The Health Effects Institute
"A Partnership of the U.S. Environmental Protection Agency and Industry"

Request for Applications 1998

Introduction
What is HEI
How does HEI work
The HEI Research Program

INTRODUCTION

This is the introduction to the Fall 1998 Research Agenda of the Health Effects Institute (HEI). We thank you for your interest in HEI and its research program. The areas of research for which the Institute is requesting applications at this time are described below.

RFPA 98-4 seeks to develop a research program on metals of concern from current or future motor vehicles and fuels. Metals are used in a variety of ways in motor vehicles: In addition to their structural function and use in batteries, they are used in catalytic converters and as fuel additives to reduce certain emissions or improve engine performance, and are also found in brake pads. Although metals are added for useful purposes, such as decreasing emissions of concern, they have the potential of causing other changes in emissions that may increase the toxicity of other agents or may produce toxicity themselves. Therefore, it is important to explore the effects of these metal compounds before their widespread use in fuels or other technological developments.

Preliminary applications for RFPA 98-4 are due at HEI on January 22, 1999; full applications are due on April 20, 1999.

The purpose of this award is to bring new, creative investigators into active research on the health effects of air pollution. It will provide three years of funding for a small project relevant to HEI's research interests to a new investigator with outstanding promise at the Assistant Professor or equivalent level. For information on HEI's current research priorities, applicants should consult Appendix A, which provides an update of HEI's Strategic Plan. HEI expects to provide one award from this RFA this year and to continue the award on an annual basis. The evaluation process for these applications will consider the qualifications and background of the applicant, the quality and relevance of the research proposal, and the research environment of the applicant.

Letters of Intent for RFA 98-5 are due at HEI on December 15, 1998; applications are due on March 15, 1999.

RFPA 98-6 provides an application mechanism for investigators whose area of interest falls outside the topics targeted in other current research requests, but is relevant to HEI's current priorities. For information on HEI's current priorities, applicants should consult Appendix A, which provides an update of HEI's Strategic Plan.

Applications to RFPA 98-6 can be submitted at any time. The HEI Research Committee will review them periodically and request full applications for those considered most relevant to the needs of the Institute.

WHAT IS HEI?

HEI is a public–private partnership established in 1980 to provide decision makers, scientists, and the public with high quality, impartial, and relevant scientific information that helps answer key questions about the health effects of emissions from motor vehicles and other sources in the environment. The idea for the Institute grew from the debate between the Environmental Protection Agency and the automotive industry concerning the certification requirements in the 1977 Clean Air Act Amendments. As a result, EPA and industry representatives cooperated to establish an independent institution to carry out the much-needed health-related research. The intent of the Health Effects Institute has been to develop the facts concerning health effects carefully and credibly so that controversy about the facts themselves will be removed from the adversarial agenda and the debates over clean air can instead focus on national policy issues.

HEI is an unusual model of government-industry collaboration in support of research. The Institute receives half of its core funds from the U.S. Environmental Protection Agency and half from twenty-eight manufacturers or marketers of motor vehicles or engines in the United States. HEI also receives funding from other organizations to supplement its funding for some of its projects. For example, the Chemical Manufacturers Association and its European counterpart, the European Chemical Industry Council (CEFIC), are contributing to funding of a transitional epidemiology study evaluating biomarkers of 1,3-butadiene, and the California Air Resources Board and the Engine Manufacturers Association are contributing to new diesel epidemiology studies. The Institute has developed consultation processes with its sponsors and others to help focus its research priorities. However, none of the contributors has control over the selection, conduct, or management of HEI studies, and HEI makes no recommendations on how to apply research to regulatory policy.

The Institute's autonomy is supported, even beyond the statements in its charter, by the integrity and commitment of both its scientific leadership and its Board of Directors. Subject to the approval of the Board of Directors, the work of the Institute is carried out by two external and independent committees for research and review, each consisting of distinguished scientists knowledgeable about the scientific issues inherent to investigating the health effects of mobile source emissions. HEI's staff works with committee members in carrying out the work of the Institute.

HOW DOES HEI WORK?

After seeking advice from HEI's sponsors and others interested in its work, the HEI Research Committee determines the research priorities of the Institute. When an area of inquiry has been defined, the Institute announces to the scientific community that applications are being solicited on specific topics by issuing requests for applications such as those in this booklet. Applications are reviewed first for scientific quality by an ad hoc panel of appropriate experts. They are then reviewed by the HEI Research Committee both for quality and relevance to the goals of the research program.

Before a study is recommended for funding, there is often a negotiation period in which the investigators may be asked to address the reviewers' comments or modify the study design or budget. Studies recommended by the Research Committee undergo final approval by the Board of Directors, which also reviews the procedures, independence, and quality of the selection process. HEI's mechanism for providing funds to its investigators is a cost-reimbursement contract (Research Agreement) containing a Statement of Work, which is a description of the work to be performed in each contract year, and a budget. Because HEI is sensitive to the fact that research may generate unexpected results leading to a need for a change in the scope of work, HEI's contracts can be amended upon agreement by both parties.

During the course of each study, the Research Committee and scientific staff maintain close contact with HEI-funded investigators by means of progress reports, site visits, workshops, and the HEI Annual Conference. The ten-month progress report serves as the basis for contract renewal for multi-year projects. A site visit is conducted to many investigators' laboratories, not only to assess the conduct of the study, but also to provide an opportunity for discussion and exchange of ideas. At the annual conference, HEI investigators, Research Committee and Review Committee members, HEI staff, representatives of sponsor organizations, and invited guests meet to share information and develop new ties to strengthen the HEI community of scholars. A more detailed description of the relationship between HEI and investigators can be found by clicking here.

In order to fulfill its mission of providing timely, high-quality research results for decision makers, HEI has developed a rigorous review process to evaluate results of the research it funds. When a study is completed, the investigator is required to submit a comprehensive final report. The HEI Review Committee, which has no role in the review of applications or in the selection of projects, assesses the scientific quality of each completed study and evaluates its contribution to unresolved scientific questions. The investigator's final report and the commentary of the Review Committee are published together by HEI. Additionally, all HEI investigators are urged to publish the results of their work in the peer-reviewed literature. More information on the final report and review process can be found by clicking here.

THE HEI RESEARCH PROGRAM

The HEI research program has addressed many important questions about the health effects of a variety of pollutants, including carbon monoxide, methanol, diesel exhaust particles, nitrogen oxides, and ozone. The current research program focuses on air toxics, ambient particles, and oxygenates added to gasoline. HEI has funded studies to understand the mechanisms of diseases, to develop better methods to assess health effects and determine exposure and dose, and to address issues common to many pollutants. The program has included theoretical , in vitro, animal, controlled human exposure, and epidemiologic studies. The choices of which pollutants to study or scientific questions to investigate have been made based on many considerations, including evaluation of issues raised by sponsors and analysis of the regulatory needs and uncertainties about health effects of specific pollutants. HEI has, on some occasions, produced special reports to evaluate the state of existing science in areas related to policy and to determine research needs in new areas.

In August 1994, after extensive consultation with sponsors, scientists, and others, HEI completed the HEI Strategic Plan for Vehicle Emissions and Fuels, 1994-1998. In a 1996 update of the plan, in order to reflect better the broad scope of HEI's missions, HEI redesignated it the HEI Strategic Plan for the Health Effects of Air Pollution. HEI has always recognized that most pollutants from motor vehicles are not unique air pollutants, but are also contributed by other sources and that understanding the effects of exposure to each of several pollutants does not provide a complete picture of health effects of those pollutants together in the air. While emphasizing the broader relevance of its research program, HEI has maintained its efforts to study in a timely way pollutants that are specific to motor vehicles, such as ethers added to gasoline or particles in exhaust from diesel engines, and now with RFPA 98-4, metals emitted from motor vehicles. HEI is striving to project further into the future the possible new fuels and technologies for which health effects information would be needed to inform decisions before their widespread use. Appendix A provides an update of HEI's strategic plan.

The problems associated with the evaluation of the health effects of mobile source emissions are complicated, as researchers who have devoted their efforts to this field are well aware. The resolution of questions pertaining to the effect on health of relatively low levels of these complex mixtures is perhaps a more challenging area of scientific investigation than is often realized by industry, policymakers, or the general scientific community. HEI seeks to develop a community of scientists and scholars who can generate new collaborations and fresh approaches to the problems of air pollution. To this end, HEI has funded both established investigators and newcomers, attracting a number of scientists into this area who did not work in it before. With RFA 98-5, in this RFA book, HEI is making an additional effort to attract new investigators. The scientific community is encouraged to reach for its best tools, methods, and approaches—new or old—to address the problems of the health effects of mobile source emissions.

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