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
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 the evaluation and interpretation of those results. They are distributed free of charge to HEI’s public and private sponsors, 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 and the reports are indexed by bibliographic services such as PubMed. All HEI Research Reports can be found under Publications
ABOUT THE REVIEW PROCESS
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 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 revise the report. 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 may request additional data analyses. All reviews are done single-blinded, i.e. the applicant does not know the identity of the reviewers or which Review Committee member provided comments.
After revisions are received at HEI and the Review Committee has discussed them and approved the report, the Review Committee prepares its commentary and an HEI scientific editor edits the report for clarity and accuracy. The investigator is given an opportunity to respond to the commentary prior to publication and is asked to address the editor’s queries. 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 journal’s — distinguishes HEI from most other funding agencies.
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.
Investigators should report all sources of revenue paid (or promised to be paid) directly to them or their institution on their behalf over the past 36 months greater than $3,000. They should disclose any personal fees (monies paid to you for services rendered, generally honoraria, royalties, or fees for consulting, lectures, speakers bureaus, expert testimony) and non-financial support (for example reagents or equipment, travel costs, etc.). They should also report any patents, whether planned, pending or issued, broadly relevant to the work; and any other relationships or activities, including investment interests (stocks, bonds, and other financial instruments and investments, including partnerships).
Sample disclaimer to be added to the final report submitted to HEI:
In accordance with Health Effects Institute policy and my ethical obligation as a researcher, I am reporting that I [have a financial and/or business interests in] [am a consultant to] [receive funding from] (delete or modify as appropriate) __________ company that may be affected by, or has a financial interest, the research reported in this final report. I have disclosed those interests fully to Health Effects Institute.
This research is co-sponsored by [company A] (and may lead to the development of products which may be licensed to [company B] (optional),) in which I have a business and/or financial interest. I have disclosed those interests fully to Health Effects Institute.
If there is no disclosure, HEI will publish the following statement: “No potential conflict of interest was reported by the authors.”
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. Detailed instructions regarding the content of the final report and how to submit it are provided in the Investigators’ Guide: Preparing the Final Report
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 will require additional time at a later date.
Investigators should be prepared to submit, upon request from HEI, information underlying the final data analyses included in the report. Such information may include data sets that contain individual data as well as statistical code and output of statistical analyses with appropriate documentation. This information will be used internally at HEI and will be made available to the Review Committee to assist in their evaluation of the final report. Selected information may be included as appendices to the final report, in consultation with the investigator. Please note that this request is separate from the Quality Assurance and Quality Control
requirements. Please also see the Data Access policy and our page on Data Access and Transparency