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 301/435-0714, Email: GrantsInfo@nih.gov.

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.


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