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)

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)

Many studies revealed a link between temporal information processing (TIP) in a millisecond range and speech perception. Previous studies indicated a dysfunction in TIP accompanied by deficient phonemic hearing in children with specific language impairment (SLI). In this study we concentrate in SLI on phonetic identification, using the voice-onset-time (VOT) phenomenon in which TIP is built-in. VOT is crucial for speech perception, as stop consonants (like /t/ vs. /d/) may be distinguished by an acoustic difference in time between the onsets (...) of the consonant (stop release burst) and the following vibration of vocal folds (voicing). In healthy subjects two categories (voiced and unvoiced) are determined using VOT task. The present study aimed at verifying whether children with SLI indicate a similar pattern of phonetic identification as their healthy peers and whether the intervention based on TIP results in improved performance on the VOT task. Children aged from 5 to 8 years ( n = 47) were assigned into two groups: normal children without any language disability (NC, n = 20), and children with SLI ( n = 27). In the latter group participants were randomly classified into two treatment subgroups, i.e., experimental temporal training (EG, n = 14) and control non-temporal training (CG, n = 13). The analyzed indicators of phonetic identification were: (1) the boundary location (α) determined as the VOT value corresponding to 50% voicing/unvoicing distinctions; (2) ranges of voiced/unvoiced categories; (3) the slope of identification curve (β) reflecting the identification correctness; (4) percent of voiced distinctions within the applied VOT spectrum. The results indicated similar α values and similar ranges of voiced/unvoiced categories between SLI and NC. However, β in SLI was significantly higher than that in NC. After the intervention, the significant improvement of β was observed only in EG. They achieved the level of performance comparable to that observed in NC. The training-related improvement in CG was non-significant. Furthermore, only in EG the β values in post-test correlated with measures of TIP as well as with phonemic hearing obtained in our previous studies. These findings provide another evidence that TIP is omnipresent in language communication and reflected not only in phonemic hearing but also in phonetic identification. (shrink)

The goal of the present paper is to examine Wierzbicka¿s (1992, 1998a, 1999) claims that the connection between emotions and the body is encoded and emphasized in Russian to a higher degree than it is in English, and that English favors the adjectival pattern in emotion discourse, while Russian prefers the verbal one. The study analyzes oral narratives elicited through the same visual stimuli from 40 monolingual Russians and 40 monolingual Americans. The results of the quantitative and qualitative analyses of (...) the narrative corpus support Wierzbicka¿s claims, suggesting that ¿the reading of the body¿ is not a culture- and language-free experience, but is shaped by cultural, social, and linguistic forces, as well as by individual differences. At the same time, neither quantitative nor qualitative differences have been identified with regard to gendered use of emotion discourse. (shrink)

Der Band Matka odchodzi von Różewicz ist ein Buch über die Familie des Dichters. Zwischen der personlich Erklärung: „Ich bin ein Dichter”, und der ergreifenden Erinnerung: „Das Schönste und Wertwolle bei uns zu Hause ist die Muter”, ist ein Teil der Geschichte der Różewicz-Familie enthalten. Das ist auch ein Buch über eine alte Frau – die Muter, die einzige Ikone des für Różewicz charakteristischen Stils, die keine Banalität erlitten hat und den Weltzerfall nicht bewiest. Die Unabhängigkeit des Buches hat keinen (...) autonomischen Charakter, sondern ist eine schriftliche Bezeugungsweise der Ich – Identität. In den Band, in dem mehrere Lippenbekenntnisse von dem Beruf des Verfassers zu finden sind, gibt es kein einziges Gedicht. Man kann also keinesfalls einer Frage nach der originalität des Buches entweichen. Ich habe vor allem die Antwort darauf in Erwägung gezogen. (shrink)

Studie se zabývá analýzou politické teorie modu vivendi britského politického filosofa Johna Graye, přičemž za její hlavní cíl lze považovat především určení autorovy ideologické pozice v kontextu liberálního myšlení, jakož i posouzení koherence Grayovy teorie s koncepcí liberalismu strachu. Na základě kritické reflexe převažujícího univerzalistického pojetí liberalismu článek identifikuje a analyzuje stěžejní atributy Grayova specifického uchopení liberální teorie v podobě ideálu modu vivendi, etické teorie hodnotového pluralismu, univerzálního minima a hodnoty tolerance. V návaznosti na tuto identifikaci je následně zkoumán i (...) etický rozměr Grayovy politické teorie, jehož charakteristika umožňuje zhodnotit, do jaké míry lze autorovu teorii interpretovat v kontextu liberálního myšlení. V této souvislosti se studie rovněž snaží ukotvit Grayovu tvorbu v širším rámci alternativních projektů liberální teorie, když usiluje o prokázání principiálních paralel mezi Grayovým politickým modelem a politickým myšlením Bernarda Williamse jakožto stěžejním představitelem tzv. liberalismu strachu. Výzkum těchto paralel pak přispívá především k nastolení otázek souvisejících s možností důsledného odlišování politické a morální teorie a chápání konfliktu jakožto neodmyslitelné součásti politické reality v rámci současného liberalismu. The paper aims to analyse the political theory of modus vivendi by political philosopher John Gray and to determine the ideological standpoints of Gray's theory within the context of liberal thought as well as to assess its coherence with the concept of liberalism of fear. On the basis of a critical reflection of the prevailing universalistic conception of liberalism, the study identifies and analyses essential attributes of Gray's specific but controversial political theory: the ideal of modus vivendi; ethical theory of value pluralism; universal minimum and the value of toleration. Having interpreted all those main parts of the concept, the study is supposed to clarify also the ethical dimension of Gray's theory which makes it possible to decide to what extent the author might be identified as a liberal thinker. In this regard, the study endeavours to embed Gray's thought in a broader framework of alternative projects of liberal theory by demonstrating fundamental parallels between Gray's model and political thought of Bernard Williams as the main theoretician of liberalism of fear. Investigations of those parallels thus contributes towards articulating questions concerning the possibility of consistently distinguishing between the political and the moral theory as well as perception of a conflict as an ineradicable part of political reality in the framework of contemporary liberalism. (shrink)

To the extent that we expect ideographs to be closer to the reality they depict than spoken or written words we are succumbing to the perennial allure of positivistic thinking. Morin powerfully argues that human communication, including ideography, cannot be understood apart from practice, thus removing the positivistic assumption that made the “puzzle of ideography” puzzling in the first place.

Although rituals are believed to lower anxiety, the underlying mechanism of anxiety reduction has not been explained well enough. According to Boyer and Liénard (2006), ritualized behavior decreases the anxiety levels because it swamps working memory. This blocks anxious thoughts’ access to consciousness. As a result, ritualized behavior lowers anxiety temporarily but maintains it in the long run. In the article, I analyze what processes should be engaged in ritualized behavior to bring the aforementioned outcomes. I propose that ritualized behavior (...) has anxiolytic properties if it preoccupies consciousness without placing too many demands on cognitive control. While conscious preoccupation with ritualized behavior should reduce anxiety, cognitive control load related to efforts to concentrate on ritualized behavior may bring immediate paradoxical effects of self-regulation, i.e., anxiety increases. Moreover, since anxiety disrupts attentional control capabilities, ritualized behavior should not be too cognitively demanding if an anxious person is to perform it. (shrink)

Nowadays, creativity has become one of the most important determinants of the development of modern economy. In it lies the potential for economic success not only of entire regions, but above all of business entities. Although creativity is difficult to define, it more frequently becomes the subject of scholarly considerations. In this study, an attempt was made to explore the climate for creativity because it determines the development of creativity and creative attitudes in creative sectors. The main research goal was (...) to show the importance and pattern of the determinants creating a climate conducive to creativity and its impact on the development of creative industries. The method of the study was a critical analysis of the source literature and the author’s own research. The aim of the work became the basis for formulating the following research hypothesis: recognising the components constituting a pattern of the climate conducive to creativity in the city will enable better development of entities included in the creative sector. In order to achieve the set goal and verify the research hypothesis, quantitative and qualitative research was carried out among representatives of creative professions employed in the creative sectors. (shrink)

Judges wield enormous power in modern society and it is not surprising that scholars have long been interested in how judges think. The purpose of this article is to examine how US judges reason on language issues. To understand how courts decide on comprehension of constitutional rights by speakers with Limited English Proficiency (LEP), I analyzed 460 judicial opinions on appeals from LEP speakers, issued between 2000 and 2020. Two findings merit particular attention. Firstly, the analysis revealed that in 36% (...) of the interrogations, LEP speakers were advised of their rights only in English. This means that two decades after the Executive Order 13166 (2000) _Improving Access to Services for Persons with Limited English Proficiency_, law enforcement still doesn’t have adequate resources to advise LEP speakers of their constitutional rights in their primary languages. Secondly, the analysis revealed that some courts treat second language proficiency as an all-or-none phenomenon. This approach results in linguistic discrimination against LEP speakers who cannot comprehend legal language but are denied the services of an interpreter because they can answer basic questions in English. I end the discusson with recommendations for best practices in delivery of constitutional rights. (shrink)

Euclid in the Rainforest combines the literary with the mathematical to explore logic--the one indispensable tool in man's quest to understand the world. Mazur argues that logical reasoning is not purely robotic. At its most basic level, it is a creative process guided by our intuitions and beliefs about the world.

J. L. Austin’s article ‘Truth’ is a remarkable example of his method of ordinary language analysis by which he investigates the notoriously recalcitrant philosophical concept of truth. This paper attempts to specify the character of Austin’s truth conception, defending the view that despite his opinion of it being a semantic one, it is actually of a mixed nature. Correspondence is what determines the truth or falsity of a statement, but semantics delineates the segment of the world to which our statements (...) correspond. An explication of the notions of demonstrative and descriptive conventions is given in order to add flash to the outlinegiven by Austin. (shrink)

The article presents findings from three studies designed to validate and culturally adapt the Polish version of the Revised Illness Perception Questionnaire, a measure of the cognitive and emotional components of illness representations among oncology patients. The tool is conceptually based on Leventhal’s Self-Regulatory Model. The results of the study 1 show that it can be successfully used in a Polish cultural context as a reliable equivalent to its original English version. Analyses conducted in Study 2 provided good evidence for (...) construct and criterion validity as well as the internal reliability of the IPQ-R subscales. Study 3 revealed that the IPQ-R subscales present good test–retest reliability. Overall, the results show that the Polish version of the IPQ-R provides a comprehensive and psychometrically acceptable assessment of the representation of cancer and can be reliably used in studies involving Polish oncology patients. (shrink)

The article investigates the autobiographical aspects of Ryszard Kapuściński’s reportage pieces. The journalist’s complete works provide the material for this study. Autobiographism is understood here broadly, not only as the presence of a selfnarrative in the documentary accounts, but also as the implicit influence of the foreign correspondent’s life experiences on his interpretation of the events he reports. Kapuściński’s work early was primarily influenced by the experiences of poverty during the Second World War and the post-war period, the post-war loss (...) of his little homeland as Poland entered the orbit of the Soviet Union’s influence, as well as his involvement in a socialist youth organization. These personal experiences constitute an important context for the interpretation of his works, which is shown using examples from his reports. (shrink)

We analyze the relationship between corporate social responsibility and the stock market performance in the post-global financial crisis period. A new measure of social responsibility by Thomson Reuters, called the ESG Combined Score, is used. As a novel feature of our analysis, socially responsible engagement is divided into the strategic activities closely related to the examined companies’ core business and the remaining secondary activities. The results of the fixed effects regression show a positive and statistically, as well as economically, significant (...) impact of the strategic activities on the corporate stock market performance of companies. This impact is up to 103% higher compared to the secondary activities. The empirical results suggest that if companies aim to increase their share prices via the corporate social responsibility channel, they should strategically select their socially responsible initiatives. (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.

The importance of pedagogy as a science is in exploration and improvement of education as an integral part of the social reality. Theory of education, General pedagogy and Methodics of educational work are the scientific disciplines that are most directly related to examining the educational work, and represent its theoretical and methodological basis in the process of its realization. Educational work provides the essence of the overall education process, since it refers and unites the knowledge, skills, attitudes, beliefs and values (...) of the individual, and its results are seen in developing student’s unique personality. In this paper the focus is on the Methodics of educational work, as a pedagogical discipline which is most closely related to the process of realization of educational work. The aim is through analysis of the basic theoretical and terminological aspects to emphasize its role in the overall education process. Taking into consideration the complexity of educational work and difficulties related to the process of assessment of the outcomes, application of the taxonomy of the affective domain is suggested as a possible approach. Also, the importance of some topics that are particularly relevant in pedagogy is emphasized, but which, due to terminological inconsistencies, are not sufficiently recognized as part of the Methodics of educational work. (shrink)

While victimization is as old as human history, the notion of victimhood as currently understood is a relatively recent phenomenon. Over the last several decades, the notion of victimhood has been increasing discussed both within academia and the wider public, a trend that has intensified in recent years. In order to gain a clearer vision of this social phenomenon, the current piece follows the lead of Georg Simmel, and identifies a new Simmelian social type—the Victim. After discussing Simmel’s understanding of (...) social types and tracing the origins of the Victim, we examine some of the characteristics of this new social type. While the Victim is best understood on a high level of abstraction—as are all social types—a richer appreciation of the emergence and nature of the Victim will help us to better understand current discussions around victimhood in both academia and the wider public. These philosophical and sociological reflections on the nature of the Victim can thus be of help for better understanding a social phenomenon of considerable importance in today’s world. (shrink)

Die Reise von Róewicz an die Ouellen der Kultur des Mittelmeerraumes ist ein der vielen Versuche, die den Ziel hatten, die Weltmitte neu aufzubauen. Die vergeblichen, metamorphischen Reisen des verlorenen Sohnes an die mit seiner Geburt genetisch verbundenen Orte, die missgelungenen Versuche der Wiederholung dieser Struktur, liessen den Dichter seine Hoffnung woanders suchen: die Wiege der Mittelmeerraumkultur, loci communes aller Topeen, Archetypen und Mythen unseres Kulturkreises. El in Arcadie ego beweist, dass die Italiamythe nichts mehr Neues zeigt, ihre Schönheit wurde (...) sprachlos. Die Gegenwart – der perfekte Mörder der Vergangenheit – zeigte die Unfruchtbarkeit der für die vergangenen Generationen mehrdeutigen Mythe des italienischen Kulturparadises. Meine Erorerung ist ein Versuch, den Poem im Zusammenhang mit dem Bankrott der bisherigen Esthetiksprachen abzulesen. (shrink)

In the history of Miron Białoszewski as a poet the main issues are on the exploitation of commonplace and the continuation of literary tradition of low and high culture. Apart from the mentioned traditional literary genres, allusions to certain literary texts and the visible traces of Hindu ideas, one can correspondingly find here references to the Biblical symbolism, the combination of elements from various artistic spheres and polemics with traditional literary patterns. In my study I described some particular references to (...) high literary culture and presented the examples of metatextual and intertextual references to such culture. At the same time I strove to explain the poet’s motives for using them. (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)

Biomedical research on humans is an important part of medical progress. But, when lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. IRB members face difficult decisions every day. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues (...) involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the lives of human participants. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process. (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)