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Emerging Legal Trends Impacting Animal Research

Unlike humans, animals cannot provide or deny consent for experimentation; therefore, animal protection must come from self-imposed rules or external government guidelines and regulations, said session chair Arthur Sussman. Against this background there is growing concern about the quality of animal-use enforcement and increasing public demands that there be new ways to address the interests or rights of animals. Panelists discussed the impact of current legal trends on the use of animals in research, specifically, emerging animal rights laws and the use of Freedom of Information requests at the national level and open-record laws or sunshine laws at the state level to gain access to information.

RIGHTS, REGULATORY SYSTEMS, AND REGULATION

Margaret Foster Riley, professor at the University of Virginia School of Law, suggested that a consideration of animal research regulations might extend beyond “regulation” to a consideration of the interactions among different forms of regulations, different systems that create and enforce regulations, and different uses of “rights.” Rights involve many different social interactions. There are moral rights and legal rights. Rights are often not absolute and, in most legal systems, different rights may conflict with each other.

Recalling Blakemore’s discussion of the cost-benefit analysis (Chapter 1), Foster Riley said that modern moral values can affect the way the law reflects people’s perceptions of rights. Moral norms change over time, but not necessarily as a result of ethical or philosophical arguments. Philosophy



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3 Emerging Legal Trends Impacting Animal Research Unlike humans, animals cannot provide or deny consent for experimen- tation; therefore, animal protection must come from self-imposed rules or external government guidelines and regulations, said session chair Arthur Sussman. Against this background there is growing concern about the qual- ity of animal-use enforcement and increasing public demands that there be new ways to address the interests or rights of animals. Panelists discussed the impact of current legal trends on the use of animals in research, specifi- cally, emerging animal rights laws and the use of Freedom of Information requests at the national level and open-record laws or sunshine laws at the state level to gain access to information. RIGHTS, REGULATORY SYSTEMS, AND REGULATION Margaret Foster Riley, professor at the University of Virginia School of Law, suggested that a consideration of animal research regulations might extend beyond “regulation” to a consideration of the interactions among different forms of regulations, different systems that create and enforce regulations, and different uses of “rights.” Rights involve many different social interactions. There are moral rights and legal rights. Rights are often not absolute and, in most legal systems, different rights may conflict with each other. Recalling Blakemore’s discussion of the cost-benefit analysis (Chapter 1), Foster Riley said that modern moral values can affect the way the law re- flects people’s perceptions of rights. Moral norms change over time, but not necessarily as a result of ethical or philosophical arguments. Philosophy 21

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22 INTERNATIONAL ANIMAL RESEARCH REGULATIONS sets the foundation for cultural values, but context and psychology play significant roles in what is culturally acceptable. An individual’s relationship with animals, for example, colors his/her general view on issues relating to animals. Foster Riley said the perception of research using animals is also im- pacted by the perceived decline in the value of science in the United States. Foster Riley noted that while the Bayh-Dole Act1 achieved its intended goal to facilitate the translation of basic science into clinical practice, it also re- sulted in a “loss of purity” for science. A public perception is that science now is done for profit and is subject to the influence of industry and special interest groups. This decline in the status of science has had a profound effect in law, noted Foster Riley. Legal Rights, Property, and Legal Standing In the public eye, legal rights are often a moral issue, with many believ- ing that animals should not be viewed as property. For legal scholars, this is a crucial issue that determines what rights are at stake and who has legal standing to bring a lawsuit. It has been suggested that animals should be able to bring lawsuits themselves, in the same way that a child or a corpo- ration can. Another approach is that people should have broader rights to bring lawsuits on behalf of animals. Some of the most creative current litigation on animal research regula- tions, Foster Riley said, involves new uses of the False Claims Act, with lawsuits based on an improper use of public money. Under the National Institutes of Health (NIH) grants policy, if an investigator violates Public Health Service (PHS) policy on animal care or the Animal Welfare Act, the institution must return the NIH funds used in violation of grants policy. Moreover, an institution can be found in violation of government policy if it fails to report a problem once it is discovered. Under a “false claim” an argument could be made that the institution was claiming to be conducting research appropriately when indeed it was not, noted Foster Riley. Trade law also can affect animal use. For example, Foster Riley sug- gested that at least some of the opposition to genetically modified organ- isms in Europe is based on trade protectionism concerns rather than public health and environmental concerns. 1 The Bayh-Dole Act (Public Law 96-517, Patent and Trademark Act Amendments of 1980) created a uniform patent policy among the many federal agencies that fund research, enabling small businesses and non-profit organizations, including universities, to retain title to inven- tions made under federally funded research programs (NRC, 2006).

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23 EMERGING LEGAL TRENDS IMPACTING ANIMAL RESEARCH FREEDOM OF INFORMATION ACT Margaret Snyder, Freedom of Information Act (FOIA) coordinator in the Office of Extramural Research at the NIH, noted that the NIH has a long history of transparency. As early as the 1950s, the NIH produced public booklets about its grant awards, listing the grants, institutions, in- vestigators, and amount of funding. In 1998, the Computer Retrieval of Information on Scientific Projects (CRISP) database was launched, provid- ing the same basic information as well as abstracts. The database could be searched for trends, techniques, specific projects, or particular investiga- tors. Continuing this tradition of transparency, in September 2009, the NIH launched Research Portfolio Online Reporting Tools (RePORTER), the newest searchable database incorporating all of the information in the CRISP system as well as publications and patents. One question that often comes up is how much the NIH spends on animal research. Although it is not possible to disaggregate the budgets to identify money spent on animal research for individual projects, it is pos- sible to get a sense through Institutional Animal Care and Use Committee (IACUC) information. Snyder calculated that about 47 percent of NIH- funded grants have an animal research-based component. This number has been fairly steady over the past 10 years. Snyder noted, with animals being used in about 70 percent of the projects awarded funding through the National Institute of Neurological Disorders and Stroke. FOIA Requests Snyder gave a brief overview of FOIA (Box 3-1) and noted that for fiscal years 2006 through 2010, the NIH received 6,055 FOIA requests. Requesters are seeking information on a range of topics, including health information for themselves or a family member with a severe illness. The NIH also receives a considerable number of requests from individuals at academic and research institutions, some of whom are looking for a suc- cessful grant to model their application after, while others are seeking data for a policy or funding analysis for a scientific publication. The NIH also receives FOIA requests from animal advocates. Snyder noted that the number of requests to 6 institutes with neuroscience ac- tivities2 from advocates peaked in 2008; of the 70 FOIA requests from animal advocates across 27 institutes and centers, 35 (50 percent) were for 2 The six institutes highlighted by Snyder are the following: National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Drug Abuse (NIDA), National Eye Institute (NEI), National Institute of Mental Health (NIMH), and National Institute of Neurological Disorders and Stroke (NINDS).

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24 INTERNATIONAL ANIMAL RESEARCH REGULATIONS BOX 3-1 Freedom of Information Act (FOIA) Overview History • 966—FOIA signed into law by President Johnson. 1 • 996—Electronic Freedom of Information Act (E-FOIA) signed by President 1 C linton; the Internet and electronic distribution should be used as a means to improve public access to records. • 007—Open Government Act signed by President G. W. Bush imposed con- 2 sequences for agency non-compliance with new FOIA 20-day response time. • 009—Attorney General Holder, at the direction of President Obama, issued 2 a Memorandum on a “New Era of Open Government,” stressing transparency. Provisions • rovides the statutory right of a person or organization to obtain U.S. govern- P ment information: o ncluding that from federal agencies. I o xcluding the personal staff of the President, the Congress, or the courts. E Exemptions • ine exemptions are intended to protect privacy, financial information, and N personal security. • xemptions most often used by the National Institutes of Health (NIH): E o xemption 4: “Trade secrets and commercial or financial information.” E o xemption 5: Interagency or intra-agency memorandums and incorporates; E certain privileges (e.g., deliberative process, attorney–client communica- tions, and attorney work projects). o xemption 6: Certain information if disclosure would constitute clearly E unwarranted invasion of personal privacy (e.g., personnel actions). o xemption 7: Protects certain information in law enforcement files. E • he responding agency may not consider the identity of the requester or what T the requester intends to do with records when deciding whether to release or withhold records. SOURCE: Snyder presentation. these 6 institutes. Snyder noted that overall requests are not only increas- ing in number, but in magnitude. Of particular interest to animal rights advocates is information regarding research using non-human primates and information about institutions found in non-compliance. This second category can include institutions failing to report deficiencies or reports of actions by researchers in violation of either the Animal Welfare Act or PHS policy.

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25 EMERGING LEGAL TRENDS IMPACTING ANIMAL RESEARCH FOIA Exemptions A request by researchers to withhold information must be targeted, and any assertion of harm from disclosure must be very specific. Only the NIH FOIA officer can decide to withhold information. A written record then becomes part of the file that will be used in the event of an appeal or litigation. Snyder pointed out that even though the NIH has increased transpar- ency though RePORTER, CRISP, and other venues, the number of FOIA requests is not declining. Of concern, she said, is that the NIH relies heavily on institutional self-monitoring and self-reporting. The NIH works closely with grantee institutions and engages them in an interactive, collaborative exchange of information to correct any deficiencies. The success of this pro- cess depends on maintaining a confidential, collegial, interactive relation- ship, and that relationship is now in jeopardy. The NIH is finding it more difficult to protect information. There are no more blanket or categorical exemptions; arguing the need for protection involves case-by-case, line-by- line review. She did note that the NIH perspective is that unfunded grants are protected as intellectual property. The NIH releases names of researchers because that information is already public in the RePORTER database, Snyder said. In some cases, such as in non-compliance reports, she asks the FOIA requester if he/she will allow the NIH to redact the names of secondary individuals (i.e., the institutional official, chair of the IACUC, veterinarian, and investigator are disclosed and all others are redacted). In most cases the requester agrees. STATE SUNSHINE LAWS Richard Cupp, professor of law at Pepperdine University School of Law, explained that U.S. political power is shared between the federal gov- ernment and the states. Each state has an open-records law, or “sunshine law,” that is often very similar to the federal FOIA. There are limitations on the type of information that can be obtained through state sunshine laws. Most of the disclosure obligations and excep- tions under state sunshine laws are the same as FOIA. Possession dictates whether FOIA or state sunshine laws apply. If something is in the posses- sion of a federal agency (e.g., NIH), a FOIA request is made; if something is in the possession of a state institution (e.g., the University of California, Los Angeles [UCLA]), that state’s document release laws will apply. Some documents may be in the possession of both a federal agency and a state entity and there may be both a FOIA request and a state sunshine request. The 50 states have 50 different laws dealing with disclosing information, Cupp said. While they are generally overlapping, there are some distinc-

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26 INTERNATIONAL ANIMAL RESEARCH REGULATIONS tions.3 California, for example, has a general exemption clause that allows an entity to withhold information even if there is not a specific exemption. The entity must demonstrate that on the facts of the particular case, the public interest served by not disclosing the record clearly outweighs the public interest served by disclosing the record. The state organization has a strong burden of proof. Misuse of Sunshine Laws Cupp noted that transparency is important to a democratic government and most of the information obtained under sunshine laws is used for its intended purpose of supporting democratic discussion and the democratic process. Some information, however, has been obtained with the intent to threaten and harass researchers and institutions. Cupp shared a recent case at UCLA as an illustration of how sunshine laws have been used by U.S. activists. Two UCLA researchers received envelopes containing what an animal rights group press release described as “a dangerous present at their home.” They also received other threats, including “we are watching you and we know about your wife” and “we have been following you for the past 6 months all over campus, to your car, visits to [a local grocery store], to movies, and to social gatherings.” There is a long history of incidents similar to this at UCLA, including firebombing a researcher’s car, use of Molotov cocktails to firebomb re- searchers’ homes, and flooding of a researcher’s home with a garden hose. Researchers have also received razor blades that were allegedly covered in HIV-infected blood. During this time period, Cupp noted that UCLA and animal rights groups have battled over how much information about research is required to be disclosed under California’s sunshine law. In one case that has been active for a number of years, the judge overseeing an appellate court review stated that there is a “causal nexus between [UCLA’s] disclosure of animal research records and subsequent attacks on the researchers identified in such records after they are disseminated to the public.” In another court ruling that was upheld on appeal, the judge found that releasing some of the documents sought by animal rights activists “would result in a significant and specific risk of unlawful intimidation and physical harm to researchers and to their families.” 3The website http://www.sunshinereview.org provides information on all 50 states’ sunshine laws.

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27 EMERGING LEGAL TRENDS IMPACTING ANIMAL RESEARCH Transparency Cupp noted that greater transparency would not necessarily result in fewer FOIA or sunshine requests. Increased public access to documents would reduce the amount of work on the part of those tasked with respond- ing to these requests. But would that be a good balance of risk and utility for an institution, Cupp asked? Cupp suggested exercising care in writing documents and communica- tions to avoid unnecessary disclosure of sensitive information, or infor- mation that may be misinterpreted. For example, researchers could keep e-mails related to research short and on point. Cupp also suggested that personal e-mail accounts not be used when writing about research as all personal e-mails might become subject to FOIA requests or state sunshine law requests. Cupp suggested that researchers avoid jokes or sarcasm that could be misunderstood. He also encouraged institutions to make public and strong expressions of support for scientific research involving animals. With the encourage- ment of faculty members, the UCLA administration in 2007 began making strong press statements backing the research work of the university.

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