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 Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)
Title: Translational Tools for
Clinical Studies of CAM Interventions (R01)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-AT-09-002
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)
93.213
Key Dates - (New Dates per NOT-AT-09-003) Key Dates - (Old Dates) Due Dates for E.O. 12372 Additional
Overview Content Table
of Contents Part I Overview Information Section I. Funding Opportunity Description 1. Research Objectives Rigorous
study of all clinical interventions requires
well-established methodology that has undergone careful preliminary assessment
and feasibility testing. Multi-site studies are considered an essential
component of the evidence base for clinical efficacy, but in order to implement multi-site studies detailed treatment
algorithms need to be developed that can be subject to rigorous efficacy
testing. Methods need to be in place to ensure consistent protocol
implementation and minimize practitioner variability. In addition, well-characterized outcome measures are needed that will
accurately assess the impact of interventions on patient well-being. This
FOA focuses on the development of improved research methodology to study
safety, efficacy, and clinical effectiveness of mind-body
interventions, manual therapies, yoga, and acupuncture. Applications proposing
research on natural products, herbal therapies, vitamins, minerals, or other
dietary supplements will be considered non-responsive. Study
of many CAM interventions pose a number of special challenges, as
highlighted in the July 2008 Meditation for Health Purposes Workshop
(http://nccam.nih.gov/news/pastmeetings/meditation08/summary.htm).
Practitioners frequently use highly variable approaches, and indeed the
personalization of treatment may be a fundamental
aspect of the intervention. For some interventions, the subjective experience
of the patient may be an important component of the treatment effect; hence
blinding of subjects may not always be feasible or appropriate, but the identification of appropriate controls is
nonetheless critical. Standardized treatment algorithms and manualization
approaches (see Wilson GT, Behav Res Ther, 1996) have recently begun to be
utilized in developing more rigorous methods for conducting
CAM clinical trials (see Schnyer & Allen, J Alt Comp Med, 2002 and Schnyer
et al., J Alt Comp Med, 2008), Such algorithms enable the study of
individualized approaches within reasonable constraints that facilitate the
conduct of a well-designed and interpretable clinical
trial. The
extent of patient adherence can be an important variable for some
interventions, and methods to assess adherence, which pragmatically affects the
dose of the intervention, could be of great utility. There is also a critical need for a more systematic approach to measurement of
subjective outcomes, for example perceived psychological stress, that are of
particular relevance to CAM interventions. In addition, there is need for the
identification and validation of biological measures
that would provide objective correlates of improvement or suggest mechanisms
for health benefits. Improvement
in such translational tools for CAM clinical research will potentially increase
the quality and consistency of clinical trials in CAM
and ultimately elucidate new understanding of the clinical utility and
applicability of CAM interventions. It is anticipated that many types of studies may be appropriate
for the development and validation of translational tools, including ancillary
collections of new data in on-going clinical studies,
psychometric investigations, and primary validation studies. Multidisciplinary
studies and collaboration among investigators with expertise in appropriate
disciplines are encouraged. When investigators are at
different institutions, individual R01 applications may include consortium
arrangements. Collaborative
arrangements with ongoing studies that provide patient populations, specimens,
and data may be particularly relevant for the purposes of this FOA. Such arrangements should be clearly delineated in the
application. Examples
of Research Topics include but are not
limited to the following: See Section VIII, Other Information
- Required Federal Citations, for policies related
to this announcement. 1.
Mechanism of Support 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 http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, a U.S. organization submitting an application with direct costs
in each year of $250,000 or less (excluding consortium Facilities and
Administrative [F&A] costs) must use the PHS398 Modular Budget component. U.S. applicants requesting more than
$250,000 in annual direct costs and all Foreign applicants must complete and
submit budget requests using the Research & Related Budget component. 2.
Funds Available A maximum of $300,000 (direct costs) per year may be
requested and the total project period for an application submitted in response
to this FOA will be five years. Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds. Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004. NIH
grants policies as described in the NIH Grants Policy
Statement will apply to the applications submitted and awards made in
response to this FOA. Section III. Eligibility Information 1.
Eligible Applicants 1.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. The NIH review criteria for approach, investigators, and
environment have been modified to accommodate applications involving either a
single PD/PI or multiple PDs/PIs. 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 Number
of Applications. Applicants may submit more than one application,
provided each application is scientifically distinct. Resubmissions. Resubmission
applications are not permitted in response to this FOA. Renewals. Renewal applications are not permitted in response to this
FOA. Section IV. Application and Submission Information 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. 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 PDs/PI(s) and
AOR/SO need separate accounts in the NIH eRA Commons since both are authorized
to view the application image. 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 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 for this FOA
through Grants.gov/Apply. The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. Some fields within the SF424 (R&R) application components, although
not marked as mandatory, are required by NIH (e.g., the Credential log-in
field of the Research & Related Senior/Key Person Profile component must
contain the PD/PI’s assigned eRA Commons User ID). Agency-specific
instructions for such fields are clearly identified in the Application Guide.
For additional information, see Frequently Asked Questions Application
Guide, Electronic
Submission of Grant Applications. The SF424 (R&R)
application has several components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components: Required Components: Optional Components: 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 15 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 [Section
14 of the Research Plan Component in the SF424 (R&R)], must be included. A
rationale for choosing a multiple PD/PI approach should be described. The
governance and organizational structure of the leadership team and the research
project should be described, and should include communication plans, process
for making decisions on scientific direction, and procedures for resolving
conflicts. The roles and administrative, technical, and scientific
responsibilities for the project or program should be delineated for the
PDs/PIs and other collaborators. If
budget allocation is planned, the distribution of resources to specific
components of the project or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award (NoA). Applications Involving a
Single Institution When all PDs/PIs are
within a single institution, follow the instructions contained in the SF424
(R&R) Application Guide. Applications Involving
Multiple Institutions When
multiple institutions are involved, one institution must be designated as the
prime institution and funding for the other institution(s) must be requested
via a subcontract to be administered by the prime institution. When submitting
a detailed budget, the prime institution should submit its budget using the
Research & Related Budget component. All other institutions should
have their individual budgets attached separately to the Research & Related
Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R)
Application Guide for further instruction regarding the use of the subaward
budget form. When
submitting a modular budget, the prime institution completes the PHS398 Modular
Budget component only. Information concerning the consortium/subcontract
budget is provided in the budget justification. Separate budgets for each
consortium/subcontract grantee are not required when using the Modular budget
format. See Section 5.4 of the Application Guide for further instruction
regarding the use of the PHS398 Modular Budget component. 3.
Submission Dates and Times 3.A. Submission, Review, and Anticipated Start Dates 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 In order to expedite the
review, applicants are requested to notify the NCCAM Referral Office by email ([email protected]) when the application has been
submitted. Please include the FOA number and title, PD/PI name, and
title of the application. 3.C.
Application Processing 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 CSR and responsiveness by the IC. Incomplete and
non-responsive 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
the application status in the Commons. The
NIH will not accept any application in response to this funding opportunity
that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application. 4.
Intergovernmental Review In accordance with NCCAM’s policy and applicant guidance
for studies of biologically active agents used in CAM (http://nccam.nih.gov/research/policies/index.htm), after
peer review, applicants with a better likelihood of being supported will be
notified by NCCAM to submit product information for evaluation. This evaluation
will contribute to funding decisions. This policy
does not apply to applicants for NCI or NIA grants that NCCAM does not
co-fund. In accordance with NIH policy, all NCCAM-supported clinical
investigations of biologically-based CAM interventions should be conducted
under an IND, unless
the FDA will not consider an application. For each
protocol involving a biologically-based CAM intervention in humans, the principal investigator must
request FDA review and approval. If the FDA accepts the protocol for IND review, the IND must be obtained prior to funding and initiation of the clinical portion of the
study. If the FDA does not accept the protocol for IND review, it is the responsibility of the principal
investigator to inform NCCAM of this decision. These steps are not required
prior to submission and review of an application. Protocols involving human participants are considered by
NCCAM’s Office of Clinical and Regulatory Affairs with regard to NCCAM policies
and guidance for clinical research (http://nccam.nih.gov/research/policies/index.htm)
including protocol aims, study design, entry criteria, intervention, outcomes,
analytic plan, and data and safety monitoring plan. These items must be
adequately addressed prior to funding by NCCAM. This
policy does not apply to applicants for NCI or NIA grants that NCCAM does not
co-fund. 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. 6. Other Submission
Requirements and Information PD/PI
Credential (e.g., Agency Login) The
NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE
Project Director/Principal Investigator section, Credential log-in field
of the Research & Related Senior/Key Person Profile component. Organizational
DUNS The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For
additional information, see Frequently Asked Questions Application Guide, Electronic
Submission of Grant Applications. PHS398
Research Plan Component Sections Page
limitations of the PHS398 Research Plan component must be followed as outlined
in the SF424 (R&R) Application Guide. While each section of the Research
Plan component 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 are
to be followed, incorporating "Just-in-Time" information concepts,
and with the following additional requirements: Appendix
Materials Applicants must follow the
specific instructions on Appendix materials as described in the SF424 (R&R)
Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Do not use the Appendix to circumvent the page limitations of
the Research Plan component. An application that does not comply with the
required page limitations may be delayed in the review process. 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 Only
the review criteria described below will be considered in the review process. 2.
Review and Selection Process Applications
that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an
appropriate peer review group convened by NCCAM and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below. As
part of the scientific peer review, all applications will: Applications
submitted in response to this FOA will compete for available funds with all
other recommended applications submitted in response to this FOA. The following will be
considered in making funding decisions: The mission
of the NIH is to support science in pursuit of knowledge about the biology and
behavior of living systems and to apply that knowledge to extend healthy life
and reduce the burdens of illness and disability. As part of this
mission, applications submitted to the NIH for grants or cooperative agreements
to support biomedical and behavioral research are evaluated for scientific and
technical merit through the NIH peer review system. Overall
Impact. Reviewers will provide an overall impact 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? How will the
proposed research improve the design and conduct of eventual randomized clinical trials of CAM interventions? 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? Environment. Will the scientific environment in which the
work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit
from unique features of the scientific environment, subject populations, or
collaborative arrangements? Additional
Review Criteria. As applicable for the project proposed,
reviewers will consider the following additional
items in the determination of scientific and technical merit, but will not give
separate scores for these items. Protections
for Human Subjects. For research that
involves human subjects but does not involve one of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate the
justification for involvement of human subjects and the proposed protections
from research risk relating to their participation according to the following
five review criteria: 1) risk to subjects, 2) adequacy of protection against
risks, 3) potential benefits to the subjects and others, 4) importance of the
knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research
that involves human subjects and meets the criteria for one or more of
the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. Inclusion
of Women, Minorities, and Children. When
the proposed project involves clinical research, the committee will evaluate
the proposed plans for inclusion of minorities and members of both genders, as
well as the inclusion of children. Vertebrate
Animals. The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following five points: 1) proposed use of the animals, and
species, strains, ages, sex, and numbers to be used; 2) justifications for the
use of animals and for the appropriateness of the species and numbers proposed;
3) adequacy of veterinary care; 4) procedures for limiting discomfort,
distress, pain and injury to that which is unavoidable in the conduct of
scientifically sound research including the use of analgesic, anesthetic, and
tranquilizing drugs and/or comfortable restraining devices; and 5) methods of
euthanasia and reason for selection if not consistent with the AVMA Guidelines
on Euthanasia. Biohazards. Reviewers will assess whether materials or procedures proposed are
potentially hazardous to research personnel and/or the environment, and if
needed, determine whether adequate protection is proposed. Additional
Review Considerations. As applicable for the project proposed,
reviewers will address each of the following items, but will not give scores
for these items and should not consider them in providing an overall impact
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
Agent Research. Reviewers will assess the information
provided in this section of the application, including 1) the Select Agent(s)
to be used in the proposed research, 2) the registration status of all entities
where Select Agent(s) will be used, 3) the procedures that will be used to
monitor possession use and transfer of Select Agent(s), and 4) plans for
appropriate biosafety, biocontainment, and security of the Select Agent(s). 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). 3.
Anticipated Announcement and Award Dates 1.
Award Notices 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. 3.
Reporting 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 Contact(s): Dr. Partap S. Khalsa 2.
Peer Review Contact(s): Dr. Martin Goldrosen 3.
Financial/Grants Management Contact(s): Mr. George Tucker Section VIII. Other Information Required
Federal Citations Use of Animals
in Research: Human Subjects
Protection: Data and Safety
Monitoring Plan: Sharing Research Data: Policy for Genome-Wide
Association Studies (GWAS): Sharing of Model Organisms: Inclusion of Women And Minorities in Clinical Research: Inclusion of Children as Participants in Clinical Research: Required Education on the Protection of Human Subject Participants: Human Embryonic Stem Cells (hESC): NIH Public Access Policy Requirement: Standards for Privacy of Individually Identifiable Health Information: URLs
in NIH Grant Applications or Appendices: Healthy People 2010: Authority and Regulations:
Release/Posted Date: February 2, 2009
Opening Date: April 14, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
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): May 14, 2009
AIDS Application Due Date(s): N/A
Peer Review Date(s): July-August, 2009
Council Review Date(s): October 2009
Earliest Anticipated Start Date(s): December 2009
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 15, 2009
Release/Posted Date: February 2, 2009
Opening Date: June
17, 2009 (Earliest
date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
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): July
17, 2009
AIDS Application
Due Date(s): N/A
Peer Review
Date(s): October November,
2009
Council Review Date(s): January 2010
Earliest Anticipated Start Date(s): April 1, 2010
Additional
Information To Be Available Date (Activation Date): Not Applicable
Expiration
Date: July 18, 2009
Not Applicable
Executive Summary
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. Receipt, 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
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
This Funding
Opportunity Announcement (FOA) issued by the National Center for Complementary and Alternative Medicine (NCCAM) of the
National Institutes of Health (NIH) encourages
investigator(s)-initiated applications that propose to develop, enhance, and
validate translational tools to facilitate rigorous study of complementary and
alternative medicine (CAM) approaches that are in wide use by the public. Recent
data from the National Health Interview Survey [http://www.cdc.gov/nchs/data/nhsr/nhsr012.pdf] continue to show that
large numbers of Americans are utilizing CAM approaches to promote health and well-being, and to treat chronic health problems. Specifically
adults used CAM most
often to treat pain including back or neck pain, joint pain or stiffness,
arthritis, and other musculoskeletal conditions. CAM approaches being widely used include massage and manipulative therapies, meditation, yoga, and acupuncture, and
non-vitamin/non-mineral natural products. Compared to results from 2002 there
has been a significant increase in the use of deep breathing, meditation,
massage therapy, and yoga.
Section
II. Award Information
This
FOA will use the R01 award mechanism. The Project Director/Principal Investigator (PD/PI) will
be solely responsible for planning, directing, and executing the proposed project.
NCCAM
intends to award up to $3 million (total costs) per year, to support
approximately 4 6 new grants.
1.A.
Eligible Institutions
The following
organizations/institutions are eligible to apply:
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
A one-time registration is required for institutions/organizations at both:
Grants.gov Customer
Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]
Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
SF424 (R&R) (Cover component)
Research & Related
Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related
Budget, as
appropriate (See Section IV.6., Special Instructions, regarding appropriate
required budget component.)
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
See Section IV.3.A. for details.
Opening Date: New Date: April 14, 2009 (Per NOT-AT-09-003) (Earliest
date an application may be submitted to Grants.gov)
Application Due Date(s): July 17, 2009 New Date: May 14, 2009 (Per NOT-AT-09-003)
Peer Review
Date(s): October November 2009 New Date: July-August 2009 (Per NOT-AT-09-003)
Council Review Date(s): January 2010 New Date: October 2009 (Per NOT-AT-09-003)
Earliest Anticipated Start Date(s): April 1, 2010 New Date: December 2009 (Per NOT-AT-09-003)
To submit an application in response to this
FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
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.
This initiative is not
subject to intergovernmental
review.
5.
Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement.
The 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).
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? How will the
proposed translational tools improve the measurement
of important and relevant outcomes of CAM interventions, document clinical
effects of such interventions, enhance the comparability and generalizability
of CAM interventions, and/or otherwise facilitate rigorous study of CAM practices?
Not Applicable
Section
VI. Award Administration Information
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 NIH eRA Commons.
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.
Awardees will be
required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
Division
of Extramural Research
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707
Democracy Boulevard, Suite 401
Bethesda,
MD 20892-5475 (for express/courier service use 20817)
Telephone: (301) 594-3462
Fax:
(301) 480-1587
Email: [email protected]
Division
of Extramural Activities
National Center for Complementary and Alternative Medicine
National
Institutes of Health
6707
Democracy Blvd, Suite 401
Bethesda, MD 20892-5475 (for express/courier
service use 20817)
Telephone:
(301) 594-2014
Fax:
(301) 480-2419
Email: [email protected]
Grants
Management Branch
National
Center for Complementary and Alternative Medicine
National
Institutes of Health
6707
Democracy Blvd, Suite 401
Bethesda,
MD 20892-5475 (for express/courier service use 20817)
Telephone:
(301) 594-9102
Fax:
(301) 480-1552
Email: [email protected]
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.
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 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).
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 priority score.
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/
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.
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.
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).
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.
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.
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 Medicine’s 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/.
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.
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.
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.
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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