Abstract:Human and animal research both operate within established standards. In the United States, criticism of the human research environment and recorded abuses of human research subjects served as the impetus for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the resulting Belmont Report. The Belmont Report established key ethical principles to which human research should adhere: respect for autonomy, obligations to beneficence and justice, and special protections for vulnerable individuals and (...) populations. While current guidelines appropriately aim to protect the individual interests of human participants in research, no similar, comprehensive, and principled effort has addressed the use of (nonhuman) animals in research. Although published policies regarding animal research provide relevant regulatory guidance, the lack of a fundamental effort to explore the ethical issues and principles that should guide decisions about the potential use of animals in research has led to unclear and disparate policies. Here, we explore how the ethical principles outlined in the Belmont Report could be applied consistently to animals. We describe how concepts such as respect for autonomy and obligations to beneficence and justice could be applied to animals, as well as how animals are entitled to special protections as a result of their vulnerability. (shrink)

How far does a researcher’s responsibility extend when an incidental finding is identified? Balancing pertinent ethical principles such as beneficence, respect for persons, and duty to rescue is not always straightforward, particularly in neuroimaging research where empirical data that might help guide decision making are lacking. We conducted a systematic survey of perceptions and preferences of 396 investigators, research participants, and Institutional Review Board members at our institution. Using the partial entrustment model as described by Richardson, we argue that our (...) data supports universal reading by a neuroradiologist of all research MRI scans for incidental findings and providing full disclosure to all participants. (shrink)

On December 15, 2011, a final report was issued by the Committee on the Use of Chimpanzees in Biomedical and Behavioral Research, which had been convened by the U. S. Institute of Medicine (IOM) in collaboration with National Research Council (NRC) of the National Academies. Within a month of its release, this report was designated by Wired Science one of the “top scientific discoveries of 2011” (Wired Science Staff 2011). The ad hoc Committee responsible for this report was formed at (...) the request of the National Institutes of Health (NIH) in response to congressional inquiry that had been prompted by expressions of public concern.1 The issues addressed in the report are profoundly ethical, despite NIH’s .. (shrink)

In the relatively short time since 2006—when Theoretical Medicine and Bioethics published an issue on moral issues relevant to the use of nonhuman animals in research [1]—significant changes have occurred for nonhuman animals in many quarters. Public sentiment, new policy initiatives, and scientific studies of nonhuman animals’ capacities have all influenced the ways in which nonhuman animals are perceived and treated in research. Today, a large body of information is available for use in decision making about the acceptability of using (...) nonhuman animals in research. The articles in this issue assess how moral argument and empirical studies stand to guide animal research policies and practices in future years.Many in bioethics have come to regard issues of animal research as a subfield of research ethics, bringing it closer to human research ethics. Animal ethics, like public health ethics, has struggled for recognition in bioethics. As the contributions to this issue show, some in bioe. (shrink)

The first set of case studies on animal use, this volume offers a thorough, up-to-date exploration of the moral issues related to animal welfare. Its main purpose is to examine how far it is ethically justifiable to harm animals in order to benefit mankind. An excellent introduction provides a framework for the cases and sets the background of philosophical and moral concepts underlying the subject. Sixteen original, previously unpublished essays cover controversies associated with the human use of animals in a (...) broad range of contexts, including biomedical, behavioral, and wildlife research, cosmetic safety testing, education, the food industry, commerce, and animal use as pets and in religious practices. Scientific research is accorded the closest scrutiny. The authors represent a wide range of expertise within their specialized areas of research--physiology, public policy, ethics, philosophy, law, veterinary science, and psychology. The careful analysis of each case makes it possible to elevate the discourse beyond over-simplified positions, and to demonstrate the complexity of the issues. The Human Use of Animals will be welcomed by students and faculty in law, philosophy, ethics, public policy, religion, medicine, and veterinary medicine. It will also interest activists in the animal protection movement, and members of animal protection organizations and Institutional Animal Care and Use Committees. (shrink)

It is correctly asserted that the intensity of the current debate over the use of animals in biomedical research is unprecedented. The extent of expressed animosity and distrust has stunned many researchers. In response, researchers have tended to take a strategic defensive posture, which involves the assertion of several abstract positions that serve to obstruct resolution of the debate. Those abstractions include the notions that the animal protection movement is trivial and purely anti-intellectual in scope, that all science is good (...) (and some especially so), and the belief that an ethical consensus can never really be reached between the parties. (shrink)

Debriefing is a standard ethical requirement for human research involving the use of deception. Little systematic attention, however, has been devoted to explaining the ethical significance of debriefing and the specific ethical functions that it serves. In this article, we develop an account of debriefing as a tool of moral accountability for the prima facie wrong of deception. Specifically, we contend that debriefing should include a responsibility to promote transparency by explaining the deception and its rationale, to provide an apology (...) to subjects for infringing the principle of respect for persons, and to offer subjects an opportunity to withdraw their data. We also present recommendations concerning the discussion of deception in scientific articles reporting the results of research using deception. (shrink)

Although gender differences in attitudes toward animal research have been reported in the literature for some time, exploration into the nature of these differences has received less attention. This article examines gender differences in responses to a survey of attitudes toward the use of animals in research. The survey was completed by college students and consisted of items intended to tap different issues related to the animal research debate. Results indicated that women were more likely than men to support tenets (...) of the animal protection movement. Likewise, women were more likely than men to favor increased restrictions on animal use and were more concerned than men about the suffering of research animals. Analysis of item contents suggested that women endorsed items reflecting a general caring for animals, were more willing than men to make personal sacrifices such as giving up meat and medical benefits in an effort to protect animals, and were more likely than men to question the use of animals in research on scientific grounds. Men, on the other hand, tended to emphasize the potential benefits arising from the use of animals in research. (shrink)

Since 1985, the US Animal Welfare Act and Public Health Service policy have required that researchers using nonhuman primates in biomedical and behavioral research develop a plan “for a physical environment adequate to promote the psychological well-being of primates.” In pursuing this charge, housing attributes such as social companionship, opportunities to express species-typical behavior, suitable space for expanded locomotor activity, and nonstressful relationships with laboratory personnel are dimensions that have dominated the discussion. Regulators were careful not to direct a specific (...) set of prescriptions (i.e., engineering standards) for the attainment of these goals, but to leave the design of the programs substantially up to “professional judgment” at the local level. Recently, however, the Institute of Medicine, in its path-finding 2011 report on the necessity of chimpanzee use in research, bypassed this flexible and contingent concept, and instead, required as a central precondition that chimpanzees be housed in “ethologically appropriate” environments. In so doing, obligations of ethical treatment of one great ape species were elevated above the needs of some research. The evolution and significance of this change are discussed. (shrink)

In a broad-based study of experiences in psychological research, 65 undergraduates participating in a wide range of psychological experiments were interviewed in depth. Overall findings demonstrated that participants hold varying views, with only 32% of participants characterizing their experiences as completely positive. Participants' descriptions of their debriefing experiences suggest substantial variability in the content, format, and general quality of debriefing practices. Just over 40% of the debriefing experiences were viewed favorably. Positive debriefing experiences were described as including a thorough explanation (...) of the study and detailed information concerning the broader relevance of the experiment to the field of psychology. The most common complaint, characterizing 28.8% of the responses, was that the debriefing was unclear and that insufficient information was provided. Participants' views of psychological research and the discipline of psychology were also elicited. Results are discussed in terms of ethical and methodological implications. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:FDA Releases Draft Guidance on Regulation of Genetically Engineered AnimalsJohn P. Gluck (bio) and Mark T. Holdsworth (bio)On 18 September 2008, the U.S. Food and Drug Administration (FDA) issued a draft set of guidelines for those involved in developing genetically engineered animals with heritable recombinant DNA (rDNA) constructs and is requesting comment from industry and the public about their content. The document does not impose new regulations but details (...) how existing laws and regulations apply to genetically engineered (GE) animals and offers advice to developers on how to negotiate the laws in the most efficient and productive manner. The draft guidance document is not legally enforceable at this juncture, but the guidelines are recommendations reflecting the FDA's "current thinking on a topic."The modification of GE animals being developed for commercialization, which are the focus of the document, fall into six categories: modifications intended to (1) enhance food quality—e.g., faster growing fish and meats with better nutritional profiles; (2) improve animal health via increased resistance to disease—e.g., mastitis in dairy cattle and Bovine Spongiform Encephalopathy (BSE); (3) create so-called "biopharm" animals capable of producing therapeutic products such as insulin, clotting factors, and tissues for human transplantation; (4) reduce the barriers to human animal interaction—e.g., hypoallergenic pets; (5) develop valid animal models of human disease—e.g., Parkinson's disease, Lesh-Nyhan's syndrome, and cancer; and (6) improve production of industrial or consumer products such as fiber. The timing of the guidelines coincides with the FDA's belief in an expected boon in the number of GE animals approaching the stage of commercialization.The FDA's involvement in the approval process emerges from the new animal drug provisions of the Federal Food Drug and Cosmetic Act and the definition of what constitutes a drug. The Act defines a new animal drug as "an article (other than food) intended to affect the structure or any function of the body of... animals." A rDNA construct intended to affect the structure or function of an animal meets the definition of a new animal drug, regardless of whether the resulting GE animals are intended for human food or the production of pharmaceuticals or any other substances. [End Page 393]Before proceeding to a review of the draft guidelines, it is important briefly to set the controversies around GE animals in historical and ethical context.The Ethical DebateFrom its inception, the intentional genetic modification or genetic engineering of molecules, plants, and animals by the techniques of gene splicing has consistently elicited strong responses from both the scientific community and the public. There are some data to suggest that although the concerns of scientists fall primarily into the category of possible biohazards, those of the public also reflect great concern about the intrinsic moral issues, such as whether there is something fundamentally wrong with this line of work, making it a form of forbidden knowledge (see, e.g., Gaskell 1997). When news of Paul Berg's attempts in 1970 to graft the primate tumor virus (SV 40) onto the intestinal tract bacteria Escherichia coli for the purpose of studying how normal cells may be transformed into cancerous cells was shared with colleagues, he was strongly encouraged to reflect on the potential public health risks if somehow the altered bacteria broke containment and entered the environment. Thanks to Berg's leadership, these concerns soon resulted in conferences held in Asilomar, California, and New Hampton, New Hampshire, where the ethical responsibilities of microbiologists involved in this research were discussed. These initial discussions resulted in what has come to be known as "The Moratorium Letter" (Shattuck 1996) published in the journal Science in 1974. This letter, signed by 11 leaders in the field, actually recommended restrictions on several types of experiments that were considered to be particularly risky and stated "that adherence to our major recommendations will entail postponement or possibly abandonment of certain types of scientifically worthwhile experiments" (Berg 1974). An international conference on the issues came to similar conclusions about the need for a research moratorium for the sake of public safety. Recommendations arising from conference participants led to the formation of the National Institutes... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Deception in Psychological ResearchJohn P. Gluck and Stephen Hahn-SmithMadam: In the March 1995 issue of the KIEJ, Sissela Bok adds meaningfully to her consistent and important analysis of the harms associated with deception in biomedical and behavioral research. She reminds us that investigator and review committee domination of the analysis of costs and benefits deprives the prospective research subjects of the opportunity to apply their unique sense of values (...) and preferences, an obligation that flows from an authentic respect for persons and a recognition of the importance of autonomy.She also correctly points out that the American Psychological Association (APA) is unique in that it acknowledges the harms of deception by requiring scientific [End Page 386] justification, limiting the scope of what factors can be part of the deception, and supporting minimal duration of deception, at the same time as it maintains a very permissive stance toward its use. For example, the APA code of conduct requires that alternatives to deception be implemented only when they are deemed to be "equally effective."What Bok omits in her critique is that a common justification for the use of deception by psychologists is the belief that many research subjects actually benefit from being deceived. This impression is based on studies that interview subjects at some point in time after their experimental experience. For example, Smith and Richardson (1983, p. 1080) concluded that: "In general, respondents who have been deceived while participating in psychological research did not report negative effects of their experience. In fact, they perceived their experiences more positively that did respondents who had not participated in studies employing deception." Christensen (1988, p. 668), after reviewing the literature on subject reaction to deception, states that the evidence supports the notion that deception experiments are perceived as "more enjoyable and beneficial than nondeception experiments." He goes on to say that in the face of these data it may be that deception has gotten its bad name from philosophers!Basing the acceptability of deception on direct sampling of subjects' highly personal reactions assumes that the procedure yields responses that are valid on their face. If this is true, it would seem to undermine the typical justification for deception in the first place, which is that subjects when asked for personal information are likely to respond in misleading ways. It is important to note that evidence suggests that if subjects are queried about the acceptability of deception prior to actual participation, substantial proportions of subjects judge deception to be unacceptable (Korn 1987). These results are consistent with our own recently completed research, which shows that subjects asked about their reactions following participation in a deception experiment did indeed tend to indicate its acceptability. However, when asked to make a judgment about what reactions other students had to the same experiment, they expressed concern that others may have been harmed by the deception.For psychologists to selectively disregard the distinct possibility of dynamically motivated minimization of harm in order to justify deceptive research practices further supports Bok's characterization of today's competitive research environment and the standards of personal integrity that it challenges.Stephen Hahn-SmithDepartment of Psychology The University of New Mexico Albuquerque, NMReferencesChristensen, Larry. 1988. Deception in Psychological Research: When is it Justified? Personality and Social Psychology Bulletin 14: 664-75. Google ScholarKorn, James H. 1987. Judgements of Acceptability of Deception in Psychological Research. Journal of General Psychology 114: 205-6. [End Page 387]Google ScholarSmith, Steven S., and Richardson, Deborah. 1983 Amelioration of Deception and Harm in Psychological Research: The Important Role of Debriefing. Journal of Personality and Social Psychology 44: 1075-82. [End Page 388]Google ScholarCopyright © 1995 The Johns Hopkins University Press... (shrink)

With respect to the ethical debate about the treatment of animals in biomedical and behavioral research, Harry F. Harlow represents a paradox. On the one hand, his work on monkey cognition and social development fostered a view of the animals as having rich subjective lives filled with intention and emotion. On the other, he has been criticized for the conduct of research that seemed to ignore the ethical implications of his own discoveries. The basis of this contradiction is discussed and (...) propositions for current research practice are presented. (shrink)

In his challenging article, Steneck (1997) criticized the creation of the Institutional Animal Care and Use Committee (IACUC) system established by the 1985 amendments to the Animal Welfare Act. He saw the IACUC review and approval of biomedical and behavioral research with animals as an unnecessary "reassignment" of duties from existing animal care programs to IACUC committees. He argued that the committees are unable to do the work expected of them for basically three reasons: (a) the membership lacks the expertise (...) in matters relevant to animal research and care, (b) there exists an inherent and disabling conflict of interest, and (c) the committee's operational base of authority is alien to academic culture and violates essential aspects of academic freedom. In addition, he found that the system is burdensome, requiring enormous expenditures of time and money that inappropriately diverts resources away from the business of scientific discovery. We dispute several aspects of Steneck's historical account and the coherence of his proposals. We believe his proposals, if followed, would be a step back into a failed past. (shrink)