by Charles Walter and Edward P. Richards, III, 19 IEEE Engineering In Medicine And Biology Magazine 120-2, 143 (2000).
Over the past 30 years the federal government and most states have dramatically increased public access to information held by the government. Access to federal government information is provided by the Freedom of Information Act (FOIA), and most states have passed similar laws. More recently, governments are providing this information on the Internet. In the last Congress, legislation was passed to extend FOIA access to information developed with federal research grants. This legislation was driven by a valid concern that the results of publicly financed research be available to the public and by pressure from special interest groups that wanted access to research date for commercial and political purposes. One the most common reasons for wanting access to date is to refute findings that support legislation that the groups oppose. While such data should be available for independent analysis, such requests can also be used to intimidate researchers by tying up their staff and other resources in providing access to the data.
Recognizing that implementing this legislation would be controversial, the proposed changes were published and the public was given a chance to comment on the proposal. Part I of this article outlined the first part of the process used by the Office of Management and Budget (OMB) to amend Circular A-110 to extend the Freedom of Information Act (FOIA) to "require Federal awarding agencies to ensure that all data produced under an award will be made available to the public under the FOIA." The first step occurred when Congress enacted Pub. L. 105-277 which was the legislation directing the change quoted above in Circular A- 110. The next step occurred on February 4, 1999 when OMB offered interested parties an opportunity to comment on its first version of the proposed revision. 64 Fed.R. 5684. The comment period ended on April 5, 1999. After receiving over 9,000 comments, OMB revised its proposed revision of Circular A-110 and requested further comment on August 11, 1999. 64 Fed.R. 43786. As described in Part I, the second version of OMB's proposed revision of Circular A-110 was substantially different from its first version in that "all data" was limited to certain research findings published in a peer- reviewed scientific or technical journal or that had been cited publicly and officially by a Federal agency in support of a regulation for which notice and comment is required under 5 U.S.C. 553.
OMB received over 3,000 comments in response to the changes proposed in the August 11, 1999 revision. These comments fall in the following eight categories:
A number of commenters objected that the proposed definition of "research data" would transfer authority to determine which records are exempt from mandatory disclosure under FOIA from Federal agencies to recipients. Since "research data" is not defined in Pub. L. 105-277, OMB merely provided a definition and did not intend to transfer the agency's FOIA exemption authority to recipients. 64 Fed.R. 54926 at 54928. Accordingly, the grantee, not Federal agency staff, must identify the research data in the recipient's files which are responsive to a FOIA request. Moreover, when the recipient searches files for responsive research data, and in so doing applies the definition of "research data," the recipient is not exercising the agencies' authority under FOIA to determine exemptions. Rather, the recipient is simply identifying the research data that must be provided to the agency. Thus, the fact that the recipient is responsible for searching for, and identifying, the research data does not mean that Circular A-110 has transferred the agencies' responsibility to recipients. The Federal awarding agency retains its right to ask the recipient for additional information, if it believed the recipient's submission was not complete. Several commenters expressed concern because the proposed definition of "research data" no longer included "information which may be copyrighted or patented." These commenters believed the proposed language was too broad. They argued that, under copyright law, a wide range of materials "may be" copyrighted, and therefore that such a test could unexpectedly broaden the scope of the public access. Many commenters suggested a change to the definition of "research data" to ensure that appropriate data were protected from disclosure, no matter what the format. Their suggestion was to replace the word "files" with the word "information" in the phrase "[p]ersonnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy." Examples of research data that might not be considered to be in the form of a "file" include video or audio tapes of research subjects. Finally, several commenters asked for a clarification to the revision pertaining to research data already available to the public. They suggested that if a request is made for research data the recipient has already made available to the public, through a data archive or other means, further action should not be necessary. Since this principle is used when a Federal agency responds to FOIA requests, it makes sense to apply it in this case as well. However, the Federal awarding agency should respond to the FOIA request with directions on how the requester can access the publicly available research data.
A number of commenters objected to the definition which applied the revision to research data that are used by the Federal Government in developing a "regulation." These commenters had generally been satisfied with the language found in the proposed revision ("used by the Federal Government in developing policy or rules"), because it had been used by congressional sponsors during the legislative consideration of Public Law 105-277. However, these commenters believed that the clarifying changes significantly narrowed the scope of the revision. Finally, as described in Part I, OMB also requested comment on whether limiting the scope of the proposed revision to regulations that meet (a) $100 million [impact] threshold would be appropriate in the August 11th notice. 64 FR 43791. Such a limitation received strong support, as well as strong opposition from commenters. OMB decided, at least "for now," not to limit the scope of the revision to agency actions that have an impact in excess of $100 million. As OMB and the agencies develop experience from implementing the revision, OMB may revisit this issue.
Commenters generally supported the proposed definition of "published." Some in the research community were more supportive of the first part of the definition (when "(r)esearch findings are published in a peer-reviewed scientific or technical journal") rather than the second part (when "(a) Federal agency publicly and officially cites the research findings in support of" an agency action). However, those who support the provision in Public Law 105 - 277 argued that the second part is necessary to ensure that the public can have access to the data that underlies Federally-funded research findings on which agencies rely to support their actions. OMB concluded that both parts of the definition are important to successful implementation of a data access provision that furthers the interest of the public in obtaining information while ensuring that research can continue to be conducted in accordance with the traditional scientific process. Therefore, the only change made in the definition of "published" is to make conforming revisions to reflect the previously-discussed change from "used by the Federal Government in developing a regulation" to "used by the Federal Government in developing an agency action that has the force and effect of law."
Many commenters, particularly recipients of Federally-funded research awards, expressed concern about the reimbursement mechanisms available under the proposed revision. In cases where the award's funding period expires before a request is made, neither the direct nor indirect methods of charging would allow reimbursement. Comments generally focused on the need for a separate agreement between the Federal awarding agency and the recipient, which would cover the full incremental cost of responding to the request. OMB suggested the following process: When a request is received by the Federal awarding agency, it would pass the request on to the recipient for an assessment of the costs of complying. Once the recipient has estimated an amount, the Federal awarding agency can apply its existing standards for requesting appropriate prepayments from the requester, as with the FOIA fee. When the recipient transmits the responsive research data to the agency, it should include an accounting for the associated costs. The Federal awarding agency will then seek reimbursement from the FOIA requester and reimburse the recipient.
Some commenters questioned whether the final revision would impose additional record retention requirements on recipients. The final revision only affects Section 36, which does not discuss recordkeeping responsibilities. Section 53, which does, requires that "(f)inancial records, supporting documents, statistical records, and all other records pertinent to an award shall be retained for a period of three years from the date of submission of the final expenditure report." In addition, "(t)he Federal awarding agency * * * ha(s) the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to the awards * * *. The rights of access in this paragraph are not limited to the required retention period, but shall last as long as records are retained." Therefore, if a recipient chooses to keep records longer than three years, the recipient must make them available for review in response to requests from the Federal awarding agency.
Many commenters sought clarification on the effective date for the final revision. As stated above, the revised Circular is effective thirty days after it appears in the Federal Register. The revised Circular is effective for awards issued after the effective date and those continuing awards which are renewed after the effective date.
Some commenters asked whether the final revision would apply in situations where research was funded not only by the Federal Government but also by other entities. As described in Part I, the legislative history to the provision contained in Public Law 105-277 indicates that "the amended Circular shall apply to all Federally-funded research, regardless of the level of funding or whether the award recipient is also using non-Federal funds." 144 Cong. Rec. S12134 (October 9, 1998) (Statement of Sen. Campbell). This statement is consistent with OMB's longstanding interpretation of the Circular which holds that it is applicable to all recipients, regardless of whether they also receive non-Federal funds.
Some commenters asked whether the final revision would apply to research that is funded by a Federal agency through a procurement contract. Section 2(e) of the Circular defines "award," and specifically excludes "contracts which are required to be entered into and administered under procurement laws and regulations." Therefore, Circular A-110 does not apply to procurement contracts.
After a review of these comments about the proposed August 11 revision, OMB is issued its final revision to Circular A-110 on October 9, 1999. 64 Fed.R. 54926. Specifically, OMB amended Section 36 of OMB Circular A-110 by revising paragraph (c), redesignating paragraph (d) as paragraph (e), and adding a new paragraph (d) to read as follows:
36 Intangible property. * * * * *
(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.
This final revision is identical to the second version proposed on August 11, 1999, except as follows:
(1) Data used by an agency does not have to be made available to the public unless the agency action has the force and effect of law.
While Senators Shelby, Lott, Campbell, and Gramm told OMB that the revision should not be limited to regulations, but should apply generally to "federal actions that can dramatically impact the public." 64 Fed.R. 54926 at 54928, as described in Part I, OMB concluded that the scope of the revision should not be extended to agency guidance documents and other issuances that do not have the force and effect of law. OMB intended the August 11 proposed version "to ensure that members of the public can obtain the information needed to validate those Federally-funded research findings on which Federal agencies rely when they take actions that have the force and effect of law, while at the same time ensuring that the provision contained in Public Law 105 - 277 can be administered in a manner that is workable for members of the public, Federal agencies and their recipients." 64 FR 43791. Originally, OMB referred to agency actions that have "the force and effect of law" when it included "a regulation (for which notice and comment is required under 5 U.S.C. 553)" in the proposed definitions.
Within the power granted to them by congress, federal agencies both legislate and adjudicate. They also give a lot of non-binding advice as to what they believe the law is and how to comply with it. When they legislate they do it by promulgating rules or regulations that provide the details to more general legislation passed by Congress. These have the force and effect of law, unlike the non-binding advice. Sometimes, as with the Americans with Disabilities Act, Congress passes a very detailed and specific law, leaving little discretion to the agency. In other cases, especially those involving public health and safety, the agency is given substantial discretion to collect data and to use that data to craft regulations based on the best available science. When agencies promulgate such regulations, they must publish the proposed regulation and how it was developed. In most cases, the agency only cites to published studies they rely on and sometimes to unpublished data provided directly to the agency. Prior to this change, opponents of the proposed regulations were often unable to properly rebut the government's conclusion because they cannot get access to the data behind the published studies.
While agencies also take actions that have "the force and effect of law" when they issue administrative orders (e.g., decisions issued by administrative law judges), OMB believed that agencies rarely rely on Federally-funded research in the context of their administrative orders. More importantly, agency adjudications provide more opportunity for parties to have access to the agency decisionmaking process and to question agency personnel and cross-examine their decisions. Nevertheless, in response to the comments, OMB changed the revision to refer to "an agency action that has the force and effect of law" rather than to "a regulation" or "federal actions that can dramatically impact the public." Thus if data is relied on as part of an adjudication, it would be available under these regulations.
(2) Instead of information which "may be copyrighted or patented," information which "is protected under law" may be withheld from the public.
OMB did not incorporate this language to create additional protection for intellectual property, but to harmonize the definition of research data with the other disclosure exceptions in Section (2)(i)(A) and 2(i)(B)) (trade secrets, commercial information, medical records, etc.), and "to avoid having to sort out the complexities of copyright law (and how it might apply in various areas of federally-funded research)." 64 Fed.R. 54926 at 54928. However, this change does more than clarify the scope of research data which is not subject to disclosure. It also narrows that scope from information which "may be" copyrighted or patented to information which "is" protected by copyright, patent or other law. As a practical matter, this essentially eliminates such information from protection from disclosure. Copyright law does not protect ideas or facts. Therefore, copyright law does not protect research data per se, although it may protect the creative way in which such data is compiled, a computer program, or a written article or book. It is therefore unlikely that anyone would even request disclosure of any "recorded factual material" in a form protected by copyright law or that this exception will have much applicability to research data generated in grant-sponsored research. Patent law does not protect factual material either. Utility patents are issued only for useful inventions. Patent protection arises after a patent is issued. Copies of U.S. patents are available from the U.S. Patent and Trademark Office in Washington, DC. and foreign patents from the respective patent agency where the patent issued. Therefore, this exception is also unlikely to have application to "recorded factual material" generated in grant-sponsored research. It is also unlikely that the "trade secret" and "commercial information" exceptions to the definition of "research data" will be found to apply to information generated during research sponsored by Federal agencies, especially when such research is being conducted at academic centers. Academic research is ordinarily not conducted in strict secrecy, indeed is at odds with secrecy, in part because the mission of academic research and certainly most Federally-funded academic research is the advancement and sharing of information with colleagues and students. Trade secret law, including the specie of trade secret law that protects commercial or proprietary information, generally does not protect information unless the proprietor makes extensive efforts to maintain its secrecy. As described above, recipients of Federal research grants generally have neither the capability nor the inclination to meet the usual standards imposed by the courts for information to be protected by trade secret law. Thus, these disclosure exceptions are unlikely to be applicable to most information generated in grant-sponsored research.
(3) Broaden protection of personnel and medical "files" and similar "files" to "information."
OMB agreed with this technical change and included it in the final revision to Circular A-110.
The revised circular became effective November 8, 1999.
You may obtain the full text of Revised Circular A-110, the text of the final notice, and the text of the February 4th and August 11th notices at http://www.whitehouse.gov/OMB, under the heading "Grants Management." You many obtain copies of Public Law 105-277 at http://thomas.loc.gov.
In Part III we describe the overview of the process for implementing the revision to Circular A-110 at NIH and NIH's FAQs. We will also discuss the application of state FOIA laws to state universities and research centers.
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