HEI PROJECT NEGOTIATION, MANAGEMENT, AND INVESTIGATOR COMMITMENTSScientific Negotiation of
Project Plans HEI has two main goals in funding research. One is to build a coherent research program for each set of related studies addressing questions that are more comprehensive than would be possible with independent studies. Another is to provide timely, high-quality information to its sponsors and regulatory agencies for technological and regulatory decisions. In order to accomplish these goals, HEI works in a cooperative fashion with investigators and keeps in close contact with them through such means as progress reports, workshops, and its annual conference. The progress reports are reviewed by the HEI Research Committee and staff. In addition, HEI requires a comprehensive final report at the end of each study, which undergoes an in-depth review by the HEI Review Committee and additional experts. The purpose of this section is to provide information to future HEI investigators about HEI's management of studies and about the process for review and publication of final reports from HEI-funded studies. Applicants should read this section carefully to ensure that they understand the commitments in conducting studies with HEI funding. SCIENTIFIC NEGOTIATION OF PROJECT PLANSThe Research Committee may request modifications in the project plan or budget before making a final funding recommendation to the HEI Board of Directors. For example, the Research Committee may request deletion of parts of the proposed project that are less relevant to HEI's objectives or overlap considerably with other studies; sometimes changes in the range of exposure concentrations of pollutants are recommended to make them more representative of ambient conditions. This approach enables HEI to mold diverse investigator-designed studies into a more coherent program and to generate data more relevant to regulatory needs. HEI staff scientists act as liaisons between the Research Committee and investigators in this scientific negotiation process. The end product is a project plan that is acceptable to both the investigator and Research Committee. RESEARCH AGREEMENT (CONTRACT)Upon satisfactory negotiation of the project plan and budget, a contract for the study is negotiated with the Principal Investigator's institution. HEI's Research Agreement is a cost-reimbursement contract rather than a grant. Investigators should be aware that because scientific and administrative contract negotiations may extend through a period of several months, and may result in changes in the scope or cost of the proposed study, certain portions of the applications may have to be updated prior to contract signing. In general, HEI requires that any significant changes in personnel, scope of work, and/or budget be reflected via submission of revised budgets, project plans, or other appropriate application materials prior to the signing of the contract. For human studies and major animal studies, a protocol and Standard Operating Procedures (SOPs) should be written before the study starts (see Use of Human Subjects and Quality Assurance Program below). The contract contains a Statement of Work, which is an approved description of work to be performed in each contract year, and the budget. The scope of the research conducted should be consistent with the Statement of Work. If results suggest new directions for research, however, the contract can be amended to allow changes in the Statement of Work upon written agreement by the investigator's institution and HEI. Contracts are usually issued for one year, although HEI expects to provide support for the number of years initially approved by the Research Committee if work is progressing satisfactorily. The Research Agreement has been designed to maximize the integrity of the scientific process while providing needed protections and meeting applicable federal regulations. Once a contract is signed by both parties, an Abstract and Statement of Work written by the principal investigator may be distributed to the Institute's sponsors. These also will be available to members of the public who request them. No work should be started nor should any study costs be incurred prior to signing of the contract unless explicit written authorization is provided in advance by HEI's Director of Science or Director of Finance and Administration. STUDIES INVOLVING HUMAN SUBJECTSAs mentioned in the Instructions for Completing the Application, Additional Submissions, the applicant must submit, with the application, a written assurance for compliance with the guidelines established by the Department of Health and Human Services (DHHS) concerning protection of human subjects. This is OMB form No. 0990-0263 (HEI FORM 9). If HEI decides to fund a study involving human subjects, the investigator needs to submit, before starting the study, a detailed protocol and documentation certifying that an appropriate Institutional Review Board (IRB) has reviewed and approved the proposed study in accordance with the DHHS regulations. The specific documentation that needs to be provided to HEI prior to starting the study is the following: • Application
to the IRB (including supporting documentation such as the study protocol);
According to EPA’s rules, the EPA needs to review and approve all IRB-related documentation for all EPA-funded studies (including HEI studies) prior to the investigator starting subject recruitment. Therefore HEI will generally not sign a contract until it has received written approval from the EPA that the study’s use of human subjects complies with EPA regulations (40 CFR 26). The timely submission of the items listed above will avoid delays in the start of the study. HEI also asks that the application to the IRB (including the informed consent) be provided to HEI at the time it is submitted to the IRB. HEI may propose modifications to the informed consent if it believes that the risks to the subjects are not properly represented. Applicants who are (a) utilizing data or samples from subjects recruited for other studies or (b) collecting additional samples from subjects recruited for other studies, need to provide the IRB approval and informed consent obtained for original study and the IRB approval for the HEI study. In addition, investigators will be asked to comply with HEI’s Special Quality Assurance (QA) procedures (see below). QUALITY
ASSURANCE The Principal Investigator has the primary responsibility for development and implementation of the procedures required by HEI for QA. HEI is willing to provide some funds to support the investigator’s time required to develop the protocol and the SOPs. In that case the applicant should indicate the period required for these activities and provide a separate budget. A qualified individual selected by HEI will serve as a quality assurance officer to aid in HEI's assessment of QA activities in a study. The QA officer may conduct periodic audits to ascertain compliance with the study protocol or to examine records. He or she reports to HEI's Director of Science. The audit reports are confidential and are not released to persons not directly involved in management of the project. PROGRESS REPORTSProgress reports are one of the ways by which HEI keeps informed of the progress of the studies that it supports. Investigators are required to submit progress reports at five and ten months of the first year of the study. In subsequent years, generally only a ten-month report is required. In the final year of the contract, the ten-month progress report is replaced by a comprehensive final report (see below). The basic objective of the reports, particularly in the first year, is to indicate how much progress has been made in the development of experimental procedures, which objectives have been completed, and what problems, if any, have arisen. The ten-month report is actually a combined progress report and renewal application for the next year's funding. HEI's decision regarding renewal of the contract is based upon the information provided by the investigator in this report. The ten-month report should provide a detailed account of the experimental results obtained during the funding period, as well as a work plan, and a budget for the coming year. Progress reports are reviewed by the Research Committee and by HEI's scientific staff. SITE VISITSHEI sometimes conducts site visits to the laboratories of its funded investigators during the course of their studies. The site visit team consists of members of the HEI Research Committee, HEI scientific staff, and outside consultants. The purpose of these visits is to evaluate the status of the project, to provide the investigator with expert technical advice, and to provide an opportunity for an exchange of ideas between the investigator and other experts in the field. ANNUAL CONFERENCE AND OTHER MEETINGSEach year HEI holds an annual conference that investigators are expected to attend. The annual conference provides an opportunity for HEI's sponsors to learn more about HEI studies, for HEI to receive feedback on its research program, and for informal interactions among investigators, Research and Review Committee members, sponsor representatives, and the HEI staff. For the past several years HEI has requested that each investigator submit an abstract and poster. Abstracts are published in the annual conference booklet. In addition to discussion of HEI program areas, the annual conference generally includes special symposia on broader issues of current interest. Periodically, small workshops are organized for investigators working on projects in a particular research area. These meetings offer an opportunity for investigators doing related research to understand each other's research better and may open opportunities for coordination of studies or collaboration among investigators. In addition, critical gaps in HEI's program or ideas for new research may be identified. Providing access to data from studies of the health effects of air pollution is an important element in ensuring credibility, especially for studies used in controversial policy debates. HEI has developed a policy to provide access to data for studies that it has funded in a manner that facilitates the review and validation of the work. The policy also protects the confidentiality of any subjects who may have participated in the study and respects the intellectual interests of the investigators who conducted the study. A copy of the HEI Policy on the Provision of Access to Data Underlying HEI-funded Studies is in Appendix D. FINAL REPORTHEI has set as one of its goals to publish research reports of the highest scientific quality that will be of value to regulators, government officials, scientists, and the interested public. After a study is completed, each HEI-funded Principal Investigator prepares a comprehensive final report that describes the study and its findings. Because some of HEI's research projects are designed to provide information to be used in regulatory decisions, HEI places an emphasis on timeliness. The HEI Review Committee, which has no role in either the selection of investigators for funding or the oversight of studies, evaluates the investigator's final report. The objectives of the HEI review process are to (1) evaluate the scientific quality and significance of the research, (2) point out the strengths and limitations of the study, (3) place the study into scientific and regulatory perspective, (4) identify future research opportunities, and (5) communicate all the findings (positive and negative) to the Institute's sponsors and the public. Each draft final report is peer-reviewed by scientists with appropriate technical expertise, including a biostatistician. A compilation of the comments of the reviewers, together with the Review Committee's initial review, is sent to the investigator, who has an opportunity to respond to these comments and, if necessary, to revise the report. Occasionally, the Review Committee may request major changes such as additional analyses. Subsequently, the Review Committee prepares its commentary. The investigator is given an opportunity to comment on the commentary prior to publication. The contractual obligation to prepare a comprehensive final report and to participate in the HEI review process distinguishes HEI from most other funding agencies. Potential applicants should be aware of the effort associated with this responsibility. The HEI Research Reports, which consist of the investigator's final report and the Review Committee's commentary, are the principal means by which the Institute communicates results of its research and review processes. They are distributed to the motor vehicle industry, the EPA, the scientific community, libraries that serve medical and scientific communities, and the general public. In addition, the HEI research reports are registered with the National Technical Information Services. Reports that have been published are available in our online Publications database. PUBLICATIONSIt is the policy of the Institute that investigators are encouraged to publish results of research conducted under HEI funding in the open scientific literature. HEI retains a nonexclusive license to publish material from work funded by HEI; it is the responsibility of the investigator and his/her institution to notify other publishers of HEI's rights. A statement acknowledging HEI support and a disclaimer must appear in all publications resulting from work funded by HEI. Please use the disclaimer language in Article 16 of your Research Agreement with HEI. The Article states that investigators are free to present material derived from work conducted under this Agreement in peer-reviewed scientific journals or at meetings of established scientific organizations. Investigators are required, however, to inform HEI about the dissemination of the findings, in particular, to send HEI a copy of a manuscript based on all or part of the HEI-funded work when it is submitted to a peer-reviewed journal. Similarly, investigators are also required to send HEI meeting abstracts and presentations as far in advance of the meeting as possible. Article 16 states that HEI "discourages the disclosure of the results of the work performed under this agreement outside the scientific community until after such results have undergone scientific peer review." |
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