and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
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
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.
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