The institutional review board is an impediment to human research: the result is more animal-based research

Biomedical research today can be generally classified as human-based or nonhuman animal-based, each with separate and distinct review boards that must approve research protocols. Researchers wishing to work with humans or human tissues have become frustrated by the required burdensome approval panel, the Institutional Review Board. However, scientists have found it is much easier to work with the animal-based research review board, the Institutional Animal Care and Use Committee. Consequently, animals are used for investigations even when scientists believe these studies should be performed with humans or human tissue. This situation deserves attention from society and more specifically the animal protection and patient advocate communities, as neither patients nor animals are well served by the present situation.     

A plea for pragmatism in clinical research ethics

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.     

Behavioral pragmatism: no place for reality and truth

The current article begins by reviewing L. J. Hayes's claim that pragmatism relies on a correspondence-based truth criterion. To evaluate her claim, the concept of the observation sentence, proposed by the pragmatist philosopher W. V. Quine, is examined. The observation sentence appears to remove the issue of correspondence from Quine's pragmatist philosophy. Nevertheless, the issue of correspondence reemerges, as the problem of homology, when Quine appeals to agreement between or among observation sentences as the basis for truth. Quine also argues, however, that the problem of homology (i.e., correspondence) should be ignored on pragmatic grounds. Because the problem is simply ignored, but not resolved, there appears to be some substance to Hayes's claim that pragmatism relies ultimately on correspondence as a truth criterion. Behavioral pragmatism is then introduced to circumvent both Hayes's claim and Quine's implicit appeal to correspondence. Behavioral pragmatism avoids correspondence by appealing to the personal goals (i.e., the behavior) of the scientist or philosopher as the basis for establishing truth. One consequence of this approach, however, is that science and philosophy are robbed of any final or absolute objectives and thus may not be a satisfactory solution to philosophers. On balance, behavioral pragmatism avoids any appeal to correspondence-based truth, and thus it cannot be criticized for generating the same philosophical problems that have come to be associated with this truth criterion.     

Moral outrage and pragmatism: Explanations for collective action

Two explanations for collective behavior were contrasted. The first, exemplified by relative deprivation theory, stresses the importance of feelings of moral outrage and perceived economic injustice. The second focuses on more pragmatic considerations, such as the availability of resources for mobilization. The present study examines these explanations for collective behavior in a laboratory setting. Subjects were members of a disadvantaged group. In a 3 × 2 factorial design two independent variables were manipulated. The magnitude of pay inequality between the disadvantaged group and a more advantaged group was manipulated to be large, moderate, or small. Mobilization resources available to the disadvantaged group were manipulated to be either present or absent. In accord with predictions based on relative deprivation theory, as the magnitude of the inequality increased, stronger feelings of deprivation were expressed. However, contrary to relative deprivation theory, larger magnitudes of inequality and stronger feelings of deprivation were not associated with greater willingness to engage in legitimate or illegitimate forms of collective behavior. Instead, as predicted by some critics of relative deprivation theory, willinginess to engage in illegitimate forms of collective behavior was affected only by a gragmatic consideration: the presence or absence of mobilization resources.     

American pragmatism as a guide for professional ethical conduct for engineers

The ethical choices faced by engineers today are increasingly complex. Competing and conflicting ethical demands from clients, communities, employees, and personal objectives combine to suggest that engineers employ ethical approaches that are adaptive yet grounded in three concrete professional circumstances: first, that engineers apply unique professional skills in the service of a client, subject to protecting the public interest; second, that engineers advance the state of knowledge of their professional field through reflection, research, and sharing experience in journals and conferences, and third, that they develop new professionals by active mentoring. This paper examines five features of American pragmatism and suggests that its emphasis on specific, context-based ethical decision making can assist engineers in a postmodern setting. In particular, it considers the venues of interpersonal ethical choices, institutional ethical conflicts, and social choices that have ethical components. Pragmatism suggests that in such a complex ethical climate, there is a need for the co-evolution of judgment and action, for individual reflective judgment in particular situations, and for ceasing to search for a single, immutable principle for ethical choice. An earlier version of this paper was presented at the “Ethics and Social Responsibility in Engineering and Technology” meeting, New Orleans, 2003.     

Trauma and sex surveys meet minimal risk standards: implications for institutional review boards

Institutional review boards assume that questionnaires asking about "sensitive" topics (e.g., trauma and sex) pose more risk to respondents than seemingly innocuous measures (e.g., cognitive tests). We tested this assumption by asking 504 undergraduates to answer either surveys on trauma and sex or measures of cognitive ability, such as tests of vocabulary and abstract reasoning. Participants rated their positive and negative emotional reactions and the perceived benefits and mental costs of participating; they also compared their study-related distress with the distress arising from normal life stressors. Participants who completed trauma and sex surveys, relative to participants who completed cognitive measures, rated the study as resulting in higher positive affect and as having greater perceived benefits and fewer mental costs. Although participants who completed trauma and sex surveys reported slightly higher levels of negative emotion than did participants who completed cognitive measures, averages were very low for both groups, and outliers were rare. All participants rated each normal life stressor as more distressing than participating in the study. These results suggest that trauma and sex surveys pose minimal risk.     

Training for institutional change

If counselors are going to perform functions different from dyadic therapeutic counseling, institutions preparing counselors must change the context and processes of their programs. Assisting an individual to change is difficult; intervention for institutional change is infinitely complex. Yet many of the concepts and skills are the same for both. Dustin describes the procedures he has used to equip counselors to utilize the basic principles of change with an organization as a target. Other trainers may use other methods in this relatively new extension of counselor functioning; what is clear, however, is the need for new training models if our goals of creating humane environments is to be reached.     

Neo‐pragmatism,Representationalism and the Emotions

This paper offers a neo‐pragmatist account of the representational character of the emotions, for those emotions that have such a character. Put most generally, neo‐pragmatism is the view that language should not be conceived primarily in terms of a robust relation of reference to or representation of antecedently given objects and properties. Rather, we should view it as a social practice that lets us do various quite different sorts of things. One of those things might be called ‘assessing representational accuracy’, but this need not be thought of in terms of a metaphysically heavyweight relation. In applying neo‐pragmatist techniques to the domain of the emotions, the result will be an alternative to currently popular accounts that individuate emotions partly in terms of what they represent. This alternative continues to allow us to use representational language in connection with some emotions. And it also helps to explain the awkwardness of representational talk in connection with other emotions: an awkwardness that was always a liability of monolithic representationalist views.     

Reasons for pragmatism: affording epistemic contact in a shared environment

Phenomenology and the Cognitive Sciences - Theorizing about perception is often motivated by a belief that without a way of ensuring that our perceptual experience correctly reflects the external...     

Militant atheism,pragmatism, and the God-shaped hole

This paper addresses recent examples of militant atheism. It considers the theistic reply that describes atheism as deriving from a “God-shaped hole” in the human soul. The paper will argue that American pragmatism offers a middle path that avoids militant atheism without suffering from this problem. The paper describes this middle path and considers the problem that is seen in Rorty’s recent work: how the pragmatist can remain critical of religious fundamentalism without succumbing to a militant version of atheism. The solution proposed is tolerant acceptance of religion along with melioristic criticism developed within shared norms of inquiry.     

An open letter to institutional review boards considering Northfield Laboratories' PolyHeme trial

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme and saline in the field and, still without consent, randomized between PolyHeme and blood after arrival at an emergency department. The Federal regulations that govern the waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood-the standard treatment for hemorrhagic shock-is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards.     

The insanity sentence: Oregon's psychiatric security review board

In response to the dilemma of management of mentally ill persons who commit crimes, Oregon has created the Psychiatric Security Review Board (PSRB) to administrate the supervision and treatment of insanity acquittees. This paper presents an overview of the PSRB structure and examines the quasi-criminal justice features of Oregon's Insanity Sentence. The primary goal of the PSRB is the protection of societý. The maximum sentence, had the individual been found guilty, becomes the PSRB's jurisdictional period for that former defendant. A review of the administrative rules for conditional release and revocation of release that the PSRB is now in the process of adopting are described. The authors conclude that the PSRB is a promising approach which offers better community protection and better treatment for mentally ill offenders (NGRIs) than does the present prison parole system.