APPENDIX D: POLICY ON THE PROVISION OF ACCESS TO DATA UNDERLYING HEI-FUNDED STUDIES

The provision of access to data underlying studies of the health effects of air pollution is an important element of ensuring credibility, especially when the studies are used in controversial public policy debates. The open and free exchange of data is also an essential part of the scientific process. Therefore, it is the policy of the Health Effects Institute to provide access expeditiously to data for studies that it has funded and to provide that data in a manner that facilitates review and validation of the work but also protects the confidentiality of any subjects who may have participated in the study and respects the intellectual interests of the investigator in the work.

This policy applies to all research funded by HEI, whether that research was funded prior to or after November 8, 1999, when amendments to OMB Circular A-110 took effect to require access under the federal Freedom of Information Act (FOIA) to data from federally-supported research that was used in developing a federal agency action that has the force and effect of law.

In responding to FOIA requests through the U.S. EPA or other federal agency for HEI data that are subject to the Circular A-110 amendments, HEI will follow the principles established in the amendments.

In responding to non-FOIA, direct requests to HEI for data, HEI will in general follow the principles described below, which are designed to be consistent with the principles contained in the recent A-110 Amendments, although specific cases may require other arrangements for providing access.

1. Data The data to be provided will vary from study to study, but in general will consist of the recorded factual material commonly accepted in the scientific community as necessary to validate research findings. It will not include any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. The "recorded" material excludes physical objects (e.g. laboratory samples). Research data also excludes (a) trade secrets, commercial information, materials necessary to be held confidential by a researcher until published, or similar information which is protected under law; and (b) personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.

In some cases, where all of the data used is from publicly available data sets and the analytic data set can readily and expeditiously be re-created, HEI and/or the Investigator might provide detailed descriptions of how to access and use these public data sets to re-create the analytic data set in lieu of providing the full analytic data set.

2. Timing HEI will seek to provide access to data as expeditiously as possible after the completion and publication of the HEI Research Report (or Reports) resulting from the study. In doing so, HEI will, to the maximum practical extent, take into consideration the legitimate intellectual interests of the investigator to have the opportunity to benefit from his or her intellectual endeavors and to publish subsequent analyses from the data set (including additional analyses funded by HEI). In some cases, e.g for studies of particularly high regulatory importance being used to inform decisions over a short time frame, HEI may need to work to balance the investigator=s interests against the need for interested parties to obtain access in a timely manner.

3. Responsibility and Reimbursement for Costs To the maximum extent possible, HEI will encourage the Principal Investigator to be the primary sharer of the data. To the extent that providing the data would place an undue burden on the Investigator (e.g. in a situation where the sheer number of requests would not allow the Investigator to continue to conduct her or his research), HEI will be prepared to establish an alternative procedure for it to share the data. In either case, HEI will expect to receive from data requesters reasonable reimbursement for both the direct costs of providing the data, and for the time of the Investigator and/or HEI staff to gather, transmit, and explicate the data. In order to facilitate data access for all future and current studies in which HEI and the investigator expect that the results have a high likelihood of being used in supporting a regulatory decision, HEI will consider requests from the investigator for a reasonable budget of data archiving funds, to be provided as part of the project budget.

4. Confidentiality Any requester of data will be expected to obtain and adhere to all confidentiality approvals necessary to handle the data from the appropriate agencies (e.g. the National Center for Health Statistics). HEI will not knowingly itself provide, or require an investigator to provide, information that can be used to identify a specific individual.

5. Responsibility of the Data Requester In addition to the payment of reasonable costs and the obtaining of any necessary confidentiality approvals, HEI will ask the data requester, as would be normal courtesy in the scientific community, to inform both the Principal Investigator and HEI of any findings emerging from their analysis, to provide the Principal Investigator an opportunity to respond to those findings prior to publication, to provide copies to both the Principal Investigator and HEI of any papers submitted for publication from the data, and to cite both HEI and the Principal Investigator in any publication, noting explicitly that the views expressed are those of the new analyst and not those of the Principal Investigator, HEI, or HEI's sponsors.

6. HEI Decision Making All requests for data will be reviewed and decided upon by a Committee of the HEI Science Director, and the Chairs of the HEI Research and Review Committees, in consultation with both the research and review staff scientists responsible for the study in question. Any significant policy questions arising from a particular request will be considered, upon recommendation of the Committee and the President, by the Board of Directors.

The provision of data will not be simple to accomplish and will at times raise concerns and controversy from one or more parties. HEI will attempt to provide data in a manner that to the maximum extent practical fosters an atmosphere of collegiality and mutual respect among all parties, with the aim of obtaining from the sharing of data the maximum benefit for science and for the quality of the public policy decision-making process.

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

APPENDIX D: POLICY ON THE PROVISION OF ACCESS TO DATA UNDERLYING HEI-FUNDED STUDIES

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