and Human Services (HHS)
Department of Health and Human Services
Participating Organizations
National Institutes of Health
(NIH), (http://www.nih.gov)
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov/)
Components of Participating Organizations
National Institute of Mental Health
(NIMH), (http://www.nimh.nih.gov)
National Institute of Child Health and Human Development
(NICHD), (http://www.nichd.nih.gov/)
National Institute of Drug Abuse (NIDA), (http://www.nida.nih.gov/)
Center for Primary Care, Prevention, and Clinical
Partnerships (CP3), (http://ahrq.gov/about/CP3)
Title: Women’s Mental Health in Pregnancy and the Postpartum
Period (R21)
Announcement Type
This is a reissue of PA-03-135,
which was previously released on June 6, 2003.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this 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 4 weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-06-377
Catalog of Federal Domestic Assistance Number(s)
93.242, 93.279,
93.865, 93.226
Key Dates
Release/Posted Date: April 28,
2006
Opening Date: May 2, 2006 (Earliest date an application may be submitted
to Grants.gov).
NOTE:
On time submission requires that applications be successfully submitted to
Grants.gov no later than 5:00 p.m. local time (of applicant
institution/organization).
Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (Url
Activation Date): Not applicable.
Expiration Date: March 2, 2009 (now May 8, 2009 per NOT-OD-07-093)
Due Dates for E.O.
12372
Not
Applicable.
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible
Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
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
In this FOA, the
National Institute of Mental Health (NIMH), the National Institute of Drug
Abuse (NIDA), the National Institute of Child Health and Human Development
(NICHD), and the Agency for Healthcare Research and Quality (AHRQ) encourage
research on women's mental health in relation to pregnancy and the postpartum
period. As illustrated by a few highly publicized cases, the consequences of
severe untreated postpartum depression and psychosis can be devastating for
individuals, families, and communities. In July 2002, NIMH held a major
interdisciplinary conference to identify research needs in the areas of
pregnancy-onset and postpartum depression and postpartum psychosis (hereafter
referred to collectively as perinatal mood disorders). In February 2003,’s 450
and HR 846 were introduced in the 108th Congress. The bills call for the
Secretary of Health and Human Services, working through the Director of NIMH to
provide for basic, epidemiological, diagnostic, clinical, and intervention
research on postpartum depression and psychosis.
Research Objectives
Perinatal mood disorders are potentially devastating conditions that affect many women during pregnancy (often referred to as gestational or antepartum) and after pregnancy (often referred to as postpartum, puerperium or postnatal). Perinatal mood disorders are broadly termed maternal depression. Perinatal mood disorders are classified into three groups: the (postpartum) blues, which is a common and less severe form of postpartum depression; clinical mood and anxiety disorders, which can occur during pregnancy and following childbirth, usually within six months to a year later (depending on the definition used) and often necessitating treatment; and postpartum psychosis, which is the most extreme form of perinatal mental illness, usually occurring within a few weeks of childbirth and constituting a medical emergency. The causes of these conditions are complex and most likely heterogeneous, with putative distinct and shared risk factors. Biologically oriented explanations are likely to consider changes in levels of estrogen and progesterone following delivery, genetic vulnerability factors sensitive to hormonal changes, and hypothyroidism as possible triggering events. Environmental factors associated with perinatal mood disorders include difficult delivery, marital stress, and lack of social support. A personal or family history of mood disorders, particularly bipolar disorder or prior postpartum psychosis, is also a major risk factor for a perinatal mood disorder. A subset of women with perinatal mood disorders may also manifest mood disorders particularly in relation to other reproductive transitions such as those that occur during the premenstrual period. It is estimated that 8-15 percent of women having children suffer from a clinically significant postpartum mood disorder; of these women, many experienced depressive symptoms as well during pregnancy. An estimated .5 to 1 percent of women will experience a postpartum psychosis. There are limited epidemiological data on postpartum psychosis because of the low incidence.
Perinatal mood disorders are under-diagnosed and under-treated. It is estimated that health care providers identify only 20-30 percent of these conditions. Maternal depression, anxiety, and stress during pregnancy are associated with a variety of poor physical and emotional outcomes in offspring. Untreated perinatal mood disorders can have a range of poor maternal functional outcomes, from substance abuse, loss of employment, and divorce to suicidal behavior or death by suicide. Untreated perinatal depression also impacts society through its effect on a mother's ability to promote the infant's cognitive and emotional development. Maternal depression has been associated with poorer pregnancy outcomes as well as impaired child cognitive and psychological development. In extreme cases, such as postpartum psychosis, it has been associated with poorer neonatal outcomes, even infanticide.
In addition to the mood disorders, many women enter the perinatal period with active and/or relapsing/recurring drug or alcohol use disorders as well as mental illness (anxiety disorders, eating disorders, schizophrenia) and with medical conditions related to substance abuse such as infectious disease (HIV, HBV, HCV). These conditions and other co-occurring conditions of higher prevalence in women such as autoimmune disorders must be explored at the level of basic, epidemiological, diagnostic, clinical, and intervention research in relation to maternal perinatal health.
This FOA encourages research on perinatal mood and other mental disorders in four areas: (1) clinical course, epidemiology and risk factors; (2) basic and clinical neuroscience; and (3) interventions; and (4) services. Research is encouraged both on perinatal non-psychotic mood disorders and on psychotic disorders.
Clinical Course, Epidemiological and Risk Factors Research
Current national epidemiology studies have paid surprisingly little attention to the postpartum period and even less attention to pregnancy in terms of risk for different kinds of perinatal mental disorders and distinguishing risk factors. This critical gap must be addressed, as clinical and epidemiology studies form the basis of intervention research. The prevalence of perinatal depression in different racial/ethnic groups of women is undetermined, with some reports of much higher rates in low-income and/or ethnic minority women and other reports of comparable rates among women.
Below are examples of clinical, epidemiological, and risk factors research encouraged by NIMH:
Below are examples of research encouraged by NICHD:
Below is an example of research encouraged by NIDA:
Basic and Clinical Neuroscience
Very little basic neuroscience research is currently aimed specifically at addressing the neurobiology of perinatal mood disorders. There is a need to apply the knowledge of hormone-sensitive brain circuits and neurotransmitter systems to developing an understanding of the neurobiology of perinatal mood disorders in clinical populations. The development of appropriate models of the peripartum period will be essential for understanding the neurobiology of perinatal mood disorders. Consideration of combined genetic and environmental influences on postpartum hormonal status, emotionality, and maternal behavior is also appropriate for model development. Finally, new tools are needed to advance the understanding of neuroendocrine control of mood and cognition in humans, non-human primates, and other species.
The following are examples of clinical neuroscience research encouraged by NIMH:
Below are examples of model development research encouraged by NIMH:
Below are examples of tool development research encouraged by NIMH:
Below is an example of research encouraged by NIDA:
Below is an example of research encouraged by NICHD:
Interventions Research
There is a need to develop more systematic knowledge about the impact of known pharmacological and psychosocial depression treatments for perinatal mood disorders. There is also a need to develop new behavioral interventions for these conditions, in particular interventions that can be adapted to general medical or group settings.
The following are examples of the kinds of intervention studies encouraged by NIMH:
Below is an example of research encouraged by NICHD:
Below is an example of research encouraged by NIDA:
Services Research
Increased screening and referral to accurate, accessible, and sustainable mental health assessment, treatment, and needed services is a public health strategy with the potential to improve outcomes in perinatal mood disorders. To determine the effectiveness of such an approach, a variety of factors must be evaluated at the individual, practitioner, organizational, community, and systems levels.
The following are examples of services research encouraged by NIMH:
Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
This FOA 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, since 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
Although the financial plans of the Institutes
and Centers (ICs) provide support for this program, awards pursuant to this
funding opportunity are contingent upon the availability of funds and the
submission of a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, 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. 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.
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 as the Project
Director/Principal Investigator (PD/PI) is invited to work with his/her
organization to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.
2. Cost Sharing or
Matching
This program does not require cost sharing as
defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applicants may submit more than one application, provided
each application is scientifically distinct.
Section IV. Application and Submission Information
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 eRA 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 organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application
Information
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: GrantsInfo@nih.gov.
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 PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed
research should provide special opportunities for furthering research programs
through the use of unusual talent, resources, populations, or environmental
conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates
and Times
See Section IV.3.A for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: May 2, 2004 (earliest date an application may be submitted to
Grants.gov).
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s) http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
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 on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt,
applications will be evaluated for completeness by the Center for Scientific
Review, NIH. Incomplete applications will not be reviewed.
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.
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 such an application is considered a "resubmission" for the SF424 (R&R).
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.
All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications:
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.
AHRQ
does not use the Modular Grant Application and Award Process. Applicants for
funding from AHRQ will have to submit full budgets
(on a just-in-time basis) prior to the funding of any grant awards in
connection with this PA. However, for the purposes of peer review, grant
applications containing only modular budgets will be acceptable.
Plan for Sharing Research Data
A data sharing plan is
not required; however, one may be proposed. 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.
Sharing Research Resources
NIH policy requires that grant
awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted
for this funding opportunity will be assigned to the ICs on the basis of
established PHS referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications
will:
The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; 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 SF424 (R&R).
Inclusion of Women, Minorities and
Children in Research: The adequacy
of plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional
Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. Is the percent effort listed for the
PD/PI appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods?
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH
policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
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.
3. Reporting
When multiple years are
involved, 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.
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:
Kathleen M. O'Leary, M.S.W.
Office for Special Populations
National Institute of Mental Health
6001 Executive Boulevard, Room 8125, MSC 9659
Bethesda, MD 20892-9659
Telephone: (301) 443-3945
FAX: (301) 443-8552
Email: olearyk@mail.nih.gov
Caroline Signore, MD, MPH
Program Officer/Project Scientist
Pregnancy and Perinatology Branch
NICHD, NIH
6100 Executive Blvd., Room 4B03, MSC 7510
Bethesda, MD 20892
(For FedEx use Rockville, MD 20852)
Tel. 301-496-5577
Fax 301-496-3790
Email: signorec@mail.nih.gov
Cora Lee Wetherington, Ph.D.
Women & Gender Research Coordinator
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Rockville, MD 20857 (for overnight/courier service)
Telephone: (301) 435-1319
FAX: (301) 594-6043
Email: wetherington@nih.gov
Charlotte
A. Mullican, M.P.H.
Center
for Primary Care, Prevention, and Clinical Partnerships
Agency
for Healthcare Research and Quality
540
Gaither Road, Suite 6129
Rockville, MD 20850
Telephone:
(301) 427-1495
FAX:
(301) 427-1597
Email: cmullica@ahrq.gov
2. Peer Review
Contacts:
Not
applicable
3. Financial or Grants
Management Contacts:
Joy R. Knipple
Grants
Management Branch
National
Institute of Mental Health
6001
Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone:
(301) 443-8811
FAX:
(301) 443-6885
Email: jk173@nih.gov
Kathy
Hancock
Grants
Management Branch
National
Institute of Child Health and Human Development
6100
Executive Boulevard, Room 8A17M, MSC
7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for
express/courier service)
Telephone:
(301) 496-5482
FAX:
(301) 480-4782
Email:
kh246t@nih.gov
Debra Dudley
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3124
Bethesda, MD 20892
Telephone: (301) 443-6710
ddudley@nida.nih.gov
Michelle Burr
Office of Performance, Accountability, Resources, and
Technology
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1451
FAX: (301) 427-1462
Email: mburr@ahrq.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, 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 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 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 Part 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles,
and other considerations described in the NIH Grants
Policy Statement.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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