Some organisations make vaccination a condition of employment. This means prospective employees must demonstrate they have been vaccinated (eg, against measles) to be hired. But it also means organisations must decide whether _existing_ employees should be expected to meet newly introduced vaccination conditions (eg, against COVID-19). Unlike prospective employees who will not be _hired_ if they do not meet vaccination conditions, existing employees who fail to meet new vaccination conditions risk being _fired_. The latter seems worse than the former. Hence, (...) objections to vaccination mandates commonly centre on the harms that will be visited on existing employees who are unwilling to be vaccinated. However, because this objection does not necessarily entail the claim that vaccination is unnecessary for the effective and safe performance of certain jobs, those making this objection should have less of an objection, or no objection at all (at least on these grounds), to introducing vaccination requirements in some cases for _prospective_ employees. Yet, in this paper, I shall argue that if one has reason to believe vaccination requirements can be justified for prospective employees, one should also believe they are justified for existing employees _despite_ any asymmetry in consequences experienced by the two groups. As a consequence, common objections made against vaccination mandates grounded solely in the harms that may be experienced by existing employees who are unwilling to be vaccinated should be considered unpersuasive. (shrink)

In _Neuroscience and Philosophy_ three prominent philosophers and a leading neuroscientist clash over the conceptual presuppositions of cognitive neuroscience. The book begins with an excerpt from Maxwell Bennett and Peter Hacker's _Philosophical Foundations of Neuroscience_ (Blackwell, 2003), which questions the conceptual commitments of cognitive neuroscientists. Their position is then criticized by Daniel Dennett and John Searle, two philosophers who have written extensively on the subject, and Bennett and Hacker in turn respond. Their impassioned debate encompasses a wide range of (...) central themes: the nature of consciousness, the bearer and location of psychological attributes, the intelligibility of so-called brain maps and representations, the notion of qualia, the coherence of the notion of an intentional stance, and the relationships between mind, brain, and body. Clearly argued and thoroughly engaging, the authors present fundamentally different conceptions of philosophical method, cognitive-neuroscientific explanation, and human nature, and their exchange will appeal to anyone interested in the relation of mind to brain, of psychology to neuroscience, of causal to rational explanation, and of consciousness to self-consciousness. In his conclusion Daniel Robinson (member of the philosophy faculty at Oxford University and Distinguished Professor Emeritus at Georgetown University) explains why this confrontation is so crucial to the understanding of neuroscientific research. The project of cognitive neuroscience, he asserts, depends on the incorporation of human nature into the framework of science itself. In Robinson's estimation, Dennett and Searle fail to support this undertaking; Bennett and Hacker suggest that the project itself might be based on a conceptual mistake. Exciting and challenging, _Neuroscience and Philosophy_ is an exceptional introduction to the philosophical problems raised by cognitive neuroscience. (shrink)

The aim of the article is to present the application of the lean management method as appropriate for the management of the organizational system of psychiatric care in the Zealand region of Denmark. The organizational solutions of the Danish psychiatric care system presented in this paper are individualized and adapted to the regional needs of the residents. In Denmark, there are five administrative regions, in which each independently organizes its own system of medical (psychiatric) care. This means that the regions (...) have considerable independence in choosing the acceptable and necessary methods of management, including – as is clear from the conducted research – the use of methods put-upon other areas of economy. Although the national laws in Denmark define certain conditions and guidelines for the functioning of psychiatric care (e.g. regarding the use of direct coercion/restrains for patients treated in the centres), there is a distinct separation of structures and methods of functioning throughout the whole country, which constitutes unique observation material – from the cognitive point of view. The authors of this paper conduct extensive research and analyse the systems of psychiatric care organizations in various countries (including Spain, Italy and Japan) and, as a result, the obtained results may lead to the selection of the best models from other systems (good organizational practices and management, the management methods in use), which can be applied in the currently reorganised system of the Polish psychiatric care. The choice of Denmark for the observational study is not accidental and is related not only to the fact that there is a large degree of systemic identity within the country and between the regions, but also because the country applies solutions addressed to patients with very different cultural conditions and needs, resulting from their descent, religion, and (world)-views. Denmark is one of those European countries that express a significant acceptance of diversity and tolerance, which is why communities with very different imponderables, denominations, and worldviews co-exist. In the area related to the organization of the psychiatric system, these conditions are of key importance. In the period from January 2015 to December 2017 the authors participated in study visits in Denmark, conducting research aimed at identifying the key success factors of the psychiatric care organization system in the country. The conducted analysis is also based on the analysis of literature and own and participant observations. The conclusions concerning this subject are also the result of interviews conducted with employees of the visited hospitals and system users, both professionals and patients. As the search for an optimal organizational model of psychiatric care is currently an ongoing concern in Poland, it seems justified to review the existing solutions in Europe and perform their critical analysis. A comparison of the adopted solutions was performed, in the context of, above all, the improvement of the quality of these services, their availability, and the satisfaction of patients and their families from the proposed organizational changes. The economic benefits of these solutions are also significant. (shrink)

In The Platonizing Sethian Background of Plotinus's Mysticism, Zeke Mazur offers a radical reconceptualization of Plotinus with reference to Gnostic thought and praxis. A crucial element in the thought of the third-century CE philosopher Plotinus-his conception of mystical union with the One-cannot be understood solely within the conventional history of philosophy, or as the product of a unique, sui generis psychological propensity. This monograph demonstrates that Plotinus tacitly patterned his mystical ascent to the One on a type of visionary (...) ascent ritual that is first attested in Gnostic sources. These sources include the Platonizing Sethian tractates Zostrianos (NHC VIII,1) and Allogenes (NHC XI,3) of which we have Coptic translations from Nag Hammadi and whose Greek Vorlagen were known to have been read in Plotinus's school. (shrink)

Positivism has had a tremendous impact on the development of the social sciences over the past two centuries. It has deeply influenced method and theory, and has seeped deeply into our broader understandings of the nature of the social sciences. Postmodernism has attempted to loosen the grip of positivism on our thinking, and while it has not been without its successes, postmodernism has worked more to deconstruct positivism than to construct something new in its place. Psychologists today perennially wrestle to (...) find and retain their intellectual balance within the methodological, theoretical, and epistemological struggles between positivism and postmodernism. In the process, pre-postmodern criticisms of positivism have been largely forgotten. Although they remain deeply buried at the core of psychology, these early alternatives to positivism are rarely given explicit hearing today. The current piece explores some of the early critiques of positivism, particularly of its scientism, as well as early suggestions to tip the scales (back) in favor ofsapientia(“wisdom”). This third option, largely overlooked within mainstream psychology, is of tremendous value today as it is both deconstructive and constructive relative to the shortcomings of positivism. It avoids the overly reductionistic “trivial order” of positivism, as well as the deeply unsatisfying and disorienting “barbaric vagueness” of postmodernism, while simultaneously embracing important core elements of both currents of thought. (shrink)

Investigating Animal Abuse Crime Scenes: A Field Guide is designed for first responders-such as animal control officers and police officers-as well as forensic scientists and other criminal justice professionals who are who are tasked with processing and analyzing animal crime scenes and evidence. The book serves equally as a useful resource for those in the field and laboratory, in addition to those professionals who are further along in the investigative and judicial process.

In their target paper, Bruineberg and colleagues provide us with a timely opportunity to discuss the formal constructs and philosophical implications of the free energy principle. I critically discuss their proposed distinction between Pearl and Friston blankets. I then critically assess the distinction between inference with a model and inference within a model in light of instrumentalist approaches to science.

An important debate in the reasoning literature concerns the extent to which inference processes are domain-free or domain-specific. Typically, evidence in support of the domain-specific position comprises the facilitation observed when abstract reasoning tasks are set in realistic context. Three experiments are reported here in which the sources of facilitation were investigated for contextualised versions of Raven's Progressive Matrices (Richardson, 1991) and non-verbal analogies from the AH4 test (Richardson & Webster, 1996). Experiment 1 confirmed that the facilitation observed for the (...) contextualised matrices was in part due to extraneous aspects of commentaries originally intended to activate domainspecific processes. Experiments 2 and 3 indicated that the remainder of the facilitation for the matrices, and all of the facilitation for the analogies, could be explained by visual salience: Converting the item elements into realistic objects had enabled them and their transitions to be identified more easily. Hence, performance at simplified abstract items was as good as, or better than, at contextualised items. It is concluded that facilitation effects cannot be interpreted as showing that domain-specific processes constitute a self-contained system separate from domain-free processes. In turn, this means that domain-free processes cannot be dismissed as being unimportant for reasoning. (shrink)

In Ruling Majorities and Reasoning Pluralities, Professor Saul Levmore explores the “division of labor” between the various thresholds of agreement required for collective action—supermajority, simple majority, or plurality rule. His particular emphasis is on the choice between the last two options. To improve our understanding of this choice in various settings, Professor Levmore considers the relationship between two well-known contributions to the study of group decisionmaking, namely, the Condorcet Jury Theorem and the Condorcet Criterion, which have not generally been treated (...) together. This essay explores the relationship between these two insights in the context of judicial decisionmaking. Counterintuitively, the essay demonstrates that while the Condorcet Criterion continues to hold great promise as a tool of decision in en banc appellate courts, the Condorcet Jury Theorem is most appealing in judicial contexts that appear less collegial and thus less like a jury. In contexts in which jurists engage in deliberation and in which they anticipate that their outputs will have precedential effect, the Jury Theorem has little if any role to play. In contrast, the Theorem might prove more useful in evaluating low-level judicial outputs or decisions that otherwise are not expected to be treated as precedent. Thus, common law trial court decisions and civil law court decisions are more likely to be useful benchmarks in a Condorcet Jury Theorem analysis. It is because such courts do not anticipate that their decisions will have the force of precedent that they are more likely to be derived from governing legal texts, and thus more prone to characterizations of accuracy, than are judicial outputs that are driven by policy concerns and are generated with the understanding that they will be treated as precedent. (shrink)

In _The Platonizing Sethian Background of Plotinus’s Mysticism_, Zeke Mazur offers a radical reconceptualization of Plotinus with reference to Gnostic thought and praxis, chiefly as evidenced by Coptic works among the Nag Hammadi Codices whose Greek Vorlagen were read in Plotinus’s school.

Recent work on empathy has focused on the phenomenon of feeling on behalf of, or for, others, and on determining the role it ought to play in our moral lives. Much less attention, however, has been paid to ‘feeling-with.’ In this paper, I distinguish ‘feeling-with’ from ‘feeling-for.’ I identify three distinguishing features of ‘feeling-with,’ all of which serve to make it distinct from empathy. Then, drawing on work in feminist moral psychology and feminist ethics, I argue that ‘feeling-with’ has unique (...) moral value over and above ‘feeling-for.’ I end by rebutting some likely objections to the claim that ‘feeling-with’ is morally valuable. (shrink)

Research conducted during epidemics may warrant adaptations or adaptive designs owing to practical constraints, time pressures, uncertainty, the importance of flexibility, and the potential for research to detract from epidemic response. Adapting research entails choosing different research designs or methods if research goals, contexts or constraints justify or require a different approach. Adaptive research, by contrast, is a type of research that prospectively plans for modifications after research has been initiated, while maintaining the validity and integrity of the research. While (...) adaptation and adaptive designs introduce an important degree of flexibility to research conducted during epidemics and help to address research objectives and constraints, adaptation and adaptive designs require close ethical scrutiny and are no different from other research in that they are expected to align with universally accepted ethical standards. Important ethical questions exist regarding the conditions that justify adaptations to research, the kinds of adaptive research designs that can be ethically justified, and how ethics review bodies ought to evaluate such novel approaches to research in epidemic contexts. The five cases included in this chapter prompt reflection on the ethical considerations and implications of adapting research in response to epidemic-related risks and the public health measures deployed in response to those risks, as well as the ethical implications of not adapting research in such contexts. These cases also highlight ethical questions and issues arising during the conduct of adaptive trials, including when treatments under study, treatment doses, sample size, and other study features are reviewed in response to evolving evidence. This chapter invites reflection on these key ethical dimensions when considering adaptive designs and adaptations to standard research procedures during epidemics. What these cases make clear is that adaptive designs and adaptations to research do not reduce the need for rigorous scientific evaluation and adherence to universal ethical standards, and must be explicitly ethically justified and reviewed through transparent and inclusive processes. (shrink)

RESUMO : Será que um dia serão desenvolvidos computadores digitais capazes de pensar de modo similar ao nosso? Ou será que, independentemente da tecnologia, os computadores digitais estarão sempre limitados a manipularem dados sem compreendê-los? Neste trabalho, apresentarei duas concepções antagônicas de Filosofia da Mente: a Inteligência Artificial Forte, que responde afirmativamente à primeira questão, e a crítica de John Searle a esta corrente, que, por sua vez, responde de maneira afi rmativa à segunda questão. Para tanto, iniciarei o artigo (...) apresentando o famoso jogo da imitação proposto por Alan Turing para decidir se uma máquina é ou não inteligente, jogo este que ficou conhecido como teste de Turing. Logo em seguida, analisarei minuciosamente o experimento mental do quarto chinês, que é uma crítica ao teste de Turing e ao programa de pesquisa da Inteligência Artificial Forte. PALAVRAS-CHAVE : Teste de turing; Inteligência artificial; Quarto chinês; John Searle. (shrink)

Originally published in 1939, this book builds on Garnett's earlier work on similar topics to re-emphasise the role of education in integrating 'the character of every man and woman' for the overall benefit of both the individual and society. Garnett also surveys previous aims of education and the role of education in moulding the future. This book will be of value to anyone with an interest in the history of education.

as Denniston pointed out in his note on the passage, ‘is difficult’. Various suggestions have been made to explain it, from Kvicala's emendation on the analogy of Medea 923, to Parmentier's note, ‘la joue blanche ou claire, c'est-à-dire en sa fleur de jeunesse’; but none is altogether convincing or satisfactory. May one, then, advance the idea of retaining as the Oxford recension does, not on the ground of faute de mieux, but for the sake of the very striking image it (...) contains? How to Cite This Article. (shrink)

A group of statesmen known as the InterAction Council, in consultation with theologians and philosophers representing many cultures, has drafted a proposed Universal Declaration of Human Responsibilities.

A thorough survey of the field of learning. _Learning & Behavior_ covers topics such as classical and operant conditioning, reinforcement schedules, avoidance and punishment, stimulus control, comparative cognition, observational learning, motor skill learning, and choice. The book includes thorough coverage of classic studies and the most recent developments and trends, while providing examples of real-world applications of the principles discovered in laboratory research. It also emphasizes the behavioral approach but not exclusively so; many cognitive theories are covered as well, and (...) there is a chapter on comparative cognition. Learning Goals Upon completing this book readers will be able to: Understand the field of learning Discuss real-world applications of learning principles. (shrink)

In men, high levels of endogenous testosterone (T) seem to encourage behavior intended to dominate other people. Sometimes dominant behavior is aggressive, its apparent intent being to inflict harm on another person, but often dominance is expressed nonaggressively. Sometimes dominant behavior takes the form of antisocial behavior, including rebellion against authority and law breaking. Measurement of T at a single point in time, presumably indicative of a man's basal T level, predicts many of these dominant or antisocial behaviors. T not (...) only affects behavior but also responds to it. The act of competing for dominant status affects male T levels in two ways. First, T rises in the face of a challenge, as if it were an anticipatory response to impending competition. Second, after the competition, T rises in winners and declines in losers. Thus, there is a reciprocity between T and dominance behavior, each affecting the other. We contrast a reciprocal model, in which T level is variable, acting as both a cause and effect of behavior, with a basal model, in which T level is assumed to be a persistent trait that influences behavior. An unusual data set on Air Force veterans, in which data were collected four times over a decade, enables us to compare the basal and reciprocal models as explanations for the relationship between T and divorce. We discuss sociological implications of these models. (shrink)

We are in a state of impending crisis. And the fault lies in part with academia. For two centuries or so, academia has been devoted to the pursuit of knowledge and technological know-how. This has enormously increased our power to act which has, in turn, brought us both all the great benefits of the modern world and the crises we now face. Modern science and technology have made possible modern industry and agriculture, the explosive growth of the world’s population, global (...) warming, modern armaments and the lethal character of modern warfare, destruction of natural habitats and rapid extinction of species, immense inequalities of wealth and power across the globe, pollution of earth, sea and air, even the aids epidemic (aids being spread by modern travel). All these global problems have arisen because some of us have acquired unprecedented powers to act, via science and technology, without also acquiring the capacity to act wisely. (shrink)

In November of 1997, a letter from my professor AM came to my name. Hoodies from Ternopil Medical Academy named after. V.Ya. Gorbachevsky The letter mentioned that Arsen Richinsky was born in Kremenets'kyi, therefore the Department of Religious Studies at the Institute of Philosophy named after GS Pots of the National Academy of Sciences of Ukraine want to hold a scientific conference, whose participants should be taken immediately. [Mazur P., The immortalism of Arsen Rychinsky's memory on his native land (...) // Arsen Rychinsky - prominent Ukrainian public figure and scholar and religious scholar. Science collection. - Kyiv-Kremenets, 2007. - P. 27-32]. Motivating that the conference should be carefully prepared, we agreed with scientists of the National Academy of Sciences of Ukraine to hold the first Rychinsky readings on the basis of the school in the spring of 1998. (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)