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 Child
Health and Human Development (NICHD) (http://www.nichd.nih.gov)
Title: Limited Competition: Study of Attitudes and Factors Affecting Infant Care (U10)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-HD-07-102
Catalog of Federal Domestic Assistance Number(s)
93.865
Key Dates
Release Date: September 28,
2007
Letters
of Intent Receipt Date(s): October 28, 2007
Application Receipt Date
(s): November 28,
2007
Peer Review Date(s): February/March 2008
Council Review Date(s): May 2008
Earliest Anticipated
Start Date: August 1, 2008
Expiration
Date: November
29, 2007
Due Dates for E.O. 12372
Not applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) 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. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and 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
A. Cooperative Agreement Terms
and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3. Collaborative
Responsibilities
4. Arbitration Process
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 purposes of this Request for Applications are (1) to
continue to evaluate trends in infant sleep practices and the dissemination and
adoption of the American Academy of Pediatrics and the Public Health
Service’s "Back to Sleep" recommendations to reduce the risk of
Sudden Infant Death Syndrome, and (2) to expand on current studies by
conducting a new study that examines in greater depth the factors influencing
these trends and the racial disparity in dissemination and adoption.
Despite the dramatic decline in rates of Sudden Infant Death Syndrome (SIDS), it remains the leading cause of post-neonatal infant mortality in the US. In addition, while the SIDS rate has declined among all races/ethnicities, disparities in rates remain, with the rate of SIDS among African Americans twice that of whites. The National Infant Sleep Position Study (NISP), an annual telephone survey of nighttime caregivers of infants, has provided information on the prevalence of infant care practices associated with SIDS risk. Between 1992 and the present, the prevalence of stomach sleep position has dropped to 11 percent, while the prevalence of back sleep position has risen to 72 percent. The improvement in SIDS can be attributed mainly to the change in sleep position as a result of the Back to Sleep campaign. However, the full benefit of the campaign has not been uniformly distributed across all populations. Infants in families from racial and ethnic minority backgrounds, as well as those from lower socioeconomic groups, are still more likely to be placed in a prone sleeping position and are more likely to die from SIDS. In addition, in recent years both the decline in the SIDS rate and the increase in the prevalence of supine sleep position have reached plateaus in all populations.
Interviews conducted at WIC clinics in Boston, Dallas, Los Angeles, and New Haven have revealed themes to be explored regarding the disparity in the diffusion and implementation of the SIDS risk reduction messages. The WIC Supplemental Nutrition Program is a federally funded program for low-income women who are pregnant, breastfeeding, and/or postpartum, and for children who are younger than five years and are from low-income families. Women were more likely to place the baby on the back if they trusted the advice given by their baby’s doctor. About half of women were concerned that the baby would choke while sleeping on the back and, thus, were less likely to place the infant on the back. Advice from a relative or female friend and perceived comfort for the baby were most influential in determining what position the baby should be placed for sleep.
In order to understand and eliminate the disparity in SIDS mortality and the resultant contribution to infant mortality, it is imperative to fully understand the barriers to diffusion of the Back to Sleep message into vulnerable minority or low socioeconomic status populations. This is a particularly important period to continue this investigation because of the recent issuance of guidelines on pacifier use and avoidance of co-sleeping that are focused on reducing SIDS risks even further. Without an understanding of what influences infant care practices among all population groups, the delayed diffusion of effective SIDS prevention strategies will serve to exacerbate disparities, rather than eliminate them.
The objectives of the research program are to examine trends in infant care practices, and environmental and cultural influences, on the diffusion of the public health recommendations in a nationally representative sample of minority and non-minority mothers. It will add new domains to the research that go beyond current investigations of health disparity in adoption of medical recommendations: (1) Racial and ethnic concordance of parent and health provider; (2) Exploration of family's competing priorities; (3) Effectiveness of provider in eliciting health beliefs; and (4) Parental views on areas of health provider expertise.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding
opportunity will use the NIH Cooperative Clinical Research (U10) award
mechanism. The NIH U10 is a
cooperative agreement award mechanism. In the cooperative agreement mechanism,
the Principal Investigator retains the primary responsibility and dominant role
for planning, directing, and executing the proposed project, with NIH staff
being substantially involved as a partner with the Principal Investigator, as
described under Section VI. 2. Administrative
Requirements, "Cooperative Agreement Terms and Conditions of Award."
2. Funds Available
NICHD
intends to commit approximately $675,000 in total costs [Direct plus Facilities
and Administrative (F & A) costs] in FY 2008 to fund one competing grant in
response to this RFA. The applicant may request a
project period of up to five years.
Although
the financial plans of the NICHD provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds and the receipt of a of meritorious application.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
This is a continuation of the National Infant Sleep Position Study (NISP) and related research studies, previously reviewed in response to HD-02-104. Any application awarded as part of this initiative is eligible to apply for continuation.
The application may involve multiple sites that may be domestic or foreign non-profit and for-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State or local government; and eligible agencies of the Federal government.
1.B. Eligible Individuals
Any eligible
individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with the eligible institution to develop
an application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
2. Cost Sharing or Matching
Cost sharing
is not required.
The most current Grants Policy Statement can be found
at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special
Eligibility Criteria
The
investigators should be prepared to work collaboratively with the NICHD to
achieve the goals of this solicitation and accept the cooperative agreement
Terms of Award.
Only one application
from the eligible institution may be submitted in response to this
announcement.
Section
IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398
application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. 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
Applications must
be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number
should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A.
Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date(s): October 28, 2007
Application
Receipt Date(s): November 28,
007
Peer Review Date(s): February/March 2008
Council Review
Date(s): May 2008
Earliest
Anticipated Start Date(s): August 1, 2008
3.A.1. Letter of
Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The
letter of intent is to be sent by the date listed at the beginning of this
document.
The letter of
intent should be sent to:
Marian Willinger, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03D,
MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for
express/courier service; non-USPS service)
Telephone: (301) 435-6896
FAX: (301) 496-3790
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must
be prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three signed photocopies in one package
to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal
deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01D,
MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for
express/courier service; non-USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]
Using
the RFA Label: The RFA label available in the PHS 398 application
instructions must be affixed to the bottom of the face page of the application.
Type the RFA number on the label. Failure to use this label could result in
delayed processing of the application such that it may not reach the review
committee in time for review. In addition, the RFA title and number must be
typed on line 2 of the face page of the application form and the YES box must
be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications must be received
on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after
that date, it will be returned to the applicant without review. Upon receipt,
applications will be evaluated for completeness by the CSR and responsiveness
by the NICHD. Incomplete and
non-responsive applications will not be reviewed.
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.
Information on the status of an application should be
checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new or competing continuation award if such costs: are necessary to
conduct the project, and would be allowable under the grant, if awarded,
without NIH prior approval. If specific expenditures would otherwise require
prior approval, the grantee must obtain NIH approval before incurring the cost.
NIH prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or competing
continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission
Requirements
In the
research plan, the applicant should plan for one more year of the NISP study
and the study at WIC clinics, and four years of annual data collection for the
Study of Attitudes and Factors Affecting Infant Care. The
applicant should describe the rationale for the Study of Attitudes and
Factors Effecting Infant Care to include what has been learned from the
NISP and WIC studies performed in the prior grant periods. The applicant
should describe the design elements of the Study of Attitudes and
Factors Affecting Infant Care that will build on past efforts and
expand our knowledge and understanding of barriers to the adoption of SIDS risk
reduction strategies. There should be a description of the proposed study
sample, the methods of data collection, the domains of information, and a draft
analytic plan that addresses the primary specific aims/hypotheses of the
study. If the grantis funded, the final study instruments and analytic
plan will be developed post-award in collaboration with NICHD.
The applicant should also provide a timeline for study development, piloting, implementation, and analysis, and public availability of data.
The applicant should have a clearly expressed intent to participate in a cooperative agreement with the NIH in all aspects of collaborative research as outlined in this RFA.
Future years budgets will include an annual increment of base salary and travel not to exceed three percent. Federal agencies shall use negotiated rates for F&A costs in effect at the time of the initial award throughout each competitive segment of the project. Award levels for sponsored agreements may not be adjusted in future years as a result of changes in negotiated rates.
Awardees
must agree to the "Cooperative Agreement Terms and Conditions of
Award" in Section VI.B "Award Administration Information".
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.
The applicant must include a plan for sharing research data in their
application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
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 expects
that grant 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_2003/index.htm 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 Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
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.
The following will be
considered in making funding decisions:
2. Review and Selection Process
Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NICHD in
accordance with the review criteria stated below.
As part of the initial
merit review, all applications will:
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, clinical
practice or public health strategies be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field? Is the rationale
for the Study of Attitudes and Factors Affecting Infant Care
solid?
Approach: Are the conceptual, design,
methods, and analyses adequately developed, well integrated, well reasoned, and
appropriate to the proposed Study of Attitudes and Factors Affecting Infant Care ? Is the research plan for the study adequate to meet the
objectives? Does the applicant acknowledge potential problem areas and
consider alternative tactics? Do the design elements of the Study
of Attitudes and Factors Affecting Infant Care build on past
efforts and expand our knowledge and understanding of barriers to the adoption
of SIDS risk reduction strategies, to include the study sample, methods, and
information to be obtained? Is the timeline for study development,
piloting, implementation, and analysis, and public availability of data
appropriate?
Innovation: Is the project original and innovative? For example:
Does the project challenge existing paradigms or public health 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? Does the research
team have the knowledge and experience to develop, conduct, and analyze the
proposed studies on infant care practices and health disparities as they relate
to risk of Sudden Infant Death Syndrome? Does the investigative team bring
complementary and integrated expertise to the project? Is the commitment of
staff time satisfactory to the conduct of the studies? Does the applicant adequately express
their intent to participate cooperatively with the NIH in all aspects of
collaborative research as outlined in this RFA?
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 the Research Plan, Section E on Human Subjects in the PHS Form
398).
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 the Research Plan, Section E on Human Subjects in
the PHS Form 398).
2.B.
Additional Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
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. data sharing policy.
2.D.
Sharing Research Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to
this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
Program
staff will be responsible for the administrative review of the plan for sharing
research resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
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 (designated in item 12 on the
Application Face Page). If a grantee is not email enabled, a hard copy of the
NoA will be mailed to the 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).
The following Terms and
Conditions will be incorporated into the award statement and will be provided
to the Principal Investigator as well as to the appropriate institutional
official, at the time of award.
2.A. Cooperative Agreement
Terms and Conditions of Award
The
following special terms of award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and
local Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.
The
administrative and funding instrument used for this program will be the
cooperative agreement (U 10), an "assistance" mechanism (rather than
an "acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees the NICHD scientific collaborator, as
described in these terms and conditions. The substantial
programmatic involvement by the NICHD scientific collaborator is above and
beyond the levels required for traditional program management and stewardship
of awards.
2.A.1.
Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary
responsibility for:
Awardees
will retain custody of and have primary rights to the data and software
developed under these awards, subject to Government rights of access consistent
with current HHS, PHS, and NIH policies.
2.A.2. NIH
Responsibilities
An NICHD Project Scientist will have
substantial programmatic involvement that is above and beyond the normal
stewardship role in awards, as described below. The Project Scientist is
a partner within the research team representing the government's interest in
the substantive work of the research team. The primary role of the
Project Scientist is to facilitate the work of the awardee. The Project
Scientist will:
2.A.3.
Collaborative Responsibilities
The NICHD Project Scientist and the awardee will work as
partners in the development of research protocols and analytic plans, and the
dissemination of research findings.
2.A.4.
Arbitration Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An Arbitration
Panel composed of three members will be convened. It will have three members: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.
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:
Marian Willinger, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03D,
MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for
express/courier service; non-USPS service)
Telephone: (301) 435-6896
FAX: (301) 496-3790
Email: [email protected]
2. Peer Review Contacts:
Robert
Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01D,
MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for
express/courier service; non-USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]
3. Financial or Grants Management
Contacts:
Bryan S. Clark, M.B.A.
Chief Grant Managements Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01, MSC
7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for
express/courier service; non-USPS service)
Telephone: (301) 435-6975
FAX: (301) 402-0915
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).
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 the 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 public 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 new PHS Form 398; 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. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information necessary for 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 RFA 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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