and Human Services (HHS)
EXPIRED
PARTNERSHIPS FOR HIV/AIDS RESEARCH IN AFRICAN POPULATIONS
Release Date: November 6, 2001
RFA: RFA-HD-02-003
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov)
National Institute of Mental Health
(http://www.nimh.nih.gov)
National Center for Complementary and Alternative Medicine
(http://nccam.nih.gov/)
Fogarty International Center
(http://www.nih.gov/fic/)
Letter of Intent Receipt Date: March 19, 2002
Application Receipt Date: April 16, 2002
PURPOSE
The National Institute of Child Health and Human Development (NICHD), the
National Institute of Mental Health (NIMH), the National Center for
Complementary and Alternative Medicine (NCCAM), and the Fogarty International
Center (FIC) invite applications for resource-related grants in support of
behavioral and social science research relevant to the critical and expanding
prevention and care needs of women, children, and families affected by
HIV/AIDS in Africa. The unprecedented and accelerating HIV/AIDS epidemic in
Africa, particularly among women and young people, requires focused,
intensified, innovative, multi-disciplinary, and culturally relevant research
activity that is responsive to local African needs, challenges, priorities,
and realities.
A primary goal of this Request for Applications (RFA) is to encourage
partnerships between skilled African investigators and U.S. and/or other
developed country investigators that will result in the increased capacity
and capability of the African scientific community to conduct rigorous
HIV/AIDS-related behavioral and social science research. These partnerships
are intended to support the strengthening of the research capability and
capacity of African investigator(s), research team(s), and/or institution(s).
African scientists and clinical researchers are encouraged strongly to apply
as the Principal Investigators and/or to assume other leadership roles in the
proposed studies. Grants may be awarded to Principal Investigators from the
United States, other developed countries, or from countries in Africa,
particularly those that have been most affected by the HIV epidemic.
This RFA encourages projects designed to: (1) develop research
infrastructure and strengthen the capacity of African institutions and
investigators to conduct relevant HIV/AIDS research; (2) establish and/or
enhance linkages among local in-country investigators, public health
officials, community institutions, and health care providers, including
traditional health practitioners; and (3) support relevant developmental
and/or exploratory studies. It is anticipated that such research projects
will contribute to the field as well as enhance the ability of African
investigators to compete successfully for HIV/AIDS-related funding under
other research grant mechanisms.
For the purposes of this RFA, infrastructure development and capacity-
strengthening refer to the enhancement of resources (including laboratory,
field support, training, administration, ethical review and oversight, sample
storage and management, instrument design and data collection, data
management and analysis, information exchange and dissemination, and other
resources) that are needed by investigators to pursue research independently
and to compete successfully for research funding.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of Healthy People 2010, a PHS-
led national activity for setting priority areas. This RFA is related to one
or more of the priority areas. Potential applicants may obtain Healthy
People 2010 at http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic or foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Faith-based organizations are eligible
to apply for these grants. Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as Principal Investigators.
Applications from U.S. or other developed country scientists and institutions
must demonstrate a strong commitment to and record of partnership involving
African scientists in Africa and African institutions. Principal
Investigators from the U.S. or other developed nations are required to
partner with investigators from Africa. Principal Investigators from Africa
are eligible to apply on their own but are strongly encouraged to submit an
application in partnership with investigators from the U.S. or other
developed countries.
Eligible applications must demonstrate a linkage between the applicant
research institution and in-country African clinical, community-based or
other public health organizations, and institutions that provide preventive
services, care and/or support to the populations that are the focus of the
research effort. The goal of this linkage should be to facilitate the use of
research findings directly to improve or expand HIV/AIDS prevention, care or
management programs in Africa.
This program is designed to complement other NIH programs focused on global
HIV/AIDS research and research training, such as the Fogarty International
Center’s AIDS International Training and Research Program (AITRP).
Investigators from applicant institutions that are applying for a
Comprehensive International Program of Research on AIDS (CIPRA) grant
(http://www.niaid.nih.gov/daids/cipra;
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-01-018.html)
from the National Institute of Allergy and Infectious Diseases
(NIAID) must demonstrate that their applications in response to this RFA do
not overlap with (though they may be complementary to) their institution’s
CIPRA application. Applicants should make clear all levels of involvement
and provide scientific justification if investigators or other staff proposed
for this RFA are also proposed for involvement on a CIPRA application.
Potential applicants are strongly encouraged to contact staff listed under
INQUIRIES, below, to discuss eligibility prior to submission of an
application.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) resource-related
research project grant (R24) award mechanism. Responsibility for the
planning, direction, and execution of the proposed project will be solely
that of the applicant. This RFA is a one-time solicitation. The anticipated
award date is September 30, 2002.
FUNDS AVAILABLE
The NICHD intends to commit approximately $2 million in total costs [Direct
plus Facilities and Administrative (F&A) cost] in FY 2002. The NIMH intends
to commit approximately $300,000 and the NCCAM intends to commit
approximately $500,000 in total costs in FY 2002 to fund or partially fund
grants relevant to their missions in response to this RFA. The FIC intends
to commit approximately $200,000 in total costs in FY 2002, with the highest
priority accorded to proposals that link to existing FIC training and
capacity building programs (e.g., AITRP, the International Maternal and Child
Health Research Training program, etc.). It is anticipated that available
funds will support up to 10 grants in response to this RFA. An applicant may
request a project period of up to five years and a budget for total costs of
up to $300,000 in the first year. Incremental increases for direct costs may
not exceed three percent in each subsequent year.
It is expected that a majority of the direct costs requested will be used in
Africa. Applicants should request support appropriate to the size and impact
of their scientific portfolio and to the goals and justified needs of their
infrastructure development and capacity-building program. Because the
nature and scope of the research proposed may vary, it is anticipated that
the size of each award also will vary. Although the financial plans of the
NICHD and the other co-sponsors provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds and the
receipt of a sufficient number of meritorious applications.
RESEARCH OBJECTIVES
Background
In Africa, HIV/AIDS affects entire populations, societies, and countries with
enormous and tragic consequences at the national, community, family, and
individual level. More than 25 million adults and children are living with
HIV/AIDS in sub-Saharan Africa, where the access to care is severely limited.
In 16 African countries, more than 10 percent of the population in the 15-49
year old age group is HIV-infected. Overall, in sub-Saharan Africa, where
the mode of transmission is overwhelmingly heterosexual, 55 percent of HIV-
positive adults are women, with many at risk of transmitting the virus to
their infants. Twelve to 13 African women are currently infected for every
10 African men. AIDS is now the leading cause of mortality in this region
where 2.4 million people died from the disease in 2000 and over 17 million
people have died since the beginning of the epidemic. By the end of 2000, an
estimated 3.8 million adults and children were newly infected with HIV, and
millions of Africans infected in earlier years are experiencing ill health.
More than 90 percent of the 11 million children worldwide who have lost one
or both parents to AIDS are African children. It is estimated that by 2010,
AIDS will account for 68.4 percent of parental deaths leading to orphaning--
an increase from 16.4 percent in 1990. Because the large majority of AIDS-
orphans are HIV-negative, it is estimated that the total number of children
orphaned by AIDS will continue to grow through at least 2020. The cumulative
impact of HIV/AIDS-related death and illness has radically diminished the
expected life spans of the African population, and has created unprecedented
challenges in coping with the effects of the epidemic for African orphans,
other survivors, families, care providers, communities, and countries.
There is increasing recognition worldwide that AIDS-related activities and
support must be expanded dramatically to address the epidemic in Africa.
There is also growing recognition that the appropriate implementation of
effective prevention, care, and treatment strategies must be informed by a
clear understanding of African contexts. This understanding can evolve from
research into the social, cultural, and behavioral milieu within which the
HIV epidemic is occurring in Africa. To expand understanding of these
contextual issues, research is needed that is designed to address conditions
specific to African experiences. Moreover, research infrastructure
development and capacity-strengthening activities are urgently needed to
support research efforts that can inform and foster the development of
realistic and sustainable African solutions to the HIV challenges in African
populations.
Prevention efforts face significant challenges in all countries. In many
African countries, adoption of effective prevention strategies by individuals
and by institutions remains low and unprotected sex between men and women
continues, contributing to increasing rates of heterosexual transmission of
HIV and other sexually transmitted infections. Family systems and lack of
autonomy often reduce a woman’s ability to introduce protective measures or
to refuse sex with a possibly infected partner. As is the case in many
countries, women and girls are sometimes forced into sex work for economic
reasons. School and community-based sex education efforts are too few and
are often started too late in parts of Africa. Yet improved understanding by
the general population of the route of transmission of HIV and how to stop it
is critical to interrupt the cycle of disease transmission from one
generation to the next.
Around the world, women are most often responsible for the health and health
care of all family members. In addition, women in Africa often are expected
to undertake other productive household and communal labor and activities,
the loss of which, during serious illness, may have long-term and disastrous
consequences for the social, economic, physical, and psychological well-being
of the household. The care-giving role of women includes not only husbands,
children, or other immediate family members, but also may extend to the care
of children of other relatives or neighbors, who become orphans when one or
both parents have died from AIDS.
Investigators undertaking research in response to this RFA should be mindful
of the efforts by more than 20 African countries to develop and implement
strategic plans on the national and community levels to address the HIV/AIDS-
related challenges and problems in their respective countries. Research
efforts should support the achievement of objectives included in these plans,
to the greatest degree possible. It is understood that research priorities
and goals will differ depending on the African country, region, and
population groups that are the focus of the resource projects or studies
proposed.
Objectives and Scope
Research Infrastructure Development and Capacity-Strengthening:
Applications may request funds to strengthen the research infrastructure of
African institutions to enhance the capability of African investigators to
undertake rigorous behavioral and social science research in relation to
HIV/AIDS prevention, care, and management problems and issues in African
populations. These grants should provide capacity-strengthening support that
will enhance the competitiveness of African institutions, organizations, and
scientists in future efforts to obtain research support. As a result of this
program, it is anticipated that the African investigators involved in these
grants will emerge as recognized African leaders in the fields of behavioral,
social, biomedical, and traditional medicine research related to HIV/AIDS.
All infrastructure development and capacity-strengthening requests must
relate to the general goals of the research program.
Research Projects:
Proposed studies under this program must address problems and issues
considered of urgent scientific and public health importance by the African
scientific and health care communities. Recommendations that emerged at the
March 2001 Botswana Consultation to Explore a Research Agenda to Improve the
Care and Management of Mothers and Children Affected by HIV in Africa may
suggest relevant areas of need and concern (see Consultation report under
clinical conferences at http://www.NICHDnetwork-PACTG.org). These
recommendations include behavioral, cultural, social, psychosocial, and
institutional factors that are thought to have an impact on prevention, care
and management, child development, nutrition, and reproductive health in
relation to HIV/AIDS in Africa. Although the focus of the Botswana
Consultation was primarily on the improvement of HIV/AIDS care and
management, the participants concluded that care and prevention of HIV are
interconnected. They noted that the provision of treatment, care, and
illness management options often is one key to effective prevention
activities.
Research questions of interest may focus on social, cultural, psychosocial,
and biological factors that have an impact on nutrition status of HIV-
affected women and children; stigma associated with all aspects of HIV/AIDS;
gender inequities and their impact on prevention, health-seeking behavior,
care, treatment, and diagnosis of HIV-infected individuals and their
families. Research may also address the impact of HIV/AIDS on families,
including child development and family structure; types of traditional health
practices applied to HIV/AIDS prevention and treatment; role and/or impact of
traditional healers/practices in the prevention and/or treatment of HIV/AIDS;
models of HIV/AIDS care integration between traditional healers and Western
trained physicians; and biomedical and behavioral studies of the role of
reproductive health on the risk of HIV and related diseases.
Each of these grants will also support a portfolio of relevant and innovative
research, optimally to be conducted with the leadership and involvement of
African scientists in Africa, in partnership with scientists in the U.S.
and/or other developed countries. Applicants may concentrate on any
combination of relevant topics that are broadly described below. Each
application should propose one to three developmental or exploratory projects
that will contribute to the knowledge base required to address the HIV/AIDS
epidemic in Africa. It is envisioned that the developmental projects funded
under this RFA may have the potential to be developed into larger-scale
research proposals that might lead to funding under other grant programs
through the NIH or other funding sources. The research projects described in
the application should be designed to take advantage of the infrastructure
development and capacity-building activities also proposed for funding.
Potential areas for research, often interrelated and overlapping, are
described below. Illustrative, but not exhaustive, examples of possible
research questions can be found at
http://www.nichd.nih.gov/RFA/HD-02-003/HD-02-003.htm.
1. Behavioral, Cultural, Social, and Psychosocial Factors that Influence
HIV/AIDS Prevention, Care and Management.
Preventing HIV transmission, encouraging acceptance of care, and providing
care and treatment in Africa involve the development of locally sustainable,
effective interventions, designed for or adapted to the unique needs and
conditions of specific populations and communities, and the understanding of
behavioral, cultural, social, economic, and institutional factors that
influence individual and community actions. In Africa, such behavior must be
seen in the context of individual, family, and community resources, including
the limited availability of health care and services. Research is needed to
increase understanding of gender inequities and their relation to prevention,
health care-seeking behavior, and care of HIV-infected individuals and their
families. Gender-based customs, beliefs, and behaviors in different African
settings influence all aspects of prevention and health care, including a
woman’s risk of HIV acquisition and the subsequent provision of support and
care for her and her children who are affected and/or infected by HIV/AIDS.
Women often are expected to follow traditional health practices and to use
only health care resources available through such practices. The role of
African men in relation to HIV/AIDS prevention, care, and treatment in
families requires more attention. Efforts to reach and educate men about
their own sexual health and that of their partners need to be increased.
Raising awareness of their risk can change certain of these behaviors. There
is a need for behavioral interventions that reach men, as well as women, if
women and other family members are to be protected and to obtain the care
they need.
2. The Role and Impact of Traditional Health Practitioners and Practices
Traditional health practitioners in Africa provide preventive, curative,
psychological, palliative, and spiritual help and support in many
communities. The care and support provided may be based on different
concepts of health and illness than those of the biomedical model.
Traditional health practitioners also play a prominent role in shaping and
promulgating public opinion and practice in their communities. Because they
often function outside the context of conventional scientific endeavor or
rely on different evidence for decision-making, imposition of standards and
practices derived from outside cultures might be problematic. A better
understanding of decision-making paradigms of traditional health
practitioners might contribute to their more effective involvement in HIV
prevention and care. Research is needed to understand a) the efficacy and
safety of traditional practices in the prevention and treatment of HIV/AIDS,
their effect on HIV viral load and on opportunistic infections, and their
impact on patients quality of life; b) how effective traditional practices
could be integrated in current public health efforts, and c) the influence of
traditional practices and practitioners on issues related to stigma,
prevention, and HIV/AIDS care.
3. The Impact of HIV/AIDS on Child Health and Development in Africa
The HIV/AIDS epidemic is creating an unprecedented threat to children’s
health, well-being, and development in Africa, yet there is little research
available to guide response and intervention. Of concern are the well-being
and development of children who are HIV-infected as well as those who are
uninfected, but may be living in AIDS-affected families. Little is known
about the consequences of HIV/AIDS and its treatment for child development.
The effects of AIDS-related morbidity and mortality on children’s
vulnerability and development begin well before a parent dies, and are not
limited to effects on children who themselves are HIV-infected. Deepening
poverty leads to withdrawal from schooling, food insecurity, reduced access
to health services, and worsening material resources. Children are pressed
into caring for ill and dying parents and earning income for the family,
becoming the de facto head of household at unknown cost to their development.
Girls, in particular, are pressured into sex to earn favors or income for the
family, thereby increasing their risk of HIV-exposure.
The psychosocial and economic problems related to the loss of parental and
family support at a young age may be further compounded by the stigma of
HIV/AIDS and the impact of the pandemic on the community and extended family.
Once orphaned, children may find themselves living with caregivers too old or
too young (including child heads of household) and without the means to
provide for them. They may also be abused, exploited or abandoned by
relatives charged with caring for them. They may be unable to obtain health
care for themselves. This RFA encourages research to increase knowledge and
understanding of the long-term effects of the HIV/AIDS epidemic on African
children’s health, development, and access to education and training, among
both uninfected and infected children.
4. Understanding Stigma and its Influence on HIV/AIDS Prevention, Care, and
Management
Countries like Senegal and Uganda have demonstrated that the growth of the
AIDS epidemic can be reduced through effective prevention efforts and multi-
sector initiatives, including schools,
faith-based organizations, and health facilities, to address the problems.
In these countries, the topic of HIV/AIDS has been brought more into the
open, reducing the stigma associated with the disease, and enabling progress
related to prevention, treatment, and care. This RFA encourages research
that would contribute to an understanding of the role and causes of HIV/AIDS-
related stigma in Africa, and its influence on all aspects of HIV/AIDS
prevention, care, and management. Studies are encouraged that would evaluate
strategies and interventions to reduce stigma associated with the use of
prevention, such as increasing and expanding the use of voluntary counseling
and testing, undertaking child-feeding approaches that do not conform to the
social norm, and the use of antiretroviral therapy and other effective
treatment strategies.
5. Factors Affecting the Availability and Acquisition of a Healthy Diet for
HIV-Affected People
The interaction of HIV infection and AIDS with nutritional status and dietary
behavior 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, the HIV epidemic has been superimposed on a
preexisting and longstanding background of extensive malnutrition, both in
terms of macronutrient malnutrition, i.e., marasmus and kwashiorkor, and the
hidden hunger of micronutrient deficiencies. Most of the research
attention related to nutrition and HIV has been focused on the impact of the
disease on metabolism and, in particular, the AIDS wasting syndrome. Less
attention has been paid to the identification of factors that limit the
access to and acquisition of a healthful diet as part of the prevention,
care, and management of HIV/AIDS-infected and -affected individuals,
particularly in Africa. Furthermore, 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 metabolic effects of HIV infection on the growth of
infected children, little data exist about the impact of HIV on the access to
and availability of food, the development of healthful food/eating behaviors,
or related social factors relevant to growth and development in HIV-infected
and -affected children. Behavioral and social factors related to
breastfeeding and the impact of breastfeeding on infants and mothers also are
critical areas for additional research. A better understanding of the social
and cultural factors that underlie the acquisition of a nutritionally well-
balanced and safe diet is essential to support the role of diet in the care
and treatment of HIV-infected and -affected women, infants, and children in
Africa.
6. The Role of Reproductive Health in the Acquisition, Prevention,
Progression, and Treatment of HIV
There are many issues associated with the reproductive health of women in
Africa that may have an impact on HIV disease acquisition, transmission, and
progression. For example, women are at increased risk of sexually
transmitted infections (STIs) for biological as well as social and cultural
reasons. There appears to be a linkage between certain STIs and increased
risk of HIV. Likewise, use of hormonal contraceptives may place women at
increased risk of disease acquisition. Certain culturally-condoned sexual
practices may also increase the risk of infection. Women who are HIV positive
are less fecund, which may cause family problems. In addition, although
pregnancy appears to have no adverse effect on disease progression in HIV-
infected women in the U.S., little is known about the effect in developing
countries. The highest rate of transmission to African women reportedly
occurs within the first few months following delivery. Short inter-birth
intervals and the sequelae of abortion may facilitate disease transmission as
well. In the U.S., epidemiological cohorts have been established to
understand the impact of reproductive health status of HIV-infected and
uninfected women, but few cohorts have been established in Africa. Research
is needed to better understand the effect of HIV on reproductive health
behavior of at-risk adolescent girls and women in Africa and, conversely, how
the status of women’s reproductive health influences HIV acquisition and
transmission. The initial focus of such research in response to this RFA
should be on social and behavioral factors.
SPECIAL REQUIREMENTS
Minimum Application Requirements
o Each application should include three components: (1) a description,
including justification, of the infrastructure development and capacity-
strengthening support requested and the activities proposed; (2) a
description of the local linkages and international partnerships to be
established or enhanced; and (3) a description of one to three developmental
research projects that will be conducted.
o The application must clearly demonstrate how the infrastructure
development and capacity-strengthening support requested will be used to
enhance the research project(s) proposed.
o The application must also include a statement of long-term research
objectives and a description of how the research and infrastructure
components of the application will contribute to the achievement of these
long-term objectives.
o The proposed Principal Investigator must commit to spending at least 25
percent effort annually on the award over the entire period of support, with
a significant effort expended in Africa engaged in project implementation and
oversight of the appropriate use of resources on the project.
o The research component of the grant should not exceed 50 percent of the
total costs.
Allowable Costs
The participating NIH co-sponsors recognize that the applicant institutions
in Africa may require different types and levels of research infrastructure
development and capacity-building support depending on the particular
research needs, activities, and initiatives proposed in the application. The
NIH also allows (beginning October 1, 2001) foreign and international
organizations to request facilities and administrative (F&A) costs up to
eight percent of total direct costs, less equipment. Also, domestic
organizations that submit applications with a foreign or international
consortium, may request eight percent of total direct costs, less equipment,
for the consortium. Information about the allowability of F&A costs for
foreign and international organizations is available in the NIH Guide for
Grants and Contracts at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html.
Areas considered as infrastructure development and capacity-strengthening
support include those listed above under PURPOSE: recruitment, training and
retention of staff, statistical and other relevant consultations, data
management, and collaborations with other institutions. In this regard,
funds may be requested for the following:
o Salary support for trainers/educators and trainees, based on level of
effort and institutional salary commitments, for individuals involved in the
project, including research technicians and assistants and staff from local
non-governmental organizations, who may also be trainees.
o Laboratory or research facility enhancement directly required for the
implementation of the proposed research. Enhancement may include improvement
of existing facilities, but support for de novo construction is not allowed.
o Project-specific equipment and supplies, including computing and
electronic communications hardware and software.
o Acquisition of reference and other library materials, or electronic access
to such materials, related to the research effort.
o Information dissemination and diffusion of research results through modern
technology to ensure wide distribution of findings among relevant end-users.
o Support for planning, implementing, and evaluating mechanisms, including
specialized training, to ensure effective ongoing, sustainable research
programs and retention of skilled investigators and other technical staff.
Areas for which research-related support may be requested include, but are
not limited to, the following:
o Salary support for African and other scientists, clinicians, and technical
staff to enhance their capability to conduct research linked to the goals of
this project and future research, including training in the use of locally
appropriate and transferable research tools, techniques, and methods.
o Research subject costs and support for informing subjects participating in
the research about the results.
o Field site support and field site visit costs.
o Data acquisition, data management, and statistical analysis costs,
including scientific and statistical consultation, as well as the costs of
making data available to others.
o Well-justified travel to scientific meetings for the Principal Investigator
and other research staff to present findings from the studies.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
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 biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are 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 research involving human subjects should read the
UPDATED NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research, published in the NIH Guide for Grants and Contracts on
August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The
revisions relate to NIH-defined Phase III clinical trials and require: a)
all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH 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, published in the NIH Guide for Grants and
Contracts, March 6, 1998, and available on the Internet at:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
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. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
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 RFA 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.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should read the
policy that was published in the NIH Guide for Grants an Contracts, June 5,
2000 (Revised August 25, 2000), available at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other key personnel
and participating institutions, and the number and title of this RFA.
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NICHD staff to estimate the potential review workload and
plan the review.
The letter of intent is to be sent to Mr. F. Gray Handley at the address
listed under INQUIRIES, below, by March 19, 2002.
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev. 5/2001)
available at http://grants.nih.gov/grants/funding/phs398/phs398.html must be
used in applying for these grants. This version of the PHS 398 is available
in an interactive, searchable format. For further assistance contact
GrantsInfo, Telephone 301/710-0267, Email: [email protected].
Application Instructions
Instructions accompanying the research grant application form PHS 398 (rev.
5/2001), including page limitations, are to be used in applying for these
grants, with the modifications described below:
The application in response to this RFA should also contain the following:
1) Infrastructure Development, Capacity-Strengthening, and Linkages Plan (25
page limit)
o Identification of gaps and needs that can be met through this grant award
o Specific goals
o Proposed activities to be undertaken to develop and strengthen the
research infrastructure of the African institution and the capacity and
capability of the African investigators to conduct the research
o Description of institutional commitment to provide additional or matching
support for the proposed infrastructure development and staff capacity
building, including contributions from FIC training and capacity building
programs
o Description of the partnership between the African investigator and the
U.S. and/or other developed country partner(s) to strengthen infrastructure
and capacity building
o Description of any relevant linkages that are to be developed or
strengthened among the researchers, public health officials, health care
providers, non-governmental agencies and community organizations
o Description of equipment, space, and other resources available to support
the infrastructure development and capacity-strengthening plan and extent to
which enhancement of these resources is needed
o Detailed budget (application not to be submitted in modular format)
2) Research Project Plan (10 page limit for Sections a d for each proposed
research project)
For each proposed research project, in addition to the requirements outlined
in PHS 398, address:
o Linkages to overall infrastructure development and capacity-strengthening
plan
o Identification of unmet needs in African populations or community(ies)
that can be addressed through the proposed research project
o Relevant recent past or ongoing research activity
o Plan for dissemination of research results and their application in an
appropriate program or intervention
o Detailed budget for each proposed project
For the purpose of this RFA, key personnel is defined as follows: All
personnel involved in each application, regardless of whether salary support
is requested. Names of all personnel should be included in the application
with their specific responsibilities in support of the infrastructure
development, capacity-strengthening, and research effort outlined and with
their percent time and effort specified. Alphabetized biographical sketches
for all personnel should follow the budget justifications.
Submission Instructions
The RFA label available in the PHS 398 (rev. 5/2001) application form must be
affixed to the bottom of the face page of the application. Type the RFA
number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review. In addition, the RFA title and number must be typed on
line 2 of the face page of the application form and the YES box must be
marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed, photocopies, in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application should be
sent to:
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Applications must be received by April 16, 2002. If an application is
received after that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA 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 substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
for responsiveness by the NICHD and the other participating Institutes and
Centers. Incomplete and/or non-responsive applications will be returned to
the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NICHD in accordance with the review criteria stated below.
As part of the initial merit review, all applications will receive a written
critique and may undergo a process in which only those applications deemed to
have the highest scientific merit, generally the top half of the applications
under review, will be discussed, assigned a priority score, and receive a
second level review by the appropriate National Advisory Council.
Review Criteria
The following criteria will be used to evaluate the overall merit of each
application:
o Quality of the scientific program and its impact on the field, including
the significance, innovation, and quality of the current and recent
contributions of program scientists in the areas of HIV/AIDS research
relevant to the scope of this RFA.
o Quality and potential impact of proposed infrastructure development and
capacity-strengthening program, including overall quality, scientific merit,
and innovation of the activities to be supported. Consideration will be
given to the likelihood that, based on the existing capabilities, resources
and activities, the proposed program will enhance behavioral and social
science HIV/AIDS-related research in Africa, promote new research directions,
foster on-going research partnerships, facilitate interactions across
disciplines, and advance knowledge that will contribute to the improvement of
prevention, care, and management services.
o Research competence of key personnel, including the capability and
scientific credentials of the Principal Investigator to direct the program
and to maintain high standards of research collaboration, as well as the
scientific and technical accomplishments of all participating investigators
and individuals engaged in capacity-building.
o Adequacy of plans and procedures for monitoring expenditures at both the
African and non-African sites engaged in research.
o Institutional commitment and research environment of the applicant
institution and any cooperating institutions, including contributions from
FIC training and capacity building programs. Institutional commitment will
be evaluated relative to the institutional context. Reviewers will consider
the existing academic and physical environment as it relates to research
opportunities, space, equipment, and the potential to conduct the proposed
collaborations and research through the appropriate use and application of
proposed resources to develop research infrastructure and enhance staff
research skills and capabilities.
o Institutional partnerships, linkages, and collaborations, including
overall plans to establish and/or enhance linkages between the research
investigators/institutions and the local public health community,
nongovernmental organizations, and other sectors. Consideration will be
given to the quality of the plans for collaboration and the likelihood that
the research findings will be used to improve prevention, care and management
services. Consideration will also be given to the applicant’s demonstrated
commitment to and record of partnership involving African investigators and
institutions and U.S. and/or other developed country scientists and
institutions. Please note that applications submitted by African
investigators and institutions without developed country partners are
eligible for consideration.
o Sustainability of the proposed infrastructure development and capacity-
strengthening elements, including the extent to which they will enable the
African scientists and institutions to conduct the proposed research as well
as to improve and enhance their ability to conduct, over time, quality
behavioral, social science, and biomedical research in the area of HIV/AIDS.
o Demonstrated awareness of the ethical and cultural issues and concerns
related to the conduct of HIV/AIDS research within developing countries,
especially focused on the African site(s) proposed in the application.
The following criteria will be used to evaluate the merit of individual
research projects:
The goals of NIH-supported research are to advance our understanding of
biological systems and behavioral and social factors that improve the control
of disease and enhance health. In the written comments, reviewers will
consider 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. Each of these criteria will be addressed and
considered in assigning the overall score, weighting them as appropriate for
each application. Note that 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 the field forward.
(1) 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? To what extent will the research findings
contribute to improvement of HIV prevention, care, and management services in
Africa? To what extent will the findings likely be transferable into program
interventions appropriate to and sustainable in Africa?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, multi-disciplinary and collaborative,
and appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics? Are the plans to
guarantee the quality and integrity of collected data adequate?
(3) 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?
(4) 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)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed studies take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of prior successful scientific
collaboration involving the U.S. (or other developed country) investigators
and the involved African researchers? Is there evidence of foreign and U.S.
(or other developed country) institutional support, e.g., letters of support
and other documentation of commitment?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for human, animals or the
environment, to the extent they may be adversely affected by the project(s)
proposed in the application.
SCHEDULE
Letter of Intent Receipt Date: March 19, 2002
Application Receipt Date: April 16, 2002
Peer Review Date: June/July 2002
Council Review: September 2002
Earliest Anticipated Start Date: September 30, 2002
AWARD CRITERIA
Criteria that will be used to make award decisions include:
o scientific and technical merit (as determined by peer review)
o responsiveness to the goals and objectives of the RFA including the intent
to foster African research leadership
o program balance, relevance, and priorities
o geographic distribution
o availability of funds.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or answer questions from potential applicants is welcome. A complete
listing of contacts for programmatic, review, and fiscal/administrative
inquiries may be found at:
http://www.nichd.nih.gov/RFA/HD-02-003/contact.htm.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance Nos.
93.865 and 93.864 (NICHD), 93.242 (NIMH), 93.213 (NCCAM), and 93.154 (FIC).
Awards are made under authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284) and administered under NIH
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
This program is not subject to intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-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
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||