Grantee Research Project Results

Closed - for reference purposes only

Recipients List

 

United States Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
National Institute of Environmental Health Sciences
Interagency Announcement of Opportunity

1998 CENTERS FOR CHILDREN'S ENVIRONMENTAL HEALTH AND DISEASE PREVENTION RESEARCH

Opening Date: August 29, 1997
Letter of Intent Receipt Date: September 30, 1997
Application Receipt Date: January 21, 1998

PURPOSE

The National Institute of Environmental Health Sciences (NIEHS), the Environmental Protection Agency (EPA) and the National Center for Environmental Health, Centers for Disease Control and Prevention (CDC), share the common objective of fostering research that will ultimately reduce the extent of adverse human health effects occurring as a consequence of exposure to hazardous environmental agents. The agencies recognize that these health impacts can be particularly detrimental for children due to pronounced differences in nature and extent of environmental exposure as well as in functional development when compared to adults. A Federal Executive Order of April 21, 1997 "Protection of Children from Environmental Health Risks and Safety Risks," charges agencies to consider special environmental risks to children in their activities. Accordingly, NIEHS and EPA invite grant applications for Centers that will develop multidisciplinary basic and applied research in combination with community-based prevention research projects to support studies on the causes and mechanisms of children's disorders having an environmental etiology, identify relevant environmental exposures, intervene to reduce hazardous exposures and their adverse health effects, and eventually decrease the prevalence, morbidity, and mortality of environmentally related childhood diseases. The purpose of awards in this program of Centers for Children's Environmental Health and Disease Prevention Research is to:

• Provide for multidisciplinary interactions among basic, clinical, and behavioral scientists interested in establishing outstanding, state-of-the-art research programs addressing environmental contributions to children's health and disease.

• Support a coordinated program of research/prevention Centers pursuing high quality research in environmental aspects of children's disease, with the ultimate goal of facilitating and accelerating translation of basic science knowledge into clinical applications or intervention strategies that can be used to reduce the incidence of environmentally related childhood disease.

• Develop fully coordinated programs that incorporate exposure assessment and health effects research with development and validation of risk management and health prevention strategies.

• Establish a national network that fosters communication, innovation, and research excellence with the ultimate goal of reducing the burden of morbidity among children as a result of exposure to harmful environmental agents.

The long-range goal of this program is to promote translation of basic research findings into applied intervention and prevention methods, thereby enhancing awareness among children, their families, and health care practitioners regarding detection, treatment, and prevention of environmentally related diseases and health conditions.

Each application is to be designed around a central scientific theme, specifically examining the role of environmental agents in one of the following research foci: (1) children's respiratory disease; (2) childhood learning; (3) growth and development (see Research Scope below). A minimum of two (2) basic biomedical research projects and one (1) community-based intervention research component must be proposed within each Center (see Description of a Center below).

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), "Centers for Children's Environmental Health and Disease Prevention Research," is related to the priority area of Environmental Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).

THE EPA CHILDREN'S ENVIRONMENTAL HEALTH INITIATIVE

The EPA recognizes that children's environmental health issues are a top priority and must become a central focus of the agency's efforts. This RFA is a component of the agency's overall initiative that, together with the efforts of partner agencies, will ensure that children receive the protection they need and deserve and help our nation fulfill its obligation to protect future generations. Potential applicants may obtain a copy of the EPA's National Agenda to Protect Children's Health from Environmental Threats (EPA 175-F-96-001) from the EPA program contact listed under INQUIRIES.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic non-profit organizations, public and private, that meet the requirements stated in this RFA. Minority individuals, persons with disabilities, and women are encouraged to apply as Principal Investigators. The need for communication and interaction among awarded sites dictates that only domestic institutions in the United States will be eligible for these Center grant awards.

MECHANISM OF SUPPORT

The funding mechanisms to be used to assist the scientific community in participating in this grant program will be those of: 1) the National Institutes of Health (NIH) Specialized Center (P50); or 2) the Environmental Protection Agency's Office of Research and Development, administered in accordance with 40 CFR Parts 30 and 40. Policies that govern grant award programs of each agency will prevail for respective sources of support. Support of grants pursuant to this RFA is contingent upon receipt of a sufficient number of applications of high scientific merit and of appropriated funds for this purpose.

Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will also vary within the funding limits available (see Description of a Center). The maximum award will be $1 million in direct costs in the first and all subsequent years. Funding in subsequent years is contingent upon satisfactory progress during the preceding year and availability of funds.

The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is August, 1998.

FUNDS AVAILABLE

Although this solicitation is included in fiscal plans of EPA and NIEHS for FY 1998, support for these Center grants is contingent upon availability of funds for this purpose. It is anticipated that an estimated total of $10 million, including direct and indirect costs, will be available for the first year of the program, which will support up to six Centers in FY 1998. It is expected that NIEHS and EPA may solicit additional new Specialized Center applications through subsequent issuance of a similar RFA addressing children's environmental health.

RESEARCH OBJECTIVES

Background

Establishment by NIEHS and EPA of Centers for Children's Environmental Health and Disease Prevention Research recognizes the unique vulnerability of children to hazardous environmental exposures. The greater susceptibility of children to such exposures is likely related to changes in organ system growth as well as developmental and metabolic capacities that adjust during childhood. For example, lung surface area increases tenfold and gas exchange areas increases more than twenty-fold from birth to adulthood. Since many xenobiotics are absorbed through the alveolar epithelium, the lung represents a particularly sensitive organ. Moreover, the diets of children and their unique behavioral patterns such as crawling and hand-to-mouth activities augment the probability of certain exposures.

In the past, standards regulating exposure to environmental health threats have been, in some cases, based on research and assessment of risks to adults. Often, the knowledge base to ensure that standards are protective of infants and children has not been adequate. Because children have very different metabolic, physiologic, and developmental processes, diets, and exposure patterns than adults, their health outcomes can differ drastically. There is a clear need for additional research that can more fully incorporate children's unique traits into risk assessment paradigms.

Environmentally related childhood diseases represent an enormous public health problem. For example, asthma, the most common chronic childhood illness, afflicts nearly five million children and is the leading cause of children's emergency room use, hospital admission, and school absences. From 1982 to 1993, the prevalence, morbidity, and age-adjusted mortality rates for asthma increased significantly despite improvements in asthma diagnosis and management and improved understanding of the biology and immunology of the disease. The mortality rate attributed to asthma for children five to fourteen years of age has doubled since 1980 and is highest among African-American children, who are three times more likely than Caucasian children to die of this illness. Chronic asthma in children is highly associated with chronic respiratory disease in adulthood and has a huge health, societal, and economic impact.

Approximately 20% of the 76.7 million children in the United States live in poverty. Children who live in these impoverished communities are exposed to multiple indoor and outdoor environmental pollutants at disproportionally high levels. Preambulatory and crawling children spend significant time indoors and are subjected to high levels of allergens found in carpeting, bedding, upholstered furniture, and house dust. Indoor pollution levels may also depend on heating sources, use of household chemicals, parental smoking habits, and the presence of nearby industrial or waste facilities, which may result in increased amounts of polycyclic aromatic hydrocarbons, volatile organic compounds, and particulates. In addition, it is estimated that 20 60% of children between one and five years of age are exposed to unsafe levels of organophosphate pesticides. Exposure to such agents may occur in both indoor living space and outdoor play areas. There is thus a particular need to address environmental health problems of children living in socioeconomically disadvantaged or medically underserved communities.

The current initiative is intended to foster advancement in children's health through enhancing our understanding of basic disease mechanisms and promoting community-based prevention activities related to children's respiratory disorders, childhood learning, and growth and development. Collaborative, multidisciplinary research approaches are required to explore the dynamic interaction of children with their environment. This Center program therefore emphasizes integration of basic laboratory science with applied intervention strategies. Because the latter are also research projects, it is important to note that each intervention research project should include appropriate methodology for assessing its effectiveness (see 'Description of a Center' below). Centers are expected to have fully coordinated programs that incorporate exposure assessment and health effects research with development and validation of risk management and health prevention strategies. Moreover, involvement of the affected community in planning, implementing, and evaluating an intervention effort is essential. Community-based prevention/intervention research not only expands our understanding of the causes and remedies of environmentally related disorders, but also enhances the capacity of communities to participate in processes that shape research and intervention approaches. By bridging gaps between basic and applied researchers and between institutional researchers and community members, this program aims to improve our knowledge regarding detection, treatment, and prevention of environmentally related diseases in children.

Research Scope and Objectives

Centers for Children's Environmental Health and Disease Prevention Research are research-based Center grants designed to support interactive groups of research projects and core service facilities. Research activities included in these Center grants must comprise, by definition, a multidisciplinary approach to biomedical problems addressing one or more of the specific research topic areas announced in this RFA (see below).

A Center should identify a central theme or focus of its research effort so that the subprojects involved are responsive to one or more of the specific research areas of children's environmental health supported by this grant program. Furthermore, the translational objective of this program requires that one of the subprojects consist of a community-based intervention.

The following is the list of specific research topics that will be considered to be responsive, for purposes of the current RFA, to the research mission areas of EPA and NIEHS. These topics identify areas where research at the basic/applied interface is essential to potential development of new approaches that can be used for detection, prevention, treatment, and effective management of environmentally related childhood disorders.

Respiratory Diseases

Particulate and gaseous pollutants and volatile organic compounds, when inspired, can lead to inflammation of the airways and development of a spectrum of respiratory and systemic disturbances and diseases. This is especially true in the case of environmental agents, or their metabolic products, which have the capacity to access alveolar spaces and to diffuse or be transported into the blood stream. Such compounds may then exert adverse health effects at systemic target organs. The principal objective of research in this focus area is to understand the mechanisms of respiratory disease in children, including asthma, chronic obstructive pulmonary diseases, and allergy associated with chemical and biological environmental exposures. Additional research is needed to examine mechanisms of tissue damage, including that produced by reactive oxygen species generated as a result of exposure to environmental oxidants. These oxidants include ozone, nitrogen dioxide, and particulate matter. By virtue of their greater physical activity out-of-doors when pollution levels may be high, children may experience higher exposures to these hazards than adults. In response to such pollutant exposure, epithelial cells in the lung synthesize and release a variety of potent mediators that can contribute to a local inflammatory reaction and play a role in pathogenesis of respiratory disturbances. It is important to understand the basic mechanisms by which pollutants alter the inflammatory response in airways, resulting in airway hyperactivity, IgE antibody production, and asthma. It is equally important to address other mechanisms of lung dysfunction, including compromise of immunologic responsiveness and modulations of receptor signaling pathways.

Childhood Learning

Exposure to a number of common environmental contaminants, such as lead, polychlorinated biphenyls (PCBs), and mercury, may inhibit intellectual development in children and ultimately result in behavioral problems. For example, PCBs and their heat degradation products have long half-lives, cross the placenta, and are excreted in breast milk. Prenatal exposure to PCBs can cause significant developmental toxicities in animals. Children are more susceptible to PCB-induced toxic effects than adults, and these effects are more severe and influence more organ systems in children than in adults. These effects may persist throughout a child's lifespan, while in an adult only a portion of the lifespan may be affected. Continued research on toxic effects associated with low level developmental exposure to these contaminants is needed. Enhancing our understanding of the pathways by which these contaminants exert their toxic action may result in development of more effective interventions. Effects of intrauterine exposure to environmental hazards are of interest, including changes that occur in maternal biokinetics during pregnancy and determinants of placental transport and fetal accumulation of toxicants. Additional effort should also be focused on defining how such contaminants modify intellectual and behavioral development, especially in areas such as hyperactivity and learning disabilities. Alterations in cognitive and behavioral function due to exposure to such agents as metals, solvents, and pesticides have to date received little systematic attention. For the purposes of this RFA, research focusing exclusively on lead poisoning in children will be considered nonresponsive.

Growth and Development

In utero or postnatal exposure to a variety of environmental agents can have a profound influence on initial growth and development. One such area that merits research attention in both basic and applied science is sexual development. Endocrine-disrupting chemicals may affect a number of physiological processes, including onset of menses and puberty. Moreover, exposures during early windows of vulnerability may carry risks for later onset of adult diseases. For example, children susceptible to effects of air pollution have reduced lung development, leading to smaller lung capacity in adulthood; this difference may in turn have important ramifications for adult respiratory morbidity and mortality. It is also important to expand our understanding of the potential role of environmental factors in the etiology of birth defects. Parental exposure to organic solvents, agricultural chemicals, or heavy metals may increase the risk of having a child with a neural tube defect.

For all of these research areas, attention should be given to mechanistic studies of toxicity. It is also desirable that exposure assessment research be included, where appropriate. Furthermore, it is important to evaluate the contribution of genetic heterogeneity to the disease process. Information on individual variability with respect to chemical sensitivity and metabolism of xenobiotic agents has a significant role in defining disease onset and progression. Asthma susceptibility, for example, is known to run in families. Identification of asthma susceptibility genes, which might interact with environmental factors to contribute to the rising incidence of this disease, would hold significant promise for designing new prevention and treatment approaches.

Prospective applicants are strongly encouraged to discuss potential program relevancy issues as well as application preparation with the program staff contact cited under INQUIRIES in this RFA. Applicants should note that the research scope of this RFA does not include any long-term (longer than five years) studies.

DESCRIPTION OF A CENTER

A Specialized Center provides the opportunity for investigators to engage in interdisciplinary and collaborative research directed toward a specific focus in children's environmental health. It is required that each Center include community-based intervention research as well as basic studies clearly related to a disease or dysfunction. The foundation of the intervention should be strongly linked to the basic science research. The basic science studies should be driven by the needs of the intervention project. Thus, a Center should have a central theme to which all research projects pertain. In addition, a Center may include core units to provide services to the various research projects and to support the organizational and administrative aspects of the program.

Applications that include only basic or only intervention/ prevention research will not be responsive to this RFA.

The minimal requirements for a Specialized Center of Research in Children's Environmental Health are as follows:

• Each Center will propose an overall research mission and plan that are responsive to the objectives of the Specialized Center Program set forth in the RFA (see Research Objectives above).

• Each Center will support at least two basic research projects that thematically address one or more research areas listed under Research Scope. Potential basic research projects should include mechanistic studies of environmental agents which contribute to adverse health outcomes in children. These may include: basic cellular and molecular mechanisms of toxicity; pathophysiology; epidemiology; and individual susceptibility. These basic research projects should be linked to the intervention research project described below. Interactions between investigators responsible for basic research and intervention research projects are expected to strengthen the research, enhance transfer of fundamental findings to an applied setting, and identify new research directions. [It is anticipated that a Center will devote 30-45% of its budget to basic research projects.]

• Each Center will support one project that develops, implements, and evaluates a community based intervention/prevention program. Activities conducted under this RFA should be consistent with Federal Executive Order No. 12988 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, disproportionally high and adverse human health effects of environmental contaminants on minority, low-income, and medically underserved children, including African, Hispanic, Asian, and Native Americans. It is strongly encouraged that basic science projects be in a similar scientific area as the intervention research project in order to facilitate transfer of information from laboratory to the community. This project may take the form of a primary, secondary, or tertiary prevention. It is important to note that this project must specifically address all of the following parameters: (a) scientific basis of the proposed research and the hypothesis to be tested; (b) sample size needed, power considerations, procedures for sample selection, and recruitment and retention of a study population; (c) detailed description of a research design for the proposed intervention; (d) measurement instruments and their reliability and validity, considering both process and outcome evaluation; (e) data management and analysis methods; (f) identification and description of target community and known environmental health hazards; (g) means of establishing effective interaction and collaboration with community members. Because this project is intended to be community-based, the application must demonstrate a specific, existing linkage to a community-based organization and specific involvement of community members in development, conduct, and interpretation of the intervention. NIEHS, EPA, and CDC recognize that local health departments often play an important role in delivering public health services to the community. Therefore, applicants are also encouraged to consider including local, county, or state health departments in the proposed intervention research project. However, involvement of a local health department will not substitute for the required community-based organization. Applications lacking a demonstrable linkage to a community-based organization will be considered nonresponsive. [It is anticipated that a Center will devote 20-30% of its budget to one community-based intervention research project.]

• Each Center may support facility cores that provide a technique, service, or instrumentation that will enhance ongoing research efforts. Examples of such facilities are animal resources, cell/tissue culture, pathology, biostatistics, molecular biology, analytical chemistry, exposure assessment, etc. Budgeted Center projects as well as research projects external to the Center may have access to facility cores. The application should provide a total operational budget for each facility core together with the percentage of support requested from the Center grant. In addition, the Center must have in place and adequately described in the application management policies which ensure that budgeted Center projects are given highest priority in receiving services provided by the facility core. The application should explain the organization and proposed mode of operation of each core, including a plan for usage, priority setting, allocation of resources, and any applicable chargeback system. [It is anticipated that a Center will devote 10-20% of its budget to facility cores.]

• An administrative core unit which provides overall oversight, coordination, and integration of Center activities. An External Advisory Committee to the Center Director must be established. This group should consist of a group of three (3) to five (5) scientists, having expertise appropriate for the Center's research focus, plus one (1) representative from a community based organization involved in community-based intervention research. Representation from a local or state health department is also encouraged. At least 67% of Committee members should be from outside the grantee institution. The membership of the advisory committee must be approved by the funding agency. The function of this Committee is to assist in evaluating the merit, value, and contribution of research projects; the relevance and importance of individual organizational elements to accomplishing the overall goals of the Center; and the effectiveness of the newly recruited Center scientist program. [It is anticipated that a Center will devote 10-15% of its budget to an administrative core.]

• To attract new investigators into children's environmental health research, each Center is encouraged to partially support up to two (2) newly recruited Center scientists. Up to $70,000 per year, direct cost, may be used for each newly recruited Center scientist to provide up to 75% salary support, technical support, equipment, and supplies. The duration of support as a newly recruited scientist is limited to two (2) years. Following termination of support as a newly recruited Center scientist, such an individual may, if appropriate, become or continue to be a part of a basic or community-based intervention research project and make use of Center facilities. Recruitment of women and under represented minority scientists is specifically encouraged. To the extent possible, the types of individuals sought and their expected roles should be described in the application if specific individuals have not been identified. [It is anticipated that a Center will devote no more than 14% of its budget to recruitment of new scientists.]

SPECIAL REQUIREMENTS

Annual meetings, to be held in Washington, DC or 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.

In addition, since these Centers include a community-based intervention, 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.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

The NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) requires that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. Grantees, regardless of funding source, will be expected to adhere to this policy.

All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide further discussion concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by September 30, 1997, 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 subsequent applications, the information that it contains allows EPA and NIEHS staff to estimate potential review workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:
Ethel Jackson, DDS,
Chief, Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-24
Research Triangle Park, NC 27709

APPLICATION PROCEDURES

Content of Applications

A response to this RFA should consist of an application that includes a detailed description of a Specialized Center of Research in Children's Environmental Health consisting of at least two individual basic research projects, a community-based intervention research project, an administrative core, up to two newly recruited Center scientists, and, if applicable, one or more facility cores. The proposed research plan should present the applicant's perception of the Center's organization and component functions. This plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment in organizing a multiproject research infrastructure for conducting basic and applied studies in children's environmental health sciences. The research plan for the Center and all component projects must address the "Research Scope" described earlier.

The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these awards. Application kits are available at most institutional offices of sponsored research or may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov.

For individual projects or cores, page limits stated in the PHS 398 instructions must be followed. The overall Center application must also use the PHS 398 format to provide at the beginning of the application an overall summary of the Center's organization and cumulative aggregate budgeting for various research subprojects and cores. All information essential for evaluation of the application must appear in the body of the application rather than in an appendix.

If IRB or IACUC review is unavoidably delayed beyond submission of the application, a follow up IRB certification and/or IACUC verification from an official signing for the applicant organization must be sent to and received by the Scientific Review Administrator of the Special Emphasis Panel by March 2, 1998. If IRB certification and/or IACUC verification is not received by March 2, 1998, the application will be considered incomplete and returned to the applicant.

The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. 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, Centers for Children's Environmental Health and Disease Prevention Research, and number, RFA ES-97-004, must be typed on line 2 of the face page of the application form and the YES box must be checked. To simplify administration of this joint NIEHS/EPA initiative, submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to:

DIVISION OF RESEARCH GRANTS
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:

Ethel Jackson, DDS
Chief, Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-24
Research Triangle Park, NC 27709
[For overnight delivery, use:
111 T.W. Alexander Drive, EC-24
Research Triangle Park, NC 27709]

Applications must be received by January 21, 1998.

SCHEDULE

The following is the schedule planned for this initiative. It should be noted that this schedule may be changed without notification due to factors that were unanticipated at the time of announcement. Please contact the program official listed below regarding any changes in the schedule.

Letter of Intent Receipt Date: September 30, 1997
Application Receipt Date: January 21, 1998
Initial Review Group Peer Review: March, 1998
NAEHS Councilhttps://www.epa.gov/research-grants Review: May, 1998
Earliest Award Date: August 1, 1998

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness to the RFA by NIEHS and EPA Staff. Incomplete applications will be returned to the applicant without further consideration. Any application that does not meet the minimum requirements as set forth in the 'Description of a Center' section of this RFA will be considered unresponsive to the RFA and returned to the applicant. This includes, but is not limited to, an evaluation by EPA and NIEHS Staff of the program relevancy of the proposed basic research and intervention research subprojects.

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 and the EPA. This initial review group will function according to PHS policy, utilizing the review criteria stated below. As part of the initial merit review, a triage process may be used in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to this RFA. Applications determined to be noncompetitive by the review committee will be withdrawn from further consideration, and the principal investigator will receive a summary statement reflecting the reviewers' evaluation. Applications judged to be competitive will be further discussed and assigned a priority score.

Applications recommended for funding will then receive a second level review by both EPA's National Center for Environmental Research (NCER) and NIEHS's National Advisory Environmental Health Sciences Council (NAEHSC).

REVIEW CRITERIA

Evaluation of applications will be based upon the following:

1. Research Plan

• Scientific and technical merit of each proposed basic research project, including originality, feasibility, innovation, and adequacy of experimental design.

• Scientific and technical merit of the proposed intervention research study, including the extent of community sanction, interaction, and participation. Extent to which the design demonstrates sensitivity to cultural and socioeconomic factors in the community. Demonstration of effective communication channels between institutional researchers and community members. Plans for useful and practical dissemination of findings within the affected community. Adequacy of statistical and analytical methods, data management, and process and outcome evaluation measures.

• Integration of basic and intervention research into a coherent enterprise with adequate plans for interaction and communication of information and concepts among investigators.

• Cohesiveness and multidisciplinary scope of the Center as a whole. Degree of interrelationships, collaboration, and synergism of research that might be expected to derive from Center support. Coordination and interdependence of individual projects and their capacity to result in a greater contribution to the overall goals of the Center than if each were pursued independently.

• Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for recruitment and retention of subjects will also be evaluated. (See INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS.)

• Appropriateness of policies to ensure the protection of human subjects and the humane care and use of laboratory animals.

2. Personnel

• Scientific, administrative, and leadership abilities of the Principal Investigator and other key participants, particularly, but not exclusively, in the area of the proposed research. The Principal Investigator should be an established research scientist with the ability to ensure quality control and the experience to administer effectively and integrate all components of the Center. A minimum time commitment of 25% is expected for this individual.

• Documented commitment of time by key personnel for the proposed studies.

• Procedures established for recruitment and evaluation of new Center scientists. Evidence of efforts to develop novel mechanisms for recruiting candidates among women and under represented minority investigators. Potential of new Center Scientists to become independent investigators in clinical, basic, or intervention research in children's environmental health.

3. Facilities and Management

• Adequacy of administrative and technical capabilities to conduct the research proposed.

• Scientific and organizational structure of the Center, including adequacy of arrangements for external review.

• Nature and quality of facility cores. Technical merit, justification, cost effectiveness, qualifications of staff, utility to investigators, and arrangements for internal quality control, allocation of resources, priority of usage, and day-to-day management.

• Adequacy of animal facilities and appropriateness of animal care management where animal work is proposed.

• Adequacy of clinical facilities and appropriateness of patient care management where clinical work is proposed. As appropriate, access to inpatient and outpatient children's health care units providing adequate numbers of patients for intervention research projects that require patient participation. [Applications from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting proposed research. In such a case, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application.]

• Institutional assurance to provide support to the Center in such areas as fiscal administration, personnel management, space allocation, procurement, planning, and budgeting.

4. Budgeting

• Appropriateness of the proposed budget and duration in relation to proposed research.

AWARD CRITERIA

The anticipated date of award is August, 1998. Approved applications will be considered for award based on scientific and technical merit; program balance; and availability of funds. Funding will be provided to each Center by a single award from either EPA or NIEHS or a combination of two separate awards. Administrative and budgetary policies of EPA and NIEHS will apply to these awards.

In order to receive funding, an individual domestic institution's application for a Specialized Center grant must have three or more related, interactive, and high quality research subprojects that provide a multidisciplinary, yet thematic, approach to the problems to be investigated. At least one of the subprojects must be a community-based intervention. Awards will not be made for applications with research activities focused exclusively on intervention research or exclusively on basic research or for applications or components thereof proposing long-term epidemiological or large-scale clinical trial research.

INQUIRIES

Written and telephone 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:

Allen Dearry, Ph.D.
Program Administrator
Chemical Exposures and Molecular Biology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-21
Research Triangle Park, NC 27709
Telephone: 919/541-4500
FAX: 919/541-2843
Email: dearry@niehs.nih.gov

Christopher Saint, Ph.D.
Assistant Center Director
National Center for Environmental Research
U.S. Environmental Protection Agency
401 M Street, SW (8723R)
Washington, DC 20460
Telephone: 202/564-6909
FAX: 202/565-2448
Email: saint.chris@epamail.epa.gov

Direct inquiries regarding fiscal matters to:

Mr. David Mineo
Chief, Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Science
P.O. Box 12233, EC-22
Research Triangle Park, NC 27709
Telephone: 919/541-1373
FAX: 919/541-2860
Email: mineo@niehs.nih.gov

Mr. Jack Puzak
Deputy Director
National Center for Environmental Research and Quality Assurance
U.S. Environmental Protection Agency
401 M Street, SW (8701R)
Washington, DC 20460
Telephone: 202/564-6825
FAX: 202/565-2444
Email: puzak.jack@epamail.epa.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Number 66.500, 93.113, 93.114 and 93.115. Awards by NIEHS are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 100-607) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. EPA awards are made under the authority of 40 CFR Parts 30 and 40. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS and EPA strongly encourage 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 EPA and PHS missions to protect and advance the physical and mental health of the American people.