We present a probabilistic extension to active path analyses of token causation (Halpern & Pearl 2001, forthcoming; Hitchcock 2001). The extension uses the generalized notion of intervention presented in (Korb et al. 2004): we allow an intervention to set any probability distribution over the intervention variables, not just a single value. The resulting account can handle a wide range of examples. We do not claim the account is complete --- only that it fills an obvious gap in previous active-path approaches. (...) It still succumbs to recent counterexamples by Hiddleston (2005), because it does not explicitly consider causal processes. We claim three benefits: a detailed comparison of three active-path approaches, a probabilistic extension for each, and an algorithmic formulation. (shrink)

The investigation of probabilistic causality has been plagued by a variety of misconceptions and misunderstandings. One has been the thought that the aim of the probabilistic account of causality is the reduction of causal claims to probabilistic claims. Nancy Cartwright (1979) has clearly rebutted that idea. Another ill-conceived idea continues to haunt the debate, namely the idea that contextual unanimity can do the work of objective homogeneity. It cannot. We argue that only objective homogeneity in combination with a causal interpretation (...) of Bayesian networks can provide the desired criterion of probabilistic causality. (shrink)

We present a minimum message length (MML) framework for trajectory partitioning by point selection, and use it to automatically select the tolerance parameter ε for Douglas-Peucker partitioning, adapting to local trajectory complexity. By examining a range of ε for synthetic and real trajectories, it is easy to see that the best ε does vary by trajectory, and that the MML encoding makes sensible choices and is robust against Gaussian noise. We use it to explore the identification of micro-activities within a (...) longer trajectory. This MML metric is comparable to the TRACLUS metric – and shares the constraint of abstracting only by omission of points – but is a true lossless encoding. Such encoding has several theoretical advantages – particularly with very small segments (high frame rates) – but actual performance interacts strongly with the search algorithm. Both differ from unconstrained piecewise linear approximations, including other MML formulations. (shrink)

This paper presents an attempt to integrate theories of causal processes—of the kind developed by Wesley Salmon and Phil Dowe—into a theory of causal models using Bayesian networks. We suggest that arcs in causal models must correspond to possible causal processes. Moreover, we suggest that when processes are rendered physically impossible by what occurs on distinct paths, the original model must be restricted by removing the relevant arc. These two techniques suffice to explain cases of late preëmption and other cases (...) that have proved problematic for causal models. (shrink)

We present a probabilistic extension to active path analyses of token causation. The extension uses the generalized notion of intervention presented in : we allow an intervention to set any probability distribution over the intervention variables, not just a single value. The resulting account can handle a wide range of examples. We do not claim the account is complete --- only that it fills an obvious gap in previous active-path approaches. It still succumbs to recent counterexamples by Hiddleston, because it (...) does not explicitly consider causal processes. We claim three benefits: a detailed comparison of three active-path approaches, a probabilistic extension for each, and an algorithmic formulation. (shrink)

Paper presented to the Twenty-seventh Hume Society Conference, 26 July 2000, Williamsburg, Virginia. -/- At the time I thought there was a stronger link between Maclaurin and Hume, but in discussions at and after the meeting, decided Hume was not taking his mechanics out of Maclaurin’s Account. Although I still have found Maclaurin useful in interpreting Hume -- see Sapadin 1997 for a discussion of popular Newtonianism in Hume's day -- I suspect my draft suffers somewhat from ambivalence. There are (...) still similarities, and possible avenues of influence, arguing that Hume was not ignorant of the new mechanics, but it also becomes clear that he did not understand it: although he adopts the Newtonian measure of force, he misapplies it. (shrink)

Part of our fascination with the Maya can be attributed to the fact that they were literate . . . that is, the Classic Maya possessed a visible language that consisted of letters and a grammar, and one of the products of their literacy was the book. (Aveni 1992b, p.3).

In this revised edition of his 1979 classic Political Theory and International Relations, Charles Beitz rejects two highly influential conceptions of international theory as empirically inaccurate and theoretically misleading. In one, international relations is a Hobbesian state of nature in which moral judgments are entirely inappropriate, and in the other, states are analogous to persons in domestic society in having rights of autonomy that insulate them from external moral assessment and political interference. Beitz postulates that a theory of international (...) politics should include a revised principle of state autonomy based on the justice of a state’s domestic institutions, and a principle of international distributive justice to establish a fair division of resources and wealth among persons situated in diverse national societies. (shrink)

The description for this book, Political Equality: An Essay in Democratic Theory, will be forthcoming.

_A concise history of “just price,” from Aristotle to the present day_ The question of what constitutes a fair price has been at the center of market interactions since the time of Aristotle. Should a seller sell to the highest bidder, or is there some other standard, such as a morally defined price, to be applied? Charles R. Geisst traces the ways that philosophers, religious leaders, and economists have sought to answer that question, from antiquity through the modern era. (...) Aristotle’s thinking on usury influenced the idea of pricing well into the Renaissance. In his view, money was barren and should not be used to beget more money. As trade became more extensive, the strictures placed on pricing by Aristotelian thinking began to fall away, replaced by Roman and common-law conceptions of value and interest. Geisst’s book follows the evolution of that thought—influenced along the way by figures such as Copernicus, Fibonacci, Adam Smith, Marx, Cassel, and Keynes—and charts parallel developments in European and Islamic notions of fair pricing. Today, pricing is seen as an economic inevitability, dictated by the laws of supply and demand. But this has not always been the case. As Geisst argues, the idea of a just price was once a moral concept, long before it was an economic one. (shrink)

Charles Beitz rejects two highly influential conceptions of international theory as empirically inaccurate and theoretically misleading. In one, international relations is a Hobbesian state of nature in which moral judgments are entirely inappropriate, and in the other, states are analogous to persons in domestic society in having rights of autonomy that insulate them from external moral assessment and political interference. Beitz postulates that a theory of international politics should include a revised principle of state autonomy based on the justice (...) of a state's domestic institutions, and a principle of international distributive justice to establish a fair division of resources and wealth among persons situated in diverse national societies. (shrink)

Human rights have become one of the most important moral concepts in global political life over the last 60 years. Charles Beitz, one of the world's leading philosophers, offers a compelling new examination of the idea of a human right.

Nihilism, Nietzsche and the Doppelganger Problem Was Nietzsche a nihilist? Yes, because, like J. L. Mackie, he was an error-theorist about morality, including the elitist morality to which he himself subscribed. But he was variously a diagnostician, an opponent and a survivor of certain other kinds of nihilism. Schacht argues that Nietzsche cannot have been an error theorist, since meta-ethical nihilism is inconsistent with the moral commitment that Nietzsche displayed. Schacht’s exegetical argument parallels the substantive argument (advocated in recent years (...) by Wright and Blackburn) that Mackie’s error theory can’t be true because if it were, we would have to give up morality or give up moralizing. I answer this argument with a little bit of help from Nietzsche. I then pose a problem, the Doppelganger Problem, for the meta-ethical nihilism that I attribute to Mackie and Nietzsche. (If A is a moral proposition then not-A is a moral proposition: hence not all moral propositions can be false.) I solve the problem by reformulating the error theory and also deal with a variant of the problem, the Reinforced Doppelganger, glancing at a famous paper of Ronald Dworkin’s. Thus, whatever its demerits, the error theory, is not self-refuting, nor does it require us to give up morality. (shrink)

The collapse of historicism was not merely the demise of an academic tradition but signified a shift in the understanding of hermeneutics and metaphysics. Whereas earlier books have explored the rise and dominance of historicism within academic history, this is the first to trace its collapse and to show how it was shaped by larger philosophical and scientific concerns. Charles R. Bambach's lucid account of the demise of historicism within the context of German metaphysics provides a rich new perspective (...) on the development of the young Heidegger's concept of "historicity" and on the origins of postmodern thought. Bambach reconstructs the methodological debates arising from a pervasive sense of crisis among German philosophers in the late nineteenth century. He details the divergent attempts by the Neo-Kantians, Nietzsche, and Dilthey to overcome the limitations of historical relativism. Heidegger's view of "historicity," Bambach shows, radically transforms the problematic of historicism into a discourse concerning the crisis of philosophical modernity. (shrink)

This book is meant to help resolve a couple of uncertainties.

My first paper on the Is/Ought issue. The young Arthur Prior endorsed the Autonomy of Ethics, in the form of Hume’s No-Ought-From-Is (NOFI) but the later Prior developed a seemingly devastating counter-argument. I defend Prior's earlier logical thesis (albeit in a modified form) against his later self. However it is important to distinguish between three versions of the Autonomy of Ethics: Ontological, Semantic and Ontological. Ontological Autonomy is the thesis that moral judgments, to be true, must answer to a realm (...) of sui generis non-natural PROPERTIES. Semantic autonomy insists on a realm of sui generis non-natural PREDICATES which do not mean the same as any natural counterparts. Logical Autonomy maintains that moral conclusions cannot be derived from non-moral premises.-moral premises with the aid of logic alone. Logical Autonomy does not entail Semantic Autonomy and Semantic Autonomy does not entail Ontological Autonomy. But, given some plausible assumptions Ontological Autonomy entails Semantic Autonomy and given the conservativeness of logic – the idea that in a valid argument you don’t get out what you haven’t put in – Semantic Autonomy entails Logical Autonomy. So if Logical Autonomy is false – as Prior appears to prove – then Semantic and Ontological Autonomy would appear to be false too! I develop a version of Logical Autonomy (or NOFI) and vindicate it against Prior’s counterexamples, which are also counterexamples to the conservativeness of logic as traditionally conceived. The key concept here is an idea derived in part from Quine - that of INFERENCE-RELATIVE VACUITY. I prove that you cannot derive conclusions in which the moral terms appear non-vacuously from premises from which they are absent. But this is because you cannot derive conclusions in which ANY (non-logical) terms appear non-vacuously from premises from which they are absent Thus NOFI or Logical Autonomy comes out as an instance of the conservativeness of logic. This means that the reverse entailment that I have suggested turns out to be a mistake. The falsehood of Logical Autonomy would not entail either the falsehood Semantic Autonomy or the falsehood of Ontological Autonomy, since Semantic Autonomy only entails Logical Autonomy with the aid of the conservativeness of logic of which Logical Autonomy is simply an instance. Thus NOFI or Logical Autonomy is vindicated, but it turns out to be a less world-shattering thesis than some have supposed. It provides no support for either non-cognitivism or non-naturalism. (shrink)

Proponents of the view that social structures are ontologically distinct from the people in whose actions they are immanent have assumed that structures can stand in causal relations to individual practices. Were causality to be no more than Humean concomitance correlations between structure and practices would be unproblematic. But two prominent advocates of the ontological account of structures, Bhaskar and Giddens, have also espoused a powers theory of causality. According to that theory causation is brought about by the activity of (...) particulars, in the social psychological case, individuals of some sort. Consistence would demand that structure be those individuals. But neither Giddens nor Bhaskar wish to reify structure to the extent that would fit it for a role as a powerful particular. If only human beings can be powerful particulars in these contexts, the only way that structures can be real must be as properties of conversational interactions. Human action is social just in so far as people direct themselves to engage well in joint activities with others. (shrink)

Philosophical attention to problems about global justice is flourishing in a way it has not in any time in memory. This paper considers some reasons for the rise of interest in the subject and reflects on some dilemmas about the meaning of the idea of the cosmopolitan in reasoning about social institutions, concentrating on the two principal dimensions of global justice, the economic and the political.

Information theory provides a quantitative conceptual framework for understanding the flow of information from the world into and through brains. It focuses our attention on the sets of possible messages a brain's anatomy and physiology enable it to receive. The meanings of the messages arise from the inferences licensed by the brain's processing of them. Different meanings arise at different levels because different representations of the input license different inferences.

In his celebrated 'Good and Evil' (l956) Professor Geach argues as against the non-naturalists that ‘good’ is attributive and that the predicative 'good', as used by Moore, is senseless.. 'Good' when properly used is attributive. 'There is no such thing as being just good or bad, [that is, no predicative 'good'] there is only being a good or bad so and so'. On the other hand, Geach insists, as against non-cognitivists, that good-judgments are entirely 'descriptive'. By a consideration of what (...) it is to be an A, we can determine what it is to be a good A, even where the ‘A’ in question is ‘human being’. These battles are fought on behalf of naturalism, indeed, of an up-to-date Aristotelianism. Geach plans to 'pass' from the 'purely descriptive' man to good/bad man, and from human act to good/bad human act. I argue: (l) That the predicative 'good' does have a genuine sense and that it is a mistake to suppose that ‘good’ is a purely attributive adjective. This does not entail that the predicative good (as used by Moore) denotes a non-natural property, but his mistake, if any is metaphysical or ontological not conceptual. (2) That the attributive 'good' cannot be used to generate a naturalistic ethic. It is difficult to extract a set of biologically based requirements out of human nature that are a) reasonably specific; b) rationally binding or at least highly persuasive; and c) morally credible. -/- On the way I protest against Geach’s tendency to try to win arguments by affecting not to understand things. -/- My views to some extent anticipate those of Kraut in *Against Absolute Goodness*. (shrink)

Are conspiracy theorists epistemically vicious? That is the conventional wisdom. It has distinguished supporters, including Quassim Cassam, Cass Sunstein and Adrian Vermeule. For me, a trait is an epistemic virtue if leads to the discovery of salient truths and the avoidance of pernicious falsehoods, and an epistemic vice the contrary. As such epistemic virtues and vices are role‐relative, context‐relative and end‐relative. I argue that that it is not necessarily or even usually vicious to be a conspiracy theorist, even if we (...) restrict the conspiracies in question to conspiracies on the part of Western government agencies, the reason being that many such theories are now known to be true. Finally I contend that the policy suggested by some polemicists of systematic skepticism towards conspiracy theories would be intellectually suicidal and hence vicious. (shrink)

Global economic and political inequalities are in most respects greater today than they have been for decades. From one point of view inequality is a bad thing simply because it involves a deviation from equality, which is thought to have value for its own sake. But it is controversial whether this position can be defended, and if it can, whether the egalitarian ideal on which the defense may depend applies at the global level as in individual societies. Setting aside directly (...) egalitarian reasons for concern about global inequality, this paper explores several reasons for concern that derive from nonegalitarian values – primarily those associated with poverty and material deprivation, humiliation, the impact of inequality on the capacity for self‐control and self‐government, and the unfairness of political decision‐making procedures with large economic inequalities in the background. (shrink)

l. There is an antinomy in Hare's thought between Ought-Implies-Can and No-Indicatives-from-Imperatives. It cannot be resolved by drawing a distinction between implication and entailment. 2. Luther resolved this antinomy in the l6th century, but to understand his solution, we need to understand his problem. He thought the necessity of Divine foreknowledge removed contingency from human acts, thus making it impossible for sinners to do otherwise than sin. 3. Erasmus objected (on behalf of Free Will) that this violates Ought-Implies-Can which he (...) supported with Hare-style ordinary language arguments. 4. Luther a) pointed out the antinomy and b) resolved it by undermining the prescriptivist arguments for Ought-Implies-Can. 5. We can reinforce Luther's argument with an example due to David Lewis. 6. Whatever its merits as a moral principle, Ought-Implies-Can is not a logical truth and should not be included in deontic logics. Most deontic logics, and maybe the discipline itself, should therefore be abandoned. 7. Could it be that Ought-Conversationally-Implies-Can? Yes - in some contexts. But a) even if these contexts are central to the evolution of Ought, the implication is not built into the semantics of the word; b) nor is the parallel implication built into the semantics of orders; and c) in some cases Ought conversationally implies Can, only because Ought-Implies-Can is a background moral belief. d) Points a) and b) suggest a criticism of prescriptivism - that Oughts do not entail imperatives but that the relation is one of conversational implicature. 8. If Ought-Implies-Can is treated as a moral principle, Erasmus' argument for Free Will can be revived (given his Christian assumptions). But it does not 'prove' Pelagianism as Luther supposed. A semi-Pelagian alternative is available. (shrink)

Patronizing the Public is the first detailed and comprehensive examination of how American philanthropy has transformed culture, communication, and the humanities. Drawing on an impressive range of archival and secondary sources, the chapters in the volume shed light on philanthropic foundations have shaped numerous fields, including film, television, radio, journalism, drama, local history, museums, as well as art and the humanities in general.

"The Moral Standing of States" is the title of an essay Michael Walzer wrote in response to four critics of the theory of nonintervention defended in "Just and Unjust Wars." It states a theme to which he has returned in subsequent work. Beitz offers four sets of comments.

The myth of the homeland -- The Nietzschean self-assertion of the German University -- The geo-politics of Heidegger's Mitteleuropa -- Heidegger's Greeks and the myth of autochthony -- Heidegger's "Nietzsche".

Patrick Stokes has argued that although many conspiracy theories are true, we should reject the policy of particularism (that is, the policy of investigating conspiracy theories if they are plausible and believing them if that is what the evidence suggests) and should instead adopt a policy of principled skepticism, subjecting conspiracy theories – or at least the kinds of theories that are generally derided as such – to much higher epistemic standards than their non-conspiratorial rivals, and believing them only if (...) they are proven up to the hilt. The reason is that although some conspiracy theories are true (or otherwise epistemically kosher) there is a widespread practice of conspiracy theorizing which leads to the social acceptance of conspiracy theories which (much like Lord Byron) are mad, bad and dangerous to ‘know’, leading to radically false beliefs about the natural and political worlds (for instance to Trump’s claim that Global Warming is a ‘Chinese Hoax’). Thus Stokes is a defender of the epistemic status quo in which the punditocracy routinely dismisses and sneers at ‘conspiracy theories’, simply because they are conspiracy theories, whilst admitting sotto voce that once in a blue moon there are some conspiracy theories that are true. It is just the he would prefer the epistemic policy of the punditocracy to be the policy of the populace at large. Stokes seems to be suggesting that although particularism looks like a sensible epistemic policy (and might indeed be the correct policy in an ideal world), if it were put into practice at the level of public debate it would give a specious air of plausibility to many false and dangerous conspiracy theories with pernicious social effects. I reply that the actual moral costs of conspiracy ‘skepticism’ (as it is currently practiced) exceed the likely costs of particularism, especially if it is informed by some sensible heuristics, ruling out some conspiracy theories as crazy and ruling in others as relatively sane. For the conspiracy ‘skepticism’ as currently practiced is highly selective, pouring scorn and contempt on conspiracy theories which threaten current elites whilst giving the conspiratorial concoctions of those elites something close to a free pass. (shrink)

Classifying species as ‘native’ or ‘alien’ carries prescriptive force in the valuation and management of ‘nature’. But the classification itself and its application are contested, raising philosophical and geographical questions about place, space, rights, identity and belonging. This paper discusses leading critiques of the native/alien paradigm, including its conceptual fluidity, dichotomous rigidity and ethical difficulties, as well as the incendiary charge of xenophobia. It argues that valorizing ‘native nature’ as inherently the ‘best nature’ is not only obsolete but impracticable in (...) the Anthropocene, and that the preeminence of biogeographic origins should be replaced with a pragmatic focus on species’ behavior. (shrink)

The paper reconstructs Moore's Open Question Argument (OQA) and discusses its rise and fall. There are three basic objections to the OQA: Geach's point, that Moore presupposes that ?good? is a predicative adjective (whereas it is in fact attributive); Lewy's point, that it leads straight to the Paradox of Analysis; and Durrant's point that even if 'good' is not synonymous with any naturalistic predicate, goodness might be synthetically identical with a naturalistic property. As against Geach, I argue that 'good' has (...) both predicative and attributive uses and that in moral contexts it is difficult to give a naturalistic account of the attributive 'good'. To deal with Lewy, I reformulate the OQA. But the bulk of the paper is devoted to Durrant's objection. I argue that the post-Moorean programme of looking for synthetic identities between moral and naturalistic properties is either redundant or impossible. For it can be carried through only if 'good' expresses an empirical concept, in which case it is redundant since naturalism is true. But 'good' does not express an empirical concept (a point proved by the reformulated OQA). Hence synthetic naturalism is impossible. I discuss direct reference as a possible way out for the synthetic naturalist and conclude that it will not work. The OQA may be a bit battered but it works after a fashion. (shrink)

In February 1993, Judge Charles R. Richey of the United States District Court issued a summary judgment in the case of Animal Legal Defense Fund, et al. v. The Secretary of Agriculture, et al. The decision, which was in favor of the Animal Legal Defense Fund, requires the U.S. Department of Agriculture to withdraw its current regulations governing exercise for dogs and the psychological well-being of nonhuman primates used for biomedical research and to issue new regulations containing only minimum, (...) measurable standards. Both plaintiffs and defendants contended that they were seeking the best interests of the laboratory animals. The issue at stake is whether animals are better protected if the government establishes limited minimal standards or is allowed to require institutions to provide additional standards, which will be judged on the basis of their effectiveness in maintaining healthy animals. The Court avoided this dispute, however, by placing primary emphasis on applying the Administrative Procedures Act and stating that it was merely interpreting the "plain meaning" of the Animal Welfare Act, as amended. In this article, arguments are presented for interpreting the law in a far more flexible way than Judge Richey did. The conclusion is also reached that there were no winners in the Animal Legal Defense Fund case and that the real losers are the laboratory animals. (shrink)

Numbers are symbols manipulated in accord with the axioms of arithmetic. They sometimes represent discrete and continuous quantities, but they are often simply names. Brains, including insect brains, represent the rational numbers with a fixed-point data type, consisting of a significand and an exponent, thereby conveying both magnitude and precision.

In lieu of an abstract, here is a brief excerpt of the content:Update on Waiving Informed Consent in Emergency ResearchCharles R. McCarthyMadam: The closing statement of my article on Waiving Informed Consent in Emergency Research published in the June 1995 issue of the Kennedy Institute of Ethics Journal was: "No doubt we shall hear more of this issue."Indeed, we have heard much more on this issue. (1) In May 1995, after my article had already gone to press, the Food and (...) Drug Administration (FDA) and the National Institutes of Health (NIH) jointly published a report on the Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances. (2) On July 26, 1995, the Department of Health and Human Services (HHS) published in the Federal Register a Notice of Action Related to Emergency Research Activity (60 FR 38353-54). This action constituted a waiver of the requirement to obtain prior informed consent from subjects, as required by the Department's Regulations for the Protection of Human Subjects (45 CFR 46), for one specific NIH-funded project under strictly defined circumstances. (3) On September 21, 1995, FDA published a proposed rule to amend its current informed consent regulations (21 CFR 50) to permit harmonization of federal policies on emergency research and to reduce confusion as to when such research can proceed without obtaining prior informed consent from research subjects. The proposed regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human research subject.The HHS waiver (a harbinger of a proposed amendment to its regulations) and the FDA proposed rule are intended to be harmonized so that an Institutional Review Board (IRB) in compliance with one set of regulations relative to the waiver of informed consent will be, ipso facto, in compliance with the other set of regulations.In brief: The FDA proposed amendments will allow an IRB to waive informed consent in emergency situations when:1. The human subjects are in a life threatening condition;2. Obtaining informed consent is not feasible because: (i) the subjects will not be able to provide consent because of their medical condition, (ii) the intervention must be administered before consent from legally authorized representatives is feasible, (iii) there is no reasonable way to identify prospectively the individuals likely to become eligible for the research because the emergence of the condition to be studied cannot be predicted reliably in particular individuals; [End Page 385]3. The opportunity to participate is in the interest of the subjects because: (i) a life threatening situation necessitates intervention, (ii) the risk of the intervention is reasonable in the light of what is known about the medical condition and the patient, the risks and benefits of current therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity;4. The research could not practicably be carried out without the waiver;5. Additional protection of the rights and welfare of the subjects will be provided including, at least: (i) consultation (which may include consultation carried out by the IRB itself) with representatives of the communities from which the subjects will be drawn, (ii) public disclosure prior to commencement of the study sufficient to describe the study and its risks and benefits, (iii) public disclosure of sufficient information following completion of the study to apprise the community and researchers of the study and its results, and (iv) the establishment of an independent data and safety monitoring board;6. The IRB has reviewed and approved an informed consent document for use with subjects or legal representatives in situations in which obtaining such consent may be feasible for some subjects.The preamble to the proposed amendments to the regulations and the amendments themselves contain much more information than is presented here. Readers are therefore encouraged to study the proposals carefully. The public comment period ended November 6, and the FDA is expected to issue a final rule in 1996.Charles R. McCarthyKennedy Institute of Ethics Georgetown University Washington, DCCopyright © 1995 The Johns Hopkins University Press... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:To Be or Not to Be:Waiving Informed Consent in Emergency ResearchCharles R. McCarthy (bio)The requirements for prior, legally authorized informed consent constitute a necessary condition for recruiting subjects into biomedical or behavioral research. However, informed consent requirements pose a serious problem for most research conducted in emergency care settings. For this reason, the Food and Drug Administration's (FDA) regulations governing investigational devices and the Department of Health and Human (...) Services' (HHS) regulations for the protection of human subjects allow narrow exceptions to the general requirements of informed consent. In a joint effort to clarify the applicability of the current FDA regulations and to better understand the intent of the HHS regulations as they apply to emergency research, the FDA and the National Institutes of Health (NIH) cosponsored a public forum on the ethical conduct of emergency research in January 1995.Although the forum was not designed as a consensus conference and participants vigorously disagreed on some of the details, a broad consensus emerged on several major points: (1) both HHS and FDA regulations should, in the immediate future, be interpreted to allow for randomized clinical trials in emergency situations so long as the subjects are carefully protected; and (2) consideration should be given to producing new, closely harmonized regulations from both agencies that will provide greater clarity concerning what kinds of emergency research may be allowed without obtaining prior informed consent.The FDA-NIH forum in January was occasioned primarily by controversy about the hypothermia research protocol described below, but it is obvious that many other kinds of emergency research also await the outcome of deliberations concerning waiver of informed consent in emergency situations. These include research into the care and treatment of: occlusive stroke; subarachnoid hemorrhage due to intracranial aneurysm; metabolic coma; status epilepticus; cardiac arrest; myocardial infarction; cardiac arrhythmia; hemorrhagic shock; pulmonary embolism; acute asthmatic attack; and poisoning. All of these conditions [End Page 155] are encountered in emergency settings where obtaining informed consent from the patient-subjects to participate in research is seldom possible, and obtaining consent from legally authorized representatives of the subjects is either not feasible, or, if obtained, is of doubtful validity.The Hypothermia Research Case and HHS RegulationsA $7.2 million grant for research on the use of hypothermia in the treatment of severe head trauma, the largest award ever made to the University of Texas Health Sciences Center at Houston, is in danger of expiring before the study is completed. The protocol, which involves the use of cooling blankets to induce hypothermia in patients suffering from severe head injuries, is designed to test the hypothesis that: "Early lowering of the body temperature of patients suffering from severe head trauma to approximately 91 degrees Fahrenheit will slow patients' metabolism and will/will not, as a consequence, reduce the rates of both morbidity and mortality in these patients." The protocol was approved by seven Institutional Review Boards (IRBs), each of which waived the requirement to obtain informed consent from research subjects in accordance with Sec. 46. 116(d) of the HHS Regulations for the Protection of Human Subjects.1However, NIH's Office for Protection from Research Risks (OPRR), which is responsible for assuring compliance with the HHS regulations, has taken a controversial regulatory position by requiring informed consent from a legally authorized representative of each subject to be entered in the hypothermia trial. Because the obtaining of surrogate consent has proved to be very difficult, OPRR's position has slowed the research to a point where it may have to be terminated.At issue in the controversy is a fundamental question of ethics and public policy. Is it ever permissible to involve incompetent subjects in research without either their consent, or the consent of their legally authorized representatives? Pertinent HHS regulations for the protection of human subjects seem to answer the question affirmatively by allowing local IRBs to waive some or all of the elements of informed consent under carefully limited circumstances (45 CFR 46 116(d)). Nevertheless, OPRR has signalled the research community that use of the informed consent waiver provision for the Houston hypothermia study is not permitted under the regulations. OPRR judged that the risks... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When OPRR Comes Calling:Enforcing Federal Research RegulationsCharles R. Mccarthy (bio)In an update following this article, Ruth Macklin responds to the revelation that the controversial Hall-Stillman embryo-splitting experiment at George Washington University was conducted—contrary to federal regulations—without prior institutional review board (IRB) review. This revelation altered Dr. Macklin's view of the ethical status of the research. Undoubtedly such revelations also raise general questions for administrators and researchers in many institutions, (...) including, for example: How do allegations of noncompliance with federal regulations arise? When should allegations of infractions of the regulations be reported? Who has an obligation to report? To whom should reports be made? What sort of inquiry should take place? Who should conduct the inquiry? If a determination is made that infractions have occurred, what sanctions are appropriate? And, what publicity is given to the allegations, before, during, and after an evaluation?Some of these questions can be answered in a straightforward manner, while the answers to others depend on the circumstances of the case. This article provides some general answers to these questions.1BackgroundThe Department of Health and Human Services (DHHS) is the largest supporter of biomedical and behavioral research in the world. Somewhere between 25 and 33 percent of its medical research budget is devoted to the support of research involving human subjects. In accordance with the Public Health Service Act, DHHS has issued Regulations for the Protection of Human Subjects (45 CFR 46). The DHHS Secretary has delegated responsibility for promulgating and administering the regulations to the Office for Protection from Research Risks (OPRR), which is located within the National Institutes of Health.When an institution receives an award from a DHHS agency to carry out research involving human subjects, it is required to negotiate, or to have on file, an "assurance of compliance" document that provides detailed information [End Page 51] specifying how the institution plans to comply with the regulations for the protection of human subjects. Most major research institutions in the country have on file a "multiple project assurance" (MPA) document, which extends DHHS regulations to all human subjects research conducted or sponsored by that institution, irrespective of the source of funding. The regulations and the assurance of compliance require any research project involving human subjects to be reviewed and approved by an institutional review board (IRB) prior to initiation of the research. In addition, the project must be re-reviewed by the IRB at appropriate intervals—in no case, less than once a year. Institutional compliance with these and other requirements of the regulations has improved during the last 30 years and appears to be at a high level. However, from time to time, allegations of noncompliance arise, as they did in the George Washington University embryo-splitting experiment, and set in motion the review process described below.How do Allegations of Noncompliance Arise?Allegations or indications of noncompliance with federal regulations for the protection of human subjects may come from a variety of sources. Most commonly, the institution's IRB discovers that research involving humans is going forward without the required prior IRB review and approval, or that approved research is being conducted in a way that is contrary to the stipulations of the IRB. The Hall-Stillman case came to the attention of George Washington University's IRB because the research protocol was submitted to the IRB after the research had been carried out. In this case, there could be no doubt that an infraction had occurred.Information about possible noncompliance also frequently derives from a funding agency's Initial Review Group (IRG) (commonly called a Study Section) when it has reason to suspect noncompliance in a project it is reviewing for possible funding. An actual case that occurred some years ago involved a research application that proposed to perform brain biopsies on normal volunteers. The IRG that reviewed the application lost little time in questioning whether an IRB had approved the protocol. In this case, it was not enough for the IRG to recommend disapproval of the proposal for funding; it also was obliged to report the possible infraction to OPRR.Whistleblowers, including research subjects, nurses, students, members of the... (shrink)