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The Role of Legal Policies in Data Sharing Joe Shelby Cecil and Eugene Gnff~n INTRODUCTION As an abstract principle, the sharing of research data is a noble goal and meets with little opposition. However, when data sharing is attempted in a particu- lar circumstance, the conflicting interests of the parities can thwart the ex- change. A glance at the benefits and obstacles to data sharing discussed by Hedrick (in this volume) reveals the reason: few of the benefits and most of the burdens fall to the possessor of a data set. Of course, if the person seek- Joe Shelby Cecil is at the Federal Judicial Center, Washington, D.C.; Eugene Griffin is in the Department of Psychology at Northwestern University, Evanston, Illinois. We wish to thank Hugh O'Neill, Gilbert Beebe, and other members of the American Society of Access Professionals for assisting us in sorting out the policies of the various federal agencies in disclos- ing research data. Since we did not accept all of their suggestions, it may be assumed that the er- rors that remain are our own. This manuscript was prepared for consideration by the Subcommittee on Sharing Research Data of the Committee on National Statistics at its meeting in 1982. 148
Role of Legal Policies 149 ing the data set and the person possessing it are colleagues or if the sharing of data is seen by the possessor as beneficial, then the exchange usually takes place without difficulty. But if the possessor does not view the exchange as beneficial, discussion of data sharing can turn quickly to conflict and allega- tions of the rights and responsibilities of the venous parties. ' Conflict is rarely over the simple right of possession. More likely, it is conflict in defining the limits of the proprietary interest in the data set retained by the one who develops it. Clearly, one who devotes time and effort to develop a data set has a right to capitalize on the investment through publica- tion of findings based on the data, and an adequate return on this investment may require several publications over a period of time. However, others may wish to verify the initial findings, a purpose well grounded in the traditions of science. As a conflict sharpens, the parties may look to the law in an effort to define the extent of their rights. This paper discusses several areas of the law that are relevant in defining the balance between these conflicting interests. There is no specific body of law that addresses the sharing of research data. In fact, most relevant legal standards fail to acknowledge the unusual nature of research records.2 Researchers must turn to statutes and case law developed for administrative records3 and to literatures for the standards to resolve their differences. Since these standards fail to consider the unique characteristics of research data, the results are awkward and unsatisfying. Little effort is made to balance the proprietary rights of the primary researcher and the rights of data requesters. In some circumstances the legal standards do not permit adequate disclosure for data sharing, and in other circumstances they permit such open disclosure that the interests of primary researchers in receiving rec- ognition for their work are threatened. By specifying the legal relationships among the parties, however, a role for professional standards and guidelines can be seen. Professional standards will be most effective in defining data- shar;ing practices in areas that are unregulated or where federal regulations permit but do not require disclosure. As discussed in Hedrick (in this volume), data sharing affects the interests of at least five parties: the possessor of the data set, usually the person who developed it; the data requester; the research participants; the scientific com- munity; and society. Frequently the interests of these parties are in conflict. The interests of data requesters and society generally favor access while He interests of the primary researcher and the research participants generally op- pose access (see Hedrick, in this volume). While the law has not specifically attended to the problem of access to data for research purposes, it has acknowledged in other contexts some of the inter- ests of some of the parties. The proprietary interests of primary researchers are recognized through copyright laws.S The interests of data requesters are acknowledged in exceptions to copyright protection and in statutes and case
150 Joe S. Cecil and Eugene Griffin law allowing access to federal records.6 However, neither of these private interests have received the legal recognition accorded to the public interest in developing and having available accurate information for decision making. Across a wide variety of situations, this underlying public interest in accurate information guides the legal resolution of disputes between persons who seek information and persons who possess it. The legal standards governing access to research information vary with the public or private employment status of the primary researcher and the source of funding for development of the research record system. This paper consid- ers three circumstances. The first circumstance involves access to research records developed with private funds and in the possession of a researcher supported by a private institution. This is the most basic circumstance, since the proprietary rights of the primary researcher are not affected by public funding of the research. Some proprietary rights are recognized through co- pyright protection; however, copyright law offers less protection of proprie- tary interests of a primary researcher than is available through simply with- holding the data set. In this circumstance, professional standards can be most useful in encouraging data sharing. The second circumstance involves the other end of the spectrum, research records developed and maintained by federal agencies. Legal standards in this area are well developed. The Freedom of Information Act provides a mechanism for data requesters and others to gain access to anonymous federal records. Access to identifiable federal records is more problematic since the restrictions of the Privacy Act of 1974 must be considered. The extent of fed- eral regulation of agency records suggests a limited role for professional stan- dards in this circumstance. The Bird circumstance, combining elements of Me first two, concerns ac- cess to research records developed and maintained by private researchers but sponsored through public funding of the research. This is the most difficult circumstance since He proprietary interest of He primary researcher must be balanced against the broader interest of society, an interest derived from the public sponsorship of He research. This is also an increasingly important cir- cumstance considering He extent of federal support for scientific research.7 The lack of an effective mechanism for obtaining access to research records in this circumstance also suggests a role for professional standards.8 ACCESS TO RESEARCH RECORDS MAINTAINED BY A PRIVATE RESEARCHER SUPPORTED BY PRIVATE FUNDS The first circumstance occurs when Here is a request for access to a data set developed by an independent researcher supported by private funds. This si- tuahon usually occurs when a data set is developed Trough an inexpensive la-
Role of Legal Policies 151 boratory study or from publicly available documents without federal funding for the research. The lack of federal support for either the researcher or the individual research project is the essential characteristic of this circumstance. In such a situation the right of the researcher to control access to the data is strongest, since the researcher's proprietary interest in the data is not com- promised by public funding of the data collection. Such a researcher may re- tain and use the information he or she develops just as any individual may ex- ercise a private right over personal information. The rights of those seeking access to data and the rights of research participants are very limited.9 Since there is no specific case law or legislation discussing proprietary rights in privately developed research data, those rights must be deduced from the general protection offered to intellectual property by the copyright laws. However, formal copyright protection is not the only means researchers have of protecting their investments. Unlike authors or composers who must pub- licly distribute their intellectual products to gain from their creation, research- ers can benefit from the creation of a data set through publication of analyses without distribution of a data set itself. A Protection under the copyright laws, however, must offer incentives for public distribution that outweigh the bene- fits of private possession if researchers can be expected to take advantage of ~em. Public Benefit as the Basis of Copyright Protection When researchers create a data set, they create objects of value, objects in which they can claim a property right. But it is a property right that can be difficult to protect since the property right is in information rather than in some tangible good. i~ Copyright protection, developed to meet the needs of authors and composers, can provide similar protection to researchers. The foundation of copyright protection is in the Constitution, which gives Congress the power to pass legislation (art. I, §81: "To Promote the Progress of Science and Useful Arts, by Securing for Limited Times to Authors and Inventors the Exclusive Right to their Respective Writings and Discoveries." "Science" has typically been associated with copyright protection while "Useful Arts" has been associated with patent protection. This passage can be misinterpreted to imply a general property right in the products of intellectual endeavors. However, the primary purpose of such constitutional protection is to obtain "the general benefits derived by the pub- lic from the labors of the authors" (Nimmer, 19801.~2 The Constitution seeks to further the public benefits in "Science and Useful Arts" by guarding the economic rights of authors and inventors (and researchers) in the intellectual property they create. 13 Men the private interests of authors or researchers in controlling dissemination of Heir intellectual product cannot be justified as a
152 Joe S. Cecil and Eugene Griffin means of obtaining an ultimate public benefit, those private interests will not be sanctioned by the Constitution. Copyright Protection of Research Data Sets The specific policy for obtaining the public benefits is expressed in the Copyright Act, which reflects a congressional determination of the optimal balance between the proprietary rights of those who create the information and the public benefits from distribution of that information. 14 According to the Copyright Act (§ 102), a copyright may be obtained for "original works of authorship fixed in any tangible medium of expression."~5 As implied by the language of the statute, the only two necessary characteristics for copyright protection are originality and tangible expression. A research data set can meet both of these requirements. Research data expressed in any tangible form will qualify for protection, including data on computer tape, disks, paper cards, or even scribbled data in a lab book. 16 While some forms of expression may make it more difficult to obtain copyright protection, the form of the ex- pression will not bar Me copyright as long as the expression "can be per- ceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or a device." Originality is the more fundamental requirement, since the Copynght Act (§102) restricts protection to "onginal works of authorship" [emphasis added]. Only a minimum level of originality is required, permitting copy- right even if the resulting work is substantially similar to a work previously produced (Nimmer, 1980:2.01tAl). Any nontrivial "distinguishable variation" that results from an author's independent intellectual effort will offer sufficient originality to support a claim for copyright (Nimmer, 1980:2.01[Bl; Denicola, 19811. If a data set is an original expression of a researcher, as described above, the data set can be protected as a ''compilation,,' defined by the Copyright Act (§101~7 as: A work formed by the collection and assembling of preexisting materials or of data that are selected, coordinated, or arranged ir1 such a way that the resulting work as a whole constitutes an original work of authorship. Examples of works that have been protected as compilations include city tele- phone directones,~8 interest and discount tables,~9 and other utilitarian collec- tions of facts (Nimmer, 1980:2.04EBl). Although no instance in case law was found, a scientist's collection of data, arranged in such a way as to permit some meaningful analysis, would certainly qualify as a compilation under the Copyright Act.20 Since a data set can be eligible for copyright protection, the issue becomes whether the copyright law offers sufficient control over release
Role of Legal Policies 153 and distribution of the data to encourage researchers to choose this form of protection over simple secrecy. The copyright laws attempt to promote disclosure while protecting the pro- prietary interest of the creator of a work. Consequently, copyright protection extends only to "original works of authorship" (Copyright Act, §102(a); see also Nimmer, 1980:2.011. This seemingly innocent phrase has been ~nter- preted in ways that do not suit the needs of primary researchers. The emphasis on the original work of the author or artist means that protection extends only to the original expression of facts and ideas, not the facts and ideas them- selves; a copyright on a data set will not give an exclusive right to the informa- tion itself (Nimmer, 1980:2.01; Squires, 1979:205,213~.2' Thus, the copy- right will not bar another researcher from creating an identical data set con- taining the same facts and based on the same ideas if the second data set is developed as an independent effort.22 This is true even if the purpose of the second researcher is to duplicate the work of the primary researcher.23 While the policy of the copyright law favoring dissemination may be met, a researcher's interest in retaining control over distribution of the work product may be lost.24 Even if the second data set is developed directly from the facts presented in the copyrighted data set, either for a replication of the original analysis or for a novel analysis, there may be no infringement of the copyright held by the pri- mary researcher.25 In some circumstances, even direct copying of a co- pyrighted data set will not be an infringement of the rights of the primary re- searcher. This apparent infringement is justified by the doctrine of "fair use," defined by one commentator as a "privilege in others than the owners of a co- pynght to use the copyrighted material in a reasonable manner without his consent, notwithstanding the monopoly granted to the owner by the copynght', (Ball, 1944, quoted in Freid, 1979~.26 The fair use doctrine was first developed by the courts as a means of avoid- ing unnecessary hindrances to progress in the development of the arts and sciences Mat could result from a strict interpretation of a copyright owner's exclusive rights (Freid, 1979~.27 The Copyright Act recognizes fair use of a copyrighted work, by limiting the exclusive rights of the copyright owner (§107): [T]he fair use of a copyrighted work, including such use by reproduction in copies or phonorecords or by any other means specified by [section 106], for purposes such as criticism, comment, newsreporting, teaching (including multiple copies for classroom use), scholarship, or research' is not an infringement of copyright. In determining whether the use made of a work in any particular case is a fair use the factors to be considered shall include- (1 ) the purpose and character of the use, including whether such use is of a com- mercial nature or is for non-profit educational purposes;
154 Joe S. Cecil and Eugene Griffin (2) the nature of the copyrighted work; (3) the amount and substantiality of the portion used in relation to die co- pynghted work as a whole; and work. (4) the effect of the use upon the potential market for or value of the copyrighted The four factors listed in section 107 form the test for determining if a use that overwise might be an infringement may be permitted as a fad use of a co- pyrighted work. Two of the factors, the nature of the use and the economic consequences of the use, seem to be most important in determining whether a use qualifies for the exception to copyright protection (Freid, 1979:46~7; Squires, 1979:216,232~. In general, a use that would otherwise be an infringement will be permitted if the use is for a noncommercial educational purpose and results in no appar- ent economic injury to the copyright holder (Freid, 1979:4691. Scholarly and educational uses of copyrighted material have received great deference in de- termining if a use is to be permitted: courts have permitted liberal use of co- pyrighted material if science and the arts are ~ered.28 One case noted that the doctrine of fair use will be given broader scope when a "field of learning" is concerned, and a narrower scope when the use is solely for commercial purposes.29 This deference to scholarly uses is also evident in the legislative history of the Copyright Act.30 Some commentators claim that the fair use doctrine can be explained solely by looking to Me economic consequences to the copyright holder; if there is no detrimental effect the use will be permitted (Squires, 1979:216,2321. The test for determining if the use has an adverse economic effect is prospective: Does the use of the copyrighted work "tend to diminish or prejudice the poten- tial sale of the plaintiffs work?" (Nimmer, 1980:13.05~. The relevant com- parison is between the actual market for the copyright holder's work and the market that would have existed had the use not occurred (Freid, 1979:4721. While it is always difficult to prove that this hypothetical market exists, there must be some evidence that the use diminished the market value of die co- pynghted work.3~ When the use of copyrighted work furlers the constitutional purpose of promoting "~e progress of Science and the Useful Arts," without diminishing the market value of the copyrighted work, the courts have little trouble finding that such a use is permitted under the fair use standard. An example of such an instance is Rosemont Enterprises, Inc. v. Random House, inc. ,32 in which copyrighted information was used in a biography. The court permitted the use after finding that the use served a public purpose and that the copyright owner did not suffer any detrimental economic effects from the use. Since it will be difficult for the copyright holder of a data set to show a diminished market for the data set if it is used for other scholarly purposes, it is likely Mat
Role of Legal Policies 155 the courts would find it to be a fair use. Even if there is some likelihood of demonstrating economic injury, the courts have not been willing to find that scholarly use of a copyrighted work is an infringement of the copyright protection. In Williams and Wilkins Co. v. United States,33 a publisher brought an action for infringement against a number of federal medical libraries that had been engaged in photocopying and distributing various copyrighted articles from medical journals and books to agency researchers and other libraries. This case posed a more difficult issue, since the public benefit would seem to be offset by a more obvious economic detriment to the publisher. But in this case, too, the Supreme Court permitted the use, relying heavily on findings that the photocopying practice benefited medicine and research, Hereby furthering the constitutional purpose of the protection. Though interpretation of the Court's standard of proof of economic injury is somewhat confused, 34 it seems clear that the hold- er of a copyright will have a difficult time of proving infringement when the copyrighted work is used is a way that furthers a noncommercial scholarly or educational purpose. The fair use section of the Copyright Act, along with its legislative history and judicial interpretations, suggests that the use of a copyrighted data set by a researcher for purposes of reanalysis or some over noncommercial scholarly pursuit will not be considered an infringement of the copyrighted work; the difficulty a pruna~y researcher would have in demonstrating a market for the data set, much less a diminution in market value in the data set as a result of its use for research purposes, suggests that a broad range of scholarly uses of the copyrighted work will be permitted without resulting in an infringement of the copyright protection afforded the primary researcher. Though an individual researcher may have little personal incentive to seek copyright protection for a data set, the publisher of the research may insist on an exclusive copyright to all of the material in the publication, perhaps includ- ing published portions of the data. Apparently, scholarly journals, which rely on profits from selling reprints to subsidize publication costs, are particu- larly eager to bargain for exclusive rights to as much of a scholar's work as possible (Patton, 1980~. A publishing contract will specify those rights that are transferred from the scholar to the publisher, researchers under great pres- sure to publish may have little leverage or interest in bargaining on behalf of others for broad access to the data. In some circumstances the practices of publishers of scholarly journals may discourage dissemination of research data by undercutting the fair use provi- sions of He copyright laws. If data are published, the fair use provisions of the copyright law will permit other interested parties to use the data; but when a secondary researcher seeks to publish a reanalysis of a data set previously published, the publisher of the reanalysis may choose not to rely on the fair
156 Joe S. Cecil and Eugene Griffin use exemption and insist that the secondary researcher obtain a copyright re- lease from the original publisher of the data set. If the original publisher is re- luctant to provide such a release or if the process of obtaining such a release is too time-consuming, the reanalysis may remain unpublished. While this is less a legal issue than one of customary practices among publishers, it may still unnecessarily restrict the dissemination of previously published informa- t~on. ACCESS TO RESEARCH RECORDS MAINTAINED BY FEDERAL AGENCIES Records maintained by federal agencies can be a rich source of research data.35 However, obtaining access to agency records can be a difficult problem.36 Unlike data sets developed by private researchers, records main- tained by federal agencies are governed by a web of federal statutes that are "inconsistent at best and chaotic at worst" (Commission on Federal Paperwork, 19771. These statutes determine the rights of researchers who seek access to federal records. The basic policy governing access and distribution of federal records is found in the Federal Records Act of 1950,37 part of the Administrative Procedures Act.38 These general policies have been modified by the Freedom of Information Act (FOIA),;39: and the Privacy Act of 1974.;40: Both stat- utes attempt to establish standards for appropriate disclosure of federal rec- ords. However, each was drafted to control abuses from administrative mi- suse of records and fails to distinguish between access for administrative pur- poses and access for research purposes. Consequently, researchers seeking federal records must frame their requests within the regulations and standards that do not consider the needs of research. Not all federal records are accessible through these statutes. Both the Freedom of Information Act and the Privacy Act extend only to federal execu- tive "agencies," defined as: Any executive department military department, Government corporation, Govemment-con~olled co~porahon, or other establishment in the executive branch of the government . . . or any independent regulatory agency.4~ This definition is important for what it omits. The Freedom of Information Act and the Privacy Act do not extend to either the legislative or judicial branches of government, whose agencies generally follow more restrictive policies of disclosure. The General Accounting Office, a congressional agency, has adopted policies that comply with the spirit of the Freedom of Information Act,42 but this compliance remains a matter of agency discretion rather Can a statutory right. Agencies of the judicial branch are not within
Role of Legal Policies 157 the scope of the acts,43 and no independent statement suggests adoption of these policies.44 Finally, the statutes do not extend to the Executive Office of the President.45 The next section discusses the use of the Freedom of Information Act in ob- taining access to anonymous research information maintained by federal agencies. The subsequent section examines the role of the Privacy Act of 1974 in restricting access to identifiable agency records. Finally, the interac- tion of the Freedom of Information Act and the Privacy Act is discussed in re- lation to requests for identifiable information when federal agencies are un- willing to disclose the inflation. Request for Anonymous Records for Research Purposes- The Freedom of Information Act The Freedom of Information Act (FOIA) amended the Administrative Procedures Act, a statute that had allowed the government to withhold infor- mation "for good cause" or when the requesting party was not "properly and directly concerned."46 These restrictions permitted federal agencies to inter- pret the Administrative Procedures Act in ways that severely limited access by private parties to federal records. The FOIA, based on a citizen's "right to know" (Comment, 1976a), was introduced to correct these restrictive pr~c- tices by assuring "the free flow of governmental information 'necessary to an informed electorate"' (Note, 1976a).47 The ambiguous "good cause" exemp- tion was replaced by nine specific exemptions.48 The requirement that a re- questing party be "properly and directly concerned" was dropped, with infor- mation now being disclosed to "any person."49 The FOIA requires federal agencies to make available all information to the public unless the records come under one of the nine specific exemptions.s° Two exemptions have been used by federal agencies in attempting to restrict disclosure of research information when that information is not already pro- tected by some other statute.5' Identifiable records may be protected from dis- closure under exemption 6, which applies to "personnel and medical and simi- lar files the disclosure of which would constitute a clearly unwarranted inva- sion of privacy."52 Other records, including anonymous data, may be pro- tected under exemption 4, which applies to "trade secrets and commercial or financial information obtained from a person and privileged or confidential . "53 All exemptions to the FOIA are subject to judicial interpretation. Thus far the courts have been very conservative in qualifying information as exempt from disclosure, holding that the nine exemptions of the FOIA are to be nar- rowly construed.54 Furthermore, few courts have endorsed the theory of a
158 Joe S. Cecil and Eugene Griffin court's equitable discretion in FOlA cases, which pemuts a court to refuse to order disclosure of information even when that information does not qualify as one of the nine FOLA exemptions.55 Such a narrow reading of the exemp- tions to the FOLD generally has resulted in the release of unidentifiable rec- ords for research purposes. The Trade Secret Exemption The exemption most frequently invoked to thwart disclosure of unidentifiable research data is the trade secret exemption of the FOLD, exemption 4.56 However, this effort has met with limited success. The exemption extends only to "trade secrets and to information which is commercial or financial, ob- tained from a person, and privileged or confidential."57 Anonymous research data are not customarily considered to be a business "trade secret" and Bus the data must be protected under the second part of He exemption, which has three requirements. The first requirement, that the information be commercial or financial, has been narrowly def~ned.59 For example, information has been held to be com- mercial or financial when it contained "knowledge of production, overhead and operating costs, levels of profit, sales and pricing data, as well as other factors."60 Anonymous research records do not generally meet this criterion. Documents concerning the evaluation of federally funded medical services were held not to be commercial information, since they were not "data con- cerning fees, payment schedules, or other commercial arrangements. Furthermore, [the] studies contain no information about secret formulas or rare treabnent needs; their object is He review of prevalent medical ser- vices, not esoteric expenments."6i Efforts to characterize He interests of researchers as commercial interests wormy of protection against disclosure have been unsuccessful. Washington Research Project, Inc. v. Dept. of HEW62 involved a request under the FOLD for information concerning 11 research projects being funded by the National Institute of Mental Health (NIMH). The government agency argued that since the research designs had been submitted win He expectation of con- fidentiality and since researchers' ideas are their"stock-in-trade," such infor- mation should be considered trade secrets or commercial or financial inforrnation.63 The federal appellate court held Hat the initial grant applica- tions, as well as any continuation, renewal, or supplemental applications (both approved and pending), were not exempt from disclosure.64 The court rejected the agency's stock-in-trade argument, holding Hat the reach of ex- emption 4 "is not necessarily coextensive with the existence of competition in any form.',65 Furthermore, the court stated ~at:
Role of Legal Policies 159 It is clear enough that a noncommercial scientist's research design is not literally a trade secret or item of commercial information, for it defies common sense to pre- tend that the scientist is engaged in trade or commerce. This is not to say that the scientist may not have a preference for or an interest in nondisclosure of his research design, but only that it is not a trade or commercial interest.... We cannot, con- sistently with the Act's recognized mandate to construe exemptions narrowly, . . . extend them by analogies that lead so far away from the plain meaning of Exemption 4.66 Similarly, in St. Paul's Benevolent Educational and Missionary Institute v. United States67 a group of privately funded researchers failed in their attempt to prevent disclosure of their data by the Centers for Disease Control (CDC). The researchers had conducted a survey concerning the feeding of infants in low-income families in the United States. The CDC was not involved in the survey or the analysis, but it assisted the researchers in release copies to others after they had published their results. Two companies that produce infant formula requested the CDC data prior to the researcher's publication, and the court ordered the CDC to disclose the information. The court agreed with an administrative hearing officer's findings that the trade secret exemption did not apply, since: The information in the requested materials is not confidential, commercial or finan- cial information. [The researchers do] not argue that it is privileged. The infomla- tion is certaunly not financial, and [the researchers are] not engaged in any commer- cial enterpnse.68 Even if research information is found to be commercial or financial, in ord- er to be withheld under exemption 4 it must meet two additional criteria: the information must have been obtained from a person, and it must be privileged or confidential. The requirement that information be obtained from a person simply means that the agency must have obtained the commercial or financial information from a private source rather than from a government source.69 Thus, a research contractor or grantee would qualify as a "person" under ex- emption 4. The requirement that information be privileged or confidential was ad- dressed in National Park and Conservation Association v. Morton,70 where Me court held that: [a] commercial or financial matter is "confidential" for purposes of the exemption if disclosure is likely to have either of the following effects: (1) to impair the government's ability to obtain necessary information in the future; or (2) to cause substantial harm to the competitive positive of the person from whom the informa- hon was obtained.7~ Though one need only demonstrate the likelihood of substantial competitive harm, 72 it will still be a difficult burden for one who wishes to thwart the dis-
160 Joe S. Cecil and Eugene Griffin closure of anonymous research data. Nonetheless, the substantial harm clause was successfully used in conjunction with the trade secret clause to pre- vent the release of Food and Drug Administration (FDA) data concerning manufacturers' clinical testing of artificial optical lenses in Public Citizen Health Research Group v. Food and Drug Administration.73 There the court noted that since the manufacturers were required to submit the information to the government, the agency would not be harmed by the disclosure, but that, since the manufacturers "would sustain substantial competitive injury because their competitors would be receiving, free of charge, We benefits of this costly research and testing," the data was considered "confidential commercial in- formation exempt from disclosure under FOIA exemption 4." Sections of anonymous research data have also been withheld because their release might "impair the government's ability to obtain necessary informa- tion in the future." For example, in Orion Research Inc. v. Environmental Protection Agency74 the court held that a technical proposal by a private bidder relating to the development of a monitoring system qualified as a trade secret exemption, partly because disclosure could result in a chilling effect on submission of proposals to the agency. More interestingly, in Consumers Union v. Veterans Administration7s the court found that certain data con- cerning the testing of hearing aids did not qualify for nondisclosure under ex- emption 4, yet, by applying its "equity jurisdiction"76 the court still decided to withhold some of the information since it might mislead the public and result in the government's receiving a more limited selection of hearing aids which, in turn, would curtail its research program.77 Thus, it appears that the trade secret exemption to the Freedom of Information Act will not restrict the release of agency research infonnation when that data is not identifiable unless such release might "impair the government's ability to obtain necessary information in the future" or substan- tially harm a business's competitive position. Ire the few instances in which the courts have limited access under these interpretations, there were circums- tances that are unlikely to be present when most researchers seek access to agency records.78 If the release will not hann a business or jeopardize the government's ability to obtain information, the requested information will be released without consideration of the propriety interest of Me persons who developed the information. The same standard of disclosure will permit re- lease of research proposals and data submitted as interim reports from OIlgO- ing research.
Role of Legal Policies Other Issues 161 Though not dealing specifically with the trade secret exemption, three other issues have arisen in cases dealing with the release of anonymous research da- ta. First, in order to be considered anonymous under the Act, records must have all names and identifiable numbers removed, as well as any information that might allow indirect identification.79 Second, the removal of identifiers from a set of records does not create a new set of records.~° Thus, an agency cannot avoid a request for anonymous records by claiming that it maintains the records only in identifiable for. Third, the courts may require raw data as well as statistical summary data to be released. In Long v. I.R.S.,82 a party requested data that the Internal Revenue Service had compiled in a series of national studies measuring the level of compliance with federal tax law. The Internal Revenue Service re- leased the statistical summary data but would not release the raw data on which the analyses were conducted. The Long court ordered the raw data re- leased, stating that: [tlhe [distract] court reasoned that what was really important were the statistical ta- bulations previously disclosed, not the raw data, because it was only from the statis- tical summary that the effectiveness of the IRS could be evaluated. This conclusion is valid only if we assume that the IRS statistics encompass every useful analytic conclusion that could be down from the information. We find no evidence in the record to support that proposition.83 The Role of the Privacy Act in Regulating Disclosure of Identifiable Records Maintained by Federal Agencies The Freedom of Information Act provides researchers with a mechanism to obtain access to anonymous federal records even if the federal agency is reluc- tant to release them. But some research purposes require identifiable records (see Boruch and Cecil, 1979~. This section addresses the general restrictions on the ability of agencies to release identifiable information even if the agency is willing to release such information. Most of these restrictions are found in the Privacy Act of 1974.84 Judicial interpretation of the Privacy Act has been slow to develop, and no case directly addresses the problems of access to sta- tistical and research record systems.85 In addition, published commentary from the research community concerning implications of the Privacy Act and other restrictive legislation has been limited.86 With no case law and only lim- ited commentary on this problem, observations and conclusions concerning the impact of the Privacy Act on research records must necessarily be specula- t~ve.
162 Overview of Me Privacy Act Joe S. Cecil and Eugene Griffin The Privacy Act of 1974 is the first attempt by Congress to provide compre- hensive protection of an individual's right to privacy by regulating the collec- tion, management, and disclosure of personal information maintained by gov- ernmental agencies. The Act regulates over 6,500 federal record systems, in- cluding bow administrative and research record systems.87 Before the Privacy Act was passed, federal policy toward data management practices encouraged data sharing among agencies in order to reduce the burden and expense of reporting. This open-access policy was restricted only when statutes pro- vided for the confidentiality of specific sensitive record systems.89 The Privacy Act reversed this general policy by recognizing the right of individ- uals to control dissemination of information provided about themselves to fed- eral agencies. The Privacy Act seeks to strike a sensitive balance, preserving individuals' interests in controlling identifiable information while recognizing the legitimate uses of that information. In general, research and statistical uses of identifiable information receive no special recognition under the Privacy Act. However, the act does make a distinction in Me definition of administrative records, the primary concern of the legislation, and the definition of statistical records. The term "record" is defined as "any item, collection or grouping of information about an individ- ual Tat is maintained by an agency, . . . and that contains his name, or ident~- fying number, symbol, or other identifying particular assigned to the individ- ual, such as a finger or voice print or photograph."90 This general definition is Men narrowed by the subsequent definition of He term "statistical record," defined as: A record in a system of records maintained for statistical or reporting purposes only, and not used in whole or in part ~ making any detenninahon about an identifiable individual, except as provided by Section 8 of Title 13 [authorizing certain research activities by the Bureau of Me Census].9~ Thus, statistical records are distinguished from administrative records in terms of the uses of He information and the consequences to the individual supplying the information. Recognition of this distinction suggests congres- sional awareness of He utility of such research record systems. However, He Privacy Act imposes He same general scheme of regulation on statistical and administrative records that are identifiable. Briefly, the Privacy Act of 1974 requires that federal agencies must (1) grant access by individuals to Heir identifiable records maintained by fed- eral agencies; (2) ensure Hat existing information is bow accurate and timely, and limit He collection of unnecessary information; and (3) limit the disclo- sure of identifiable information to third parties. This Bird provision of the Privacy Act, forbidding the disclosure of any identifiable record without He
Role of Legal Policies 163 prior written consent of the individual,92 is most relevant to researchers' ac- cess to federal data. This prohibition is also the crux of the right of privacy provided by the act, since an enforceable consent requirement could thwart the disclosure of identifiable information for purposes that the individual nev- er considered and would not approve. In recognition of legitimate needs for identifiable information, the Privacy Act carves out 11 categories of exceptions to the consent requirement. For instance, an agency may, at its discretion, disclose records without prior writ- ten consent to officers and employees of the agency who have a need for the record in the performance of their duties.93 Other exemptions include disclo- sures that are required by the Freedom of Information Act; to the Bureau of the Census for planning or carrying out a census, survey, or related activity under Title 13; to the General Accounting Office to permit auditing of federal programs; and in emergency circumstances involving the health and safety of any individual. In addition, the act permits disclosure without written con- sent to other federal agencies for authorized civil or criminal law enforcement activities,94 and, pursuant to a court order, disclosures to which individuals would most likely decline to consent. Perhaps it was this same concern that led Congress to include an exemption for itself.95 Of special interest to researchers is an exemption that permits disclosure "to a recipient who has provided the agency with advance adequate written assur- ance that the record is to be transferred in a form that is not individually identifiable" (§552a~b)~5~. While the practical benefits of such an exemp- tion may be questioned (see discussion below), the exemption indicates an at- tempt by Congress to accommodate the need for access to agency records for research purposes. Similarly, agency records of historical interest may be transferred to the National Archives without obtaining consent (§552atb)~6~. Fearing that it had failed to provide for all of the legitimate needs for identi- fiable infonnation Mat merit an exclusion, Congress also included a "safety- valve" exemption, permitting disclosure without consent for a "routine use" of the record (§552a~b)~3~. A "routine use" is "for a purpose that is compati- ble with the purpose for which it was collected" (§552aka)~7~. Instead of ob- taining individual consent prior to disclosure for such a use, the agency must only publish a notice of the anticipated routine uses of the record in the Federal Register and accept comments from the public for a period of 30 days (§552ake)~4~(D), (e)~51~111) 96 Two furler points regarding disclosure should be noted. First, the re- quirement of prior written consent of an individual may be avoided by in- serting broad waiver provisions in the original request for inflation. If a person signs such a waiver, identifiable inflation may be released for pur- poses consistent with We waiver.97 Finally, the Privacy Act places no obliga- tion on the recipients of information to maintain the confidentiality of the rec-
164 Joe 5. Cecil and Eugene Griffin ords or limit subsequent disclosure. Once the records are released to a party not under the jurisdiction of the act, there is no assurance that the individual's rights will be protected. Subject to the exemptions noted above, the Privacy Act prohibits disclosure by any agency of any record contained in a system of records to a person or to another agency without the written consent of the individual to whom the rec- ord pertains (§552aLb)~. The extent of the regulation of social research by the act is determined by the manner in which it defines such terms as "record," "system of records," and "agency." "Record" is defined as "any item, collection, or grouping of information about an individual that is maintained by an agency . . . and that contains his name, or the identifying number, symbol, or other identifying particular as- signed to the individual . . ." (§552afa)~4~. Since such a record can include "as little as one descriptive item about an individual . . . ,"98 identifiable re- search data can clearly qualify as a "record" for the purpose of the act. The Privacy Act extends to record systems maintained by "agencies" of the federal government:99 clearly, systems of research and statistical records maintained by such agencies are regulated by the act; just as clearly, private data archives or record systems maintained by state or local governments without federal assistance are exempt from the act. However, not all "records" maintained by "agencies" are regulated by the Privacy Act. Mindful of the administrative burden on agencies that would re- sult if access were permitted to all identifiable information, Congress res- ~icted We protection of the Act to records that are contained in a "system of records" (§552a~b)), further defined as "any group of records from which in- fo~ation is retrieved by the name of the individual or by some number, sym- bol, or other identifying particular assigned to the individual" (§552ata)~5~. This definition encompasses a vast number of identifiable records maintained by federal agencies,~°° but it does not extend to those record systems in which the information is not actually retrieved by individual identifier. Restrictions on Researeb Access to Agency Record Systems by the Privacy Act of 1974 The Privacy Act's prohibition on disclosure of identifiable information with- out the prior written consent of the individual can sharply restrict the use of identifiable federal records for research purposes. Researchers usually seek access to agency record systems either to obtain a sample of individuals for anticipated research or to supplement existing research information.'°~ The consent requirement can interfere with both of these activities. When seeking to supplement existing research data with information from agency records, in an ideal situation researchers would be able to anticipate
Role of Legal Policies 165 this need and obtain the informed consent of research participants at the time the information is gathered. But even if a research participant agrees to subsequent release of agency information, the consent may be invalid if the researcher seeks access to records in a system that did not exist at the time consent was obtained.'02 And when the need for research access to agency records was not anticipated or when the initial consent becomes invalid, a re- searcher may have to recontact the participants to obtain proper consent. Recontacting a participant in an earlier research study imposes special diffi- culties. Some target populations are highly mobile, so addresses and tele- phone numbers obtained at the initial encounter may be outdated. Some tar- get populations are difficult to recruit for research, so subsequent attempts to obtain consent to release agency information will likely be expensive and sub- iect to self-selection biases. Even more formidable obstacles are faced by researchers who seek access to agency records to generate a sample of identified individuals to be con- tacted for participation in anticipated research. Since the purpose is to obtain a list of names and addresses of individuals, the researcher will be unable to contact the individuals to obtain consent for release of this information. Researchers employed by the agency maintaining the records may avoid such consent requirements by demonstrating a need for the record in the perfor- mance of their duties. 103 But some researchers outside the agency have found the consent requirement a frustrating hurdle.~04 At hearings of the Privacy Protection Study Commission, a number of researchers who rely on file link- age to conduct longitudinal research were sharply critical of the potential for disruption of their research by the restrictions of the Privacy Act,~05 although some of these problems have apparently been avoided by designation of re- search as a "routine use" of many of the most important systems (Bebee, 1981:661,666~.~°6 However, without such a designation, the Privacy Act represents a considerable obstacle to researchers who seek to use federal rec- ords to identify or locate persons they wish to include in their sample of re- search subjects. Several of the exemptions to Me disclosure requirements in the Privacy Act may be of some aid to researchers. i07 Me most obvious example is the ex- emption that permits agencies to disclose information for purposes of statisti- cal research if the record is transferred in a form that is not individually identi- fiable (§552atb)~51~. In fact, this exemption offers very little: a record that is not individually identifiable is not a "record" within the definition of the Privacy Act (§552ata)~41) and therefore is not subject to the restrictions on disclosure imposed by the act.~°8 Nevertheless, the Privacy Act will not thwart requests for anonymous research records. Such records may be useful for a number of research purposes. Statistical and administrative procedures have been developed that permit meaningful statistical analysis of data while
166 Joe S. Cecil and Eugene Griffin preserving the anonymity of the respondents.~09 For example, techniques of microaggregation permit statistical analysis of information on identified groups of individuals (Campbell et al., 1975~. Release of such aggregated in- formation would seem to be permitted under the act: since the information is not individually identifiable, disclosure is not restricted. A mutually insulated file linkage technique may even permit agencies to share large archives of aggregated data without violating the act (Campbell et al., 1975~. Merely removing the name or individual identification number may be suf- ficient to permit disclosure under the exemption for statistical research. The exemption states that disclosure is permitted only if the record is "in a form which is not individually identifiable" (§552atb)~5~. The guidelines for implementation of We Privacy Act interpret this phrase to mean: Not only that the infonnation disclosed or transferred must be stripped of individual identifiers, but also Hat the identity of the individual cannot be reasonably deduced by anyone from tabulations or over presentations of Be infonnation (i.e., the iden- tity of the individual cannot be determined or deduced by combining venous statisii- cal records or by reference to public records or other available sources of information). A This guideline implies that where the research population is small and some of the variables are also recorded with names on publicly available lists, precau- tions beyond We deletion of identifiers must be taken to guard against public disclosure. ~ ~ ~ For example, the data may be "inoculated" wide random error or the reporting categories may be structured so that they do not correspond to categories available in public reports (Riecken and Boruch, 1974~.~2 Unless such methods are used, the identities of the individuals may be inadvertently disclosed, in violation of Me act. Many research needs cannot be satisfied by anonymous data (Boruch and Cecil, 19791. Researchers may attempt to ob- tain identifiable agency records by tailoring Weir requests to fit the exemp- tions of Me Privacy Act. One of the most important exemptions (§552a(b)~2~) permits disclosure of agency records required to be disclosed under the Freedom of Information Act. Since Me Freedom of Information Act requires an agency to disclose recordsunlike the Privacy Act, which simply permits an agency to disclose if it chooses to do sothis exemption is most useful to researchers when an agency resists disclosure. The interrela- tionship between the Privacy Act and the Freedom of Information Act is quite complicated (see below). Another exemption Mat may assist researchers seeking identifiable infor- mation permits the transfer of identifiable agency records to Me Bureau of the Census for planning or carrying out a census, survey, or over related activity (0552a~b)~41~. The law also permits linkages between agency files when conducted by Me Bureau of the Census for some purpose, such as to establish the credibility of these alternative sources of information. Furthermore, this
Role of Legal Policies 167 exemption allows the Census Bureau to accept identifiable agency records to perform certain statistical analyses for researchers outside the Census Bureau who are unable to gain access to these records. ~13 Since such analyses appear to be a "related activity" under the exemption, the Bureau has been acting as a broker for such research (Office of Federal Statistical Policy and Standards, 1980b; Commission on Federal Paperwork, 19771. The final exemption that might benefit researchers permits disclosure of an identifiable record for a "routine use" of such a record (§552aLb)~31~. "Routine use" is defined as a use "for a purpose which is compatible with the purpose for which [the record] was collected" (§552aka)~7~.~4 Such ambi- guity in statutory language suggests that an agency may define "statistical analysis" as a routine use of all or a selected portion of agency record systems, permitting researchers outside the agency to have access to identifiable rec- ords without gaining the consent of the individuals to whom the records per- tain. In fact, a great many agency notices allow for disclosure involving sta- tistical research programs as a routine use. The Department of Health and Human Services has been particularly thorough in identifying record systems that have research potential and publishing notices permitting research as a routine use (see, generally, O'Neill and Fanning, 1976~. One version of the routine-use notice requires an assessment of the risks and potential benefits of the research and requires the recipient to sign an agreement to protect the rec- ords from subsequent disclosure. ~15 This is one instance in which the discre- tion delegated to agencies by the Privacy Act has been used to fashion a spe- cific set of standards to permit data sharing while maintaining the proper safe- guards. However, We need to rely on the routine-use exemption to overcome the failure of He statute to provide for research and statistical access to identi- fiable records is an awkward solution to the problem. Without a statutory policy concerning research access to federal records, individual agencies are free to develop inconsistent regulations that may either be too restrictive or fail to offer adequate protection to the identified individuals. ~16 In summary, the Privacy Act's failure to distinguish research and statistical purposes from administrative purposes in restricting access to records may pose a major obstacle for researchers who seek identifiable information, espe- cially when a list of names and addresses is needed to develop a sampling frame for research. In general, a researcher must structure a request for ac- cess to identifiable infonnation to fit within one of the exceptions to the con- sent requirement of the Privacy Act, such as the routine-use exemption. Request for Identifiable Information for Research Purposes When an Agency is Unwilling to Disclose As mentioned above, both the Freedom of Information Act (FOLD) and the Privacy Act of 1974 deal with the release of identifiable records by the federal
168 Joe S. Cecil and Eugene Griffin government. However, the two statutes have opposite purposes. The FOIA is designed to encourage disclosure of agency records, while the Privacy Act is designed to protect the privacy of any individual who is the subject of a gov- ernment record. Prior to the implementation of the Privacy Act, researchers could use the FOIA to obtain identifiable information within the constraints of the exceptions to disclosure. The impact of the Privacy Act on disclosure practices under the FOLD remains a matter of speculation and dispute. A third party seeking an identifiable record without permission of the iden- tif~ed individual must base the claim for access either on the FOIA or on one of the Privacy Act's exemptions to the consent requirement. As noted above, the Privacy Act lists 11 exceptions to the requirement of prior consent, one of which is disclosure under the FOLA (5 U.S.C. &552atb)~211. This exception to the consent requirement for disclosure is the crucial exemption when a third party requests identifiable records and the agency resists disclosure (as dis- cussed above). Most commentators contend this exemption indicates a con- gressional intention to exempt from the restrictions of the Privacy Act all per- sonal information not constituting a '~clearly unwarranted invasion of personal privacy" under the standards of exemption 6 of the FOIA as they existed prior to the implementation of He Privacy Act.~7 In other words, this interpreta- tion suggests that the Privacy Act was not intended to change existing prac- tices of disclosure of identifiable information under the Freedom of Information Act. Other commentators believe that the adoption of the Privacy Act indicates an additional interest by Congress in He privacy of indi- viduals that should be considered by the courts, resulting in greater restric- tions on disclosure under the FOLA (see, e.g., Arnold and Kiss~loff, 1976, and M. HuleK, 1975~. Unfortunately, case law has not addressed this con- flict. However, under either of these interpretations release of identifiable in- formation will have to meet at least the standards of the Freedom of Information Act. The major exemption used to prohibit disclosure of identifiable information under the FOIA is exemption 6, which applies to "personnel and medical and similar files the disclosure of which would constitute a clearly unwamnted in- vasion of privacy." While there have been many court cases concerning this exemption,~9 including two Supreme Court cases, it is still not clear what constitutes a "clearly unwarranted invasion of privacy." Nonetheless, the Supreme Court has suggested that exemption 6 permits the withholding of information only when two requirements have been met: [Flirst, the inflation must be contained in personnel, medical or "similar" files, and second, the infonnation must be of such a nature that its disclosure would con- stitute a clearly unwarranted invasion olpersonal privacy. i2}
Role of Legal Policies 169 The first requirement, that a record be classified as a "personnel," "medical," or"similar" record, was given a fairly broad definition in United States Department of State v. The Washington Post Co.,]22 in which the Supreme Court held that records containing passport and citizenship informa- tion qualified as "similar" files. After a review of the legislative history of exemption 6, the Court concluded that the term "similar" files was not limited to files that contain "intimate details" and '`highly personal" ~nformation.~23 Instead, the Court looked to congressional statements that exemption 6 was a '~general exemption" protecting information in "great quantities of files," and Me Court concluded that: We do not think that Congress meant to limit Exemption 6 to a narrow class of files containing only a discrete kind of personal information. Rather, 'the exemption twas] intended to cover demled Government records on an individual which can be identified as applying to that individual....' When disclosure of information that applies to a particular individual is sought from government records, courts must determine whether release of the information would constitute a clearly unwarranted invasion of that person's privacy. 124 Thus, the Court quickly reached the second part of the test. While Me Supreme Court in the Washington Post case did not decide the issue of the clearly unwarranted invasion of privacy, the Court did in Department of Air Force v. Rosettes examine bow the probability and conse- quences of identification before deciding to release anonymous case summar- ies of honor code hearings. The Court pointed out that the exemption did "not protect against disclosure every incidental invasion of privacy only such disclosures as constitute 'clearly unwarranted' invasions of personal pnvacy,"~26 and that the exemption required a balancing of the individual's right to privacy against the public's right to open govemment. In conducting this balancing test, the lower courts have first looked for the possible privacy interests that might be invaded. For example, in Washington Research Project, inc. v. Department of HEWS the district court pointed out that "the identity of an institutional applicant [may not] be concealed because the right to privacy envisioned in the [FOIA] is personal and cannot be claimed by a corporation or association." Similarly, in Public Citizen Health Group v. Department of HEWS a group sought access to agency records that evaluated federally funded medical services, including information from hospital profiles, patient records, and physician profiles. The district court held that the hospitals did not have a cognizable privacy interest but that the patients and physicians did. }30 Having found a privacy interest, that interest must then be balanced against the degree of public interest served by the disclosure. The party seeking the information must be able to point to a public interest being served by the court would not release personnel information to a group of employees, stating that
170 Joe S. Cecil anal Eugene Griffin "[tithe disclosure of personnel records in the instant case would be a serious in- vasion of privacy" since the information sought was "personal and capable of causing embarrassment" while "practically no public interest is advanced by disclosure."~32 Also, it is not enough for the party seeking the information to have another private interest to be balanced against the subjects' privacy. A public interest is necessary to justify the disclosure. Thus, researchers were granted access to a list of employees eligible to vote in a union election so that a study of He effectiveness of National Labor Relations Board (NLRB) election regulations could be conducted.~33 Lists of names and addresses were also disclosed when the requester wished to lobby for those persons. ~34 The court ordered that an agency preserve certain records to avoid mooting an FOIA request when the plaintiff sought to identify parties for an antitrust class action. t35 However, disclosure has not been required when the coot perceives a private rather than public interest furthered by disclosure. In one case an employer was denied access to union cards maintained by the NLRB since the cards were to be used by the employer to attack the validity of union registration, fi,rthenng what the court determined to be a private rather Han a public interest.~36 Similarly, a business was refused access to a list of names and ad- dresses it sought for purposes of sending out store catalogues and announce- ments, with He court again discerrung little public interest. i37 Several commentators have criticized a court's emphasis on He requester's purpose in seeking disclosure (Kronman, 1980; Easterbrook, 1980), especial- ly since once the information is released to someone outside the federal gov- erurnent it is no longer protected under the Privacy Act or He FOLA. Thus (Easterbrook, 1980:775,7811: A requester might juster his inquiry on the ground of scientific research and then sell the information to someone else who will use it for different purposes, because it seems clear that anyone who obtains information under the FOIA can broadcast it as he please. Finally, just as with exemption 4 cases, agencies have argued that disclo- sure under exemption 6 would "impair the government's ability to obtain ne- cessary information in the future." For example, in Public Citizen Health v. HEW,~38 BW argued that disclosure would result in diminished participation by He medical profession in He evaluation process and in the medicare and medicaid programs. The court found that such considerations were valid, but Hat in this case Hey were simply broad speculations without supporting evidence. 139 ~ addition, as one commentator Aries ~asterbrook, 1980:797-799), the impact of disclosure on an agency is a major considera- tion in He agency's decision of whether to oppose release of the infonnation in the first place. In fact, most FOLA litigation involves only the agency Hat
Role of Legal Policies 171 possesses the information and the requesting party. The individual whose rec- ords are being sought is rarely allowed to participate in He litigation, if the person is informed of it at all. In summary, the confusion regarding research access to identifiable data under the Privacy Act becomes even greater when identifiable information is sought under the Freedom of Information Act. Although He courts have or- dered the release of some identifiable records under the FOIA, the relation- ship between He FOIA and He Privacy Act continues to be controversial. Of course, if disclosure of records is pe~tted, the proprietary interest of the pn- mary researcher in the data will not be considered. The extent of federal re- gulation of agency records leaves little opportunity for professional standards for data sharing to influence the process. While waiting for case law and new legislation to address these issues,~40 researchers must do their best to weave Neil way Trough He conflicting standards. ACCESS TO RESEARCH RECORDS DEVELOPED WITH PUBLIC FUNDS THAT ARE MAINTAINED BY PRIVATE RESEARCHERS The first two sections of this paper addressed circumstances in which there is little confusion over the private or public character of the research informa- tion. However, the private or public status of a data set can be difficult to de- termine when research data sets are developed through public funding of pn- vate researchers. This is a common circumstance. During fiscal 1979, for ex- ample, the federal government spent almost $4 billion to fund research by uni- versities, usually by research grants or contracts (National Commission on Research, 19801. The question is whether public funding of such data per- mits access through the laws regulating the federal data archives or the private status of He researcher removes these data sets from federal regulation. \4} Scope of Federal Regulation of Research As noted above, the two federal laws most relevant to general access to feder- al data archives are He Freedom of Information Act and He Privacy Act of 1974; they extend only to agency records and define "agency" as: Any executive department, military department, Government corporation, Government controlled corporation, or other establishment in the executive branch of the government . . . or any independent regulatory agency. 142 The Freedom of Information Act authorizes the federal district courts to en- join an "agency from withholding agency records and to order He production of any agency records improperly withheld from He complainant."~43 Recent
172 Joe S. Cecil awl Eugene Griffin interpretations of the term `'agency records" have been rather restrictive and not likely to aid researchers who seek access to data sets maintained by private researchers but developed with public funds through either contracts or grants. Two recent Supreme Court cases in which scholars sought records not maintained by federal agencies suggest that the FOLA and the Privacy Act will not be an effective means of obtaining access to data sets developed through research grants. The most widely known case is Forsh~m v. Harris,~44 in which researchers sought access to data developed under an extended research grant. In that case a federal agency, the National Institute of Arthritis, Metabolism, and Digestive Diseases (the institute), awarded a series of re- search grants to the University Group Diabetes Program (the university group), a group of private physicians and scientists conducting a long-term study of the effectiveness of certain treatments of diabetes. The study was funded solely by the federal government at a cost of approximately $15 mil- lion. The study generated more than SS million records documenting the treatment of over 1,000 diabetic patients who were monitored for 5-8 years. As with most such research grants, the institute exercised some supervision over the research and had a right of access to the raw data, even a right to ob- tain permanent custody of the raw data generated by the university group. However, the day-to-day administration of the research was by He university group. The institute did not exercise its right to review or obtain custody of the raw data, which remained at all times in the possession and control of the university group. Ultimately, the university group's reports on the results of its study indi- cated that the use of certain drugs for the treatment of diabetes resulted in an increased risk of death from cardiovascular disease compared with treatment by the other methods studied. These findings then led the Food and Drug Administration (EDA) and the secretary of the Department of Health, Education, and Welfare to adopt regulations to control He labeling and use of those drugs. When the university group began releasing its preliminary findings in 1970, its conclusions were challenged by other researchers. The Committee on the Care of the Diabetic (the committee), a national association of physicians ins valved in the treatment of diabetes patients, was among He most persistent critics of the university group study. The committee requested access to the raw data to facilitate its review of He university group's findings, and the uni- versity group declined its request. The committee then sought to obtain ac- cess to the research data under the Freedom of Information Act. 145 The case was furler complicated by He involvement of the federal agency in authorizing a review of the findings Although no employees of the insti- tute reviewed the research records of the grantee, He institute did contact in
Role of Legal Policies 173 1972 with another private grantee, the Biometric Society, for an assessment of the university group study. The Biometric Society was given direct access to the raw data by the terms of its contract with the institute. The Biometric Society issued a report to the institute in 1974 concluding that the university group results were "mixed" but '`moderately seong." The researchers seeking access to the data under the Freedom of Information Act found no friend in the courts. The Court of Appeals denied the FOIA request, concluding that records of grantees are not "agency records" since the FOIA applies only to records that have been "created or obtained . . . in the course of doing its work."~46 In a dissenting opinion, Judge Bazelon concluded that the university group data were "agency records" under the FOIA since the government had been `'significantly involved" in the study Trough its funding, access to raw data, and reliance on Me study in its regulatory actions. 147 The Supreme Court, in an opinion written by Justice Rehnquist, made clear that In normal circumstances the FOLA does not extend to records developed by research grants: We hold here that written data generated, owned, and possessed by a privately con- trolled organization receiving federal study grants are not "agency records" within the meaning of the Act when copies of those data have not been obtained by a feder- al agency subject to the FOIA. Federal participation in the generation of the data by means of a grant from HEW does not make the private organization a federal "agency" within the teens of the Act. Nor does this federal funding in combination with a federal right of access render the data "agency records" of HEW, which is a federal "agency" under the teens of the Act. t48 In reaching this conclusion the court relied heavily on the legislative history of the FOIA, i49 and found that Congress chose not to confer any direct public rights of access to such federally funded project information. ~50 This inte~pre- tation suggests Cat federal funding of a research record system alone is not sufficient to provide a right of access to the data to other researchers. The Committee on the Care of the Diabetic advanced a second argument, contending that while in ordinary circumstances the records of a grantee are not agency records, the reliance by the federal agencies on the research data of grantees in developing their regulations was sufficient to transform these rec- ords into "agency records" within the meaning of the statute. It argued that in this case, in which the agency was actively involved in the development of the research records, had a right of access, exercised that right of access through a second grantee, and then based its regulations on the conclusions of the re- search, the extent of involvement and reliance of the agency on the records of We grantee was sufficient to transform them into agency records within the meaning of the statute. 15 ~ The Supreme Court also rejected this argument, turning to the legislative
174 Joe 5. Cecil and Eugene Griffin history of related statutes that emphasize the possession and control of records in defining an "agency record."~52 The court did suggest that in some cir- cumstances, such as if a grant created a partnership or joint venture between an agency and a grantee, there may be a right of access to records held by a grantee,~53 but it concluded that no such relationship existed in this case. Since the court found that the records were not "agency records" within the meaning of the statute, the court affirmed the action of the Court of Appeals in dismissing the FOIA request. In a dissenting opinion, Justice Brennan, joined by Justice Marshall, showed more sympathy to the second argument of the committee. Justice Brennan contended that In some circumstances the relationship between an agency and a grantee, and the importance of the information in developing public policy, can transform the research records of a grantee into "agency records" within the meaning of the Freedom of Information Act, therefore making them available to the public. Justice Brennan noted that the purpose of the Freedom of Information Act was to "open the processes of government to public inspection," and that "[nlothing in the legislative history suggests that Congress meant to allow agencies to insulate important steps in decision making on the basis of technical niceties of who 'owns' crucial docurnents."~54 Justice Brennan concluded: Where the nexus between the agency and the requested information is close, and where the importance of the information to public understanding of the decisions or the operation of the agency is great, I believe the congressional purposes require us to hold that the information sought is an "agency record" within the meaning of the Freedom of Information Act.... The existence of this factor can be tested by ex- aniining, inter alia, He degree to which the impetus for the creation of the record came from the agency or was developed independently, the degree to which the creation of the record was funded publicly or privately, the extent of governmental supervision of the creation of the record, and the extent of continuing governmental control over the record. ]55 The dissenting opinion of Justice Brennan took into account a number of the issues mentioned by Hedrick (in this volume) concerning justification for data sharing. He noted the scholarly debate that surrounded the dispute and We public impedance of research data when they become involved in the re- gulatory process. In conclusion, he noted: "If the records of such organiza- tions [i.e., grantees], when drawn directly into the regulatory process, are im- mune from public inspection, Hen government by secrecy must surely red ,,~56 The interpretation of He majority in Forsham suggests that the research records of a grantee cannot be obtained through He Freedom of LnfoImation Act. The fact Hat He research findings are controversial and that He findings are used in establishing public policy Trough various agency proceedings will
Role of Legal Policies 175 not be considered in determining the right of access to research records through the FOIA. This case suggests that an agency can insulate its actions from public scrutiny by funding a grant for controversial research and then basing its action on those findings. As long as the agency does not take pos- session or control of the records, the FOlA will not assist those who wish to challenge the findings that underlie the agency action. Of course, if the data are filed with the agency, the FOIA will be a more effective means of obtain- ing disclosure. In the companion case to Forsh~m, Kissinger v. Reporters Committee for Freedom of the Press,~57 the Supreme Court sounded another discouraging note for researchers who seek to use the FOIA to gain access to data not in the direct possession of federal agencies. In that case, several reporters, along with representatives of the American Historical Association and the American Political Science Association, attempted to gain access to telephone notes made by Henry Kissinger while he was Secretary of State. They sought to rely on the Freedom of Information Act. Their FOIA requests were filed after the records were wrongfully removed from the State Department, tran- sported to a private estate, then deeded to the Library of Congress with specif- ic restrictions concerning who should have access to them. When the State Department denied the FOIA request, the parties turned to the federal courts, contending that because the records had been wrongfully removed from the State Department, the State Department still had access to the records and should be required to retrieve them and make them available for inspection. Both the federal district court and the court of appeals ordered production of the requested information.~58 The Supreme Court reversed. Again, Justice Rehnquist wrote for the majority, and he stated: We hold today that even if a document requested under the FOLA is wrongfully in the possession of a party not an "agency," the agency which received the request does not "improperly withhold" Hose materials by its refusal to institute a retrieval action. When an agency has demonstrated that it has not "withheld" requested rec- ords in violation of the standards established by Congress, the federal courts have no authority to order production of such records under the FOLA. ~s9 The majority in Kissinger reasoned that an agency cannot withhold records, under the meaning of the Freedom of Information Act, if it does not have pos- session of those records. ~60 To the plaintiffs' contention that the wrongful re- moval of the records from the control of the agency should not defeat their right to obtain access, the court responded that Congress has established a scheme for management and disposal of records under the Federal Records Act of 1950~6~ and the Records Disposal Act,~62 and that scheme did not con- template a private right of action for wrongful removal. t63 After another ex- tensive examination of legislative history, the court concluded that "Congress did not mean that an agency improperly withholds a document which has been
176 Joe S. Cecil and Eugene Groan removed from the possession of the agency prior to the filing of the FOIA request."~64 In emphasizing the timing of the FOLA request, the Court sug- gested that it might permit access to records if it is shown that an agency pur- posefully routed a document out of its possession in order to circumvent a FOLA request, but it did not decide this issue. ]65 Justice Brennan, again writing in dissent, took exception to what he de- scribed as, "the Court's crabbed interpretation of 'improper withholding' und- er He Freedom of Information Act." Again he cited the public access purpose of the Freedom of Inflation Act, and thought it "plainly unacceptable for an agency to devise a records routing system aimed at frustrating FOLA re- quests in general by moving documents outside agency custody with unseem- ly haste."l66 Justice Stevens, also writing in dissent, emphasized the wrongful removal of the documents from the agency, and noted that the decision of the majority, ". . . creates an incentive for outgoing agency officials to remove potentially embarrassing documents from their files in order to frustrate future FOIA requests." He interpreted the Freedom of Information Act to modify the con- gressional scheme expressed by He Federal Records Act of 1950 and the Records Disposal Act and to require an agency to produce requested docu- ments if it retains a legal right to the custody of those documents wrongfully removed from its files. 167 The majority opinion in Kissinger suggests Hat researchers' efforts to ob- lain research data in possession of an agency will be unsuccessful if the agen- cy removes those documents from its custody prior to He filing of He FOIA requesteven if the documents are wrongfully removed from agency custo- dy. However, if the documents are removed after the filing of the FOLD re- quest and He persons requesting access can show that the purpose of the re- moval was to thwart access, the court has implied that access may be permit- ted. The Forsham Ed Kissinger cases indicate the importance of the timing of the FOLA request: it must be feed while He agency has custody of the data. If it is filed before custody passes from the grantee to the agency, Forsham indi- cates that there will be no right of access, if it is filed after custody passes from the agency, even if the documents are wrongfully removed, Kissinger indi- cates there will be no right of access. Together these cases provide a conven- ient means of pennitiing agencies to thwart access to research records while still basing Heir regulatory actions on controversial findings. An alternative way of obtaining data may be available to some parties af- fected by an agency's regulatory action, even when Pose data are not accessi- ble through the FOLD or the Privacy Act. In Dow Chemical Co. v. Allen, 168 He Environmental Protection Agency suspended the use of two herbicides manufactured by Dow and scheduled cancellation heanogs. The emergency
Role of Legal Policies 177 suspension was ordered as a result of certain animal toxicity studies conducted at the University of Wisconsin. The researchers had voluntarily turned over the data from the study that the agency had relied on in ordering the suspen- sion, but they refused to turn over the data from other, similar uncompleted studies. Since the data remained at Wisconsin and were not in the agency's possession, under the Forsham decision the data were not accessible through the FOIA. However, under section 6(d) of the Federal Insecticide, Fungicide, and Rodenticide Act,~69 an administrative law judge can issue a subpoena for documents relevant to cancellation heanngs. Dow subpoenaed all of the data from the ongoing Wisconsin studies, and Dow pressed its case on appeal even though the researchers did not plan to testify at the cancellation hearings and the findings of the disputed studies were not to be introduced as evidence in the hearings. The Court of Appeals refused to enforce the sub- poena, holding that it would be an unreasonable burden on the researchers to require them disclose this additional information since the incompleted stu- dies were of little probative value and since the risk of inadvertent, premature disclosure outweighed the need for the information. Furthermore, the court noted that requiring such a disclosure would unreasonably restrict the re- searchers' first amendment interest in academic freedom. 170 Such a factor has not been considered by any other courts in FOIA or Privacy Act cases. The Forsham case considered access to records developed through a re- search grant. The issue with regard to research contracts is not so clear. Typically, agencies are more involved in the conduct of research funded through contracts. The Privacy Act indicates that its regulations apply when "an agency provides by contract for the operation by or in behalf of the agency of a system of records to accomplish an agency function...."171 Since a contract to conduct research would appear to be a contract to "accomplish an agency function," the record systems necessary to conduct research supported by federal contracts would seem to fall within the terms of the Privacy Act. However, for some time after the passage of the Privacy Act and the deve- lopment of clarifying guidelines,~72 some agencies contended that contractors performing statistical surveys were not subject to the act, even though it may be necessary to establish a system of records to perform the contract.~73 Apparently this situation is still somewhat confused. The Commission on Federal Paperwork (1977) suggested that federal contractors arid grantees should be required to comply with the Privacy Act (see also Privacy Protection Study Commission, 1977, and Office of Federal Statistical Policy and Standards,1980b), and apparently there has been increasing compliance by contractors. However, to the extent that federal contractors and grantees avoid complying with the Privacy Act, federal agencies will be able to avoid responsibility for record keeping practices, even though the records come into existence only because of federal funding. As long as the research data are
178 Joe S. Cecil and Eugene Griffin not filed with the agency, the records remain beyond the reach of the Freedom of Information Act and may be disclosed at the discretion of the primary re- searchers without regard to the Privacy Act's restrictions on disclosure. Professional standards for data sharing can play an important role in directing disclosure practices of research contractors and grantees. SUMMARY AND CONCLUSIONS Legal standards for access to research data vary with the status of the person or institution possessing the data. This paper examined access to data in three circumstances: (1) a data set developed by a private researcher with private funding, (2) a data set developed by a federal agency, and (3) a data set deve- loped by a private researcher with federal funding. The first circumstance, in which He primary researcher both develops and maintains the data set with private resources, is the simplest case. Since pos- session of the data by the primary researcher is not compromised by federal funding, he or she may exercise great discretion in restricting access. Control over data allows primary researchers to adequately protect their own interests. From this perspective, the available legal protection can offer few advantages over simple secrecy. And although primary researchers may choose to copy- nght the data set, such protection may be ineffective in restricting disclosure to those persons they choose. Once data are published, the fair-use provi- sions of the copyright laws will permit broad use of the data by others for scholarly purposes. The absence of effective legal standards in this circumstance suggests an important role for professional guidelines. Such guidelines can recognize the rights of primary researchers to be the first to publish their findings, while en- couraging data sharing once those proprietary interests have been realized. Such guidelines can be tailored to individual professional associations with specific needs and customs concerning data access. Professional guidelines may also be useful in encouraging publishers to adopt less restrictive practices in permitting republication of previously published data sets. Standards for data access established by scholarly journals affiliated with professional asso- ciations may be able to lead the way in reforming overly restrictive publishers' practices. The second circumstance, in which data sets are developed and maintained by federal agencies, is Be most heavily regulated area in which data sharing occurs. This circumstance may be of particular interest since it includes many data sets that are relevant to the study of public policy issues. Since federal laws and regulations were drafted to correct abuses of administrative records, Nose star~dlards do not address He needs of He research community, permitting overly broad disclosure in some instances and unnecessarily re- stricting disclosure in others.
Role of Legal Policies 179 The legal standards governing access to records possessed by federal agen- cies turn on whether or not identifiable records are requested. If unidentifi- able records are sought, the Freedom of Information Act usually requires re- lease of the information. The broad disclosure provisions of the FOIA can be helpful in obtaining a range of unidentified federal agency records, even if the agency resists disclosure. Unfortunately, these same broad disclosure provi- sions may be used to obtain information that trespasses on the proprietary rights of those who submit research proposals to federal agencies. In addition to research data from completed studies, such proprietary information in- cludes literature reviews, preliminary theoretical analyses, and even clinical trial data from ongoing research. In general, if the information is not identifi- able and is maintained by a federal agency, the FOIA requires the agency to disclose the information, whether or not such disclosure interferes with the proprietary rights of the person who gathered the information. In instances in which identifiable records are sought for research purposes, federal policy is too restrictive. The Privacy Act of 1974 places sharp limita- tions on release of identifiable records, permitting no exception for research. The resulting restrictions on access to identifiable federal records can be a per- sistent problem faced by researchers who need to develop sampling frames. Though the Privacy Act offers a few exemptions that may permit release of identifiable records for research (such as the "routine-use" exemption), these exemptions are exercised at the discretion of agencies. Without agency coop- eration, and sometimes even with it, researchers will face a difficult time ob- taining access to identifiable federal records. When an agency does not wish to provide access to identifiable federal rec- ords, a researcher may attempt to obtain the records under the Freedom of Information Act. In cases in which the courts have ordered disclosure of identifiable records, an awkward balance has been shuck between the con- flicting goals of the Freedom of Information Act and the Privacy Act. Legal standards in this area remain unclear. However, a researcher who seeks iden- tifiable records without the support and assistance of the federal agency that has them should anticipate a long and frustrating smuggle. While federal regulation of agency records leaves little opportunity for pro- fessional guidelines, there is a clear need for researchers to contribute to res- tructuring the legal standards in this area. Though the Freedom of Information Act is quite helpful in obtaining a wide range of anonymous fed- eral records, it also permits access to research proposals and other information that may trespass on the proprietary rights of those who are seeking federal funding for their research, even if no such funding is granted. Disclosure of anticipated research plans and data frown research in progress seems to go beyond appropriate sharing of information. While arguing for a more restric- tive disclosure for research proposals under the Freedom of Information Act, researchers should also seek broader disclosure exemptions for research pur-
180 Joe 5. Cecil and Eugene Griffin poses under the Privacy Act. This legislation was intended to correct adminis- trative abuses of identifiable records; no instance of research abuse of identif~- able records was cited. Yet the same restrictive interpretations are extended to requests for identifiable data for research purposes. The third circumstance involving data sets, those developed through federal funding of priorate researchers, presents the most complicated area of regula- tion. In this circumstance the proprietary rights of the private researcher are compromised only by the source of funding for the research, since possession of the data is retained by the private researcher. Recent Supreme Court deci- sions suggest that unless the research records are directly maintained by the federal agency, He FOLA will be an ineffective tool in obtaining access. Though the precedents are confusing and regulations vary from agency to agency, it appears that if an agency does not take possession of the research data, the agency can fund the research, participate in the design and develop- ment of the research, permit access by third parties to the data, base regulatory findings on the conclusions of the research, and yet thwart access to the rec- ords by persons and organizations the agency does not wish to have them. Even if the agency once possessed the data and wrongly forfeited possession before access was sought, no access to the records is required. This standard invites agencies to structure their relationships with research grantees and contractors in such a way that controversial or sensitive federal research rec- ords relied on by the agencies will be beyond public scrutiny. One solution to this problem may be to require agencies to take possession of research data sets they rely on in setting policy. Once the records are in the possession of the agency, the FOLA may be used to compel disclosure. As indicated throughout this paper, the statutes and case law relevant to ac- cess to research records have been developed without consideration of the unique aspects of research records. In some areas access is too broad; in oth- er areas access is too restrictive. In those areas in which access is permitted but not required, professional guidelines and standards may encourage agen- cies to adopt more open disclosure policies. In other areas, in which statutes and regulations result in access that is either too broad (e.g., release of prelim- inary research data) or too restrictive (e.g., no release of identifiable records, no release of data from grantees and contractors, even if the findings are used by the agency), modifications of existing legal standards should be sought. NOTES 1. Nelkin (1982) offers an excellent overview of the variety of disputes Mat involve control of research data and findings. 2. The unique character of research data is discussed in Privacy Protection Study
Role of Legal Policies 181 Commission (1977). 3. Freedom of Information Act, 5 U.S.C. §552 (1976); Privacy Act of 1974, 5 U.S.C. §552a ( 1976); see below. 4. Pub. L. No. 9~553, §102(a) (1976), encoded as 17 U.S.C. §101 er seq. (1976); see be- low. 5. Pub. L. No. 9~553, §102(a) (1976), encoded as 17 U.S.C. §101 et seq. (1976); see be- low. 6. Freedom of Information Act, 5 U.S.C. §552 (1976); Privacy Act of 1974, 5 U.S.C. §552a (1976); Forsham v. Harris, 445 U.S. 169 (1980); see below. Though Hedrick (in this volume) identifies a fifth group, the scientific co~Tununity, it has received no special recognition under the law. When the interests of the scientific community are considered, it is in the context of further- ing some general societal purpose. Rights of research participants are also given little recogni- tion in law governing access to data, but are acknowledged in statutes and regulations specifying the proper conduct of federally funded research. 42 U.S.C. §242(a) (1976); 21 U.S.C. §1175a (1976); 42 U.S.C. §3771 (1976); 42 U.S.C. §242m(d) (1976); Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects, 45 C.F.R. §46 (1981). Consequently, this paper focuses on the rights of the primary researcher and the data requester, interpreting these rights in the context of the benefits to society, the interest given greatest defer- ence under the law. 7. The federal government spent approximately $12 trillion on basic and applied research in 1980 (National Science Board, 1981). Reductions in federal funding for scientific research may result in renewed attention to the data sets developed with federal funding in past years. The pol- icy of the Reagan administration toward funding of social and behavioral sciences is discussed by Holden (1981), Mosteller (1981), Prewitt and Sills (1981), Holden (1982), NonTlan (1983a, 1983b). 8. There is a fourth circumstance that may be considered as a separate category, arising when a privately developed data set is maintained by a federal agency; see, e.g., St. Paul's Benevolent Educational and Missionary Institute v. U.S., 506 F. Supp. 822 (N.D. Ga. 1980). This situation is very rare and appears to be governed by the standards discussed under circumstances involving access to agency records under the Freedom of Information Act (see below and Dickson, 1980). 9. No general right of access to privately developed research data exists outside the context of litigation. The rights of those seeking access to data arise only in those rare circumstances in which both the primary researcher and the person seeking access to the data are parties to litiga- tion. Even then only limited access may be permitted to meet the needs of the litigation. For an example of an instance in which the court refused to permit access to confidential research records developed by a researcher who was not a party to litigation, see Richards of Redford v. Pacific Gas and Electric, 71 F.R.D. 388 (N.D. Cal. 1976). The general rights of research participants to control access to research records is even more limited. The legal relationship between a re- searcher and research participants who have received promises of confidentiality is discussed by Teitlebaum (1983); see also Boruch and Cecil (1979). 10. "Secrecy is likely to work most effectively where the uncopyrighted product is an inter- mediate good which is itself used in the production of other goods, e.g., if it is a computer pro- gram used to process other people's data. When this is the case it is easier for the investor to bear the cost of his investment without revealing his secret because his product need never leave his hands" (Braunstein et al., 1979). 11. Unlike other products, which are consumed upon use, information is not diminished by use and requires special protection. It is this characteristic that causes information to be "a some- what recalcitrant economic good" (Thompson, 1979:30). Posner has summarized He relation- ship between this unique property of infonnation and the need for legal protection as follows (Posner, 1979:1 193): 'the underlying problem of inflation production is tile difficulty of ap- propnating private profits from any of the social benefits that the disseminator of inforrnanon
182 Joe S. Cecil and Eugene Gri.~rz creates.... [I]f I sell you an idea, and you use it to produce something that reveals the idea, anyone else can use the idea without dealing with me.... The point, however, is that some legal intervention or other 'artificial' resmction is necessary to make an idea a saleable commodity." Hammond (1981) has found this conception of information as a private commodity to be outdated and has urged a reformulation of information property rights that would recognize the character of information as a "collective economic good". He believes that traditional Western legal systems "have been too much concerned with the creation of a sufficient stock of information and too little concerned with usage and access (p. 55)." Nevertheless, it is access to and dissemination of infor- mation that must be controlled if researchers are to realize the value of the objects they create. 12. In Twentieth Century Music Corp. v. Aiken, 422 U.S. 151, 156 (1975) the Court said: "Creative work is to be encouraged and rewarded, but private motivation must ultimately serve the cause of promoting broad public availability of literature, music, and the other arts. The im- mediate effect of our copyright law is to secure a fair return for an 'author's' creative labor. But the ultimate ann is, by this incentive, to stimulate artistic creativity for the general public good." See also Fox Film Corp. v. Doyal, 286 U.S. 123, 127 (1932). 13. This economic incentive system was acknowledged by the Supreme Court in Maser v. Stein, 347 U.S. 201, 219 (1954): 'The economic philosophy behind the clause empowering Congress to grant patents and copyrights is the conviction that encouragement of individual effort by personal gain is the best way to advance public welfare through the talents of authors and in- ventors in 'Science and Useful Arts."' Of course, a similar incentive process is at work in the scholarly community. 14. Copyright protection is part of a larger body of law, lmown generally as "intellectual proper~." This broad area also includes patent protection and trade secret protection. Neither patent protection nor trade secret protection is appropriate for guarding the proprietary interest of a researcher who develops a data set. Patent protection may be extended to "[w]homever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof . . ." (35 U.S.C. §101 (1976)) [emphasis added]. The term "process" has been given a narrow interpretation that would not include development of a data set, even under the recently expanded standards set by the Supreme Court in Diamond v. Diehr, 450 U.S. 175 (1981). See also Gottschalk v. Benson, 409 U.S. 63 (1972). Although in Diamond v. Diehr, the Supreme Court indicated Hat a process that involves a scientific truth my be eligible for patent protection, the development of a data set is not such a process, since there is no ''lt]ransformation of an article to a different state or thing" (Gottschalk v. Benson, 409 U.S. 63, 700 (1972)). Trade secret protection is also inappropriate to general research data sets, since this form of protection is extended by statute to a limited number of areas that require federal re- pordng of commercial information: see, e.g., Energy Supply and Environmental Coordination Act of 1974, §11(d), 14 U.S.C. §796(d) (1976); and the Flammable Fabrics Act, §4(c), 15 U.S.C. §1193(c) (1976). Many of these statutes simply reference the general protection offered by the Trade Secrets Act, 18 U.S.C. §1905 (1976). For a discussion critical of trade secret pro- techon of health and safety testing information conceming drugs and pesticides, see T.O. McGanty and S. Shapiro (1980). A final alternative for a researcher who believes that his or her data set has been misused is to bnag a claim in a state court under the common law tort of misappropnation. This doctrine has been extended to protect compilations of facts distributed for commercial purposes, such as news gathering services: e.g., International News Serv. v. Associated Press inc., 248 U.S. 215 (1918); Veatch v. Wagner, 116 F. Supp. 904 (a:). Alaska 1953). However, in the circumstance presented here of a data set being copied for use in subse- quent analyses, it is likely that the courts would find that the state misappropriation doctrine is preempted by the federal copyright law: see Denicola (1981) and Comment (1977b). Therefore, this paper focuses on the protection afforded data sets under the copyright law of the federal gov- ernment. 15. Pub. L. No. 9~553, §102 (1976); codified at 17 U.S.C. §1 et seq. (Supp. 1977). When
Role of Legal Policies 183 this act became effective on January 1, 1978, all other forms of copyright protection for new works were preempted. Copyright protection has been extended to a wide variety of tangible ex- pressions, including computer programs, pantomimes and choreographic works (when expressed in tangible forms, blank forms, and color arrangements (Nimmer, 1980:2.04 2.19). 16. The requirement of expression in a tangible form is also found in the constitutional provi- sion that gives authors an exclusive right to "their respective wrinngs and discoveries" U.S. Constitution, art. I, §8 [emphasis added]. For a discussion of the difficulties in extending tradi- tional doctrines of copyright protection to computer data bases, see Denicola (1981:531). 17. See also Denicola (1981). 18. Leon v. Pacif c Tel. § Tel., 91 F.2d 484 (9th Cir. 1937). 19. Edward § Deutsch Lithographing Co. v. Boorrnan, 15 F.2d 35 (7th Cir. 1926). 20. The process of copyrighting a data set expressed as a list of numbers on sheets of paper is straightforward. Copyright protection attaches to the data set as the data are "fixed in a tangible medium of expression" (i.e., entered onto the data sheet). However, when the data set is distrib- uted or made public, the author's rights will be protected only if: the copyright notice is affixed to the data set in such a way as to give fair notice of the author's claim to the copyright; the data set is registered with the copyright office; and two copies of the data set are filed with the Library of Congress within three months of publication. The copyright notice must contain the following: the letter "c" in a circle, or the word "copyright" or the abbreviation "copr."; the year of first pub- lication of the data set; and the name of the owner of the copyright. The filing of copies with the Library of Congress is usually accompanied by registration of a claim to copyright with the Copyright Office. Failure to register a claim to copyright and deposit the copies with the Library of Congress limits the damages that the copyright holder can obtain from an infnnger. Of course, once a document is registered with the Library of Congress, it becomes a publicly avail- able document (Copyright Act §§101, 401 et seq. (1976)); see also Note (1982). While the no- tice and registration requirements are only a nuisance for hard-copy data sets, they pose more of a difficulty for large data sets in machine readable foully. The statute seems to contemplate copy- right of machine readable data sets, since copyright protection attaches to works, "in any tangible medium of expression, now known or later developed, from which they can be perceived, repro- duced or otherwise communicated, either diremly or with the aid of a machine or device" (Copyright Act §§102, 117 (1976)). Yet the notice provision in the statute remains ambiguous as to the notice necessary for copyright of machine readable data sets that are not also available in hard copy (Copyright Act §§1 17, 401 et seq. (1976)). 21. Compare International News Service v. Associated Press, 248 U.S. 215 (1918). 22. See Squires, 1979; and Nimmer, 1980:2.01[A]. Note especially the discussion by Squires (1979:21~215) of "slipping" where a compilation of information is used to guide the fact-gathering in the development of a compilation of the same information. The difficulty and importance of distinguishing between facts and the expression of facts in deterlIiiIiing the 1iIIiits of copyright protection is discussed in Miller v. Universal City Studios, 650 F.2d 1365 (Sth Cir. 1981). For an argument that copyright protection should be expanded to protect an "author's research," in circumstances where the selection of facts is the essence of the creative contribution of the author, see Comment (1982). 23. Such a circumstance is likely to occur if the principal investigator develops a data set from publicly available sources. For an example of such a replication, see Passell and Taylor (1977), attempting to replicate the study by Ehrlich (1975). Passell and Taylor relied on an unpublished list of data sources made available by Ehrlich. See also <Comment (1977a). 24. As discussed above, the law offers its full protection only if the the copyrighted work is registered with Library of Congress and made available to Me public. Therefore, if researchers wish to enforce their rights under the Copyright Act, they must register their data sets in such a way that the public will have access to them. This registration requirement, which is quite suit- able for authors and composers, is fundamentally inconsistent with the interest of researchers in
184 Joe 5. Cecil and Eugene Griffin retaining control over data sets. 25. Protection of the original contribution of the copyright holder amounts to " . . . little more than a prohibition of actual copying.... Any 'distinguishable variation' of a prior work will constitute sufficient originality to support a copyright if such variation is the product Al.~ed Bell § Company v. Catalda Fine Arts, Iliac., 191 F.2d 99 (2d Cir. 1951)). Since facts themselves cannot be copyrighted, a pnacipal researcher's original contribution is in the expression of the facts through Heir arrangement. As discussed above, if a second researcher copies the facts in the principal researcher's data set, but varies He arrangement, perhaps to permit some novel analysis, this vanation in selection and arrangement of facts may be an original contribution of the second researcher and may not infringe on the copyright of the principal investigator. The quantum of originality present in the work of the second researcher required to remove it from the constraints of copyright protection is not great. For a more restrictive interpretation, see Denicola (1981 :522). 26. Freid (1979) offers an excellent review of the fair use provisions of die Copynght Act. 27. See also Encyclopaedia Britannica Educational Corp. v. Crooks, 447 F. Supp. 243 (W.D.N.Y. 1978). 28. As Freid (1979:468) notes: "If copyrighted material is used in such a way that the arts and sciences are benefited, the purposes of the copyright laws are being furthered, despite the appar- ent invasion of the copyright owner's 'exclusive' nghts." Freid cites Rosemont Enterprises, Inc. v. Random House, Inc., 366 F.2d 303 (2d Cir. 1966), cert. denied, 385 U.S. 1009 (1967) and Time Inc. v. Bernard Geis Associates, 293 F. Supp. 130 (S.D.N.Y. 1968), and he notes that these cases also Support the proposition that the arts and sciences should be interpreted in broad terms, since the first case involved the use of a copyrighted article in a biography about Howard Hughes, and He second case involved die use of copyrighted frames of a Notion picture in a book about the assassination of President Kennedy. 29. Loew's inc. v. Columbia Broadcasting System, 131 F. Supp. 165 (D.C. Cal. 1955), Firmed, 356 U.S. 43 (1957), rehearing denied, 356 U.S. 934 (1957). See also Williams § Wilkins Co. v. United States, 487 F.2d 1345 (Ct. C1. 1973), Ed by art equally divided Court, 420 U.S. 376 (1975), discussed below. 30. When the law was being revised, the House judiciary subcommitte recognized the special needs of teachers to copyrighted material and requested that the educational community draft guidelines for "educational" fair use for printed material and music (H. R. Rep. No. 1476, 94 Cong., 2d Sess. 66 (1976)). The resulting guidelines were dlen adopted by the House commit- tee as "a mammal interpretation of the standard of '[air use"' and incorporated into its report (p. 72). It remains open to the courts to decide that minimal acts of photocopying by a teacher, though they go beyond the guidelines, nevertheless constitute fair use (Nimmer, 1980:1305[E]). 31. Williams § Wilkins Co. v. United States, 487 F.2d 1345 (Ct. C1. 1973), ~dby an equally divided Court, 420 U.S. 376 (1975); but see Fluid (1979:471 177). 32. 366 F.2d 303 (2d Cir. 1966), cert. denied, 385 U.S. 1009 (1967). The court also noted ~at, " . . . the arts and sciences should be defined in Heir broadest teens, see Sampson § Murdock Co. v. Seaver-Ra~ord Co., 140 F. 539, 541 (1st Cir. 1905), particularly in view of die development of He field of social sciences" (366 F.2d at 307). 33. 487 F.2d 1345 (Ct. C1. 1973), Ed by an equally divided Court, 420 U.S. 376 (1975); see also discussion by Freid (1979:467-477). 34. Williams § Wilkins Co. v. United Stales, 487 F.2d 1345, 1359 (Ct. C1. 1973), he'd by an equally divided Court, 420 U.S. 376 (1975); see also Freid (1979:472, 475). This also appears to be true for large machine-readable data sets (Keplinger, 1977). 35. See, generally, Office of Federal Statistical Policy and Standards (1980b). Another com- mon source of research data from federal agencies is public-use data tapes, developed from the records of federal agencies. For a statement of basic federal policy and a list of federal statistical data file catalogs and directones, see Sprehe (1981). For examples of studies that have relied on
Role of Legal Policies 185 public-use data tapes prepared by the National Center for Health Statistics and the Social Security Administration, see Flaherty (1979Appendices 1 and 2). 36. See Privacy Protection Study Commission (1977), and Sprehe (1981). For a discussion of state statutes, see Braverman and Heppler (1981). For an international perspective on the prob- lems of obtaining research access to governmental records, see Mochmann and Muller (1979), Flaherty (1979), and Rozsa and Foldi (1980). 37. 44 U.S.C. §2901 et seq. (1976); see also The Records Disposal Act, 44 U.S.C. §3314 (1976). 38. Administrative Procedure Act, ch. 324 §3, 60 Stat. 238 (1946) (amended 1966). 39. 5 U.S.C. §552 (1976). The original version of the Freedom of Inflation Act was passed in 1967, Pub. L. No. 9~23 (1967); the 1974 amendments were contained in Pub. L. No. 9~502 (1974). 40. 5 U.S.C. §552a (1976). 41. 5 U.S.C. §552(e) (1976). 42. 4 C.F.R. §81 (1980). 43. According to an opinion issued by Carl H. Imlay, general counsel, Administrative Office of the United States Court, November 16, 1978: "[Clouts of the United States and the Administrative Office are exempt from coverage under The Freedom of Information Act]." See also 5 U.S.C. §§551(1)(B), 552(e) (1976); United States v. Dingle, 546 F.2d 1378, 138~81 (10th Cir. 1976); United States v. Caning, 521 F.2d 565, 573 (2d Cir. 1975); Cook v. Willingham, 400 F.2d 885 (10th Cir. 1968). The cou,-ts are frequently faced with requests for disclosure of presentence reports. Rule 32(c)(3) of the Federal Rules of Criminal Procedure provide for the dis- closure of the report to the defense, although judges retain broad discretion to prohibit or limit the defendant's access to the report. Circumstances in which presentence information can be dis- closed to third parties are quite rare and within the discretion of the court (Volume X of the Guide to Judiciary Policies and Procedures, §3004 (1978)). For a discussion of the disclosure prac- tices of presentence reports by federal judges, see Pennell and Hall ( 1980). 44. From time to time, the U.S. Probation Office, a part of the judiciary, receives requests from researchers for access to probation records. In the past these requests have been reviewed on a case-by-case basis. However, a policy statement by the U.S. Probation Office suggests that access to records maintained by the U.S. Probation Office for the Distnct of Columbia can be on tained if the records remain anonymous or, if identifiable records are necessary, if the informed consent of the research participant is obtained. The Probation Office also reviews research pro- posals to determine that they are of scientific merit (memorandum and attachments, Mr. Stephen 3. Reynolds, U.S. Probation Office, October 6, 1978). See also, Federal Judicial Center Advisory Committee on Experimentation in the Law ( 1982). 45. Kissinger v. Reporters Committee for Freedom of the Press, 445 U.S. 136, 15~157 (1979). 46. Administrative Procedure Act, ch. 324 §3(c), 60 Stat. 238 (1946) (amended 1966). 47. Some have argued that a similar public right to information resides in the Constitution; see Lewis (1980). 48. A number of proposals have been introduced that would restrict access to information und- er the Freedom of Information Act: see, e.g., Hill Panel Votes Bill to Restnct Information Act (WashingtorlPost, December 15,1981)i6). 49. 5 U.S.C. §552(b) (1976). 50. 5 U.S.C. §552(a)(3) (1976). 51. Once an agency receives a request that "reasonably describes" the desired records, the agency has ten working days to decide if any or all of the material comes under any of the nine ex- emptions. The requesting party must be properly informed of the agency's decision, and, if am plicable, of the agency's reasons for denying access to the information. An individual denied any information may pursue an administrative appeal for disclosure. Should the appeal fail, the re-
186 Joe 5. Cecil aMEugerle Griffin quester can then file for disclosure in federal district court. The court decides the matter de nova and may examine any documents in detenn~ng whether they are, in part or in whole, exempt. The agency has the burden of proving that the materials in question come under a particular ex- emption: 5 U.S.C. §§552(a)(3) (a)(6)(A)(i) (a)(4)(B) (1976). 52. If the research data are exempted from disclosure by some other statute, they need not be disclosed under the Freedom of Information Act: 5 U.S.C. §552(b)(3) (1976). An amendment to the Freedom of Information Act in 1977 limited this exemption to records governed by conf~den- tiality statutes that require the records to be withheld from Me public; confidentiality statutes that permit the exercise of discretion in withholding records are not adequate to meet the standards of this exemption: Government in the Sunshine Act, Pub. L. 91 409 (1976). The effect of this change was to substantially narrow the applicability of this exemption and shift attention to other relevant exemptions (Office of Federal Statistical Policy and Standards, 1978). See also Comment (1981). 53. 5 U.S.C. §552(b)(6) (1976). 54. 5 U.S.C. §552(b)(4) (1976). 55. See, for example, Washington Research Projects v. DHEW, SW F.2d 238 (D.C. Cir. 1974). This policy of narrow construction of the exemptions was farther aided by die policy of the Justice Department in die previous administration of defending Freedom of Information suits only when "disclosure is demonstrably harmful, even if the documents technically fall within the exemptions in the Act." Letter from Attorney General Griffin Bell to Heads of Federal Departments and Agencies (May 5, 1977). The current administration has apparently reversed this policy (New York Times, May 5, 1981418). 56. Compare Consumers Union v. Veterans Administration, 301 F. Supp. 796 (S.D.N.Y. 1969), dismissed as moot, 436 F.2d 1363 (2nd Cir. 1971), with Getman v. NLRB, 450 F.2d 670 (D.C. Cir. 1971); see also Note (1975). In fact, a recent Supreme Court case took a contrary stand, holding that an agency can decide to release information even when that infonnabon quali- fies as berg exempt from disclosure: Chrysler Corp. v. Brown, 441 U.S. 281 (1979). 57. 5 U.S.C. §552(b)(4) (1976). 58. 5 U.S.C. §552(b)(4) (1976). See also Note (1976c); Comment (1976a); Braintree Elec. Light Dept. v. Dept. of Energy, 494 F. Supp. 287 (D.D.C. 1980); National Park § Conservation Assn. v. Morton, 498 F.2d 765 (D.C. Cir. 1974); Consumers Union v. Veterans Administration, 301 F. Supp. 796 (S.D.N.Y. 1969), dismissed as moot, 436 F.2d 1363 (2nd Cir. 1971). 59. While the FOLA does not define "trade secret," an older edition of the Restatement of Torts (American Law Institute, 1938:§757(b)), which is often cited for its definition, states that "a trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business, and which gives him an opportunity to obtain an advantage over competitors or suppliers who do not know or use it. It may be a formula for a chemical compound, a process of manufacturing, treating or preserving materials, a pattern for a machine or other device, or a list of customers." See also Public Citizen Health Research Group v. Food and Drug Administration, 539 F. Supp. 1320, 1325 (D.D.C. 1982); Connelly (1981); and Stevenson (1982). 60. "Lacking any legislative history defining the scope of the terms 'commercial' and 'financial,' the courts have given them their ordinary meanings": Board of Trade v. Commodity Futures Trailing Co., 627 F.2d 392, 403 (1980). 61. Fisher v. Renegotiation Board, 355 F. Supp. 1171, 1 175 (D.D.C. 1973). 62. Public Citizen Health Research Group v. DHEW, 477 F. Supp. 595, 605 (D.D.C. 1979). The district court order to release the information was later reversed following the decision by the Supreme Court in Forsham v. Hams. After an extensive examination of the legislative history of the act establishing Professional Standard Review Organizations, the court of appeals held that the medical foundation did not have to tum over the documents since it, serving as a Professional Standard Review Organization, was not an "agency" under the FOLD: Public Citizens Health Research Group v. HEW668 F.2d 537 (D.C. Cir. 1981).
Role of Legal Policies 187 63. 504 F.2d 238 (D.C. Cir. 1974). 64. 504 F.2d 244 (D.C. Cir. 1974). 65. 504 F.2d 253 (D.C. Cir. 1974). 66. 504 F.2d 244 (D.C. Cir. 1974). The federal appellate court did hold that the NIMH sum- mary statements and site visit reports were exempt from disclosure since they were intra-agency memoranda. Intra-agency memoranda are exempt from disclosure under the FOLA: 5 U.S.C. §552(b)(5) (1976). 67. 504 F.2d 244 245 (D.C. Car. 1974). The court adds, in a footnote to this section, that "[o]nly an individual grantee engaged in profit-oriented research, or a non-profit organization that engages in profit-making ventures based on biomedical research, could conceivably be shown to have a commercial or trade interest in his research design." Some commentators have contended that the FOIA and its interpretation in Washington Research Products v. WHEW greatly interfere with the proprietary rights of researchers (see, e.g., Morns et al., 1981). 68. 506 F. Supp. 822 (N.D. Ga. 1980). 69. 506 F. Supp. 830 (N.D. Ga. 1980). 70. See Board of Trade v. Commodity Futures Trading Co. 627 F.2d 392, 403 (1980) and Consumers Union v. Veterans Administration, 301 F. Supp. 796 (S.D.N.Y. 1969), dismissed as moot, 436 F.2d 1363 (2nd Cir. 1971). 5 U.S.C. §551 (2) defines "person" as including individ- uals, partnerships, corporations, or associations. Information produced by a government agency would not be protected under exemption 4, but it may be protected as interoffice memoranda, an- other FOIA exemption. 71. 498 F.2d 765 (D.C. Cir. 1974). 72. 498 F.2d 770. Accord, Pacific Architects § Engineers, inc. v. Renegotiation Board, 505 F.2d 383 (D.C. Cir. 1974) See also Comment (1976a). At least one commentator maintains that, even though the information in Washington Research Projects v. DREW was not considered commercial or financial, it would have passed the confidentiality test set up under the National Park v. Kleppe case (Note, 1976c). 73. Substantial competitive hann is a factual question. The party claiming that it will be banned usually attempts to prove the likelihood of the harm through expert testimony or af- fidavits. While detailed economic analysis or elaborate antitrust-type market analyses are not re- quired, the resisting party usually must show the likelihood of a specific harm: National Parks v. Kleppe, 547 F.2d 673 (D.C. Cir. 1976); Sears, Roebuck and Co. v. General Services Administration, 553 F.2d 1378 (D.C. Cir. 1974). 74. 539 F. Supp. 1320 (D.D.C. 1982). 75. 615 F.2d 551 (1st Cir. 1980). 76. 301 F. Supp. 796 (S.D.N.Y. 1969), dismissed as moot, 436 F.2d 1363 (2nd Cir. 1971). 77. The court held: "Even though the records sought are not exempt, the court is not bound under the Act to automatically order their disclosure. In exercising the equity jurisdiction con- fe~Ted by the Act, it must, according to traditional equity principles, weight the effects of disclo- sure and non-disclosure and determine the best course to follow at the present tune. In an action under the Freedom of Information Act, which shifts the burden of proof to the defendant, the bal- ance of the equities is presumptively on the side of disclosure. The rule that will be followed, therefore, is this: where agency records are not exempted from disclosure by the Freedom of Information Act, a court must order their disclosure unless the agency proves that disclosure will result in significantly greater harm than good. Because the Act was intended to benefit the public generally, it is primarily the effects on the public rather than on the person seeking the records that must be weighted": 301 F. Supp. 806 (S.D.N.Y. 1969). On appeal the agency abandoned its assertion of a public interest in withholding Me information, and the case was dismissed as moot after the agency released the requested information: 436 F.2d 1336, 1365 (2nd Cir. 1971). Compare with German v. NLRB, 450 F.2d 670 (D.C. Cir. 1971), which denies that the courts have such equity junsdiction.
188 Joe S. Cecil and Eugene Griffin 78. 301 F. Supp. 808 (S.D.N.Y. 1969); see also Kronman (1980). 79. In Consumers Union the court permitted release of the raw data, but refused to disclose the scoring system used to assess the raw data. While such a precedent may make it difficult for re- searchers to replicate findings based on raw data, it would not stand in the way of developing competing analyses. The precedent in Orion Research Inc. v. Envirorunental Protection Agency, 615 F.2d 551 (1st Cir 1980), extended to technical information in a proposal identifiable to an individual bidder and is unlikely to be extended to requests for anonymous research data. 80. Long v. lR.S., 596 F.2d 362 (9th Cir. 1979). 81. Long v. IR.S., 596 F.2d 362, 366 (9th Cir. 1979). 82. See Forsham v. Harris, 445 U.S. 169 (1980); also see Note (1978), which distinguishes Washington Research Projects from Forsham on the grounds that ~ Washington Research Projects the government already possessed the private report while In Forsharn the data remained with the researcher. 83. 596 F.2d 362 (9th Cir. 1979). 84. 596 F.2d 369 (9th Cir. 1979). 85. 5 U.S.C. §552a (1976). However, there are areas in which more specific statutes and re- gulations control access to agency data. In these circumstances, the presence of a specific regula- tory scheme may better accommodate the needs of researchers. Sasfy and Siegel (1982) exam- ined the practices of a number of criminal justice agencies in permitting research access to agency records and found that there was no general "chilling effect" on criminal Justice research due to the Privacy Act and related privacy and confidentiality statutes. Access to such records is typical- ly governed by specific statutes and regulations that apply to individual agencies and agency rec- ords. They found that there may be "chilling effects" on research access in specific agencies if We statutes governing records in these agencies do not contain provisions permitting access for re- search in the statutes governing agency records. Sasfy and Siegel's work is one of the few stu- dies of such disclosure practices, and it suggests that if research needs are anticipated by the stat- ute, research access to agency records can proceed without difficulty. 86. An early statement of difficulties resulting from the regulation of research records by the Privacy Act is found in "Notice of Heanags and Draft Recommendations: Research and Statistics," 41 Fed. Reg. 55007 (proposed, December 16,1976). 87. See Privacy Protection Study Commission (1977), Mochmann and Muller (1979), and Flaherty (1979); for early discussion of this issue, see D.T. Hulett (1975), and Martin (1974). 88. The Privacy Protection Study ComIIiission (1977, Appendix 4:11) found that as of December 21, 1975, there were 6,723 systems of records of varying size containing 3.8 billion individual records. 89. 44U.S.C.§3501-3S12(1976). 90. For example, federal tax returns and information have specific statutory protection against disclosure: 26 U.S.C. §1603(a) (1976); see also discussion of Freedom of Infonnation Act, above. 91. 5 U.S.C. §552a(a)(4) (1976). 92. 5U.S.C.§552a(a)(6)(1976). 93. 5 U.S.C. §552a(b) (1976). For an overview of the Privacy Act of 1974, see Note (1976a); Note (1976b); Davidson (1976); Eastman (1975); and Project) (1975). 94. 5 U.S.C. §552a(b)(1) (1976). 95. I-he act requires the head of an agency or instrumentality to make a written request to the agency maintaiIiing die record specifying the particular portion desired and the law enforcement activity for which Me record is sought. 96. Apparently this exemption was intended to permit access for resolving problems of con- stituents, but through a drafting error the exemption was extended to Congress as a body rawer than individual members. Access to members of Congress for solving constituents' problems is now considered to be a routine use of most record systems (Privacy Protection Study
Role of Legal Policies 189 Co~runission, 1977:51~520). Allof these exemptions are founding U.S.C. §552a(b) (1976). 97. There is general agreement that this publication requirement has been an ineffective means of notifying the public (Commission on Federal Paperwork, 1977). 98. While no court has considered such a practice, one commentator (Note, 1976a) has sug- gested that the courts should construe the consent provision narrowly and reject an agency's claim of prior consent, absent a clause in the original request specifically stipulating not only the antici- pated uses, but also the potential recipients of the data. 99. 20 Congressional Record H. 12246 (December 18, 1974). 100. According to 5 U.S.C. §552a(a)(1) (1976), the term "agency" means agency as defined by the Freedom of Information Act, ~ U.S.C. §552(e) (1976); see also discussion of the FOIA, above. 101. See note 88. The distinction favoring records retrieved by individual identifiers seems to presume a manual rather than a computer-based information system, but most federal records are contained in automated record systems. Of those personal data systems reported to the Office of Management and Budget (OMB), only 21 percent are fully or partially automated; but 81 percent of the total number of individual records are maintained in these systems (Federal Personal Data Systems Subject to the Privacy Act of 1974, First Annual Report to the President, Calendar Year 1975, page 2, cited in Privacy Protection Study Committee, 1977, Appendix 4:1 1). Some peo- ple have questioned whether this "systems of record" definition is adequately broad to serve as a triggering mechanism for the protections of the Privacy Act (Appendix 4:6). Computer technolo- gy permits identification of an individual's record based on some combination of attributes or characteristics, as well as by individual identifiers. Yet, without regard to the ease with which an at~ibutional search by computer can be made, an agency may place the record system beyond the scope of the act by retrieving the records by some means other than individual identifiers. 102. The Commission on Federal Paperwork (1977:115) strongly endorsed the use of adminis- trative records for research and statistical purposes. For examples and a discussion of agencies sharing administrative records for research purposes, see Privacy Protection Study Commission (1977:588). 103. For commentary regarding standards of consent required by the acts, see Project (1975:1309 1310) and Note (1976a:682). 104. 5 U.S.C. §552a(~)(1) (1976). Some people have contended that the designation of large organizations, such as the Department of Health and Human Services (HHS), as a single agency has permitted improper and unmonitored transfer of sensitive records to diverse units (Commission on Federal Paperwork, 1977:67). Of course, disclosures within an agency may be restricted by a number of other statutes. For example, the Talc Reform Act of 1976 will not pennit disclosure of tax infonnation by the Social Security Administration to other researchers in HHS, even though the Social Security Administration is part of HHS (Office of Federal Statistical Policy and Standards, 1980b:97). There have been a number of legislative proposals to improve the interagency shanag of information for research purposes. The proposals vary in their details, but nearly all involve some "functional separation" of statistical and administrative records with greater centralization of research and statistical responsibilities (see, e.g., Alexander, 1983). Since these proposals are intended to improve the interagency shanug of research information rather than to improve directly the opportunity for persons outside the federal government to ob- tain access to this information these proposals are not addressed in this paper. 105. The Privacy Protection Study Commission (1977, Appendix 4:67) found that the Privacy Act has resulted in a modest overall decline in the amount of individual information agencies dis- close to others, but Hat impact has been greatest at the margins of agency duties, such as support for nonfederal research. Researchers and statisticians who have received identifiable information are mostly federal agency employees or contractors, some grantees, and a relatively small number of persons who have neither contracts nor grants. Disclosure usually consisted of a list of names and addresses (Privacy Protection Study Commission, 1977:590).
190 Joe S. Cecil anal Eugene Griffin 106. See the testimony of Drs. Leonard T. Kurland and Lee Robins before the Privacy Protection Study Commission (June 11, 1976 and September 20, 1976). At least one epidemio- logist contended that restrictions such as those contained in the Privacy Act "will spell a virtual end to population-based studies directed toward solving public health problems" (statement by Helen Chase of the Joint Committee on National Data Resources of the American Public Health Association, cited in the testimony of Leonard Kurland); see also Curran (1978), and Kelsey (1981). 107. Apparently the greatest difficulty now facing researchers who wish to link archival rec- ords for longitudinal studies is the maze of state and federal privacy legislation that followed the Privacy Act, which extends to specific agencies or specific kinds of records, such as medical rec- ords (Beebe, 1980). For a review of the effects of recommendations of the Privacy Protection Study Commission on longitudinal research, see Robins (1978). 108. Some commentators contend that the exemptions, coupled with He ineffective scheme for enforcement, largely defeats the requirement of obtaining informed consent prior to disclosure of personal records (Note, 1 976a:69 1 ) . 109. The Commission on Federal Paperwork (1977:111) took exception to this limitation on disclosure and noted that if the record "is to be used solely for statistical purposes, there seems no need for requiring that it be transferred 'in a form that is not individually identifiable.' Such res- trictions have severely limited not only the interagency flow of information but the release to the public of much worthwhile information, such as that contained in statistical microdata files.'' 110. A review of these techniques is found in Boruch and Cecil (1979); see also Office of Federal Statistical Policy and Standards (1978, 1980a). 111. Office of Management and Budget (1975); see also Privacy Protection Study Commission (1977:571). 112. Examples of injures to individuals from improperly disclosed research data are difficult to find. Efforts by the Office of Federal Statistical Policy and Standards (1978) and by the Privacy Protection Study Commission to identify instances of injury resulting from improperly disclosed federal records turned up no examples. Of course, individuals may be adversely af- fected by interpretations of data that identify characteristics of a group of which they are a member. See Moms et al. (1981), for an example of embarrassment to a group of teachers re- sulting from publication of statistical characteristics of the group based on improper interpretation of personnel test data. Similarly, the only "injury" found by the Office of Federal Statistical Policy and Standards (1978:34) involved complaints by several persons that "release of popula- tion census summary data by zi~code area has contributed to their increasing receipt of junk mail." However, even if the identities of individuals are withheld, it may be possible to deduce their identities from the public information that is released. For example, Nelson and Hedrick (1983:34) sought to identify researchers who received grants of confidentiality under the Drug Abuse Act of 1970. Although their FOIA request for the names of the researchers was denied (with misplaced reliance on the Privacy Act), some information concerning the general nature of the research project was released. While the agency's decision to withhold the names of the grantees was being appealed (an appeal that was ultimately successful), the names of 76 percent of the grantees were identified by matching the released information (contract numbers, telephone numbers, etc.) with other publicly available information. 113. For a list of specific epidemiological studies that would have been "virtually impossible" to conduct without identifiable ~nfonnation, see Gordis et al. (1977). 114. In the past some academic researchers and personnel from other agencies have been sworn in as Census Bureau officials to conduct special analyses (Martin, 1974:265). Sasfy and Siegel (1982) also found the use of "temporary employees" to be a common practice of criminal justice agencies. 115. The routine uses of a record must be listed in the annual system notices and must be pu- blished for comment in the Federal Register at least 30 days before they are included for the first
Role of Legal Policies 191 time in the annual system notice, 5 U.S.C. §552a(e)(11) (1976). 116. A routine-use provision that permits access to identifiable records for research, which ap- pears in many record systems notices of the Department of Health and Human Services, reads as follows: "A record may be disclosed for a research purpose, when the Department: (A) has deter- mined that the use of disclosure does not violate legal or policy limitations under which the record was provided, collected, or obtained; (B) has determined that the research purpose (1) cannot be reasonably accomplished unless the record is provided in individually identifiable fonn, and (2) warrants the risk to the privacy of the individual that additional exposure of the record might bong; (C) has required the recipient to (1) establish reasonable administrative, technical, and physical safeguards to permit unauthorized use or disclosure of the record (2) remove or destroy the information that identifies the individual at the earliest time at which removal or destruction can be accomplished consistent with the purpose of the research project, unless the recipient has presented adequate justification of a research or health nature for retaining such information, and (3) make no furler use or disclosure of the record except (a) in emergency circumstances af- fecting the health or safety of any individual (b) for use in another research project, under these same conditions, and with the written authorization of the Department (c) for disclosure to a properly identified person for purpose of an audit related to the research project, if information that would enable research subjects to be identified is removed or destroyed at the earliest oppor- tunity consistent with the purpose of the audit, or (d) when required by law; (D) has secured a written statement attesting to the recipient's understanding of, and willingness to abide by these provisions." For examples of such notices of routine use for research purposes, see the Department of Health and Human Services' annual publication of the systems of records, 46 Fed. Reg. 52693, 52697, 52700 (venous Medicare, Medicaid, and health insurance record systems), 52781 (mental health record systems), 52809, 52782, 52794, 52809, and 52867 (various clinical research record systems) (October 27, 1981). Many other record systems permit research access to "approved or collaborating researchers, including HHS contractors and grantees." For exam- ples of such notices, see the Department of Health and Human Services' annual publication of the systems of records, 46 Fed. Reg. 52796, 52797, 52798 (October 27, 1981). For even more general notices of research as a routine use, see 41 Fed. Reg. 39719, 39720 (September 15, 1976) (personnel records maintained by the Federal Trade Commission), and 41 Fed. Reg. 55568 (December 14, 1976) (personnel records of the Civil Service Commission). Of course, the first version of the notice is preferable, since it permits disclosure to those who are not collaborating researchers while establishing the necessary safeguards to protect the identified individuals. 117. Reliance on the routune-use provision of the Privacy Act to permit sharing of identifiable research data is also risky for another reason. IT} examining agency practices, the Commission on Federal Paperwork (1977:66 7) found that in many instances, "agency 'routine use' notices authorize transfers for purposes which, by no stretch of the imagination, could be considered 'compatible' with the purpose for which it was collected. Typical of these is the practice of many agencies to share medical information with law enforcement agencies" [footnotes omitted]. It seems that such excesses may make the routine-use exemption ripe for reform. The relevant House committee in its initial report promised vigorous oversight of agency practices in this area (H. Rep. No. 9~1416, 93rd Cong., 2d Sess. 12, 1974). A well-tailored routine-use exception permitting access for research to specific record systems seems proper under the Privacy Act. However, if the rounne-use section of the Privacy Act is restricted without consideration of die consequences to research that relies on the current exemptions, one of the few mechanisms for perrIiitting access to identifiable records may be lost. 118. See Confluent (1976b), Note (1976b), Note (1976a), and Project (1975:1337). This in- terpretabon is consistent with the analysis offered in Continent (1976a:135, 140), which main- tained that: "the important point is that the FOLA is the parent act and ultimately governs access to information The Privacy Act is relegated to the backseat when a successful disclosure request is made under the FOLA. Thus, even if a record has been declared exempt under the Privacy Act,
192 Joe S. Cecil and Eugene Griffin access may still be sought under the FOIA with its nine exemptions. If the record is available under the FOLA, access must be granted, the Privacy Act notwithstanding." 119. 5 U.S.C. §552(b)(6) (1976). 120. For a review of these cases, see Kronman (1980). 121. Dept. of Air Force v. Rose, 425 U.S. 352 (1975); U.S. Dept. of State v. The Washington Post Co., 456 U.S . 595 ( 1982). 122. U.S. Dept. of State v. The Washington Post Co., 456 U.S.595, 596 (1982), citing the standard used by Me court of appeals. 123. 456U.S.595(1982). 124. Prior to the Washington Post decision, many lower courts had used this stricter standard: German v. NLRB, 450 F.2d 670 (D.C. Cur. 1971); see also Note (1975); Robles v. E.P.A., 484 F.2d 843 (4th Cir.1973); Rural Housing Alliance v. Dept. of Agriculture 498 F.2d 73,77 (D.C. Car. (1974); Sinns v. C.I~4., 692 F.2d 562 (D.C.C. 1980). 125. 456 U.S.595,602 (1982). 126. 425U.S.352(1975). 127. 425 U.S.352,382 (1975). 128. 366 F. Supp.929 (D.D.C.1973). 129. 366 F. Supp.929, 937-38 (D.D.C.1973). 130. 477 F. Supp. 595 (D.D.C. 1979), rev'd on other grounds, 668 F.2d 537 (D.C. Car. 1981); see note 62. 131. The cow also found Mat dhe padent's privacy interest was protected by We remove of persona identified and the doctor' privacy interest, while mom substance, sell did not make disclosure"clearly unwarranted" 477 F. Supp.595, 604-605 (D.D.C.1979). 132. 539 F.2d 58 (lath Cu.1976). 133. 539 F.2d 58,62 (1oth C~.1976). 134. Getman v. NUMB, 450 F.2d 670 (D.C. C~.1971). 135 Disabled Dicers Associated v. Run~feLd, 428 F. Supp. 454 (D.~.C.1977). 136. Ditlow v. Schultz, 517 F.2d 166 (D.C. Cir. 1975). 137. Co~runittee on Masonic Homes v. NLRB, 556 F.2d 214 (3d Cir. 1977). 138. Wine Hobby U.S~. v. Internal Revenue Service, 502 F.2d 133 (3d Cir. 1974). 139. 477 F. Supp. 595, 605 (D.D.C. 1979), rev'd on other grounds, 668 F.2d 537 (SAC. Cir. 1981). 140. 477 F. Supp. 595, 604 605 (D.D.C. 1979). 141. There have been a number of legislative proposals to amend the Privacy Act to permit greater access for research purposes; see, for example, the Privacy of Research Records Act, in- troduced in the House as H.R. 3409, 96th Cong., 1st Sess. (1979), and in the Senate as S. 867, 96th Cong., 1st Sess. (1979); the Privacy of Medical Information Act, S. 865, 96th Cong., 1st Sess. (1979); and the Confidentiality of Statistical Records Act, which was never introduced but was intended to be part of the Paperwork Reduction Act, Pub. L. No. 9~511 (1980). See also the recommendations of the Privacy Protection Study Commission (1977). 142. This discussion assumes that an agency has not made some provision for release of infor- mation at the time it awards funds to contractors and grantees. In fact, several agencies have es- tablished policies to ensure that research data collected through funds provided by the agency will become available to the public at the termination of the grant or contract. For example, the National institute of Justice includes in its research grants a condition that requires the grantee to furnish the Institute a documented, computer-readable copy of all data sets and programs deve- loped in connection win the project; these data sets are mainlined by the agency and other data archives (Garner, 1981). For an account of the frustrations faced by researchers who must share delta with Me federal sponsors of the research, see Dawber (1980). 143. 5 U.S.C. §552(e) (1976). The Privacy Act adopts this definition of "agency," 5 U.S.C. §552a(1) (1976); see, generally, Note (1981).
Role of Legal Policies 193 144. 5 U.S.C. §552(a)(4)(B) (1976). 145. 445 U.S. 169 (1980). There was also an canter FOIA suit for the same information by a pharmaceutical manufacturer: Ciba-Geigy v. Manhews, 428 F. Supp. 523 (S.D.N.Y. 1977~. 146. The Committee on the Care of the Diabetic also sued the FDA to enjoin the proposed la- beling of the controversial drugs. The First Circuit remanded the case to the FDA for exhaustion of administrative remedies: Bradley v. Weinberger, 483 F.2d 410 (1st Cir. 1973). The adminis- trative law judge then found that one of the drugs, phenformin hydrochloride, was not shown to be safe and ordered it withdrawn from the market: 44 Fed. Reg. 20967 (1979). However, this decision was not based substantially on the raw data of the University Group study, but on refer- ence to the study as the basis of an expert opinion. 147. Forsham v. Califano, 587 F.2d ~ 128, 1136 (D.C. Cir. 1978). 148. Forsham v. Califano, 587 F.2d 1128, 1141-1142 (D.C. Cir. 1978). 149. Forshamv.Harris,445U.S.169?171 (1980). 150. A legislative conference report indicated that Congress did not "intend to include cor- porations that receive appropriated funds but are neither chartered by the Federal Government nor controlled by it, such as the Corporation for Public Broadcasting": H. Conf. Rep. No. 9~1380, 93rd Cong., 2d Sess. (1974), cited by the Court in Forsharn v. Harris, 445 U.S. 169, 179 (1980). 151. The court mentioned in a footnote that a number of bills seeking to expand the FOIA to federal grantees have been introduced in each Congress since the 92nd, but none has yet been re- ported out of committee: Forsham v. Harris, 445 U.S. 169, 179, footnote 10 (1980). 152. Forsham v. Harris, 445 U.S. 169, 182 (1980). 153. Forsham v. Harris, 445 U.S. 169, 182-187 (1980). The court stated: "Petitioners place great reliance on the fact that HEW has a right of access to the data, and a right if it so chooses to obtain permanent custody of the UGDP records. Citation omitted] But in this context FOIA ap- plies to records which have been In fact obtained, and not to records which merely could have been obtained. [emphasis in original, footnote omitted] To construe FOIA to embrace the latter class of documents would be to extend the reach of the Act beyond what we believe Congress Intended." Forsham v. Harris, 445 U.S. 185-6 154. Forsham v. Harris, 445 U.S. 169, 180 (1980). 155. Forsham v. Harris, 445 U.S . 169, 188 (1980). 156. Forsham v. Harris, 445 U.S. 169, 188-190 (1980). 157. Forsham v. Hams, 445 U. S. 169, 192 (1980). 158. 445 U.S. 136 (1980). 159. Reporters Committee for Freedom of the Press v. Vance, 442 F. Supp. 383 (D.D.C. 1977)7 Add, 589 F.2d 1116 (D.C. Cir. 1978). 160. Kissinger v.ReportersCommitteeforFreedomofthe Press, 445 U.S. 136, 139(1980). 161. 445 U.S. 150 (1980). 162. 44 U.S.C. §2901 et seq. (1976). 163. 44 U.S.C. §3314 (1976). 164. Transamerica Mortgage Advisors, Inc. v. Lewis, 444 U.S . 11 (1979). 165. Kissinger v. Reporters Committeefor Freedom of the Press, 445 U.S. 136, 150 (1980). 166. 445U.S. 136, 150,note9(1980). 167. 445 U.S. 136, 159 (1980). 168. 445 U.S. 136, 161 (1980). 169. 672 F.2d 1262 (7th Cir. 1982). 170. 7 U.S.C. §136d(d) (1976). 171. 672 F.2d 1262, 12701277 (7th Cir. 1982). One of the three judges did not concur with the section on academic freedom. There is some uncertainty over the extent of this protection. According to Michael A. Liethen, the attorney representing the University of Wisconsin re- searchers (quoted in Broad, 1982): "Our view is that a scientist has to be free to take his inquiries where they lead him, and that a scientist should not be forced to disclose his research data until he
194 Joe 5. Cecil and Eugene Griffin has results he is willing to stand behind.'' However, other language in the opinions suggests that if the data were the evidentiary basis of He administrative condemnation proceeding, the court may well have enforced the subpoena. 172. SU.S.C.§552a(m)(1976). 173. OMB Guidelines, 40 Fed. Reg. 28947 (July 9, 1975). 174. The general counsel of HEW (now HHS) contended that the requirements of the Privacy Act did not extend to record systems maintained by contractors, since, "[w]here the contracting agency is interested only in obtaining the results of the research or other work performed under the contract (generally in the form of a report) and does not require the contractor to furnish it with individually identifiable records, the system is not one which 'but for' the contract, the agen- cy would have established" (memorandum from Mr. William H. Taft IV, General Counsel, to Mr. John Ottina, Assistant Secretary for Administration and Management, May 14, 1976). REFERENCES Alexander, L. 1983 Proposed legislation to improve statistical and research access to federal records. Pp. 27~292 in R.F. Boruch and J.S. Cecil, eds. Solutions to Ethical and Legal Issues in Social Research. New York: Academic Press. American Law Institute 1938 Restatement of Torts. Vol. 4. St. Paul: American Law Institute. Arnold, M., and Kissiloff, A. 1976 An introduction to the federal Privacy Act of 1974 and its effect on the Freedom of Infol'`lation Act. New Engl~uul Law Review 11:463096. Ball, H. 1944 The Law of Copyright and intellectual Property, cited in S. Freed, Fair use and the new act. Pp. 46~87 in G. P. Bush and R. H. Dreyfuss, eds., Technology and Copyright: Sources and Materials. Mt. Airy, Md.: Lomond Books. Beebe, G. W. 1981 Record linkage and needed improvement in existing data resources. Cancer: Branbury Report 9. Cold Spring Harbor, N.Y.: Cold Spring Harbor Laboratory. 1980 Problems of long-term recordkeeping. In Issues in Research with Human Subjects. (NIH Pub. No. FIC8~1858). Washington, D.C.: Department of Health, Education, and Welfare. Boruch, R.F., and Cecil, J.S., eds. 1983 Solutions to Ethical and Legal Problems to Social Research. New York: Academic Press. Boruch, R.F. and Cecil, J.S. 1979 Assuring the Confidentiality of Social Research Data. Philadelphia: University of Pennsylvania Press. Braunstein, Y.M., Fischer, D.M., Ordoner, J.A., and Baumol, W.J. 1979 Economics of property rights as applied to computer software and data bases. Pp. 23~246 in G. P. Bush and R. H. Dreyfuss, eds., Tech~wlogy and Copyright: Sources and Materials. Mt. Airy, Md.: Lomond Books. Braverman, B.A., and Heppler, W.R. 1981 A practical review of state open records laws. George Washington Law Review. 49:72~760. Broad, W.3. 1982 Court upholds privacy of unpublished data. Science 216(Apnl 2):3~36.
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198 Joe S. Cecil and Eugene Griffirz Patton, W. 1980 An Author's Guide to the Copyright Law, 31-32, 8085. Lexington, Mass.: D.C. Heath § Co. Posner, R.A. 1979 Information and antitrust: reflection on the Gypsum and Georgetown Law Journal 67:1187-1203. Prewitt, K., and Sills, B. 1981 Federal funding for the social Engineers decisions. science: threats and responses. Items 35(September):33ff. Privacy Protection Study Commission 1977 Personal Privacy in an Information Society. Washington, D.C.: U.S. Government Printing Office. Project 1975 Government information and rights of citizens. Michigan Law Review 73:791-1339. Riecken, H.W., and Boruch, R.F. 1974 SocialExperimentation. New York: Academic Press. Robins, L.N. 1978 The Consequences of the Recommendations of the Privacy Protection Study Commission for Longitudinal Studies. Paper presented at the Life History Research in Psychopathology Meeting, Cincinnati, Ohio. Rozsa, G., and Foldi, T. 1980 International cooperation and trends in social science data transfer. UNESCO Journal of Information Sciences, Librarianship and Archive Administration 2:23~239. Sasfy, J.H., and Siegel, L. 1982 A Study of Research Access to Confidenizal Criminal Justice Agency l~ata. Washington, D.C.: The MINCE Corporation. Sprehe, J.T. 1981 A federal policy for improving data access and user services. Statistical Reporter 81 (March):32~344. Squires, J. 1979 Copyright and compilations in the computer era: old wine in new bottles. Pp. 20~234 in G.P. Bush and R.H. Dreyfilss, eds., Technology and Copyright: Sources and Materials. Mt. Airy, Md.: Lomond Books. Stevenson, R.B., Jr. 1982 Protecting business secrets under the Freedom of Information Act: managing Exemption 4. Administrative Low Review 34:297-261. Teitlebaum, L.E. 1983 A positivist approach to law and social science research. Pp. 11~8 in R. F. Boruch and J. S. Cecil, eds., Solutions to Ethical and Legal Problems to Social Research. New York: Academic Press. Thompson, G.B. 1979 Merno From Mercury: Informanon Technology is Different. Montreal: Institute for Research on Public Policy.