Confidentiality of data
D. R. Forsdyke
forsdyke at post.queensu.ca
Sun Sep 5 07:49:36 EST 1999
--- Forwarded mail from "Eckstrand, Irene (NIGMS)"
<ECKSTRAI at nigms.nih.gov>
Date: Fri, 3 Sep 1999 07:48:37 -0400
Earlier this summer, I posted a notice about a new Freedom of
requirement passed by Congress. The Office of Management and Budget
developing an implementation plan, and many scientists were concerned
preliminary data, lab notebooks, patient information, and other
information could be accessed by industry, the federal government, or
individuals. OMB is now proposing a modified implementation plan, and
are due on September 10. The summary below is from the Washington
address for responding is at the end of the article.
This issue is of considerable important to science, so if you have
please make your voice heard.
Irene Anne Eckstrand, Ph.D.
National Institute of General Medical Sciences
National Institutes of Health
45 Center Drive, Room 2AS.25K
Bethesda, MD 20892-6200
e-mail: Irene_Eckstrand at nih.gov
August 26, 1999
RESEARCH ADVOCATES LEERY OF NEW OMB PROPOSAL, THOUGH IT DOES NARROW
ACCESS TO RESEARCH DATA-DEADLINE FOR COMMENTS IS SEPTEMBER 10
The White House Office of Management and Budget (OMB) has gone part
far enough-toward fashioning a rule that science can live with for
Information Act (FOIA) access to researchers' data, federal and
research officials said this week.
Fine-tuning a proposed rule that would make federally funded
subject to FOIA, OMB this month significantly reduced the potential
the provision by suggesting narrow definitions for such key terms as
"published," and "policy," and by tightening confidentiality
published its new proposal in the August 11 Federal Register; the
comments is September 10. (FR Aug. 11, Vol. 64, No. 154, pp
The FOIA requirement is Congress' idea, not OMB's. In an amendment to
appropriations legislation proposed by Sen. Richard Shelby, R-AL, last
Congress ordered OMB to issue a rule "to ensure that all data produced
award will be made available to the public through procedures
(FOIA)." Efforts to repeal this mandate have so far been unsuccessful.
Washington Fax 7/15/99 and 7/16/99)
"We're really pleased that OMB is being so thoughtful, trying not to
said Wendy Baldwin, NIH deputy director for extramural research.
absolutely the best they can under the circumstances," and the
clarifications are "very useful," she told Washington Fax this week.
"But ultimately we keep coming back to the fact that they're using
FOIA as the
lever for this, and FOIA's the wrong lever," Baldwin said. She noted
scientists fear industry advocates of FOIA access to research data
want to use
FOIA to "harass" individual researchers. In addition, she still
protecting the confidentiality of patients and institutions that take
Jordan Cohen, president of the Association of American Medical
also praised "the remarkably conscientious and commendable effort OMB
to meet scientists' objections. OMB's proposed definitions and
"would further help to narrow the application and mitigate some of the
posed by the statute," he said in an August 18 letter to OMB, although
suggested some additional tightening.
But Cohen warned that universities' cost of complying would not be
recaptured by fees levied on people or companies seeking FOIA access
researchers' data. Staffing up to handle such requests would increase
institutions' costs, he said. Therefore, he urged that if OMB adopts
rule, it should raise the current 26 percent cap on "administrative"
costs institutions are permitted to charge federal research-funding
Cohen also cautioned that the final scope of any FOIA research data
determined not by OMB but by federal courts, in response to likely
"The AAMC remains deeply concerned that the sweeping breadth of the
statute and the absence of explicit legislative guidance as to its
implementation will undermine this revision, no matter how thoughtful
intent," he said.
Technically, the FOIA access requirement is being drafted as a
Circular A-110, which lays down administrative rules for grants and
with universities, hospitals and other nonprofit institutions.
OMB issued its initial proposal on February 4, after consultation with
research-funding agencies-and even that proposal significantly
potential reach of the FOIA requirements. Rather than ordering that
notebooks, and patient records be opened on a free-for-all basis, OMB
limiting FOIA access to "data relating to published research findings
under an award that were used by the federal government in developing
The agency received more than 9,000 comments on that proposal--36
individual university researchers and 55 percent from "individual
public, without any organizational identification," OMB said in its
notice. Fifty-five percent of the comments supported the February 4
and 37 percent opposed it, OMB said.
Those endorsements have the earmarks of an industry-sponsored campaign
masquerading as a grass-roots effort, according to AAMC. "AAMC
most of these endorsements were generated by last-minute actions and
campaigns from interest groups favoring the Shelby statute as a tool
regulatory action on environmental protection, handgun control and
issues," the organization says in a notice posted on its web site.
On both sides, however, many of the comments asked for clarification
terms in the February 4 proposal. OMB responded by narrowing the FOIA
requirement even more in this month's version.
"Research data," under OMB's proposal, would be defined as "the
material commonly accepted in the scientific community as necessary to
research findings, but not any of the following: preliminary analyses,
scientific papers, plans for future research, peer reviews, or
with colleagues." FOIA also would not touch lab materials, commercial
information, copyright- or patent-protected information, data that
confidential before publication, personnel or medical files, or other
might invade privacy, such as information that could identify subjects
research study, OMB said.
Confidentiality decisions would be up to the universities, not federal
agencies-at least initially. OMB said that under its proposal, in
FOIA requests universities would not have to give federal agencies
secrets, commercial information, or information that would constitute
unwarranted invasions of personal privacy. But the federal agency
back and request that information.
Moreover, NIH's Baldwin notes that researchers must be able to promise
confidentiality not just to individuals but also to institutions, such
clinics or schools, that agree to participate in research studies. The
protections of FOIA do not extend to institutions.
Research results will be considered "published"-and thus subject to
disclosure-only "when (A) research findings are published in a
scientific or technical journal, or (B) a federal agency publicly and
cites the research findings in support of" an agency action, OMB's
said. Thus scientists need not fear that FOIA could be triggered by a
presentation at a scientific conference, or a university press
release, or the
distribution of a draft paper to peer reviewers.
OMB's latest proposal also narrows dramatically the kind of federal
research that would make research vulnerable to FOIA requests.
proposed that FOIA would apply only to research "used by the federal
in developing policy or rules." But on August 11, acknowledging that
a vague and potentially open-ended term, OMB suggested limiting FOIA
research findings "used by the federal government in developing a
under the strict notice-and-comment procedures of the federal
Procedures Act. Such regulations, OMB noted, have the force of law,
formal record of such rule-making procedures makes clear whether or
research findings were "used" in the process.
Going even further, OMB asked for comment on the idea of limiting such
major federal regulations that would have a total cost of $100 million
threshold Congress has set for requiring special review of regulatory
OMB has yet to settle the cost reimbursement issue. Answering one
said the fee for FOIA access to research data should be separate from
agencies charge to offset the cost of FOIA requests. It also said
should be able to hold onto the new fee-instead of giving it to the
Treasury-so they can reimburse universities for their costs. But it
estimates of the potential costs of such requests and for comment on
those reimbursements should be paid out.
OMB said it intends to issue a final rule by September 30. That still
time for research advocates to press Congress to repeal or delay the
but they face an uphill fight. On July 13, the House Appropriations
turned back the latest attempt to postpone implementation of the FOIA
provision by a vote of 33-25.
* Bruce Agnew
The August 11 OMB notice is available on the Internet at:
AAMC's "Issue Brief" on FOIA access to research data is at:
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Executive Editor: Shirley Haley
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All material =A9 1999 by Washington Fax, Inc.
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