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HARVARD-UNIVERSITY

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HARVARD-UNIVERSITY

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									HARVARD UNIVERSITY
NORMA M. ALLEWELL ASSOCIATE VICE PRESIDENT FOR SPONSORED PROGRAMS AND TECHNOLOGY TRANSFER OFFICE FOR SPONSORED RESEARCH HOLYOKE CENTER – 440 1350 MASSACHUSETTS AVENUE CAMBRIDGE, MASSACHUSETTS

02138

M E M O R A N D U M

TO: FROM:

Harvard University Deans, Department Chairs, Faculty and Research Staff Norma Allewell, Office of Sponsored Research; Diane E. Lopez, Office of the General Counsel; Kevin Casey, Office for Government, Community and Public Affairs; and Susanne Churchill, Associate Dean for Research, Harvard Medical School

DATE: December 6, 1999 SUBJECT: Research Data and the Freedom of Information Act _________________________________________________________________________ As many of you know, last year Congress passed and the President signed new law requiring that research data gathered under federally funded projects be made available to the public via the Freedom of Information Act (FOIA). The law required the Office of Management and Budget to implement this requirement through a revision to OMB Circular A-110 which governs research grants to non-profit institutions. Harvard University, along with many other institutions, opposed the broad application of FOIA to data collected under research grants and attempted, unsuccessfully, to repeal the new law or revise it statutorily. During the rulemaking process, OMB provided two comment periods for the public to respond to draft implementing language. Harvard, and others, recommended significant modifications to the draft language in order to ameliorate a disclosure scheme that potentially would have interfered with the research process, violated the privacy of research subjects, jeopardized researchers' or corporate partners’ intellectual property rights, or subjected investigators or research subjects to harassment. OMB has now published the final regulation that will apply to federal research grants awarded or renewed after November 8, 1999. While the University continues to believe that FOIA is an inappropriate vehicle for providing broader public access to research data, we appreciate that the OMB accepted many of the suggestions we made during the comment period. The final revision to Circular A-110 is significantly improved over OMB's initial versions as a result. Research Data and the Freedom of Information Act December 6, 1999 Page 2
TELEPHONE: 617-496-4971 FAX: 617-495-2900 EMAIL: norma_allewell@harvard.edu

We have appended to this memo the relevant portions of the final OMB document. As you can see, a data request under the new Circular A-110 procedure can only reach data that have been used by the federal government in developing agency actions that have the force and effect of law. The agency must have publicly and officially cited the findings in conjunction with the agency’s actions or relied on findings published in peer reviewed journals. Certain research materials, such as preliminary analyses, plans for future research, and communications with colleagues, also have been excluded from the definition of data. Moreover, data is excluded when its disclosure would violate personal privacy (for example, information that would identify individuals in a clinical trial) or endanger patent rights or other intellectual property rights of investigators and/or research partners. In the past, federal funding agencies had the right to obtain research data from grant recipients, but rarely exercised this authority. Under the new disclosure scheme, a member of the public may use the Circular A-110 procedure to require the agency to contact the investigator to obtain the data. The requesting party may then obtain the data from the agency under FOIA. If you receive such a request for research data, you should immediately notify the appropriate Sponsored Research office:  For grants funded through Harvard University (with the exception of HMS/HSDM grants), notify the Associate Vice President for Sponsored Programs and Technology Transfer (Norma Allewell) in the Awards Management office of OSR. For grants to HMS/HSDM, notify the Associate Dean for Research at HMS (Susanne Churchill). For grants to affiliated hospitals, notify the hospital’s Sponsored Research office.

 

OSR will provide assistance for grants funded through Harvard in responding to the request and tracking the costs associated with your compliance. (In certain circumstances, the government will pay the costs of compliance.) When necessary, OSR will consult with the Office of the General Counsel concerning interpretations of the law. Our goal will be to comply with federal law while protecting the integrity of our research data. If you have any questions, please contact any one of us. happy to discuss this matter with you. NA:vq
FOIAmemo11-29-99-1.doc

We will be

Appendix: From the Federal Register of October 8, 1999. (c) The Federal Government has the right to: (1) Obtain, reproduce, publish or otherwise use the data first produced under an award; and (2) Authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes. (d)(1) In addition, in response to a Freedom of Information Act (FOIA) request for research data relating to published research findings produced under an award that were used by the Federal Government in developing an agency action that has the force and effect of law, the Federal awarding agency shall request, and the recipient shall provide, within a reasonable time, the research data so that they can be made available to the public through the procedures established under the FOIA. If the Federal awarding agency obtains the research data solely in response to a FOIA request, the agency may charge the requester a reasonable fee equaling the full incremental cost of obtaining the research data. This fee should reflect costs incurred by the agency, the recipient, and applicable subrecipients. This fee is in addition to any fees the agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A)). (2) The following definitions apply for purposes of paragraph (d) of this section: (i) Research data is 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. This ``recorded'' material excludes physical objects (e.g., laboratory samples). Research data also do not include: (A) Trade secrets, commercial information, materials necessary to be held confidential by a researcher until they are 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. (ii) Published is defined as either 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 that has the force and effect of law. (iii) Used by the Federal Government in developing an agency action that has the force and effect of law is defined as when an agency publicly and officially cites the research findings in support of an agency action that has the force and effect of law


								
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