--- 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
Information
requirement passed by Congress. The Office of Management and Budget
was
developing an implementation plan, and many scientists were concerned
that
preliminary data, lab notebooks, patient information, and other
confidential
information could be accessed by industry, the federal government, or
individuals. OMB is now proposing a modified implementation plan, and
comments
are due on September 10. The summary below is from the Washington
Fax. The
address for responding is at the end of the article.
This issue is of considerable important to science, so if you have
concerns,
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
MSC 6200
Bethesda, MD 20892-6200
Phone: 301-594-0943
Fax: 301-402-2228
e-mail: Irene_Eckstrand at nih.govhttp://www.nih.gov/nigms/
******************************************************
August 26, 1999
RESEARCH ADVOCATES LEERY OF NEW OMB PROPOSAL, THOUGH IT DOES NARROW
FOIA
ACCESS TO RESEARCH DATA-DEADLINE FOR COMMENTS IS SEPTEMBER 10
The White House Office of Management and Budget (OMB) has gone part
way-but
not
far enough-toward fashioning a rule that science can live with for
Freedom of
Information Act (FOIA) access to researchers' data, federal and
nongovernment
research officials said this week.
Fine-tuning a proposed rule that would make federally funded
researchers'data
subject to FOIA, OMB this month significantly reduced the potential
impact of
the provision by suggesting narrow definitions for such key terms as
"data,"
"published," and "policy," and by tightening confidentiality
protections.OMB
published its new proposal in the August 11 Federal Register; the
deadline for
comments is September 10. (FR Aug. 11, Vol. 64, No. 154, pp
43786-43791)
The FOIA requirement is Congress' idea, not OMB's. In an amendment to
appropriations legislation proposed by Sen. Richard Shelby, R-AL, last
October,
Congress ordered OMB to issue a rule "to ensure that all data produced
under
an
award will be made available to the public through procedures
establishedunder
(FOIA)." Efforts to repeal this mandate have so far been unsuccessful.
(see
Washington Fax 7/15/99 and 7/16/99)
"We're really pleased that OMB is being so thoughtful, trying not to
do harm,"
said Wendy Baldwin, NIH deputy director for extramural research.
"They're
doing
absolutely the best they can under the circumstances," and the
proposed
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
thatsome
scientists fear industry advocates of FOIA access to research data
want to use
FOIA to "harass" individual researchers. In addition, she still
worries about
protecting the confidentiality of patients and institutions that take
part in
research.
Jordan Cohen, president of the Association of American Medical
Colleges
(AAMC),
also praised "the remarkably conscientious and commendable effort OMB
hasmade"
to meet scientists' objections. OMB's proposed definitions and
clarifications
"would further help to narrow the application and mitigate some of the
hazards
posed by the statute," he said in an August 18 letter to OMB, although
he
suggested some additional tightening.
But Cohen warned that universities' cost of complying would not be
fully
recaptured by fees levied on people or companies seeking FOIA access
to
researchers' data. Staffing up to handle such requests would increase
institutions' costs, he said. Therefore, he urged that if OMB adopts
sucha
rule, it should raise the current 26 percent cap on "administrative"
indirect
costs institutions are permitted to charge federal research-funding
agencies.
Cohen also cautioned that the final scope of any FOIA research data
rule may
be
determined not by OMB but by federal courts, in response to likely
lawsuits.
"The AAMC remains deeply concerned that the sweeping breadth of the
underlying
statute and the absence of explicit legislative guidance as to its
implementation will undermine this revision, no matter how thoughtful
its
intent," he said.
Technically, the FOIA access requirement is being drafted as a
revision to
OMB's
Circular A-110, which lays down administrative rules for grants and
agreements
with universities, hospitals and other nonprofit institutions.
OMB issued its initial proposal on February 4, after consultation with
federal
research-funding agencies-and even that proposal significantly
narrowed
potential reach of the FOIA requirements. Rather than ordering that
labs,
notebooks, and patient records be opened on a free-for-all basis, OMB
proposed
limiting FOIA access to "data relating to published research findings
produced
under an award that were used by the federal government in developing
policy
or
rules."
The agency received more than 9,000 comments on that proposal--36
percentfrom
individual university researchers and 55 percent from "individual
members of
the
public, without any organizational identification," OMB said in its
August 11
notice. Fifty-five percent of the comments supported the February 4
proposal,
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
believes that
most of these endorsements were generated by last-minute actions and
grass
roots
campaigns from interest groups favoring the Shelby statute as a tool
to
restrict
regulatory action on environmental protection, handgun control and
other
issues," the organization says in a notice posted on its web site.
On both sides, however, many of the comments asked for clarification
of key
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
recorded
factual
material commonly accepted in the scientific community as necessary to
validate
research findings, but not any of the following: preliminary analyses,
drafts
of
scientific papers, plans for future research, peer reviews, or
communications
with colleagues." FOIA also would not touch lab materials, commercial
information, copyright- or patent-protected information, data that
must be
kept
confidential before publication, personnel or medical files, or other
data
that
might invade privacy, such as information that could identify subjects
ina
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
response to
FOIA requests universities would not have to give federal agencies
trade
secrets, commercial information, or information that would constitute
unwarranted invasions of personal privacy. But the federal agency
could come
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
asdrug
clinics or schools, that agree to participate in research studies. The
privacy
protections of FOIA do not extend to institutions.
Research results will be considered "published"-and thus subject to
FOIA
disclosure-only "when (A) research findings are published in a
peer-reviewed
scientific or technical journal, or (B) a federal agency publicly and
officially
cites the research findings in support of" an agency action, OMB's
proposal
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
use of
research that would make research vulnerable to FOIA requests.
Originally, OMB
proposed that FOIA would apply only to research "used by the federal
government
in developing policy or rules." But on August 11, acknowledging that
"policy"
is
a vague and potentially open-ended term, OMB suggested limiting FOIA
access to
research findings "used by the federal government in developing a
regulation"
under the strict notice-and-comment procedures of the federal
Administrative
Procedures Act. Such regulations, OMB noted, have the force of law,
and the
formal record of such rule-making procedures makes clear whether or
not
specific
research findings were "used" in the process.
Going even further, OMB asked for comment on the idea of limiting such
access
to
major federal regulations that would have a total cost of $100 million
or
more-a
threshold Congress has set for requiring special review of regulatory
agency
actions.
OMB has yet to settle the cost reimbursement issue. Answering one
question, it
said the fee for FOIA access to research data should be separate from
thefees
agencies charge to offset the cost of FOIA requests. It also said
agencies
should be able to hold onto the new fee-instead of giving it to the
U.S.
Treasury-so they can reimburse universities for their costs. But it
askedfor
estimates of the potential costs of such requests and for comment on
justhow
those reimbursements should be paid out.
OMB said it intends to issue a final rule by September 30. That still
leaves
time for research advocates to press Congress to repeal or delay the
mandate,
but they face an uphill fight. On July 13, the House Appropriations
Committee
turned back the latest attempt to postpone implementation of the FOIA
research
provision by a vote of 33-25.
* Bruce Agnew
The August 11 OMB notice is available on the Internet at:
http://www.whitehouse.gov/OMB/fedreg/2ndnotice-a110.html
AAMC's "Issue Brief" on FOIA access to research data is at:
http://www.aamc.org/advocacy/issues/research/a110foia.htm
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