and Human Services (HHS)
EXPIRED
REDUCING PRETERM & LOW BIRTH WEIGHT IN MINORITY FAMILIES
RELEASE DATE: December 1, 2003
PA NUMBER: PA-04-027
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date for these
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms
expires on the date indicated below. Other mechanisms relating to this announcement
will continue to be accepted using paper PHS 398 applications until the stated
expiration date below, or transition to electronic application submission. Parent
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been
issued for the submission date of June 1, 2006 and submission dates for AIDS and
non-AIDS applications thereafter. Applications relating to R33 and R34 activities
must be in response to NIH Institute/Center (IC)-specific announcements.
EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for All R01 Applications: December 5, 2006, unless reissued.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov)
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):
No. 93.361, Nursing Research
No. 93.865, Center for Research for Mothers and Children
No. 93.121, Oral Diseases and Disorders Research
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Institute of Nursing Research (NINR), National Institute of Child
Health and Human Development (NICHD), and the National Institute of Dental and
Craniofacial Research (NIDCR) invite applications to encourage collaborative
multidisciplinary biobehavioral research that can elucidate the mechanisms
underlying disparities in pregnancy outcomes as well as interventions to
reduce such disparities. The disparity in pregnancy outcomes among minorities
is largely due to preterm delivery (PTD) and low birth weight (LBW), which
disproportionately affect these populations. While these problems occur across
populations, and there are most likely commonalities among all groups, their
greater incidence among minorities makes research with these groups
particularly important. This program announcement solicits research to expand
our understanding of the underlying mechanisms that contribute to the racial
and ethnic variations in PTD and LBW and strategies for prevention. The goals
of this program announcement are: (1) to develop innovative strategies to
prevent PTD and LBW in minority populations; and, (2) to expand our
understanding of how psychosocial and environmental factors affect or interact
with the biologic mechanisms that influence pregnancy outcomes. This
solicitation strongly encourages multidisciplinary biobehavioral approaches,
defined as studies proposed by teams of scientists with the requisite
expertise from diverse disciplines (e.g., nursing, medicine, social,
behavioral, biological, health sciences, epidemiology) that reflect an
integrated framework of social and biologic phenomena.
RESEARCH OBJECTIVES
Background
Preterm delivery or short gestation (birth occurring before 37 weeks of
pregnancy), low birth weight (less than 2,500 grams) and very low birth weight
(VLBW; less than 1,500 grams), consequences of which can be profound, continue
to be major public health concerns. Despite tremendous advances in medicine
and a growing body of research on explanatory risk factors for adverse
pregnancy outcomes, the gap between whites and nonwhites in pregnancy outcomes
has widened. Black infants are more than twice as likely to die as White
infants. For example, low birth weight and very low birth weight percent of
live births are 13.1 and 3.1 percent, respectively, for Blacks or African
Americans, compared to 6.5 and 1.1 percent, respectively, for Whites (Healthly
People, 2010). Similarly, rates for American Indians and Alaska natives are
approximately 50% higher than rates for White women. Rates for Hispanic women
approximate or are slightly higher than rates for White women except for
Puerto Ricans whose rates are 50% higher than Whites (Healthy People, 2010).
Similarly, with respect to maternal mortality, Black mothers are three times
more likely to die than White mothers. In a recent study on pregnancy related
mortality from pre-eclampsia and eclampsia, it was reported that Black women
were 3.1 times more likely to die from pre-eclampsia or eclampsia than White
women. Women who had received no prenatal care had a higher risk of death from
pre-eclampsia or eclampsia than women who had received any level of prenatal
care. The overall pre-eclampsia/eclampsia case-fatality rate was 6.4 per
10,000 cases at delivery, and the rate was twice as high for Black women as
for White women.
It is well known that much of the disparity of preterm delivery and low birth
weight is associated with racial and ethnic groups living under the burden of
sub-optimal social, economic and health conditions. However, poverty, race
and ethnicity are not the only contributing factors and, in and of
themselves, do not explain the disparities in pregnancy outcomes between
Whites and non-Whites. Hypotheses centering on prenatal care, health
behaviors, teen births, poverty, education and genetics have not sufficiently
explained the causes of PTD and LBW, nor the disparities in outcomes. The
complexity of the issue is evidenced by the known variation within racial and
ethnic groups. There may be a simple difference in "dose" of the experience
or exposure to certain risk factors that leads to the poor outcome or it may
be that a combination of common and uncommon experiences in one individual
culminates in a poor outcome. There may also be an intergenerational effect
of these experiences and associated risks factors and fetal exposures to
these factors may trigger this risk in the next generation. There is most
probably a convergence of factors but these hypotheses need to be tested.
Increasingly, social stress has become the focus of much research and, at the
same time, it has become apparent that it is important to understand the
context, especially the neighborhood context, in which women at risk for poor
pregnancy outcomes live their lives. Maternal psychosocial stress, including
the stress of infection, and racially based discrimination, can be linked to
biological mechanisms that are associated with PTD. Maternal stress may
affect PTD via neuroendocrine, immune/inflammatory and vascular pathways.
Stress appears to decrease immunity thereby leaving the host susceptible to
infection. Stress-induced changes may be caused, at least in part, via
physiological mechanisms involving the autonomic nervous system and the
hypothalamic-pituitary-adrenal (HPA) axis. If the stress activation is
chronic it can then result in allostatic load or the inability to achieve
stability in the face of stress. Elements of weathering such as poverty,
racism and family functioning can lead to vulnerability prior to conception
via alterations in HPA reactivity and degradation of the immune response and
to risk factors for PTD such as elevations in corticotrophin-releasing
hormone (CRH), hypertension, pre-eclampsia, and inflammatory responses that
are associated with PTD/LBW. Clearly more research is needed on PTD and LBW
as the outcomes of chronic exposure to stressors prior to pregnancy. Stresses
in the environment vary by ethnic background and the degree of acculturation.
Potential buffers like hardiness, resilience and social support systems may
mitigate some of the effects of stress. In order to develop effective
interventions the mutability of risk factors needs to be understood.
Interventions such as increased social support and other means of increasing
the resistance of the host to the insult are important and may require
collaboration with basic scientists to understand what is immutable.
Additionally, when measuring stress, it is necessary to differentiate between
stressors and stress responses.
Another area of maternal-fetal interaction receiving much attention is
inflammation. One hypothesis is that immune hyper-responsiveness in pregnancy
can lead to inflammation and contribute to adverse pregnancy outcomes. In the
presence of a hyper-inflammatory response the mother may avoid death via
sepsis by delivering the baby early. There may be a genetic susceptibility to
maternal hyper-responsiveness carried by the mother. Additionally, women with
Syndrome X (also termed "metabolic syndrome" and defined as a clustering of
heart disease risk factors in some people including central obesity, glucose
intolerance, hyperlipidemia and high blood pressure), molar pregnancy or HIV
positive women not taking anti-viral medications may be more at risk for pre-
eclampsia. It is interesting to note that in perinatal and neonatal mortality
cases there is a higher rate of infection seen among minority populations.
Infection appears to trigger premature rupture of membrane and morbidity,
however, PTD may occur at various levels of bacterial burden and may be
influenced by cytokine polymorphisms. Infection is only part of the problem,
however, and requires further study as evidenced by the finding that when
placentas are examined post delivery, a relatively high proportion of the
cases have pathologies that are vascular in origin, not the result of
infections.
PTD and LBW contribute substantially to both infant mortality and to childhood
physical impairment. Recent evidence suggests that these impairments persist
well into adulthood. Although infant mortality in the United States has
declined steadily over the past several decades and is at a record low of 7.2
per 1,000 live births, the United States still ranks 25th in infant mortality
compared with other industrialized nations, largely due to its high PTD and
LBW rates. The strong association between LBW and preterm delivery places LBW
children at risk for neurosensory, developmental, physical, and psychological
problems. Cerebral palsy is a major neurologic abnormality in LBW occurring
much more commonly in LBW infants than their normal weight peers.
Additionally, LBW children are at risk for lower scores on intelligence tests
and developmental delay. As a group, LBW children experience more health
problems, such as asthma, upper and lower respiratory infections and ear
infections. A decade ago, the costs associated with LBW were estimated at more
than $5.4 billion, with 75% of these costs due to infant care. Approximately
10% of annual health care expenditures for children result from LBW-related
problems. As the rate of low birth weight rate increases among minority
families, associated costs will increase as well.
Although the exact causes of PTD and LBW are not known, associations with
modifiable causes have been demonstrated in the literature but the underlying
biologic mechanisms are poorly understood. These include genital tract and
oral microbial infections and inflammation, poverty, social support, stress
and its correlates, housing (i.e., physical environment such as lead paint,
safety, crowding, pollution), community resources, toxic habits including
smoking, alcohol use during pregnancy and risky behaviors and exposure to
violence. To date, interventions directed toward these risk factors have not
been effective in reducing disparities associated with PTD and LBW. More
research is needed on health behaviors including smoking, nutrition, eating
patterns and exercise. Some women report that smoking helps reduce stress but
smoking exposes them to cadmium and benzopyrene, which can have toxic
effects. Similarly, the effects of fasting on CRH levels are not known and
further research is needed on the role of micronutrients and vitamins.
Minority women are more likely to have high fat, low protein diets and little
exercise. They may have less social support, including childcare, to enable
them to take time from parenting to exercise. A group oriented, community
supported form of exercise might be a solution. Women of color are more
likely to experience unwanted pregnancies that lead to not taking proper care
of their health. As such, there is still much to be gleaned from studies
investigating the impact of behavioral influences on maternal health as it
relates to disparities in pregnancy outcomes.
Finally, the impact of cultural beliefs and practices on disparities in
pregnancy outcome is poorly understood. Although information on the nature of
these practices exists, knowledge of the mechanisms of action on pregnancy
outcome is sparse.
Disentangling the underlying psychosocial and biologic mechanisms responsible
for racial and ethnic variations in LBW and preterm delivery and eliminating
or significantly reducing this variation is an ongoing challenge to research
in this area. While race and ethnicity are clearly implicated, caution has
been urged in defining and using race as a variable, rather than as a
process. There may be a case for a relationship between health outcomes and
genes with no strong evidence to link the outcome to race. A unifying
paradigm to study minority women at risk of PTD or LBW takes into account the
environment, socio-cultural experiences or exposures, lifestyle, maternal-
fetal interactions, physiologic responses and weathering.
Research Scope
The National Institute of Nursing Research (NINR), National Institutes of
Health (NIH), convened the workgroup Optimizing Pregnancy Outcomes in
Minority Populations on March 3-4, 2003 in Bethesda, Maryland. This
workgroup brought together researchers in the fields of nursing,
epidemiology, psychology, and clinical and basic sciences in a collaborative,
multi-disciplinary approach to address this issue and formulate future
research strategies. In addition, each of
the sponsors of this PA has a strategic plan, which addresses research
related to minority health and health disparities. This is located on their
websites. For purposes of this initiative, the definitions of health
disparities and minority populations are those outlined in the NINR’s
Strategic Plan on Reducing Health Disparities located at
http://www.ninr.nih.gov. Health disparities are defined as differences in the
incidence, prevalence, mortality, and burden of diseases and other adverse
health conditions that exist among specific population groups in the US.
Specific population groups are identified as African American, Asian and
Asian Pacific Islander, Hispanic and Latino, American Indian and Alaska
Native. These groups are the target populations for this announcement.
Clinical and basic research applications that address questions pertaining to
the goals of this PA are appropriate. The following are offered as
illustrations of topics that would be appropriate for this PA. Applications
need not, however, be limited to these specific topics:
o Interventions targeting underlying health problems among minorities, e.g.,
anemia, hypertension, diabetes, infections and their relationship to
disparities in birth outcomes.
o Investigations to further identify specific stressors and associated
mechanisms related to the weathering hypothesis (e.g., poverty, racism,
family functioning), including quantifying weathering and its link to
pregnancy outcomes.
o Interventions targeting specific physiologic pathways and biochemical
markers known to be associated with poor pregnancy outcomes, including serial
measurements to ascertain critical time periods.
o Studies focused on the relationship of stressors and stress response, pre-
eclampsia, CRH, and cytokine polymorphisms in PTD and LBW.
o Investigations representing collaborations among diverse disciplines (e.g.,
basic, clinical and social scientists) focused on delineating risk and
protective factors and biological pathways utilizing interdisciplinary
theoretical and methodological approaches (e.g., What risk factors for poor
pregnancy outcomes are mutable? How are biologic phenomena impacted? What are
the biologic markers of risk?)
o Studies focused on acute and chronic stress, with special attention to
measures of stressors and stress responses including the role of antecedent
and concurrent environmental exposures as risk factors for pregnancy outcomes
(e.g., Are there familial patterns or patterns of acquired risk? Are all
stressors associated with some biologic phenomena? How are additive and
interactive effects linked with PTD and LBW?)
o Investigations to explore the relationship between metabolic syndrome and
allostatic load, in response to the stress of internalized racism, and its
impact on PTD and LBW.
o Studies to identify biomarkers in the fetus, mother, cord, and placenta
associated with disparities in pregnancy outcomes.
o Studies focused on gene/environment interactions (e.g., studies to isolate
the genetic components of hardiness/resilience in subgroups within specific
ethnic groups).
o Investigations to examine the role of nutrition and its impact on
disparities in pregnancy outcomes (e.g., fasting and its impact on CRH levels;
the role of micronutrients; the effects of culture on diet patterns and
physical activity.)
o Development and testing of interventions, including the effectiveness of
social supports, home visitation, and other approaches that mediate adverse
psychological, social, and environmental effects, and improve or prevent
microbial infections and inflammation.
o Interventions to test the impact of culturally competent preconception and
prenatal care, access to care and linkages with public health and social
services, on pregnancy outcomes.
o Investigation of the role of environmental and occupational factors (i.e.,
exposure to chemicals in the home and work environment, indoor and outdoor air
pollution, contaminants in the food supply) on disparities in pregnancy
outcomes.
o Investigation into the diagnosis, mechanisms and treatment of intrauterine
growth restriction.
o Studies focused on new or novel methodologies, conceptual models, data
analytic approaches, or the development and testing of culturally sensitive
instruments to capture psychosocial and biologic influences resulting in
disparities in PTD and LBW (e.g., lifestyle exposure, sociocultural factors,
risk factors associated with weathering, data mining techniques).
MECHANISMS OF SUPPORT
This PA will use the NIH R01 and R21 award mechanisms. As an applicant, you
will be solely responsible for planning, directing, and executing the
proposed project. The objective of the R01 mechanism is to support a
discrete, specified circumscribed project. Investigators are encouraged to
explore the feasibility of an innovative research question or approach that
will provide a basis for future research projects. Exploratory/developmental
grants (R21) are limited to 2 years of support with a combined budget for
direct costs of up $275,000 for the two-year period. For example, the
applicant may request $100,000 in the first year and $175,000 in the second
year. The request should be tailored to the needs of the project. Normally,
no more than $200,000 may be requested in any single year. Please see the
NIH-wide R21 program announcement (PA-03-107) (see
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Please see the
"Submitting an Application" section for more details.
This PA uses just-in-time concepts. It also uses the modular budgeting as
well as the non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000
or less, use the modular budget format. Otherwise follow the instructions
for non-modular budget research grant applications. This program does not
require cost sharing as defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Data and safety monitoring is required for all types of clinical trials. The
establishment of data and safety monitoring boards (DSMBs) is required for
clinical trials involving interventions that entail potential risk to the
participants.
Starting with the October 1, 2003 receipt date, 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.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two
areas: scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Yvonne Bryan, PhD
Program Director
National Institutes of Health
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-6908
Fax: (301) 480-8260
Email: [email protected]
John V. Ilekis, PhD
Health Scientist Administrator
National Institutes of Health
National Institute of Child Health and Human Development
Center for Developmental Biology and Perinatal Medicine
Pregnancy and Perinatology Branch
6100 Executive Blvd, Room 4B03C, MCS 7510
Bethesda, MD 20892-7510
Telephone: 301-435-6895
Fax: 301-496-3790
Email: [email protected]
Richard L. Mowery, Ph.D.
Chief, Clinical, Epidemiology and Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS-43F
45 Center Drive, MSC 6401
Bethesda, MD 20892-6401
Telephone: (301) 594-4848
Fax: (301) 480-8322
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Lawrence Haller
Office of Grants and Contracts Management
NIH, National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 402-1878
FAX: (301) 451-5652
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/ The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. For further assistance contact Grants Info,
Telephone (301) 710-0267, Email: [email protected].
The title and number of this PA must be typed on line 2 of the application
form and the YES box must be checked.
SUPPLEMENTARY INSTRUCTIONS
When submitting an R21 application, all instructions for the PHS 398 (rev.
5/2001) must be followed, with these exceptions:
o Research Plan
Items a - d of the Research Plan (Specific Aims, Background and Significance,
Preliminary Studies, and Research Design and Methods) may not exceed a total
of 15 pages. No preliminary data is required but may be included if it is
available. Please note that a Progress Report is not needed; competing
continuation applications for an exploratory/developmental grant will not be
accepted.
Appendix. Use the instructions for the appendix detailed in the PHS 398
except that no more than 5 manuscripts, previously accepted for publication,
may be included.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular budget grant format. The modular budget grant format simplifies the
preparation of the budget in these applications by limiting the level of
budgetary detail. Applicants request direct costs in $25,000 modules.
Section C of the research grant application instructions for the PHS 398
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular grants. Additional
information on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five 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
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will
not accept any application in response to this PA that is essentially the
same as one currently pending initial review unless the applicant withdraws
the pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an unfunded version of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned 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:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council
or board
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to evaluate application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of the following criteria in assigning
the application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The 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 be advanced? What
will be the effect of these studies on the concepts or methods that drive
this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
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.
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 criteria included in the
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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 Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting $500,000 or more in direct costs in any year of the
proposed research are expected to include a data-sharing plan in their
application. The reasonableness of the data-sharing plan or the rationale for
not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data-sharing plan into the
determination of scientific merit or priority score. The Final NIH Statement
on Sharing Research data is found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
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
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). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $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, 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.
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 -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
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 that is available at
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 proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, 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 (see 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.
PUBLIC 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 PA 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.
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). Those who must comply with the Privacy Rule (classified
under the Rule as covered entities ) must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
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.healthypeople.gov/.
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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