On the second day of the meeting, the STL Panel explored several areas where law places constraints and requirements on the conduct of academic research. Specifically, the Panel reviewed issues regarding 1) access to research data, 2) intellectual property, and 3) research misconduct.
The social and economic stakes of research are rising. Federal regulatory and policy decisions of great importance hinge more and more on questions of cutting-edge science and technology. Traditional mechanisms for conveying policy-relevant research findings permit researchers to retain a proprietary interest in their underlying research data. However, in today's climate a variety of legal proceedings require scientists and engineers to justify their findings and disclose their research data and methods in unaccustomed degrees of detail. These include the following:
recent federal legislation gives the public the authority under the Freedom of Information Act (FOIA) to access federally sponsored research data
scientists' data are on occasion subpoenaed even in cases in which the scientists have no involvement in the litigation.
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Page 12 3 Law and the Conduct of Scientific and Engineering Activities On the second day of the meeting, the STL Panel explored several areas where law places constraints and requirements on the conduct of academic research. Specifically, the Panel reviewed issues regarding 1) access to research data, 2) intellectual property, and 3) research misconduct. ACCESS TO RESEARCH DATA The social and economic stakes of research are rising. Federal regulatory and policy decisions of great importance hinge more and more on questions of cutting-edge science and technology. Traditional mechanisms for conveying policy-relevant research findings permit researchers to retain a proprietary interest in their underlying research data. However, in today's climate a variety of legal proceedings require scientists and engineers to justify their findings and disclose their research data and methods in unaccustomed degrees of detail. These include the following: recent federal legislation gives the public the authority under the Freedom of Information Act (FOIA) to access federally sponsored research data scientists' data are on occasion subpoenaed even in cases in which the scientists have no involvement in the litigation.
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Page 13 These proceedings represent another area where the cultures of science and law clash. Openness and a willingness to share research data are paramount to the scientific enterprise. For the scientific community, the common means of ensuring accuracy and quality of research is replication. Publication of one's findings is the means by which scientists communicate with each other and provide the information necessary for replication and reanalysis. Most scientific journals rely on peer review to ensure that scientific papers meet a threshold of credibility. Peer review is handled in a decentralized way, much of it by volunteers, and coordinated by editors of individual professional journals. While peer review is not a substitute for replicability, it does provide the scientific community with a level of confidence about the integrity of the research findings. In litigation, however, a lawyer, in carrying out his or her duty to represent his client, may seek independent verification of research results. Consequently, he or she may accord little weight to the fact that the results may have been peer reviewed and published when questioning and challenging the expert. A vigorous attack of the expert witness and his or her research results may be just what is needed in order to provide his or her client with a good defense, but it may leave the expert most uneasy. PUBLIC ACCESS TO FEDERALLY FUNDED RESEARCH DATA THAT UNDERLIES REGULATION The regulatory requirement of publication and notice seeks public consensus as to the accuracy of facts and reasonableness of proposed new rules and regulations. However, the facts may be disputed, and regulators then labor under a handicap in establishing public credibility. For example, the U.S. Environmental Protection Agency (EPA) in 1997 proposed to tighten federal air quality regulations for particulate matter. The proposed new standard was based partly on the results of the Harvard “Six Cities” epidemiological study, which identified a correlation between death rates and airborne particulates in several middle-sized cities. Implementing these standards would cost industry billions of dollars, much of it passed on to industry. While EPA's action followed a typical regulatory path, concerns about the underlying data resulted in a legislative action that sought to change the manner in which the public gains access to federally sponsored research data. Industry groups (and several members of Congress) asked EPA for the underlying research data from these studies in order to conduct their own analysis. The Harvard researchers, funded by the National Institutes of Health (NIH), refused to release the research data, citing privacy concerns of the human subjects and the researcher's traditional right to control data. EPA agreed with this view. As an alternative, EPA and the
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Page 14 researchers offered to have the data reanalyzed by the Health Effects Institute (HEI), an independent research institute jointly funded by industry and the EPA, whose policy is set by an independent board. The results of that study were not expected to be available, however, until 2 years after the regulation had become final. EPA argued that the peer review undergone by the Harvard study was sufficient to support regulations. Critics (for example, Cohen and Hahn, 1999) pointed out that academic peer reviews are often flawed (the expectation is that mistakes will wash out in the long run, as other scientists try to replicate the results), and that regulations costing billions of dollars to enforce should not be built solely on such a foundation. Meanwhile, Congress, through the Shelby amendment, directed the Office of Management and Budget (OMB) to revise regulations covering research grants to nonprofit organizations (OMB Circular A-110, subpart C.36) to give the public access under FOIA to data relating to all federally funded research. After much public discussion, OMB issued the final rule. The final rule provides public access to “research data relating to published research findings produced under an award that were used by the Federal Government in developing an agency action that has the force and effect of law.” The rule—which applies only to nonprofit research grantees—raises a number of questions that may lead to litigation: 1. Does the new rule apply retroactively or only prospectively? 2. What are the potential costs and administrative burdens of complying with requests, and how will researchers be reimbursed? 3. How, in practice, will privacy concerns regarding research data that involve human subjects or patient records be handled? 4. How will agencies and courts set the threshold of cost or significance below which federal “agency actions” are not subject to this requirement? 5. Will requests be made to harass researchers or hinder their ability to conduct research? As was pointed out during the STL Panel discussion, achieving the right balance for the public good in such cases is difficult. The results of complex statistical studies used for regulatory purposes can be subject to various interpretations, and on these grounds deserve the widest possible scrutiny. Traditional peer review alone may not be sufficient in such cases to ensure credibility. On the other hand, many in the academic community see the new OMB rule as an invasion of privacy, a potentially onerous burden that will divert researchers from work that is of broader benefit, and in the extreme case, view the rule as a license to harass and discour
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Page 15 age federally funded researchers from pursuing areas of research that are meaningful to broad advances in public health and safety. COURT-ORDERED DISCLOSURE OF ACADEMIC RESEARCH The STL Panel turned its attention to the situation that arises when parties bring academic researchers into a legal proceeding by obtaining subpoenas for their research data. A federally funded researcher studying the effects on communities of the Exxon Valdez oil spill, for example, was served with a subpoena from Exxon demanding all materials from an ongoing study, including notebooks, letters, working papers, handwritten survey responses from residents, and other raw material (Picou, 1996).5 In another case, several researchers studying impacts of cigarette advertising on children were served with similarly broad subpoenas by a cigarette manufacturer defending a suit in a California court (Fischer, 1996). It has been suggested that in these cases, the legal process was bent to serve extralegal purposes—in fishing expeditions that had little to do with resolving the case. Some Panel members suggested that the duty to provide evidence, which is strongly rooted in law, must be balanced against the potential for harassment in such cases. Even more important, courts, when they review subpoenas, might require a demonstration of a substantial need for the research information that cannot otherwise be satisfied. CONFLICTS BETWEEN INTELLECTUAL PROPERTY RIGHTS AND OPENNESS OF RESEARCH Another topic discussed by the STL Panel is the concern of some researchers that an emphasis on intellectual property in academic institutions has led to internal tension between those who advocate the traditional goal of open scientific communication and those who promote the newer goal of royalty income to the institution. As discussed below, some fear that recent developments may have a chilling affect on research. The Patenting of Research Tools Intellectual property claims on research tools are proliferating. Researchers who wish to use some basic research tools or databases are now 5 In 1991, the NRC sponsored a workshop on science and litigation that explored the effect of confidential settlements and sealed court records on scientific research. See Anderson, Frederick R., “The legal system obstructs science,” in The Atlanta Journal and Constitution, November 29, 1991.
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Page 16 being required to sign license agreements, material transfer agreements, or nondisclosure agreements. Some experts believe that the delays and costs involved in these transactions are so large that they discourage research in certain fields (Heller and Eisenberg, 1998). Others (Rosenthal, 1996) view nondisclosure agreements as immoral, since theoretically they can require a clinical researcher to withhold an effective treatment simply because it is based on proprietary knowledge. Tighter Restrictions on Publication Industrial sponsors of research at universities impose controls (generally delays) on publication to allow their companies to assess the potential for intellectual property in their findings. Do these controls shift researchers' incentives? NIH and other research agencies regard a 60-day publication delay as acceptable (although they have not issued blanket policies). Surveys suggest that many agreements sanctioned by universities permit longer withholding periods. More worrisome, one study found, is that universities tend to understate the degree of commercial secrecy they tolerate (Blumenthal et al., 1997). QUASI-JUDICIAL PROCEEDINGS IN RESEARCH MISCONDUCT CASES The STL Panel received a briefing on the new federal policy governing research misconduct for researchers who have accepted federal awards. Such a policy is necessary due to the fact that researchers are sometimes accused of misconduct, such as misrepresenting research results or plagiarism. In investigating these cases, research institutions have developed a variety of quasi-judicial procedures in the past decade. The White House National Science and Technology Council recently revised the federal policy on research misconduct. The new policy defines research misconduct more narrowly, limiting it to “fabrication, falsification, or plagiarism in proposing, performing or reviewing research, or in reporting research results.” Other types of misconduct (e.g., theft, harassment, and discrimination) that have been subjects of such inquiries in the past are left to be addressed through other laws and regulations. In implementing the new policy, the HHS Office of the Inspector General will assume the main responsibility for investigating research misconduct. The ORI will then be responsible for the tasks of oversight and education. Under the new policy, institutions that administer HHS grants are responsible for initial inquiries and investigations when research misconduct is suspected or alleged. When further fact-finding is
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Page 17 required by the federal government, it will be carried out by the HHS Office of Inspector General rather than the ORI. In the worst cases of research misconduct, the courts become involved. A researcher who is penalized or debarred by administrative action of the agency may appeal to federal court. Federal courts do not have jurisdiction to review scientific or research misconduct investigations under the Administrative Procedure Act until there is a final agency action and the imposition of a sanction [Abbs v. Sullivan, 963 F.2d 918 (7th Cir. 1992)].