Throughout the biological and biomedical sciences there is a growing need for, prescriptive ‘minimum information’ (MI) checklists specifying the key information to include when reporting experimental results are beginning to find favor with experimentalists, analysts, publishers and funders alike. Such checklists aim to ensure that methods, data, analyses and results are described to a level sufficient to support the unambiguous interpretation, sophisticated search, reanalysis and experimental corroboration and reuse of data sets, facilitating the extraction of (...) maximum value from data sets them. However, such ‘minimum information’ MI checklists are usually developed independently by groups working within representatives of particular biologically- or technologically-delineated domains. Consequently, an overview of the full range of checklists can be difficult to establish without intensive searching, and even tracking thetheir individual evolution of single checklists may be a non-trivial exercise. Checklists are also inevitably partially redundant when measured one against another, and where they overlap is far from straightforward. Furthermore, conflicts in scope and arbitrary decisions on wording and sub-structuring make integration difficult. This presents inhibit their use in combination. Overall, these issues present significant difficulties for the users of checklists, especially those in areas such as systems biology, who routinely combine information from multiple biological domains and technology platforms. To address all of the above, we present MIBBI (Minimum Information for Biological and Biomedical Investigations); a web-based communal resource for such checklists, designed to act as a ‘one-stop shop’ for those exploring the range of extant checklist projects, and to foster collaborative, integrative development and ultimately promote gradual integration of checklists. (shrink)

We formulate an elementary statistical game which captures the essence of some fundamental quantum experiments such as photon polarization and spin measurement. We explore and compare the significance of the principle of maximum Shannon entropy and the principle of minimum Fisher information in solving such a game. The solution based on the principle of minimum Fisher information coincides with the solution based on an invariance principle, and provides an informational explanation of Malus' law for photon polarization. (...) There is no solution based on the principle of maximum Shannon entropy. The result demonstrates the merits of Fisher information, and the demerits of Shannon entropy, in treating some fundamental quantum problems. It also provides a quantitative example in support of a general philosophy: Nature intends to hide Fisher information, while obeying some simple rules. (shrink)

Since the first edition of this work, _Checklist of Writings about John Dewey, 1887–1973, _appeared in 1974, more_ _than three hundred new works—pub­lished and unpublished—about John Dewey have been written. In addition, many items from the years covered by the first edition have been discovered. All these writings are listed here in the “Supplement to the First Edition,” which, like the earlier edition, is thor­oughly indexed by author and by title. As the first exhaustive compilation of information about such (...) works, the _Checklist, _now comprising more than twenty-five hundred entries, will be the indispensable starting point for future scholarly study of any facet of Dewey’s career. (shrink)

An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject’s right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which results to (...) return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws. (shrink)

BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and (...) nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews : Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs followed by accessibility, comprehension engagement, autonomy, confidentiality, language, and parental consent. Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/rec members during a review process on electronic informed consent and useful to the future preparation of a checklist. (shrink)

Cognitive archaeologists attempt to infer the cognitive and cultural features of past hominins and their societies from the material record. This task faces the problem of _minimum necessary competence_: as the most sophisticated thinking of ancient hominins may have been in domains that leave no archaeological signature, it is safest to assume that tool production and use reflects only the lower boundary of cognitive capacities. Cognitive archaeology involves selecting a model from the cognitive sciences and then assessing some aspect of (...) the material record through that lens. We give examples to show that background theoretical commitments in cognitive science that inform those models lead to different minimum necessary competence results. This raises an important question: what principles should guide us in selecting a model from the cognitive sciences? We outline two complementary responses to this question. The first involves using _independent_ lines of evidence to converge on a particular capacity. This can then influence model choice. The second is a broader suggestion. Theoretical diversity is a good thing in science, but is only beneficial over a limited amount of time. According to recent modelling work, one way of limiting diversity is to introduce extreme priors. We argue that having a broad spectrum of views in the philosophy of cognitive science may actually help cognitive archaeologists address the problem of minimum necessary competence. (shrink)

John Rawls argues that it is possible to describe a suitably defined initial situation from which to form reliable judgements about justice. In this initial situation, rational persons are deprived of information that is . It is rational, Rawls argues, for persons choosing principles of justice from this standpoint to be guided by the maximin rule. Critics, however, argue that (i) the maximin rule is not the appropriate decision rule for Rawls's choice position; (ii) the maximin argument relies upon (...) an imprecise account of the satisfactory minimum to be secured under the maximin rule; or that (iii) Rawls relies upon unrealistic assumptions about diminishing marginal value. These critics, I will suggest, argue from a number of assumptions that are confused or false. The satisfactory minimum that choosers in the original position seek to achieve is not a minimum level of primary goods, nor is the satisfactory minimum sought under the maximin rule supplied by the difference principle. I will argue that the maximin argument is more robust than has generally been recognized and that this argument performs a number of important functions in clarifying the nature and implications of Rawls's argument for justice as fairness. (shrink)

Clustering plays an important role in data mining, pattern recognition, and machine learning. Then, single-valued neutrosophic sets are a useful means to describe and handle indeterminate and inconsistent information, which fuzzy sets and intuitionistic fuzzy sets cannot describe and deal with. To cluster the data represented by single-value neutrosophic information, the article proposes a single-valued neutrosophic minimum spanning tree clustering algorithm. Firstly, we defined a generalized distance measure between SVNSs. Then, we present an SVNMST clustering algorithm for (...) clustering single-value neutrosophic data based on the generalized distance measure of SVNSs. Finally, two illustrative examples are given to demonstrate the application and effectiveness of the developed approach. (shrink)

The goal was create and validate a booklet about sustainable environmental practices in the production line of commercial restaurants. Theoretical, empirical and analytical references were used. The theoretical procedure was based on the literature. Contents considered relevant to sustainable environmental practices were identified. In the empirical research, an on line checklist was applied to restaurant owners, which resulted in the content and illustration of the booklet. In the analytical research, the booklet was submitted for the final evaluation of a panel (...) of nutritionists. A subject was considered relevant when it obtained a minimum agreement of 80% of the judges. The booklet presented a result of 96% to 100% agreement in eleven topics and their respective items and illustrations. The final booklet was composed of six topics. Because it’s comprehensive, it’s an information tool that makes possible to assist managers and other workers in the food segment, allowing adaptations to the different food Units. (shrink)

Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four‐step checklist aiming to (...) facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU. (shrink)

Among the letters, memorabilia, manu­scripts, films, and tapes in the eighty-four warehouse boxes of the John Dewey Papers that came to Southern Illinois University at Carbondale in 1972 were a number of boxes that contained the books and journals from Dewey’s personal and professional library. The circumstances surrounding the growth of that library were these: after John Dewey died in 1952, the second Mrs. Dewey, Roberta Grant Dewey, continued to live in the same apartment with the couple’s two adopted children. (...) Upon her death in 1970, the household was dismantled and all the books there were packed away. The library therefore comprises the many volumes col­lected through the years by the two families of John Dewey: the first, John and Alice Chipman Dewey and their children—Lucy, Evelyn, Jane, Fred, Gordon, and Sabino; the second, John and Roberta Dewey and their adopted children—Adrienne and John, Jr. In addition to the books signed or anno­tated by Dewey—well over a hundred have marginalia—or inscribed to him, a number of books with the names of other family members have been included in this checklist because evidence exists that Dewey also used them; others have been included because they were available for possible use. Only school textbooks have been excluded. The checklist is divided into two basic sections: works in English and works in other languages; entries in both sections are anno­tated to indicate Dewey’s notes, marginalia, inscriptions, and similar information. Beyond its use as a research tool, both in editing the Collected Works and in verifying Dewey’s references, this checklist of Dewey’s library provides interesting, often important, insights into his life and work. (shrink)

According to the standard view of informed consent, a prospective subject's consent to participate in a research study is invalid if the individual fails to comprehend the information about the study standardly disclosed to him. I argue that this involves three mistakes. First, the standard view confuses an ethical aspiration with a minimum ethical standard. Second, it assigns the entire responsibility for producing comprehension in study participants to the investigators. Most importantly, the standard view requires the termination of (...) many otherwise perfectly ethical research studies. This last conclusion follows from appreciating a pervasive phenomenon that is known as the "therapeutic misconception." I argue that a prospective subject's consent to participate in research can be perfectly valid even if he or she does not comprehend the information that investigators are required to disclose. Furthermore, I explain that this alternative view does not in the least compromise the vital goal of ensuring the protection of subjects in research. (shrink)

Encouraged by the financial incentives in the Health Information Technology for Economic and Clinical Health Act of 2009, electronic health record adoption is on the rise. According to a study by the Centers for Disease Control and Prevention published in 2014, 78% of office-based physicians had adopted some type of EHR system, up from 18% in 2001. Implementation of EHRs able to support the Department of Health and Human Services “meaningful use” requirements has also significantly increased since 2010. Such (...) a growth in EHR adoption with the capacity to achieve “meaningful use” standards suggests that the goal of nationwide, interoperable health records is moving closer to a reality.While movement toward a system-wide, interoperable EHR promises benefits of such an electronic information management tool, the risks related to patients’ privacy of their health information remains a concern. (shrink)

Encouraged by the financial incentives in the Health Information Technology for Economic and Clinical Health Act of 2009, electronic health record adoption is on the rise. According to a study by the Centers for Disease Control and Prevention published in 2014, 78% of office-based physicians had adopted some type of EHR system, up from 18% in 2001. Implementation of EHRs able to support the Department of Health and Human Services “meaningful use” requirements has also significantly increased since 2010. Such (...) a growth in EHR adoption with the capacity to achieve “meaningful use” standards suggests that the goal of nationwide, interoperable health records is moving closer to a reality.While movement toward a system-wide, interoperable EHR promises benefits of such an electronic information management tool, the risks related to patients’ privacy of their health information remains a concern. (shrink)

This book is an introduction to the current developments in model-theoretic semantics, which has become an essential part of the work in theoretical linguistics over the last decade. The author examines the model structure of Montague's theory and then presents elaborations on this basic model that have been of particular importance in the last few years: generalized quantifiers, the introduction of more structure in the domain of individuals, properties as primitive elements in the model, situations and similar 'smaller' worldlike entities. (...) Nothing is presupposed about knowledge of the mathematical and logical tools used in formal semantics, and Bach presents the informal with a minimum of formalism. (shrink)

Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient’s values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to (...) gauge the information needs of the individual patient. The aim of this paper is to describe ‘core information sets’ which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this ‘core information’. We propose that such information addresses the ‘reasonable patient’ standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice. (shrink)

BackgroundApproval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.MethodsWe obtained ethical approval from UK and Sri Lanka. A series of consensus (...) generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.ResultsTwenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form.The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.ConclusionThe number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent. (shrink)

This study assessed challenges faced by researchers with the informed consent process (ICP). In‐depth interviews were used to explore challenges encountered by Investigators, Research assistants, Institutional Review Board members and other stakeholders. An electronic questionnaire was also distributed, consisting of Likert‐scale responses to questions on adherence to the ICP, which were derived from the Helsinki Declaration and an informed consent checklist of the US Department of Health and Human Research (HSS). Responses were weighted numerically and scores calculated for each participant. (...) The median score of the level of adherence to the informed consent process was 93%. Most of the respondents (60%) cited the lack of time for the ICP to be a challenge, with 65% indicating a lengthy consent document to be the main challenge with the informed consent document. Challenges with language and communication were the dominant theme among informants. Despite the high adherence of Ghanaian researchers and research assistants to the ICP, challenges are still prevalent, requiring diligent and continuous efforts in research implementation. (shrink)

Background HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods A total of 1146 women at increased risk of HIV acquisition working as alcohol (...) and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews conducted immediately after their 4, 24 and 52 week follow-up visits. Results 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks. In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings. Trial registration Current Controlled Trials ISRCTN64716212. (shrink)

This paper suggests a way of formalizing the amount of information that can be conveyed to each player along every possible play of an extensive game. The information given to each player i when the play of the game reaches node x is expressed as a subset of the set of terminal nodes. Two definitions are put forward, one expressing the minimum amount of information and the other the maximum amount of information that can be (...) conveyed without violating the constraint represented by the information sets. Our definitions provide intuitive characterizations of such notions as perfect recall, perfect information and simultanetty. (shrink)

We show that the minimum Fisher information (MFI) approach to estimating the probability law p(x) on particle position x, over the class of all two-component laws p(x), yields the complex Schrödinger wave equation. Complexity, in particular, traces from an “efficiency scenario” (demanded by MFI) where the two components of p(x) are so separated that their informations add.

It was not until the nineteenth century that Western nations came to replace mutilation, corporal punishment, and banishment as the favored method of criminal punishment with the more humane concept of imprisonment. Even then, however, a convicted inmate was viewed as nothing more than a slave of the state, entitled only to the most basic of human rights and subject to the whim and peril of his jailor's desire. The shift to imprisonment gradually was accompanied by the additional humanitarian demand (...) that prisons avail their charges of some minimum standard of human decency and necessity, which, by the early part of the twentieth century, had come to encompass the provision of medical care. The courts later came to acknowledge this as a fundamental right grounded in the Eighth Amendment's proscription against cruel and unusual punishments.Although the scope of a prisoner's constitutional right to medical care has been the subject of much debate before the courts, the majority of cases have focused only on the circumstances under which the deprivation of care will amount to a violation of the rights guaranteed by the Eighth Amendment. (shrink)

It was not until the nineteenth century that Western nations came to replace mutilation, corporal punishment, and banishment as the favored method of criminal punishment with the more humane concept of imprisonment. Even then, however, a convicted inmate was viewed as nothing more than a slave of the state, entitled only to the most basic of human rights and subject to the whim and peril of his jailor's desire. The shift to imprisonment gradually was accompanied by the additional humanitarian demand (...) that prisons avail their charges of some minimum standard of human decency and necessity, which, by the early part of the twentieth century, had come to encompass the provision of medical care. The courts later came to acknowledge this as a fundamental right grounded in the Eighth Amendment's proscription against cruel and unusual punishments.Although the scope of a prisoner's constitutional right to medical care has been the subject of much debate before the courts, the majority of cases have focused only on the circumstances under which the deprivation of care will amount to a violation of the rights guaranteed by the Eighth Amendment. (shrink)

Violations of Bell's Inequality can only be reliably produced if some information about the apparatus setting on one wing is available on the other, requiring superluminal information transmission. In this paper I inquire into the minimum amount of information needed to generate quantum statistics for correlated photons. Reflection on informational constraints clarifies the significance of Fine's Prism models, and allows the construction of several models more powerful than Fine's. These models are more efficient than Fine claims (...) to be possible and work for the full range of possible analyzer settings. It also demonstrates that the division of theories into those that violate parameter independence and those that violate outcome independence sheds no light on the question of superluminal information transmission. (shrink)

Traditional statistical model evaluation typically relies on goodness-of-fit testing and quantifying model complexity by counting parameters. Both of these practices may result in overfitting and have thereby contributed to the generalizability crisis. The information-theoretic principle of minimum description length addresses both of these concerns by filtering noise from the observed data and consequently increasing generalizability to unseen data.

Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy. During the last several years, a number of genetic research proposals involving Omani nationals were submitted to the Department of Research and Studies, Ministry of Health, Oman.The objective of this paper is to report on the results of an internal quality assurance initiative to determine the extent of the information being provided in genetic research informed consent forms. In (...) order to achieve this, we developed checklists to assess the inclusion of basic elements of informed consent as well as elements related to the collection and future storage of biological samples. Three of the authors independently evaluated and reached consensus on seven informed consent forms that were available for review.Of the seven consent forms, four had less than half of the basic elements of informed consent. None contained any information regarding whether genetic information relevant to health would be disclosed, whether participants may share in commercial products, the extent of confidentiality protections, and the inclusion of additional consent forms for future storage and use of tissue samples. Information regarding genetic risks and withdrawal of samples were rarely mentioned (1/7), whereas limits on future use of samples were mentioned in 3 of 7 consent forms.Ultimately, consent forms are not likely to address key issues regarding genetic research that have been recommended by research ethics guidelines. We recommend enhanced educational efforts to increase awareness, on the part of researchers, of information that should be included in consent forms. (shrink)

This article presents a simple derivation of optimization models for reaction networks leading to a generalized form of the mass-action law, and compares the formal structure of Minimum Information Divergence, Quadratic Programming and Kirchhoff type network models. These optimization models are used in related articles to develop and illustrate the operation of ontology alignment algorithms and to discuss closely connected issues concerning the epistemological and statistical significance of sharp or precise hypotheses in empirical science.

This study investigates the joint influences of three factors on the discovery of new word‐like units in a continuous artificial speech stream: the statistical structure of the ongoing input, the initial word‐likeness of parts of the speech flow, and the contextual information provided by the earlier emergence of other word‐like units. Results of an experiment conducted with adult participants show that these sources of information have strong and interactive influences on word discovery. The authors then examine the ability (...) of different models of word segmentation to account for these results. PARSER (Perruchet & Vinter, 1998) is compared to the view that word segmentation relies on the exploitation of transitional probabilities between successive syllables, and with the models based on the Minimum Description Length principle, such as INCDROP. The authors submit arguments suggesting that PARSER has the advantage of accounting for the whole pattern of data without ad‐hoc modifications, while relying exclusively on general‐purpose learning principles. This study strengthens the growing notion that nonspecific cognitive processes, mainly based on associative learning and memory principles, are able to account for a larger part of early language acquisition than previously assumed. (shrink)

BackgroundInformed consent forms for clinical research are several and variable at international, national and local levels. According to the literature, they are often unclear and poorly understood by participants. Within the H2020 project CORBEL—Coordinated Research Infrastructures Building Enduring Life-science Services—clinical researchers, researchers in ethical, social, and legal issues, experts in planning and management of clinical studies, clinicians, researchers in citizen involvement and public engagement worked together to provide a minimum set of requirements for informed consent in clinical studies.MethodsThe template (...) was based on a literature review including systematic reviews and guidelines searched on PubMed, Embase, Cochrane Library, NICE, SIGN, GIN, and Clearinghouse databases, and on comparison of templates gathered through an extensive search on the websites of research institutes, national and international agencies, and international initiatives. We discussed the draft versions step-by-step and then we referred to it as the “matrix” to underline its modular character and indicate that it allows adaptation to the context in which it will be used. The matrix was revised by representatives of two international patient groups.ResultsThe matrix covers the process of ensuring that the appropriate information, context and setting are provided so that the participant can give truly informed consent. It addresses the key topics and proposes wording on how to clarify the meaning of placebo and of non-inferiority studies, the importance of individual participants’ data sharing, and the impossibility of knowing in advance how the data might be used in future studies. Finally, it presents general suggestions on wording, format, and length of the information sheet.ConclusionsThe matrix underlines the importance of improving the process of communication, its proper conditions (space, time, setting), and addresses the participants’ lack of knowledge on how clinical research is conducted. It can be easily applied to a specific setting and could be a useful tool to identify the appropriate informed consent format for any study. The matrix is mainly intended to support multicentre interventional randomized clinical studies, but several suggestions also apply to non-interventional research. (shrink)

Hype over novel quantum technologies has prompted discussion on the likely societal impacts of the sector. Calls to ensure the responsible development of quantum technologies are complicated by a lack of concrete case studies or real-world examples of irresponsible quantum. At this stage, responsible quantum faces a situation reminiscent of the Collingridge dilemma. In this dilemma, the moment in which discussion on societal risks and benefits can be most impactful is also the time when the least information is available. (...) The flipside of this challenge is an opportunity to build processes for examining the public good of quantum before the trajectory (and potential problems) of the sector become “locked in”. Recent work in this space has argued that quantum researchers and innovators must work with society to address uncertainties and concerns. By engaging quantum stakeholders and understanding their perspectives on responsibility, this paper seeks to support this proposition and enable further dialogue on responsible development and use of quantum technologies. (shrink)

OBJECTIVES: To study the opinions of nationals (Emiratis) and doctors practising in the United Arab Emirates (UAE) with regard to informing terminally ill patients. DESIGN: Structured questionnaires administered during January 1995. SETTING: The UAE, a federation of small, rich, developing Arabian Gulf states. PARTICIPANTS: Convenience samples of 100 Emiratis (minimum age 15 years) and of 50 doctors practising in government hospitals and clinics. RESULTS: Doctors emerged as consistently less in favour of informing than the Emiratis were, whether the patient (...) was described as almost certain to die during the next six months or as having a 50% chance of surviving, and even when it was specified that the patient was requesting information. In the latter situation, a third of doctors maintained that the patient should not be told. Increasing survival odds reduced the number of doctors selecting to inform; but it had no significant impact on Emiratis' choices. When Emiratis were asked whether they would personally want to be informed if they had only a short time to live, less than half responded in the way they had done to the in principle question. CONCLUSIONS: The doctors' responses are of concern because of the lack of reference to ethical principles or dilemmas, the disregard of patients' wishes and dependency on survival odds. The heterogeneity of Emiratis' responses calls into question the usefulness of invoking norms to explain inter-society differences. In the current study, people's in principle choices did not provide a useful guide to how they said they would personally wish to be treated. (shrink)

Aim: To assess, against a checklist of specific areas of required information and using standard published criteria, to what extent leaflets given before cataract surgery provided patients with enough information to give adequately informed consent.Method: Twelve ophthalmology departments in the West Midlands region were asked to submit the cataract information leaflets given to their patients at the preoperative assessment for analysis. Using criteria published by the General Medical Council, British Medical Association, and Medical Defence Union the leaflets (...) were assessed for their contribution to informed consent for patients considering cataract surgery. Leaflets were scored according to the information they provided on: diagnosis, prognosis, treatment options, costs to the patient, details about the procedure, its purpose, likely benefits, how to prepare for it, what to expect during and after the operation, and the common as well as serious complications that may occur. The readability of the information was also assessed.Results: All the units’ leaflets provided information on diagnosis, the lifestyle changes required postoperatively, and cost involved to the patient. Only five units had leaflets that mentioned the risks involved in cataract surgery. The other areas of information were covered by 50–75% of the leaflets. Fifty per cent of the leaflets included a diagram. The average SMOG readability score was high.Conclusion: Although present cataract information leaflets make some contribution to the process of informed consent, most do not address important areas outlined by the General Medical Council. Many of the areas of information that are required for informed consent could easily be covered, and should be borne in mind when designing patient information leaflets. Resources are available on the internet including toolkits, guides, and means of assessment for the production of patient information leaflets. (shrink)

Approximately three decades ago the question was first answered whether parasitoids are able to assess the number or origin of eggs in a host for a solitary parasitoid, Leptopilina heterotoma, by fitting theoretically derived distributions to empirical ones. We extend the set of different theoretically postulated distributions of eggs among hosts by combining searching modes and abilities in assessing host quality. In the models, parasitoids search either randomly (Poisson) (1) or by vibrotaxis (Negative Binomial) (2). Parasitoids are: (a) assumed to (...) treat all hosts equally, (b) able to distinguish them in unparasitised and parasitised hosts only, (c) able to distinguish them by the number of eggs they contained, or (d) able to recognise their own eggs. Mathematically tractable combinations of searching mode (1 and 2) and abilities (a,b,c,d) result in seven different models (M1a, M1b, M1c, M1d, M2a, M2b and M2c). These models have been simulated for a varying number of searching parasitoids and various mean numbers of eggs per host. Each resulting distribution is fitted to all theoretical models. The model with the minimum Akaike's information criterion (AIC) is chosen as the best fitting for each simulated distribution. We thus investigate the power of the AIC and for each distribution with a specified mean number of eggs per host we derive a frequency distribution for classification.Firstly, we discuss the simulations of models including random search (M1a, M1b, M1c and M1d). For M1a, M1c and M1d the simulated distributions are correctly classified in at least 70% of all cases. However, in a few cases model M1b is only properly classified for intermediate mean values of eggs per host. The models including vibrotaxis as searching behaviour (M2a, M2b and M2c) cannot be distinguished from those with random search if the mean number of eggs per host is low. Among the models incorporating vibrotaxis the three abilities are detected analogously as in models with random search. (shrink)

This chapter argues that as the online informational landscape continues to expand, shortcuts to source credibility evaluation, in particular the revered checklist approach, falls short of its intended goal, and this method cannot replace the acquisition of a more formally acquired and comprehensive information literacy skill set. By examining the current standard of checklist criteria, the authors identify problems with this approach. Such shortcuts are not necessarily effective for online source credibility assessment, and the authors contend that in cases (...) of high-stakes informational needs, they cannot adequately replace the expertise of information professionals, nor displace the need for proper and continuous information literacy education. (shrink)

Human judgements are affected by the words in which information is presented —or ‘framed’. According to the standard gloss, ‘framing effects’ reveal counter-normative reasoning, unduly affected by positive/negative language. One challenge to this view suggests that number expressions in alternative framing conditions are interpreted as denoting lower-bounded (minimum) quantities. However, it is unclear whether the resulting explanation is a rationalising one. I argue that a number expression should only be interpreted lower-boundedly if this is what it actually means. (...) I survey how number expressions might be assigned lower-bounded meanings, due to their conventional semantics or pragmatic enrichment in context. I argue that deciding between these possibilities requires foundational philosophical input. (shrink)

While their strength, electrical, optical, or magnetic properties are expected to contribute a trillion dollars in global commerce before 2015, nanomaterials also appear to pose threats to human health and safety. Nanotoxicology is the study of these threats. Do nanomaterial benefits exceed their risks? Should all nanomaterials be regulated? Currently nanotoxicologists cannot help answer these questions because too little is known about nanomaterials, because their properties differ from those of bulk materials having the same chemical composition, and because they differ (...) so widely in their applications. Instead, this paper answers a preliminary ethical question: What nanotech policies are likely to contribute to society’s ability to give or withhold free informed consent to the potential risks associated with production and use of nanomaterials? This paper argues that at least four current policies appear to jeopardize the risk-disclosure condition that is required for informed consent. These are the funding problem, the conflict-of-interest problem, the labeling problem, and the extrapolation problem. Apart from future decisions on how to ethically make, use, and regulate nanomaterials, this paper argues that, at a minimum, these four policies must be modified. Government must spend greater monies on nanotoxicology; ensure independent nanotoxicology research; label consumer products containing nanomaterials; and avoid assuming that nanotoxicological properties are based merely on mass and chemical composition. Otherwise free informed consent to these new technologies and materials may be jeopardized. (shrink)

BackgroundInternational guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.MethodsWe obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 (...) available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.ResultsOf 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.ConclusionOnly one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. (shrink)

The objective of the paper is to explore the issue that despite the absence of adequate formal and systematic ways for the poor and disadvantaged people to get access to health benefit like in a rich liberal society, there are active social customs, feelings and individual and collective responsibilities among the people that help the disadvantaged and poor people to have access to the minimum health care facility in both liberal and non-liberal poor countries. In order to explain the (...) importance and functional contribution of the social norms in this respect, some examples will be illustrated from Bangladesh which is a poor liberal country. There will be two sections of the paper. In the first section, it will be exhibited how the naturally and socially disadvantaged people in a liberal society get benefit following Rawls‟ theory of distributive justice. In the second section, it will be showed that in a poor country where there are less resources of the government to provide enough services to the poor and disadvantaged people, the communal feelings and the informal social institutions play a vital role that helps the disadvantaged and poor people to get access to the health benefit. The traditional social norms impose indirect sanction on its people to come forward to help the worse off people of the country. It is depicted that Rawlsian theory of distribution does not work properly in these countries, rather the communitarian feelings is more welcomed for the benefit of the overall welfare of the society and this will be shown in the conclusion of the paper. (shrink)

Adaptations during phylogenesis or ontogenesis can occur either by maintaning constant or by increasing the informational content of the organism. In the former case the increasing adaptations to external perturbation are achieved by increasing the rate of genome replication; the increased amount of DNA reflects an increase of total but not of law informational content. In the latter case the adaptations are achieved by either istructionist or evolutionary mechanism or a combination of both. Evolutionary adaptations occur during ontogenesis mainly in (...) the brain-mind, immunological and receptor systems and involve a repertoire of receptors that are., clonally distributed, genome-conditioned and amplified by somatic mutation. Specificity and intensity of responses are achieved a posteriori as a result of natural selection of the clones. The major adaptations during phylogenesis are accompanied by increased complexity. They have been attributed to shifts, short in time and space, against the entropic drive and thus occur notwithstanding the entropic drive and the second law of thermodynamics. The alternative view, is that the generation of complexity is due to the second law of thermodynamics in its extended formulation which includes Prigogine's theorem of minimum entropy production. This view requires however that natural selection provides the biological system with structures that bring the reactions within Onsager's range. The hierarchical organization of the natural world thus reflects a stratified thermodynamic stability. As the evolutionary adaptations generate new information they may be assimilated to Marxwell demon type of processes. (shrink)

Case 1 reminds us that patients have duties too, while case 2 presents an instance of justified withholding of informationHow refreshing to read these two cases! No conjoined twins, fantastical chimeras, or other incredible scenarios at the fringes of medical reality. Each case highlights the practical and theoretical difficulties that doctors face in their everyday practice.Case 1: In case 1, the patient, who had declined an HIV test, changed his mind and requested an HIV test on the request form without (...) informing the doctor. The pathologist performed the tests and returned the results to the unsuspecting doctor, who duly investigated the matter. The doctor’s anxiety at the situation, as well as the worries of the entire practice and pathology laboratory, must have been deeply unpleasant. Thus the patient, no doubt unintentionally, caused much distress by requesting the HIV test. He was, at the very least, guilty of a lack of foresight and consideration. As a minimum, he should have informed the doctor of his last minute alteration. This would have enabled the doctor to discuss the implications of the test, to organise appropriate counselling, and, most importantly, to receive the results in full knowledge of the situation.As Dr Fraser points out, the experience of case 1 reinforces the importance of taking good medical notes. Even if the patient’s refusal had been documented in the notes, however, this would not have prevented him from requesting the HIV test, and indeed other tests, on the blood form. Pharmacists may still occasionally be faced with situations when they are unsure whether the doctor prescribed 10 capsules of a drug, or 110 capsules, as the patient may have added a “1” in front of the doctor’s original prescription. Similarly, how …. (shrink)

Nowadays, the modern management is promoted to resolve the issue of unreliable information transmission and to provide work efficiency. The basic aim of the modern management is to be more effective in the role of the school to train talents and serve the society. This article focuses on the application of data mining (DM) in the development of information management system (IMS) in universities and colleges. DM provides powerful approaches for a variety of educational areas. Due to the (...) large amount of student information that can be used to design valuable patterns relevant to student learning behavior, research in the field of education is continuously expanding. Educational data mining can be used by educational institutions to assess student performance, assisting the institution in recognizing the student’s accomplishments. In DM, classification is a well-known technique that has been regularly used to determine student achievement. In this study, the process of DM and the application research of association rules is introduced in the development of IMS in universities and colleges. The results show that the curriculum covers the whole field and the minimum transaction support count be 2, minconf = 70%. The results also suggested that students who choose one course also tend to choose the other course. The application of DM theory in university information will greatly upsurge the data analysis capability of administrators and improve the management level. (shrink)

A new axiomatic characterization with a minimum of conditions for entropy as a function on the set of states in quantum mechanics is presented. Traditionally unspoken assumptions are unveiled and replaced by proven consequences of the axioms. First the Boltzmann–Planck formula is derived. Building on this formula, using the Law of Large Numbers—a basic theorem of probability theory—the von Neumann formula is deduced. Axioms used in older theories on the foundations are now derived facts.