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://nccam.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov/)
Title: NCCAM Exploratory/Developmental Grant for Clinical
Studies (R21)
Announcement Type
This is a reissue of PAR-03-153,
which was previously released on July 17, 2003.
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 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 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 (see “Key Dates” below).
2) Applicants must complete a verification step in the eRA Commons within two (2) 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: PAR-06-091
Catalog of Federal Domestic Assistance Number(s)
93.213
Key Dates
Release/Posted
Date: March 3, 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 Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Dates(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS for
details.
Peer
Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details.
Council
Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details.
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details.
Additional
Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: July 2, 2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
The primary goal of this Funding Opportunity Announcement (FOA), issued by the National Center for Complementary and Alternative Medicine (NCCAM), National Institutes of Health (NIH), is to encourage the submission of high quality, preliminary studies that will provide a solid foundation and justification for larger clinical studies to determine the efficacy of complementary and alternative medicine (CAM) therapies.
Table of Contents
Part I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research
Objectives
Section
II. Award Information
1. Mechanism of
Support
2. Funds
Available
Section
III. Eligibility Information
1. Eligible
Applicants
A.
Eligible Institutions
B.
Eligible Individuals
2.Cost Sharing
or Matching
3. Other -
Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Request
Application Information
2. Content and
Form of Application Submission
3. Submission
Dates and Times
A.
Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B.
Sending an Application to the NIH
C.
Application Processing
4.
Intergovernmental Review
5. Funding
Restrictions
6. Other
Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and
Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Sharing Research Data
D.
Sharing Research Resources
3. Anticipated
Announcement and Award Dates
Section
VI. Award Administration Information
1. Award
Notices
2.
Administrative and National Policy Requirements
3. Reporting
Section
VII. Agency Contact(s)
1.
Scientific/Research Contact(s)
2. Peer Review
Contact(s)
3. Financial/
Grants Management Contact(s)
Section VIII. Other Information - Required Federal
Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The National Center for Complementary and Alternative Medicine (NCCAM) invites high quality exploratory/developmental clinical research grant applications, in all domains of complementary and alternative medicine (CAM), in order to provide preliminary data that can be used as a foundation for larger clinical studies. NCCAM defines five domains of complementary and alternative medicine, which are whole medical systems; biologically-based practices; energy medicine; manipulative and body-based therapies; and mind-body medicine. These are described more fully in the NCCAM five-year strategic plan (2005-2009) http://nccam.nih.gov/about/plans/2005/index.htm.
While many CAM therapies are in extensive use by the public, few have been thoroughly tested for safety and/or efficacy. One of the primary missions of NCCAM is to support clinical research to test the efficacy of CAM therapies being used by the public. However, before investing in a large clinical study to test the efficacy of a CAM therapy, it is necessary to first provide preliminary data from pilot studies and small phase I and phase II trials as a basis for such a larger clinical study. Thus, an important goal of this exploratory/developmental research grant solicitation is to provide independent investigators, at all career levels, with the opportunity to design rigorous feasibility and developmental projects in the clinical area that will serve as the basis for planning and scientifically justifying larger clinical research projects to test the efficacy of CAM therapies. If the results from preliminary studies submitted in response to this program announcement, along with published reports in the literature, support the performance of a larger clinical study, then a future grant application soliciting support for such a study can be submitted through the Research Project Grant (R01) mechanism. Examples of types of investigations appropriate for this clinical exploratory/developmental program announcement include, but are not limited to the following:
Preliminary data are not required as a prerequisite for submission in response to this announcement, because part of the goal of this program announcement is to produce the preliminary data as the first necessary step in the process required for planning a larger clinical study. However, a clear rationale for the study must be presented. A rigorous project design is required as well. A thorough summary of the published literature that justifies initiating the specific clinical project proposed must be presented in the grant application. In addition, applicants should describe their future research plans as they relate to how the results of this exploratory/developmental research will lead to a larger clinical study. Furthermore, applicants should provide justification regarding why it is important to perform this larger clinical study in the context of the present knowledge of clinical research on CAM therapies.
Large Phase II trials or Phase III trials, with the goal of determining efficacy of a CAM therapy, should not be submitted in response to this Funding Opportunity Announcement (FOA). Such proposals should be submitted as Research Project (R01) grants.
Exploratory/developmental CAM basic and preclinical studies, including mechanistic studies in humans, should not be submitted in response to this FOA. Instead such studies should be submitted in response to the NCCAM program announcement on "Basic and Preclinical Research on Complementary and Alternative Medicine" (http://nccam.nih.gov/research/instructions/r21/index.htm).
See 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 Exploratory/Developmental Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
The R21 awards are to demonstrate feasibility and to obtain preliminary data testing innovative ideas that represent clear departure from ongoing research interests. These grants are intended to: 1) provide initial support for new investigators; 2) allow exploration of possible innovative new directions for established investigators; and 3) stimulate investigators from other areas to lend their expertise to research within the scope of this FOA.
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).
The R21 exploratory/developmental grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted. Continuation of projects developed under this program will be through the regular Research Project (R01) grant mechanism. 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.
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
NCCAM 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.
Applicants may request a project period of up to three
years with a combined budget for direct costs of up to $400,000 for the
three-year period. The budget request should be tailored to the needs of the
project. For example, you may request $100,000 in the first year, $200,000 in
the second year, and $100,000 in the third year. However, no more than
$250,000 in direct costs may be requested in any single year.
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 Project Director/Principal
Investigator (PD/PI) is invited to work with his/her institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH programs.
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
There is no limit to
the number of applications an applicant may submit under this FOA, 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 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY 301-451-0088.
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
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)
Letter of Intent Receipt Date(s): Not applicable
Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for
details
Peer
Review Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details
Council
Review Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details
3.A.1. Letter of
Intent
A letter of intent is not required for the funding
opportunity.
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.
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 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
If the
clinical study will involve a biologically active agent (e.g., dietary supplement),
then the applicant must follow the NCCAM Interim Applicant Guidance: Product
Quality: Biologically Active Agents Used in Complementary and Alternative
Medicine and Placebo Materials: http://nccam.nih.gov/research/policies/bioactive.htm.
Instructions are provided on the type of information that should be included in
the application, as well as the type of information that NCCAM may request
after review but before grant award.
In addition to the required Federal Citations listed in Section VIII. related to clinical research, applicants submitting applications in response to this announcement should also follow the “NCCAM Terms of Award for Clinical Trials.”
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.
All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications:
WARNING: Please be sure that you observe the direct costs, project period, and page number limitations specified for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
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 will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research
Resources
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the
resources sharing plan and any related data sharing plans will be considered by
NCCAM Program staff 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.”
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
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 NCCAM in accordance with the review
criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
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 quality information. The information will be evaluated by a working group of the National Advisory Council for Complementary and Alternative Medicine. This evaluation will contribute to funding decisions.
The 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 20 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications in response to this FOA; 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 PD/PI 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 SF 424 (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
Budget: The reasonableness of the proposed
budget and 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?
Period of Support: The appropriateness of the
requested period of support in relation to the proposed research.
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. NCCAM does not require a data sharing plan
for applications requesting less than $500,000.
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 (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
NCCAM Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the resources sharing plan and any related
data sharing plans will be considered by NCCAM Program staff 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.”
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 NIH eRA Commons.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General.
A formal
notification in the form of a Notice of Award (NoA) will be provided to the
applicant organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”
2. Administrative and
National Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as
part of the NoA. For these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
In
addition, grants awarded in response to this FOA will include the “NCCAM Terms
of Award for Clinical Trials.”
3. Reporting
In addition to the reporting requirements below, starting
six months after grant award, the NCCAM will request quarterly accrual reports
to monitor recruitment and enrollment.
Awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
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:
For scientific/research contacts, refer to the NCCAM’s
staff contact list for the scientific area most closely related to your
project: http://nccam.nih.gov/research/contact/
2. Peer Review Contacts:
Martin Goldrosen, Ph.D.
Chief,
Office of Scientific Review
National Center for Complementary and Alternative
Medicine
6707
Democracy Blvd., Suite 401
Bethesda, MD 20892-5475 (for express/courier service use
20817)
Telephone:
(301) 594-2014
Fax:
(301) 480-2419
Email: goldrosem@nccam.nih.gov
3. Financial or Grants Management Contacts:
George Tucker, MBA
Grants
Management Office
National Center for Complementary and Alternative
Medicine
6707
Democracy Blvd., Suite 401
Bethesda, MD 20892-5475 (for express/courier service use
20817)
Telephone:
(301) 594-8853
Fax:
(301) 480-2419
Email: gt35v@nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, 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. 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.
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) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
The 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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Office of Extramural Research (OER) |
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National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
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Department of Health and Human Services (HHS) |
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