Objective: To assess the adequacy of the process of informed consent for surgical patients at the University Hospital of the West Indies. Method: The study is a prospective, cross-sectional, descriptive study. 210 patients at the University Hospital of the West Indies were interviewed using a standardised investigator-administered questionnaire, developed by the authors, after obtaining witnessed, informed consent for participation in the study. Data were analysed using SPSS V.12 for Windows. Results: Of the patients, 39.4% were male. Of the surgical procedures, (...) 68.6% were scheduled, 7.6% urgent and 23.8% emergency, 35.2% were minor and 64.8% major. Information imparted/received was acceptable in 40% of cases, good in 24% and inadequate (unacceptable) in 36% of cases. Almost all (97.6%) patients stated that they understood why an operation was planned and 93.3% thought that they had given informed consent. Most (95.2%) thought that they had free choice and made up their own mind. A quarter (25.2%) of all patients were told that it was mandatory for them to sign the form. There was a discussion of possible side effects and complications in 56.7% of patients. Conclusions: This study clearly indicates that surgical patients at the University Hospital of the West Indies feel that they have given informed consent. However, it also suggests that more information should be given to patients for consent to be truly informed. (shrink)

The starting point for this article is the question of the relationship between Darwinism and Christian theology. I suggest that evolutionary theory presents three broad issues of relevance to theology: the phenomena ofcontinuity, naturalism, andcontingency. In order to formulate a theological response to these issues I draw on the semiotics (theory of signs) and cosmology of the American philosopher Charles Sanders Peirce. Peirce developed a triadic theory of signs, underpinned by a threefold system of metaphysical categories. I propose a semiotic (...) model of the Trinity based on Peirce's semiotics and categories. According to this model the sign‐processes (such as the genetic “code”) that are fundamental to life may be understood as vestiges of the Trinity in creation. I use the semiotic model to develop a theology of nature that addresses the issues raised by evolutionary theory. The semiotic model amounts to a proposal for a new metaphysical framework within which to understand the relationship between God and creation and between theology and science. (shrink)

To say that something is extreme, as solipsism is, implies that there exists a spectrum of which this extremity is one limit. Knowing one limit, we are then curious about the other, the opposite end of the spectrum. In many cases the answer is too well-known to cause comment: i.e., the spectrum of greyness has black as one extreme and white as the other. But in the case of solipsism neither the spectrum nor the other extreme is obvious.

The starting point for this article is the question of the relationship between Darwinism and Christian theology. I suggest that evolutionary theory presents three broad issues of relevance to theology: the phenomena ofcontinuity, naturalism, andcontingency. In order to formulate a theological response to these issues I draw on the semiotics (theory of signs) and cosmology of the American philosopher Charles Sanders Peirce. Peirce developed a triadic theory of signs, underpinned by a threefold system of metaphysical categories. I propose a semiotic (...) model of the Trinity based on Peirce's semiotics and categories. According to this model the sign‐processes (such as the genetic “code”) that are fundamental to life may be understood as vestiges of the Trinity in creation. I use the semiotic model to develop a theology of nature that addresses the issues raised by evolutionary theory. The semiotic model amounts to a proposal for a new metaphysical framework within which to understand the relationship between God and creation and between theology and science. (shrink)

Reflecting Alan Robinson's fundamental contribution to computational logic, this book brings together seminal papers in inference, equality theories, and logic programming. It is an exceptional collection that ranges from surveys of major areas to new results in more specialized topics. Alan Robinson is currently the University Professor at Syracuse University. Jean-Louis Lassez is a Research Scientist at the IBM Thomas J. Watson Research Center. Gordon Plotkin is Professor of Computer Science at the University of Edinburgh. Contents: Inference. Subsumption, (...) A Sometimes Undervalued Procedure, Larry Wos, Ross Overbeek, and Ewing Lusk. The Markgraf Karl Refutation Procedure, Hans Jurgen Ohlbach and Jorg H. Siekmann. Modal Logic Should Say More than it Does, Melvin Fitting. Interactive Proof Presentation, W. W. Bledsoe. Intelligent Backtracking Revisited, Maurice Bruynooghe. A Science of Reasoning, Alan Bundy. Inductive Inference of Theories from Facts, Ehud Y. Shapiro. Equality. Solving Equations in Abstract Algebras: A Rule-based Survey of Unification, Jean-Pierre Jouannaud and Claude Kirchner. Disunification: A Survey, Hubert Comon. A Case Study of the Completion Procedure: Proving Ring Commutativity Problems, Deepak Kapur and Hantao Zhang. Computations in Regular Rewriting Systems I and II, Girard Huet and JeanJacques Levy. Unification and ML Type Reconstruction, Paris Kanellakis, Harry Mairson, and John Mitchell. Automatic Dimensional Analysis, Mitchell Wand. Logic Programming. Logic Programming Schemes and Their Implementations, Keith Clark. A Near-Horn Prolog for Compilation, Donald Loveland and David Reed. Unfold/Fold Transformations of Logic Programs, P. A. Gardner and J. C. Shepherdson. An Algebraic Representation of Logic Program Computations, Andrea Corradini and Ugo Montanari. Theory of Disjunctive Logic Programs, Jack Minker, Arcot Rajasekar, and Jorge Lobo. Bottom-Up Evaluation of Logic Programs, Jeffrey Naughton and Raghu Ramakrishnan. Absys, the First Logic Programming Language: A View of the Inevitability of Logic Programming, E. W. Elcock. (shrink)

It is a commonplace that, to a great extent, the way we think depends upon the categories we think with. In this paper I propose to introduce a group of related categories which, if they do not obviously lead to new discoveries, at least provide new ways of understanding and interrelating old ideas. The basic category I am concerned with is that of imperceptibles: not particularly a new one, but always previously a confused one because proper definition of it requires (...) specification of the perceiver. I wish to propose a set of definitions which cures such ambiguities, and then to examine some of the uses to which it may be put. (shrink)

This long-awaited new edition contains eight of the dialogues of Plato, and is the first in a new five-volume complete edition of his works in the OCT series.

Plato is one of the key ancient authors studied by both classicists and philosophers. This long-awaited new edition contains seven of the dialogues of Plato, and is the first in the five-volume complete edition of his works in the Oxford Classical Texts series. The result of many years of painstaking scholarship, the new volume will replace the now nearly 100 year old original edition, and is destined to become just as long-lasting a classic.

In editing Plato's Sophist for the new OCT vol. I, ed. E. A. Duke, W. F. Hicken, W. S. M. Nicoll, D. B. Robinson, and J. C. G. Strachan , there was less chance of giving novel information about W = Vind. Supp. Gr. 7 for this dialogue than for others in the volume, since Apelt's edition of 1897 was used by Burnet in 1900 and was based on Apelt's own collation of W. The result was better than the (...) somewhat confused information printed by Burnet, even in his 1905 reprint, for W for the other dialogues in vol. I. But in the Sophist as elsewhere in vol. I collations largely due to Dr W. S. M. Nicoll added new facts about all of BDTWP and their correctors, and the search for testimonia largely carried out by Dr E. A. Duke added new facts in that area. A reviewer counts 66 changes in our text of the Sophist, which may perhaps be a slight over-estimate. Classification of changes as substantive or as falling into different groups is sometimes difficult, but I think plausible figures are as follows. We have in 25 places made a different choice of readings from the primary mss. and testimonia. We have printed conjectures where Burnet kept a ms. reading in 17 places, but conversely we have reverted to a ms. reading where Burnet had a conjecture in 8 places. We have printed alternative conjectures to conjectures adopted by Burnet in 6 places. So we have actually departed from the primary sources on at most 9 more occasions overall than Burnet. What must be noted is that Burnet had already printed conjectures on something like 87 occasions , so our percentage addition to Burnet's departures from the primary sources is modest. Moreover Burnet printed about 25 readings from testimonia; we have followed him in 20 or so of these cases, and this in turn implies that the primary mss. are in error at these further 20 places. It needs to be underlined that though Burnet undoubtedly deserved to be regarded as a safe and cautious editor, nevertheless he departed from the primary mss. on average about twice per Stephanus page in this dialogue. Sometimes, of course, testimonia showed him right to do this, but testimonia cover only a quite small part of this dialogue. Otherwise Burnet accepted almost 90 conjectures. For the Politicus the figures are fairly similar; Burnet accepted 22 Byzantine conjectures and 35–40 more modern ones. The new OCT there adds 15 or so more conjectures. (shrink)

Lanczos, C. Einstein's path from special to general relativity.--Balazs, N. L. The acceptability of physical theories: Poincaré versus Einstein.--Ellis, G. F. R. Global and non-global problems in cosmology, by G. F. R. Ellis and D. W. Sciama.--Ehlers, J. The geometry of free fall and light propagation, by J. Ehlers, F. A. E. Pirani and A. Schild.--Trautman, A. Invariance of Lagrangian systems.--Penrose, R. The geometry of impulsive gravitational waves.--Exact solutions of the Einstein-Maxwell equations for an accelerated charge.--Taub, A. H. Plane-symmetric similarity (...) solutions for self-gravitating fluids.--Robinson, I. Equations of motion in the linear approximation, by I. Robinson and J. R. Robinson.--Florides, P. W. Rotating bodies in general relativity.--Chandrasekhar, S. A limiting case of relativistic equilibrium.--Israel, W. The relativistic Boltzmann equation.--Thompson, W. B. The self-consistent test-particle approach to relativistic kinetic theory. (shrink)

Recourse to a being’s moral status is the ‘nuclear option’ of moral theorising—it tells us not only what obligations we have and to what degree, but whether we have obligations to them in the first place and whether their moral concern trumps concern for other beings simply in virtue of the kind of being they are. As such, we should only explain obligations in terms of a being’s moral status if doing so is principled and necessary to defend that obligation. (...) In ‘Pregnancy and Superior Moral Status: A Proposal for Two Thresholds of Personhood’, Robinson1 argues that pregnant women achieve a second and therefore superior threshold of moral status to ‘mere persons’. She insists that this is not a view about the woman and the fetus together but that ‘the pregnant woman herself is more than one individual’. This gives us strong reason to re-balance the imbalanced burdens experienced by women due to pregnancy. I will argue her proposal is neither principled nor necessary. We can explain special obligations to pregnant women without appealing to a distinct moral status, without reaching for the ‘nuclear option’. First, consider Robinson’s1 claim that pregnant women ‘are performing a role which is of supreme importance: that of creating new human life, and maintaining the survival of the human species’. …. (shrink)

In the first part of this paper we indicate how Meredith's condensed detachment may be used to give a new proof of Belnap's theorem that if every axiom x of a calculus S has the two-property that every variable which occurs in x occurs exactly twice in x, then every theorem of S is a substitution instance of a theorem of S which has the two-property. In the remainder of the paper we discuss the use of mechanical theorem-provers, based either (...) on condensed detachment or on the resolution rule of J. A. Robinson, to investigate various calculi whose axioms all have the two-property. Particular attention is given to D-groupoids, i.e. sets of formulae which are closed under condensed detachment. (shrink)

In a recent article, D. A. Truncellito (2004, ‘Running in Circles about Begging the Question’, Argumentation 18, 325–329) argues that the discussion between Robinson (1971, ‘Begging the Question’, Analysis 31, 113–117), Sorensen (1996, ‘Unbeggable Questions’, Analysis 56, 51–55) and Teng (1997, ‘Sorensen on Begging the Question’, Analysis 57, 220–222) shows that we need to distinguish between logical fallacies, which are mistakes in the form of the argument, and rhetorical fallacies, which are mistakes committed by the arguer. While I basically (...) agree with Truncellito’s line of thinking, I believe this distinction is not tenable and offer a different view. In addition, I will argue that the conclusion to draw from the abovementioned discussion is that validity is not a sufficient criterion of begging the question, and that we should be wary of the containment-metaphor of a deductive argument. (shrink)

The Wittgensteinian claim that meaning is immanent to 'practices', influential in contemporary theology, is capable of two readings: the first takes `practice' to refer to the social activities of actual communities; the second implies no more than a way of going on that is in principle communicable. The first reading is palpably unattractive, both philosophically and exegetically; the second reading is much less ambitious, providing a plausible critique of empiricist theories of meaning. I suggest that it is the first implausible (...) reading that is often at work in theological appropriations of Wittgenstein, such as we find in Stanley Hauerwas. I fill-out this claim by exploring — with an ear to Scripture — the implications for ecclesiology of adopting either of the two readings. I conclude by raising the alarm about two dangers: of being too Wittgensteinian in some respects, and not Wittgensteinian enough in others. (shrink)

Heath Robinson could perhaps draw a diagram that made sense of the legislative and regulatory structure Bonnicksen describes in this book. However Heath Robinson machines, no matter how baroque, actually achieve something: in the four years covered by this contemporary history the American “system” seems to have achieved very little. That we have not yet seen a confirmed cloned child produced in the USA or elsewhere does not seem due in any part to the activity that Bonnicksen describes. (...) This is not a history of America’s progress towards crafting a policy; it is an account of its failure to make one.The bulk of this book details the legal and regulatory responses to emerging reproductive technology in America following the announcement of the birth of Dolly the cloned lamb in 1997. The remainder gives an overview of the position of other countries around the world, and a brief concluding chapter outlines the options open to the US in the future. Lest anything that follows might suggest otherwise, I found this book interesting and informative, and …. (shrink)

Prior to August Weismann’s 1889 germ-plasm theory, social reformers believed that humans could inherit the effects of a salubrious environment and, by passing environmentally-induced modifications to their offspring, achieve continuous progress. Weismann’s theory disrupted this logic and caused many to fear that they had little control over human development. As numerous historians have observed, this contributed to the birth of the eugenics movement. However, through an examination of the work of social scientists Lester Frank Ward, Richard T. Ely, Amos Griswold (...) Warner, James Mark Baldwin, Simon Nelson Patten, Alfred Kroeber, Walter Robinson Smith, and Luther Lee Bernard, I demonstrate that Weismann’s ideas also prompted scholars to create of theories of human progress in which the social environment had a central role and biological heredity had a diminished one. Furthermore, in creating a new theory of social progress based on a concept called “social heredity,” the thinkers surveyed in this article separated biological and social thought and asserted the independence of the American social sciences. I argue that this represents an important moment in the maturation of the human sciences, and I suggest that the germ-plasm theory of heredity deserves a larger place in histories of the development of the American social scientific disciplines. (shrink)

It seems to me certain that the perception of foreign bodies of a certain sort, although a necessary, is not the only, part of the basis of our belief in other persons. The greatest disagreement with this view that I know of has been expressed by Professor Aaron in a paper published in Philosophy , XIX, 72. He claims that, since one does not really know “what it means to be a mind in one's own case,” the question whether we (...) can be certain that there are other minds is meaningless except as reducible to the question whether such propositions as “Robinson exists” are propositions which we can be certain about. And he tries to show that no more is involved in the analysis of “Robinson exists” than would be involved in the analysis of propositions of whose truth we can be perceptually certain, such as “That table over there exists” or “The Eiffel Tower exists.” My assurance that Robinson exists is not the assurance that something called Robinson's mind exists. It is the perfectly ordinary perceptual assurance that ‘the person over there’ exists. “You ask me how I am certain that Robinson exists and I answer, ‘Well, look, there he is.’ It would be absurd for anyone to say that he does not exist when I see him here before me and hear him talk and watch him move that chair.”. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy and Rhetoric 34.4 (2001) 322-334 [Access article in PDF] From Mysticism to Skepticism: Stylistic Reform inSeventeenth-century British Philosophy and Rhetoric Ryan J. Stark The idea of stylistic plainness captured the imaginations of philosophers in the seventeenth century. Francis Bacon's early attacks on "sweet falling clauses" and Thomas Sprat's invectives against "swellings of style" are especially quotable, and have been cited often by scholars from R. F. Jones to (...) Ian Robinson as evidence that a new attitude toward style emerged in the seventeenth century in conjunction with the new science. Still, even Robinson, who acknowledges the scientific influence on prose, cannot reconcile the plain style ideology with the less-than-sparse styles of the plain style advocates themselves. "The paradox," Robinson notes, "is that Sprat's language is itself imaginative and rhetorical," adding that Sprat denounced "the imagination... in a quite strongly imaginative way" with his "anti-rhetorical rhetoric" (160). This problem leads Robinson to charge that Sprat, Joseph Glanville, Bishop John Wilkins, and the other plain style advocates contradicted themselves by using highly metaphorical styles to criticize metaphorical styles, or were hypocrites in a stronger phrasing, even "painted hypocrites," to borrow a metaphor from one of Wilkins's complaints against metaphorical language.I will address this persistent argument that members of the Royal Society contradicted themselves by using elaborate metaphors to denounce elaborate metaphors, calling into question the very premise of the plain style mandates. The fact that members of the Royal Society continued to use figurative language in their writings is irrelevant. The plain style advocates did not attempt to remove figurative language from all discourses, or even scientific discourses. 1 "Plainness," instead, denotes a lack of occult influence in language. This forgotten philosophical meaning of "plainness" shows clearly that the plain style advocates did not share an antipathy toward ornamental styles, as is often suggested; rather, they shared an antipathy toward entelechial conceptions of style. The Royal Society's [End Page 322] arguments against obscure styles are arguments against the assumptions of a magical worldview, that enchanted cosmos occupied by Faustus and Macbeth, not arguments against any specific type of sentence structure or kind of metaphor. Technical issues of grammar and syntax played a minor role in these stylistic debates. In an ontological sense, the plain style advocates from Bacon to Sprat reconceptualized the very nature of linguistic form. This reconceptualization is best described as a movement away from mystical understandings of style and toward skeptical understandings of style, and this shift from mysticism to skepticism marks the stylistic reformation in the seventeenth century. 1. Entelechies and ornaments Bacon complains famously against "tropes and figures," "sweet falling of clauses," and "watery writings" in an introductory section of The Advancement of Learning entitled "Discredits to Learning from the Follies of the Learned--Ciceronianism, Scholasticism, Alchemy, and Natural Magic" (24-26). 2 Bacon includes a section for distempers of learning that do not fit neatly into categories, called "Other Errors of Learned Men Which Hinder the Progress and Credit of Learning." The coupling of these styles with alchemy and natural magic is not incidental. Bacon and the subsequent plain style advocates of the Royal Society target Ciceronian and scholastic styles specifically because of their strange cosmic elements, not because of their grammatical structures. For the new scientists, these vital styles recall a mystical worldview full of celestial influences, magical emblems, oneiric visions, and attendant spirits. The introductory section of Bacon's Advancement of Learning codifies in the newly scientific community the negative association between mysterious styles (e.g., Ciceronian, Senecan, baroque, metaphysical) and various kinds of occult behavior. Perhaps more so than any other English text, Bacon's Advancement banishes those mystical high styles of the late Renaissance to the mists and shadows of the credulous past, as Cowley describes in his "Ode to the Royal Society," to the "Kingdom of Darkness and Night" in Pope's Dunciad, or to "the island of savage women and moonlight" in Tennyson's "Locksley Hall."In Sciri Tuum Nihil Est, Glanville defends the plain style programs... (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)