and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health
(NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Dental
and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
Title: NIDCR Clinical Pilot Data Grant (R21)
Announcement Type
This is a reissue of PAR-06-025 which was previously released on October 19, 2005.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines provided with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see Key Dates below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
Program Announcement (PA) Number: PAR-06-244
Catalog of Federal Domestic Assistance Number(s)
93.121
Key Dates
Release/Posted
Date: March 17, 2006
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://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council
Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date:
http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information
To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: May 2, 2009 - (New Expiration Date April 15, 2008 per NOT-DE-08-002)
(now May 8, 2009 per NOT-OD-07-093)
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
The goal of this funding opportunity
announcement (FOA) is to support the collection of clinical pilot data that can
be used in preparing an application for a Clinical Trial Planning Grant or a
definitive Phase III clinical trial; or, will show that a Phase III clinical
trial is not feasible at this time.
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
PURPOSE
The NIDCR announces a grant program to support the collection of clinical pilot data to be used in preparing applications for definitive Phase III clinical trials. These pilot data grants should focus on research that has potential of leading to a Phase III clinical trial with the goal of providing information to change clinical practice and inform policy change in public health. The research conducted may involve small feasibility studies in which the technological, methodological, or theoretical approach to a problem lacks sufficient preliminary data. Given the exploratory nature of this pilot data grant, these studies are not required to be generalizable to the eventual target population in the Phase III clinical trial. This grant is not intended to support small pilot clinical trials; i.e., applications may not include randomization to treatment groups.
Before submitting an NIDCR Clinical Pilot Data Grant, an investigator may wish to submit a brief description of the Proposed Phase III clinical trial to the NIDCR for review for programmatic relevance although this is not required (see http://www.nidcr.nih.gov/ClinicalTrials/ClincalTrialsProgram/ProposalProcedures.htm).
RESEARCH OBJECTIVES
The NIDCR is committed to identifying effective preventive, diagnostic, and treatment approaches to craniofacial, oral, and dental diseases and disorders that will improve health by supporting well-designed, definitive Phase III clinical trials. Before proceeding to a Clinical Trial Planning Grant and a full-scale Phase III clinical trial, pilot data are often required.
The objective of the NIDCR Clinical Pilot Data Grant is to provide a mechanism for the collection of preliminary data that is necessary to support the development of definitive Phase III clinical trials to evaluate interventions for the treatment or prevention of craniofacial, oral, and dental conditions and to promote craniofacial, oral, and dental health. By providing resources to collect essential data required for the design of a subsequent full-scale Phase III clinical trial, it is anticipated that applicants will be in a better position to definitely address the core clinical trial design issues. The research supported under this award may involve limited pilot testing of novel experimental hypotheses, design-driven development of new or novel techniques or technologies, and/or the acquisition of a body of data that has potentially high-impact on craniofacial, oral, and dental research. The NIDCR Clinical Pilot Data Grant may include but is not limited to: collection of preliminary data for establishing measures of effectiveness and/or safety; testing and documenting recruitment mechanisms and their effectiveness; short-term studies to address questions to optimize the design of the definitive trial; small studies to refine an intervention strategy (e.g., dosage, duration, delivery system, etc.); and, the development and testing of participant inclusion criteria and data collection instruments.
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 National
Institutes of Health (NIH) Exploratory/Developmental Research Grant (R21). As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
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).
Exploratory/developmental
grant support is for new projects only; competing renewal (formerly competing
continuation ) applications will not be accepted. Up to two resubmissions
(formerly revisions/amendments") of a previously reviewed
exploratory/developmental grant application may be submitted. See NOT-OD-03-041,
May 7, 2003.
2. Funds Available
The NIDCR has not
set aside funds for this Program Announcement. The number of awards will be
dependent on their scientific merit.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Direct costs are limited to $275,000 over the two years of the R21 award, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. The request should be tailored to the needs of the project. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.
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 and the receipt of a
sufficient number of meritorious applications.
Facilities
and administrative (F&A) costs requested by consortium participants are not included
in the direct cost limitation. See NOT-OD-05-004.
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 is invited to work with their 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
Exploratory/developmental
grant support is for new projects only. Competing continuation applications
will not be accepted. Two revisions of a previously reviewed
exploratory/developmental grant application may be submitted as defined in NIH
Policy at http://grants.nih.gov/grants/policy/amendedapps.htm.
Section
IV. Application and Submission Information
Registration and Instructions for Submission via Grants.gov
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1.
Request Application Information
Applicants
must download the SF424 (R&R) application forms and SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.
For further
assistance contact GrantsInfo, Telephone 301-710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2.
Content and Form of Application Submission
Prepare all applications using the SF424
(R &R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R &R) (Cover
component)
Research & Related Project/Performance Site Locations
Research
& Related Other Project Information
Research
& Related Senior/Key Person
PHS398
Cover Page Supplement
PHS398
Research Plan
PHS398
Checklist
PHS398 Modular Budget
Optional Components:
PHS398
Cover Letter File
R&R
Subaward Budget Attachment(s) Form
Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)
The Program Announcement
Number should be entered in the Opportunity Number space on the SF 424
(R&R).
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. See
http://grants.nih.gov/grants/funding/submissionschedule.htm for
details.
Peer Review Date(s): Standard dates apply, please see
http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details.
Council Review Date(s) : Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details.
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.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
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.
Application Characteristics
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Specific Instructions for Modular Grant applications.
Applications
requesting direct costs in each year of $250,000 or less (excluding consortium
F&A costs), must be submitted in a modular budget format using the Modular
Budget Component provided in the SF424 (R&R) Application Package and
Instructions Guide (see specifically Section 5.4). The modular budget format
simplifies the preparation of the budget in these applications by limiting the
level of budgetary detail. Applicants request direct costs in $25,000 modules.
Plan for Sharing
Research Data
No data-sharing plan is
required for this R21 Exploratory/Development Grant award mechanism.
Sharing Research
Resources
The development of
research resources under this R21 Exploratory/Development Grant award mechanism
is not anticipated. Thus, no research resources sharing plan need be included
in the application.
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
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
Applications that
are complete will be evaluated for scientific and technical merit by an
appropriate review group convened by NIDCR in accordance with the review criteria stated below.
As part of the
initial merit review, all applications will:
The following will be considered in making funding decisions:
The
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? Will a
successful outcome from this pilot work potentially lead to the development of
a definitive Phase III clinical trial application that would likely change
clinical practice or inform public health policy?
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: Are the aims original? Will
the project potentially generate data or other information that may provide the
foundation for developing new clinical trials research?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed. See item 6 of the Research Plan component of the 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 SF 424
(R&R).
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
Sharing of research data is not required for the Clinical Pilot Data Grant.
2.D. Sharing
Research Resources
Sharing research resources is not required for the Clinical Pilot Data Grant.
3. Anticipated Announcement and Award Dates
N/A
Section VI. Award Administration Information
1. Award Notices
After
the peer review of the application is completed, the PD/PI will be able to
access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS
Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
Jane C. Atkinson, D.D.S.
Program Director, Clinical Trials Program
Center for Clinical Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS25L
45 Center Drive, MSC 6401
Bethesda, MD 20892-6401
Telephone (301) 435-7908E-mail: [email protected]
Dr. Lynn King
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN32F
45 Center Drive MSC 6402
Bethesda, MD 20892-6402
Telephone: (301) 594-5006
E-mail: [email protected]
Mary Daley
Division
of Extramural Activities
National
Institute of Dental and Craniofacial Research
Building
45, Room 4AN44B
45 Center
Drive MSC
6402Street Address
Bethesda, MD 20892
Telephone:
(301) 594-4808
FAX:
(301) 480-3562
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Human Subjects Protection:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Access to Research Data through the Freedom of Information
Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R); and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. Unless otherwise specified in
an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This 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 NIH Grants Policy
Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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