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
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.gov
  http://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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  All material =A9 1999 by Washington Fax, Inc.



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