The draft Common Frame of Reference is likely to play a prominent role in the further development of European contract law. Therefore, with a view to its acceptability it is crucial to assess the draft from the point of view of social justice.The DCFR has all the characteristics of a typical European compromise. Ideological and esthetical purists will certainly be disappointed. This is not necessarily something to be worried about. A common frame of reference is not drafted, in the first (...) place (if at all), for esthetical or ideological reasons; it is meant to provide some normative guidance in the further development of European contract law. European citizens have very different interests, preferences and opinions in relation to almost all the subjects dealt with in the DCFR. A DCFR consistently based on only one conception about the right choices would inevitably have disappointed all European citizens with a different idea of social justice in European private law. Therefore, if we really want the further Europeanization of private law we will have to accept that it will probably look rather different from both the particular Member State law that each of us is familiar with and our personal ideas of social justice. The publication of the interim outline edition of the draft CFR, which is the result of a close collaboration between hundreds of legal scholars from all Member States, has brought that message home. The characterisations of the DCFR as 'a law for big business and competent consumers' or, alternatively, as a 'massive reduction of private autonomy' are both unfounded. Overall, from the point of view of social justice, the DCFR is fairly balanced. Nevertheless, there is certainly room for improvement.Even if the DCFR is going to remain only a soft law instrument it is still likely to have a considerable influence on the further development of private law in Europe and will therefore also affect, directly or indirectly, the lives of all European citizens. For this reason it is crucial that European citizens will not only be the addressees of the CFR, or of the legislative measures based thereon, but can also rightly consider themselves as its authors. After the drafting by legal experts and the rather one-sided 'stakeholders'' input that were both organised by the European Commission it is now time for the citizens' voice. Only a meaningful input from the European and national Parliaments can provide the final CFR with the regulatory legitimacy that it needs.The level of consumer protection in the DCFR is sufficiently high for it to be acceptable as the content of an optional instrument, which could be made applicable, for example, by clicking on a 'blue button'. However, as an absolute maximum beyond which the Member States would not be allowed to go in the case of full harmonisation, it is submitted, the level of protection in the DCFR is insufficient. Moreover, the DCFR draws a sharp distinction between B2C and B2B contracts. It categorically excludes from the protection that it grants to consumers all businesses, even the smallest ones that may be as vulnerable as consumers (or even more so) when it comes to a lack of information, inexperience and dependence. This sharp distinction deviates from the law in many Member States, is not required by the EC Treaty (which is relevant with a view to the CFR's role as a toolbox for revising the acquis and for drafting new acquis), and is potentially contrary to the fundamental principle of justice that any distinction between groups of people should favour the least privileged.General private law - the bulk of the model rules contained in the DCFR - cannot be said to be 'neoliberal' as the Social Justice Group feared it would. Nor is it 'socialist' as some business stake holders warned for. It strikes a balance between autonomy and solidarity that is quite similar to the ones drawn in the modern private laws (including the case law, i.e. not merely the civil codes) of the Member States. However, where the DCFR deviates from the Principles of European Contract Law (PECL) it is always in the liberal direction.Throughout the last Century general clauses, such as good faith, have played a prominent role in promoting social justice in private law in the Member States. In fact they became delegations of law-making power to the courts in order to allow them to find just and fair solutions in new cases. This tradition was codified in the PECL. However, in the DCFR the role of good faith is narrower and deliberately so. From the point of view of social justice it is important that in the final CFR the role of good faith as an undisputed legal basis for judge-made law should be restored.The catalogue of underlying values and principles, that is meant to become the preamble to the final CFR and is likely to play a crucial role in the interpretation and further development of the CFR, brings back to the foreground some fundamental values that have played a prominent role in private law making in the Member States but that have been overshadowed, on the European level, by the narrow focus on market building. Having said that, the list of values in the DCFR could be framed so as to be more balanced. In particular, the privileged position of party autonomy as the only principle that is also contained in the black-letter model rules seems unjustified. (shrink)

ABSTRACT The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. (...) For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. (shrink)

The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. For (...) example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Update on Waiving Informed Consent in Emergency ResearchCharles R. McCarthyMadam: The closing statement of my article on Waiving Informed Consent in Emergency Research published in the June 1995 issue of the Kennedy Institute of Ethics Journal was: "No doubt we shall hear more of this issue."Indeed, we have heard much more on this issue. (1) In May 1995, after my article had already gone to press, the Food and (...) Drug Administration (FDA) and the National Institutes of Health (NIH) jointly published a report on the Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances. (2) On July 26, 1995, the Department of Health and Human Services (HHS) published in the Federal Register a Notice of Action Related to Emergency Research Activity (60 FR 38353-54). This action constituted a waiver of the requirement to obtain prior informed consent from subjects, as required by the Department's Regulations for the Protection of Human Subjects (45 CFR 46), for one specific NIH-funded project under strictly defined circumstances. (3) On September 21, 1995, FDA published a proposed rule to amend its current informed consent regulations (21 CFR 50) to permit harmonization of federal policies on emergency research and to reduce confusion as to when such research can proceed without obtaining prior informed consent from research subjects. The proposed regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human research subject.The HHS waiver (a harbinger of a proposed amendment to its regulations) and the FDA proposed rule are intended to be harmonized so that an Institutional Review Board (IRB) in compliance with one set of regulations relative to the waiver of informed consent will be, ipso facto, in compliance with the other set of regulations.In brief: The FDA proposed amendments will allow an IRB to waive informed consent in emergency situations when:1. The human subjects are in a life threatening condition;2. Obtaining informed consent is not feasible because: (i) the subjects will not be able to provide consent because of their medical condition, (ii) the intervention must be administered before consent from legally authorized representatives is feasible, (iii) there is no reasonable way to identify prospectively the individuals likely to become eligible for the research because the emergence of the condition to be studied cannot be predicted reliably in particular individuals; [End Page 385]3. The opportunity to participate is in the interest of the subjects because: (i) a life threatening situation necessitates intervention, (ii) the risk of the intervention is reasonable in the light of what is known about the medical condition and the patient, the risks and benefits of current therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity;4. The research could not practicably be carried out without the waiver;5. Additional protection of the rights and welfare of the subjects will be provided including, at least: (i) consultation (which may include consultation carried out by the IRB itself) with representatives of the communities from which the subjects will be drawn, (ii) public disclosure prior to commencement of the study sufficient to describe the study and its risks and benefits, (iii) public disclosure of sufficient information following completion of the study to apprise the community and researchers of the study and its results, and (iv) the establishment of an independent data and safety monitoring board;6. The IRB has reviewed and approved an informed consent document for use with subjects or legal representatives in situations in which obtaining such consent may be feasible for some subjects.The preamble to the proposed amendments to the regulations and the amendments themselves contain much more information than is presented here. Readers are therefore encouraged to study the proposals carefully. The public comment period ended November 6, and the FDA is expected to issue a final rule in 1996.Charles R. McCarthyKennedy Institute of Ethics Georgetown University Washington, DCCopyright © 1995 The Johns Hopkins University Press... (shrink)

The Second World War offered an excellent opportunity for some U.S. think tanks to influence foreign-policy-making processes and get involved in transatlantic diplomacy. This study seeks to demonstrate that the Council on Foreign Relations (CFR) challenged the stalemate between the U.S. and French authorities by gathering together U.S. experts and non-collaborationist French leaders. A first-hand reconstruction of this informal network is based on the unreleased Peace Aims Group’s records. This was a unique CFR exchange programme for European governments-in-exile’s representatives. In (...) the first part, a general reconstruction of Council on Foreign Relations’ planning introduces an original assessment of the meetings with some prominent French intellectuals and politicians. It is argued that these conferences can be interpreted as rare examples of wartime public diplomacy. The second part discloses new historical evidence demonstrating the participation of Jean Monnet in a Peace Aims session. This discovery proves the existence of a long-term partnership between one of the key protagonists of the European integration process and the most authoritative foreign-policy think tank working for the Roosevelt administration. Overall, the analysis of Peace Aims Group’s off-the-record discussions sheds new light on the WWII transatlantic debate on postwar Europe and France. (shrink)

: Subpart D of 45 CFR 46 focuses on research involving children. Section 46.407 addresses research that is not otherwise approvable. The research is not otherwise approvable because either (1) it seeks to enroll healthy children, but offers no prospect of direct benefit and entails more than minimal risk; or (2) it seeks to enroll children with a disorder or condition, but offers no prospect of direct benefit and entails more than a minor increase over minimal risk. According to 46.407, (...) such research can be permissible if it is approved by a panel of experts. Prior to 2000, only two 407 panels had been convened, but in 2001, the Office for Human Research Protections received more than 20 protocols for 407 review. The first, entitled "Precursors to Diabetes in Japanese American Youth," serves here as a case study in human subject protections. (shrink)

Collaborative filtering recommender system (CFRS) plays a vital role in today’s e-commerce industry. CFRSs collect ratings from the users and predict recommendations for the targeted product. Conventionally, CFRS uses the user-product ratings to make recommendations. Often these user-product ratings are biased. The higher ratings are called push ratings (PRs) and the lower ratings are called nuke ratings (NRs). PRs and NRs are injected by factitious users with an intention either to aggravate or degrade the recommendations of a product. Hence, it (...) is necessary to investigate PRs or NRs and discard them. In this work, opinion mining approach is applied on textual reviews that are given by users for a product to detect the PRs and NRs. The work also examines the effect of PRs and NRs on the performance of CFRS by evaluating various measures such as precision, recall, F-measure and accuracy. (shrink)

The purpose of the present study is to investigate gender differences in the use of double standards in ethical judgements of questionable conduct instigated by business or consumers. We investigate if consumers are more critical towards unethical corporate versus consumer actions and if these double standards depend on the gender of the respondent. In the first study, we compared evaluations of four specific unethical actions [cfr. DePaulo, 1987, in: J. Saegert (ed.) Proceedings of the Division of Consumer Psychology (American Psychological (...) Association, Washington DC)] instigated by either the consumer or the corporation. In a second study, we investigated the perception of some general consumer and corporate (un)ethical actions in addition to DePaulo's unethical scenarios. Both researches show that females are less likely to use double standards when it comes to their own (un)ethical behaviour compared to corporate (un)ethical actions. Furthermore, gender differences in the use of double standards depend on the type of unethical behaviour. Limitations and suggestions for further research are discussed. (shrink)

The purpose of the present study is to investigate gender differences in the use of double standards in ethical judgements of questionable conduct instigated by business or consumers. We investigate if consumers are more critical towards unethical corporate versus consumer actions and if these double standards depend on the gender of the respondent. In the first study, we compared evaluations of four specific unethical actions [cfr. DePaulo, 1987, in: J. Saegert (ed.) Proceedings of the Division of Consumer Psychology (American Psychological (...) Association, Washington DC)] instigated by either the consumer or the corporation. In a second study, we investigated the perception of some general consumer and corporate (un)ethical actions in addition to DePaulo’s unethical scenarios. Both researches show that females are less likely to use double standards when it comes to their own (un)ethical behaviour compared to corporate (un)ethical actions. Furthermore, gender differences in the use of double standards depend on the type of unethical behaviour. Limitations and suggestions for further research are discussed. (shrink)

Research risks have to meet minimal risk requirements in order for the research to qualify for expedited ethics review, to be exempted from ethics review, or to be granted consent waivers. The definition of “minimal risk” in the Common Rule (45 CFR 46) relies on the risks-of-daily-life and risks-of-routine-tests as comparators against which research activities are assessed to meet minimal risk requirements. While either or both comparators have been adopted by major ethics codes, they have also been criticized. In response (...) to criticisms, elaborations, and alternative comparators have been proposed. In this paper, I approach the search for workable comparators from the point of view that ethical reasoning about minimal risk involves analogical reasoning using comparators. In this regard, I develop two necessary conditions for an adequate minimal risk conception, which I use to assess three comparators. I conclude that the risks-of-routine-tests best fits the analogical reasoning operating in minimal risk assessments. (shrink)

Carte Blanche is the alarming tale of how the right of Americans to say "no" to risky medical research is eroding at a time when we are racing to produce a vaccine and treatments for Covid-19. This medical right that we have long taken for granted was first sacrificed on the altar of military expediency in 1990 when the Department of Defense asked for and received from the FDA a waiver that permitted it to force an experimental anthrax vaccine on (...) the ranks of ground troops headed for the Persian Gulf. Since then, the military has pressed ahead to impose nonconsensual testing of the blood substitute PolyHeme in civilian urbanities, quietly enrolling more than 20,000 non-consenting subjects since 2005. Most Americans think that their right to give or withhold consent is protected by law, but the passing in 1996 of modifications to the Code of Federal Regulations, such as statute CFR 21 50.24, now permit investigators to conduct research with trauma victims without their consent or event their knowledge. More than a dozen studies since have used the 1996 loophole to recruit large numbers of subjects without their knowledge. The erosion of consent is the result of a U.S. medical-research system that has proven again and again that it cannot be trusted. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of human subjects (45 CFR (...) 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)

Recent empirical work has offered strong support for ‘biased pluralism’ and ‘economic elite’ accounts of political power in the United States, according a central role to ‘business interest groups’ as a mechanism through which corporate influence is exerted. Here, we propose an additional channel of influence for corporate interests: the ‘policy-planning network,’ consisting of corporate-dominated foundations, think tanks, and elite policy-discussion groups. To evaluate this assertion, we consider one key policy-discussion group, the Council on Foreign Relations. We first briefly review (...) the origins of this organization and then review earlier findings on its influence. We then code CFR policy preferences on 295 foreign policy issues during the 1981–2002 period. In logistic regression analyses, we find that the preferences of more affluent citizens and the CFR were positive, statistically significant predictors of foreign policy outcomes while business interest group preferences were not. These findings are discussed with a consideration of the patterns of CFR ‘successes’ and ‘failures’ for the issues in our dataset. Although a full demonstration of a causal connection between corporate interests, the policy-planning network and policy outcomes requires further research, we conclude that this has been shown to be a plausible mechanism through which corporate interests are represented and that ‘biased pluralism’ researchers should include it in their future investigations. (shrink)

The Third Revolution is an examination of the historic transformations in contemporary China. Elizabeth C. Economy is director for Asia Studies at the Council on Foreign Relations. According to its mission statement, the CFR is a think tank “dedicated to being a resource for … government officials, business executives, journalists, educators and students … to help them better understand the world and the foreign policy choices facing the United States.” The Third Revolution is about the societal, economic, and political changes (...) under the administration of General Secretary Xi Jinping. Published by Oxford as a CFR Book, the study is written from a foreign policy perspective with regard to strategic U.S.... (shrink)

O estudo visa apresentar os supostos teóricos e as tensões essenciais da tematização da ideia de Quinto Império na Defesa Perante o Tribunal do Santo Ofício, do P.e António Vieira. A visão profética de Vieira assume o contraste entre um tempo de inautenticidade na relação teândrica, subsidiário da Queda adâmica e objectivado na sucessão dos quatro impérios (cf. Daniel, 2, 27-45), e a novidade absoluta do acontecimento de Cristo, que se espera vir a manifestar-se na pacificação terrena do processo histórico (...) e na constituição duma comunidade universal segundo o Espírito. A tese, que só um estudo ulterior poderá demonstrar, é a de que a perspectiva do Quinto Império, em Vieira, será, ainda subsidiária das categorias dominantes no tempo dos quatro impérios, em que a experiência escatológica se refracta antropocentricamente pelas finalidades, e relações de poder, político-civilizacionais. /// Cette étude presente les présupposés théoriques et les tensions essentielles de Ia thématisation de Tidée de Cinquième Empire dans Ia Défense Auprès du Tribunal du Saint-Office, du P. António Vieira. La vision prophétique de Vieira assume le contraste entre un temps d'inauthenticité dans Ia relation théandrique, temps faisant suite à Ia chute adamique et objective dans Ia suc-cession des quatre empires (Cfr. Daniel, 2, 27-45), et Ia nouveauté absolue de Pévénement du Christ, dont on attend Ia maniféstation dans Ia pacification terrestre du cours de Thistoire et dans Ia constitution d'une communauté univer-selle selon l'Esprit. La thèse, que seule une étude ultérieure pourra démon-trer, considere que Ia perspective du Cinquième Empire, chez Vieira, será encore marquée par les catégories dominantes au temps des quatre empires, ou Texpérience eschatologique se refracte anthropocentriquemente à travers les fínalités, et relations de pouvoir, d'ordre politico-civilisationnel. /// The aim of this study is to show the theoretical suppositions and the essential tensions that exist in the thematization of Father António Vieira's Fourth Empire in the Defense before the Court of the Holy Office. Vieira's prophetic vision assumes the contrast of the time of inautenticity, related to the fali of Adam and exemplified in the succession of the fourth empires (Cfr. Daniel, 2, 27-45), with the absolute novelty implied in Christ's Comming; this awaited Event promises to produce a terrestrial pacification in the historical process and a universal community lives according to the Spirit. The thesis, which only a letter study will demonstratem is that the perspective of the Fifth Empire is still dependent on the dominant categories of time in the fourth empiresm were eschatological experience displays itself in the finalities and relations of civilization and political power. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.3 (2002) 299-303 [Access article in PDF] Bioethics Inside the Beltway What Should IRBs Consider When Applying the Privacy Rule to Research? Julie Waltz Gerlach In 1996, Congress mandated the establishment of standards for the privacy of individually identifiable health information through the Health Insurance and Portability and Accountability Act of 1996 (HIPAA). Until the establishment of HIPAA, personal health information could be distributed (...) without notice or consent for reasons that had nothing to do with a patient's medical treatment or health care reimbursement. Patient information held by a health plan could be passed on to a lender who then might deny the patient's application for a home mortgage or a credit card or to an employer who might use it for personnel decisions. Congress failed to meet its 21 August 1996 deadline established by HIPAA to pass privacy legislation; the Act passed the responsibility to Department of Health and Human Services (DHHS). On 28 December 2000, the Secretary of Health and Human Services released final privacy regulations relating to the protection of patients' individually identifiable health information. The "Standards for Privacy of Individually Identifiable Health Information" (Privacy Rule/current) took effect 14 April 2001. As required by HIPAA, the Privacy Rule established conditions for the collection, use, and disclosure of protected health information by covered entities for research purposes. Covered entities, defined as health plans, health care clearinghouses, and health care providers that engage electronically in a wide range of financial and administrative transactions related to payment and reimbursement, must comply by 14 April 2003 (DHHS 2000, p. 82462). To ensure that the provisions of the final rule provide strong privacy protection without hindering access to health care, the Department of Health and Human Services (DHHS 2002, p. 14776) has proposed modifications to the Privacy Rule.The final Privacy Rule (DHHS 2001) grants substantial rights to individuals/research participants to be informed of how their protected health information is maintained and how that information may be used or disclosed. It also defines individual's/research participants' rights with regard to gaining access to information about themselves, when such information is held by covered entities. [End Page 299]The Privacy Rule requires researchers either to receive authorization from individuals/research participants to collect, use, and disclose protected health information, or to obtain a waiver of authorization that is approved by an institutional review board (IRB) or Privacy Board, or to use de-identified data. Section 164.508 of the Privacy Rule, entitled "Use and Disclosures for Which an Authorization Is Required," describes how IRBs will be directly affected. The rule focuses not just on research but on the overall privacy of all identifiable health information. Institutions have the option of adding these required duties to IRBs or establishing "privacy boards." Privacy boards, as defined by the Privacy Rule, are to be composed of members with varying backgrounds and professional competency to review the effect of the research protocol on the individual/research participant's privacy rights. The board must include at least one member who is not affiliated with the covered entity, or any entity conducting or sponsoring the research, and not related to any person who is affiliated with such entities. Board members cannot participate in the review of any research project in which the member has a conflict of interest.The basic concepts and tenets of privacy and confidentiality are well known to IRBs in the United States, which operate under the Common Rule (45 CFR 46) and/or the Food and Drug Administration's (FDA) human subject protection regulations. Both sets of regulations require IRBs to ensure that risks (including privacy risks) are minimized. Under these regulations, IRBs must consider the confidentiality of research data and whether researchers should have access to confidential medical information. IRBs also must review the consent form as a process of communication that will inform research subjects about the research study.One noteworthy aspect of the Privacy Rule is its application to all research regardless of funding source. Currently, research funded by... (shrink)

This paper illustrates the importance of monitoring health facility-level information to monitor changes in maternal mortality risks. The annual facility-level maternal mortality ratios (MMRs), complications to live births ratios and case fatality ratios (CFRs) were computed from data recorded during 2007 and 2009 in 31 upgraded public sector health facilities across Pakistan. The facility-level MMR declined by about 18%; both the number of Caesarean sections and the episodes of complications as a percentage of live births increased; and CFR based on (...) Caesarean sections and episodes of complications declined by 29% and 37%, respectively. The observed increases in the proportion of women with complications among those who come to these facilities point to a reduction in the delay in reaching facilities (first and second delays; Thaddeus & Maine, 1994); the decrease in CFRs points to improvements in treating obstetric complications and a reduction in the delay in receiving treatment once at facilities (the third delay). These findings point to a decline in maternal mortality risks among communities served by these facilities. A system of woman-level data collection instituted at health facilities with comprehensive emergency obstetric care is essential to monitor changes in the effects of any reduction in the three delays and any improvement in quality of care or the effectiveness of treating pregnancy-related complications among women reaching these facilities. Such a system of information gathering at these health facilities would also help policymakers and programme mangers to measure and improve the effectiveness of safe-motherhood initiatives and to monitor progress being made toward achieving the fifth Millennium Development Goal. (shrink)

Let’s consider the following paradox (Fodor [1989], Jackson and Petit [1988] [1992], Drestke [1988], Block [1991], Lepore and Loewer [1987], Lewis [1986], Segal and Sober [1991]): i) The intentional content of a thought (or any other intentional state) is causally relevant to its behavioural (and other) effects. ii) Intentional content is nothing but the meaning of internal representations. But, iii) Internal processors are only sensitive to the syntactic structures of internal representations, not their meanings. Therefore it seems that if we (...) want to defend the idea -absolutely plausible from an intuitive point of view- that mental / intentional states are causally responsible for behavioural outputs and we want to do it on the physicalist basis of any scientific methodology, we will have to give up the conviction that such intentional states qua intentional, i. e. as having a particular meaning, are the ones causally responsible for our behaviour. The path that takes us to mental epiphenomenalism is clear: 1) the causal powers of any event are completely determined by its physical properties; 2) although intentional properties supervene on physical properties, they can’t be identified with them; 3) intentional properties, as intentional, are not causally responsible for behaviour, because they don’t take part in the causal powers of the states to which they belong, i. e., intentional properties are epiphenomenal. Let’s consider now a different yet parallel position to the one just described. There is an important debate in cognitive science about whether the class of mechanisms to which we belong and which the computational modelling project of cognitive processes refers to is best represented by classical or connectionist approaches (McClelland, Rumelhart et. al [1986], Smolensky [1987] [1988], Fodor and Pylyshyn [1988], Pinker and Prince [1988], Clark [1989], Ramsey, Stich and Rumelhart [1991], Clark and Karmiloff-Smith [forthcoming]).In classical, serial processing models, information is encoded in terms of rules that have a linguistic character. In connectionist or parallel distributed processing (PDP) models, the causal relationships among the units that constitute the system determine how the information is processes by the network, although these units don’t have a direct semantic interpretation. But, for both, classical and connectionist models, all the computations can be explained without any reference to the content of the processed information, i.e., in both cases the properties that seem to be responsible for the system’s behaviour are ultimately physical properties nor intentional ones. This situation mirrors thus, within cognitive science, the philosophical discussion concerning the causal efficacy of semantic properties. Now, if in this debate we opt for the classical paradigm, there is a way of finding a solution to the computational version of the epiphenomenalism paradox. This solution is based mainly on the notion of supervenience or, more precisely, on the notion of mereological supervenience (Kim [1984] [1988])1 . The idea of intentional properties supervening on physical properties makes sense within the classical context because there exists an easily isolable supervenience base comprising the syntactic items in the socalled language of thought. But, what happens if we opt for the connectionist paradigm?. The situation here doesn’t seem to favour the use of the same supervenience strategy. For it has been argued (Ramsey, Stich and Garon [1991]) that beliefs, desires, and other mental states are nor, in the connectionist paradigm, individuable as weight or activation states of the system. This is because information is encoded by the network in distributed and superpositional representations, i.e., there are no straightforwardly isolable vehicles at the physical level that can be identified as the articulated supervenience base on which the semantic properties supervene2 . If this is true, then the connectionist not only loses the battle against epiphenomenalism but more drastically, seems to offer a standing invitation to eliminativism, since talk of beliefs and desires, etc. now seems to be floating free of any acceptable scientific underpinning, i.e., she has lost the necessary theoretical apparatus for supporting the intuitive idea that propositional attitudes -beliefs, desires and any mental states with semantic content- are physically realized. This second line of argumentation doesn’t take us to a paradox but to a dilemma: either we accept eliminativism, if connectionist hypothesis are correct or we defend the causal efficacy of mental states with semantic content by showing that, after all, connectionist networks are not plausible cognitive models (Davies [1991]). From my point of view, however, both lines of argumentation need to be revised. The aim of this paper is to find an account of the causal efficacy of content that avoids the aforementioned epiphenomenalist objections and that doesn’t require the discovery of inner symbols in the computational modelling of such contentful mental states. In short, the aim is to find a meeting point where a philosophical story about content and cause and the connectionist computational model can be brought together (Cfr. Clark [1989]). (shrink)

With the aid of the Cahiers de laboratoire, the Correspondance and, of course, the Oeuvre de Pasteur, this work reconstructs the extraordinary scientific undertakings of the great French scientist in his study of silkworm diseases. The focus of this study consists in the attempt to explain the initial perplexing behaviour of Pasteur, even in the presence of correct interpretations regarding the causes of these diseases (cfr. the results obtained by Béchamp); for a good three years he insisted on maintaining that (...) the aetiology of silkworm diseases could not be attributed to pathogenetic germs from outside. And this was in spite of the fact that previously (through fermentation and spontaneous generation) he had been able to demonstrate the importance of micro-organisms in biological processes. Finally it is intended to highlight the extraordinary methodological depth of that initial 'error', which was capable of paving the way for the future conquests of Pasteur in the field of aetiology and the prevention of infectious diseases. (shrink)

The investigation aims at analysing the two general notions of mankind and people in two lexicographic reference works on trade and commerce published in London in the 1750s: Rolt’s A New Dictionary of Trade and Commerce (1756) and Postlethwayt’s The Universal Dictionary of Trade and Commerce (1757). An overview of the same notions in universal dictionaries of arts and sciences (cfr. References, Primary Sources), issued before and after ND and UD, will also be of help to define a more general (...) background. Starting from the key words mankind and people, their frequency and relevance in the two dictionaries, the investigation is widened to include related terms (e.g. multiword expressions and language patterns in which mankind and people occur) and semantic categories (e.g. specific contexts of use: social condition, social values, demography, identity and citizenship, etc.). The many entries, cross-references, and the various lexical clusters reveal a complex lexicographic and lexicological network. This network, beyond providing information and contents on specific topics, ultimately emphasises the hierarchical organising principle at the basis of Late Modern British society: in particular, people unfolds into a myriad of ‘entities’. Dictionaries of trade and commerce are plentiful sources of knowledge, from general concepts and notions to more specific contents, but also powerful ideological tools. (shrink)

In this work we extend results from [4], [3] and [2] about propositional calculi with graded modalities to the predicative level. Our semantic is based on Kripke models with a single domain of interpretation for all the worlds. Therefore the axiomatic system will need a suitable generalization of the Barcan formula. We haven't considered semantics with world-relative domains because they don't present any new difficulties with respect to classical case. Our language will have, as in [1], constant and function symbols, (...) but they will have a rigid interpretation. In this instance the terms will be considered rigid designators, that is, their interpretations will be the same in all possible worlds (cfr. [5]). Nevertheless we will not consider languages with identity: in this way we avoid the problems of identity in modal contexts. On the other hand, we think that in that context would arise essentially the same problems which occur in classical predicative modal logic. Finally we will consider only denumerable languages because the extension to non denumerable ones isn't conceptually problematic. (shrink)

The Association Henri Capitant des Amis de la Culture Juridique Française and the Société de législation comparée joined the academic network on European Contract Law in 2005 to work on the elaboration of a "common terminology" and on "guiding principles" as well as to propose a revised version of the Principles of European Contract Law. The results of this work were sent to the European Commission and have already been published in French. The English translation is now being published by (...) sellier.elp. This work could contribute to the wider European project. The part on the guiding principles could be a component of the CFR, in the form of "black letter" model rules or recitals. The part on terminology is, in itself, useful for the elaboration of the final various linguistic versions of the CFR. It finds its place within the materials which will accompany the model rules. Last but by no means least, the revised version of the PECL should be considered by the European institutions as an alternative set of model rules on contract law. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:To Be or Not to Be:Waiving Informed Consent in Emergency ResearchCharles R. McCarthy (bio)The requirements for prior, legally authorized informed consent constitute a necessary condition for recruiting subjects into biomedical or behavioral research. However, informed consent requirements pose a serious problem for most research conducted in emergency care settings. For this reason, the Food and Drug Administration's (FDA) regulations governing investigational devices and the Department of Health and Human (...) Services' (HHS) regulations for the protection of human subjects allow narrow exceptions to the general requirements of informed consent. In a joint effort to clarify the applicability of the current FDA regulations and to better understand the intent of the HHS regulations as they apply to emergency research, the FDA and the National Institutes of Health (NIH) cosponsored a public forum on the ethical conduct of emergency research in January 1995.Although the forum was not designed as a consensus conference and participants vigorously disagreed on some of the details, a broad consensus emerged on several major points: (1) both HHS and FDA regulations should, in the immediate future, be interpreted to allow for randomized clinical trials in emergency situations so long as the subjects are carefully protected; and (2) consideration should be given to producing new, closely harmonized regulations from both agencies that will provide greater clarity concerning what kinds of emergency research may be allowed without obtaining prior informed consent.The FDA-NIH forum in January was occasioned primarily by controversy about the hypothermia research protocol described below, but it is obvious that many other kinds of emergency research also await the outcome of deliberations concerning waiver of informed consent in emergency situations. These include research into the care and treatment of: occlusive stroke; subarachnoid hemorrhage due to intracranial aneurysm; metabolic coma; status epilepticus; cardiac arrest; myocardial infarction; cardiac arrhythmia; hemorrhagic shock; pulmonary embolism; acute asthmatic attack; and poisoning. All of these conditions [End Page 155] are encountered in emergency settings where obtaining informed consent from the patient-subjects to participate in research is seldom possible, and obtaining consent from legally authorized representatives of the subjects is either not feasible, or, if obtained, is of doubtful validity.The Hypothermia Research Case and HHS RegulationsA $7.2 million grant for research on the use of hypothermia in the treatment of severe head trauma, the largest award ever made to the University of Texas Health Sciences Center at Houston, is in danger of expiring before the study is completed. The protocol, which involves the use of cooling blankets to induce hypothermia in patients suffering from severe head injuries, is designed to test the hypothesis that: "Early lowering of the body temperature of patients suffering from severe head trauma to approximately 91 degrees Fahrenheit will slow patients' metabolism and will/will not, as a consequence, reduce the rates of both morbidity and mortality in these patients." The protocol was approved by seven Institutional Review Boards (IRBs), each of which waived the requirement to obtain informed consent from research subjects in accordance with Sec. 46. 116(d) of the HHS Regulations for the Protection of Human Subjects.1However, NIH's Office for Protection from Research Risks (OPRR), which is responsible for assuring compliance with the HHS regulations, has taken a controversial regulatory position by requiring informed consent from a legally authorized representative of each subject to be entered in the hypothermia trial. Because the obtaining of surrogate consent has proved to be very difficult, OPRR's position has slowed the research to a point where it may have to be terminated.At issue in the controversy is a fundamental question of ethics and public policy. Is it ever permissible to involve incompetent subjects in research without either their consent, or the consent of their legally authorized representatives? Pertinent HHS regulations for the protection of human subjects seem to answer the question affirmatively by allowing local IRBs to waive some or all of the elements of informed consent under carefully limited circumstances (45 CFR 46 116(d)). Nevertheless, OPRR has signalled the research community that use of the informed consent waiver provision for the Houston hypothermia study is not permitted under the regulations. OPRR judged that the risks... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When OPRR Comes Calling:Enforcing Federal Research RegulationsCharles R. Mccarthy (bio)In an update following this article, Ruth Macklin responds to the revelation that the controversial Hall-Stillman embryo-splitting experiment at George Washington University was conducted—contrary to federal regulations—without prior institutional review board (IRB) review. This revelation altered Dr. Macklin's view of the ethical status of the research. Undoubtedly such revelations also raise general questions for administrators and researchers in many institutions, (...) including, for example: How do allegations of noncompliance with federal regulations arise? When should allegations of infractions of the regulations be reported? Who has an obligation to report? To whom should reports be made? What sort of inquiry should take place? Who should conduct the inquiry? If a determination is made that infractions have occurred, what sanctions are appropriate? And, what publicity is given to the allegations, before, during, and after an evaluation?Some of these questions can be answered in a straightforward manner, while the answers to others depend on the circumstances of the case. This article provides some general answers to these questions.1BackgroundThe Department of Health and Human Services (DHHS) is the largest supporter of biomedical and behavioral research in the world. Somewhere between 25 and 33 percent of its medical research budget is devoted to the support of research involving human subjects. In accordance with the Public Health Service Act, DHHS has issued Regulations for the Protection of Human Subjects (45 CFR 46). The DHHS Secretary has delegated responsibility for promulgating and administering the regulations to the Office for Protection from Research Risks (OPRR), which is located within the National Institutes of Health.When an institution receives an award from a DHHS agency to carry out research involving human subjects, it is required to negotiate, or to have on file, an "assurance of compliance" document that provides detailed information [End Page 51] specifying how the institution plans to comply with the regulations for the protection of human subjects. Most major research institutions in the country have on file a "multiple project assurance" (MPA) document, which extends DHHS regulations to all human subjects research conducted or sponsored by that institution, irrespective of the source of funding. The regulations and the assurance of compliance require any research project involving human subjects to be reviewed and approved by an institutional review board (IRB) prior to initiation of the research. In addition, the project must be re-reviewed by the IRB at appropriate intervals—in no case, less than once a year. Institutional compliance with these and other requirements of the regulations has improved during the last 30 years and appears to be at a high level. However, from time to time, allegations of noncompliance arise, as they did in the George Washington University embryo-splitting experiment, and set in motion the review process described below.How do Allegations of Noncompliance Arise?Allegations or indications of noncompliance with federal regulations for the protection of human subjects may come from a variety of sources. Most commonly, the institution's IRB discovers that research involving humans is going forward without the required prior IRB review and approval, or that approved research is being conducted in a way that is contrary to the stipulations of the IRB. The Hall-Stillman case came to the attention of George Washington University's IRB because the research protocol was submitted to the IRB after the research had been carried out. In this case, there could be no doubt that an infraction had occurred.Information about possible noncompliance also frequently derives from a funding agency's Initial Review Group (IRG) (commonly called a Study Section) when it has reason to suspect noncompliance in a project it is reviewing for possible funding. An actual case that occurred some years ago involved a research application that proposed to perform brain biopsies on normal volunteers. The IRG that reviewed the application lost little time in questioning whether an IRB had approved the protocol. In this case, it was not enough for the IRG to recommend disapproval of the proposal for funding; it also was obliged to report the possible infraction to OPRR.Whistleblowers, including research subjects, nurses, students, members of the... (shrink)