for cancer. Thus, the types of research applications which NCI is interested in supporting include human clinical studies evaluating weight change in populations of interest to NCI, which include individuals with a genetic propensity for cancer as well as those with cancer or those at risk for recurrence of cancer.
Objectives and Scope
Studies on the prevention or treatment of overweight or obesity in children or adults, including dietary, physical activity, behavioral, psychosocial, pharmacologic, and surgical, and other biomedical approaches are of interest. The creative use of various devices, technologies, or communication strategies to help individuals monitor energy intake or energy expenditure in weight control programs would be appropriate. Innovative studies that test the synergy of creative partnerships among various groups such as industry, business, faith-based, academic, or community organizations to enhance obesity prevention or treatment outcomes are of interest. Studies of various approaches in combination to achieve weight maintenance or to maintain weight loss, such as physical activity or diet in combination with pharmacologic or surgical regimens would also be appropriate.
Basic laboratory research or studies of laboratory animals are not appropriate for this announcement. Studies that do not involve human subjects or are not patient-oriented research or epidemiological studies will not be supported through this funding opportunity and will be returned to the proposed Project Director/Principal Investigator (PD/PI) without undergoing peer review consideration. Applications for clinical studies that overlap with ongoing studies sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) may be denied funding.
Specific examples of research areas of interest include but are not limited to:
Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity will use the NIH Exploratory/Development Research Grant (R21) award mechanism (see http://grants.nih.gov/grants/funding/r21.htm ). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
This funding opportunity uses just-in-time concepts. It also uses the 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 5.4, Modular Budget Component, of the Application Guide).
Submission of an application under this FOA precludes
concurrent submission of any other Public Health Service (PHS) application
containing substantially the same research proposal. In addition, these R21
awards may not be used to supplement research projects currently supported by
Federal or non-Federal funds, or to provide interim support of projects under
review by the PHS.
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 (IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Direct costs are limited to $275,000 over the 2 years of the R21 award, 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 2-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 Program Announcement funding opportunity.
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
You may submit (an)
application(s) if your organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his or 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.
Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or the PD/PI should be included with the application.
Applicants are encouraged to collaborate with the investigators in the Silvio O. Conte Digestive Diseases Centers and Clinical Nutrition Research Units or Obesity Nutrition Research Centers for consultation in experimental design, intervention, and methodology, as well as usage of core facilities appropriate for carrying out their projects.
Applications from Veterans Administration (VA) Medical Centers and collaborations with VA Medical Centers are encouraged. Obesity and overweight are very common in Veteran patient populations. VA Medical Centers often provide the ideal milieu for clinical investigation of therapies that might benefit Veteran populations. The advanced medical information systems developed by the Department of Veterans Affairs and the ability to follow and maintain patient contact over many years make the VA Medical Centers particularly well adapted to clinical and epidemiological research in prevention and treatment of obesity and overweight.
Interaction is encouraged between NIH-funded investigators
and investigators at Centers for Disease Prevention and Control (CDC) Prevention Research Centers, a national network of 28 academic research centers that engage
communities as participants in research on preventing chronic diseases such as
cancer, heart disease, and arthritis. Information about CDC Prevention Research
Centers may be found at: http://www.cdc.gov/prc/.
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
Applicants
may submit more than one application, provided each application is
scientifically distinct
Section IV. Application and Submission Information
Registration and Instructions for Submission via Grants.gov
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, 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:
PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
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.
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 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 GrantsInfo, 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/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of 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 Cover
Page Supplement
PHS398
Research Plan
PHS398
Checklist
PHS398 Modular
Budget
Optional Components:
PHS398 Cover Letter
File
R&R Subaward Budget Attachment(s) Form
Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS 398 Modular Budget.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed
research should provide a unique research opportunity not available in the United States.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review,
and Anticipated Start Dates
Opening Date: May 2, 2006 (Earliest date an application may
be submitted to Grants.gov)
Letters of Intent
Receipt Date(s): Not Applicable
Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer
Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council
Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.B.
Sending an Application 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 to Grants.gov on
or after the opening date and must be submitted no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application submission date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by
the submission date(s) and time, the application may be delayed in the review
process or not reviewed.
Upon receipt,
applications will be transferred from Grants.gov to the NIH Electronic Research
Administration process for validation. Both the PD/PI and the Signing Official
for the organization must verify the submission via Commons within 2 business days
of notification of the NIH validation.
Upon receipt,
applications will be evaluated for completeness by the Center for Scientific
Review, NIH. Incomplete applications will not be reviewed.
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. This does not preclude the
submission of an application already reviewed with substantial changes, but
such application must include an Introduction addressing the previous
critique. Note that such an application is considered a
"resubmission" for the SF424 (R&R).
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
4. Intergovernmental Review
This initiative is
not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm).
Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new award if such costs: are necessary
to conduct the project, and would be allowable under the grant, if awarded,
without NIH prior approval. If specific expenditures would otherwise require
prior approval, the grantee must obtain NIH approval before incurring the cost.
NIH prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or competing
continuation award.
The
incurrence of pre-award costs in anticipation of a competing or non-competing
award imposes no obligation on NIH either to make the award or to increase the
amount of the approved budget if an award is made for less than the amount
anticipated and is inadequate to cover the pre-award costs incurred. NIH
expects the grantee to be fully aware that pre-award costs result in borrowing
against future support and that such borrowing must not impair the grantee's
ability to accomplish the project objectives in the approved time frame or in
any way adversely affect the conduct of the project. See the NIH
Grants Policy Statement.
6. Other Submission Requirements
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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
Renewal (formerly competing continuation or Type 2 ) applications are not permitted.
Specific
Instructions for Modular Grant applications.
Applications
requesting direct costs in each year of $250,000 or less (excluding consortium
F&A costs), must be submitted in a modular budget format using the PHS398 Modular
Budget Component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget
Component, of the Application Guide). The modular
budget format simplifies the preparation of the budget in these applications by
limiting the level of budgetary detail. Applicants request direct costs in
$25,000 modules.
Application Characteristics
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan 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.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing
Research Resources
NIH policy requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (see
the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
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 PHS referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
Applications that
are complete will be evaluated for scientific and technical merit by an
appropriate review group convened by the Center for Scientific Review, NIH in
accordance with the review criteria stated below.
As part of the
initial merit review, all applications will:
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 Plan is limited to 15 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; 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 high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the
above criteria, the following items will continue to be considered in the determination
of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed. See item 6 of the Research Plan component of the SF424 (R&R).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional
Review Considerations
Special review considerations: Because the
research plan is limited to 15 pages, an exploratory/development grant
application need not have background material or preliminary information as one
might normally expect in an R01 application. Accordingly, reviewers should
focus their evaluation on the clinical significance of the scientific question,
the robustness of the clinical study implementation plan, and the potential to
significantly advance our knowledge or understanding and whether the proposed
research is likely to generate data that will lead to additional studies that
could potentially be funded as a regular research project grant (R01).
Reviewers should place less emphasis on methodological details and certain
indicators traditionally used in evaluating the scientific merit of the 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.
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to the
proposed research may be assessed by the reviewers. Is the percent effort
listed for the PD/PI appropriate for the work proposed? Is each budget category
realistic and justified in terms of the aims and methods?
2.C.
Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research
Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
3. Anticipated Announcement and Award
Dates
Not Applicable
Section VI. Award Administration Information
1. Award Notices
After
the peer review of the application is completed, the PD/PI will be able to
access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS
Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
Carolyn W. Miles,
Ph.D.
Director,
Clinical Obesity and Nutrition Program
Division
of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707
Democracy Blvd., Room 665
Bethesda, MD 20817
Telephone:
(301)451-3759
FAX:
(301)480-8300
Email: [email protected]
Mary Horlick, M.D.
Director,
Pediatric Clinical Obesity Program
Division
of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707
Democracy Blvd., Room 679
Bethesda, MD 20817
Telephone:
(301)594-4726
FAX:
(301)480-8300
Email: [email protected]
Robert
Kuczmarski, Dr. P.H.
Division
of Digestive Diseases and Nutrition
6707
Democracy Blvd., Room 673
Bethesda, MD 20817
Telephone:
(301)451-8354
FAX:
(301) 480-8300
|Email: [email protected]
James
Everhart, M.D., M.P.H.
Chief,
Epidemiology and Clinical Trials Branch
Division
of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707
Democracy Blvd., Room 655
Bethesda, MD 20817
Telephone:
(301)594-8878
FAX:
(301)480-8300
Email: [email protected]
Mary
Frances Picciano, Ph. D.
Senior
Nutrition Research Scientist
Office of
Dietary Supplements
National
Institutes of Health
6100
Executive Blvd. 3B01
Bethesda, MD 20892-7517
Telephone:
301-435-3608
FAX:
301-480-1845
Email: [email protected]
Eva Obarzanek,
Ph.D., R.D.
Research
Nutritionist and Deputy Leader
Behavioral
Medicine and Prevention Scientific Research Group
Division
of Epidemiology and clinical Applications
National
Heart, Lung, and Blood Institute
6707
Rockledge Drive, Room 8136
Bethesda, MD 20892-7936
Telephone:
301-435-0382
FAX:
301-480-1669
Email: [email protected]
Sharon A.
Ross, Ph.D.
Division
of Cancer Prevention
National
Cancer Institute
6130
Executive Blvd. EPN Room 3175
Bethesda, MD 20892-7328
Telephone:
301- 594-7547
FAX:
301-480-3925
Email: [email protected]
2. Peer Review Contacts:
Not applicable.
3. Financial or Grants Management Contacts:
Sharon T. Bourque
Grants
Management Specialist
National Institute of Diabetes, Digestive and Kidney Diseases
6707
Democracy Blvd., Room 719
Bethesda, MD 20892 MSC 5456
Telephone:
(301)594-8846
FAX:
(301)480-3504
Email: [email protected]
Craig E.
Bagdon, MPA
Grants
Management Specialist
|National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 7129
Bethesda, MD 20892-7926
Telephone:
301-435-0480
FAX:
301-451-5462
Email: [email protected]
Romy Reis
Office of
Grants Administration
National
Cancer Institute
6120
Executive Blvd. EPS Suite 243
Bethesda, MD 20892-7150
Telephone:
301-496-2834
FAX:
301-496-8601
Email: [email protected]
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications
and proposals involving human subjects must be evaluated with reference to the
risks to the subjects, the adequacy of protection against these risks, the
potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of scientific merit or the priority score.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to elect
and retain title to subject inventions developed with Federal funding pursuant
to the Bayh Dole Act (see the NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R); and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously supported
NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career
development award mechanisms, cooperative agreements, contracts, Institutional
and Individual Ruth L. Kirschstein National Research Service Awards, as well as
NIH intramural research studies. The Policy applies to peer-reviewed, original
research publications that have been supported in whole or in part with direct
costs from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more information about the Policy or the
submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. Unless otherwise specified in
an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This 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 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy
Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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