Freedom of Information and Research Data (Proposed Revision to OMB Circular A-100)
lpacker
>From: "Hilary Lamb. MPA" <hl...@olsonmgmt.com>
>To: <in...@acepidemiology.org>
>Subject: Proposed Revision to OMB Circular A-100
>Date: Fri, 19 Mar 1999 17:08:01 -0500
>
>Subject: Proposed Revision to OMB Circular A-100 -- To extend
>the Freedom of Information Act (FOIA) by proposing that Federal
>agencies will make available research data produced under
>Federal awards, in response to FOIA requests.
>
>This OMB proposed rule-making has significant and far-reaching
>implications for the scientific research community. There are
>many areas of concern and issues that have not been clarified.
>Thus far, there has been little comment from the research
>community, despite the serious implications.
>
>Individual scientists and investigators are strongly encouraged
>to submit comments to OMB. Although NIH will be preparing
>a single response, comments from individuals will carry great
>weight in the final decision. Government employees CAN
>submit comments to Federal Register notices as individual private citizens.
>To make that clear, it's suggested they use home address in the
>correspondence.
>
>>>> Public Comment Period through April 5, 1999 <<<
>
>Comments to OMB can be submitted via E-mail to:
>fcha...@omb.eop.gov. Please include comments in the body
>of the E-mail, NOT as an attachment. Include name, title,
>organization, postal address, and E-mail address.
>If mailing comments, send to F. James Charney, Policy Analyst,
>Office of Management and Budget, Room 6025, New Executive
>Office Building, Washington, DC 20503. If possible, include a
>word processing version of comments on a computer disk.
>
>A sample letter will be placed on the ACE website at www.acepidemiology.org
>
>FOR FURTHER INFORMATION: F. James Charney,
>Policy Analyst, OMB, at (202) 395-3993.
>The Federal Register Notice, of February 4, 1999, (Volume 64,
>Number 23, pgs. 5684-5685) is available on the Internet at
>OMB Federal Register Notice:
>http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1999_register&doci
>d=99
>_____________
>FACT SHEET: A document on the NIH Web site provides a summary
>of some areas of concern and major implications of the use of FOIA
>for data release. http://www.nih.gov/grants/policy/a110implications.htm
>Some highlighted issues --
>
>This legislation has significant implications for the conduct of research
>and the protection of research data as well as for the sharing of
>research data. While the NIH supports the sharing of research data,
>it is important that such sharing take place in the context of
>well-developed policies and procedures to address the many questions
>that may arise. The public comment period for this Notice of Proposed
>Rulemaking is an opportunity for the affected communities to raise their
>concerns and offer strategies for effective data sharing that could be
>endorsed by many different constituencies.
>
>What is data? Biomedical and behavioral research encompasses a
>wide range of types of data which might be produced under awards.
>When do data have to be released? Would the publication of any data
>require the release of all data? If not, would grantees be asked to make
>new releases with each publication? Is publication restricted to formal,
>peer-reviewed publications or does it include any public sharing of data,
>such as verbal presentations or press releases?
>
>Is privacy of individual subjects protected? Will current practices to
>ensure confidentiality and appropriate use of data be affected? How
>can such guidelines be enforced under the proposed new regulations?
>Informed consent documents frequently tell the potential subjects that
>their data will be used only for research purposes. These documents
>would have to be modified since the FOIA places no restrictions on
>the use of data.
>
>How far-reaching is this legislation? The present language applies to
>data regardless of the level of funding by the Federal government.
>This raises concerns for researchers with some Federal support who
>have collaborative studies supported by private funds and/or funds
>from other countries; this could be a serious disincentive to
>collaborative research. How will the new regulations affect the
>increasing linkages to administrative records?
>
>How long does such access remain in force? Circular A-110 essentially
>requires that grantees retain data for three years following the completion
>of a grant, although researchers may work on data far longer than that.
>If researchers still have data, are they required to provide it? Is there
>any point in time at which grantees do not have to provide data? If a
>project continues for many years--perhaps with evolving data sets--does
>the access continue as long as there is any funding for the research?
>How is compliance assured? Is the original institution obligated to
>retain and make available such data even if the investigator moved and
>completed the study elsewhere?
>
>Who bears the cost of compliance? While the legislation indicates
>that reasonable charges could be levied, it does not offer a strategy
>to ensure that the costs that are recovered are actually made available
>to those who bear the burden of preparing and providing the data.
>How might data archives be affected? Could these regulations
>perversely affect data archives designed to disseminate data? Will this
>reduce the willingness of researchers and others to donate data to these
>archives? If data are already archived, does that fulfill the request for
>release of data, and can the researchers simply direct the requester to
>the archive?
>
>Are proprietary data and data collected under CRADAs protected? Are
>there areas where potential release of early data would hinder
>collaborations?
>
>How are "regulations" and "policy" defined? There is considerable
>difference between data that are used directly to develop a policy or
>regulation and data that provide a broad background for such activities.
>It would be important to clarify how directly linked the data must be to
>invoke release under FOIA.
>
>Are there ways to assure appropriate release of data? Given the wide
>variety of types of data that might be involved, agencies might elect to
>develop their own data-sharing policies that would encompass the specific
>circumstances that they face. This would provide appropriate access to
>data for both researchers and the public, avoid disincentives to research
>collaboration and involvement for both investigators and those who would
>participate in clinical studies, and ensure that appropriate protections
>were in place for personal and institutional privacy.
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