NUTRITION AND THE DEVELOPMENT, TREATMENT, AND PREVENTION OF HIV DISEASE IN
WOMEN, INFANTS, AND CHILDREN
RELEASE DATE: August 11, 2003
PA NUMBER: PA-03-163
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 R03 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for All R01 Applications: July 15, 2006 unless reissued.
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Institute of Child Health and Human Development (NICHD) invites
new and experienced basic scientists, epidemiologists, and clinical
investigators to submit research grant applications to further understanding
of the relationship between nutrition and HIV. Applications are encouraged
that address preclinical or clinical, biomedical and/or behavioral research
that concentrates on studies of: (1) nutritional factors and HIV
transmission; (2) nutritional requirements for optimal growth, development,
and maintenance of health; (3) impact of HIV infection on breastfeeding; (4)
interactions between antiretroviral therapies, diet, nutrition and health;
(5) nutritional assessment methodologies; and (6) specific functional
biomarkers of outcome related to the nutrition/HIV relationship.
This announcement is intended to stimulate and strengthen a multidisciplinary
approach to a complex, under-researched area and to form a basis for future
research.
RESEARCH OBJECTIVES
Background
The interaction of HIV infection and AIDS with nutritional status has been a
distinguishing characteristic of the disease course since the earliest days
of the epidemic. In many areas of the developing world, particularly sub-
Saharan Africa where HIV infection is endemic, concomitant malnutrition both
in terms of macronutrient malnutrition, i.e., marasmus and kwashiorkor, and
the "hidden hunger" of micronutrient deficiencies is also prevalent.
In the early days before the infectious agent was identified, AIDS was
referred to as "slim disease" to reflect the characteristic wasting syndrome
associated with the natural history of HIV/AIDS and related diseases. In
reference to the nutrition and HIV relationship, most of the research
attention has been focused on the impact of the disease on metabolism and, in
particular, the AIDS wasting syndrome. Little attention has been paid to the
potential role of nutrition in relation to the infectivity of the virus
(nutrition-viral interaction), transmission of the virus (nutrition-host
interaction), HIV pathogenesis and disease progression, resistance to
opportunistic infections, or the efficacy of available interventions.
Further, much of the evidence that does exist with regard to either the
metabolic consequences of HIV infection or the potential role of diet or
specific nutrients in the course of HIV infection is limited to data
collected from adult patients. Although some data exist about the
deleterious effect of HIV infection on the growth of infected children,
little data exist about the role of nutrition in either mother-to-child
transmission, subsequent sequelae of the disease or response to treatment in
infants or children.
In assessing the diet/disease relationship, four general approaches are
available: measurement of dietary intake, anthropometric assessment,
assessment of biochemical indices of nutrient status, or direct nutritional
intervention. The use of one of these approaches to the exclusion of the
others to explore the nutrition and HIV relationship is problematic for the
following reasons:
1. It is difficult to make any inferences about biochemical indices without
knowing an individual's dietary intake.
2. Given the metabolic consequences of HIV disease and its treatment, e.g.,
the effect of antiretroviral (ARV) therapy on body composition, reliance on
anthropometry in the absence of information about diet and/or nutritional
biochemistry will result in potential invalid conclusions about HIV and
nutrition per se.
3. Aberrant circulating levels of a particular nutrient may be due to
inadequate intake or an inherent biochemical problem associated either
directly with HIV infection or in response to HIV-related opportunistic
infections (OI).
4. Without knowing the pre-supplementation status of an individual, it is
difficult to distinguish between the elimination of dietary deficiency and
the correction of an inherent nutritional anomaly associated with either HIV
infection or concomitant OI.
5. It is necessary to use the appropriate biochemical or physiological
biomarker to distinguish between these latter two contingencies, to avoid
drawing invalid or inaccurate conclusions concerning the role of essential
nutrients in HIV infection.
Research Scope
This PA encourages research using appropriate combinations of available
nutritional assessment methodologies to address any of the issues listed
below. The following are examples of topics that might be proposed for study
in response to this announcement. However, these are only examples and are
not meant to be limiting.
o Nutritional/dietary factors affecting maternal to child transmission of HIV
infection;
o Nutrient requirements of HIV-infected infants and children for optimal
growth, development, and maintenance of health;
o Impact of HIV infection on breastfeeding, to include changes in maternal
nutritional requirements before and during lactation, changes in milk
composition consequent to HIV infection, impact of suboptimal nutritional
status on lactation in HIV-infected women, differences between children
infected in utero or perinatally and those infected during breastfeeding in
terms of health outcomes;
o Potential interactions among ARV therapies, diet, nutrition and health
including: (a) Potential impact of nutritional status on efficacy of
interventions including ARV in women and children; and (b) potential impact
of ARV on nutritional status of HIV-infected women, infants, and children;
o Impact of sub-optimal nutritional status on health of HIV-infected women of
reproductive age;
o Potential interactions among nutritional status, "traditional medicine,"
and/or ARV;
o Surveillance of at-risk populations: Part of the difficulty in extracting
the role that nutrition might play in the course of HIV infection is that
once the infection is established, it has its own metabolic consequences.
Therefore, pre-infection data are needed in high-risk populations as well as
comparative data by age and sex for demographically similar, uninfected
children. Such data sets should include an appreciation of current dietary
intake patterns utilizing available food composition data for indigenous
foods.
Applications that include proposals for the development of nutritional
assessment methodologies and specific functional biomarkers of outcome
related to the nutrition/HIV relationship are encouraged, as are proposals
that employ methods that could be effectively deployed in field settings in
resource-poor environments.
MECHANISM OF SUPPORT
This PA will use the NIH Research Project Grant (R01) and Small Grant (R03)
award mechanisms. As an applicant you will be solely responsible for
planning, directing, and executing the proposed project.
For information on the new NIH Small Grant Research Program (PA-03-108) see
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html.
The R01 should be used for full-scale research projects. The R03 mechanism
is appropriate for small research projects that can be carried out in a short
period of time with limited resources (total annual direct costs of up to
$50,000 per year for up to two years). Examples of such projects include
pilot or feasibility studies; secondary analysis of existing data; small,
self-contained research projects; development of research methodology; or
development of new research technology.
This PA uses just-in-time concepts. It also uses the modular 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 format. Otherwise follow the instructions for non-
modular 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 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
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 his/her institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Jack Moye, Jr., MD
Pediatric, Adolescent and Maternal AIDS Branch
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-7350
FAX: (301) 496-8678
Email: moyej@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5482
FAX: (301) 402-0915
Email: mc113b@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular grant format. The modular 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:
Contact the IC program staff at least six 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 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 eight weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate R01 applications for
scientific and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
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 second level review by the appropriate national advisory council
or board.
REVIEW CRITERIA
The following criteria will be applied to both R01 and R03 applications.
However, the NIH R03 small grant is a mechanism for supporting discrete,
well-defined projects that realistically can be expected to be completed in
two years and that require limited levels of funding. Because the research
plan is restricted to 10 pages, a small grant application will not have the
same level of detail or extensive discussion found in an R01 application.
Accordingly, reviewers should evaluate the conceptual framework and general
approach to the problem, placing 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 from investigator-generated data.
Preliminary data are not required, particularly in applications proposing
pilot or feasibility studies.
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 discuss the following
aspects of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning the application's overall score, weighting them as appropriate
for each application. 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:
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.)
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.)
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
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
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN 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.
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.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
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