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Final Report and Review Process

An important goal of HEI is to publish research reports of the highest scientific quality that will be of value to regulators, government officials, scientists, and the interested public. After the research has been completed, each HEI-funded Principal Investigator is required to prepare a comprehensive final report that describes the study and its findings.

About the Report

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 the evaluation and interpretation of those results. They are made available free of charge on our Publications page. The contractual obligation to prepare a comprehensive final report and to participate in the HEI review process — which is more comprehensive and rigorous than that used by most professional journals — distinguishes HEI from most other funding agencies.

About the Review Process

The HEI Review Committee, which has no role in 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) highlight 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 final report is peer-reviewed by scientists with appropriate technical expertise. The Review Committee considers comments from external reviewers together with its own assessment to produce an initial review that clearly identifies essential comments that need to be addressed. At this stage, the Review Committee generally raises questions about methods, data, results and their interpretations and conclusions drawn by the Principal Investigator. Occasionally, the Committee might request additional data analyses. As with submission of a manuscript to a journal, investigators have an opportunity to address or rebut review comments.

The investigator typically responds to the review comments and submits a revised final report. The Review Committee then discusses the report and typically approves it for publication by HEI. Only rarely has the Review Committee decided not to publish a report. Once the report has been accepted, it is prepared for publishing by HEI editors.

Review Committee's Commentary

While the accepted final report is being edited and prepared for publication, the Review Committee prepares a Commentary. It is written to reach an audience of scientists in various fields of research, technical and nontechnical members of HEI’s sponsoring organizations, scientific advisors to decision makers, and other interested individuals and groups. The Commentary places the study into a broader context of scientific issues, highlights its strengths and limitations, and discusses conclusions, interpretations, and implications of the findings. The investigator has the opportunity to review the Commentary and address any inaccuracies in the description of the work performed and respond to the Committee’s evaluation. HEI also publishes a Statement, a brief synopsis of the research written for a broad audience. The Commentary and Statement are included in the report file.

Quality Assurance Audit

HEI conducts an external quality assurance audit for any study that involves human subjects and other studies that have a high potential for use in regulatory decisions. The audit includes an evaluation of the revised final report by the auditors. In such cases, a signed statement from the auditors is included in the published report. Publication of the report is contingent on completion of the audit process and the authors addressing any concerns identified by the auditors. Please refer to HEI’s Quality Assurance and Control Procedures for more information.

Conflict of Interest

HEI requires investigators to disclose any actual or potential conflicts of interest. Investigators should report financial relationships with entities in the exposure science or environmental health arenas that could be perceived to influence or that give the appearance of potentially influencing the research described in the final report. For more information, see the HEI Conflict of Interest Policies.

Timeliness

Timeliness of research and reporting of results is an important aspect of science, and HEI expects its investigators to follow the milestones and deadlines carefully. If the results of some research are likely to play a role in regulatory processes, HEI will work with the investigators to ensure that the results, after HEI review, are available in a timely fashion.

HEI-funded investigators should be aware of the effort associated with this responsibility and plan for it accordingly. HEI expects that the Principal Investigators and key members of the team will devote time during the last year of the study to the preparation and submission of the final report. Investigators should also be aware that report revisions and answering queries from HEI editing staff during the publication process requires additional time. 

 

Templates and Guidance for writing an HEI Research Report