ALCOHOL ABUSE AND HIV/AIDS IN RESOURCE-POOR SOCIETIES

RELEASE DATE:  January 14, 2003
 
RFA: AA-03-009
 
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov/)

LETTER OF INTENT RECEIPT DATE: March 25, 2003

APPLICATION RECEIPT DATE: April 25, 2003
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA  

The National Institute on Alcohol Abuse and Alcoholism seeks 
applications for international, cross-disciplinary research on 
HIV/AIDS, other blood-borne infections [i.e., hepatitis B virus (HBV), 
and hepatitis C virus (HCV)], tuberculosis (TB), and comorbid 
conditions and consequences in alcohol abusing and dependent 
individuals, their sexual partners, and their children.  This RFA is 
intended to build on lessons learned in developed countries in response 
to the interrelated epidemics of alcohol and HIV/AIDS and other 
infectious diseases.  It seeks to foster cross-national and 
international research collaborations that, through both independent 
research and the recruitment, training, and mentoring of new, multi-
disciplinary researchers, lead to the development, adaptation, 
replication, and evaluation of effective interventions and approaches 
to slow or reverse the spread of HIV and other infections in vulnerable 
heavy drinking populations.

Epidemiologic studies on the dynamics of alcohol abuse and HIV 
demonstrate a continual need to reach new and emerging risk groups in 
diverse geographic settings with effective prevention interventions.  
Data from the WHO indicate that while alcohol consumption is declining 
in most of the developed countries, it is rising in many resource-poor 
countries and the countries of Central and Eastern Europe.  Males do 
most of the drinking in these countries, and evidence available 
regarding patterns of drinking suggests that heavy drinking is 
prevalent in these countries.  The contribution of alcohol to the 
global burden of disease is significant and growing in some regions, to 
the point that in parts of Central and Eastern Europe, alcohol use is 
contributing to an unprecedented decline in male life expectancy.  
These same parts of the world have seen significant increases in rates 
of HIV infection over recent years, and there is growing evidence that 
escalating rates of alcohol abuse and HIV infection are closely 
related. For example, while the epidemic in sub-Saharan Africa, home of 
two-thirds (23.3 million) of the 33.6 million people in the world 
living with HIV/AIDS in 1999, has been largely driven by heterosexual 
transmission, there, as elsewhere, alcohol use is becoming increasingly 
important as rates of alcohol use continue to rise.

It is well known that alcohol use increases the risk of exposure to HIV 
through its association with high risk sexual and substance abuse 
behaviors.  However, there is also growing evidence that alcohol 
consumption may play an important role in susceptibility to infection 
and the progression of HIV disease.  This latter includes the 
occurrence and course of comorbid conditions such as HCV and TB. 
Research also suggests that alcohol use has important influences on 
adherence to medications and provider advice, provider and patient 
attitudes towards treatment, and survival. Challenges for cross-
national and international HIV research efforts lie in the diversity of 
risk groups and communities of alcohol users; the rapidly changing 
alcohol, Alcohol- and sex-related risk profiles of susceptible 
populations; the variability in global alcohol use patterns; the 
complex interactions among behavioral, ethnic/racial, sociocultural, 
environmental, and biomedical factors that influence the initiation and 
progression of alcohol abuse and the spread of HIV and other 
infections; and the differences among resource-abundant and resource-
poor countries as to their understanding of the interrelationship of 
alcohol abuse and HIV, their public health knowledge and experience, 
and their capacities to respond with durable, effective measures to 
contain the epidemic.

This RFA will support cross-national and international 
multidisciplinary research on the intersection of alcohol consumption 
and the HIV epidemic. Investigators representing a broad array of 
academic disciplines and engaged in cross-cutting fields of science are 
encouraged to consider designing hypotheses-driven studies that utilize 
rigorous methodologies from epidemiological, biomedical and behavioral 
research traditions.  Special emphasis areas include:  the prevention 
and treatment of HIV and other blood-borne infections in sexually 
active populations of alcohol users; the clinical course and 
consequences of HIV and related health conditions in diverse 
communities of alcohol users, their sexual partners, and their 
children; the causes and consequences of differences in HIV-associated 
risks, morbidity, and mortality between men and women, adults and 
adolescents, and majority and minority populations who consume alcohol 
at various levels; and the design, development, and evaluation of 
behavioral and biomedical prevention measures to reduce the impact of 
alcohol use and sex-related risk behaviors on the primary and secondary 
transmission of  HIV and other infectious diseases.  Community-level 
interventions which address related social and health policy issues 
(e.g., alcohol outlet density, alcohol taxation policies, prevention 
and treatment service distribution) are also of interest.  

Researchers are encouraged to utilize integrative, multi-method 
approaches in their study designs. Examples of newer technologies which 
may be employed include but are not limited to geospatial coding of 
alcohol-related events and alcohol prevention and treatment resources 
and medical informatics systems with the capacity to integrate multiple 
clinical databases.  

Established researchers are urged to recruit new, domestic and foreign 
researchers to work on their projects, to provide training and 
mentoring to help achieve their project's specific aims, and to nurture 
the career development and independence of new researchers with 
potential to enrich the multiple disciplines involved in preventing HIV 
and other infections in high-risk alcohol-using populations.

RESEARCH OBJECTIVES
 
BACKGROUND

Alcohol consumption and its consequences together with HIV/AIDS are 
major public health burdens in many parts of the world. Chronic abusive 
alcohol use can lead to life threatening organ system damage. Light to 
moderate consumption can induce behavioral and organ system changes 
which may influence HIV transmission, pathogenesis, and disease 
progression.  There is an overlap between persons at risk for alcohol-
related problems and individuals at risk for HIV infection. Regardless 
of the level consumed, alcohol is likely to influence the health status 
of persons infected with HIV and those whose behaviors place them at 
risk for acquiring the virus.

In addition to being a risk factor in the contraction and progression 
of HIV disease, alcohol misuse affects adherence to complex HIV 
medication regimens and to physician advice. Recent evidence has 
indicated interactive effects of alcohol use and HIV infection on brain 
functioning and cognitive processes. Whether alcohol consumption 
increases susceptibility to opportunistic infections in HIV+ patients 
and whether alcohol-induced immunosuppression affects pathogenesis and 
disease progression are important questions. However, carrying out 
research on the effects of alcohol consumption and drinking behaviors 
on HIV-related health outcomes is challenging. While clinical findings 
have associated increased levels of chronic alcohol consumption with 
diminished immune function, as evidenced by reduced levels of CD4 and 
CD8 activity, many questions about the relationship between alcohol 
consumption, increased susceptibility to HIV infection, and accelerated 
progression to AIDS remain unanswered. Strain variations of HIV, 
individual differences in susceptibility, long incubation time 
following seroconversion, and varying patterns of adherence to HIV 
medications are only some of the challenges in studying disease 
progression. Comorbid mental and somatic illnesses and environmental 
stress are additional confounding factors, each of which may vary in 
its impact across cultures and subcultures. 

Cumulative research on alcohol and HIV/AIDS has shown that reductions 
in alcohol consumption are associated with declining incidence in HIV 
and other blood-borne infections in at-risk populations. Despite the 
significant advances that have been made, however, HIV and other 
infectious diseases continue to spread among alcohol-using populations 
in the U.S. and worldwide.  The cumulative evidence from research on 
prevention and treatment programs for alcohol use disorders shows that 
no single approach is sufficient to avert new HIV and other infections 
in all alcohol users and their sexual partners.  Research gaps remain 
in a number of key areas, including but not limited to: our 
understanding of the epidemiology of risks for HIV/AIDS in alcohol-
using populations and others at risk; the clinical course and 
consequences of HIV and co-occurring infections associated with 
continual risky alcohol use and sexual practices; the individual (e.g., 
age, gender, race/ethnicity) and environmental (e.g., social, economic, 
cultural) factors that influence attitudes, beliefs, and behaviors 
related to alcohol use and risky sex; and the impact of alcohol abuse, 
HIV/AIDS, and related infectious diseases on diverse community 
populations throughout the world. It is therefore of continuing 
importance to conduct cross-national and international research which 
seeks to clarify the role of alcohol in HIV transmission and disease 
progression, and to develop and test comprehensive, cost-effective 
preventive interventions which both reduce the risk of alcohol-related 
HIV transmission and improve the treatment of HIV infected alcohol 
abusing and/or alcohol dependent individuals.

Areas of Research Focus
 
This initiative will support cross-national and international research 
that includes but is not limited to the following interrelated areas: 

1)  Adaptation, replication, and evaluation of community-based 
prevention interventions to reduce risk behaviors and avert incident 
HIV and other infections in high-risk populations.  This includes 
studies of the effectiveness of such interventions and their 
adaptability and diffusion to societies and cultures different from 
those in which they were originally developed. 

2)  Comparative effectiveness and sustainability of prevention and 
treatment interventions among alcohol-abusing populations in diverse 
international settings, including studies of environmental factors 
affecting availability,  access and adherence to multiple types of 
behavioral and therapeutic interventions, the development of improved, 
accessible clinical management approaches, and research on models for 
facilitating cooperation among research and service professionals in 
international settings. Studies examining community-level interventions 
which address related social and health policy issues (e.g., alcohol 
outlet density, alcohol taxation policies, prevention and treatment 
service distribution, etc.) are of particular interest.

3)  Comparative studies of the single and combined components of 
various prevention/ intervention strategies and services among alcohol-
using men and women and their sexual partners in diverse international 
settings, including studies of their differential impacts on the 
incidence, prevalence, and transmission of HIV and other blood-borne 
infections, their cost-effectiveness, and the nature and extent of 
their linkages to other social, health, and medical services.

4)  Studies which identify and evaluate outcome measures and data 
collection systems appropriate to the evaluation of research-based HIV 
prevention interventions for reducing alcohol-related HIV exposure 
implemented in international settings.

5)  Research on the integration of alcohol treatment services with 
other medical services provided to AIDS patients.  This includes 
studies of access to alcoholism treatment services, outcomes and cost 
effectiveness of integrated treatment, organizational configurations 
that best facilitate the delivery of combined services, and cross 
training of both addiction and other medical care specialists to 
increase competence in delivering combined care.

6)  Studies of the translation of research findings into improved 
clinical practice for HIV patients.  Especially relevant are studies of 
the international diffusion and cross-cultural adaptation of improved 
treatment practices.

7)  Development of innovative, comprehensive interventions to improve 
access to and delivery of HIV vaccines, antiretroviral and other 
therapeutic agents, routine screening services for sexually transmitted 
diseases (STDs), and HIV testing and counseling services to alcohol-
using populations.

8)  Bioethical considerations in research methodologies, and in the 
design and implementation of culturally appropriate, available, and 
affordable prevention interventions for alcohol use and HIV risk, 
including counseling and testing services, medical care, and alcohol 
treatment services to men and women with alcohol abuse/dependence, 
their sexual partners, and their children infected with HIV and other 
infectious diseases.

9)  Risk-factor epidemiology of HIV and co-occurring blood-borne 
infections in alcohol-using men and women, in their sexual partners, 
and in their children.  

10)  Behavioral dynamics and alcohol use-related processes associated 
with the acquisition and transmission of HIV and other infections, 
including individual, social, environmental, cultural, economic, 
gender-based, and other factors which influence alcohol-related risk 
behaviors.

11)  Socioeconomic and demographic characteristics, sexual and alcohol-
using behaviors, health care utilization and treatment seeking, HIV 
virologic and immunologic status, and the health and medical 
consequences of HIV and other blood-borne infections in alcohol-using 
populations.

12) Virologic, immunologic, genetic, and alcohol use factors and the 
mechanisms by which they may influence susceptibility, recovery and 
persistence, and progression of HIV and other diseases in alcohol-using 
men and women, in their sexual partners, and in their children. 
13  Research on the characteristics of community-based organizations 
and coalitions most likely to be successful in implementing effective 
science-based interventions for reducing alcohol-related HIV exposure 
in at-risk communities.

MECHANISM OF SUPPORT
 
This RFA will use NIH (NIH) Exploratory/Developmental Grant (R21) award 
mechanism.  As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.  This RFA is a 
one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-
initiated applications and will be reviewed according to the customary 
peer review procedures.  The anticipated award date is September 29, 
2003. 

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting format. (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).   
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.

FUNDS AVAILABLE 
 
The NIAAA intends to commit approximately $2 million in FY 2003 to fund 
8 to 16 new and/or competitive continuation grants in response to this 
RFA. An applicant may request a project period of up to 3 years and a 
budget for direct costs of up to $250,000 per year. Because the nature 
and scope of the proposed research will vary from application to 
application, it is anticipated that the size and duration of each award 
will also vary. Although the financial plans of the NIAAA 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. 

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based or community-based organizations
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.   

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
three areas:  scientific/research, peer review, and financial or grants 
management issues:

o Direct your questions about scientific/research issues to:

Michael Hilton, Ph.D.
Office of Collaborative Research 
National Institute on Alcohol Abuse and Alcoholism
Willco Bldg, Suite 302
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 402-9402
FAX: (301) 443-480-2358
Email: mhilton@niaaa.nih.gov

o Direct your questions about peer review issues to:

Eugene Hayunga, Ph.D.
Chief, Scientific Review Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Bldg, Suite 409
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-4375
FAX: (301) 443-6077

o Direct your questions about financial or grants management matters 
to:

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
Telephone: 301-443-2434
FAX: 301- 443-0788
Email: jfox@willco.niaaa.nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:
 
- Descriptive title of the proposed research
- Name, address, and telephone number of the Principal Investigator
- Names of other key personnel
- Participating institutions
- 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 NIAAA staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

RFA-AA-03-009
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Willco Bldg, Suite 409
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-4375
FAX: (301) 443-6077

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular grants.  Additional
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: 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.
 
SENDING AN APPLICATION TO THE NIH: 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 
must be sent to:

RFA-AA-03-009
Extramural Project Review Branch
Office of Scientific Affairs 
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard, Room 409, MSC 7003 
Bethesda, MD 20892-7003 
Rockville, MD 20852 (for express/courier service) 

APPLICATION PROCESSING: Applications must be received by the 
application receipt date listed in the heading of this RFA.  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.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NIAAA. 

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 NIAAA in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Receive a written critique
o 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 and assigned a priority score
o Receive a second level review by the NIAAA National Advisory Council. 
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your 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, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  What will be the effect of these studies on the concepts or 
methods that drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 
technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

o INCLUSION:  The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data. 

o BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: March 25, 2003
Application Receipt Date: April 25, 2003
Peer Review Date: June-July 2003
Council Review:  September 17, 2003
Earliest Anticipated Start Date:  September 29, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research 
components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy 
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health of 
the subjects or the purpose of the research. This policy results from 
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_
2001.htm.   The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  
NIH policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom of 
Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, Internet 
addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the 
Internet sites.   Furthermore, we caution reviewers that their anonymity 
may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.273 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children.  This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.

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