An EXACT reproduction from the original book BODY AND WILL: BEING AN ESSAY CONCERNING WILL IN ITS METAPHYSICAL, PHYSIOLOGICAL and PATHOLOGICAL ASPECTS by Henry Maudsley first published in 1884. This book may have occasional imperfections such as missing or blurred pages, poor pictures, errant marks, etc. that were either part of the original artifact, or were introduced by the scanning process. We believe this work is culturally important, and despite the imperfections, have elected to bring it back into print (...) as part of our continuing commitment to the preservation of printed works worldwide. We appreciate your understanding of the imperfections in the preservation process, and hope you enjoy this valuable book. (shrink)

Introductory.--Life and mind.--The social system.--Imagination and idealism.--Ethical theory and action.--Religion, philosophy, science.--Nature, mind, reason.--Habit, intonation, experience, truth.--Education, mental culture, character.--Friendship, love, desire, grief, joy.--Fate, folly, crime.--Pain, life, death.--End and aim.

With the rapidly expanding catalogue of scientific publications, especially within the Biomedical Sciences field, it is becoming increasingly difficult for researchers to search for, read or even interpret emerging scientific findings. PubMed, just one of the current biomedical data repositories, comprises over 33 million citations for biomedical research, and over 2500 publications are added each day. To further strengthen the impact biomedical research, we suggest that there should be more synergy between publications and machines. By bringing machines into the realm (...) of research and publication, we can greatly augment the assessment, investigation and cataloging of the biomedical literary corpus. The effective application of machine-based manuscript assessment and interpretation is now crucial, and potentially stands as the most effective way for researchers to comprehend and process the tsunami of biomedical data and literature. Many biomedical manuscripts are currently published online in poorly searchable document types, with figures and data presented in formats that are partially inaccessible to machine-based approaches. The structure and format of biomedical manuscripts should be adapted to facilitate machine-assisted interrogation of this important literary corpus. In this context, it is important to embrace the concept that biomedical scientists should also write manuscripts that can be read by machines. It is likely that an enhanced human–machine synergy in reading biomedical publications will greatly enhance biomedical data retrieval and reveal novel insights into complex datasets. (shrink)

Background: Magnetic resonance spectroscopic imaging is a neuroimaging technique that may be useful for non-invasive mapping of brain temperature over a large brain volume. To date, intra-subject reproducibility of MRSI-based brain temperature has not been investigated. The objective of this repeated measures MRSI-t study was to establish intra-subject reproducibility and repeatability of brain temperature, as well as typical brain temperature range.Methods: Healthy participants aged 23–46 years were scanned at two time points ~12-weeks apart. Volumetric MRSI data were processed by reconstructing (...) metabolite and water images using parametric spectral analysis. Brain temperature was derived using the frequency difference between water and creatine for 47 regions of interest delineated by the modified Automated Anatomical Labeling atlas. Reproducibility was measured using the coefficient of variation for repeated measures, and repeatability was determined using the standard error of measurement. For each region, the upper and lower bounds of Minimal Detectable Change were established to characterize the typical range of TCRE values.Results: The mean global brain temperature over all subjects was 37.2°C with spatial variations across ROIs. There was a significant main effect for time [F = 37.0, p < 0.0001] and for brain region [F = 2.66, p < 0.0001]. The time*brain region interaction was not significant [F = 0.80, p = 0.83]. Participants' TCRE was stable for each ROI across both time points, with ROIs' COVrep ranging from 0.81 to 3.08% ; majority of ROIs had a COVrep <2.0%.Conclusions: Brain temperature measurements were highly consistent between both time points, indicating high reproducibility and repeatability of MRSI-t. MRSI-t may be a promising diagnostic, prognostic, and therapeutic tool for non-invasively monitoring brain temperature changes in health and disease. However, further studies of healthy participants with larger sample size and numerous repeated acquisitions are imperative for establishing a reference range of typical brain TCRE, as well as the threshold above which TCRE is likely pathological. (shrink)

Brings together and interprets previously hard-to-find texts, new translations and passages detailing the interplay between philosophy and psychopathology.

In 1938, doctors Eric Guttmann and Walter Maclay, two psychiatrists based at the Maudsley Hospital in London, administered the hallucinogenic drug mescaline to a group of artists, asking the participants to record their experiences visually. These artists included the painter Julian Trevelyan, who was associated with the British surrealist movement at this time. Published as ‘Mescaline hallucinations in artists’, the research took place at a crucial time for psychiatry, as the discipline was beginning to edge its way into the (...) scientific arena. Newly established, the Maudsley Hospital received Jewish émigrés from Germany to join its ranks. Sponsored by the Rockefeller Foundation, this group of psychiatrists brought with them an enthusiasm for psychoactive drugs and visual media in the scientific study of psychopathological states. In this case, Guttmann and Maclay enlisted the help of surrealist artists, who were harnessing hallucinogens for their own revolutionary aims. Looking behind the images, particularly how they were produced and their legacy today, tells a story of how these groups cooperated, and how their overlapping ecologies of knowledge and experience coincided in these remarkable inscriptions. (shrink)

This article examines three films made during the 1950s by Elwyn James Anthony at the psychotic clinic for children at the Maudsley Hospital that marked an important transition in the purpose and practice of visual documentation in a clinical setting: film as a research tool was transitioning from the recording of external signs as indicators of internal subjective states, to the capture of the visual flow of communication between subjects. It is a shift that had a particular impact on (...) the emergent classification of autism, a modality not yet properly separated from the broader term of psychosis, as a non-relational condition whose visual capture demonstrated a void of inter-human communicational exchange. Film was significant not only as a recording apparatus, but as a method of cutting and crafting sequences of movements into brief repetitive motifs. The filmed behaviour of children remained opaque to interpretation, a ‘finding’ that facilitated the modelling of an emergent autism as subjects who were isolated, alienated and automaton-like, inhabiting a separate temporality. The article situates this ‘second’, affectless autism, within a broader context of post-war research into gestures as a language of the body, developed largely through an intellectual network of German émigré psychoanalysts who had fled to the US and UK in the 1930s. (shrink)

In the second half of the nineteenth century, in Great Britain, a group of scientists decided to challenge the intellectual authority of theologians and clergymen. Because of the recently discovere...

Psychopathy fascinates. Modernist writers construct out of it an image of alienated individualism pursuing the moment, killing they know not why, exploiting in passing, troubled, if troubled at all, not by guilt, but by perplexity (Camus 1989; Gide 1995; Mailer 1957; Musil 1996). Psychiatrists and psychologists—even those who should know better—are drawn by it to take off into philosophical speculation about morality, evil, and the beast in man (Mullen 1992; Simon 1996). Philosophers succumb to the temptation of attempting to ground (...) speculation in the supposed facticity of psychopathy. -/- Psychopathy is a cultural construct with roots going back to the eighteenth century, but which only came to full flower over the last fifty years (Hare 1998; Lewis 1974). The currently fashionable constructions of psychopathy find wide acceptance among clinicians and academics. The problem is, however, whether the concept has connections that have been established to the behavior, psychopathology, or the structure and function of brain worthy of according even a modest level of scientific status. There is little point in basing an argument on some supposed scientific gold standard if what glitters is iron pyrites (fools' gold). -/- Neil Levy's opening paragraph contains the statement "Yet in other respects they seem quite irrational; so much so that the term moral insanity has sometimes been applied to them" (p. 129). This both asserts that there is a category "them," namely the psychopaths, and connects them to "moral insanity." Moral insanity entered the language of psychiatry when Pritchard chose to use the term to translate Pinel's category of mania sans deliré (Pritchard 1836). Pinel was attempting to conceptualize a range of disorders that bordered on insanity in the sense of severe disturbances of affect, judgment, and behavior, but that were not accompanied by hallucinations or delusions (Pinel 1798/1964). In today's terminology, the cases he described would probably fall into diagnostic groups, including major depression, bipolar disorder, epilepsy, and a range of personality disorders. A number of his more striking case histories involved antisocial and even murderous behavior, which probably reflected Pinel's role in assessing offenders for the criminal courts of Paris. Pritchard's use of the English word "moral" reflected an appeal first to its use at the time to designate something which was like or similar, but not identical (a usage the OED labels "vulgar"), and second moral in the sense of ethical, conforming to virtuous behavior. Anglophones seized on the latter meaning, although Pinel emphasized the former. Forty years later, Henry Maudsley, the most widely read psychiatrist of his generation, could assert that moral insanity was as real as Colour blindness, some people being Colour blind and some moral blind (Maudsley 1879). Moral insanity became connected variously to phrenology with its own bump over the underlying moral cortex, with the twisted genetics of degeneration, with atavistic theories of criminality, and with a range of disorders of brain from epilepsy to frontal lobe damage (Combed 1853; Ellis 1890; Pick 1989). Although it is anachronistic to use the terms "psychopathy" and "moral insanity" together, it is clear they occupied a similar social and psychiatric space, albeit in different era. This should caution against too ready acceptance of psychopathy which may turn out to be as empty and dangerous a conceptualization as moral insanity. Why dangerous? Dangerous to those labeled, because the morally insane and the moral imbeciles were placed in preventive detention in asylums and prisons, and even sterilized in some jurisdictions. Dangerous to society, because it gave a spurious scientific justification for viewing crime not as reflecting the social evils of deprivation, ignorance, and inequality but as the ravages of the born criminals. -/- Psychopaths are not, as Levy asserts, "(causally) responsible for … more than fifty percent of violent crime" (p. 129). A proportion of violent offenders, which varies widely between observers, are labeled psychopaths. This is often on the basis of Hare's psychopathy checklist, which is a subjective, albeit through training aspiring to be reproducible, and to some extent self-sustaining, evaluation system (Hare 1980, 2003). Part of the checklist gathers data on prior antisocial behavior; part constrains the examiner to subjectively estimate such matters as glibness and callousness, part requires judgments about whether the... (shrink)

The Netherne Hospital in Surrey is perhaps the most prestigious site in the history of British art therapy, associated with the key figures Edward Adamson and Eric Cunningham Dax, whose pioneering work involved the setting-up of a large studio for psychiatric patients to create expressive paintings. What is little-known, however, is the work of the designated scientist for psychiatric research, Hungarian Jewish émigré Francis Reitman, who was charged with an overall scientific analysis of the artistic products of the studio. Schooled (...) in the biological psychiatric tradition of Ladislas J. Meduna in Budapest prior to his exile to the Maudsley Hospital in 1938 – and committed to treatments such as leucotomy and electro-convulsive therapy (ECT) – Reitman was an unusual candidate for research into the unconscious processes behind art and psychosis. Yet he authored two highly popular and widely reviewed books on his analyses of the abundant artistic output created by patients with schizophrenic diagnoses at the Netherne. In his Psychotic Art (1950) and Insanity, Art and Culture (1954), Reitman compared such schizophrenic images with those produced by artists under the influence of mescaline and examined the artistic output of patients having undergone leucotomy. This article draws on archival materials and Reitman’s original research publications in order to reconstruct his theory of schizophrenic art within the complex context of postwar British psychiatry, negotiating as he did between biologically reductive understandings of Freudian and Jungian psychoanalytic categories, and ultimately synthesizing concepts from both. It also analyses Reitman’s implicit theory of the therapeutic mechanism of art in the treatment of psychiatric patients. (shrink)

Objectives: Childhood cancer is a life-threatening disease that poses significant challenges to the life of the diagnosed child and his/her family members. Based on the ABCX-model, the aim of the current study was to explore the association between family functioning, cancer appraisal and the individual adjustment of patients, parents and siblings. Method: Participants were 60 children with leukemia or non-Hodgkin lymphoma, 172 parents and 78 siblings (115 families). Time since diagnosis varied from zero to 33 months. Patients, parents and siblings (...) completed the Family Environment Scale, Perceived Stress Scale, Situation-Specific Emotional Reactions Questionnaire and Pediatric Quality of Life Inventory/Maudsley Marital Questionnaire. Results: Family functioning and the appraisal of the cancer diagnosis proved to be related to patients’, parents’ and siblings’ cancer-related emotions and quality of life post-diagnosis. In addition, family members differed in their perception of some family functioning domains, the appraisal of the cancer diagnosis, positive feelings and quality of life. Discussion: Our findings led to the conclusion that family functioning and the appraisal of the cancer diagnosis are important for the individual adjustment of patients, parents and siblings when facing a diagnosis of cancer in the child. Differences across members within one family speak to the need of screening all family members and intervening at the level of the family unit. (shrink)

This special issue considers the significance of film to the establishment and development of scientific approaches to the mind. Bonnie Evans explores how the origins of film technologies in 1895 in France encouraged a series of innovative collaborations, influencing both psychological theorisation, and new filming techniques. Jeremy Blatter explains how Harvard psychologist Hugo Münsterberg created early films specifically designed to engage audiences using psychological tactics. Scott Curtis’ article examines how Yale psychologist Arnold Gesell was able to extract scientific data from (...) a film. Felix Rietmann’s article explores a collection of infant observation films from the 1930s and 1960s and how they developed unique narratives of mothers’ engagement with their children that did not necessarily match up with dominant scientific theories. Janet Harbord's article considers how a trilogy of films made at the Maudsley Hospital in the 1950s engaged with innovative film-making techniques that captured behaviour as discrete units. Seth Watter further examines how William S. Condon's use of the unique technology of the Bell and Howell 173BD projector in the 1960s created new understandings of human behaviour that could not have been predicted in advance, and which were highly influenced by the technology itself. Finally, Des O’Rawe explores how radical approaches in both anti-psychiatry, and documentary film-making in the 1960s created new opportunities for audiences to engage with different psychological states. All of these developments in film and psychology continue to influence understandings in both these fields to the present day. (shrink)

This article historicizes a single stage in how the contemporary obsessive–compulsive disorder (OCD) category was built. Starting from the position that the two central components which make up OCD are ‘obsessions’ and ‘compulsions’, it illustrates how these concepts were taken apart by a small group of clinical psychologists working at the Institute of Psychiatry and the Maudsley psychiatric hospital in south London in the early 1970s, and why compulsions were investigated whilst obsessions were ignored. The decision to distinguish the (...) previously undifferentiated symptoms is attributed to the commitment amongst psychologists at the Maudsley, most notably Stanley Rachman, to an empirical conception of science which emphasized observability. Two aspects of this are discussed. First, compulsions were deemed ‘visible’ through their correspondence with animal behaviour. Second, the symptom was seen as open to an experimental modification procedure which privileged visible outcomes. Ultimately, the article concludes that the historical division between ‘obsessions’ and ‘compulsions’, and the extensive investigation of the latter, has had substantial implications for the development of OCD as a category centred on visible behaviours and treated through behavioural means. (shrink)

Metacognitive training (MCT) was developed to promote awareness of reasoning biases among patients with schizophrenia. While MCT has been translated into 31 languages, most MCT studies were conducted in Europe, including newer evidence recommending an individualized approach of delivery. As reasoning biases covered in MCT are separable processes and are associated with different symptoms, testing the effect of selected MCT modules would help to develop a targeted and cost-effective intervention for specific symptoms and associated mechanisms. This study tested the efficacy (...) of a 4-session metacognitive training for delusions, MCTd (in Traditional Chinese with cultural adaptations, provided individually), as an adjunct to antipsychotics in reducing severity and conviction of delusions, jumping to conclusions bias and belief inflexibility. Forty-four patients with delusions were randomized into the MCTd or the wait-list control condition. Patients on wait-list received the same MCTd after four weeks of treatment as usual. Assessment interviews took place before and after the treatment, and at 4-week follow-up. There was an additional baseline assessment for the controls. Jumping to conclusions and belief flexibility were measured by the beads tasks and the Maudsley Assessment of Delusions Scale. Attendance rate of the MCTd was satisfactory (84.5%). Compared to treatment as usual, there was a greater reduction in psychotic symptoms, delusional severity and conviction following MCTd. There was a large treatment effect size in improvement in belief flexibility. Improvement in reaction to hypothetical contradiction predicted treatment effect in positive symptoms and delusions. Jumping to conclusions bias was reduced following MCTd, although the treatment effect was not significantly larger than TAU. Our results support the use of process-based interventions that target psychological mechanisms underlying specific psychotic symptoms as adjuncts to more conventional approach. (shrink)

Excerpt from The Mathematical Psychology of Gratry and Boole: Translated From the Language of the Higher Calculus Into That of Elementary Geometry Dear Dr. Maudsley, - You have often asked me to explain, for students unaquainted with the Infinitesimal Calculus, certain doctrines expressed in terms of that Calculus by P. Gratry and my late husband. That you permit me to dedicate my attempt to you will, at least, be a guarantee that the main ideas of mathematical psychology are based, (...) not on mystic dreams, but on scientific induction. I am glad of this opportunity of expressing to you my gratitude, both for your published works, and for much personal kindness to myself. About the Publisher Forgotten Books publishes hundreds of thousands of rare and classic books. Find more at www.forgottenbooks.com This book is a reproduction of an important historical work. Forgotten Books uses state-of-the-art technology to digitally reconstruct the work, preserving the original format whilst repairing imperfections present in the aged copy. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in our edition. We do, however, repair the vast majority of imperfections successfully; any imperfections that remain are intentionally left to preserve the state of such historical works. (shrink)

Dans la seconde moitié du me siècle britannique, le nombre de textes traitant des rapports entre l'esprit et le corps est particulièrement conséquent. Cette époque est caractérisée par la formulation de la théorie de l'évolution de Darwin, par l'émergence des sciences du cerveau, et par une lutte pour l'autorité intellectuelle entre les élites traditionnelles et certains hommes de science. Le problème des rapports de l'esprit et du corps constitue à nos yeux une nouvelle porte d'entrée dans les débats de cette (...) époque et nous a permis d'identifier un mouvement philosophique, la philosophie psychophysiologique victorienne. Les auteurs étudiés sont les suivants : T.H. Huxley, Tyndall, Clifford, Maudsley, Bain, Carpenter, Lewes et Romanes"--Page 4 of cover. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Tyranny of the BureaucratsSimon Wilson (bio) and Gwen Adshead (bio)Keywordsviolence, mental health, bureaucracyWe are grateful for the opportunity to respond to the two kind and thoughtful commentaries on our paper. Sadler suggests irrationality may be the key to distinguishing psychiatric from nonpsychiatric violence. We are not so sure that this is necessarily as helpful as it might at first seem. Who gets to decide what is rational? Much (...) “normal” violence, committed in the heat of the moment, impulsively, and drunkenly, may not appear that rational, even to the perpetrator, in the cold light of day. We are not sure one would wish to bring this sort of violence within the province of psychiatric explanations. Likewise, a point we made in our paper: Even delusionally driven violence often has its own internal coherence and rationality within an irrational framework.We found much to agree with in McCallum’s commentary, and perhaps his alternative approach is more helpful. He proposes a more sociological model of understanding what is going on in these complex cases, one that starts with societal dividing practices. Our present times have been described as the tyranny of the bureaucrats. Professional approaches are devalued. Diagnosis is only relevant in terms of its bureaucratic utility in moving people from one category to another. Since the writing of our paper, the criminal law has changed further in England and Wales. The Criminal Justice Act 2003 brought with it new sentences of indeterminate detention for public protection for those offenders categorized as “dangerous.” The presence or absence of psychiatric disorder being largely irrelevant for these purposes. This would seem to fit nicely with McCallum’s analysis, and in principle rather takes the wind out of our sails when we argued about the discrimination against psychiatric violence—now a diagnosis is not necessary for the state to intervene in a probabilistic fashion to prevent future violence. Deciding between what sort of violence counts as psychiatric and what does not, does not have quite the same drastic differential effect on the individual as perhaps it did. Its importance is now, as predicted by McCallum’s model, more to do with bureaucracy: Which government department will be paying for the individual’s preventive detention (Department of Health or Ministry of Justice)? [End Page 75]Related ArticlesFeature Article: When Violence Becomes a Psychiatric SymptomCommentary: The Contingent Object of PsychiatryCommentary: Reasons CountResponse: The Tyranny of the BureaucratsSimon Wilson Simon Wilson is a Consultant Forensic Psychiatrist at the Maudsley Hospital and an Honorary Senior Lecturer at the Institute of Psychiatry, London, UK. He qualified at Leeds University and trained in psychiatry at the Maudsley Hospital. He was previously Consultant Forensic Psychiatrist at HM Prison, Brixton, UK. He has particular interests in prisons, philosophical, and ethico-legal issues in psychiatry. He can be contacted via e-mail at:[email protected] Adshead Gwen Adshead is a Forensic Psychiatrist and Psychotherapist. She works as a psychotherapist in a high-security hospital. She is a group analyst and researcher in attachment theory as it relates to offenders. She has a Master’s degree in Medical Law and Ethics, and is a founder member of the Philosophy Special Interest Group of the Royal College of Psychiatrists. She can be contacted via e-mail at:[email protected] © 2009 The Johns Hopkins University Press... (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)

This paper reconvenes Samuel Beckett’s psychotherapy with Wilfred Bion during 1934–1936 during which time Beckett’s conceived and began writing this second novel, Murphy . Based on Beckett’s visits to the Bethlem & Maudsley Hospital and his observation of the male nurses, the climax of Murphy is a chess match between Mr Endon (a male schizophrenic patient) and Murphy (a male psychiatric nurse). The precise notation of the Endon v Murphy chess match tells us that the Beckett intended it to (...) be an exemplar of an anti-match, perhaps a metaphor for the tragedy of being locked into madness. It is also argued that the match offers us insight into Beckett’s experience of the process of psychotherapy with Bion. Based on new information from Beckett’s nephew and Bion’s widow, hypotheses about the long term impact of the Bion-Beckett analysis are advanced as a mutual experience which shaped the lives and later literary output of both men, producing conjoined career writings which continue to offer us stark and sublime condensations of depression, psychosis, and the challenges of therapy and recovery. (shrink)