The most significant moments of restoration of Lithuania’s statehood and its constitutional consolidation in the national legislation during the Atgimimas period (from the foundation of Sąjūdis on 3 June 1988) and the work of the Supreme Council of Lithuania (from February 1990 to October 1992) are discussed in this article. The author pays attention to the challenges of drafting the new Constitution – the main weapon in the political fight; the article declares the complexity of this process and (...) mentions the participating persons. The article analyses the process of adopting the fundamental legal acts, initiated by Sąjūdis, such as the Citizenship Law, the Political Parties Law, the Law on the Constitutional Court. The most important and relevant problems and aims of the Independent State’s first year legislation are discussed in the article. One of the first legal acts – the Regulation of the Supreme Council of the Republic of Lithuania, as well as considering about the functions of the officials and other staff of the Supreme Council, the functions of the Legal Department, the relations between the Supreme Council and its Legal Department are analysed. The article pays attention to the first steps of the Independent State, based on the Constitution of the Republic of Lithuania, adopted on 25 October 1992 by referendum. The restoration of the Presidential institution and the formation of the Constitutional Court is also discussed. The significant role of Professor dr. Juozas Žilys in drafting the most important legal acts, acting as preconditions for the restoration of statehood of our country and its constitutional consolidation is noted in the article. (shrink)

The Council on Ethical and Judicial Affairs of the American Medical Association examines physicians’ professional ethical responsibility in the event that the security of patients’ electronic records is breached.

In lieu of an abstract, here is a brief excerpt of the content:Bioethics Commissions: Town Meetings with a “Blue, Blue Ribbon”Susan Cartier Poland (bio)Town meetings are characteristic of New England. In theory, a quorum of registered voters in a small municipality meets annually to decide local public policy. In fact, special interests and the town bureaucracy control the meeting.Like a town meeting, a commission (or committee or council) comes into being, whether on an ad hoc or permanent basis, (...) to direct a government function. Bioethics commissions specialize in one area: the intersection of public policy with developments, either real or anticipated, in the basic and applied sciences.That specialization of commissions carries over into the selection of the members. More often than not commission members are appointed on the basis of expertise in a specific area. Although some commissions are still made up entirely of one kind of expert, usually medical, the majority of these government bodies seek breadth between the fields of law, religion, ethics, and science (including medicine and the social sciences).In the words of Mrs. Rigenbach, the law clerk to Chief Judge Carl B. Rubin of the United States District Court for the Southern District of Ohio, selection of persons “knowledgeable in the field” constitutes a “blue, blue ribbon” jury. In contrast, a “blue ribbon” jury is composed of those persons having “the greatest amount of formal education” (In re Richardson-Merrill, Inc. (Bendectin litigation), 624 Federal Supplement 1212 at 1217 (1985)). The problem with persons knowledgeable in the field is that their minds may have already been made up. For a jury, this is a disaster; for a bioethics commission, this directs and shapes the research, investigation, and discussion, or, in short, it makes for more efficient decision making.For this Scope Note, the definition of commission begins with the Bioethicsline description of its index term “advisory committees” as committees or commissions set up to advise government bodies on public policy. Furthermore, a commission [End Page 91] (or committee) receives government funding and support in exchange for its expertise in research, investigation, reporting, and recommendations.Six functions served by bioethics commissions have been clearly and succinctly described by LeRoy Walters (Commissions and Bioethics. Journal of Medicine and Philosophy 14 (4): 363–68, August 1989). The functions are: (1) to legitimize action; (2) to delay action or resolution; (3) to identify duplication; (4) to be representative; (5) to do research and find facts; and (6) to provide education and support (pp. 364–65). Since 1989, however, another government function has moved to the forefront. Instead of remaining within the legislative arena, government commissions serve the judiciary as well, in cases involving complex and technical questions. The now defunct Law Reform Commission of Canada recognized this use when it included in its annual reports a section on its “Influence on Law Reform through Judicial Decisions.”In mid-1997, the United States Supreme Court in its consolidated cases on assisted suicide used extensively the writings from a state commission, the New York State Task Force on Life and the Law, to support its rationale. Not only did the Court make use of the Task Force’s work, but in so doing the Court extended the efforts of the commission beyond its jurisdiction of New York into another jurisdiction on the opposite coast, Washington state. Furthermore, although the commission was chartered by one state, through the federal court system, its influence became national.Outside the U.S., the United Nations recently adopted its first bioethics text on the ethics of genetic research, and Canada is reworking its human research guidelines into a single set of guidelines that will apply to research in both the natural sciences and the social sciences.This Scope Note attempts to compile for the researcher and the reference librarian those commissions, existing and defunct, that have addressed bioethics issues. Only one other such attempt is known to the author, an Office of Technology Assessment [OTA] Background Paper, Biomedical Ethics in U.S. Public Policy (1993). Due to space limitations, not all publications could be listed; the selections included represent the range of topics from a particular group or the more frequently cited sources. Future updates of this compilation are planned, so please notify the... (shrink)

After the Provisional Basic Law (Provisional Constitution) had been adopted on 11 March 1990, it soon became clear that it did not meet the new needs of the society and the state. It became clear that the new Constitution had to be drafted promptly. Its drafting was taking place at the time of heated discussions about various things, but especially about the structure of branches of state power, the empowerment thereof and their interrelations. The author of the article was a (...) member of the working group drafting the new Constitution. In his article, the author presents passages from the notes made by him about the sittings of the Provisional Commission for Drafting the Constitution and those of its working group. The notes disclose the variety of the views of the deputies and legal specialists and show the difficult way of emergence of the draft Constitution. This is confirmed by the time-line of drafting the Constitution. In 1990 and at the beginning of 1991, the first draft Constitutions were published, which had been drafted by the members of the societies of Lithuanian philosophers and lawyers, by the Lithuanian Democratic Labour Party, etc. Prior to the resolution of the Supreme Council of the Republic of Lithuania of 7 November 1990, a group of deputies was formed for drafting an outline of the concept of the Constitution. On 22 October 1991, the Council of the Seimas of the Lithuanian Sąjūdis Movement made a statement “On the Restoration of the Institution of the President of the Republic”. On 5 November 1991, the Supreme Council of the Republic of Lithuania adopted a Resolution “On the Development of the Lithuanian Constitutionalism”, whereas by its resolution of 10 December 1991 it formed the Provisional Commission for Drafting the Constitution. On 3 March 1992, the said Provisional Commission approved the draft Constitution that it prepared; it was submitted to the Supreme Council. Three members of the Provisional Commission had submitted alternatives to a number of articles of the Constitution. On 21 April 1992, the Supreme Council assented to the work done by the Provisional Commission and decided to publish the draft Constitution so that it could be discussed by the public. On 6 May 1992, the Lithuanian Sąjūdis Movement, the Democratic Party, the Christian Democratic Party, and the Lithuanian Nationalist Union formed a coalition for drafting an alternative draft Constitution; soon the press published the alternative draft Constitution prepared by the Sąjūdis Movement Coalition “For the Democratic Lithuania”. On 23 May 1992, the referendum on the restoration of the institution of the President of the Republic took place—that referendum did not approve the proposal. Thus, two alternative draft Constitutions appeared. The essential difference between those drafts was a different approach to the system of branches of state powers, their empowerment and their interrelation. The draft Constitution prepared by the Provisional Commission was based on the parliamentary republic form of governance, whereas in the draft prepared by the Sąjūdis Movement Coalition “For Democratic Lithuania” the model of half-presidential republic was dominant. In order to prepare a single draft Constitution, which could then be proposed for the referendum of the Nation, political and legal compromises were sought. For this purpose, the Group for the Adjustment of Constitutional Issues was formed. At the end of September and at the beginning of October 1992, one single (the so-called “compromise”) draft Constitution was prepared from the existing two alternative drafts. The Constitution of the Republic of Lithuania was adopted by the Nation in the referendum of 25 October 1992 and came into force on 2 November 1992. (shrink)

The legal system – from the jury room to the deliberations of the Supreme Court – offers an abundance of rich resources for the study and teaching of critical thinking.The courts have (often for centuries) struggled with many of the issues central to critical thinking. The courts not only provide fascinating examples and exercises for students to examine, but in many areas – the appropriate use of ad hominem arguments, the distinction between argument and testimony, the proper placing (...) of the burden of proof, the distinction between necessary and sufficient conditions, the legitimate (and fallacious) use of appeals to authority, the nature of arguments by analogy – jurists and legal scholars have analyzed these issues carefully, and their insights are of great value to anyone concerned with rigorous critical thinking. Study of those legal resources has also had an impact on my views concerning the moral responsibility system. (shrink)

This study analyzes the ideals of responsibility and accountability, asking such questions as when it is legitimate to blame top officials of an organization for mistakes made by personnel below them in the bureaucratic hierarchy; when things go wrong in a large and complex organization like the Canadian Forces, who is responsible and accountable; and whether a plea of ignorance is a good excuse. The study also analyzes the doctrine of ministerial responsibility in both the British and Canadian parliamentary traditions, (...) asking whether it is realistic to expect that a government minister should be held responsible for everything that goes wrong in his/her department. Finally, traditional military values are examined, considering the kinds of attitudes and values expected from Canada's armed forces and the differences between the military and civilian sectors. (shrink)

Constitutional and judicial law-making is increasingly beginning to find its reflection not only in the Anglo-Saxon, but also in the Romano-Germanic legal family. However, the prerequisites for the use of this legal instrument are different, which determines the relevance of conducting a comparative analysis regarding the provision of such a mechanism in the USA and Kazakhstan. The purpose of the research is to identify common and distinctive features in the process of implementation of constitutional and judicial law-making in (...) countries belonging to different legal systems. The article uses the methods of analysis, synthesis, comparison, deduction and generalization. As a result, the specificity of ensuring the mechanism of constitutional law-making in the USA was expressed, taking into account various forms of law-making activity. It has been established that the development of constitutional provisions in the United States takes place with the help of the constitutional doctrines of the Supreme Court of the United States, which provide for the introduction of amendments to constitutional provisions without a formal procedure. As a result of the study of the experience of Kazakhstan, it was established that special priority was given to the role of precedent, in particular, the decision of the Supreme Court of the Republic of Kazakhstan. This is explained by the integrative nature of the Romano-Germanic legal system, which allows effective development of national legislation as a whole and its provisions. The obtained results can be used during the professional training of judges in the Republic of Kazakhstan. (shrink)

In 2001, three non-Aboriginal men in their twenties were charged with the sexual assault of a twelve year old Aboriginal girl in rural Saskatchewan. Legal proceedings lasted almost seven years and included two preliminary hearings, two jury trials, two retrials with juries, and appeals to the provincial appeal court and the Supreme Court of Canada. One accused was convicted. The case raises questions about the administration of justice in sexual assault cases in Saskatchewan. Based on observation and analysis of (...) the record, this paper: (1) examines relationships between legal errors dealing with availability of the defence of “belief in consent” and interpretation of the “all reasonable steps” provision, the need for retrials, and apprehended race-gender-age bias and discrimination; and 2) proposes incremental and systemic remedies to address the weaknesses in police, prosecutorial and judicial policy and practice highlighted by this case. (shrink)

Doctoral programs at U.S. universities play a critical role in the development of human resources both in the United States and abroad. This volume reports the results of an extensive study of U.S. research-doctorate programs in five broad fields: physical sciences and mathematics, engineering, social and behavioral sciences, biological sciences, and the humanities. Research-Doctorate Programs in the United States documents changes that have taken place in the size, structure, and quality of doctoral education since the widely used 1982 editions. This (...) update provides selected information on nearly 4,000 doctoral programs in 41 subdisciplines at 274 doctorate-granting institutions. This volume also reports the results of the National Survey of Graduate Faculty, which polled a sample of faculty for their views on the scholarly quality of program faculty and the effectiveness of doctoral programs in preparing research scholars/scientists. This much-anticipated update of such an essential reference will be useful to education administrators, university faculty, and students seeking authoritative information on doctoral programs. (shrink)

Although the Canadian legal system has many virtues, it has at least one major weakness – its judicial appointments and promotion systems. The paper begins by identifying six key values that need to be considered in order to assess the legitimacy of a judicial appointments process – independence, impartiality, representativeness, transparency, accountability and efficiency. In the following sections, through the use of three case studies of appointments to the Supreme Court of Canada, the superior courts of (...) Nova Scotia and a promotion to the Federal Court of Canada, we demonstrate that Canada has failed to live up to these values. We conclude by suggesting that recent reforms to the judicial appointments processes by the current government are an improvement, but that more radical reforms are essential to enhance public confidence in the integrity of Canada’s judicial appointments and promotion systems. (shrink)

Sortition, i.e. random appointment for public duty, has been employed by societies throughout the years as a firewall designated to prevent illegitimate interference between parties in a legal case and agents of the legal system. In judicial systems of modern western countries, random procedures are mainly employed to select the jury, the court and/or the judge in charge of judging a legal case. Therefore, these random procedures play an important role in the course of a case, and should (...) comply with some principles, such as transparency and complete auditability. Nevertheless, these principles are neglected by random procedures in some judicial systems, which are performed in secrecy and are not auditable by the involved parties. The assignment of cases in the Brazilian Supreme Court is an example of such a procedure, for it is performed using procedures unknown to the parties involved in the judicial cases. This article presents a review of how sortition has been historically employed by societies and discusses how Mathematical Statistics may be applied to random procedures of the judicial system, as it has been applied for almost a century on clinical trials, for example. A statistical model for assessing randomness in case assignment is proposed and applied to the Brazilian Supreme Court. As final remarks, guidelines for the development of good randomization procedures are outlined. (shrink)

The quality of doctoral-level chemistry (N=145), computer science (N=58), geoscience (N=91), mathematics (N=115), physics (N=123), and statistics/biostatistics (N=64) programs at United States universities was assessed, using 16 measures. These measures focused on variables related to: program size; characteristics of graduates; reputational factors (scholarly quality of faculty, effectiveness of programs in educating research scholars/scientists, improvement in program quality during the last 5 years); university library size; research support; and publication records. Chapter I discusses prior attempts to assess quality in graduate education, (...) development of the study plans, and the selection of disciplines and programs to be evaluated. Chapter II discusses the methodology used, focusing on each of the assessment measures. Chapters III to VIII present, respectively, findings from the analyses of the chemistry, computer science, geoscience, mathematics, physics, and statistics/biostatistics programs. Chapter IX includes a summary of results, correlations among measures, several additional analyses, and suggestions for future studies. Among the findings reported are those indicating that mathematics programs had, on the average, the largest number of faculty (N=33) in December 1980 followed closely by physics (N=28) and chemistry (N=23), and that 80 percent of computer science students had job commitments by graduation. (Survey instruments and supporting documentation are included in appendices.) (JN). (shrink)

The quality of doctoral-level biochemistry (N=139), botany (N=83), cellular/molecular biology (N=89), microbiology (N=134), physiology (N=101), and zoology (N=70) programs at United States universities was assessed, using 16 measures. These measures focused on variables related to: (1) program size; (2) characteristics of graduates; (3) reputational factors (scholarly quality of faculty, effectiveness of programs in educating research scholars/scientists, improvement in program quality during the last 5 years); (4) university library size; (5) research support; and (6) publication records. Chapter I discusses prior attempts (...) to assess quality in graduate education, development of the study plans, and the selection of disciplines and programs to be evaluated. Chapter II discusses the methodology used, focusing on each of the assessment measures. Chapters III to VIII present, respectively, findings from the analyses of the biochemistry, botany, cellular/molecular biology, microbiology, physiology, and zoology programs. Chapter IX includes a summary of results, correlations among measures, several additional analyses, and suggestions for future studies. Among the findings reported are those indicating that cellular/molecular biology programs had, on the average, the largest number of faculty and that students in cellular/molecular biology, biology, biochemistry, microbiology, and physiology received a relatively high fraction of financial support. (Survey instruments and supporting documentation are included in appendices.) (JN). (shrink)

Although many physicians have been using the internet for both clinical and social purposes for years, recently concerns have been raised regarding blurred boundaries of the profession as a whole. In both the news media and medical literature, physicians have noted there are unanswered questions in these areas, and that professional self-regulation is needed. This report discusses the ethical implications of physicians’ nonclinical use of the internet, including the use of social networking sites, blogs, and other means to post content (...) online. It does not address the clinical use of the internet, such as telemedicine, e-prescribing, online clinical consultations, health-related websites, use of electronic media for clinical collaboration, and e-mailing patients (some of which are already covered in the AMA’s Code of Medical Ethics). (shrink)

The Second Vatican Council, taking into account the modern needs of mankind, called for the mutual tolerance of denominations, reforms and compromise in church traditions and practices. This was a response to the practical life of the Ukrainian church in the diaspora. For the Eastern Churches, the Council adopted a separate Decree "The Constitution for the Eastern Churches" 1, on the basis of which a conference of the UCP bishopric, led by the Supreme Archbishop Joseph Slipy, was (...) convened on December 14, 1966 in Rome. It discussed a number of issues, including the case of Divine Liturgy, the liturgical language, the introduction of the Ukrainian spoken language, some reductions in the Service of God, and the reformation of church singing. It was for this purpose that the dioceses established Liturgical Commissions, in particular at the Chicago Department in the United States, which included the musicologist, composer, and musical culture activist of the Diaspora Myron Fedorov. One of the tasks of the commission was to preserve the traditional self-made singing, so that he "did not disappear, but he lived and developed under different kinds: single-handed, double-voiced or in choral works, which most would be out of the richness and beauty of our rite". (shrink)

The Framers understood the Constitution to be the fundamental expression of the rule of law over against the arbitrary, intemperate, and unjust “rule of men” that all too frequently existed in the political world, unfortunately both democratic as well as monarchical. Accordingly, the rule of law requires a well functioning political and legal system that includes legislative checks and balances, the separation of power between the President and Congress, an independent judiciary, federalism, etc. What happens when this “Madisonian” constitutional (...) system, designed to express “the deliberate sense of the community,” runs into a Judicial branch that, in effect, claims we live under a Constitution, but the Constitution is what we say it is. Must the Judiciary itself be subject to the rule of law, and the decisions of a constitutional majority, or does their “independence” extend to being independent of the constraints of the rule of law and, thus, decent majority rule? How did the original John Marshall Court answer these questions, and what light do the leading cases and controversies shed on the relationship between the Marshall Court and the Madisonian System? Are we facing a situation of Marshall v. Madison? (shrink)

As one of the most important episodes of change in the Ottoman Empire, the Tanzimat Era (1839-1876) was a phase when the state and its political and ideological formation witnessed structural transformation and reforms. During this period, privy councils were instituted at every level, as one of the basic changes in decision-making and the legislation process of the Ottoman State. Meclis-i Âlî-i Umûmî (the Supreme Council-General) is located at the top of the counsulting hierarchy of councils at the (...) administrative piramid, instituted in 1838. The Supreme Council-General also functioned as an equivalent to that of a “senate” of the modern parliament for the first time in this transition period. (shrink)

The literature of “power elite” theory is surprisingly silent on the role of the judiciary. This is particularly strange as the judiciary was designed to be the elite institution in the federal system, and there is a good deal of evidence that it has functioned as planned: “The Court's power is a natural outcome of the necessity for maintaining capitalist dominance under democratic forms; …judicial review has proved to be a very convenient channel through which the driving forces (...) of American economic life have found expression and achieved victory.” The elite backgrounds of the judges have been much studied, and might explain a predisposition to respond to elite interests and values. However, the “input” channels remain mysterious. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind (...) the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)

Elimination of state laws that preempt local antismoking ordinances is a national health objective. However, the tobacco industry and its supporters have continued to pursue statelevel preemption of local tobacco control ordinances as part of an apparent strategy to avoid the difusion of grassroots antismoking initiatives. And, an increasing number of challenges to local ordinances by the tobacco industry and persons supported by the tobacco industry are being decided in state supreme courts and courts of appeals. The outcomes of (...) seemingly similar cases about the validity of local smoke-free air ordinances vary signifcantly by state. This paper examines the common and unique aspects of the decisions and the potential implications of court rulings on preemption for future state tobacco control eforts and achievement of national health objectives around the elimination of preemption. Using a search strategy developed for the Centers for Disease Control and Prevention's State Tobacco Activities Tracking and Evaluation System, cases where a state or federal appellate level court made a fnding on the validity of a local smoke-free air ordinance or regulation were identifed in 19 states. In contrast to previous studies, we found that cases in approximately half of states were decided for local governments. We also found that across the states, courts were considering similar factors in their decisions including the extent to which: the local government possessed the authority to pass the ordinance, the ordinance conficted with the state constitution, and state statutes preempt the ordinance. (shrink)

This paper investigates the phenomenon of judicial law-making in the practice of the highest courts dealing with criminal matters in Germany and Poland on the basis of 200 of their decisions. While German jurisprudence principally acknowledges the right of the judiciary to create new law, the Polish legal theory generally rejects this notion. Still, research indicates that, in practice, the differences in the frequency and intensity with which these courts pass creative rulings are not as substantial as the discrepancy (...) in the theoretical stance would suggest. Owing to circumstances, both the German Federal Court of Justice and the Polish Supreme Court are willing to create new legal norms, but the dimensions of judicial law-making presented by these bodies deviate from each other. In the research sample, the German Federal Court of Justice was more inclined to introduce legal institutions that were foreign to the statutes and rule against the will of the lawmaker explicitly stated in the preparatory works. On the other hand, the Polish Supreme Court used logical conclusions more often, but did not also refrain from passing rulings against the clear wording of the statutory law, and was just as willing to go beyond the wording of the law as was the German Federal Court of Justice. Notably, only the German apex court is willing to openly admit that it creates new legal norms, whereas the Polish Supreme Court does not concede in the reasons that its decisions are of a law-making nature, especially when it applies so-called “interpretation in the wider sense”—which is, in essence, a “concealed” way of creating new legal norms. (shrink)

Table of contentsI1 Proceedings of the 4th World Conference on Research IntegrityConcurrent Sessions:1. Countries' systems and policies to foster research integrityCS01.1 Second time around: Implementing and embedding a review of responsible conduct of research policy and practice in an Australian research-intensive universitySusan Patricia O'BrienCS01.2 Measures to promote research integrity in a university: the case of an Asian universityDanny Chan, Frederick Leung2. Examples of research integrity education programmes in different countriesCS02.1 Development of a state-run “cyber education program of research ethics” in (...) KoreaEun Jung Ko, Jin Sun Kwak, TaeHwan Gwon, Ji Min Lee, Min-Ho LeeCS02.3 Responsible conduct of research teachers’ training courses in Germany: keeping on drilling through hard boards for more RCR teachersHelga Nolte, Michael Gommel, Gerlinde Sponholz3. The research environment and policies to encourage research integrityCS03.1 Challenges and best practices in research integrity: bridging the gap between policy and practiceYordanka Krastev, Yamini Sandiran, Julia Connell, Nicky SolomonCS03.2 The Slovenian initiative for better research: from national activities to global reflectionsUrsa Opara Krasovec, Renata SribarCS03.3 Organizational climate assessments to support research integrity: background of the Survey of Organizational Research Climate and the experience with its use at Michigan State UniversityBrian C. Martinson, Carol R. Thrush, C.K. Gunsalus4. Expressions of concern and retractionsCS04.1 Proposed guidelines for retraction notices and their disseminationIvan Oransky, Adam MarcusCS04.2 Watching retractions: analysis of process and practice, with data from the Wiley retraction archivesChris Graf, Verity Warne, Edward Wates, Sue JoshuaCS04.3 An exploratory content analysis of Expressions of ConcernMiguel RoigCS04.4 An ethics researcher in the retraction processMichael Mumford5. Funders' role in fostering research integrityCS05.1 The Fonds de Recherche du Québec’s institutional rules on the responsible conduct of research: introspection in the funding agency activitiesMylène Deschênes, Catherine Olivier, Raphaëlle Dupras-LeducCS05.2 U.S. Public Health Service funds in an international setting: research integrity and complianceZoë Hammatt, Raju Tamot, Robin Parker, Cynthia Ricard, Loc Nguyen-Khoa, Sandra TitusCS05.3 Analyzing decision making of funders of public research as a case of information asymmetryKarsten Klint JensenCS05.4 Research integrity management: Empirical investigation of academia versus industrySimon Godecharle, Ben Nemery, Kris Dierickx5A: Education: For whom, how, and what?CS05A.1 Research integrity or responsible conduct of research? What do we aim for?Mickey Gjerris, Maud Marion Laird Eriksen, Jeppe Berggren HoejCS05A.2 Teaching and learning about RCR at the same time: a report on Epigeum’s RCR poll questions and other assessment activitiesNicholas H. SteneckCS05A.4 Minding the gap in research ethics education: strategies to assess and improve research competencies in community health workers/promoteresCamille Nebeker, Michael Kalichman, Elizabeth Mejia Booen, Blanca Azucena Pacheco, Rebeca Espinosa Giacinto, Sheila Castaneda6. Country examples of research reward systems and integrityCS06.1 Improving systems to promote responsible research in the Chinese Academy of SciencesDing Li, Qiong Chen, Guoli Zhu, Zhonghe SunCS06.4 Exploring the perception of research integrity amongst public health researchers in IndiaParthasarathi Ganguly, Barna Ganguly7. Education and guidance on research integrity: country differencesCS07.1 From integrity to unity: how research integrity guidance differs across universities in Europe.Noémie Aubert Bonn, Kris Dierickx, Simon GodecharleCS07.2 Can education and training develop research integrity? The spirit of the UNESCO 1974 recommendation and its updatingDaniele Bourcier, Jacques Bordé, Michèle LeducCS07.3 The education and implementation mechanisms of research ethics in Taiwan's higher education: an experience in Chinese web-based curriculum development for responsible conduct of researchChien Chou, Sophia Jui-An PanCS07.4 Educating principal investigators in Swiss research institutions: present and future perspectivesLouis Xaver Tiefenauer8. Measuring and rewarding research productivityCS08.1 Altimpact: how research integrity underpins research impactDaniel Barr, Paul TaylorCS08.2 Publication incentives: just reward or misdirection of funds?Lyn Margaret HornCS08.3 Why Socrates never charged a fee: factors contributing to challenges for research integrity and publication ethicsDeborah Poff9. Plagiarism and falsification: Behaviour and detectionCS09.1 Personality traits predict attitude towards plagiarism of self and others in biomedicine: plagiarism, yes we can?Martina Mavrinac, Gordana Brumini, Mladen PetrovečkiCS09.2 Investigating the concept of and attitudes toward plagiarism for science teachers in Brazil: any challenges for research integrity and policy?Christiane Coelho Santos, Sonia VasconcelosCS09.3 What have we learnt?: The CrossCheck Service from CrossRefRachael LammeyCS09.4 High p-values as a sign of data fabrication/falsificationChris Hartgerink, Marcel van Assen, Jelte Wicherts10. Codes for research integrity and collaborationsCS10.1 Research integrity in cross-border cooperation: a Nordic exampleHanne Silje HaugeCS10.3 Research integrity, research misconduct, and the National Science Foundation's requirement for the responsible conduct of researchAaron MankaCS10.4 A code of conduct for international scientific cooperation: human rights and research integrity in scientific collaborations with international academic and industry partnersRaffael Iturrizaga11. Countries' efforts to establish mentoring and networksCS11.1 ENRIO : a network facilitating common approaches on research integrity in EuropeNicole FoegerCS11.2 Helping junior investigators develop in a resource-limited country: a mentoring program in PeruA. Roxana Lescano, Claudio Lanata, Gissella Vasquez, Leguia Mariana, Marita Silva, Mathew Kasper, Claudia Montero, Daniel Bausch, Andres G LescanoCS11.3 Netherlands Research Integrity Network: the first six monthsFenneke Blom, Lex BouterCS11.4 A South African framework for research ethics and integrity for researchers, postgraduate students, research managers and administratorsLaetus OK Lategan12. Training and education in research integrity at an early career stageCS12.1 Research integrity in curricula for medical studentsGustavo Fitas ManaiaCS12.2 Team-based learning for training in the responsible conduct of research supports ethical decision-makingWayne T. McCormack, William L. Allen, Shane Connelly, Joshua Crites, Jeffrey Engler, Victoria Freedman, Cynthia W. Garvan, Paul Haidet, Joel Hockensmith, William McElroy, Erik Sander, Rebecca Volpe, Michael F. VerderameCS12.4 Research integrity and career prospects of junior researchersSnezana Krstic13. Systems and research environments in institutionsCS13.1 Implementing systems in research institutions to improve quality and reduce riskLouise HandyCS13.2 Creating an institutional environment that supports research integrityDebra Schaller-DemersCS13.3 Ethics and Integrity Development Grants: a mechanism to foster cultures of ethics and integrityPaul Taylor, Daniel BarrCS13.4 A culture of integrity at KU LeuvenInge Lerouge, Gerard Cielen, Liliane Schoofs14. Peer review and its role in research integrityCS14.1 Peer review research across disciplines: transdomain action in the European Cooperation in Science and Technology “New Frontiers of Peer Review ”Ana Marusic, Flaminio SquazzoniCS14.2 Using blinding to reduce bias in peer reviewDavid VauxCS14.3 How to intensify the role of reviewers to promote research integrityKhalid Al-Wazzan, Ibrahim AlorainyCS14.4 Credit where credit’s due: professionalizing and rewarding the role of peer reviewerChris Graf, Verity Warne15. Research ethics and oversight for research integrity: Does it work?CS15.1 The psychology of decision-making in research ethics governance structures: a theory of bounded rationalityNolan O'Brien, Suzanne Guerin, Philip DoddCS15.2 Investigator irregularities: iniquity, ignorance or incompetence?Frank Wells, Catherine BlewettCS15.3 Academic plagiarismFredric M. Litto16. Research integrity in EuropeCS16.1 Whose responsibility is it anyway?: A comparative analysis of core concepts and practice at European research-intensive universities to identify and develop good practices in research integrityItziar De Lecuona, Erika Löfstrom, Katrien MaesCS16.2 Research integrity guidance in European research universitiesKris Dierickx, Noémie Bonn, Simon GodecharleCS16.3 Research Integrity: processes and initiatives in Science Europe member organisationsTony Peatfield, Olivier Boehme, Science Europe Working Group on Research IntegrityCS16.4 Promoting research integrity in Italy: the experience of the Research Ethics and Bioethics Advisory Committee of the Consiglio Nazionale delle Ricerche Cinzia Caporale, Daniele Fanelli17. Training programs for research integrity at different levels of experience and seniorityCS17.1 Meaningful ways to incorporate research integrity and the responsible conduct of research into undergraduate, graduate, postdoctoral and faculty training programsJohn Carfora, Eric Strauss, William LynnCS17.2 "Recognize, respond, champion": Developing a one-day interactive workshop to increase confidence in research integrity issuesDieter De Bruyn, Bracke Nele, Katrien De Gelder, Stefanie Van der BurghtCS17.4 “Train the trainer” on cultural challenges imposed by international research integrity conversations: lessons from a projectJosé Roberto Lapa e Silva, Sonia M. R. Vasconcelos18. Research and societal responsibilityCS18.1 Promoting the societal responsibility of research as an integral part of research integrityHelene IngierdCS18.2 Social responsibility as an ethical imperative for scientists: research, education and service to societyMark FrankelCS18.3 The intertwined nature of social responsibility and hope in scienceDaniel Vasgird, Stephanie BirdCS18.4 Common barriers that impede our ability to create a culture of trustworthiness in the research communityMark Yarborough19. Publication ethicsCS19.1 The authors' forum: A proposed tool to improve practices of journal editors and promote a responsible research environmentIbrahim Alorainy, Khalid Al-WazzanCS19.2 Quantifying research integrity and its impact with text analyticsHarold GarnerCS19.3 A closer look at authorship and publication ethics of multi- and interdisciplinary teamsLisa Campo-Engelstein, Zubin Master, Elise Smith, David Resnik, Bryn Williams-JonesCS19.4 Invisibility of duplicate publications in biomedicineMario Malicki, Ana Utrobicic, Ana Marusic20. The causes of bad and wasteful research: What can we do?CS20.1 From countries to individuals: unravelling the causes of bias and misconduct with multilevel meta-meta-analysisDaniele Fanelli, John PA IoannidisCS20.2 Reducing research waste by integrating systems of oversight and regulationGerben ter Riet, Tom Walley, Lex Marius BouterCS20.3 What are the determinants of selective reporting?: The example of palliative care for non-cancer conditionsJenny van der Steen, Lex BouterCS20.4 Perceptions of plagiarism, self-plagiarism and redundancy in research: preliminary results from a national survey of Brazilian PhDsSonia Vasconcelos, Martha Sorenson, Francisco Prosdocimi, Hatisaburo Masuda, Edson Watanabe, José Carlos Pinto, Marisa Palácios, José Lapa e Silva, Jacqueline Leta, Adalberto Vieyra, André Pinto, Mauricio Sant’Ana, Rosemary Shinkai21. Are there country-specific elements of misconduct?CS21.1 The battle with plagiarism in Russian science: latest developmentsBoris YudinCS21.2 Researchers between ethics and misconduct: A French survey on social representations of misconduct and ethical standards within the scientific communityEtienne Vergès, Anne-Sophie Brun-Wauthier, Géraldine VialCS21.3 Experience from different ways of dealing with research misconduct and promoting research integrity in some Nordic countriesTorkild VintherCS21.4 Are there specifics in German research misconduct and the ways to cope with it?Volker Bähr, Charité22. Research integrity teaching programmes and their challengesCS22.1 Faculty mentors and research integrityMichael Kalichman, Dena PlemmonsCS22.2 Training the next generation of scientists to use principles of research quality assurance to improve data integrity and reliabilityRebecca Lynn Davies, Katrina LaubeCS22.3 Fostering research integrity in a culturally-diverse environmentCynthia Scheopner, John GallandCS22.4 Towards a standard retraction formHervé Maisonneuve, Evelyne Decullier23. Commercial research and integrityCS23.1 The will to commercialize: matters of concern in the cultural economy of return-on-investment researchBrian NobleCS23.2 Quality in drug discovery data reporting: a mission impossible?Anja Gilis, David J. Gallacher, Tom Lavrijssen, Malwitz David, Malini Dasgupta, Hans MolsCS23.3 Instituting a research integrity policy in the context of semi-private-sector funding: an example in the field of occupational health and safetyPaul-Emile Boileau24. The interface of publication ethics and institutional policiesCS24.1 The open access ethical paradox in an open government effortTony SavardCS24.2 How journals and institutions can work together to promote responsible conductEric MahCS24.3 Improving cooperation between journals and research institutions in research integrity casesElizabeth Wager, Sabine Kleinert25. Reproducibility of research and retractionsCS25.1 Promoting transparency in publications to reduce irreproducibilityVeronique Kiermer, Andrew Hufton, Melanie ClyneCS25.2 Retraction notices issued for publications by Latin American authors: what lessons can we learn?Sonia Vasconcelos, Renan Moritz Almeida, Aldo Fontes-Pereira, Fernanda Catelani, Karina RochaCS25.3 A preliminary report of the findings from the Reproducibility Project: Cancer biologyElizabeth Iorns, William Gunn26. Research integrity and specific country initiativesCS26.1 Promoting research integrity at CNRS, FranceMichèle Leduc, Lucienne LetellierCS26.2 In pursuit of compliance: is the tail wagging the dog?Cornelia MalherbeCS26.3 Newly established research integrity policies and practices: oversight systems of Japanese research universitiesTakehito Kamata27. Responsible conduct of research and country guidelinesCS27.1 Incentives or guidelines? Promoting responsible research communication through economic incentives or ethical guidelines?Vidar EnebakkCS27.3 Responsible conduct of research: a view from CanadaLynn PenrodCS27.4 The Danish Code of Conduct for Research Integrity: a national initiative to promote research integrity in DenmarkThomas Nørgaard, Charlotte Elverdam28. Behaviour, trust and honestyCS28.1 The reasons behind non-ethical behaviour in academiaYves FassinCS28.2 The psychological profile of the dishonest scholarCynthia FekkenCS28.3 Considering the implications of Dan Ariely’s keynote speech at the 3rd World Conference on Research Integrity in MontréalJamal Adam, Melissa S. AndersonCS28.4 Two large surveys on psychologists’ views on peer review and replicationJelte WichertsBrett Buttliere29. Reporting and publication bias and how to overcome itCS29.1 Data sharing: Experience at two open-access general medical journalsTrish GrovesCS29.2 Overcoming publication bias and selective reporting: completing the published recordDaniel ShanahanCS29.3 The EQUATOR Network: promoting responsible reporting of health research studiesIveta Simera, Shona Kirtley, Eleana Villanueva, Caroline Struthers, Angela MacCarthy, Douglas Altman30. The research environment and its implications for integrityCS30.1 Ranking of scientists: the Russian experienceElena GrebenshchikovaCS30.4 From cradle to grave: research integrity, research misconduct and cultural shiftsBronwyn Greene, Ted RohrPARTNER SYMPOSIAPartner Symposium AOrganized by EQUATOR Network, Enhancing the Quality and Transparency of Health ResearchP1 Can we trust the medical research literature?: Poor reporting and its consequencesIveta SimeraP2 What can BioMed Central do to improve published research?Daniel Shanahan, Stephanie HarrimanP3 What can a "traditional" journal do to improve published research?Trish GrovesP4 Promoting good reporting practice for reliable and usable research papers: EQUATOR Network, reporting guidelines and other initiativesCaroline StruthersPartner Symposium COrganized by ENRIO, the European Network of Research Integrity OfficersP5 Transparency and independence in research integrity investigations in EuropeKrista Varantola, Helga Nolte, Ursa Opara, Torkild Vinther, Elizabeth Wager, Thomas NørgaardPartner Symposium DOrganized by IEEE, the Institute of Electrical and Electronics EngineersRe-educating our author community: IEEE's approach to bibliometric manipulation, plagiarism, and other inappropriate practicesP6 Dealing with plagiarism in the connected world: An Institute of Electrical and Electronics Engineers perspectiveJon RokneP7 Should evaluation of raises, promotion, and research proposals be tied to bibliometric indictors? What the Institute of Electrical and Electronics Engineers is doing to answer this questionGianluca SettiP8 Recommended practices to ensure conference content qualityGordon MacPhersonPartner Symposium EOrganized by the Committee on Freedom and Responsibility in the Conduct of Science of ICSU, the International Council for ScienceResearch assessment and quality in science: perspectives from international science and policy organisationsP9 Challenges for science and the problems of assessing researchEllen HazelkornP10 Research assessment and science policy developmentCarthage SmithP11 Research integrity in South Africa: the value of procedures and processes to global positioningRobert H. McLaughlinP12 Rewards, careers and integrity: perspectives of young scientists from around the worldTatiana Duque MartinsPartner Symposium FOrganized by the Online Resource Center for Ethics Education in Engineering and Science / Center for Engineering, Ethics, and Society of the National Academy of EngineeringP13 Research misconduct: conceptions and policy solutionsTetsuya Tanimoto, Nicholas Steneck, Daniele Fanelli, Ragnvald Kalleberg, Tajammul HusseinPartner Symposium HOrganized by ORI, the Office of Research Integrity; Universitas 21; and the Asia Pacific Research Integrity NetworkP14 International integrity networks: working together to ensure research integrityPing Sun, Ovid Tzeng, Krista Varantola, Susan ZimmermanPartner Symposium IOrganized by COPE, the Committee on Publication EthicsPublication without borders: Ethical challenges in a globalized worldP15 Authorship: credit and responsibility, including issues in large and interdisciplinary studiesRosemary ShinkaiPartner Symposium JOrganized by CITI, the Cooperative Institutional Training InitiativeExperiences on research integrity educational programs in Colombia, Costa Rica and PeruP16 Experiences in PeruRoxana LescanoP17 Experiences in Costa RicaElizabeth HeitmanP18 Experiences in ColumbiaMaria Andrea Rocio del Pilar Contreras NietoPoster Session B: Education, training, promotion and policyPT.01 The missing role of journal editors in promoting responsible researchIbrahim Alorainy, Khalid Al-WazzanPT.02 Honorary authorship in Taiwan: why and who should be in charge?Chien Chou, Sophia Jui-An PanPT.03 Authorship and citation manipulation in academic researchEric Fong, Al WilhitePT.04 Open peer review of research submission at medical journals: experience at BMJ Open and The BMJTrish GrovesPT.05 Exercising authorship: claiming rewards, practicing integrityDésirée Motta-RothPT.07 Medical scientists' views on publication culture: a focus group studyJoeri Tijdink, Yvo SmuldersPoster Session B: Education, training, promotion and policyPT.09 Ethical challenges in post-graduate supervisionLaetus OK LateganPT.10 The effects of viable ethics instruction on international studentsMichael Mumford, Logan Steele, Logan Watts, James Johnson, Shane Connelly, Lee WilliamsPT.11 Does language reflect the quality of research?Gerben ter Riet, Sufia Amini, Lotty Hooft, Halil KilicogluPT.12 Integrity complaints as a strategic tool in policy decision conflictsJanneke van Seters, Herman Eijsackers, Fons Voragen, Akke van der Zijpp and Frans BromPoster Session C: Ethics and integrity intersectionsPT.14 Regulations of informed consent: university-supported research processes and pitfalls in implementationBadaruddin Abbasi, Naif Nasser AlmasoudPT.15 A review of equipoise as a requirement in clinical trialsAdri LabuschagnePT.16 The Research Ethics Library: online resource for research ethics educationJohanne Severinsen, Espen EnghPT.17 Research integrity: the view from King Abdulaziz City for Science and TechnologyDaham Ismail AlaniPT. 18 Meeting global challenges in high-impact publications and research integrity: the case of the Malaysian Palm Oil BoardHJ. Kamaruzaman JusoffPT.19 University faculty perceptions of research practices and misconductAnita Gordon, Helen C. HartonPoster Session D: International perspectivesPT.21 The Commission for Scientific Integrity as a response to research fraudDieter De Bruyn, Stefanie Van der BurghtPT. 22 Are notions of the responsible conduct of research associated with compliance with requirements for research on humans in different disciplinary traditions in Brazil?Karina de Albuquerque Rocha, Sonia Maria Ramos de VasconcelosPT.23 Creating an environment that promotes research integrity: an institutional model of Malawi Liverpool Welcome TrustLimbanazo MatandikaPT.24 How do science policies in Brazil influence user-engaged ecological research?Aline Carolina de Oliveira Machado Prata, Mark William NeffPoster Session E: Perspectives on misconductPT.26 What “causes” scientific misconduct?: Testing major hypotheses by comparing corrected and retracted papersDaniele Fanelli, Rodrigo Costas, Vincent LarivièrePT.27 Perception of academic plagiarism among dentistry studentsDouglas Leonardo Gomes Filho, Diego Oliveira GuedesPT. 28 a few bad apples?: Prevalence, patterns and attitudes towards scientific misconduct among doctoral students at a German university hospitalVolker Bähr, Niklas Keller, Markus Feufel, Nikolas OffenhauserPT. 29 Analysis of retraction notices published by BioMed CentralMaria K. Kowalczuk, Elizabeth C. MoylanPT.31 "He did it" doesn't work: data security, incidents and partnersKatie SpeanburgPoster Session F: Views from the disciplinesPT.32 Robust procedures: a key to generating quality results in drug discoveryMalini Dasgupta, Mariusz Lubomirski, Tom Lavrijssen, David Malwitz, David Gallacher, Anja GillisPT.33 Health promotion: criteria for the design and the integrity of a research projectMaria Betânia de Freitas Marques, Laressa Lima Amâncio, Raphaela Dias Fernandes, Oliveira Patrocínio, and Cláudia Maria Correia Borges RechPT.34 Integrity of academic work from the perspective of students graduating in pharmacy: a brief research studyMaria Betânia de Freitas Marques, Cláudia Maria Correia Borges Rech, Adriana Nascimento SousaPT.35 Research integrity promotion in the Epidemiology and Health Services, the journal of the Brazilian Unified Health SystemLeila Posenato GarciaPT.36 When are clinical trials registered? An analysis of prospective versus retrospective registration of clinical trials published in the BioMed Central series, UKStephanie Harriman, Jigisha PatelPT.37 Maximizing welfare while promoting innovation in drug developmentFarida LadaOther posters that will be displayed but not presented orally:PT.38 Geoethics and the debate on research integrity in geosciencesGiuseppe Di Capua, Silvia PeppoloniPT.39 Introducing the Professionalism and Integrity in Research Program James M. DuBois, John Chibnall, Jillon Van der WallPT.40 Validation of the professional decision-making in research measureJames M. DuBois, John Chibnall, Jillon Van der Wall, Raymond TaitPT.41 General guidelines for research ethicsJacob HolenPT. 42 A national forum for research ethicsAdele Flakke Johannessen, Torunn EllefsenPT.43 Evaluation of integrity in coursework: an approach from the perspective of the higher education professorClaudia Rech, Adriana Sousa, Maria Betânia de Freitas MarquesPT.44 Principles of geoethics and research integrity applied to the European Multidisciplinary Seafloor and Water Column Observatory, a large-scale European environmental research infrastructureSilvia Peppoloni, Giuseppe Di Capua, Laura BeranzoliF1 Focus track on improving research systems: the role of fundersPaulo S.L. Beirão, Susan ZimmermanF2 Focus track on improving research systems: the role of countriesSabine Kleinert, Ana MarusicF3 Focus track on improving research systems: the role of institutionsMelissa S. Anderson, Lex Bouter. (shrink)

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

This paper examines the role of the straight-commissioned salesperson in the context of agency theory and asserts that because the agent acts to benefit two principals, potential conflicts of interest arise. Temporal differences in receipt of rewards create a major conflict, while the firm's exhibition of both espoused and actual behaviors and information asymmetries intensify this conflict. Finally, in light of these inconsistencies, the ethical implications of the straight-commission compensation system are examined.

The purpose of this article is to analyse world-view and mythological expressions in Russian and Soviet Constitutional acts that implicitly or explicitly refer to any kind of idea legitimising the shape of the state, its political system or the nature of political power. The object of the argument will be exclusively such provisions of fundamental laws which: having neither a purely regulatory nor a purely programmatic character, model mental representations of the world of the legal text by reference to (...) ‘situationally transcendent’ ideas in Mannheim’s sense ; justify the content of the legal provision by means of such imagery, without being part of the preamble or any different integral part of the Constitution, characterised by a different ontology of the text; justify the content of provisions linked to political power and/or the nature of the state. The materials of the analysis are: Fundamental Laws of the Russian Empire of 1906, the Constitutional texts of the Union of Soviet Socialist Republics of 1924, 1936 and 1977, and the current Constitution of the Russian Federation. Consecutive Constitutions of the Russian Soviet Federative Socialist Republic are also referred to. The analysed formulations, legally irrelevant in a conventional reading of a legal text, participate in the semiosis of both the provisions that contain them and the entire texts of the fundamental laws. In this way, the Constitutions incorporate into their complex of meanings either religious expressions, mythologised ideological figures or figures of historical memory associated with collective identity. (shrink)

The Supreme Court”, first published in 1987, is a concise and informative narrative of the highest court in the USA. It contains much that is of interest and probing about the court and the intrigues of its decision-making. Moments abound when the reader is taken on a journey through the humanity of the cases, the erudite corridors of high-law and into the intensely high-strung but level-headed hallowed chambers of the Justices and Justice. What is revealed is the exacting mask (...) of law, the humanity and affectations of those whose burden it is to deliver far-reaching judgment on the American people. However, more revealing of the storyline is, perhaps, not so much the woven narratives contained within the three pages of text as it is the peripheral story (what Gerard Genette called the ‘paratext’) unfolded in the cover wraps, what they contain and the stories they weave. In this paper, I examine the liminal devices of ‘The Supreme Court’. I argue that much of the systemic cognition of the legal system can be divined from a scholarly encounter with these elements. Furthermore, the paratexts of two editions of the book indicate a paradigmatic shift in the legal perception of both the Supreme Court and the author between the periods of publication. This underscores the law not only in its reactive form but also in its dexterity in shifting its position to reflect the reality of its time. On each occasion, it alters the legal consciousness of a nation. Yet, it stays remarkably stable and self-effacing. The essential question is one of deference. It is of great interest that the Chief Justice targets the informed and the interested as opposed to the ignorant and ambivalent. The liminal devices, I observe, are probably as eloquent with this message as the text within. The paratext bears testimony to this. -/- Keywords. (shrink)

Judicial Deliberations compares how and why the European Court of Justice, the French Cour de cassation and the US Supreme Court offer different approaches for generating judicial accountability and control, judicial debate and deliberation, and ultimately judicial legitimacy. Examining the judicial argumentation of the United States Supreme Court and of the French Cour de cassation, the book first reorders the traditional comparative understanding of the difference between French civil law and American common law (...) judicial decision-making. It then uses this analysis to offer the first detailed comparative examination of the interpretive practice of the European Court of Justice. Lasser demonstrates that the French judicial system rests on a particularly unified institutional and ideological framework founded on explicitly republican notions of meritocracy and managerial expertise. Law-making per se may be limited to the legislature; but significant judicial normative administration is entrusted to State selected, trained, and sanctioned elites who are policed internally through hierarchical institutional structures. The American judicial system, by contrast, deploys a more participatory and democratic approach that reflects a more populist vision. Shunning the unifying, controlling, and hierarchical French structures, the American judicial system instead generates its legitimacy primarily by argumentative means. American judges engage in extensive debates that subject them to public scrutiny and control. The ECJ hovers delicately between the institutional/argumentative and republican/democratic extremes. On the one hand, the ECJ reproduces the hierarchical French discursive structure on which it was originally patterned. On the other, it transposes this structure into a transnational context of fractured political and legal assumptions. This drives the ECJ towards generating legitimacy by adopting a somewhat more transparent argumentative approach. (shrink)

The question of detention of asylum seekers is specific due to the special situation of detainees (persons who have experienced human rights violations and apply for asylum in receiving country) and due to peculiarities of detention itself (persons have not committed crimes, but come or stay illegally because they have been forced to do so by fleeing from human rights violations). Therefore, lately it raises many discussions at the European level. Sooner or later, discussions influence national laws, as after adopting (...) the EU directives their provisions must be properly transposed into national laws. This article describes the recent documents: the study in Lithuania, the UNHCR guidelines, the EU developments, the Lithuania judicial practice. The authors of the article discuss the latest amendments of the Law on the Legal Status of Aliens (entering into force on 1 February 2012) related to detention of asylum seekers after the transposition of the provisions of the Return Directive. The practice of the Supreme Administrative Court of Lithuania when applying the new detention-related provisions is also reviewed in the article. The authors do not agree with the position of the Supreme Administrative Court of Lithuania that the provisions of the Return Directive are applicable to asylum seekers. The authors pay attention to the case-law of the European Court of Justice, the preamble of the Return Directive and its legal relations with the EU asylum directives. At the end, the conclusions are drawn as to the way that the provisions of the Law on the Legal Status of Aliens should be interpreted in the light of the purposes and provisions of the European Union directives. In order to avoid contradictory practice and at the same time ensure the interests of public order in Lithuania, Article 113(7) of the Law on the Legal Status of Aliens could be applied. (shrink)