BackgroundThe Patient-Centered Outcomes Research Institute is obligated to peer review and to post publicly “Final Research Reports” of all funded projects. PCORI peer review emphasizes adherence to PCORI’s Methodology Standards and principles of ethical scientific communication. During the peer review process, reviewers and editors seek to ensure that results are presented objectively and interpreted appropriately, e.g., free of spin.MethodsTwo independent raters assessed PCORI peer review feedback sent to authors. We calculated the proportion of reports in which spin was (...) identified during peer review, and the types of spin identified. We included reports submitted by April 2018 with at least one associated journal article. The same raters then assessed whether authors addressed reviewers’ comments about spin. The raters also assessed whether spin identified during PCORI peer review was present in related journal articles.ResultsWe included 64 PCORI-funded projects. Peer reviewers or editors identified spin in 55/64 submitted research reports. Types of spin included reporting bias, inappropriate interpretation, inappropriate extrapolation of results, and inappropriate attribution of causality. Authors addressed comments about spin related to 47/55 of the reports.Of 110 associated journal articles, PCORI comments about spin were potentially applicable to 44/110 articles, of which 27/44 contained the same spin that was identified in the PCORI research report. The proportion of articles with spin was similar for articles accepted before and after PCORI peer review.DiscussionJust as spin is common in journal articles and press releases, we found that most reports submitted to PCORI included spin. While most spin was mitigated during the funder’s peer review process, we found no evidence that review of PCORI reports influenced spin in journal articles. Funders could explore interventions aimed at reducing spin in published articles of studies they support. (shrink)

Background Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals. Methods This is a retrospective observational study. All clinical research published in the five leading international (...) nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. Results A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies discussed informed consent. Only half of those reported that written informed consent had been obtained; few reported oral consent, and few used other methods such as online consent or completion and return of data collection to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received. Conclusion The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required. (shrink)

Predatory journals offer the promise of prompt publication to those willing to pay the article submission or processing fee. However, these journals do not offer rigorous peer review. Studies have shown that a substantial share of corresponding authors in predatory journals come from South Asia, particularly India. This scoping review aims to assess what is known about the reasons why healthcare researchers working in South Asia publish in predatory journals. 66 reports (14 editorials, 20 letters, 5 research reports, 10 (...) opinion articles, 14 reviews, 2 commentaries and 1 news report) were included in the data charting and analysis. The analysis of the reports identified three main reasons that made South Asian healthcare researchers publish in predatory journals: pressure to publish, lack of research support, and pseudo benefits. The review shows that predatory publishing in South Asia is a complex phenomenon. Combating predatory publications requires a holistic strategy that supersedes merely blacklisting these journals or listing criteria for journals that do meet academic standards. (shrink)

Research Ethics, Volume 18, Issue 2, Page 93-113, April 2022. Twitter is an increasingly common source of rich, personalized qualitative data, as millions of people daily share their thoughts on myriad topics. However, questions remain unclear concerning if and how to quote publicly available social media data ethically. In this study, focusing on 136 education manuscripts quoting 2667 Tweets, we look to investigate the ways in which Tweets are quoted, the ethical discussions forwarded and actions taken, and the extent (...) to which quoted Tweets are “discoverable.” A concerning result is that in almost all manuscripts, and for around half of all quoted Tweets, the original author could be identified. Drawing on our findings we share some ethical dilemmas, including those that arise from an apparent lack of understanding of the technical aspects of the platform, and offer suggestions for promoting ethically-informed practice. (shrink)

The paper reports two studies exploring the relationship between scholars’ self-reported publication pressure and their self-reported scientific misconduct in research. In Study 1 the participants...

Researchers should strictly consider the participants’ rights. They are required to document such protections as an ethical approval of the study proposal, the obtaining “informed consent”, the authors’ “conflict of interests”, and the source of “financial support” in the published articles. The purpose of this study was to assess the frequency of reporting ethical issues in human subject articles published in Iranian medical journals during 2009–2013. In this cross-sectional study, we randomly reviewed 1460 human subject articles published in Iranian (...) medical journals during 2009–2013 in two Persian and English language groups. Data collection was carried out by assessing articles, focusing on the documentation “ethics committee approval”, patients’ “informed consent”, “financial support”, “confidentiality”, and “conflict of interest”. Of 1460 evaluated articles, 443 reported “ethics committee approval”, 686 reported “informed consent”, 594 reported “financial support”, and 341 reported “conflict of interest”. 13% of the articles referred to patients’ confidentiality in their text. There was a significant association between these ethical documentations and the year of publication. Articles published in English language journals reported “ethics committee approval”, “financial support”, and “conflict of interest” significantly more than Persian language journals, but the frequency of “informed consent” was similar. Ethical documentation rate in Iranian medical journals is not up to the expected standards of reputable journals which might be related to a lack of awareness and the education of the authors and the journal’s editors. Precise reporting of ethical considerations in medical articles by authors are recommended. It is suggested journals and policymakers pay more attention to reporting this issue while providing standard guidelines in this regard. (shrink)

Background: Previous studies have found lapses in ethical safeguards for subjects of critical-care research. Objective: To assess recently published empiric critical-care research conducted in the United States for the reporting of research protections as they relate to informed consent and surrogate decision-making. Methods: Systematic review of a sample of empiric critical-care research studies published between 2000 and 2004. Results: Of 51 studies reviewed, consent was reported as having been obtained in 44. Assessment of subjects' decision-making (...) capacity was noted in 35% of studies. Assessments of subjects' capacity was less likely to be reported in studies in which researchers accepted consent from either subjects or from third parties, compared to studies with only subjects' consent. Five studies did not report securing Institutional Review Board approval. Conclusion: Lapses in the reporting of critical-care research are prevalent. (shrink)

While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over (...) the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research. (shrink)

Reporting biases refer to a truncated pool of published studies with the resulting suppression or omission of some empirical findings. Such biases can occur in positive research paradigms that try to uncover correlations and causal relationships in the social world by using the empirical methods of science. Furthermore, reporting biases can come about because of authors who do not write papers that report unfavorable results despite strong efforts made to find previously accepted evidence and because of a (...) higher rejection rate of studies documenting contradictory evidence. Reporting biases are a serious concern because the conclusions of systematic reviews and meta-analyses can be misleading. The authors show that published evidence in win-win corporate social responsibility research tends to overestimate efficiency. The research field expects to find a positive association between corporate social performance and corporate financial performance, and findings meet that expectation. The authors explain how this pattern may reflect reporting bias. The empirical results show strong tentative evidence for a positive reporting bias in the CSP–CFP literature but only weak tentative evidence for CSP efficiency. The study also examines which factors, such as time trends, publication outlet, and study characteristics, are associated with higher reporting biases within this literature. (shrink)

Background: The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published.Objective: To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency.Design: Retrospective, observational study.Setting: (...) Online review of five major medical journals.Population: All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine.Measurements: Statement of REB approval and informed consent.Results: Of 1780 articles reviewed, 1133 met inclusion criteria , 36 articles lacked a statement of REB approval, 62 lacked disclosure of informed consent and 15 articles lacked both. Articles that did not state REB approval were associated with not stating informed consent . There were no editorial comments to alert readers to the lack of either REB approval or informed consent statements associated with any of the deficient articles.Conclusions: Articles that lack explicit statements of REB approval and informed consent are infrequent but continue to be published in major medical journals without editorial statements to alert the reader to this deficiency. (shrink)

This paper analyses the way articles are published in scientific journals in the field of law in the Republic of Moldova, including an experiment with a previously published article. Lack of compliance with journal publishing standards, including peer reviewing of articles, leads to the fact that virtually any article can be published. The examined journals do not perform their natural functions, but are rather used by researchers to report that they have scientific outcomes. The study allows us to consider (...) that publishing in scientific journals is an indicator of the quality of scientific research, as well as an indicator of compliance with scientific research ethical principles. Scientific misconduct and lack of scientific meritocracy that are characteristic of some of the post-Soviet science, are very well reflected in the law field in the Republic of Moldova. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) (...) research (P = 0.001), more sponsor-country authors (P = 0.003), sponsor-country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host-country involved (P = 0.002), journals having sponsor-country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor-country editors and research being biomedical.Conclusions: One-third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) (...) research (P = 0.001), more sponsor‐country authors (P = 0.003), sponsor‐country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host‐country involved (P = 0.002), journals having sponsor‐country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor‐country editors and research being biomedical.Conclusions: One‐third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

Appeals to scrutinize the use of race and ethnicity as variables in genetics research notwithstanding, these variables continue to be inadequately explained and inconsistently used in research publications. In previous research, we found that published genetic research fails to follow suggestions offered for addressing this problem, such as explaining the basis on which these labels are assigned to populations. This study, an analysis of genetic research articles using race or ethnicity terms, explores possible features of (...) journals that are associated with improved reporting of race and ethnicity in genetic research. A journal’s expressed commitment to improving how race and ethnicity are used in genetic research, demonstrated by an editorial or in its instructions to authors, was the strongest predictor of following recommendations about reporting race and ethnicity. Journal impact factor had only a limited positive effect on attention to these issues, suggesting that editorial resources associated with higher impact factor journals are not sufficient to improve practices. Our findings reiterate that race and ethnicity variables are used inconsistently in genetic research, but also shed light on how journals might improve practices by highlighting the need for scientists to carefully scrutinize the use of these variables in their work. (shrink)

The American Educational Research Association and American Psychological Association published standards for reporting on research. The transparency of reporting measures and data collection is paramount for interpretability and replicability of research. We analyzed 57 articles that assessed alphabet knowledge using researcher-developed measures. The quality of reporting on different elements of AK measures and data collection was not related to the journal type nor to the impact factor or rank of the journal but rather seemed (...) to depend on the individual author, reviewers, and journal editor. We propose various topics related to effective reporting of measures and data collection methods that we encourage the early childhood and literacy communities to discuss. (shrink)

Growing awareness of the ethical implications of neuroscience in the early years of the 21st century led to the emergence of the new academic field of “neuroethics,” which studies the ethical implications of developments in the neurosciences. However, despite the acceleration and evolution of neuroscience research on nonhuman animals, the unique ethical issues connected with neuroscience research involving nonhuman animals remain underdiscussed. This is a significant oversight given the central place of animal models in neuroscience. To respond to (...) these concerns, the Center for Neuroscience and Society and the Center for the Interaction of Animals and Society at the University of Pennsylvania hosted a workshop on the “Neuroethics of Animal Research” in Philadelphia, Pennsylvania. At the workshop, expert speakers and attendees discussed ethical issues arising from neuroscience research involving nonhuman animals, including the use of animal models in the study of pain and psychiatric conditions, animal brain-machine interfaces, animal–animal chimeras, cerebral organoids, and the relevance of neuroscience to debates about personhood. This paper highlights important emerging ethical issues based on the discussions at the workshop. This paper includes recommendations for research in the United States from the authors based on the discussions at the workshop, loosely following the format of the 2 Gray Matters reports on neuroethics published by the Presidential Commission for the Study of Bioethical Issues. (shrink)

BackgroundThe objective of this study was to evaluate the nature and extent of reproducible and transparent research practices in neurology publications.MethodsThe NLM catalog was used to identify MEDLINE-indexed neurology journals. A PubMed search of these journals was conducted to retrieve publications over a 5-year period from 2014 to 2018. A random sample of publications was extracted. Two authors conducted data extraction in a blinded, duplicate fashion using a pilot-tested Google form. This form prompted data extractors to determine whether publications (...) provided access to items such as study materials, raw data, analysis scripts, and protocols. In addition, we determined if the publication was included in a replication study or systematic review, was preregistered, had a conflict of interest declaration, specified funding sources, and was open access.ResultsOur search identified 223,932 publications meeting the inclusion criteria, from which 400 were randomly sampled. Only 389 articles were accessible, yielding 271 publications with empirical data for analysis. Our results indicate that 9.4% provided access to materials, 9.2% provided access to raw data, 0.7% provided access to the analysis scripts, 0.7% linked the protocol, and 3.7% were preregistered. A third of sampled publications lacked funding or conflict of interest statements. No publications from our sample were included in replication studies, but a fifth were cited in a systematic review or meta-analysis.ConclusionsCurrently, published neurology research does not consistently provide information needed for reproducibility. The implications of poor research reporting can both affect patient care and increase research waste. Collaborative intervention by authors, peer reviewers, journals, and funding sources is needed to mitigate this problem. (shrink)

BackgroundPublication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service research ethics committee to monitor both types of reporting bias.MethodsAs part of an internal audit we accessed research ethics database records for studies submitting an (...) end of study declaration to the Hampshire A research ethics committee between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications.ResultsOut of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32 %. Original Research Ethics Committee applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 of the published studies.ConclusionsThis study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research. (shrink)

Objective: This paper describes the variety of ways that information about ethics-related methods are included or not included in public health research articles. Methods: Information about the ethics-related content of all articles published in nine highly-respected public health journals in 2006 was extracted. Results: Of 989 primary analyses, 73% of the articles commented on ethics committee approval or exemption, 63% mentioned participant consent and 9% indicated whether or not inducement or compensation was given. 84% of articles mentioned a funding (...) source, but fewer than 4% identified any potential conflict of interest. Reporting rates for committee review and consent were higher for experimental than for observational studies and were comparatively higher in studies conducted among potentially vulnerable populations like children and residents of low income countries. Conclusions: More complete reporting would facilitate the design, evaluation and comparison of future research studies. (shrink)

The report on educational research, commissioned by the Office for Standards in Education, written by James Tooley with assistance, and published under the title Educational Research: a critique, set out to ‘help provide some badly needed evidence to inform the debate about the quality of educational research’. Whether this ‘snapshot’ actually upholds Hargreaves' contention that there is a considerable amount of ‘second rate educational research’ is far from clear, although Tooley does conclude that the majority of (...) studies surveyed lacked a clear focus, employed sloppy methodology and displayed partisanship. Now, those whose work was critiqued might, with some justification, grumble about Tooley's own ideological bias given his well‐known right‐wing, market‐oriented views about education. Concern could also be directed at the report's methodological inadequacies, including the procedures adopted to select the journal sample, the categories employed for analysis, and the validity of the conclusions reached. I leave all of these for others to address. Rather, I shall examine two basic distinctions which Tooley adopts and deems important for his investigation into the state of educational research in Britain. The first is between empirical and non‐empirical research, the second is between quantitative and qualitative empirical research. Philosophically, both of these distinctions are highly problematic and as a philosopher Tooley should, at the very least, have acknowledged their contentiousness rather than simply taking them for granted. The purpose of this short note is to indicate why Tooley's reliance on these two distinctions will not do. (shrink)

BackgroundThe trend toward open science increases the pressure on authors to provide access to the source code and data they used to compute the results reported in their scientific papers. Since sharing materials reproducibly is challenging, several projects have developed solutions to support the release of executable analyses alongside articles.MethodsWe reviewed 11 applications that can assist researchers in adhering to reproducibility principles. The applications were found through a literature search and interactions with the reproducible research community. An application was (...) included in our analysis if it was actively maintained at the time the data for this paper was collected, supports the publication of executable code and data, is connected to the scholarly publication process. By investigating the software documentation and published articles, we compared the applications across 19 criteria, such as deployment options and features that support authors in creating and readers in studying executable papers.ResultsFrom the 11 applications, eight allow publishers to self-host the system for free, whereas three provide paid services. Authors can submit an executable analysis using Jupyter Notebooks or R Markdown documents. All approaches provide features to assist readers in studying the materials, e.g., one-click reproducible results or tools for manipulating the analysis parameters. Six applications allow for modifying materials after publication.ConclusionsThe applications support authors to publish reproducible research predominantly with literate programming. Concerning readers, most applications provide user interfaces to inspect and manipulate the computational analysis. The next step is to investigate the gaps identified in this review, such as the costs publishers have to expect when hosting an application, the consideration of sensitive data, and impacts on the review process. (shrink)

BackgroundStructured, systematic methods to formulate consensus recommendations, such as the Delphi process or nominal group technique, among others, provide the opportunity to harness the knowledge of experts to support clinical decision making in areas of uncertainty. They are widely used in biomedical research, in particular where disease characteristics or resource limitations mean that high-quality evidence generation is difficult. However, poor reporting of methods used to reach a consensus – for example, not clearly explaining the definition of consensus, or (...) not stating how consensus group panellists were selected – can potentially undermine confidence in this type of research and hinder reproducibility. Our objective is therefore to systematically develop a reporting guideline to help the biomedical research and clinical practice community describe the methods or techniques used to reach consensus in a complete, transparent, and consistent manner.MethodsThe ACCORD project will take place in five stages and follow the EQUATOR Network guidance for the development of reporting guidelines. In Stage 1, a multidisciplinary Steering Committee has been established to lead and coordinate the guideline development process. In Stage 2, a systematic literature review will identify evidence on the quality of the reporting of consensus methodology, to obtain potential items for a reporting checklist. In Stage 3, Delphi methodology will be used to reach consensus regarding the checklist items, first among the Steering Committee, and then among a broader Delphi panel comprising participants with a range of expertise, including patient representatives. In Stage 4, the reporting guideline will be finalised in a consensus meeting, along with the production of an Explanation and Elaboration document. In Stage 5, we plan to publish the reporting guideline and E&E document in open-access journals, supported by presentations at appropriate events. Dissemination of the reporting guideline, including a website linked to social media channels, is crucial for the document to be implemented in practice.DiscussionThe ACCORD reporting guideline will provide a set of minimum items that should be reported about methods used to achieve consensus, including approaches ranging from simple unstructured opinion gatherings to highly structured processes. (shrink)

Abstract:Human and animal research both operate within established standards. In the United States, criticism of the human research environment and recorded abuses of human research subjects served as the impetus for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the resulting Belmont Report. The Belmont Report established key ethical principles to which human research should adhere: respect for autonomy, obligations to beneficence and justice, and special (...) protections for vulnerable individuals and populations. While current guidelines appropriately aim to protect the individual interests of human participants in research, no similar, comprehensive, and principled effort has addressed the use of (nonhuman) animals in research. Although published policies regarding animal research provide relevant regulatory guidance, the lack of a fundamental effort to explore the ethical issues and principles that should guide decisions about the potential use of animals in research has led to unclear and disparate policies. Here, we explore how the ethical principles outlined in the Belmont Report could be applied consistently to animals. We describe how concepts such as respect for autonomy and obligations to beneficence and justice could be applied to animals, as well as how animals are entitled to special protections as a result of their vulnerability. (shrink)

Authors, reviewers, and editors have critical responsibilities to ensure the validity and utility of published biomedical research.

The report on educational research, commissioned by the Office for Standards in Education, written by James Tooley with assistance, and published under the title Educational Research: a critique, set out to ‘help provide some badly needed evidence to inform the debate about the quality of educational research’ . Whether this ‘snapshot’ actually upholds Hargreaves' contention that there is a considerable amount of ‘second rate educational research’ is far from clear, although Tooley does conclude that the majority (...) of studies surveyed lacked a clear focus, employed sloppy methodology and displayed partisanship. Now, those whose work was critiqued might, with some justification, grumble about Tooley's own ideological bias given his well‐known right‐wing, market‐oriented views about education. Concern could also be directed at the report's methodological inadequacies, including the procedures adopted to select the journal sample, the categories employed for analysis, and the validity of the conclusions reached. I leave all of these for others to address. Rather, I shall examine two basic distinctions which Tooley adopts and deems important for his investigation into the state of educational research in Britain. The first is between empirical and non‐empirical research, the second is between quantitative and qualitative empirical research. Philosophically, both of these distinctions are highly problematic and as a philosopher Tooley should, at the very least, have acknowledged their contentiousness rather than simply taking them for granted. The purpose of this short note is to indicate why Tooley's reliance on these two distinctions will not do. (shrink)

The recently published Report of theAHAG on the Operation of NHS Research Ethics Committees advocates major reforms of the NHS research ethics committees system. The main implications of the proposed changes and their probable effects on the major stakeholders are described.The Ad Hoc Advisory Group on the operation of NHS research ethics committees, set up in November 2004 by Lord Warner on behalf of the Department of Health, submitted its report in June 2005.1 The report advocates major (...) reforms of the research ethics committee system. The primary aim of the report is to streamline the processes around the approval of research projects and to pursue conformity of governance across Europe. Implicit in the report is the contention that failure to achieve this objective would be harmful to everyone with vested interests in improving health and social care. Moreover, it is stated that the reforms will enhance the mechanisms that protect the interests of all parties concerned.1Being mindful of two published critiques of the Warner Report, we suggest that its alleged benefits should not be taken at face value.2,3 In fact, the reformed system will give rise to moral failings akin to those of the existing system, but will differ from the existing system in its effect on the stakeholders. Thus, whereas the outgoing system has given each stakeholder a unique mixture of benefit and harm, the incoming system offers benefit only to sponsors and researchers and nothing but detriment to participants in research and consumers of its products.In the light of this conclusion, we finally suggest that the Warner Report be construed not merely as an ill-considered document, but rather as an ideological reflection of a long-established hegemonic contract fine-tuning itself to contemporary global challenges.To avoid …. (shrink)

The Weatherall report on the use of non-human primates in research was published in 2006. Its main conclusion was that there is a strong scientific case for the use of non-human primates in some cases, but the report stressed the importance of evaluating each case in the light of the availability of alternatives. In addition to arguing for the scientific necessity of using non-human primates in research, the report also provided an ethical justification. As could be expected, the (...) report was harshly criticised by animal rights groups, but in the academic literature, only two critical replies appeared. In what follows, I will describe the ethical justification for non-human primate research as it is laid out in the Weatherall report and then consider the criticism in the academic literature. I conclude that the report’s ethical justification for the use of non-human primates in research, in particular in basic neuroscientific research, has not been convincingly challenged by its critics. Since the criticism of the report is limited and represents only a small part of the academic discussion about the use of non-human primates in research, and a still smaller part of the ethical discussion about animal research, it is important that the discussion continue both at the academic and social level. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women (...) have been inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

As a legal aid union president in New Haven, laboring within shouting distance of a different large research university, I recall how our membership rolled our eyes when Professors Greiner, Pattanayak, and Hennesy of Harvard published their study providing evidence, through a randomized control trial, that law clinic housing work made no difference for clients.1 Representing, as I was, “lawyers, secretaries, and paralegals who have dedicated their careers to serving poor clients in crisis,”2 the authors’ conclusion generated first shock, (...) then denial, and then an anxious realization that somebody’s job was to research and disseminate such conclusions. In a 2013 United States where there was one legal aid lawyer for every 8,893 people who qualified,3 where federal Legal Services Corporation funding had dropped 40% over ten years in real dollars,4 and in an America that spends as much on Halloween costumes for its pets as it does legal aid for the poor,5 the inquiry felt like a pile-on. It made no more sense to us than asking if a teacher is “good for students,” a nurse “good for the sick,” or a chef “good for the hungry.”6. (shrink)

Ethical research conduct is a cornerstone of research practice particularly when research participants include vulnerable populations. This study mapped the extent of reporting ethical research practices in studies conducted among refugees and war-affected populations in the Arab World, and assessed variations by time, country of study, and study characteristics. An electronic search of eight databases resulted in 5668 unique records published between 2000 and 2013. Scoping review yielded 164 eligible articles for analyses. Ethical research (...) practices, including obtaining institutional approval, access to the community/research site, and informed consent/assent from the research participants, were reported in 48.2, 54.9, and 53.7% of the publications, respectively. Institutional approval was significantly more likely to be reported when the research was biomedical in nature compared to public health and social, when the study employed quantitative compared to qualitative or mixed methodologies, and when the journal required a statement on ethical declarations. Institutional approval was least likely to be reported in papers that were sole-authored, when these did not mention a funding source, or when published in national journals. Similar results were obtained for access to the community site and for seeking informed consent/assent from study participants. The responsibility of inadequacies in adherence to ethical research conduct in crisis settings is born by a multitude of stakeholders including funding agencies, institutional research boards, researchers and international relief organizations involved in research, as well as journal editors, all of whom need to play a more proactive role for enhancing the practice of ethical research conduct in conflict settings. (shrink)

The advance of science and human knowledge is impeded by misunderstandings of various statistics, insufficient reporting of findings, and the use of numerous standardized and non-standardized presentations of essentially identical information. Communication with journalists and the public is hindered by the failure to present statistics that are easy for non-scientists to interpret as well as by use of the word significant, which in scientific English does not carry the meaning of "important" or "large." This article promotes a new standard (...) method for reporting two-group and two-variable statistics that can enhance the presentation of relevant information, increase understanding of findings, and replace the current presentations of two-group ANOVA, t-tests, correlations, chi-squares, and z-tests of proportions. A brief call to highly restrict the publication of risk ratios, odds ratios, and relative increase in risk percentages is also made, since these statistics appear to provide no useful scientific information regarding the magnitude of findings. (shrink)

Reports of research fraud have raised concerns about research integrity similar to concerns raised about financial accounting fraud. We propose a departure from self-regulation in that researchers adopt the financial accounting approach in establishing trust through an external validation process, in addition to the reporting entities and the regulatory agencies. The general conceptual framework for reviewing financial reports, utilizes external auditors who are certified and objective in using established standards to provide an opinion on the financial reports. (...) These standards have become both broader in scope and increasingly specific as to what information is reported and the methodologies to be employed. We believe that the financial reporting overhaul encompassed in the US Sarbanes–Oxley Act of 2002, which aims at preventing accounting fraud, can be applied to scientific research in 4 ways. First, Sarbanes–Oxley requires corporations to have a complete set of internal accounting controls. Research organizations should use appropriate sampling techniques and audit research projects for conformity with the initial research protocols. Second, corporations are required to have the chief financial officer certify the accuracy of their financial statements. In a similar way, each research organization should have their vice-president of research (or equivalent) certify the research integrity of their research activities. In contrast, the primary responsibility of the existing Research Integrity Officers is to handle allegations of research misconduct, an after-the-fact activity. Third, generally accepted auditing standards specify the appropriate procedures for external review of a corporation’s financial statements. For similar reasons, the research review process would also require corresponding external auditing standards. Finally, these new requirements would be implemented in stages, with the largest 14 research organizations that receive 25% of the total National Institutes of Health funding, adopting these research oversight enhancements first. (shrink)

Background: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants.Objective: To assess the reporting of these protections for several study designs in general medical journals.Design: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical (...) approval and patient consent. Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression.Results: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs than in randomised controlled trials . Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants.Conclusion: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants. (shrink)

Priorities in Medical Research was published in 1988 by a select committee of the House of Lords. The report ushered in an era of NHS research and development that lasted from 2001 to 2006. The inquiry's origins lay in concerns about academic medicine in the United Kingdom, yet PMR gave relatively little attention to this subject. Instead the report focused critically on the disconnect between the Department of Health and the NHS in R & D. This, the committee (...) argued, had led to the neglect of research into health services and public health. To sidestep the report's unwelcome proposal for a National Health Research Agency, the department eventually grafted R & D management onto structures created as part of wider NHS reforms. The Medical Research Council successfully pursued a strategy of keeping the committee's attention away from sensitive aspects of its own programme. The final focus of PMR was shaped by an alignment between committee members with an industrial view of research and champions of health services research. The actions of the various actors involved are interpreted using elite models of the state, and the applicability of these models is critically examined. (shrink)

In 2011 the Swiss government published a report on homeopathy. This report was commissioned following a 2009 referendum in which Swiss people decided that homeopathy and other alternative therapies should be covered by private medical insurance; before implementing this decision, the government wanted to establish whether homeopathy actually works. In February 2012 the report was published in English and was immediately proclaimed by proponents of homeopathy to be conclusive proof that homeopathy is effective. This paper analyses the report and concludes (...) that it is scientifically, logically and ethically flawed. Specifically, it contains no new evidence and misinterprets previously debunked studies; it creates a new standard of evidence in order to make homeopathy appear effective and attempts to discredit randomised controlled trials as the gold standard of evidence; and almost all the authors have conflicts of interest, despite their claim that none exist. If anything, the report proves that homeopaths are willing to distort the evidence in order to support their beliefs, and its authors appear to have violated the Swiss Academies of Arts and Sciences principles governing scientific integrity. (shrink)

It is accepted that research should be systematically examined to judge its trustworthiness and value in a particular context. No such appraisal is required of reports published by organizations that have possibly even greater influence on policy that affects the public. This paper explores a philosophical framework for appraising reports. It gives the reasons why informed engagement is important, drawing on Popper's concept of the open society, and it suggests a method for appraisal. Gadamer's concept of the two horizons (...) and Jauss's reception theory offer a methodological framework to enable the individual citizen, whether professional or lay, to engage in debate about policy that affects him or her. By way of a worked example, the framework is applied to two international reports on nursing. Conclusions suggest that nursing policy should be subjected to robust interrogatory appraisal by both profession and public for a democratic debate and creative discourse. Although this analysis is related to international nursing policy, it has a wider relevance and application beyond nursing. (shrink)

ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (...) (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).DiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research. (shrink)

This paper uses a case study of a 1970s controversy in artificial-intelligence research to explore how scientists understand the relationships between research and practical applications. It is part of a project that seeks to map such relationships in order to enable better policy recommendations to be grounded empirically through historical evidence. In 1972 the mathematician James Lighthill submitted a report, published in 1973, on the state of artificial-intelligence research under way in the United Kingdom. The criticisms made (...) in the report have been held to be a major cause behind the dramatic slowing down of such research. This paper has two aims, one narrow and one broad. The narrow aim is to inquire into the causes, motivations and content of the Lighthill report. I argue that behind James Lighthill's criticisms of a central part of artificial intelligence was a principle he held throughout his career – that the best research was tightly coupled to practical problem solving. I also show that the Science Research Council provided a preliminary steer to the direction of this apparently independent report. The broader aim of the paper is to map some of the ways that scientists have articulated and justified relationships between research and practical, real-world problems, an issue previously identified as central to historical analysis of modern science. The paper therefore offers some deepened historical case studies of the processes identified in Agar's ‘working-worlds’ model. (shrink)

The progression of research and scholarly inquiry does not occur in isolation and is wholly dependent on accurate reporting of methods and results, and successful replication of prior work. Without mechanisms to correct the literature, much time and money is wasted on research based on a crumbling foundation. These guidelines serve to outline the respective responsibilities of researchers, institutions, agencies, and publishers or editors in maintaining the integrity of the research record. Delineating these complementary roles and (...) proposing solutions for common barriers provide a foundation for best practices. (shrink)

Teaching research methods is especially challenging because we not only wish to convey formal knowledge and encourage critical thinking, as with any course, but also to enable our students dream up meaningful research projects, translate them into logical steps, conduct the research in a professional manner, analyze the data, and write up the project in APA style. We also wish to spark interest in the topics of research papers, and in the intellectual challenge of creating a (...) research report, but we have learned just how difficult these goals can be from teaching undergraduates and from serving as journal reviewers: many submissions contain flaws such as elementary errors of logic (e.g., using a null control condition instead of a placebo or dummy treatment), tangled statistics, a lack of graphs, and ungrammatical, unclear writing that violates APA rules. Yet these manuscripts are written by university faculty, often with doctorates and years of experience. Even published papers may contain egregious faults (Standing & McKelvie, 1986). And although we have both published widely, we still hone our skills. It requires optimism to expect that a typical undergraduate will do better, on the basis of just a year or two of studies in psychology. In this paper, we describe a systematic set of methodology courses and two specific practices that we think can help. Methodology Courses as the Backbone of our Psychology Program How can methodology courses promote undergraduate involvem... (shrink)

BackgroundIn their research reports, scientists are expected to discuss limitations that their studies have. Previous research showed that often, such discussion is absent. Also, many journals emphasize the importance of avoiding overstatement of claims. We wanted to see to what extent editorial handling and peer review affects self-acknowledgment of limitations and hedging of claims.MethodsUsing software that automatically detects limitation-acknowledging sentences and calculates the level of hedging in sentences, we compared the submitted manuscripts and their ultimate publications of all (...) randomized trials published in 2015 in 27 BioMed Central (BMC) journals and BMJ Open. We used mixed linear and logistic regression models, accounting for clustering of manuscript-publication pairs within journals, to quantify before-after changes in the mean numbers of limitation-acknowledging sentences, in the probability that a manuscript with zero self-acknowledged limitations ended up as a publication with at least one and in hedging scores.ResultsFour hundred forty-six manuscript-publication pairs were analyzed. The median number of manuscripts per journal was 10.5 (interquartile range 6–18). The average number of distinct limitation sentences increased by 1.39 (95% CI 1.09–1.76), from 2.48 in manuscripts to 3.87 in publications. Two hundred two manuscripts (45.3%) did not mention any limitations. Sixty-three (31%, 95% CI 25–38) of these mentioned at least one after peer review. Changes in mean hedging scores were negligible.ConclusionsOur findings support the idea that editorial handling and peer review lead to more self-acknowledgment of study limitations, but not to changes in linguistic nuance. (shrink)

As things stand today, whether we like it or not, industry funding is on the upswing. The whole enterprise of medicine in booming, and it makes sense for industry to invest more and more of one's millions into it. The pharmaceutical industry has become the single largest direct funding agency of medical research in countries like Canada, the United Kingdom and the United States. Since the goals of industry and academia differ, it seems that conflicts of interest are inevitable (...) at times. The crucial decision is whether the public welfare agenda of academia, or the corporate research agenda of industry, should occupy center stage when they conflict. There is enough evidence to show that funding by industry is very systematic, and results that are supportive of the safety and efficacy of sponsor's products alone get the funds. It is no surprise, therefore, that one finds very few negative drug trials reports published, and whatever are, are likely to be by rival companies to serve their commercial interests. Renewed and continued funding by industry decides the future prospects of many academic researchers. At the same time there is now evidence that pharmaceutical companies attempt suppression of research findings, may be selective in publishing results, and may delay or stymie publication of unfavourable results. This is a major area of concern for all conscientious researchers and industry watchers. Industry commonly decides which clinical research/trial gets done, not academia, much though the latter may wish to believe otherwise. It finds willing researchers to carry this out. This can be one area of concern. Another area of pressing concern is when industry decides to both design and control publication of research. It makes sense for researchers to refuse to allow commercial interests to rule research reporting. Research having been reported, the commercial implications of such reporting is industry's concern. But, doctoring of findings to suit commerce is to be resisted at all costs. In this even pliant researchers need have no fear, for if they indeed publish what will work, the concerned sponsor will benefit in the long run. The only decision academia has to make is refuse to comply with predestined conclusions of sponsors for the 'thirty pieces of silver'. Instead do genuine research and make sixty for themselves. The useful rule of thumb is: Keep the critical antenna on, especially with regard to drug trials, and more especially their methodology, and study closely the conflict of interest disclosed, and if possible undisclosed, before you jump on the band wagon to herald the next great wonder drug. There are three important lessons to be learnt by academia in all academia-industry relationships: i) Lesson number one: incorporate the right to publish contrary findings in the research contract itself. Which means, it makes great sense for academia to concentrate on the language and contractual provisions of sponsored research, to read the fine print very closely, and protect their research interests in case of conflict. ii) Lesson number two: a number of lawsuits successfully brought up against industry recently reflect earnest attempts by patient welfare bodies and others to remedy the tilt. It will result in a newfound confidence in academia that augurs well for academia industry relationship in the long run. Hence the second lesson for academia: do not get browbeaten by threats of legal action iii) Lesson number three: Academia should keep itself involved right from inception of the clinical trial through to ultimate publication. And this must be an integral part of the written contract. The time to repeat cliches about the exciting future of the academia-industry connect is past. A concerted effort to lay a strong foundation of the relationship on practical ethical grounds has become mandatory. (shrink)

This article examines the relationship between action research and policy and the kind of confidence teachers, policy makers and other potential users may have in such research. Many published teacher action research accounts are criticised on the grounds that they do not fully meet the conventional standards for reporting social scientific research, and by implication are held to be less trustworthy. Action research is nevertheless often seen by some academics and policy makers as a (...) potential method for developing theory, disseminating good practice, or raising standards. Through a discussion of three major approaches to action research—seen variously as professional learning, practical philosophy and critical social science—it is argued that judgements about confidence depend upon understanding the various kinds of knowledge claim that can be made by action researchers, and appropriate judgements concerning the strength of evidence or reasons. (shrink)

In June 2017, Japanese and Korean authors published the results of the CREATE‐X trial in the New England Journal of Medicine (NEJM). After we identified their inadequate disclosures of Financial Conflict of Interests (FCOIs), the authors made a post‐publication correction of their FCOIs. The purpose of this study is to evaluate the accuracy of the post‐publication corrections by the Japanese authors of the CREATE‐X trial. All the Japanese authors of the CREATE‐X trial were included in the study. We determined the (...) payments received by these authors in 2016 using publicly available data published by 78 pharmaceutical companies based on the stipulated Japanese transparency guidelines. We retrieved the original and revised versions of the FCOI disclosures as published on the NEJM website, and compared the payments reported by the pharmaceutical companies and the original and revised FCOI disclosures of the authors. Of the 12 authors, nine received payments made by the drug manufacturer involved in the CREATE‐X trial. Of these nine, only three (33.3%) originally disclosed their relationships, and another three (33.3%) later disclosed such relationships in the post‐publication corrections. Similarly, of the 11 receiving at least one payment from other manufacturers of breast cancer products, none correctly disclosed the payments in the original or the revised disclosure. In the CREATE‐X trial, FCOIs with pharmaceutical companies were not properly disclosed by 11 of the 12 Japanese authors, even after the post‐publication corrections, which highlights the need to pay more attention to the accuracy of FCOI disclosures in academic publications. (shrink)

Background: For many years, studies have shown that the results of clinical trials are often published or reported selectively with a statistically significant bias in favour of positive trial results. Trial registration as a precondition for publication had only limited effects on current practice. Results of trials which were approved by research ethics committees are often published only partially, with a substantial time lag or not at all. This study examined existing procedures of RECs in the European Union to (...) monitor and prevent incomplete registration of trials and selective reporting of trial results. It further investigated opinions of REC members about the need to update current legislation on this matter. Methods: Web-based survey on members of RECs in 22 European countries. Results: Over 90 percent of respondents agreed that the incomplete publication of trial results had a strong or somewhat negative impact on public health and on healthcare professionals’ trust in the validity of clinical research, yet only 30 percent reported that their REC had some mechanism in place to check that findings of approved studies are published in some form. Less than 10 percent stated that their REC has further specific procedures in place to prevent or minimize selective reporting of study results. Respondents stated variously that their REC did not have the resources to follow up on this matter. Conclusions: The existing legislation to regulate trial registration and encourage complete publication of trial results leaves room for improvement. REC members welcome guidelines to adequately address both problems. The new Regulation EU No. 536/2014 as well as the FDA Amendment Act from 2007 require the reporting of summary results within 1 year after study end. As recent reviews demonstrated, without any systematic approach to monitor the adherence to these regulations, publication rates remain rather low. (shrink)

This is the second instalment of a two-part article. Part 1 of this article appeared in Logos, 30. Part 2 sets out a number of suggestions to strengthen the book industries in Africa, and the way forward, especially on capacity- and skills-building; training for book industry personnel; strengthening book professional associations, South–South linkages, and knowledge-sharing; encouraging international collaboration; the need for ongoing research and documentation; African books in the global marketplace; and the important but still neglected area of (...) class='Hi'>publishing in African indigenous languages. An Appendix provides a summary of the International Publishers Association and Association for the Development of Education in Africa meetings on the African book industry, held in Nairobi in June 2019, together with links to a number of articles, reports, and press statements about the meetings. (shrink)

As new ideas arose during the Enlightenment, many political thinkers published their own versions of popular early modern "absolutist" texts and transformed them into manuals of political resistance. As a result, these works never achieved a fixed and stable edition. Publishing The Prince illustrates how Abraham-Nicolas Amelot de La Houssaye created the most popular late seventeenth- and eighteenth-century version of Machiavelli's masterpiece. In the process of translating, Amelot also transformed the work, altering its form and meaning, and his ideas (...) spread through later editions. Revising the orthodox schema of the public sphere in which political authority shifted away from the crown with the rise of bourgeois civil society in the eighteenth century, Soll uses the example of Amelot to show for the first time how the public sphere in fact grew out of the learned and even royal libraries of erudite scholars and the bookshops of subversive, not-so-polite publicists of the republic of letters. Jacob Soll is Associate Professor of History at Rutgers University. Cover art courtesy of Annenberg Rare Book Room and Manuscript Library, University of Pennsylvania Jacket Design: Stephanie Milanowski "Jacob Soll traces the origins of Enlightenment criticism to the practices of learned humanists and hard-pressed literary entrepreneurs. This learned and lively book is also a tour de force of historical research and interpretation." ---Anthony Grafton, author of Cardano's Cosmos and Bring Out Your Dead "Brilliant. How the printed page changed political philosophy into investigative reporting, and reason of state into the unmasking of power." ---J. G. A. Pocock, author of The Machiavellian Moment "Soll's path-breaking study is a 'must read' for all those interested in the history of political thought and early modern intellectual history." ---Barbara Shapiro, University of California Berkeley "Soll has done [Amelot] and his context justice, writing as he does with a clear, singular, and welcome voice." ---Margaret C. Jacobs, American Historical Review. (shrink)

Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed (...) the use of animals in research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries. (shrink)