The European Clinical Trials Directive was issued in 2001 and aimed to simplify and harmonise the regulatory framework of clinical trials throughout Europe, thus stimulating European research. However, significant complexity and inconsistency remains due to disparate interpretation by EU member states. Critical care research has been particularly impacted due to variable and often restrictive consenting procedures for incapacitated subjects, with some countries requiring a court-appointed representative, while others recognise consent from family members and occasionally professional representatives. Furthermore, the absence of (...) a waiver of consent threatened to put an end to emergency research in Europe and was met with varied responses. Approval procedures by ethics committees are equally inconsistent, particularly those relating to provision of a single opinion for multi-centre trials. Although evidence is somewhat mixed, this complexity as well as a general increase in administrative and financial burden following the Directive has been shown to cause a reduction in clinical trial activity in Europe, particularly academic trials. We aim to clarify some of these inconsistent procedures, particularly those relating to informed consent of incapacitated subjects, as well as discussing some general weaknesses and possible improvements of the Directive ahead of its planned revision in 2011. (shrink)

Objective: To develop an approach for seeking informed consent to examine tissues retained from a previous study of sudden infant death syndrome as part of a study on asthma, and to document responses and participation rate.Design: Pilot open-ended approach to 10 volunteer SIDS parents, followed by staged approach to seek consent from the target SIDS families for the asthma study.Participants: Parents of SIDS infants known to SIDS and Kids Victoria and parents of SIDS infants from the 1991–2 SIDS in Victoria (...) case–control study.Main outcomes: Qualitative responses of the piloted parents and study parents, and participation rates.Results: The pilot group responses were used to refine the written material to be provided. Of the 72 families for which contact details were available, 45 gave verbal consent for contact by the Victorian Institute of Forensic Medicine regarding the asthma study, three refused and 24 did not respond to two letters. Thirty-three completed consent forms, all positive for participation in the asthma study, giving a positive response rate of 73% .Conclusions: The use of postmortem tissue for research is acceptable to the next of kin when an approach is sensitive to their concerns and needs and is made by experienced counsellors from a familiar organisation. Despite the painful memories evoked by the approach of the research group, the acceptance rate among those who could be contacted was high. (shrink)

Anxiety and stress-related disorders constitute a large global health burden, but are still poorly understood. Prior work has demonstrated clear impacts of stress upon basic cognitive function: biasing attention toward unexpected and potentially threatening information and instantiating a negative affective bias. However, the impact that these changes have on higher-order, executive, decision-making processes is unclear. In this study, we examined the impact of a translational within-subjects stress induction (threat of unpredictable shock) on two well-established executive decision-making biases: the framing effect (...) ( N = 83), and temporal discounting ( N = 36). In both studies, we demonstrate (a) clear subjective effects of stress, and (b) clear executive decision-making biases but (c) no impact of stress on these decision-making biases. Indeed, Bayes factor analyses confirmed substantial preference for decision-making models that did not include stress. We posit that while stress may induce subjective mood change and alter low-level perceptual and action processes ( Robinson et al., 2013c ), some higher-level executive processes remain unperturbed by these impacts. As such, although stress can induce a transient affective biases and altered mood, these need not result in poor financial decision-making. (shrink)

The emphasis in this collection is clearly on logic, and this is one reason why it lacks the overall diversity and richness of the 1960 Stanford volume. However, the eight sections do contain much interesting material; in the mathematical logic section Kochen and Specker continue their study of logics appropriate for quantum theory, Vaught presents several new results about the Löwenheim-Skolem theorem, and Büchi studies second-order ordinal theory from the viewpoint of automata theory; the section on foundations of mathematical theories (...) contains papers on higher-order logic by Kaplan and Montague, model theory and ultra-products by Keisler, definability in set theory by Lévy. The topic of the justification of formal theories was the essential topic of the philosophy of logic section: an especially interesting paper is that of A. Robinson in which the present state of Hilbertean Formalism is analyzed, and in which the notion of potential truth is formalized. The section on the philosophy of science contains a single paper, by Hesse, on metaphor and explanation; Braithwaite, Hintikka, Jeffrey, and Kyburg contribute to a lively section on probability and induction; the section on methodology in physical science takes as topics the theory of relativity, causality, and irreversibility. The last two sections, on the philosophy of the life sciences, and on history of logic and philosophy of science, contain, respectively, papers by Davidson and Suppes on meaning and concept formation, and essays by Church and Geach on existential import historically considered and intentionality among the medievals. The collection would have been better if more of the contributed papers had been included.—P. J. M. (shrink)

Abraham Robinson has twice been the initiator of trends in the foundations of mathematics which have later become recognized as profound and important, although they were generally ignored at first: metamathematical problems of algebra and non-standard analysis. This book considers the second topic; before we begin analysis—especially a treatment of the classical theorems of calculus—we need basic results from logic, model theory in particular. Robinson then sketches non-standard arithmetic and proceeds to develop the usual properties and relations of (...) differentiability and integrability of functions, convergence; he then examines general topology in this new context and fortified with these results develops "modern" functional analysis in some detail: measure theory and functions of a real variable, functions of a complex variable, normed and linear spaces, topological groups and some harmonic analysis. The last two chapters cover selected topics in analysis drawn principally from applied mathematics and the history of the calculus with special reference to infinitesimals. Robinson views the development of non-standard mathematics as the renaissance of ideas about infinitesimals as serious topics of mathematical study. Robinson primarily has confined himself to analysis and not attempted to cover non-standard algebraic systems; several important results of Alling concerning non-standard arithmetic and rings of continuous functions appeared too late to be included. Of course, the real test of non-standard analysis will come in allowing us to prove new theorems about standard analysis, but although Robinson does not attempt to do this here—although he has obtained results in this direction—other mathematicians have already begun to do so: the future of this new branch of mathematics already looks secure.—P. J. M. (shrink)

Although this excellent introductory and intermediate level text is intended for students of mathematics, it could serve well in any course for philosophers on that level. The first two chapters present the propositional and predicate calculi, along with an informal discussion of some of the set-theoretic concepts needed to study logic. The third chapter discusses what exactly an axiomatic system is, and examples of various mathematical systems cast in axiomatic form are provided; the discussion here, as elsewhere in the book, (...) is generally self-contained and presupposes only an ability to deal with abstract ideas. The study of the propositional calculus is resumed in chapter four, but its formulation is now more rigorous and thoroughly axiomatic; in a similar manner the predicate calculus is treated in the next chapter, and the usual metatheorems are proved about each, but the specific techniques differ from the usual. The last chapter concentrates on the completeness proof of quantification theory, relating it to some of the axiomatic algebraic systems considered earlier. An appendix sketches some sophisticated results of Vaught and Robinson on model theory and completeness. In sum, this is one of the very best of a plethora of logic texts on the market, and it should serve well for years to come.—P. J. M. (shrink)

Reflecting Alan Robinson's fundamental contribution to computational logic, this book brings together seminal papers in inference, equality theories, and logic programming. It is an exceptional collection that ranges from surveys of major areas to new results in more specialized topics. Alan Robinson is currently the University Professor at Syracuse University. Jean-Louis Lassez is a Research Scientist at the IBM Thomas J. Watson Research Center. Gordon Plotkin is Professor of Computer Science at the University of Edinburgh. Contents: Inference. Subsumption, (...) A Sometimes Undervalued Procedure, Larry Wos, Ross Overbeek, and Ewing Lusk. The Markgraf Karl Refutation Procedure, Hans Jurgen Ohlbach and Jorg H. Siekmann. Modal Logic Should Say More than it Does, Melvin Fitting. Interactive Proof Presentation, W. W. Bledsoe. Intelligent Backtracking Revisited, Maurice Bruynooghe. A Science of Reasoning, Alan Bundy. Inductive Inference of Theories from Facts, Ehud Y. Shapiro. Equality. Solving Equations in Abstract Algebras: A Rule-based Survey of Unification, Jean-Pierre Jouannaud and Claude Kirchner. Disunification: A Survey, Hubert Comon. A Case Study of the Completion Procedure: Proving Ring Commutativity Problems, Deepak Kapur and Hantao Zhang. Computations in Regular Rewriting Systems I and II, Girard Huet and JeanJacques Levy. Unification and ML Type Reconstruction, Paris Kanellakis, Harry Mairson, and John Mitchell. Automatic Dimensional Analysis, Mitchell Wand. Logic Programming. Logic Programming Schemes and Their Implementations, Keith Clark. A Near-Horn Prolog for Compilation, Donald Loveland and David Reed. Unfold/Fold Transformations of Logic Programs, P. A. Gardner and J. C. Shepherdson. An Algebraic Representation of Logic Program Computations, Andrea Corradini and Ugo Montanari. Theory of Disjunctive Logic Programs, Jack Minker, Arcot Rajasekar, and Jorge Lobo. Bottom-Up Evaluation of Logic Programs, Jeffrey Naughton and Raghu Ramakrishnan. Absys, the First Logic Programming Language: A View of the Inevitability of Logic Programming, E. W. Elcock. (shrink)

This book consists of a selection of papers which throw new light on old problems in one of Plato s most difficult dialogues. The first set of papers deals with definitions of sophistry from different perspectives. In the central section E. Hulsz, D. O'Brien, B. Bossi, P. Mesquita and N. Cordero consider the problem of being and relative non-being with regard to Heraclitus and the legacy of Parmenides. The final section with papers by F. Fronterotta, J. de Garay, D. Ambuel (...) and L. Palumbo is devoted to ontology, predication and truth.". (shrink)

In this paper we give a positive answer to Julia Robinson's question whether the definability of + and · from S and ∣ that she proved in the case of positive integers is extendible to arbitrary integers (cf. [JR, p. 102]).

Lanczos, C. Einstein's path from special to general relativity.--Balazs, N. L. The acceptability of physical theories: Poincaré versus Einstein.--Ellis, G. F. R. Global and non-global problems in cosmology, by G. F. R. Ellis and D. W. Sciama.--Ehlers, J. The geometry of free fall and light propagation, by J. Ehlers, F. A. E. Pirani and A. Schild.--Trautman, A. Invariance of Lagrangian systems.--Penrose, R. The geometry of impulsive gravitational waves.--Exact solutions of the Einstein-Maxwell equations for an accelerated charge.--Taub, A. H. Plane-symmetric similarity (...) solutions for self-gravitating fluids.--Robinson, I. Equations of motion in the linear approximation, by I. Robinson and J. R. Robinson.--Florides, P. W. Rotating bodies in general relativity.--Chandrasekhar, S. A limiting case of relativistic equilibrium.--Israel, W. The relativistic Boltzmann equation.--Thompson, W. B. The self-consistent test-particle approach to relativistic kinetic theory. (shrink)

Competitive negotiators frequently use tactics which others view as "unethical", in that these tactics either violate standards of truth telling or violate the perceived rules of negotiation. This paper sought to determine how business students viewed a number of marginally ethical negotiating tactics, and to determine the underlying factor structure of these tactics. The factor analysis of these tactics revealed five clear factors which were highly similar across the two samples, and which parallel (to a moderate degree) categories of tactics (...) proposed by earlier theory. Data from one sample also permitted comparisons of the appropriateness of certain tactics across gender, nationality, ethnic origin and perception of one's negotiating style. (shrink)

We examine the problem of deducing the geodesic motion of test particles from Einstein's vacuum field equations and its extension to include gravitational radiation reaction. In the latter case we obtain an equation of motion for a particle which incorporates radiation reaction of the electrodynamical type, but due to shearing radiation, together with a mass-loss formula of the Bondi-Sachs type.

The assumption of materialism Howard Robinson believes is false.

This paper traces the origins of the concept of personalisation in public sector services, and applies it to school education. The original conceptualisation stressed the need for 'deep' rather than shallow, personalisation, if radical transformation of services were to be achieved. It is argued that as the concept has been disseminated and implemented through policy documents, notably the 2005 White Paper, it has lost its original emphasis on deep personalisation. The focus in this article is particularly upon gifted and talented (...) students whose education provides the best case example of how the theory of personalisation might work in practice. Two examples of the lessons in a sixth form college are used to illustrate the character ofpersonalised pedagogy in practice. The implications for theory and practice are discussed. (shrink)

This paper proposes a generalization of the Kripke semantics of intuitionistic logic IL appropriate for intuitionistic Łukasiewicz logic IŁL — a logic in the intersection between IL and (classical) Łukasiewicz logic. This generalised Kripke semantics is based on the poset sum construction, used in Bova and Montagna (Theoret Comput Sci 410(12):1143–1158, 2009) to show the decidability (and PSPACE completeness) of the quasiequational theory of commutative, integral and bounded GBL algebras. The main idea is that w \Vdash \sigma—which for IL is (...) a relation between worlds w and formulas \sigma, and can be seen as a function taking values in the booleans w \Vdash \sigma \in {B}—becomes a function taking values in the unit interval w \Vdash \sigma \in [0,1]. An appropriate monotonicity restriction (which we call sloping functions) needs to be put on such functions in order to ensure soundness and completeness of the semantics. (shrink)

ABSTRACTNegative feedback has paradoxical features to it. This form of feedback can have informational value under some circumstances, but it can also threaten the ego, potentially upsetting behaviour as a result. To investigate possible consequences of the latter type, two experiments presented positive or negative feedback within a sequence-prediction task that could not be solved. Following feedback, participants had to control their behaviours as effectively as possible in a motor control task. Relative to positive feedback, negative feedback undermined control in (...) a manner suggesting emotional upset. These reactions lasted for at least three seconds and were especially pronounced among people reporting that they typically lose control in the context of their negative emotions. The findings document a novel form of behavioural dysregulation that occurs in response to negative feedback while also highlighting the utility of motor control perspectives on self... (shrink)

When skeletal dysplasias are suspected in the prenatal period, investigation, counseling, and management become especially challenging. By better understanding the complex forces at play and parental values, prenatal health care providers may improve the ways in which they counsel patients to improve the decision-making process under conditions of significant uncertainty, including in cases of prenatally suspected skeletal dysplasia.

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)