BackgroundThere is evidence that direct journal endorsement of reporting guidelines can lead to important improvements in the quality and reliability of the published research. However, over the last 20 years, there has been a proliferation of reporting guidelines for different study designs, making it impractical for a journal to explicitly endorse them all. The objective of this study was to investigate whether a decision tree tool made available during the submission process facilitates author identification of the relevant (...) reporting guideline.MethodsThis was a prospective 14-week before–after study across four speciality medical research journals. During the submission process, authors were prompted to follow the relevant reporting guideline from the EQUATOR Network and asked to confirm that they followed the guideline (‘before’). After 7 weeks, this prompt was updated to include a direct link to the decision-tree tool and an additional prompt for those authors who stated that ‘no guidelines were applicable’ (‘after’). For each article submitted, the authors’ response, what guideline they followed (if any) and what reporting guideline they should have followed (including none relevant) were recorded.ResultsOverall, 590 manuscripts were included in this analysis—300 in the before cohort and 290 in the after. There were relevant reporting guidelines for 75% of manuscripts in each group; STROBE was the most commonly applicable reporting guideline, relevant for 35% (n = 106) and 37% (n = 106) of manuscripts, respectively. Use of the tool was associated with an 8.4% improvement in the number of authors correctly identifying the relevant reporting guideline for their study (p < 0.0001), a 14% reduction in the number of authors incorrectly stating that there were no relevant reporting guidelines (p < 0.0001), and a 1.7% reduction in authors choosing a guideline (p = 0.10). However, the ‘after’ cohort also saw a significant increase in the number of authors stating that there were relevant reporting guidelines for their study, but not specifying which (34 vs 29%; p = 0.04).ConclusionThis study suggests that use of a decision-tree tool during submission of a manuscript is associated with improved author identification of the relevant reporting guidelines for their study type; however, the majority of authors still failed to correctly identify the relevant guidelines. (shrink)

The guidelines of _Scientia et Fides_ can be found on: https://www.chicagomanualofstyle.org/tools_citationguide/citation-guide-2.html or https://apcz.umk.pl/SetF/about/submissions.

Open peer review (OPR) is moving into the mainstream, but it is often poorly understood and surveys of researcher attitudes show important barriers to implementation. As more journals move to implement and experiment with the myriad of innovations covered by this term, there is a clear need for best practice guidelines to guide implementation. This brief article aims to address this knowledge gap, reporting work based on an interactive stakeholder workshop to create best-practice guidelines for editors and journals (...) who wish to transition to OPR. Although the advice is aimed mainly at editors and publishers of scientific journals, since this is the area in which OPR is at its most mature, many of the principles may also be applicable for the implementation of OPR in other areas (e.g., books, conference submissions). (shrink)

BackgroundAssociations were examined between author-reported uses of reporting guidelines to prepare JNCI: Journal of the National Cancer Institute (JNCI) submissions, editorial decisions, and reviewer ratings for adherence to reporting guidelines and clarity of presentation.MethodsAt submission, authors were asked if they used reporting guidelines to prepare their manuscript and, if so, which one(s). Reviewers rated adherence to reporting guidelines and clarity of presentation. Data were gathered using a customized Editorial Manager Enterprise Analytics Report for submissions with (...) first or final decisions that were submitted between November 1, 2015, and April 30, 2017. Manuscript types that would benefit from the use of reporting guidelines were included. All reviews were included in the analyses. Numerical values were given to each answer (yes, 1; no, 0) or reviewer rating (not applicable, 0; fair, 1; poor, 2; good, 3; very good, 4; and outstanding, 5), and scores were compared using two-sided t tests.ResultsOf 2209 submissions included in the analysis, 1144 (51.8%) indicated that at least one reporting guideline was used. The STROBE guidelines were the most common (n = 531, 24.0%). Of the 2068 (93.6%) submissions that were rejected, 1105 (50.1%) indicated using reporting guidelines and 963 (43.6%) did not (mean [SD] scores of rejected vs not rejected, 0.53 [0.50] vs 0.49 [0.50], P =.47). Of the 1033 ratings for adherence to reporting guidelines, mean (SD) scores for not rejected vs rejected submissions were 3.2 (1.61) vs 2.9 (1.57) (P =.005), and mean (SD) scores for reporting guidelines use vs no use were 3.1 (1.48) vs 2.9 (1.70) (P =.01). Of the 1036 ratings for clarity of presentation, mean (SD) scores for not rejected vs rejected submissions were 3.6 (1.00) vs 3.1 (1.08) (P <.001), whereas mean (SD) scores for reporting guidelines use vs no use were 3.3 (1.04) vs 3.3 (1.10) (P =.64).ConclusionsAmong these JNCI submissions, reporting the use of reporting guidelines was not associated with editorial decisions or with reviewer ratings for clarity of presentation. Reviewer ratings for adherence to guidelines and clarity of presentation were associated with editorial decisions after peer review, and ratings for adherence to guidelines were associated with reported use of reporting guidelines. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:At the Vortex of Controversy:Developing Guidelines for Human Embryo ResearchRonald M. Green (bio)Because of the unavoidable time delay between the submission and publication of this article, its readers will have a significant advantage over its writer: You will know whether the recommendations of the Report of the Human Embryo Research Panel, on which I have served as a member since its inception in January of this year, (...) are progressing smoothly as the basis for evaluating future, federally-funded embryo research—or whether any of the recommendations has become stalled in controversy and political dispute. Staid journals like Science already are predicting that the Panel's Report is likely to create a stormy autumn for the National Institutes of Health.The Panel formally presented its Report to NIH Director Harold Varmus on September 27. The Panel's recommendations will be reviewed by the Advisory Committee to the Director (ACD) until the ACD's next meeting in early December. At that time, the ACD will make formal recommendations to Dr. Varmus, who then will initiate the process of drafting federal regulations that could go into effect by Spring 1995.Historical BackgroundControversy is not new to the area of human embryo research. In the United States, federal regulations enacted in the mid-1970s required any research on the human embryo to be approved by a federally mandated Ethics Advisory Board (EAB). The EAB drafted a significant report that provided ethical guidelines for research on the early, ex utero, human embryo. However, before the report could be acted upon, a new administration, which was opposed to abortion and anything remotely viewed as threatening to prenatal life, came to office, and when the EAB's charter expired in 1980, it was not renewed. In this manner, the Reagan and Bush administrations forestalled any federal support for embryo research in the United States. The next 13 years saw a significant expansion of infertility services in this country, but in the absence of federal funding and [End Page 345] review, there was very little systematic research on either infertility procedures or the human embryo.In January 1993, the U.S. political environment changed again when the Clinton administration fulfilled a campaign promise to remove a nearly five-year-old ban on fetal tissue transplantation research. Although fetal tissue research, which uses the remains of an aborted fetus, significantly differs from embryo research, which involves the developing conceptus ex utero before its transfer to and implantation in a womb, the changed political environment stimulated public discussion of embryo research as well. As a result, in June 1993, Congress nullified the federal regulations requiring EAB review for embryo research. Although this presumably left NIH free to fund embryo research without restrictions, NIH officials felt that guidelines were needed to ensure that such research was conducted in an ethically and socially responsible manner. Accordingly, in January 1994, NIH formed the Human Embryo Research Panel to propose such guidelines.The Panel Begins its WorkChaired by Steven Muller, President emeritus of the Johns Hopkins University, the Panel's 19 members included 7 basic and clinical scientists, 4 ethicists, 2 lawyers, and 6 individuals representing various backgrounds relevant to the making of public policy. Patricia King of the Georgetown University Law Center and Brigid Hogan, a cell biologist at Vanderbilt University, were appointed policy and science co-chairs respectively. Meeting for the first time in early February, the Panel was told by its chair and co-chairs that NIH's need for guidance in the face of pending proposals meant that it had approximately six months—including five one- to two-day meetings each month in Washington—in which to complete its work.In his charge, Dr. Varmus asked the Panel to place the possible areas of research into three categories: (1) acceptable for federal funding; (2) warranting additional review; and (3) unacceptable for federal support. In addition, he asked the Panel to draft guidelines for the review and conduct of the research deemed acceptable.Looking back after months of work, I vividly recall a sense of the enormity of the task facing us. We were being asked, in a short period of time, not only to master... (shrink)

BackgroundThe Transparency and Openness Promotion Guidelines describe modular standards that journals can adopt to promote open science. The TOP Factor is a metric to describe the extent to which journals have adopted the TOP Guidelines in their policies. Systematic methods and rating instruments are needed to calculate the TOP Factor. Moreover, implementation of these open science policies depends on journal procedures and practices, for which TOP provides no standards or rating instruments.MethodsWe describe a process for assessing journal policies, (...) procedures, and practices according to the TOP Guidelines. We developed this process as part of the Transparency of Research Underpinning Social Intervention Tiers Initiative to advance open science in the social intervention research ecosystem. We also provide new instruments for rating journal instructions to authors, manuscript submission systems, and published articles according to standards in the TOP Guidelines. In addition, we describe how to determine the TOP Factor score for a journal, calculate reliability of journal ratings, and assess coherence among a journal’s policies, procedures, and practices. As a demonstration of this process, we describe a protocol for studying approximately 345 influential journals that have published research used to inform evidence-based policy.DiscussionThe TRUST Process includes systematic methods and rating instruments for assessing and facilitating implementation of the TOP Guidelines by journals across disciplines. Our study of journals publishing influential social intervention research will provide a comprehensive account of whether these journals have policies, procedures, and practices that are consistent with standards for open science and thereby facilitate the publication of trustworthy findings to inform evidence-based policy. Through this demonstration, we expect to identify ways to refine the TOP Guidelines and the TOP Factor. Refinements could include: improving templates for adoption in journal instructions to authors, manuscript submission systems, and published articles; revising explanatory guidance intended to enhance the use, understanding, and dissemination of the TOP Guidelines; and clarifying the distinctions among different levels of implementation.Research materials are available on the Open Science Framework: https://osf.io/txyr3/. (shrink)

A journal editor recently apologised for publishing a 2010 paper in which authors designated an enzyme as New Delhi metallo-β-lactamase-1 (NDM-1) and its related gene bla_NDM-1 after a city, New Delhi. This name had raised an outcry in India, with health authorities, media and medical practitioners demanding New Delhi be dropped from the name. The name was actually first given in another 2009 paper, whose corresponding author remains the same as the 2010 paper. There is a tradition of eponymous names (...) in science. But those found derogatory to races, groups, cities, and countries have been changed. For example, Mongolism was changed to Down's syndrome; Australia antigen to HBsAg; Mexican Swine flu to H1N1; GRID (Gay Related Immune Deficiency) and 4H-Disease (Haitians, Homosexuals, Haemophiliacs and Heroin Users Disease) to AIDS. It is necessary that NDM-1 also be changed to a name based on scientific characteristics. NDM-1 must be changed to PCM (plasmid-encoding carbapenem-resistant metallo-β-lactamase). It is also necessary to review the tradition of naming organisms, diseases, genes, etc. after cities, countries and races. Often, such names giving amounts to names calling. It needs to be discarded by scientists in all new names giving from now on. Geographical and racial names giving must be replaced by scientific names giving. Journal editors must ensure that such scientific names giving is laid down as standard guideline in paper submissions. All such names still in currency need to be phased out by replacing them with names based on scientific characteristics, or in honour of their pioneering scientist/s or institutions. The lead author of the above 2010 paper has said he was not consulted about the final draft and did not agree with the conclusions of the paper. To ensure that corresponding authors do not ride roughshod over co-authors, and lead and other authors do not backtrack on papers, editors must ensure written concurrence of all authors, especially the lead author, to the final draft of a paper and include this in their guidelines for paper submissions. (shrink)

Since the Kierkegaard Studies Monograph Series (KSMS) was first published in 1997, it has served as the authoritative book series in the field. Starting from 2011 the Kierkegaard Studies Monograph Series will intensify the peer-review process with a new editorial and advisory board. KSMS is published on behalf of the Søren Kierkegaard Research Centre at the University of Copenhagen. KSMS publishes outstanding monographs in all fields of Kierkegaard research. This includes Ph.D. dissertations, Habilitation theses, conference proceedings and single author works (...) by senior scholars. The goal of KSMS is to advance Kierkegaard studies by encouraging top-level scholarship in the field. The editorial and advisory boards are deeply committed to creating a genuinely international forum for publication which integrates the many different traditions of Kierkegaard studies and brings them into a constructive and fruitful dialogue. To this end the series publishes monographs in English and German. Potential authors should consult the Submission guidelines. All submissions will be blindly refereed by established scholars in the field. Only high-quality manuscripts will be accepted for publication. Potential authors should be prepared to make changes to their texts based on the comments received by the referees. (shrink)

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

Since the Kierkegaard Studies Monograph Series (KSMS) was first published in 1997, it has served as the authoritative book series in the field. Starting from 2011 the Kierkegaard Studies Monograph Series will intensify the peer-review process with a new editorial and advisory board. KSMS is published on behalf of the S ren Kierkegaard Research Centre at the University of Copenhagen. KSMS publishes outstanding monographs in all fields of Kierkegaard research. This includes Ph.D. dissertations, Habilitation theses, conference proceedings and single author (...) works by senior scholars. The goal of KSMS is to advance Kierkegaard studies by encouraging top-level scholarship in the field. The editorial and advisory boards are deeply committed to creating a genuinely international forum for publication which integrates the many different traditions of Kierkegaard studies and brings them into a constructive and fruitful dialogue. To this end the series publishes monographs in English and German. Potential authors should consult the Submission guidelines. All submissions will be blindly refereed by established scholars in the field. Only high-quality manuscripts will be accepted for publication. Potential authors should be prepared to make changes to their texts based on the comments received by the referees. (shrink)

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

Since the Kierkegaard Studies Monograph Series (KSMS) was first published in 1997, it has served as the authoritative book series in the field. Starting from 2011 the Kierkegaard Studies Monograph Series will intensify the peer-review process with a new editorial and advisory board. KSMS is published on behalf of the Søren Kierkegaard Research Centre at the University of Copenhagen. KSMS publishes outstanding monographs in all fields of Kierkegaard research. This includes Ph.D. dissertations, Habilitation theses, conference proceedings and single author works (...) by senior scholars. The goal of KSMS is to advance Kierkegaard studies by encouraging top-level scholarship in the field. The editorial and advisory boards are deeply committed to creating a genuinely international forum for publication which integrates the many different traditions of Kierkegaard studies and brings them into a constructive and fruitful dialogue. To this end the series publishes monographs in English and German. Potential authors should consult the Submission guidelines. All submissions will be blindly refereed by established scholars in the field. Only high-quality manuscripts will be accepted for publication. Potential authors should be prepared to make changes to their texts based on the comments received by the referees. (shrink)

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

Recent proposals to improve public communication about animal-based biomedical research have been narrowly focused on reforming biomedical journal submission guidelines. My suggestion for communication reform is broader in scope reaching beyond the research community to healthcare communicators and ultimately the general public. The suggestion is for researchers to provide journalists and public relations practitioners with concise summaries of their ‘animal use data’. Animal use data is collected by researchers and intended for the public record but is rarely, if (...) ever, given significant media exposure. By providing healthcare communicators with specific details about their animal use, researchers can play a role informing people about a matter of serious public interest and help to promote a more open and publicly accountable animal research culture. (shrink)

Since the Kierkegaard Studies Monograph Series (KSMS) was first published in 1997, it has served as the authoritative book series in the field. Starting from 2011 the Kierkegaard Studies Monograph Series will intensify the peer-review process with a new editorial and advisory board. KSMS is published on behalf of the Søren Kierkegaard Research Centre at the University of Copenhagen. KSMS publishes outstanding monographs in all fields of Kierkegaard research. This includes Ph.D. dissertations, Habilitation theses, conference proceedings and single author works (...) by senior scholars. The goal of KSMS is to advance Kierkegaard studies by encouraging top-level scholarship in the field. The editorial and advisory boards are deeply committed to creating a genuinely international forum for publication which integrates the many different traditions of Kierkegaard studies and brings them into a constructive and fruitful dialogue. To this end the series publishes monographs in English and German. Potential authors should consult the Submission guidelines. All submissions will be blindly refereed by established scholars in the field. Only high-quality manuscripts will be accepted for publication. Potential authors should be prepared to make changes to their texts based on the comments received by the referees. (shrink)

Gadamer’s hermeneutics has met with criticism in the more than forty years since the original German publication of Wahrheit und Methode in 1960. A figure who has recently criticized Gadamer’s hermeneutics from the perspective of traditional hermeneutics is Pol Vandevelde. He published a book entitled: "The Task of the Interpreter: Text, Meaning, and Negotiation”. The first two chapters of this book, especially the second chapter, with the title “Interpretation as Event: A Critique of Gadamer’s Critical Pluralism,” is devoted to attacking (...) some aspects of Gadamer’s philosophical hermeneutics. He has called his critiques as 'Ambiguities'. In fact, he focuses on three ambiguities: the fusion of horizons, the active role of the interpreter, and the status of language. Vandevelde’s critiques, similar to the critical views of other critics, are directed to four subjects: the problem of author's intention, the problem of objectivity, the problem of validity of interpretation, and finally the problem of relativism. Although I have examined all his three ambiguities, but because of the limitations that you have mentionedin the ‘Submission Guidelines’, I have sent you only a part of my paper. It seems to me that Vandevelde’s critiques shows that he has not adequate consideration to the foundations of Gadamer’s philosophical hermeneutics. (shrink)

Gadamer’s hermeneutics has met with criticism in the more than forty years since the original German publication of Wahrheit und Methode in 1960. A figure who has recently criticized Gadamer’s hermeneutics from the perspective of traditional hermeneutics is Pol Vandevelde. He published a book entitled: "The Task of the Interpreter: Text, Meaning, and Negotiation”. The first two chapters of this book, especially the second chapter, with the title “Interpretation as Event: A Critique of Gadamer’s Critical Pluralism,” is devoted to attacking (...) some aspects of Gadamer’s philosophical hermeneutics. He has called his critiques as 'Ambiguities'. In fact, he focuses on three ambiguities: the fusion of horizons, the active role of the interpreter, and the status of language. Vandevelde’s critiques, similar to the critical views of other critics, are directed to four subjects: the problem of author's intention, the problem of objectivity, the problem of validity of interpretation, and finally the problem of relativism. Although I have examined all his three ambiguities, but because of the limitations that you have mentionedin the ‘Submission Guidelines’, I have sent you only a part of my paper. It seems to me that Vandevelde’s critiques shows that he has not adequate consideration to the foundations of Gadamer’s philosophical hermeneutics. (shrink)

The subject of values presents certain dangers. Why not the moral philosophy of Islam or even the ethics of Islam? The term “moral” seems traditional, if not antiquated: it connotes the ideas of good and evil, a long list of commandments and interdictions; it evokes a restraint of the individual, something limiting and narrow. The word “ethics” is more acceptable; it is closer to the idea of a system of values, a global vision of the moral life, but it may (...) also express a normative process. Max Weber speaks of Islam and other religions as being ethical religions, that is. “a complex of commandments and bans whose transgression is sin,” and he imputes this particularity to prophecy that “produces a centralization of ethics.” The term “values” is often used today, and it corresponds better to modern sensitivity preoccupied with the search for dispersed or connected values on which to base its behavior and its image. We know that the “theory of values” began with Western moralist philosophers as a substitute for the old morality, experienced as submission, and to introduce the idea of a personal morality, the essential being to conform to freely-chosen values. However, we may also speak of collective values or even of values attached to a particular line of conduct that they establish, for example, “martial values.” “tribal values” or “fundamental values.” A value may be isolated, like a Platonic idea, put into a package or even a system. It remains none the less abstract, since it is itself the product of an abstraction and rarely a creation. To look for the values of a culture, a religion or a society is to devote oneself to an operation of extraction from a multitude of data. It is truly a quest, one that allows for personal interpretation in selection from the lime that one becomes sensitive to one line of values rather than to another. Thus is presented the problem of the divergence of values within a single ethical system, especially if it is as vast as that of Islam. My purpose here is not selective. It is to go in search of the values of Islam in their variety while trying to find a guideline and also locating them at various levels of comprehension. (shrink)

In 2002, I wrote an editorial in this Journal arguing that it was time to review the structure and function of ethics committees in the USA, Australia and the UK.1 This followed the deaths of Ellen Roche and Jesse Gelsinger, which were at least in significant part due to the poor functioning of research ethics committees in the USA.2 In the case of Ellen Roche, it was the failure to require a systematic review of the existing literature which led to (...) her death. Iain Chalmers and I had previously documented in 1996 the failure of ethics committees to require systematic review.3 In 1998, at the time of revising the previous guidelines and forming the first Australian National Statement on Research Ethics, I made a public submission to the Australian Health Ethics Committee arguing that the new guidelines for RECs should include a person with skills in conducting systematic reviews of the literature and that the requirement to have a religious representative on the committee be replaced with the requirement to have an ethicist. Neither of these changes was made. I argued, ‘It is time to ask whether institutional RECs should be abandoned in favour of expert committees that cover many institutions—suprainstitutional specialist committees. Supraregional specialist ethics committees could specialise—for example, in genetic research, cancer clinical trials, dermatology, respiratory physiology and each of the specialist areas of medical research. An example of such a committee is provided by the Thoracic Society of Australia and New Zealand research ethics committee, which reviews multicentre trials of respiratory drugs’.4 Around that time, I was involved ‘at the coal face’ as Chair of the Department of Human Services Ethics Committee in Victoria. In a public presentation, I arguedThere are two philosophical views of what ethics review is. On the …. (shrink)

Aims and background: The present work assessed the impact of two decrees on ethics committees in Italy, aimed at bringing the national laws on the conduct of clinical trials into line with the rest of the EC, and regulating and facilitating not-for-profit research.Material and methods: Prospectively collected data from an Italian multicentre study were examined with respect to the ethics review process. Administrative and time elements of the review process were audited. Main outcome measures were time between the application (...) class='Hi'>submission and the ethics committee definitive opinion, type and number of application submission forms, number of ethics committees that refused fee exemption, and time between the ethics committee approval and the administrative authorisation.Results: A total of 134 local research ethics committees were approached. Application submission procedures and application forms varied greatly; paper submission was mandatory. The median time from submission to approval was 72 days. Only two LRECs refused the fee exemption. The median time from LREC approval to administrative agreement was 50 days and only 9.6% of local authorities came to a verbal agreement with the sponsor.Conclusions: Italian LRECs are still not sufficiently efficient in complying with the Directive 2001/20/EC requirement . Better coordination of LRECs work is needed although the optimal level of coordination between them is still not known. In the meantime, national guidelines are needed concerning the application of Directive 2001/20/EC. The behaviour of Italian LRECs towards not-for-profit research was excellent although only the fee exemption was requested. (shrink)

Objectives: To examine the perspectives of journal editors and authors on overlapping and redundant publications in clinical research.Design: Pretested cross-sectional survey, containing both forced choice and open ended questions, administered by mail to the senior editors and one randomly selected author from all journals in the Abridged Index Medicus that published clinical research.Main measurements: The views of editors and authors about the extent of redundant publications, why they occur, how to prevent and respond to cases, and when the publication of (...) overlapping manuscripts is justified.Results: Seventy two per cent of editors and 65% of authors completed the survey. There was consensus between both groups that redundant publications occur because authors feel the pressure to publish and journals do not do enough to publicise, criticise, and punish cases, and that the publication of most types of overlapping articles is unacceptable. Sixty seven per cent of authors but only 31% of editors felt, however, that it was justified to publish an overlapping article in a non-peer reviewed symposium supplement, and 68% of editors but 39% of authors supported imposing restrictions on guilty authors’ future submissions. In written comments, 15% to 30% of both groups emphasised that it was justified to publish overlapping articles when there were different or non-English-speaking audiences, new data, strengthened methods, or disputed findings.Conclusions: Editors, authors, and other academic leaders should together develop explicit guidelines that clarify points of contention and ambiguity regarding overlapping manuscripts. (shrink)

Background: Publication of ethically uncertain research occurs despite well-published guidelines set forth in documents such as the Declaration of Helsinki. Such guidelines exist to aide editorial staff in making decisions regarding ethical acceptability of manuscripts submitted for publication, yet examples of ethically suspect and uncertain publication exist. Our objective was to survey journal editors regarding practices and attitudes surrounding such dilemmas. Methods: The Editor-in-chief of each of the 103 English-language journals from the 2005 Abridged Index Medicus list publishing (...) original research were asked to complete a survey sent to them by email between September-December 2007. Results: A response rate of 33% (n = 34) was obtained from the survey. 18% (n = 6) of respondents had published ethically uncertain or suspect research within the last 10 years. 85% (n = 29) of respondents stated they would always reject ethically uncertain articles submitted for publication on ethical grounds alone. 12% (n = 4) of respondents stated they would approach each submission on a case-by-case basis. 3% (n = 1) stated they would be likely to publish such research, but only with accompanying editorial. Only 38% (n = 13) give reviewers explicit instruction to reject submissions on ethical grounds if found wanting. Conclusions: Editorial compliance with the Declaration of Helsinki in rejecting research that is conducted unethically was difficult to ascertain because of a poor response rate despite multiple attempts using different modalities. Of those who did respond, the majority do reject ethically suspect research but few explicitly advise reviewers to do so. In this study editors did not take advantage of the opportunity to describe their support for the rejection of the publication of unethical research. (shrink)

Recently, Australia became the second jurisdiction worldwide to legalize the use of mitochondrial donation technology. The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 allows individuals with a family history of mitochondrial disease to access assisted reproductive techniques that prevent the inheritance of mitochondrial disease. Using inductive content analysis, we assessed submissions sent to the Senate Committee as part of a programme of scientific inquiry and public consultation that informed drafting of the Bill. These submissions discussed a range of bioethical (...) and legal considerations of central importance to the political debate. Significantly, submissions from those with a first-hand experience of mitochondrial disease, including clinicians and those with a family history of mitochondrial disease, were in strong support of this legislation. Those in support of the Bill commended the two-staged approach and rigorous licencing requirements as part of the Bill’s implementation strategy. Submissions which outlined arguments against the legislation either opposed the use of these techniques in general or opposed aspects of the implementation strategy in Australia. These findings offer a window into the ethical arguments and perspectives that matter most to those Australians who took part in the Senate inquiry into mitochondrial donation. The insights garnered from these submissions may be used to help refine policy and guidelines as the field progresses. (shrink)

There is no shortage of pedagogical theories from the tradition formal methods of instruction to the free-play methods of unschooling. A sharp shift in education and instruction models took place with the introduction of critical pedagogy. The focus was no longer on the authority of the teacher and the submissive, passive approach taken by the learner, but rather on the engagement between the two. Still, even when critical pedagogy is utilized in a formal model of education something is missing from (...) the system—experiential learning. Although the unschooling method has been criticized it does provide the benefit of experiential learning. This paper explores the nature of education and evaluates models and theories of pedagogy with the conclusion that a paradoxical approach in which there is a merger between the formal guidelines set by traditional educational models and the experiential learning methods of unschooling approach best prepares learners for the world and to be engaged citizens. Although what, precisely, this paradoxical system would entail is not discussed in this paper, it opens the door for further discussion on the topic and for consideration of the theories which have attempted to do exactly this and improve upon them going forward. (shrink)

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

Research that has been sponsored by pharmaceutical, medical device and biotechnology companies is often presented at scientific and medical conferences. However, practices vary between organizations and it can be difficult to follow both individual conference requirements and good publication practice guidelines. Until now, no specific guidelines or recommendations have been available to describe best practice for conference presentations.This document was developed by a working group of publication professionals and uploaded to PeerJ Preprints for consultation prior to publication; an (...) additional 67 medical societies, medical conference sites and conference companies were also asked to comment. The resulting recommendations aim to complement current good publication practice and authorship guidelines, outline the general principles of best practice for conference presentations and provide recommendations around authorship, contributorship, financial transparency, prior publication and copyright, to conference organizers, authors and industry professionals.While the authors of this document recognize that individual conference guidelines should be respected, they urge organizers to consider authorship criteria and data transparency when designing submission sites and setting parameters around word/character count and content for abstracts. It is also important to recognize that conference presentations have different limitations to full journal publications, for example, in the case of limited audiences that necessitate refocused abstracts, or where lead authors do not speak the local language, and these have been acknowledged accordingly. The authors also recognize the need for further clarity regarding copyright of previously published abstracts and have made recommendations to assist with best practice.By following Good Practice for Conference Abstracts and Presentations: GPCAP recommendations, industry professionals, authors and conference organizers will improve consistency, transparency and integrity of publications submitted to conferences worldwide. (shrink)

The corporate meltdowns of this and the previous decade in the US - WorldCom, Enron, Tyco, and in Australia - FAI, HIH and AWB being among the many examples - have resulted in the governments of those two countries introducing legislation and policy guidelines aimed at minimising future corporate misbehaviour. -/- The US has introduced the Sarbanes Oxley Act, with requirements on corporate accountants and auditors, as well as its whistleblowing provisions. It has revised the Federal Sentencing Guidelines (...) for Organizations. New rules for the NYSE and NASDAQ have also been introduced. In addition, the U.S. Securities and Exchange Commission and U.S. Department of Justice have further strengthened the Foreign Corrupt Practices Act 1977, last revised in 1997. -/- Australia has revised the Corporations Act to include whistleblower protection clauses as well as adopted the ASX Corporate Governance guidelines. Standards Australia has issued its handbook on corporate governance. Although not a business issue, the Australian government has also announced that it will introduce whistleblower protection legislation for the public sector by the end of its first term in office. This legislation will likely influence whatever the private sector does in this respect. The inclusion of whistleblower protection in both Sarbanes–Oxley and the Corporations Act reflects a growing body of research that finds that people internal to an organisation are the most effective way to identify corporate wrongs. The Commonwealth Treasury has recently issued an options paper, stating that the Corporations Act has been ineffectual. It has sought submissions on revisions to the legislation that the Australian Government could take. This paper examines the policies advocated by over 20 organisations and academics concerned with whistleblowing issues. It draws the conclusion that on current indications, even after further reform, Australian legislation and policies are still likely to be less effectual than overseas practices. -/- --------------------------------- . (shrink)

BackgroundInstitutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia.MethodThis was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent (...) to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions.ResultsTwenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review.ConclusionSaudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies. (shrink)

This letter contains suggestions for editors and software providers to help avoid affiliation bias in the initial and concluding stages of the peer review process. Submission management systems have a responsibility to ensure protection against affiliation bias. This can be achieved by automatically withholding the author’s identity and affiliation information from all editors, including the Editor-in-Chief, until a decision about publication has been made. Journals relying on email-based submissions are in a more difficult situation. Not having external support in (...) confirming the submitting author’s identity, this dilemma can be resolved through the implementation of strict instructions and guidelines concerning manuscript submission and handling. In this case the “human factor” cannot be fully eliminated, while automated processes can only be changed intentionally and with a certain delay. Therefore, with the suggested steps, submission management systems could become a strong guard against unconscious bias while also making conscious bias more difficult to impact the peer review process. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Editorial Reflections on Philosophizing in Music EducationEstelle R. Jorgensen and Iris M. YobIn this article, we reflect on issues that go to the heart of teaching and scholarship in the philosophy of music education. After thirty years of editing Philosophy of Music Education Review, it is a good time to take stock of the philosophical work that has been and is being published and of challenges that remain.Over the (...) years, there has been a growing quality of philosophical articles published in the journal, due in significant part to the efforts of reviewers and the willingness of writers to work with their suggestions. Authors regularly express appreciation for the informed, critical, and constructive reviews their work receives. An exemplary body of philosophical scholarship in music education has been published over this time and PMER is regarded as a premier journal internationally devoted exclusively to the philosophy of music education. In thirty volumes of uninterrupted publication, we have sought to be responsive to important issues in music education. Our writers have engaged relevant subjects of interest to our readers, citations of articles remain strong, and articles are included in [End Page 109] university and college course reading lists. PMER is available in print and online via subscription; it has a wide digital exposure in search engines and leading indexes, and our readership continues to grow.Despite this progress, although the number of submissions has increased, their quality has sometimes been uneven. Our pedagogical commitment to foster philosophical writing and the philosophical inexperience of some writers has significantly impacted the work required to bring submissions to publication standard. Submissions sometimes evidence a lack of attention to formulating a tight argument, citing relevant sources, and polishing and editing the manuscript. The published style guidelines are too often ignored, creating a poor first impression with reviewers and editors. Writers are occasionally in a hurry to publish and less willing to entertain multiple revisions of their articles required to produce work of lasting value. The growing number of music education journals that publish philosophical work, while opening more fora, in some cases perversely result in ideologically driven, polemical, and philosophically uninformed articles in the name of philosophy. This is a good moment to reconsider the importance of philosophical fundamentals that should undergird our philosophizing in music education and what these mean for our academic responsibilities. To this end, we suggest several principles that need to be central to our philosophizing in music education. These principles also have broader implications for the expectations of scholarship in music education generally.WRITING PHILOSOPHYLike other subject areas in the academy, philosophy has its own intellectual structure, a canon of significant writings, its own interpretative methods, and its distinctive role and purpose. A philosophical paper in music education reads differently from papers in the history of music education, methods of teaching music, sociology of music education, empirical research in music education, multi-cultural, gender, and ethnic studies, music education curriculum building and policy making, and so on. And yet, the boundaries between these disciplines, which are artificial constructions when human knowledge is considered wholistically anyway, are somewhat porous with concepts and ideas and claims seeming to move easily from one discipline to another.To help distinguish between philosophy and other areas of study and research, it may be helpful to consider philosophy as a second-order activity. That is, first-order activity examines the raw data of research and experience and attempts to make sense of them. Using inference, pattern-seeking, deduction, hypotheses, statistical analysis, and so on, these activities result in claims, interpretations, and theories that give meaning to what we see, hear, and feel. [End Page 110]The second-order activity takes a step away from these first-order activities. It does not concern itself so much with raw data or with creating theories about them, but critically analyzes the claims and inferences that are made in regard to them. Where first-order disciplines analyze inputs from observation and experimentation, second-order disciplines analyze these analyses—that is, they function as meta-analyses. Philosophers do not need laboratories or fieldwork (which makes applications for grants to support philosophical research difficult to secure!). They need libraries... (shrink)

BackgroundDespite rapid growth of the scientific literature, no consensus guidelines have emerged to define the optimal criteria for editors to grade submitted manuscripts. The purpose of this project was to assess the peer reviewer metrics currently used in the surgical literature to evaluate original manuscript submissions.MethodsManuscript grading forms for 14 of the highest circulation general surgery-related journals were evaluated for content, including the type and number of quantitative and qualitative questions asked of peer reviewers. Reviewer grading forms for the (...) seven surgical journals with the higher impact factors were compared to the seven surgical journals with lower impact factors using Fisher’s exact tests.ResultsImpact factors of the studied journals ranged from 1.73 to 8.57, with a median impact factor of 4.26 in the higher group and 2.81 in the lower group. The content of the grading forms was found to vary considerably. Relatively few journals asked reviewers to grade specific components of a manuscript. Higher impact factor journal manuscript grading forms more frequently addressed statistical analysis, ethical considerations, and conflict of interest. In contrast, lower impact factor journals more commonly requested reviewers to make qualitative assessments of novelty/originality, scientific validity, and scientific importance.ConclusionSubstantial variation exists in the grading criteria used to evaluate original manuscripts submitted to the surgical literature for peer review, with differential emphasis placed on certain criteria correlated to journal impact factors. (shrink)

Context: Practice-based design research is becoming more widely recognized in academia, including at doctoral level, yet there are arguably limited options for dissemination beyond the traditional conference format of paper-based proceedings, possibly with an exhibition or “demonstrator” component that is often non-archival. Further, the opportunities afforded by the traditional-format paper presentations is at times at odds with practice-based methodologies being presented. Purpose: We provide a first-hand descriptive account of developing and running a new international conference with an experimental format that (...) aims to support more analogously the dissemination of practice-based design research. Method: Our approach herein is broadly interpretative, phenomenological and critically reflective in orientation, to analyze our own experiential insights from the conference conception, through to the event itself and post-conference reflections, alongside the reflections fed back by conference delegates. Results: We have found the roundtable format continues to function well for creating a discursive interactional context. However issues arose around the crucial nature of the session chair’s role in enabling rich and multi-voiced discussion and how presenters’, organizers’ and delegates’ voices were captured and documented, with implications for further developing the conference design. Looking forward, there are also questions raised about: balancing the stringency of a rigorous review process with provision of an encouraging platform for early-career researchers; and balancing the need for clear criteria and formatting standards with the “openness” of the submission template and formatting guidelines and/or writing. This includes designers who are new to research cultures. It should also appeal to those working in interdisciplinary research in collaboration with design practitioners (but who may not be practitioners themselves. The conference aims to foster and support a burgeoning “research through design” academic community and to provide a fitting dissemination platform for this community. We hope that the conference will encourage academic communities to give proper consideration to the concept of design as a knowledge-generating activity. Constructivist content: Knowledge about design research is generated from meaningful interaction between people and artifacts as part of the unfolding conference experience. The organizational features of the conference aim to support knowledge dissemination through dialogical relations between people and things in particular contexts of interaction. (shrink)

BackgroundMany authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials.MethodsUsing terms related to ‘medical writer’ and ‘observational study’, we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014–2018). We also hand-searched the journals (...) Medical Writing and The Write Stuff (2014–2018) and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS.ResultsOur searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed), publication in journals with an impact factor (one study), a higher quality of written English (one study), and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies).ConclusionsThis systematic review of eight observational studies suggests that PMWS is positively associated with measures of overall quality of reporting of clinical trials and may improve the timeliness of publication.Video abstract. (MP4 161000 kb). (shrink)

What role do women play in the perpetuation of patriarchy? On the one hand, popular media urges women to be independent, outspoken, and career-minded. Yet, this same media glorifies a specific, sometimes voluntary, female submissiveness as a source of satisfaction. In philosophy, even less has been said on why women submit to men and the discussion has been equally contradictory—submission has traditionally been considered a vice or pathology, but female submission has been valorized as innate to women’s nature. (...) Is there a way to explore female submission in all of its complexity—not denying its appeal in certain instances, and not buying into an antifeminist, sexist, or misogynistic perspective? -/- We Are Not Born Submissive offers the first in-depth philosophical exploration of female submission, focusing on the thinking of Simone de Beauvoir, and more recent work in feminist philosophy, epistemology, and political theory. Manon Garcia argues that to comprehend female submission, we must invert how we examine power and see it from the woman’s point of view. Historically, philosophers, psychoanalysts, and even some radical feminists have conflated femininity and submission. Garcia demonstrates that only through the lens of women’s lived experiences—their economic, social, and political situations—and how women adapt their preferences to maintain their own well-being, can we understand the ways in which gender hierarchies in society shape women’s experiences. Ultimately, she asserts that women do not actively choose submission. Rather, they consent to—and sometimes take pleasure in—what is prescribed to them through social norms within a patriarchy. -/- Moving beyond the simplistic binary of natural destiny or moral vice, We Are Not Born Submissive takes a sophisticated look at how female submissiveness can be explained. (shrink)

In Leviathan, Thomas Hobbes famously characterizes the state of nature as a predicament in which life is “solitary, poor, nasty, brutish, and short.” The only means of escape from that dire condition is to found the commonwealth, with its notorious sovereign. Hobbes invests the sovereign with virtually absolute power over the poor subjects of the commonwealth, and that vast and unlimited sovereign has drawn the reader’s eye for 350 years. -/- Yet Hobbes has a great deal to say about subjects (...) in a commonwealth as well, and he articulates a normative conception of a good subject. This book develops a novel interpretation of the role of submission in Leviathan, and it introduces the concept of subjection to explain the expectations Hobbes has for good subjects. (shrink)

Background Intensivists must provide enough analgesia and sedation to ensure dying patients receive good palliative care. However, if it is perceived that too much is given, they risk prosecution for committing euthanasia. The goal of this study is to develop consensus guidelines on analgesia and sedation in dying intensive care unit patients that help distinguish palliative care from euthanasia. Methods Using the Delphi technique, panelists rated levels of agreement with statements describing how analgesics and sedatives should be given to (...) dying ICU patients and how palliative care should be distinguished from euthanasia. Participants were drawn from 3 panels: 1) Canadian Academic Adult Intensive Care Fellowship program directors and Intensive Care division chiefs (N = 9); 2) Deputy chief provincial coroners (N = 5); 3) Validation panel of Intensivists attending the Canadian Critical Care Trials Group meeting (N = 12). Results After three Delphi rounds, consensus was achieved on 16 statements encompassing the role of palliative care in the intensive care unit, the management of pain and suffering, current areas of controversy, and ways of improving palliative care in the ICU. Conclusion Consensus guidelines were developed to guide the administration of analgesics and sedatives to dying ICU patients and to help distinguish palliative care from euthanasia. (shrink)

At the time of writing there appear to have been no electronic submissions to the Journal of Medical Ethics. It seems appropriate, therefore, to begin electronic correspondence with a consideration of some of the ethical implications of this new form of ethical dialogue.I have posted this response to Kenneth Boyd’s editorial on Mrs Pretty and Ms B1 as this article may provoke debate far beyond the medical and ethical establishment. This issue may be of tremendous concern to patients or their (...) carers who are presently suffering in circumstances similar to those described.The electronic response forum of the BMJ has been in operation for over four years.2 An editorial in the BMJ on physician assisted suicide3 has attracted 125 responses at the time of writing. An important feature of electronic responses, particularly on items that generate a lot of debate, is that the …. (shrink)

At the time of writing there appear to have been no electronic submissions to the Journal of Medical Ethics. It seems appropriate, therefore, to begin electronic correspondence with a consideration of some of the ethical implications of this new form of ethical dialogue.I have posted this response to Kenneth Boyd’s editorial on Mrs Pretty and Ms B1 as this article may provoke debate far beyond the medical and ethical establishment. This issue may be of tremendous concern to patients or their (...) carers who are presently suffering in circumstances similar to those described.The electronic response forum of the BMJ has been in operation for over four years.2 An editorial in the BMJ on physician assisted suicide3 has attracted 125 responses at the time of writing. An important feature of electronic responses, particularly on items that generate a lot of debate, is that the …. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the research (...) involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

Technologies to rapidly alert people when they have been in contact with someone carrying the coronavirus SARS-CoV-2 are part of a strategy to bring the pandemic under control. Currently, at least 47 contact-tracing apps are available globally. They are already in use in Australia, South Korea and Singapore, for instance. And many other governments are testing or considering them. Here we set out 16 questions to assess whether — and to what extent — a contact-tracing app is ethically justifiable.

Covid‐19 confronts us with tragic choices, in which every option is unacceptable. On the New York State Task Force on Life and the Law, I worked on guidelines for such situations. We did not envision the scale or character of Covid‐19. To minimize fear that the decisions made in these situations might be unfair, we all must know what guidelines or mandates inform them. Only with transparency about how decisions will be made, by whom, and according to what (...) requirements can we have confidence that fairness prevails. We now face many related questions about process, goals, leadership, and trust. For example, how might ethical guidelines evolve as scientific understanding advances? Should guidelines vary with different venues? And if, as I have argued, judgment is necessary even with the best of guidelines, how can we prepare clinicians to make good judgments? Are there implications for better training of personnel in nonemergency times for what they might face in the worst of times? (shrink)

Clinical guidelines are special types of plans realized by collective agents. We provide an ontological theory of such plans that is designed to support the construction of a framework in which guideline-based information systems can be employed in the management of workflow in health care organizations. The framework we propose allows us to represent in formal terms how clinical guidelines are realized through the actions of are realized through the actions of individuals organized into teams. We provide various (...) levels of implementation representing different levels of conformity on the part of health care organizations. Implementations built in conformity with our framework are marked by two dimensions of flexibility that are designed to make them more likely to be accepted by health care professionals than standard guideline-based management systems. They do justice to the fact 1) that responsibilities within a health care organization are widely shared, and 2) that health care professionals may on different occasions be non-compliant with guidelines for a variety of well justified reasons. The advantage of the framework lies in its built-in flexibility, its sensitivity to clinical context, and its ability to use inference tools based on a robust ontology. One disadvantage lies in its complicated implementation. (shrink)

Ontologies are being used increasingly to promote the reusability of scientific information by allowing heterogeneous data to be integrated under a common, normalized representation. Definitions play a central role in the use of ontologies both by humans and by computers. Textual definitions allow ontologists and data curators to understand the intended meaning of ontology terms and to use these terms in a consistent fashion across contexts. Logical definitions allow machines to check the integrity of ontologies and reason over data annotated (...) with ontology terms to make inferences that promote knowledge discovery. Therefore, it is important not only to include in ontologies multiple types of definitions in both formal and in natural languages, but also to ensure that these definitions meet good quality standards so they are useful. While tools such as Protégé can assist in creating well-formed logical definitions, producing good definitions in a natural language is still to a large extent a matter of human ingenuity supported at best by just a small number of general principles. For lack of more precise guidelines, definition authors are often left to their own personal devices. This paper aims to fill this gap by providing the ontology community with a set of principles and conventions to assist in definition writing, editing, and validation, by drawing on existing definition writing principles and guidelines in lexicography, terminology, and logic. (shrink)

Current guidelines treat palliative sedation to unconsciousness as an effective medical treatment for terminally ill patients who need relief from severe symptoms, yet also restrict its use in ways that are extraordinary for medical treatments. A closer look at the kinds of cases in which palliative sedation is used suggests a way of adjusting the guidelines to resolve this seeming contradiction.

Global fatalities related to COVID-19 are expected to be high in 2020–2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods—that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and (...) against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made. (shrink)