Results for 'Research standards'

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  1.  21
    The Postmodern University?: Contested Visions of Higher Education in Society.Anthony Smith, Frank Webster & Society for Research Into Higher Education - 1997 - Open University Press.
    Higher education has been changing radically in recent years, with increasing numbers of students, and complaints about declining standards. This volume brings together leading intellectuals from the US and UK to examine the issues involved.
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  2.  43
    Risk Standards for Pediatric Research: Rethinking the Grimes Ruling.David Wendler - 2004 - Kennedy Institute of Ethics Journal 14 (2):187-198.
    In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (...)
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  3.  8
    No recognised ethical standards, no broad consent: navigating the quandary in computational social science research.Seliem El-Sayed & Filip Paspalj - forthcoming - Research Ethics.
    Recital 33 GDPR has often been interpreted as referring to ‘broad consent’. This version of informed consent was intended to allow data subjects to provide their consent for certain areas of research, or parts of research projects, conditional to the research being in line with ‘recognised ethical standards’. In this article, we argue that broad consent is applicable in the emerging field of Computational Social Science (CSS), which lies at the intersection of data science and social (...)
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  4.  73
    Standards of practice in empirical bioethics research: towards a consensus.Jonathan Ives, Michael Dunn, Bert Molewijk, Jan Schildmann, Kristine Bærøe, Lucy Frith, Richard Huxtable, Elleke Landeweer, Marcel Mertz, Veerle Provoost, Annette Rid, Sabine Salloch, Mark Sheehan, Daniel Strech, Martine de Vries & Guy Widdershoven - 2018 - BMC Medical Ethics 19 (1):68.
    This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and (...)
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  5. Standards for research ethics committees: purpose, problems and the possibilities of other approaches.H. Davies, F. Wells & M. Czarkowski - 2009 - Journal of Medical Ethics 35 (6):382-383.
    Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are “fit for purpose” by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting standards for RECs in the European Union. Representatives from 27 countries were invited; 16 were represented. Problems identified were the limited and variable (...)
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  6.  51
    National Standards for Public Involvement in Research: missing the forest for the trees.Matthew S. McCoy, Karin Rolanda Jongsma, Phoebe Friesen, Michael Dunn, Carolyn Plunkett Neuhaus, Leah Rand & Mark Sheehan - 2018 - Journal of Medical Ethics 44 (12):801-804.
    Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. (...)
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  7.  19
    Defining Standard of Care in the Developing World: The Intersection of International Research Ethics and Health Systems Analysis.Liza Dawson Adnan A. Hyder - 2005 - Developing World Bioethics 5 (2):142-152.
    ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of (...)
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  8.  8
    Advance research directives: avoiding double standards.Bert Heinrichs - 2021 - BMC Medical Ethics 22 (1):1-8.
    BackgroundAdvance research directives (ARD) have been suggested as a means by which to facilitate research with incapacitated subjects, in particular in the context of dementia research. However, established disclosure requirements for study participation raise an ethical problem for the application of ARDs: While regular consent procedures call for detailed information on a specific study (“token disclosure”), ARDs can typically only include generic information (“type disclosure”). The introduction of ARDs could thus establish a double standard in the sense (...)
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  9. Ten standard Objections to Qualitative Research Interviews.Steinar Kvale - 1994 - Journal of Phenomenological Psychology 25 (2):147-173.
    Qualitative research has tended to evoke rather stereotyped objections from the mainstream of social science. Ten standardized responses to the stimulus "qualitative research interview" are discussed: it is not scientific, not objective, not trustworthy, nor reliable, not intersubjective, not a formalized method, not hypothesis testing, not quantitative, not generalizable, and not valid. With the objections to qualitative interviews highly predictable, they may be taken into account when designing, reporting, and defending an interview study. As a help for new (...)
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  10. Advance Research Directives in Germany: A Proposal for a Disclosure Standard.Matthé Scholten - 2018 - GeroPsych: The Journal of Gerontopsychology and Geriatric Psychiatry 31 (2):77-86.
    The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the (...)
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  11.  23
    Standards for Research Ethics Committees: Purpose, Problems and Possibilities.Hugh Davies - 2008 - Research Ethics 4 (4):152-157.
    This paper reports an initiative from the National Research Ethics Service and research ethics committees in the UK to develop a shared ethical debate between committees and to promote standards of ethical review, exploring the problems and practicalities of such an approach.
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  12.  50
    Standardized Study Designs, Value Judgments, and Financial Conflicts of Interest in Research.Kevin C. Elliott - 2016 - Perspectives on Science 24 (5):529-551.
    . The potential for financial conflicts of interest to influence scientific research has become a significant concern. Some commentators have suggested that the development of standardized study protocols could help to alleviate these problems. This paper identifies two problems with this solution: scientific research incorporates numerous methodological judgments that cannot be constrained by standardized protocols; and standardization can hide significant value judgments. These problems arise because of four weaknesses of standardized guidelines: incompleteness, limited applicability, selective ignorance, and ossification. (...)
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  13.  43
    Risk standards for pediatric research: Rethinking the.David Wendler - 2004 - Kennedy Institute of Ethics Journal 14 (2):187-198.
    : In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given (...)
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  14.  76
    Local Research Ethics Committees can audit ethical standards in research.J. Berry - 1997 - Journal of Medical Ethics 23 (6):379-381.
    OBJECTIVES: To show that a Local Research Ethics Committee (LREC) can carry out an audit of ethical standards in research. To find out if a researcher met certain ethical standards in recruiting subjects for clinical trials and in obtaining their consent. DESIGN: Postal questionnaire. SETTING: Clinical research by one doctor during one year. SUBJECTS: Eleven patients entered in clinical trials. MAIN OUTCOME MEASURES: Success in ethics committee obtaining data. Achievement of ethical standards in recruitment (...)
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  15.  63
    Standards for animal research: Looking at the middle.Rebecca Dresser - 1988 - Journal of Medicine and Philosophy 13 (2):123-143.
    Much of the public debate over laboratory animal use has focused on either the scientist's demand for absolute freedom of inquiry, or the abolitionist's demand for an end to animal use in science. Yet many recent proposals for reform seek instead to balance the interests of laboratory animals in avoiding harm against the interests of research beneficiaries in continued animal use. This essay is an analysis of the intermediate reform positions and their underlying ethical principles. Keywords: animal research, (...)
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  16.  50
    Defining standard of care in the developing world: The intersection of international research ethics and health systems analysis.Adnan A. Hyder & Liza Dawson - 2005 - Developing World Bioethics 5 (2):142–152.
    ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of (...)
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  17. ""Moral Standards for Research in Developing Countries from" Reasonable Availability" to" Fair Benefits".Maged El Setouhy, Tsiri Agbenyega, Francis Anto, Christine Alexandra Clerk, Kwadwo A. Koram, Michael English, Rashid Juma, Catherine Molyneux, Norbert Peshu & Newton Kumwenda - forthcoming - Hastings Center Report.
     
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  18.  33
    Moral Standards for Research in Developing Countries from "Reasonable Availability" to "Fair Benefits".Maged El Setouhy, Tsiri Agbenyega, Francis Anto, Christine Alexandra Clerk, Kwadwo A. Koram, Michael English, Rashid Juma, Catherine Molyneux, Norbert Peshu, Newton Kumwenda, Joseph Mfutso-Bengu, Malcolm Molyneux, Terrie Taylor, Doumbia Aissata Diarra, Saibou Maiga, Mamadou Sylla, Dione Youssouf, Catherine Olufunke Falade, Segun Gbadegesin, Reidar Lie, Ferdinand Mugusi, David Ngassapa, Julius Ecuru, Ambrose Talisuna, Ezekiel Emanuel, Christine Grady, Elizabeth Higgs, Christopher Plowe, Jeremy Sugarman & David Wendler - 2004 - Hastings Center Report 34 (3):17.
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  19.  17
    Standardizing Practices: A Socio-History of Experimental Systems in Classical Genetic and Virological Cancer Research, ca. 1920-1978.Joan H. Fujimura - 1996 - History and Philosophy of the Life Sciences 18 (1):3 - 54.
    This paper presents a narrative history of technologies in cancer research circa 1920-1978 and a theoretical perspective on the complex, intertwined relationships between scientific problems, material practices and technologies, concepts and theories, and other historical circumstances. The history presents several active lines of research and technology development in the genetics of cancer in the United States which were constitutive of protooncogene work in its current form. I write this history from the perspective of technology development. Scientists participating in (...)
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  20.  16
    Defining Research Risk in Standard of Care Trials: Lessons from SUPPORT.Joel K. Press & Caryn J. Rogers - 2017 - Journal of Medicine and Philosophy 42 (2):184-198.
    Recent controversy surrounding the Surfactant Positive Airway Pressure and Pulse Oximetry Trial and the Office for Human Resource Protection’s judgment that its informed consent procedures were inadequate has unmasked considerable confusion about OHRP’s definition of research risks. The controversy concerns application of that definition to trials comparing multiple treatments within the existing standard of care. Some have argued that it is impossible for such trials to pose research risks on the grounds that all risks associated with a standard-of-care (...)
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  21.  44
    Setting standards for empirical bioethics research: a response to Carter and Cribb.Michael Dunn, Jonathan Ives, Bert Molewijk & Jan Schildmann - 2018 - BMC Medical Ethics 19 (1):66.
    This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and (...)
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  22.  29
    Consensus standards for introductory e-learning courses in human participants research ethics.John Williams, Dominique Sprumont, Marie Hirtle, Clement Adebamowo & Paul Braunschweiger - 2014 - Journal of Medical Ethics 40 (6):426-428.
    This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of (...)
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  23.  16
    Standards of Conducts for Biostatisticians and Stem Cell Researchers: A Call for Self-formulated Aspirational Ethics Over Built-in Prohibitive Ethics.Keiko Sato & Mika Suzuki - 2022 - Science and Engineering Ethics 28 (2):1-20.
    We proposed the Standards of Conducts to provide a general framework that will serve as the basis for guiding each biostatistician and stem cell researcher to formulate their personal standards, rather than as rules with which they are required to comply. Given the responsibility and characteristics of their work, they are expected to maintain independence and work autonomously as professionals. Each of the Standards of Conducts comprises a preamble, mission and values to uphold, Standards of Conducts, (...)
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  24.  29
    Standard of Care in Clinical Research Involving Human Subjects: A Perspective from Developing World.Muhammad Waseem Khan, Sanam Zeib Khan, Afrasiab Khan Tareen & Imrana Niaz Sultan - 2014 - Bangladesh Journal of Bioethics 5 (2):68-72.
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  25.  13
    The Reasonable Person Standard for Research Disclosure: A Reasonable Addition to the Common Rule.Rebecca Dresser - 2019 - Journal of Law, Medicine and Ethics 47 (2):194-202.
    The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, (...)
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  26.  5
    Ethical standards for research on marine mammals.Vassili Papastavrou & Conor Ryan - 2023 - Research Ethics 19 (4):390-408.
    Conducting marine mammal research can raise several important ethical issues. For example, the continuation of whaling for commercial purposes despite the international moratorium provides opportunities for scientists to obtain data and tissue samples. In 2021 we analysed 35 peer-reviewed papers reporting research based on collaborations with Icelandic whalers. Results highlighted little consideration or understanding of the legal and ethical issues associated with the deliberate killing of whales amongst those researchers, funding bodies, universities and journals involved. Ethical statements were (...)
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  27.  76
    The 'Standard of Care' Debate and Global Justice in Research.Sapfo Lignou - 2011 - Research Ethics 7 (1):5-12.
    In this essay the ethical issues related to the ‘standard of care’ are discussed together with the implications for the treatment of the control group in transnational clinical trials. It is argued that the human right to health and the duty of justice formulate the moral basis on which this case should be debated.
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  28.  28
    Standard of care in clinical research with human tissue engineered products (hteps).Leen Trommelmans & Kris Dierickx - 2009 - American Journal of Bioethics 9 (3):44 – 45.
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  29. Legal and regulatory standards of informed consent in research.A. M. Capron - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 613--32.
     
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  30.  26
    Research towards an expanded understanding of inquiry science beyond one idealized standard.Nancy Butler Songer, Hee‐Sun Lee & Scott McDonald - 2003 - Science Education 87 (4):490-516.
  31. Research site monitoring for compliance with ethics regulatory standards: review of experience from Uganda. [REVIEW]Joseph Ochieng, Julius Ecuru, Frederick Nakwagala & Paul Kutyabami - 2013 - BMC Medical Ethics 14 (1):23.
    On site monitoring of research is one of the most effective ways to ensure compliance during research conduct. However, it is least carried out primarily for two reasons: presumed high costs both in terms of human resources and finances; and the lack of a clear framework for undertaking site monitoring. In this paper we discuss a model for research site monitoring that may be cost effective and feasible in low resource settings.
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  32. HIV prevention research and global inequality: steps towards improved standards of care.K. Shapiro - 2005 - Journal of Medical Ethics 31 (1):39-47.
    Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of care (...)
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  33. Ten standard objections to qualitative research interviews.K. Steinar - 1994 - Journal of Phenomenological Psychology 25 (2):147-173.
     
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  34.  33
    Ethical standards for human subject research in developing countries.Judith Miller & B. J. Crigger - 1992 - IRB: Ethics & Human Research 14 (3):7.
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  35.  23
    “Nanostandardization” in Action: Implementing Standardization Processes in a Multidisciplinary Nanoparticle-Based Research and Development Project.François Roubert, Marie-Gabrielle Beuzelin-Ollivier, Margarethe Hofmann-Amtenbrink, Heinrich Hofmann & Alessandra Hool - 2016 - NanoEthics 10 (1):41-62.
    Nanomaterials have attracted much interest in the medical field and related applications as their distinct properties in the nanorange enable new and improved diagnosis and therapies. Owing to these properties and their potential interactions with the human body and the environment, the impact of nanomaterials on humans and their potential toxicity have been regarded a very significant issue. Consequently, nanomaterials are the subject of a wide range of cutting-edge research efforts in the medical and related fields to thoroughly probe (...)
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  36.  10
    Action research — a model for introducing standardized health assessment in general practice: an exploratory study.K. A. Meadows, F. Twidale & D. Rogers - 1998 - Journal of Evaluation in Clinical Practice 4 (3):225-229.
  37.  12
    Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research.Yogendra KGupta Nalin Mehta - 2014 - Journal of Clinical Research and Bioethics 5 (5).
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  38.  22
    Exploitation and double standards in research in developed countries.Linda Barclay - 2008 - Monash Bioethics Review 27 (4):37-44.
    If it is so obvious that international participants should share in the spoils of research profits, why isn’t it equally obvious that participants who share nationality with the researchers should do so as well? I argue that if one believes that some form of benefit-sharing is morally obligatory in research conducted in developing countries, it is very hard to escape the conclusion that it should at least in some circumstances be thought equally obligatory in research conducted within (...)
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  39.  6
    Research under Community Standards: Three Case Studies.Sheldon Krimsky - 1986 - Science, Technology, and Human Values 11 (3):14-33.
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  40.  47
    What is the best standard for the standard of care in clinical research?Rieke van der Graaf & Johannes J. M. van Delden - 2009 - American Journal of Bioethics 9 (3):35 – 43.
    During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate . Current international research ethics guidelines contain a wide variety of standards for the standard of care—including the provision of the highest attainable, the best available, the best current, a proven , and an established effective treatment. (...)
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  41.  19
    Microbiota-gut-brain research: A plea for an interdisciplinary approach and standardization.Mattia Andreoletti & Maria Rescigno - 2019 - Behavioral and Brain Sciences 42.
    Hooks et al. note that microbiota-gut-brain research suffers from serious methodological flaws and interpretative issues. We suggest two corrective measures: first, taking more seriously the need of interdisciplinary work; second, interpreting some of the methodological issues as ordinary challenges of standardization, typical of emerging disciplines.
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  42.  90
    Citation counts for research evaluation: standards of good practice for analyzing bibliometric data and presenting and interpreting results.Lutz Bornmann, Rüdiger Mutz, Christoph Neuhaus & Hans-Dieter Daniel - 2008 - Ethics in Science and Environmental Politics 8 (1):93-102.
  43.  7
    Ideal ethical standards for contraceptive use in research.F. Baylis & C. Kaposy - 2011 - IRB: Ethics & Human Research 33 (2):19-20.
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  44.  16
    Ethical Review of Animal Research and the Standards of Procedural Justice: A European Perspective.Tomasz Pietrzykowski - 2021 - Journal of Bioethical Inquiry 18 (3):525-534.
    Committees established for the ethical review of research involving animals have become a widespread legal standard around the world. Despite many differences in their composition, powers, and institutional settings, they share many common problems related to the well-established standards of procedural justice in administrative practice. The paper adapts the general theory of procedural justice to the specific context of ethical review committees. From this perspective, the main concerns over the procedural aspects of the ethical evaluation of research (...)
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  45.  11
    A Just Standard: The Ethical Management of Incidental Findings in Brain Imaging Research.Mackenzie Graham, Nina Hallowell & Julian Savulescu - 2021 - Journal of Law, Medicine and Ethics 49 (2):269-281.
    Neuroimaging research regularly yields “incidental findings”: observations of potential clinical significance in healthy volunteers or patients, but which are unrelated to the purpose or variables of the study.
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  46.  51
    Non-beneficial pediatric research and the best interests standard: A legal and ethical reconciliation (8th edition).Paul Litton - 2008 - Yale Journal of Health Law 8.
    Federal efforts beginning in the 1990's have successfully increased pediatric research to improve medical care for all children. Since 1997, the FDA has requested 800 pediatric studies involving 45,000 children. Much of this research is "non-beneficial"; that is, it exposes pediatric subjects to risk even though these children will not benefit from participating in the research. Non-beneficial pediatric research (NBPR) seems, by definition, contrary to the best interests of pediatric subjects, which is why one state supreme (...)
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  47.  9
    Data curation-research: practices of data standardization and exploration in a precision medicine database.Niccolò Tempini - 2021 - New Genetics and Society 40 (1):73-94.
    Key to precision medicine is the development of expert database projects that gather data, integrate them in the pre-existing database, and publish the product of their processing for others to make use of. Increasingly, it is required that data infrastructure managers and curators pursue and lead research projects on the data so as to learn about new ways data could be used or information that could be potentially generated from them. I call these efforts “data curation-research” and use (...)
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  48.  14
    Does Student Research Require a Lower Standard of Ethical Scrutiny?Stephen J. Humphreys - 2008 - Research Ethics 4 (4):141-146.
    Recognizing that students are fundamentally engaged in a process of learning and self-development, ethical review of sub-doctoral student research should be proportionate to that objective. A student's tutor has the pedagogical role and an ethics committee should not interfere with that relationship other than to seek to avoid harms unforeseen by either the student or tutor. Underpowered or other statistically or methodologically flawed sub-doctoral research should not however, in general, be regarded as ethically concerning. With the proviso that (...)
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  49.  19
    Understanding the 'de jure' standard of care for research: A reply to Faust.Liza Dawson & Adnan A. Hyder - 2007 - Developing World Bioethics 7 (1):46–47.
  50.  41
    Ethics of field research: Do journals set the standard?Helene Marsh & Carole M. Eros - 1999 - Science and Engineering Ethics 5 (3):375-382.
    To determine whether ethical issues concerned with field research are addressed in the peer-review process, instructions to authors and reviewers of 141 (mainly natural science) journals were examined to ascertain how often ethical issues were mentioned. Only one-third (n=41) of responding journals addressed ethical issues in their instructions to authors or reviewers. When ethical issues were considered, most of the journals limited their concerns to ethical issues associated with animal and general human experimentation. No journal mentioned ethical practices in (...)
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