This Program Announcement expires on June 1, 2004, unless reissued.

BEHAVIORAL, SOCIAL, MENTAL HEALTH, AND SUBSTANCE ABUSE RESEARCH WITH 
DIVERSE POPULATIONS

Release Date:  May 21, 2001  

PA NUMBER:  PA-01-096  (Reissued as PA-06-218)

National Institute of Mental Health
 (http://www.nimh.nih.gov/)
National Institute on Drug Abuse
 (http://www.nida.nih.gov/)
National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov/)
Office of Behavioral and Social Sciences Research
 (http://obssr.od.nih.gov/)
Office of Research on Women"s Health
 (http://www4.od.nih.gov/orwh/)

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS PA INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.

PURPOSE

The National Institutes of Health (NIH) is committed to supporting research 
that will increase scientific understanding of the health status of various 
population groups and lead to more effective health interventions and 
services for individuals within those groups.  High priority is placed on 
research with groups that appear to have distinctive health risk profiles but 
thus far have received insufficient attention from investigators.  This 
Program Announcement (PA) highlights a particular set of such groups: 
lesbian, gay, bisexual, transgendered, and related populations (designated 
here as LGBT populations).  

The National Institute of Mental Health (NIMH), National Institute on Drug 
Abuse (NIDA), and National Institute of Child Health and Human Development 
(NICHD) invite submission of grant applications for behavioral, social, 
mental health, and substance abuse research with LGBT populations.  The 
Office of Behavioral and Social Sciences Research (OBSSR) joins this PA as 
part of its effort to promote research on the behavioral and social aspects 
of health and illness, and the Office of Research on Women"s Health (ORWH) 
joins this PA as part of its effort to promote research that will lead to 
improved health for women.  However, only NIMH, NIDA, and NICHD will provide 
direct grant support under this PA.
 
Studies relevant to the missions of the three sponsoring Institutes may be 
proposed within the areas of basic, clinical, intervention, practice, and 
services research.  Projects should make use of the most rigorous current 
methodologies and, where needed, engage in development and evaluation of new 
methodologies.  

This PA was developed in response to recommendations produced at a workshop 
on “New Approaches to Research on Sexual Orientation, Mental Health, and 
Substance Abuse,” which took place on September 27-28, 1999, under the co-
sponsorship of NIMH, NIDA, OBSSR, and ORWH.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This PA, LGBT Populations: 
Behavioral, Social, Mental Health, and Substance Abuse Research, is related 
to the priority areas of Mental Health and Mental Disorders and of Substance 
Abuse.  Potential applicants may obtain a copy of "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, 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.  The 
total project period for an application submitted in response to this PA may 
not exceed 5 years.

Specific application instructions have been modified to reflect “MODULAR 
GRANT” and “JUST-IN-TIME” streamlining efforts being examined by the NIH.  
Complete and detailed information on modular grant applications can be found 
at: http://grants.nih.gov/grants/funding/modular/modular.htm.  

Potential applicants interested in other award mechanisms are strongly 
encouraged to consult with program staff at the appropriate Institute or 
Office listed under INQUIRIES below. 

RESEARCH OBJECTIVES

Background

The primary focus of this program announcement is behavioral, social, mental 
health, and substance abuse research with lesbian, gay, bisexual, 
transgendered, and related populations.  These populations may be 
characterized as encompassing 2 broad, partially overlapping clusters:

o  People whose sexual orientation--as manifested in behaviors, attractions, 
cognitions, or identity--is directed towards the same gender or both genders.  
This cluster includes, but is not limited to, individuals who describe 
themselves by terms such as lesbian, gay, and bisexual.

o  People whose gender-related identity, roles, expression, or behavior or 
whose reproductive system structure or function are atypical or nonconforming 
to conventional standards.  This cluster includes, among others, people who 
are transgendered, transsexual, crossdressing, and intersexed.
  
Following recent usage, the term LGBT is adopted here as a general 
designation for these diverse populations as well as for individuals within 
these populations.  However, grant applicants may adopt other classification 
frameworks and terminologies as appropriate for their proposed research.

Current scientific evidence clearly indicates that the majority of LGBT 
people do not suffer from clinical disorders.  However, recent data from both 
national health surveys and targeted studies suggest that prevalence rates of 
affective disorders, tobacco addiction, alcohol abuse, certain forms of drug 
abuse, and possibly other dysfunctions are higher for LGBT populations (or 
particular segments of those populations) than for the general population.  
The data also suggest that LGBTs are more likely than the general population 
to seek mental health and substance abuse services.  But LGBT clients may 
often fail to receive appropriate and effective services, because many 
service providers have limited knowledge of or experience in working with 
LGBTs.

Further research is required to clarify the nature, extent, and determinants 
of mental disorder and substance abuse among LGBTs.  Also needed is research 
that will lead to improved forms of prevention, treatment, counseling, and 
service delivery for LGBTs.

Most LGBT people are exposed to negative stereotyping and other forms of 
stigmatization, and many also experience overt discrimination, harassment, 
threats of violence, and actual violence.  Even when not leading to clinical 
disorder or involving bodily injury, these stressful conditions often produce 
significant psychological discomfort, and may, some evidence suggests, be 
associated with physical health problems.  For some LGBT people, these 
conditions may also have the effect of restricting opportunities and progress 
in social, educational, and occupational domains.

LGBTs adopt various behavioral and psychological strategies in response to 
stigmatization and hostility.  These strategies range from concealment and 
inhibition to elaboration of a public identity organized around LGBT status.  
Such strategies can have multiple consequences, both positive and negative, 
for the LGBT person’s mental and physical health and subsequent development, 
and may affect the well-being of others in the person’s family and social 
environment as well.   

Further research is needed to better understand how stressful conditions 
arise in the various contexts of LGBT people’s daily lives and how LGBTs 
interpret and react to these conditions.  Such work must carefully consider 
the social and cultural structures that LGBTs participate in and are exposed 
to.  Research in this area can guide the development of individual-, group-, 
and community-level interventions to reduce the occurrence and adverse 
impacts of threats directed toward LGBTs.  The research may also lead to new 
insights into how people who face stigmatization due to LGBT status (and 
perhaps other characteristics) can develop and maintain successful coping 
processes and constructive forms of identity and behavior.
 
In other research areas as well, LGBT populations present behavioral and 
social scientists with opportunities for developing new hypotheses, models, 
and approaches.  Considerations of the ways in which LGBTs depart from or 
conform to conventional standards of sexuality and gender, and of how their 
behaviors and relationships are constrained by current legal and 
institutional arrangements, can lead to novel perspectives in such areas as: 
psychological development and individual differences across the lifespan, 
dynamics of interpersonal relationships, family structure and function, 
organization and influences of subcultures, demographic patterns, and health-
related behaviors.  Findings from studies of LGBTs in these areas are likely 
to have significant implications for general theory and research on 
behavioral and social processes.  They may also suggest new directions for 
research on mental health and substance abuse in both LGBTs and non-LGBTs.

It is important to recognize that LGBT people are highly diverse, varying not 
only in their specific sexual orientation and gender-related characteristics 
but also on many other dimensions, including: age, generational cohort, 
geography, ethnicity/race, culture, family structure, language, socioeconomic 
class, education, occupation, and physical and mental capacities.  All such 
variations are potentially relevant for the planning, conduct, and 
interpretation of behavioral, social, mental health, and substance abuse 
research.  Thus, LGBT samples (as well as any non-LGBT comparison samples) 
should be carefully selected and described, attempts to generalize to other 
segments of LGBT populations or to other groups should be undertaken 
cautiously, and methods should be designed and implemented in ways that are 
scientifically and ethically appropriate for all participants.  It is often 
useful for researchers to consult with knowledgeable members of the 
particular population groups being investigated, such consultants can provide 
valuable assistance in framing research issues, designing studies, 
interpreting results, and ensuring that instruments and procedures are 
sensitive to the experiences and concerns of the participants.

Although this PA refers to LGBT populations broadly, it is appropriate (and 
often preferable) for investigators to focus on one or a few well-defined 
segments of those populations.  For some topics, studies designed around 
comparisons among specific LGBT groups are useful.  It is not required that 
all studies engage in comparisons of LGBT with non-LGBT samples.

Research is invited in the areas described below.  Specific topics and 
questions may be formulated at the biological, psychological, social, and 
cultural levels.  Studies may employ experimental, observational, survey, 
clinical, ethnographic, epidemiologic, demographic, modeling, and related 
methods, as well as methods for ethical, policy, and institutional analysis.  
While the primary domain is LGBTs in the United States, research with non-
U.S. populations is acceptable if the work promises to contribute to 
scientific understanding of LGBTs in the U.S.

Investigators are also referred to other NIH program announcements that 
address issues related to gender and sexuality, including:  PA-00-074, 
Women"s Mental Health and Gender Differences Research 
(http://grants.nih.gov/grants/guide/pa-files/PA-00-074.html), PA-00-071, 
Affiliative Behaviors and HIV/STD Prevention 
(http://grants.nih.gov/grants/guide/pa-files/PA-00-071.html), and, PAS-00-
136, Demographic Research on Sexual Behaviors Related to HIV 
(http://grants.nih.gov/grants/guide/pa-files/PAS-00-136.html).  Other NIH 
program announcements and requests for applications can be found in the NIH 
Guide for Grants and Contracts at:  
http://grants.nih.gov/grants/guide/index.html. 

Basic Research

Basic research on the behavioral and social characteristics of LGBT people at 
all stages of the lifespan is invited.  Research may also address non-LGBTs 
who are members of LGBT persons" families, households, and communities or who 
otherwise have contact with or influence upon LGBTs.  Examples of basic 
research include, but are not limited to:   

o  Studies of the nature and development of sexual orientation and of gender-
related identity, roles, expression, body-image, and behavior.

o  Studies of the influences of sexual orientation and gender identity on 
personality, affective, communicative, and cognitive processes.

o  Interpersonal relationships and social networks:  Studies of the nature, 
course, and consequences of LGBT persons" relationships with others (both 
LGBT and non-LGBT), including friendships, romantic relationships, family 
relationships, caregiving relationships, and relationships at workplaces, 
schools, and other institutions.  Both supportive and non-supportive 
(including conflictual) forms of relationships may be examined.  Relationship 
dissolution may also be investigated.  In addition, studies of the 
organization and dynamics of LGBT social networks and how they influence 
members" individual and social behavior.  Investigations may consider the 
impact of broader cultural and technological influences (e.g., Internet) on 
the formation and development of relationships and networks.

o  Families and households that are headed by or include LGBT persons:  
Studies of their formation, structure, function, internal dynamics, and long-
term development, their interactions with extended family, community, and 
institutions, and the psychological and social development of child and adult 
members.

o  Adult development:  Studies of LGBT persons’ expectations, planning, 
decision-making, and evaluations concerning major conditions and transitions 
of their adult lives (e.g., education, work, retirement, residence, family, 
health, bereavement) and of related issues surrounding development of 
personality, identity, and social roles in adulthood.  Research may focus on 
the content and consequences of LGBTs" conceptions of how their options and 
status differ from those of members of other groups, as well as consider 
emerging norms and ideals within particular segments of LGBT populations.

o  Demographic and socioeconomic characteristics of LGBT populations:  
Studies of population composition and distribution (in terms of age, 
geography, ethnicity, and other demographic characteristics), migration 
(within and across national boundaries), residential patterns, family and 
household characteristics, reproductive patterns (including fertility, 
contraceptive use, alternative insemination, and adoption), morbidity and 
mortality, health care access and usage, educational attainment, employment 
and retirement patterns, economic status, usage of social services (public 
and private), interactions with criminal justice system, and related topics.

o  Multiple minority status:  Studies of self-concepts, identity management, 
and acculturation processes in LGBT persons who also belong to other minority 
or marginalized groups.

o  Concealment and disclosure of LGBT status:  Studies of the psychological 
and social processes that determine whether and how individuals conceal or 
disclose their LGBT status and related information (to various others and 
across contexts), also, studies of the effects of concealment or disclosure 
upon other aspects of behavior, identity, experience, and well-being.

o  Beliefs and attitudes concerning LGBT groups and individuals:  Studies of 
their content, expression, manifestation, determinants, and modifiability, in 
both LGBTs and non-LGBTs.  Investigations may consider the influence of 
representations of sexual orientation and gender in the mass media and 
popular culture.

o  Stigmatization, discrimination, violence, and abuse toward persons 
perceived to be LGBTs:  Studies of the determinants of perpetrators" 
motivations, behaviors, and self-perceptions, studies of the factors 
influencing victims" interpretations, responses, and outcomes, and studies of 
the effects on others who relate to or identify with victims.  Investigations 
may consider how social, cultural, institutional, and legal contexts 
influence the form of abusive behavior and its aftermath. 

Mental Health and Substance Abuse: Clinical and Intervention Research 

Investigations of the characteristics and underlying processes of mental 
disorder and substance abuse in LGBT people are invited, including studies 
concerning incidence, prevalence, risk and protective factors, 
classification, diagnosis, features, course, etiology, outcomes, and 
recurrence.  Also invited is research that will lead to more efficacious 
preventive, treatment, rehabilitative, and counseling interventions for LGBT 
people.  

Examples of relevant research include but are not limited to:

o  Studies of disorders and dysfunctions that have been hypothesized to be 
more prevalent among LGBTs or particular sub-groups of LGBTs, including mood, 
anxiety, personality, conduct, eating, and body dysmorphic disorders, 
suicidality, and the abuse of tobacco, alcohol, cocaine, anabolic steroids, 
and “club drugs” such as methamphetamine, MDMA, ketamine, and GHB/GBL.   

o  Studies of protective and resiliency factors and of coping processes in 
LGBT people.  Potential areas of investigation include:  social supports 
within the family and within LGBT communities, willingness to seek counseling 
and therapy, and involvement with spirituality or religion.  Research may aim 
to identify disorders or conditions for which LGBTs (or sub-groups) have 
reduced risk.
 
o  Stress and subclinical distress related to LGBT status: Studies of 
specific causes, manifestations, consequences, and moderating factors.

o  Studies of the nature, prevalence, and consequences of physical and sexual 
abuse of LGBT people, during childhood, adolescence, and adulthood.

o  Studies of current and emerging patterns of substance use and abuse in 
LGBT communities.  Investigations may address:  supply and distribution 
networks, social mechanisms underlying diffusion of particular forms of 
substance use, and contexts of substance use. 

o  Studies of patterns and determinants of comorbidity among mental 
disorders, substance abuse, and neurological and physical disorders in LGBT 
populations.  

o  Studies of mental health and substance abuse issues related to HIV/AIDS 
and other infectious diseases in LGBT populations.
 
o  Development and evaluation of preventive, treatment, and rehabilitative 
interventions for mental disorders and substance abuse in LGBT people.  
Interventions may involve behavioral, psychosocial, pharmacological, or other 
modalities (or combinations), and may be designed for implementation at the 
individual, group, family, school, or community levels.  Efforts may be 
directed either to developing novel interventions or to adapting existing 
approaches. 

o  Development of effective support, self-help, counseling, and therapeutic 
approaches for people in the process of examining, adopting, disclosing, and 
integrating their LGBT status ("coming out") and for members of their 
families. 

o  Transsexual persons:  Development and evaluation of approaches to 
psychosocial assessment and counseling for people who are considering, are 
undergoing, or have completed hormonal or surgical interventions to alter 
gender-related appearance and function, also, development and evaluation of 
counseling approaches for family members and partners.  Work in this area 
should be sensitive to ethical issues (e.g., rights and responsibilities of 
people seeking interventions, criteria for informed consent to interventions) 
and to the wide range of assumptions and values within contemporary culture 
regarding gender variability and body modification.  

o  Intersexed persons:  Developmental and longitudinal studies of gender 
status and mental health of persons with congenital or acquired ambiguities 
of genitalia or internal reproductive organs, including research aimed at 
clarifying influences of biological, psychological, and social factors, 
follow-up studies of children and adults who have received hormonal or 
surgical interventions, studies of ethical issues surrounding hormonal and 
surgical interventions, including criteria for informed consent, development 
and evaluation of approaches to psychosocial assessment and counseling for 
intersexed persons and their families. 
  
o  Analyses of the validity and utility of such diagnostic categories as 
gender dysphoria and gender identity disorder, and of proposals for their 
revision or replacement. 
  
o  Studies of the efficacy and ethics of interventions aimed at altering 
sexual orientation or gender identity.

Mental Health and Substance Abuse: Practice and Services Research

Research is invited that will lead to improved implementation and delivery of 
preventive, treatment, rehabilitative, and counseling interventions and 
related services for LGBT people.  Studies may address services provided or 
supervised by any type of professional mental health or substance abuse 
service provider (including psychiatrists, psychologists, primary care 
physicians, nurses, counselors, and social workers) and in any type of 
setting (including hospitals, residential treatment facilities, outpatient 
clinics, nursing homes, retirement facilities, community centers, schools, 
workplaces, juvenile facilities, prisons, hotlines, and peer support groups).  
Strongly encouraged is research concerned with those portions of LGBT 
populations that tend to have limited access to or choice of mental health 
and substance abuse services, including those who are lower-income, 
uninsured, homeless, and incarcerated, as well as adolescents, aging people, 
ethnic minorities, immigrants and refugees, and people in rural areas.  

Examples of relevant research include, but are not limited to:

o  Studies of service providers" knowledge, attitudes, and competence 
regarding the experiences and concerns commonly reported by LGBT people, 
development and evaluation of training and knowledge dissemination programs 
for service providers on LGBT topics.

o  Studies of the influence of clients" LGBT status on service providers" 
diagnostic, treatment, and referral decisions. 

o  Studies of patterns and determinants of service utilization and 
satisfaction by LGBT people.

o  Studies of the contents and determinants of LGBT people"s beliefs and 
attitudes about mental disorders and substance abuse and about the nature, 
effectiveness, and accessibility of various forms of treatment.

o  Studies of the patterns and quality of communications between service 
providers and LGBT clients and how communications can be improved.

o  Studies of accessibility and quality of LGBT-competent services within 
managed care systems, public health agencies, community health centers, 
private clinics, and other delivery and financing systems.   

o  Studies to determine factors associated with quality and outcome of 
services for LGBTs.  Factors to be investigated may include:  training and 
experience of providers, client expectations and compliance, household and 
social supports for client, service delivery setting, specialization of 
services, coordination with other services, and financing systems.   

o  Development and evaluation of individual-, group-, and community-level 
interventions aimed at reducing stigmatization and abuse of LGBT people.

o  Studies of the roles of mental health service providers in treatment 
planning for transsexual and intersexed persons, including analyses of the 
appropriate role of mental health providers in recommending and approving 
hormonal and surgical interventions.  

o  Studies of the impacts on youth and families of policies and practices 
related to: involuntary hospitalization of LGBT youth by parents/guardians, 
removal of LGBT youth from parents/guardians’ custody by child welfare 
agencies, and removal of youth from custody of LGBT parents/guardians or from 
households containing LGBT members by child welfare agencies. 

Methodology Development

Development of innovative methodologies for behavioral, social, mental 
health, and substance abuse research on LGBT topics is strongly encouraged.  
In general, methodology development should be incorporated into projects 
focused on substantive research questions, such as outlined in the preceding 
sections.  However, grant applications for projects that have methodology 
development as their primary aim will be considered if the intended product 
is likely to have an especially significant and broad impact on research 
practice.  Such projects should include a component in which the new 
methodology is implemented in an actual study and evaluated for 
effectiveness, rigor, and practicality.

Areas for methodology development include, but are not limited to:

o  Improved approaches to defining, classifying, operationalizing, and 
measuring sexual orientation and gender identity.

o  Improved approaches for involving and maximizing the contributions of LGBT 
persons in the design and performance of studies conducted within their own 
communities.

o  Improved approaches to research design and statistical analysis for 
studies of LGBTs and other groups that comprise a small proportion of the 
overall population or are difficult to access. 

o  Improved methods for sampling and obtaining participation from LGBTs (or 
sub-groups) and appropriate comparison populations in research studies. 

o  Improved methods for defining and assessing informed consent to 
participate in research and interventions relating to sexual orientation and 
gender identity.  

o  Improved methods for engaging participants in research involving sensitive 
and personal topics, obtaining accurate and complete information from them, 
ensuring privacy and confidentiality, increasing comfort, and detecting and 
alleviating any distress that arises during and following participation. 

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 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: 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.

NIH GRANTS POLICY STATEMENT

The NIH Grants Policy Statement (NIHGPS) has been revised and reissued.  The 
provisions of the revised NIHGPS are effective for all funded NIH grants and 
cooperative agreements with budget periods beginning on or after March 1, 
2001.  The revised NIHGPS is available at:  
http://grants.nih.gov/grants/policy/nihgps_2001.

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

Applicants are strongly encouraged to contact the program contacts listed 
under INQUIRIES with any questions regarding their proposed project and the 
goals of this PA.

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit.  Application kits are available at most institutional 
offices of sponsored research 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, Email: 
GrantsInfo@nih.gov.  Applications are also available on the World Wide Web 
at: http://grants.nih.gov/grants/forms.htm.

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

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 Institute staff.  The research grant application form PHS 398 (rev. 4/98) 
is to be used in applying for these grants, with the modifications noted 
below.

BUDGET INSTRUCTIONS

Modular Grant 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:

PHS 398

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.

o  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 facilities and administrative) 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 all 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 3 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 phone number of the individual 
to contact concerning fiscal and administrative issues if additional 
information is necessary following the initial review.

Applicants planning to submit an investigator-initiated new (Type 1), 
competing continuation (Type 2), competing supplement, 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 he or she must contact the 
Institute program staff before submitting the application, i.e., as plans for 
the study are being developed.  Furthermore, the application must obtain 
agreement from the Institute 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 and 
Institute 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.

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 5 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

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 understanding of 
biological, behavioral and social sciences, 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 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 humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application

o  The adequacy of the proposed plan to share data, if appropriate

AWARD CRITERIA

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

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Howard S. Kurtzman, Ph.D.
Division of Neuroscience and Basic Behavioral Science 
National Institute of Mental Health
6001 Executive Boulevard, Room 7217, MSC 9651
Bethesda, MD  20892-9651
Telephone:  (301) 443-9400
FAX:  (301) 443-9876
Email:  kurtzman@helix.nih.gov

Coryl Jones, Ph.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5153, MSC 9589
Bethesda, MD  20892-9589
Telephone:  (301) 443-6637
FAX:  (301) 480-2543
Email:  cj39g@nih.gov

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

Paula R. Skedsvold, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director, NIH
Building 31, Room B1C32, MSC 2248
Bethesda, MD  20892-2248
Telephone:  (301)435-6780
FAX:  (301) 480-7555
Email:  Paula_Skedsvold@nih.gov

Loretta P. Finnegan, M.D.
Office of Research on Women"s Health
Office of the Director, NIH
1 Center Drive, Room 201, MSC 0161
Bethesda, MD  20892-0161
Telephone:  (301) 402-1770
FAX:  (301) 402-1798
Email:  lf61d@nih.gov

Direct inquiries regarding 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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gf6s@nih.gov

Kathy Hancock
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:  kathy.hancock@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.242 (NIMH), 93.279 (NIDA), 93.864 (Population Research, NICHD), and 93.865 
(Center for Research for Mothers and Children, NICHD).  Awards are made under 
authorization of the Public Health Service Act, Title IV, Part A (Public Law 
78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 
74.  This program is not subject to the intergovernmental review requirements 
of Executive Order 12372 or 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.



Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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