COMMUNITY-BASED PARTICIPATORY RESEARCH IN ENVIRONMENTAL HEALTH

Release Date:  November 29, 2000

RFA:  ES-01-003

National Institute of Environmental Health Sciences
 http://www.niehs.nih.gov

Letter of Intent Receipt Date:  January 17, 2001
Application Receipt Date:       March 15, 2001

THIS RFA 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 RFA.

PURPOSE

The purpose of awards in this program is to develop community-based public 
health research approaches to diseases and health conditions having an 
environmentally related etiology and determine the impact of these methods. 
Moreover, awards are intended to stimulate further advances in the design and 
implementation of prevention and intervention methods that are appropriately 
applied to environmental health; accumulate and evaluate data, making 
assignments of environmental etiologies of diseases more plausible; and develop, 
implement, and evaluate community-based exposure assessment protocols.

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 Request for Applications (RFA), 
Community-Based Participatory Research in Environmental Health, is related to 
one or more of the priority areas.  Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.health.gov/healthypeople/.

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.

Although a single institution or organization must be the applicant, a multi-
institutional arrangement (consortium) is possible.  Such consortia, entailing 
active participation by more than one organization, are encouraged if there is 
clear evidence of close interaction and responsible partnership among the 
participants. It is important to note that, because of the wide range of 
environmental health problems to be addressed and the diversity of affected 
communities, applications must include at least one of each of the following:

o  A research scientist in environmental health sciences (such as those at NIEHS 
Environmental Health Sciences Centers or NIEHS/EPA Centers for Children's 
Environmental Health and Disease Prevention Research).

o  A member of a community organization in an area having an underserved 
population that is adversely affected by an environmental pollutant.  This 
individual must be someone who lives in or works directly and regularly with the 
participating community.  At least one member of both of these required 
personnel groups must have an active and meaningful role in both development of 
the application and conduct of the proposed project.  These personnel must be 
listed on page 2 of the PHS 398 application, and a biographical sketch must be 
provided for each. Applications lacking the required personnel will not be 
considered.  The role of each member of the two personnel groups in developing 
the application and carrying out the project must be clearly identified and 
fully described.  Applications that do not have collaborations between 
environmental health scientists and community-based organizations will be 
considered non-responsive and returned without review to the investigator.

MECHANISM OF SUPPORT

This RFA 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 RFA may 
not exceed five years.  Competitive continuation applications from existing 
grantees in the NIEHS Community-Based Prevention and Intervention Research in 
Environmental Health Program in their fourth year of support will be accepted 
for consideration under this RFA.  Such applications must follow PHS 398 
guidelines for competitive renewal, including a progress report.  Such 
applicants are strongly encouraged to contact Program Staff listed under 
INQUIRIES for additional guidance.  The anticipated award date is September 
2001.

It is anticipated that the maximum award will be $300,000 direct costs, 
including third party fiscal and administrative costs, per year for each grant.
Specific application instructions have been modified to reflect "MODULAR GRANT" 
and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  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 NIEHS intends to commit approximately $2.5 million in FY 2001 to fund 
approximately five new and/or competitive continuation grants in response to 
this RFA.  An applicant may request a project period of up to five years and a 
budget for direct costs of up to $300,000 per year.  Because the nature and 
scope of the research proposed may vary, it is anticipated that the size of each 
award will also vary.  Although the financial plans of the NIEHS provide support 
for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of applications of 
outstanding scientific and technical merit.

RESEARCH OBJECTIVES

Background

Research efforts to identify the sources and effects of hazardous environmental 
exposures among underserved populations have been insufficient.  Little is known 
about the types of environmental agents to which members of such groups are 
exposed, both at home and at work.  Members of economically disadvantaged and/or 
underserved populations suffer disproportionate levels of morbidity and 
mortality.  Additionally, they are most often the populations with the highest 
degree of exposure to environmental agents and are frequently the populations 
with the least information available as to the health consequences of such 
exposure(s).

This solicitation will provide an opportunity for collaborative research 
approaches with environmental health scientists and communities to engage in:

-the etiology of environmentally related diseases in low socioeconomic status 
(SES) populations;

-exposure assessments in low SES communities; and
 
-intervention/prevention strategies in low income and medically underserved 
communities.

The etiology of a number of environmental exposure influenced diseases/disorders 
is obscure at best.  Examples of adverse health outcomes thought to be 
influenced by specific exposures, but supported only by suggestive data are 
birth defects, e.g., low birth weight infants in communities near landfills or 
other toxic waste sites; autoimmune disorders in populations exposed to 
industrial wastes; and cardiovascular diseases in populations exposed to 
airborne fine particulate matter (PMs).  These types of exposures are 
disproportionately distributed in low SES and minority communities as are the 
adverse health outcomes that have been associated with them.  This initiative 
seeks to support investigations that will provide mechanistic data to either 
support or refute associations between specific environmental exposures and 
specific disease consequences. 

Low income and medically underserved populations/communities work, reside,  
attend school, and play in neighborhoods that have disproportionate 
environmental exposures due to citing of chemical/manufacturing/processing 
facilities.  This RFA will support collaborative research projects that 
scientifically evaluate/assess exposure situations that contribute to adverse 
health outcomes.  An adequate and accurate assessment of exposure(s) is 
requisite for authenticating or refuting connections between exposure and 
disease outcomes.  Accurate exposure assessments will require both biological 
and environmental monitoring. Additional parameters that must be included are 
the magnitude, routes and all sources of exposure to the agent(s) being 
investigated.

An understanding of the environmental components and basic biology of disorders 
can lead to prevention and intervention strategies to circumvent adverse health 
effects.  As our understanding of the molecular and cellular basis of 
environmentally associated diseases increases, prevention and intervention 
techniques can be developed to diagnose and treat people exposed to an 
environmental contaminant.  These molecular intervention techniques, such as 
early detection screening, rely on manipulation of underlying biological 
mechanisms, e.g., activation/inactivation of particular genes, enzymes, or 
receptors.  These methods may be especially useful in dealing with environmental 
exposures that are ubiquitous or difficult to eliminate.   Tertiary prevention 
measures seek to limit injury and disability in people already affected by a 
specific disease process.

Etiology, exposure assessments and prevention/intervention schemes may also take 
into account the social and cultural lifestyle and behavioral factors that 
contribute to environmentally associated disorders.  It is part of the 
responsibility of the NIEHS to provide the scientific underpinning that can 
delineate the contribution of societal and cultural behaviors in development of 
these disorders. Thus, there is a critical need to address diverse, culturally 
relevant contexts and disease etiologies in environmental health. 
Environmental health comprises those aspects of human health, including quality 
of life, that are determined by physical, chemical, biological, social and 
psychosocial factors in the environment.  For purposes of this RFA, the physical 
environment includes physical agents (e.g., radiation), chemical agents (e.g., 
pesticides) and biological agents (e.g., pathogens, harmful algal blooms) to 
which individuals are exposed in a multitude of settings, including home, 
school, and workplace.  The social environment includes individual and 
community-level characteristics, e.g., socioeconomic status (SES), education, 
institutional and political forces such as racism and classism, familial 
factors, and media influences.

Geographic location may play a role in determining the degree and effect of 
environmental exposure among socioeconomically disadvantaged populations.  For 
example, inner city residents often live in homes with high lead levels and are 
exposed to higher levels of air pollution.  Toxic waste sites, nuclear 
facilities, and chemical plants are often located in rural areas.  More effort 
must be devoted to identifying disadvantaged populations having high levels of 
exposure to environmental hazards and to generating prevention and intervention 
strategies to mitigate the health effects of these hazards.  Likewise, exposure 
assessments in both rural and urban communities located near these multiple 
exposure sources have not provided quantitative exposure measurements that can 
be related to adverse health outcomes.

The current RFA is intended not only to foster additional refinement of 
intervention methods, provide exposure assessment data, and study environmental 
disease etiology, but also to strengthen the participation of affected 
communities in this effort.  Given the complexity and magnitude of environmental 
health problems, research endeavors aimed at improving our knowledge of and 
ability to resolve these issues can benefit from establishing collaborative 
relationships with the communities experiencing these problems.  Such community 
research partnerships have benefits for both the researcher and the community.  
These partnerships can, for example, facilitate the definition of important 
environmental issues and concerns, the development of measurement instruments 
that are culturally appropriate, and the establishment of trust that will enrich 
the value of data collected.  This scheme emphasizes the involvement of 
community members throughout the research process, from development of research 
questions to interpretation, application, and dissemination of results.  Only 
through realization of this final leg of the NIEHS mission, i.e., communication 
and partnership formation, can we ensure that research findings reach and are 
made relevant to affected individuals and communities.

Objectives and Scope

This RFA will support collaborative research activities in three specific areas:
o  etiology
o  exposure assessment
o  prevention/intervention strategies

There are disproportionate sightings of hazardous waste facilities, landfills 
and manufacturing/industrial facilities in communities of color and/or low SES. 
In many of these communities, there are disparate adverse health outcomes with 
respect to birth defects, e.g., low birth weight, cardiovascular disease (CVD), 
diabetes, lupus, and cancer.  Currently, sufficient data that correlates 
specific exposures, biomarkers of exposure and mechanistic basis of disease is 
not available.  Data are needed to foster the development of mechanistically 
based research on the relationship between environmental agents and diseases.  
This RFA will provide an opportunity to develop fundamental data on the possible 
role of the environment in diseases in which links to exposure are suggested but 
remain unproven.  It is anticipated that these preliminary data will support 
development of hypothesis-based research to establish the cause and effect 
relationship between environmental exposures and disease etiology.  This RFA 
will utilize community-researcher partnerships to develop preliminary data that 
will lead to mechanistic studies that can either prove or disprove cause and 
effect with regards to exposure and disease outcomes in low SES and medically 
underserved communities.  An example this approach may be applied to is the 
disproportionate distribution of low birth weight infants in minority and low 
SES communities located near landfills and/or hazardous waste sites.  
Quantitative exposure data nor mechanistic data are not available that can 
provide clear associations between exposures and low birth weight infants.  
Proposals submitted in response to this RFA that focus on etiology should 
utilize human population studies to develop hypotheses relating environmental 
exposure to the initiation or exacerbation of diseases.

Human exposure may be defined as contact between an agent/toxicant/pollutant and 
a human receptor.  At threshold doses of exposure biological responses manifest 
and ultimately adverse health outcomes are observed.  Exposure assessments 
define the frequency, duration, source, dose, route of exposure, 
e.g.,inhalation, ingestion, or dermal. This initiative will support exposure 
assessment efforts that address public health concerns and are community 
responsive and driven. The RFA will support empirical observations of human 
exposure(s), e.g., biomarkers, body burdens, and personal monitoring. 
Environmental monitoring should also be included with these evaluative measures. 
As empirical data is generated, modeling strategies for assessing exposures may 
be developed as well. Research will be supported that establishes what exposure 
levels are relevant to health effects. The RFA will also support the development 
of new technologies to more accurately evaluate exposures and incorporate 
susceptibility into exposure and dose-response assessment. An example of an 
environmental health issue that would benefit from this collaborative approach 
is exposure assessment of indoor air toxicants and their relationship to asthma.
This RFA will also support research activities that develop and implement 
improved prevention and intervention strategies related to environmental health 
that are designed to include community-based, culturally appropriate approaches 
applicable to underserved populations.  Community-based participatory research 
seeks to expand our knowledge and understanding of the potential causes and 
remedies of environmentally related disorders, while at the same time enhancing 
the capacity of communities to participate in the processes that shape research 
approaches and intervention strategies. Community-based participatory research 
is thus more than just a community placed outreach activity.  These research 
projects are community driven and responsive so as to maximize the potential for 
change in knowledge, attitudes, and behavior.  They are conducted in a manner 
that reinforces collaboration between community members and research 
institutions.  Relevant results from these projects are disseminated to the 
community in clear, useful terms.  Moreover, these studies are designed to be 
culturally appropriate, i.e., due consideration is given to the social, 
economic, and cultural conditions that influence health status.  Identifying and 
incorporating unique cultural factors into intervention strategies may result in 
increased acceptability, use, and adherence.
                                 
Each application should develop a comprehensive, strategic plan with time 
schedules and milestones to address all key aspects.  This plan should include:

o  Identification of target community.  Population(s) should be clearly 
identified, community boundaries described, and known environmental health 
hazards delineated.

o  Community collaboration.  How will communication and regular exchange of 
information and ideas between community members and institutional researchers be 
initiated and enhanced?  How are productive relationships with local 
representatives established and maintained?  How are local organizations and 
leaders recruited?  What are the mechanisms for communities to identify their 
environmental health needs?  How will activities be designed to meet these 
needs?  How will findings be disseminated within the community?

o  Research program definition and implementation.  A variety of research 
designs may be proposed. 

1)Etiological studies should provide preliminary data that will lead to 
mechanistic studies that may provide linkages between specific exposures and 
disease outcomes. Dose-response relationships that are relevant to disease 
outcomes should be defined. Adverse health outcomes related to the exposure 
should be evaluated.  Use of census tract data, vital statistic records, e.g., 
birth and death certificates, clinical, and medical records should be evaluated 
in this context.  Use of standard biomarkers of exposure along with the 
development and validation of new biomarkers is encouraged. Health outcomes are 
not limited to but may include autoimmune disorders, infant morbidity and 
mortality, neurodegenerative diseases, cardiovascular diseases.

2)Exposure assessments should completely characterize the toxic material(s) 
being assessed, the dose, frequency, duration, source and route of exposure. 
This may include the development and validation of culturally appropriate 
exposures, taking into account confounders such as age, gender and socioeconomic 
status. Models of exposure may also be developed, e.g., pharmacokinetic, 
mathematical/statistical, or dermal models, provided data and results are 
disseminated to community collaborators and communities in culturally 
appropriate formats. 

3)Prevention/intervention strategies should be based on appropriate behavioral 
and scientific theories.  They should also be built on the results of previous 
methods shown to be efficacious in changing risk factors related to knowledge, 
attitudes, and behaviors.  Interventions should use multiple, culturally 
sensitive, community-based approaches and be adapted to the special needs of 
underserved populations.

o  Evaluation.  Both outcome and process evaluations should take place.  Only 
projects having well developed, comprehensive evaluation plans will be 
supported.  The application must include detailed descriptions of process and 
outcome evaluation, specify the measures and instruments for data collection, 
and indicate a time frame for conducting all evaluation activities.
Experimental design is not restricted by this RFA.  Applicants should develop 
their own independent design and provide appropriate justification.  Designs 
should focus on an integrated approach employing various culturally appropriate 
factors that have been previously shown to be effective.  It is important that 
the study population be clearly identified and that community involvement in 
developing the design be demonstrated.  An experimental design with a defined 
hypothesis is the preferred approach.  A randomized design, comparing specially 
constructed interventions against usual and customary conditions, would be one 
appropriate study design to test intervention models.  Other designs may also be 
considered responsive.  Elements that may be considered in assembling a research 
design include sampling procedures, instrumentation and measurement, data 
collection, quality control, recruitment, retention, tracking and follow up, and 
data analysis.  State-of-the-art econometric techniques for measuring cost-
effectiveness of prevention efforts may also be included.  Applicants are 
encouraged to test and compare multiple innovative strategies and to assess 
their relative effectiveness. Population based empirical study designs should be 
included in all proposals focusing on exposure assessment. Pharmacokinetic 
modeling or mathematical/statistical modeling strategies utilized in exposure 
assessments will be supported by this RFA as well. In addition the RFA will 
support mechanistically-based research designed to establish the linkage between 
two events: exposure to an environmental agent tested at environmentally 
relevant concentrations and the initiation or exacerbation of diseases. Emphasis 
should be placed on developing the preliminary data that will lead to the 
development of cause and effect relationships among environmental agents and the 
etiology of disease.

Community-Based Participatory Research

Community-based participatory research seeks to enhance the capacity of 
communities to participate in the processes that shape research approaches and 
intervention strategies.  Active cooperation and participation of organizations 
within the community(ies) that is (are) the focus of the study are essential 
components of the research.  Hence, applicants must describe an existing or 
proposed involvement with one or more community-based organizations in an area 
having an underserved population adversely impacted by an environmental 
contaminant.  This connection is essential to the development of community-based 
approaches and should also enhance the potential for long-term impact of the 
project.  Community input is most meaningful and best utilized if it is built 
into the research process from the outset.  Community representatives should be 
given a voice in choosing research topics, developing the application, 
collecting data, and interpreting results.  Thus, projects should be community-
driven and community-responsive.  Research efforts should reinforce the 
collaborations between communities, health care providers and scientists.  
Results generated by the research should be disseminated to community members in 
useful terms. This will mandate that all facets of the project design be 
culturally appropriate.  Involvement of an Historically Black College or 
University, Hispanic Serving Institution,  or Tribal College and/or recruitment 
of staff from the community-based organization may be appropriate.  However, 
such efforts will not substitute for direct involvement of a community-based 
organization.  Applications lacking an existing or proposed link to a community-
based organization will be considered to be nonresponsive to this RFA.
The NIEHS has been active in developing pioneering efforts with translational 
research programs (see http://www.niehs.nih.gov/dert/programs/translat/home.htm).  
Innovative programs linking environmental health scientists with health care 
providers, community members, educators and schools are making tremendous 
impacts on environmental health awareness in medically underserved communities 
across the nation.  The NIEHS has supported the development of programs that are 
at the forefront of community input and participation with regard to 
environmental health concerns.  Benefits of community-based participatory 
research include:

o  The formation of bridges between scientists and communities that allow both 
to gain in knowledge and experience.

o  Better definition of a particular environmental health concern.

o  Assistance in development of culturally appropriate measurement instruments, 
thus making projects more effective and efficient.

o  Establishment of a level of trust that will enhance both the quantity as well 
as the quality of data collected.

o The community gains more knowledge about environmental health problems; and 
has a role in addressing those problems.

o  Relationships are built that can have a longer term impact or influence on 
those problems.

Principles of community-based research include:

o  Community-based participatory research seeks to enhance the capacity of 
communities to participate in the processes that shape research approaches and 
intervention strategies.

o  Active cooperation and participation.

o  Community members have a voice in choosing research topics, developing 
projects, collecting data, and interpreting results.

o  Projects are community-driven and -responsive.

o  Research efforts reinforce collaboration.

o  Results are disseminated to the community in useful terms.

o  Designed to be culturally appropriate.

SPECIAL REQUIREMENTS

Annual meetings, to be held in Research Triangle Park, NC, are planned for the 
exchange of information among investigators.  Applicants must budget travel 
costs associated with these meetings in their applications for key personnel, 
including at least one community-based organization member and one environmental 
health scientist.

In addition, since these projects are community-based and embrace both research 
demonstration and dissemination, applicants are expected to maximize 
opportunities for information exchange between institutional researchers and 
community members.  As part of this program, applicants must generate a report 
that describes community input, program implementation, and relevant findings.  
This report must be produced at least annually and distributed among community 
members in such a way that it can be easily comprehended by the public. 
Applicants must budget for production and dissemination of such reports.  This 
requirement is intended to establish a minimal level of communication among 
project participants; additional, more frequent dissemination efforts may be 
appropriate.

Relationship to Environmental Justice

Activities conducted under this RFA should be consistent with Federal Executive 
Order No. 12898 entitled, Federal Actions to Address Environmental Justice in 
Minority Populations and Low Income Populations.  To the extent practicable and 
permitted by law, grantees shall make achieving environmental justice part of 
their project's mission by identifying and addressing, as appropriate, 
disproportionately high and adverse human health effects of environmental 
contaminants on minority and low income populations.

The current RFA builds upon the framework established by the separate NIEHS 
grant program entitled, Environmental Justice: Partnerships for Communication.  
That program, initiated in 1993, supports outreach, training, and education 
efforts that will become the catalyst for reducing exposure to environmental 
pollutants in underserved populations.  Its main objective is to establish 
methods for linking members of a community, who are directly affected by adverse 
environmental conditions, with environmental health researchers and health care 
providers.  This endeavor will help to ensure that the community is aware of 
basic environmental health concepts and that they have a role in defining 
problems and shaping approaches to their solution.

The present RFA differs from the Environmental Justice grant program in that the 
former is a scientific research demonstration and dissemination project, whereas 
the latter is an education project.  Thus, this RFA is intended to support 
specific, rigorous, scientific research projects that develop and implement 
community-based, culturally-appropriate, prevention/intervention strategies in 
underserved communities; conduct rigorous community exposure assessments that 
addresses source, routes, frequency, duration of the exposure and establishes 
dose - response relationships to physiological perturbations. It is designed to 
support scientific research projects that can mechanistically demonstrate 
linkage between exposure and disease outcome.   The Environmental Justice 
program supports education projects that enhance the flow of information and 
communication among scientists, health-care providers, and community members.  
Although these programs are complementary, it is important to differentiate the 
substantial research orientation of this RFA from the educational goal of the 
Environmental Justice program.

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 related 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.

LETTER OF INTENT

Prospective applicants are asked to submit, by January 17, 2001 a letter of 
intent that includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the identities of 
other key personnel and participating institutions, and the number and title of 
the RFA in response to which the application may be submitted.  Although a 
letter of intent is not required, is not binding, and does not enter into the 
review of a subsequent application, the information that it contains allows 
NIEHS staff to estimate the potential review workload and to plan the review.
The letter of intent is to be sent to:

J. Patrick Mastin, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
111 T.W. Alexander Drive
Research Triangle Park, N.C.  27709
Telephone:  (919) 541-1446
Fax:  (919) 541-2503
Email: mastin@niehs.nih.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms 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.

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.)
  
For applications requesting $250,000 or less per year in total direct costs must 
be 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 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 phone number of the individual to 
contact concerning fiscal and administrative issues if additional information is 
necessary following the initial review.

For all applications the RFA label available in the PHS 398 (rev. 4/98) 
application form must be affixed to the bottom of the face page of the 
application.  The RFA label and line 2 of the application should both indicate 
the RFA number.  Failure to use this label could result in delayed processing of 
the application such that it may not reach the review committee in time for 
review.  In addition, the RFA title and number must be typed on line 2 of the 
face page of the application form and the YES box must be marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf 
has been modified to allow for this change.  Please note this is in pdf format.
Submit a signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, in one package to:

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

At the time of submission, two additional copies of the application must be sent 
to:

J. Patrick Mastin, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-1446
Fax:  (919) 541-2503
Email: mastin@niehs.nih.gov

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will be 
returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The CSR 
will not accept any application that is essentially the same as one already 
reviewed. This does not preclude the submission of substantial revisions of 
applications already reviewed, but such applications must include an 
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIEHS staff.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.  Applications 
that are complete and responsive to the RFA will be evaluated for scientific and 
technical merit by an appropriate peer review group convened by the NIEHS in 
accordance with the review criteria stated below.  As part of the initial merit 
review, a process will be used by the initial review group in which applications 
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 the applications under review, will be discussed, assigned a priority score, 
and receive a second level review by the National Advisory Environmental Health 
Sciences Council.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In the 
written comments reviewers will be asked to discuss the following aspects of 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 all applications will also be reviewed with 
respect to the following:

o  Extent of community sanction/liaison.  Rationale for selection of the 
targeted population and documentation of environmental health needs and risk 
factors.  Evidence of access to, interaction with, and participation of 
community members and community leaders in development and conduct of the 
project.  Establishment of collaborative interactions among all project 
participants.  Extent to which the design demonstrates sensitivity to cultural 
and socioeconomic factors in the community.

o  Demonstration of effective communication channels between researchers and 
community members.  Plans for useful and practical dissemination of project 
activities and findings within the affected community(ies).  Active involvement 
of at least one community based organization is a minimal requirement for 
responsiveness to this RFA.

o  Appropriateness of proposed budget and duration in relation to the project's 
objectives.

o  Adequacy, appropriateness, feasibility, and comprehensiveness of the 
evaluation plan, including sufficient allocation of resources.

o  Feasibility of plans for independently continuing the program.  Evidence of 
continuing commitment on the part of the proposing institution(s).  The 
potential long term impact of the proposed project is especially important.
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 initial review group will also examine the provisions for the protection 
of human subjects and the safety of the research environment.

Schedule
Letter of Intent Receipt Date:    January 17, 2001
Application Receipt Date:         March 15, 2001
Peer Review Date:                 June 2001
Council Review:                   September 2001
Earliest Anticipated Start Date:  September 2001

AWARD CRITERIA

Criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:

Frederick L. Tyson, Ph.D.
Scientific Program Administrator
Chemical Exposures and Molecular Biology Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, 111 T.W. Alexander Drive, MD EC-21
Research Triangle Park, NC  27709
Telephone:  (919) 541-0176
FAX:  (919) 316-4606
Email:  tyson2@niehs.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Carolyn Mason
Grants Management Specialist
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, 111 T.W. Alexander Drive, MD EC-21
Research Triangle Park, NC  27709
Telephone:  (919) 541-1373
FAX:  (919) 541-2860
Email: mason6@niehs.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.113, 93.114, and 93.115.  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 Parts 74 and 92.  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 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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