This Program Announcement expires on October 1, 2003 unless reissued.

DEMOGRAPHIC RESEARCH ON SEXUAL BEHAVIORS RELATED TO HIV

Release Date:  September 21, 2000

PA NUMBER:  PAS-00-136

National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov)
National Institute of Mental Health
 (http://www.nimh.nih.gov)  

THIS PROGRAM ANNOUNCEMENT REPLACES PAS-97-093

THIS PA USES THE “MODULAR GRANT” AND “JUST IN TIME” CONCEPTS.  IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

The National Institute of Child Health and Human Development (NICHD) and the 
National Institute of Mental Health (NIMH) invite qualified researchers to 
submit applications to study the demographic, social, and behavioral aspects 
of the transmission of HIV through sexual intercourse.  NICHD has a 
longstanding commitment to research focusing on sexual behavior, behavior 
change, and HIV prevention among men and women of reproductive age (including 
adolescents), and especially among vulnerable populations who live in high-
risk environments.  This program announcement describes NICHD and NIMH 
programs of behavioral research in the sexual transmission of HIV, which 
include five general areas:  (1) demographic studies of sexual behaviors 
related to HIV transmission looking at individuals of all ages; (2) studies 
of the interrelationships between social, institutional, economic, and 
cultural contexts and sexual behavior; (3) studies of the interrelationships 
among pregnancy, pregnancy prevention, and HIV prevention; (4) theoretically 
grounded intervention studies within these areas; and (5) studies of the 
appropriate methodologies for addressing sensitive issues and complex data. 

This program announcement particularly encourages studies in populations most 
vulnerable to the sexual transmission of HIV both in the U.S. and world 
wide-- minority men and women, men who have sex with men, and youth, 
especially disadvantaged youth.

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 Program Announcement 
(PA) 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 and foreign for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, and units of State and local governments, and 
eligible agencies of the Federal government.  Racial/ethnic minority 
individuals, women, and persons with disabilities are encouraged to apply as 
Principal Investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) Research Project 
Grant (R01) award mechanism.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.  

For all competing R01 applications requesting up to $250,000 per year in 
direct costs, specific application instructions have been modified to reflect 
“MODULAR GRANT” and “JUST-IN-TIME” streamlining efforts being examined by the 
NIH.  Applications that request more than $250,000 in any year must use the 
standard PHS 398 (rev. 4/98) application instructions.  Complete and detailed 
instructions and information on Modular Grant applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm. 

FUNDS AVAILABLE

The NICHD intends to commit approximately $2 million in total costs [direct 
plus Facilities and Administrative (F&A) costs] in FY 2001 to support new 
and/or competing continuation applications submitted in response to this PA.  
The NIMH intends to commit approximately $1.2 million in FY 2001 to support 
new and/or competing continuation applications submitted in response to this 
PA.  An applicant may request a project period of up to five years.  Because 
the nature and scope of the research proposed may vary, it is anticipated 
that the size of awards also will vary.  Although the financial plans of 
NICHD and NIMH provide support for this program, awards pursuant to this PA 
are contingent upon the availability of funds and the receipt of a sufficient 
number of meritorious applications.

RESEARCH OBJECTIVES

Background

Until such time as vaccines and cures for infection with the HIV virus are a 
practical reality, prevention of infection must rely upon individuals 
practicing protective behavior.  Specific sexual behaviors that reduce the 
risk of infection - such as avoiding sexual intercourse with infected 
individuals and using condoms - are influenced both by personal factors such 
as attitudes, knowledge, and abilities and by more distal factors 
characterizing the contexts in which individuals’ behaviors are carried out.  
While most behaviors that are protective have been well-defined, new 
information may require altered messages regarding risk and protective 
behaviors.  For example, recent reports have suggested that oral sexual 
practices (e.g., oral-genital receptive sex), previously considered to be 
relatively risk-free, actually may pose  risks for HIV transmission.  
Individuals on HAART [Highly Active Anti-Retroviral Therapy], whose 
infectivity may be lowered, but is not at zero, may or may not alter their 
behavior.  Social and cultural environments may predispose people to act  in 
certain ways, and may also influence how easy it is for them to change their 
behaviors or to maintain  protective behaviors.  Competing motivations for 
establishing and maintaining sexual relationships, and for pregnancy or 
pregnancy prevention, may interact with HIV prevention motives and with the 
social environment to influence behavioral outcomes.  Such motives are, in 
turn, likely to be shaped in important ways by life course experience: health 
and development; educational and economic achievement; migration; entry into 
and exit from specific social and sexual networks; marriage and marital 
dissolution; and fertility.  These personal and contextual factors can 
interact in powerful and complex ways to determine behavioral risks for HIV 
infection, responses at the individual and group level to those risks, and 
the most promising pathways to reducing risk.

Methodological advances in data collection and data analytic techniques are 
beginning to make it possible to examine in detail the contexts in which 
individuals and couples make decisions about sexual risk behaviors, and to 
understand more clearly the structural factors influencing these decisions. 
This announcement calls for research grant applications that draw on both 
innovative theory and innovative methodologies to address the general areas 
of study, described below.  The goal of this program announcement is improved 
knowledge applicable to behavioral strategies for the prevention of sexual 
transmission of HIV infection.  Research is encouraged to address these 
problems worldwide, in population concentrations and geographic areas where 
the disease has been shown to have major impact or risk of HIV infection is 
high.  Other sexually transmitted diseases and other sequelae of sexual 
behavior, as well as relevant aspects of sexual behavior itself, also may be 
used as endpoints of proposed research as long as the relationship of the 
specific research question to HIV prevention is adequately demonstrated.  

Research Scope

Research sought includes but is not limited to the following topics:

(a) Demographic Studies

Theoretically grounded, population-based studies of sexual behaviors related 
to the risk of HIV infection contribute to HIV prevention in many ways.  They 
provide essential information for identifying population groups and locations 
where sexual behaviors are increasing vulnerability to HIV infection, as well 
as where the potential for increasing infection rates may exist; they provide 
a means of monitoring trends in the prevalence of risky sexual behavior as 
well as protective behaviors within groups, and they permit the testing of 
models of the determinants of such behavior over the life course within 
population samples (that is, not samples recruited from clinics or on the 
basis of some particular personal behavior or characteristic).  For example, 
they can elucidate changes in behaviors, norms, and status that permeate a 
larger population and contribute to the characteristics, resources, and 
behaviors of those most vulnerable to HIV.  They can be used to examine 
processes that influence sexual behavior regardless of HIV risk and to 
examine how, whether, and when heightened risk, or the perception of 
heightened risk, of HIV affects those processes.  Specific topics include, 
but are not limited to:

o  Trends in HIV-related sexual behaviors and the determinants of those 
trends.

o  Studies characterizing trends in the content of information provided to 
students in the health professions, health care professionals, the public or  
members of high-risk groups about sexual practices as related to risks for 
HIV transmission.  Studies examining changes in target audience perceptions 
and understandings of messages related to the prevention of HIV transmission.

o  Population group differences in the determinants of HIV risk behaviors.

o  Impacts of changes and variations in family structure and organization on 
risk exposure.

o  Patterns of  partner selection, concurrence, retention and change, and 
their effects on risk and protection.

o  The relationship of HIV-risk sexual behavior and infection to life course 
transitions such as entering cohabitation, marriage, separation and divorce, 
and parenthood, and to changes in school enrollment, labor force 
participation, and economic status. 

o  Factors, both individual and social/structural, that predispose 
individuals to initiate sexual behaviors at an early age, which may increase 
the risk of HIV infection.
  
o  Studies evaluating changes in sexual behaviors in individuals and 
populations associated with new developments in treatment and new information 
on risk and protective behaviors (e.g., use of HAART or post-exposure 
prophylaxis). 

o  Studies of norms and values related to sexual behavior, sexual 
partnerships, and disease prevention, their variation among population groups 
and over time, and their relationship to behavioral patterns.

o  Studies focusing on the relationships between migration and HIV risk and 
prevention, both in the U.S. and elsewhere.  Anecdotal evidence suggests that 
individuals who contract HIV in cities return to homes in rural areas for 
care.  Young gay men who move to large cities may be more at risk of exposure 
to HIV.  Refugee and migrant populations may also experience heightened risk.
 
(b) Contextual Determinants of Sexual Behavior

A significant body of evidence suggests that sexual and prophylactic 
behaviors are influenced in important ways  by the contexts in which they 
occur.  Relevant dimensions of context include the social (relationships with 
partners, family, friends, and co-workers and changes in those relationships 
through migration or family disruption); institutional (legal, educational, 
economic, religious, health infrastructure); cultural (norms, values, and 
beliefs shared within and across social groups); and physical (community 
composition and resources, prevalence of disease risk, poverty and housing).  
The specification of the ways in which these aspects of context can influence 
behavior and how they interact is far from complete, and there is reason to 
believe that improved understanding of contextual influences could provide a 
powerful tool for prevention of HIV.  Studies might address questions such as 
the following:

o  The individual in the community:
	
How do individuals’ involvement in religious, social, and community 
organizations both organize their opportunities for social interaction and 
influence their sexual behaviors, in both protective and risky ways?

How do individuals’ social networks influence their sexual behavior; how does 
sexual behavior influence change and stability in social networks?  How do 
social networks moderate the impact of life course transitions – e.g., new 
jobs, divorce, moves -- on risky sexual behavior?

Do (and if so, how do) social and sexual networks overlap and what are the 
implications of this for HIV-risk behavior?

What principles and processes govern the selection of sexual partners and 
participation in sexual networks that place individuals at risk of infection 
with HIV?  There is evidence that the sexual “marketplace” varies by race, 
ethnicity, age, and location.  How does the process of partnership formation 
vary by age or maturational status, gender, sexual orientation, socioeconomic 
status, and the prevalence of HIV in the individual's community?

How do the circumstances under which sexual partnerships are formed affect 
the perceptions of HIV risk within the partnership and the behaviors that 
occur within it?  What factors influence the stability and exclusiveness of 
sexual partnerships, and how do HIV-risk behaviors vary with the duration and 
other characteristics of partnerships?

o  The community around the individual:

How do the economic, social, and institutional characteristics of the 
communities, neighborhoods, or schools in which individuals and their social 
and sexual networks are embedded influence sexual behavior?  How do families 
mediate or moderate such community influences?  

Do local policies, laws, and their implementation influence sexual risk 
behaviors?

How do norms and values -- about gender, morality, marriage, monogamy or 
appropriate sexual behavior -- develop and change within and across social 
groups?  How do such norms and values interact with other contextual and 
individual factors to influence individuals’ and couples’ sexual behavior?

How do community civic, educational, economic, and religious institutions 
influence sexual behavior?  How do the positions and teachings of 
institutions – faith communities, social organizations, government agencies, 
educational and health agencies – influence community norms regarding sexual 
behavior and influence the messages to be given to particular audiences, 
especially youth?  Does institutional support for, opposition to, or conflict 
concerning appropriate messages and prevention strategies have an impact on 
patterns of sexual risk-taking in the community?

What factors, if any, affect the influence of institutionally supported norms 
and teaching on HIV risk behaviors, in adults as well as youth?

(c)  Integrating Pregnancy and HIV Prevention

Most heterosexual individuals who have sexual intercourse desire to protect 
themselves from unwanted pregnancy most of the time.  At the same time, 
almost all individuals all of the time wish to avoid infection with HIV.  
However, many of the medical methods available for pregnancy protection do 
not provide protection from HIV and other diseases.  Condoms, male and 
female, which are more effective at disease prevention, may not protect as 
well against pregnancy as do some of the hormonal methods.  Research is 
sought that examines the inter-relationships among individuals’ and couples’ 
desires for pregnancy, pregnancy prevention, and avoidance of the risk of 
infection with HIV, and the effects of these interactions upon behavior.  
Examples of questions relevant to this topic include:

o  How do individuals at risk of HIV infection balance pregnancy prevention 
and disease prevention in making decisions about sexual behavior and the 
introduction and use of methods to prevent pregnancy and/or disease?

o  How do the duration and intimacy of the partnership influence the 
partners’ communication, negotiation, and decisions concerning issues of 
pregnancy, pregnancy and disease prevention, and the use of risk reduction 
methods and strategies?  Does this vary over the life course?

o  How do individuals’ estimations and abilities to accurately estimate risks 
-- their own and their partners’ for pregnancy and HIV -- influence their use 
of protection?  How do knowledge and beliefs concerning their own or their 
partner’s serostatus affect use of protection from pregnancy and HIV?

o  How does perception concerning the efficacy of various prevention methods 
for pregnancy and disease prevention affect the ultimate use of such 
protection?

o  How does actual, objective, epidemiological risk of exposure to disease 
and to pregnancy affect individuals’ use of  protection from unwanted 
pregnancy and from disease?

(d) Intervention Studies

Innovative intervention studies are needed to build on the basic science 
findings concerning HIV-risk behavior and behavior change.  Designing, 
implementing, and evaluating interventions which utilize mediating variables 
such as, for example, improving the ways in which social/sexual networks 
support risk-reduction strategies, improving the local institutions’ 
influences on community norms concerning safer sex, or engaging relevant 
agencies in intervention work, with the goal of enabling individuals to 
change or modify risky behavior, are appropriate topics for research 
proposals.  Understanding of local issues is critical to the successful 
implementation of such  interventions.  Accordingly, interventions are 
encouraged which involve extant local organizations in design, 
implementation, and replication of the project.  Such proposals may target 
any population vulnerable to HIV and may include consideration of co-morbid 
conditions such as other STDs.  This PA particularly encourages studies of 
populations most vulnerable to the sexual transmission of HIV, both in the 
U.S. and world wide-- minority men and women, men who have sex with men, and 
youth, especially, disadvantaged youth.  Questions of particular interest 
include, but are not limited to:
 
o  How can the social context in which individuals live -- their social 
networks, communities, schools, homes, work environment -- be taken into 
consideration when designing and implementing interventions? How can the 
influence exerted by elements of the social, institutional, and cultural 
contexts be harnessed in the development of more effective interventions?

o  How can HIV-related behavior change interventions be improved to take 
account of individuals’ potentially competing concerns about  pregnancy and 
disease prevention?  Given the need to combine condom (or other barrier) use 
with hormonal contraception or sterilization to achieve the highest levels of 
protection against both pregnancy and disease among at-risk sexually active 
heterosexual  people (and the challenges inherent in such work), what 
strategies may be most effective under what conditions? 

(e)  Methodological Studies

Demographic, social, and behavioral studies of HIV risk and prevention 
continue to pose significant methodological challenges.  Studies that examine 
the influence of context require the articulation of complex designs 
involving multiple levels of analysis and multiple layers of measurement.  
Community-level intervention efforts require innovative strategies for 
evaluation.  Biases in self-reports of sensitive personal behaviors remain a 
serious concern in basic and intervention research on sexual behaviors.  
Methodological research is invited that addresses issues in design, data 
collection, measurement, and analysis related to the topics addressed in this 
announcement.  Illustrative topics include:
 
o  Cross-cutting approaches to link data collected in large population 
samples with samples selected based on high-risk behaviors.

o  Extending and improving techniques for measurement accuracy and data 
collection in studies of HIV-related sexual behavior, including the use of 
computer-assisted methods and the development and integration of appropriate 
biological endpoints or other markers of behavioral risk.

o  Defining and standardizing appropriate models and analytic methods for 
examining sexual behavior in the context of a couple, and in relation to 
networks and the larger social context.

o  Improving methodologies to design non-biased but cost-effective network 
studies.

o  Developing and refining outcome measures and indicators appropriate for 
the evaluation of policy changes, prevention interventions, and the societal 
impact of HIV.

Research Designs and Data Sources

The utilization of existing data is strongly encouraged for its 
cost-efficiency whenever scientific goals can be met by its use. There is a 
wide range of such data collected in the U.S. and available for research 
purposes.  Information concerning these data sets is available on the web at:  
http://www.nichd.nih.gov/about/cpr/dbs/resources.htm.  Each data set has its 
particular strengths and weaknesses, which the investigator must understand 
and deal with.  Such resources include, but are not limited to, the various 
rounds of the National Survey of Family Growth, the National Survey of 
Adolescent Males, the National Survey of Men, the National Longitudinal Study 
of Adolescent Health, the National Health and Social Life Survey, the Chicago 
Health and Social Life Survey, and data made available through the 
Sociometrics STD/HIV archive.  Researchers may be aware of, and have access 
to, other data that are appropriate for answering the HIV/AIDS behavior 
questions they wish to pose.  Data collected in or from other countries can 
provide powerful resources for addressing many of the research questions in 
this announcement.

New data collection is justifiable if existing data are not appropriate to 
the aim of the study.  In such cases, scientific sampling procedures are 
highly desirable to ensure that sample biases do not vitiate the research 
objectives.  Prior contact with the program staff named under INQUIRIES, 
below, is strongly encouraged for any applicant considering such an effort.  
Applicants proposing new data collection are encouraged to make their data 
available for use by other researchers and should outline plans for 
accomplishing this in the application.

Applicants proposing research that draws on social scientific approaches that 
have not been widely applied to research on HIV-related sexual behavior are 
particularly encouraged to apply. Mixed methods which include both 
qualitative and quantitative components are especially welcomed.  As noted 
recently by an Institute of Medicine workshop, “Assessing the Social and 
Behavioral Science Base for HIV/AIDS Prevention and Intervention,” improved 
strategies for behavioral intervention will require broader perspectives than 
have been applied in the past.  Collaborations involving anthropologists, 
historians, economics, sociologists, political scientists, epidemiologists, 
and psychologists may be needed to advance theoretical and methodological 
approaches to HIV prevention. Therefore, applicants are encouraged to 
consider research designs that are innovative, integrative of multiple 
perspectives, and utilize, as appropriate, a range of methods and analytic 
techniques.

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 are 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 or 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 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 also may 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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 
(revised 4/98) and will be accepted at the standard application deadlines for 
AIDS and AIDS-related applications, as indicated in the application kit.  
These forms are available at most institutional offices of sponsored 
research, on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the 
Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301-435-0714, E-mail:  grantsinfo@nih.gov. 

Applicants planning to submit an investigator-initiated new (Type 1), 
competing continuation (Type 2), competing supplement (Type 3), or any 
amended/revised version of the preceding grant application types requesting 
$500,000 or more in direct costs for any year are advised that they must 
contact the NIH program staff before submitting the application, i.e., as 
plans for the study are being developed.  Furthermore, the applicant must 
obtain agreement from NIH staff that the institute will accept the 
application for consideration for award.  Finally, the applicant must 
identify, in a cover letter sent with the application, the staff member who 
agreed to accept assignment of the application. 

This policy requires an applicant to obtain agreement for acceptance of both 
any such application and any such subsequent amendment.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998, at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

Any application subject to this policy that does not contain the required 
information in a cover letter sent with the application will be returned to 
the applicant without review.

Modular Grant Application Instructions 

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers, and NIH 
staff.  The research grant application form PHS 398 (revised 4/98) is to be 
used in applying for these grants, with the modifications noted below.

Applications will request direct costs in $25,000 modules, up to a total 
direct cost request of $250,000 per year. (Applications that request more 
than $250,000 direct costs in any year must follow the traditional PHS 398 
application instructions.)  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative (F&A) costs] for the initial 
budget period.  Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD:  Do not complete Form Page 
4 of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT:  Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page.  (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.)  At the top of the page, enter the Total Direct Costs 
requested for each year.  This is not a Form Page.

Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of Total Costs (Direct 
plus F & A) for each year, each rounded to the nearest $1,000.  List the 
individuals/organizations with whom consortium or contractual arrangements 
have been made, the percent effort of key personnel, and the role on the 
project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is 
included in the overall requested modular direct cost amount.  Include the 
Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH:  The Biographical Sketch provides information used by 
reviewers in the assessment of each individual’s qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the Form Page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST:  This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied 
in the calculation of the F&A costs for the initial budget period and all 
future budget years.

o  The applicant should provide the name and telephone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review.

Submission Instructions

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application including the 
Checklist, and five signed photocopies, in one package, to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH 
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the NIH 
Center for Scientific Review (CSR). Applications will be assigned on the 
basis of established PHS referral guidelines.  Applications will be evaluated 
for scientific and technical merit by an appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures.  As part 
of the initial merit review, all applications will receive a written critique 
and undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of applications under 
review, will be discussed, assigned a priority score, and receive a second 
level review by the appropriate national advisory council or board. 

Review Criteria

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

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

(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 experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

In addition to the above criteria, in accordance with NIH policy, all 
applications also will 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 also will 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 humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications. The following will be considered in making funding decisions:  
Merit of the proposed project as determined by peer review, availability of 
funds, and program priorities.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding NICHD-related programmatic issues to:

Susan Newcomer, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B7, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6981
FAX:  301-496-0962
Email:  Snewcomer@nih.gov

Direct inquiries regarding NICHD-related fiscal matters to:

Michael Loewe
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  301-402-0915
Email:  loewem@nih.gov

Direct inquiries regarding NIMH-related programmatic issues to:

Willo Pequegnat, Ph.D.
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6205, MSC 9619
Bethesda, MD 20892-9619
Telephone:  (301) 443-6100
FAX:  (301) 443-9719
Email:  wpequegn@nih.gov

Direct inquiries regarding NIMH-related fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.864 (Population Research) and 93.121 and 93.242 (NIMH).  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 the intergovernmental review requirements of Executive 
Order 12372, or to Health Systems Agency review.

The PHS strongly encourages all grant and contract 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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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