Industry Information CARB Updates CARB Letters Response from Dan Greenbaum, request HEI for data access
Response from Dan Greenbaum, request HEI for data access PDF Print E-mail
Wednesday, 10 February 2010 00:00

Dan Greenbaum, President of Health Effects Institute response to CDTOA's letter sent on January 27, 2010 in an email on February 10, 2010.


Dear Mr. Brown:

Thank you for your recent request for data access (received February 1), on behalf of the California Dump Truck Owners Association, the Construction Industry Air Quality Coalition, and the Southern California Contractors Association. On behalf of our Chair Richard Celeste and myself, I wanted to make sure you knew the steps we are taking to respond.

In accordance with our full policy (I have attached a copy) our Director of Science Dr. Rashid Shaikh will consult with the Chairs of our Research and Review Committees and appropriate members of our scientific staff to develop a response in as timely a manner as possible. They will also contact the investigators; since a large portion of the data you seek was not actually funded by HEI and is not owned by our funded investigators or by HEI, this process may also require contact with the original creators and owners of the data. We may also have questions of you about your request and about your willingness to agree to all of the conditions in the policy.

We are as our policy states committed to providing access to underlying data wherever and whenever that is possible, subject of course to the conditions and responsibilities described in some detail in the full policy. In that spirit, we will be working to respond to your request at the earliest reasonable date; please let us know if you have further questions.

Sincerely,

Dan Greenbaum
President
Health Effects Institute
120 Second Avenue
Boston
, MA 01930 USA

ph: +1 617 886 9330 ext. 331
fx: +1 617 886 9335

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www.healtheffects.org


As you all know, UCB Professor Michael Jerrett is a California based academic and co-author of two key Health Effects Institute (HEI) studies in 2000 and 2009 that the CARB staff widely utilized to justify their diesel emissions regulations.

HEI is a nonprofit corporation chartered in 1980 as an independent research organization to provide high-quality, impartial, and relevant science on the health effects of air pollution. Typically, HEI receives half of its core funds from the US Environmental Protection Agency (EPA) and half from the worldwide motor vehicle industry (see HEI Sponsors).

Other public and private organizations periodically support special projects or certain research programs. We asked Jerrett directly to provide us this information. We also asked UC President Yudof to compel Jerrett to provide the data, no response after three weeks.

HEI policy states that HEI will provide access to the data used in these studies, so we are directly requesting all related data from these reports to be provided to us ASAP. Their own policy concerning “access to data” is highlighted below. If HEI does not provide the information in a timely manner we will take immediate legal action against this organization.


APPENDIX D: HEI 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 recreated, HEI and/or the Investigator might provide detailed
descriptions of how to access and use these public data sets to recreate 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.