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  1. Are There Counterexamples to Standard Views About Institutional Legitimacy, Obligation, and What Institutions We Should Aim For?Mark Budolfson - 2014 - Philosophy and Law 14 (1).
    A standard view in legal and political theory is that, to a first approximation, (1) we should aim to bring about the most legitimate institutions possible to solve the problems that should be solved at the level of politics, and (2) individual people are required to follow the directives of legitimate institutions, at least insofar as those institutions have the authority to issue those directives, and insofar as other considerations are nearly equal.1 On this standard view, the philosophical analysis of (...)
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  • Consent to Epistemic Interventions: A Contribution to the Debate on the Right (Not) to Know.Niels Nijsingh - 2016 - Medicine, Health Care and Philosophy 19 (1):103-110.
    The debate on the ‘right to know’ has simmered on for over 30 years. New examples where a right to be informed is contrasted to a right to be kept in ignorance occasionally surface and spark disagreement on the extent to which patients and research subjects have a right to be self-determining concerning the health related information they receive. Up until now, however, this debate has been unsatisfactory with regard to the question what type of rights—if any—are in play here (...)
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  • Ethical Signposts for Clinical Geneticists in Secondary Variant and Incidental Finding Disclosure Discussions.Gabrielle M. Christenhusz, Koenraad Devriendt, Hilde Van Esch & Kris Dierickx - 2015 - Medicine, Health Care and Philosophy 18 (3):361-370.
    While ethical and empirical interest in so-called secondary variants and incidental findings in clinical genetics contexts is growing, critical reflection on the ethical foundations of the various recommendations proposed is thus far largely lacking. We examine and critique the ethical justifications of the three most prominent disclosure positions: briefly, the clinical geneticist decides, a joint decision, and the patient decides. Subsequently, instead of immediately developing a new disclosure option, we explore relevant foundational ethical values and norms, drawing on the normative (...)
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  • Disclosing Neuroimaging Incidental Findings: A Qualitative Thematic Analysis of Health Literacy Challenges.Caitlin E. Rancher, Jody M. Shoemaker, Linda E. Petree, Mark Holdsworth, John P. Phillips & Deborah L. Helitzer - 2016 - BMC Medical Ethics 17 (1):58.
    BackgroundReturning neuroimaging incidental findings may create a challenge to research participants’ health literacy skills as they must interpret and make appropriate healthcare decisions based on complex radiology jargon. Disclosing IF can therefore present difficulties for participants, research institutions and the healthcare system. The purpose of this study was to identify the extent of the health literacy challenges encountered when returning neuroimaging IF. We report on findings from a retrospective survey and focus group sessions with major stakeholders involved in disclosing IF.MethodsWe (...)
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  • Using Drones to Study Human Beings: Ethical and Regulatory Issues.David B. Resnik & Kevin C. Elliott - 2019 - Science and Engineering Ethics 25 (3):707-718.
    Researchers have used drones to track wildlife populations, monitor forest fires, map glaciers, and measure air pollution but have only begun to consider how to use these unmanned aerial vehicles to study human beings. The potential use of drones to study public gatherings or other human activities raises novel issues of privacy, confidentiality, and consent, which this article explores in depth. It argues that drone research could fall into several different categories: non-human subjects research, exempt HSR, or non-exempt HSR. In (...)
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  • Return of Results in Participant-Driven Research: Learning From Transformative Research Models.Susan M. Wolf - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):159-166.
    Participant-driven research is a burgeoning domain of research innovation, often facilitated by mobile technologies. Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.
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  • Lay Attitudes Toward Trust, Uncertainty, and the Return of Pediatric Research Results in Biobanking.John Lynch, Janelle Hines, Sarah Theodore & Monica Mitchell - 2016 - Ajob Empirical Bioethics 7 (3):160-166.
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  • The Clinical Investigator-Subject Relationship: A Contextual Approach.David B. Resnik - 2009 - Philosophy, Ethics, and Humanities in Medicine 4:16-.
    BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...)
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  • Seeking Context for the Duty to Rescue: Contractualism and Trust in Research Institutions.Karen M. Meagher - 2015 - American Journal of Bioethics 15 (2):18-20.
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  • Highlights in Bioethics Through 40 Years: A Quantitative Analysis of Top-Cited Journal Articles.Pingyue Jin & Mark Hakkarinen - 2017 - Journal of Medical Ethics 43 (5):339-345.
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  • Handling Ethical, Legal and Social Issues in Birth Cohort Studies Involving Genetic Research: Responses From Studies in Six Countries.Nola M. Ries, Jane LeGrandeur & Timothy Caulfield - 2010 - BMC Medical Ethics 11 (1):4.
    Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of (...)
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  • Ethical Framework for the Detection, Management and Communication of Incidental Findings in Imaging Studies, Building on an Interview Study of Researchers’ Practices and Perspectives.Eline M. Bunnik, Lisa van Bodegom, Wim Pinxten, Inez D. de Beaufort & Meike W. Vernooij - 2017 - BMC Medical Ethics 18 (1):10.
    As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like. Building on an interview study of researchers’ practices and perspectives, we identified key considerations for the set-up of pathways for the detection, management and communication of (...)
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  • A New Challenge for Research Ethics: Incidental Findings in Neuroimaging.Bert Heinrichs - 2011 - Journal of Bioethical Inquiry 8 (1):59-65.
    It has become evident that neuroimaging raises new normative questions that cannot be addressed adequately within the (in this regard unspecific) frameworks of existing research ethics. Questions that are especially troubling are, among others, provoked by incidental findings. Two questions are particularly intricate in view of incidental findings: (1) How can the research subject’s right not to know be guaranteed? And (2) should a diagnostic check of scans by a neuroradiologist become an obligatory part of neuroscientific research protocols? The present (...)
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  • Ethische und rechtliche Aspekte im Umgang mit genetischen Zufallsbefunden – Herausforderungen und LösungsansätzeEthical and legal issues when dealing with genetic incidental findings—challenges and possible solutions.Sabine Rudnik-Schöneborn, Martin Langanke, Pia Erdmann & Jürgen Robienski - 2014 - Ethik in der Medizin 26 (2):105-119.
    Mit der Vielzahl von Daten aus genetischen Untersuchungsverfahren wächst das Problem von „Zufallsbefunden“, d. h. von zufällig erhobenen Nebenbefunden, die mit der ursprünglichen Fragestellung nicht in Verbindung stehen und dennoch eine Bedeutung für Gesundheit und Reproduktionsverhalten der untersuchten Person selbst oder ihrer Anverwandten haben. In Ermangelung nationaler oder internationaler Richtlinien greifen die Autoren die aktuelle Diskussion um den Umgang mit genetischen Zufallsbefunden in Behandlungs- und Forschungskontext auf. Dabei nehmen sie auf die für Deutschland relevanten rechtlichen und ethischen Rahmenbedingungen Bezug. Nach (...)
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  • Ethics and Collateral Findings in Pragmatic Clinical Trials.Stephanie R. Morain, Kevin Weinfurt, Juli Bollinger, Gail Geller, Debra J. H. Mathews & Jeremy Sugarman - 2020 - American Journal of Bioethics 20 (1):6-18.
    Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial collateral findings,? (...)
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  • Challenges in Collecting Big Data in A Clinical Environment with Vulnerable Population: Lessons Learned From A Study Using A Multi-Modal Sensors Platform.Bing Ye, Shehroz S. Khan, Belkacem Chikhaoui, Andrea Iaboni, Lori Schindel Martin, Kristine Newman, Angel Wang & Alex Mihailidis - 2019 - Science and Engineering Ethics 25 (5):1447-1466.
    Agitation is one of the most common behavioural and psychological symptoms in people living with dementia. This behaviour can cause tremendous stress and anxiety on family caregivers and healthcare providers. Direct observation of PLwD is the traditional way to measure episodes of agitation. However, this method is subjective, bias-prone and timeconsuming. Importantly, it does not predict the onset of the agitation. Therefore, there is a need to develop a continuous monitoring system that can detect and/or predict the onset of agitation. (...)
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  • Defining Categories of Actionability for Secondary Findings in Next-Generation Sequencing.Celine Moret, Alex Mauron, Siv Fokstuen, Periklis Makrythanasis & Samia A. Hurst - 2017 - Journal of Medical Ethics 43 (5):346-349.
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  • Management of Incidental Findings From Genetic Tests: Perspectives of Ethics Committee Members.Leigh Jackson Lesley Goldsmith - 2015 - Journal of Clinical Research and Bioethics 6 (3).
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  • An Implementation Framework for the Feedback of Individual Research Results and Incidental Findings in Research.Adrian Thorogood, Yann Joly, Bartha Maria Knoppers, Tommy Nilsson, Peter Metrakos, Anthoula Lazaris & Ayat Salman - 2014 - BMC Medical Ethics 15 (1):88.
    This article outlines procedures for the feedback of individual research data to participants. This feedback framework was developed in the context of a personalized medicine research project in Canada. Researchers in this domain have an ethical obligation to return individual research results and/or material incidental findings that are clinically significant, valid and actionable to participants. Communication of individual research data must proceed in an ethical and efficient manner. Feedback involves three procedural steps: assessing the health relevance of a finding, re-identifying (...)
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  • Following the Giant’s Paces-Governance Issues and Bioethical Reflections in China.Zhaochen Wang, Vincent H. di ZhangNg, Reidar K. Lie & Xiaomei Zhai - 2014 - BMC Medical Ethics 15 (1):79.
    China has become a global player in the field of biosamples research and analysis of genetic data. The Beijing Genomics Institute is a genetics factory where enormous amounts of biosamples/data from all over the world are being analyzed. Most of the global bioethics discussions focused on research conducted by scientists from industrialized countries with subjects from poorer countries. Today, however, samples from industrialized nations are being analyzed in China on an unprecedented scale. This means that one should not just focus (...)
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  • Authorship Policies of Bioethics Journals.D. B. Resnik & Z. Master - 2011 - Journal of Medical Ethics 37 (7):424-428.
    Inappropriate authorship is a common problem in biomedical research and may be becoming one in bioethics, due to the increase in multiple authorship. This paper investigates the authorship policies of bioethics journals to determine whether they provide adequate guidance for researchers who submit articles for publication, which can help deter inappropriate authorship. It was found that 63.3% of bioethics journals provide no guidance on authorship; 36.7% provide guidance on which contributions merit authorship, 23.3% provide guidance on which contributions do not (...)
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  • Consenting Futures: Professional Views on Social, Clinical and Ethical Aspects of Information Feedback to Embryo Donors in Human Embryonic Stem Cell Research.Kathryn Ehrich, Clare Williams & Bobbie Farsides - 2010 - Clinical Ethics 5 (2):77-85.
    This paper reports from an ongoing multidisciplinary, ethnographic study that is exploring the views, values and practices (the ethical frameworks) drawn on by professional staff in assisted conception units and stem cell laboratories in relation to embryo donation for research purposes, particularly human embryonic stem cell (hESC) research, in the UK. We focus here on the connection between possible incidental findings and the circumstances in which embryos are donated for hESC research, and report some of the uncertainties and dilemmas of (...)
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  • Return of Research Results: How Should Research Results Be Handled?Bartha Maria Knoppers & Emmanuelle Lévesque - 2011 - Journal of Law, Medicine and Ethics 39 (4):574-576.
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  • Teaching Health Law: Teaching Law Students to Be Policymakers: The Health and Science Policy Workshop on Genomic Research.Benjamin E. Berkman & Karen H. Rothenberg - 2012 - Journal of Law, Medicine and Ethics 40 (1):147-153.
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  • A Social Constructivism Decision-Making Approach to Managing Incidental Findings in Neuroimaging Research.Marcie L. King - 2018 - Ethics and Behavior 28 (5):393-410.
    Functional magnetic resonance imaging is a powerful tool used in cognitive neuroscientific research. fMRI is noninvasive, safe, and relatively accessible, making it an ideal method to draw inferences about the brain–behavior relationship. When conducting fMRI research, scientists must consider risks associated with brain imaging. In particular, the risk of potentially identifying an abnormal brain finding in an fMRI research scan poses a complex problem that researchers should be prepared to address. This article illustrates how a social constructivism decision-making model can (...)
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  • The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative.Kathryn M. Porter, Marion Danis, Holly A. Taylor, Mildred K. Cho & Benjamin S. Wilfond - 2018 - American Journal of Bioethics 18 (1):39-45.
    The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...)
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  • PROs in the Balance: Ethical Implications of Collecting Patient Reported Outcome Measures in the Electronic Health Record.Joshua S. Crites, Cynthia Chuang, Anne Dimmock, Wenke Hwang, Bobbie Johannes, Anuradha Paranjape & Albert W. Wu - 2016 - American Journal of Bioethics 16 (4):67-68.
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  • Looking for Trouble: Preventive Genomic Sequencing in the General Population and the Role of Patient Choice.Gabriel Lázaro-Muñoz, John M. Conley, Arlene M. Davis, Marcia Van Riper, Rebecca L. Walker & Eric T. Juengst - 2015 - American Journal of Bioethics 15 (7):3-14.
    Advances in genomics have led to calls for developing population-based preventive genomic sequencing programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the (...)
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  • Stakeholder Opinions and Ethical Perspectives Support Complete Disclosure of Incidental Findings in MRI Research.John P. Phillips, Caitlin Cole, John P. Gluck, Jody M. Shoemaker, Linda E. Petree, Deborah L. Helitzer, Ronald M. Schrader & Mark T. Holdsworth - 2015 - Ethics and Behavior 25 (4):332-350.
    How far does a researcher’s responsibility extend when an incidental finding is identified? Balancing pertinent ethical principles such as beneficence, respect for persons, and duty to rescue is not always straightforward, particularly in neuroimaging research where empirical data that might help guide decision making are lacking. We conducted a systematic survey of perceptions and preferences of 396 investigators, research participants, and Institutional Review Board members at our institution. Using the partial entrustment model as described by Richardson, we argue that our (...)
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  • Conducting Research on Social Media—Is Facebook Like the Public Square?Kayhan Parsi & Nanette Elster - 2014 - American Journal of Bioethics 14 (10):63-65.
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  • Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?Catherine Gliwa & Benjamin E. Berkman - 2013 - American Journal of Bioethics 13 (2):32-42.
    The rapid growth of next-generation genetic sequencing has prompted debate about the responsibilities of researchers toward genetic incidental findings. Assuming there is a duty to disclose significant incidental findings, might there be an obligation for researchers to actively look for these findings? We present an ethical framework for analyzing whether there is a positive duty to look for genetic incidental findings. Using the ancillary care framework as a guide, we identify three main criteria that must be present to give rise (...)
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  • The Duty to Rescue in Genomic Research.Michael Ulrich - 2013 - American Journal of Bioethics 13 (2):50-51.
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  • Is Multiple Authorship in Conceptual Bioethics Ethically Sustainable?D. Gareth Jones - 2011 - American Journal of Bioethics 11 (10):30 - 32.
    The American Journal of Bioethics, Volume 11, Issue 10, Page 30-32, October 2011.
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  • Criteria for Authorship in Bioethics.David B. Resnik & Zubin Master - 2011 - American Journal of Bioethics 11 (10):17 - 21.
    Multiple authorship is becoming increasingly common in bioethics research. There are well-established criteria for authorship in empirical bioethics research but not for conceptual research. It is important to develop criteria for authorship in conceptual publications to prevent undeserved authorship and uphold standards of fairness and accountability. This article explores the issue of multiple authorship in bioethics and develops criteria for determining who should be an author on a conceptual publication in bioethics. Authorship in conceptual research should be based on contributing (...)
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  • On Authorship.Franklin G. Miller - 2011 - American Journal of Bioethics 11 (10):32 - 33.
    The American Journal of Bioethics, Volume 11, Issue 10, Page 32-33, October 2011.
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  • Shared Responsibility for Ensuring Appropriate Management of Incidental Findings: A Case Study From South Africa.Y. Sookrajh, S. Naidoo & G. Ramjee - 2015 - Journal of Medical Ethics 41 (3):281-283.
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  • Bioethics in Iceland.Vilhjálmur Árnason - 2016 - Cambridge Quarterly of Healthcare Ethics 25 (3):421-434.
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  • Ethical Issues Related to Computerised Family Medical Histories in Sickle Cell Disease: Inforare.S. Franrenet, N. Duchange, F. Galacteros, C. Quantin, O. Cohen, R. Nzouakou, S. Sudraud, C. Herve & G. Moutel - 2010 - Journal of Medical Ethics 36 (10):604-607.
    The Inforare project aims to set up a system for the sharing of clinical and familial data, in order to study how genes are related to the severity of sickle cell disease. While the computerisation of clinical records represents a valuable research goal, an ethical framework is necessary to guarantee patients' protection and their rights in this developing field. Issues relating to patient information during the Inforare study were analysed by the steering committee. Several major concerns were discussed by the (...)
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  • Should Researchers Offer Results to Family Members of Cancer Biobank Participants? A Mixed-Methods Study of Proband and Family Preferences.Deborah R. Gordon, Carmen Radecki Breitkopf, Marguerite Robinson, Wesley O. Petersen, Jason S. Egginton, Kari G. Chaffee, Gloria M. Petersen, Susan M. Wolf & Barbara A. Koenig - 2019 - Ajob Empirical Bioethics 10 (1):1-22.
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  • Incidental Findings in Low‐Resource Settings.Haley K. Sullivan & Benjamin E. Berkman - 2018 - Hastings Center Report 48 (3):20-28.
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  • How Should We Deal with Misattributed Paternity? A Survey of Lay Public Attitudes.Georgia Lowe, Jonathan Pugh, Guy Kahane, Louise Corben, Sharon Lewis, Martin Delatycki & Julian Savulescu - 2017 - Ajob Empirical Bioethics 8 (4):234-242.
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  • A Room with a View of Integrity and Professionalism: Personal Reflections on Teaching Responsible Conduct of Research in the Neurosciences.Emily Bell - 2015 - Science and Engineering Ethics 21 (2):461-469.
    Neuroscientists are increasingly put into situations which demand critical reflection about the ethical and appropriate use of research tools and scientific knowledge. Students or trainees also have to know how to navigate the ethical domains of this context. At a time when neuroscience is expected to advance policy and practice outcomes, in the face of academic pressures and complex environments, the importance of scientific integrity comes into focus and with it the need for training at the graduate level in the (...)
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  • Critical Social Theory Approach to Disclosure of Genomic Incidental Findings.J. L. Bevan, J. N. Senn-Reeves, B. R. Inventor, S. M. Greiner, K. M. Mayer, M. T. Rivard & R. J. Hamilton - 2012 - Nursing Ethics 19 (6):819-828.
    Technology has expanded genomic research and the complexity of extracted gene-related information. Health-related genomic incidental findings pose new dilemmas for nurse researchers regarding the ethical application of disclosure to participants. Consequently, informed consent specific to incidental findings is recommended. Critical Social Theory is used as a guide in recognition of the changing meaning of informed consent and to serve as a framework to inform nursing of the ethical application of disclosure consent in genomic nursing research practices.
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  • Alternatives of Informed Consent for Storage and Use of Human Biological Material for Research Purposes: Brazilian Regulation.Gabriela Marodin, Paulo Henrique Condeixa de França, Jennifer Braathen Salgueiro, Marcia Luz da Motta, Gysélle Saddi Tannous & Anibal Gil Lopes - 2012 - Developing World Bioethics 12 (3):127-131.
    Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES (...)
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  • The Right to Know: A Revised Standard for Reporting Incidental Findings.G. Owen Schaefer & Julian Savulescu - 2018 - Hastings Center Report 48 (2):22-32.
    The “best-medical-interests” standard for reporting findings does not go far enough. Research subjects have a right to know about any comprehensible piece of information about them that is generated by research in which they are participating. An even broader standard may sometimes be appropriate: if subjects agree to accept information that they may not understand, then all information may be disclosed.
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  • ‘Ethical Responsibility’ or ‘a Whole Can of Worms’: Differences in Opinion on Incidental Finding Review and Disclosure in Neuroimaging Research From Focus Group Discussions with Participants, Parents, IRB Members, Investigators, Physicians and Community Members: Table 1.Caitlin Cole, Linda E. Petree, John P. Phillips, Jody M. Shoemaker, Mark Holdsworth & Deborah L. Helitzer - 2015 - Journal of Medical Ethics 41 (10):841-847.
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  • Incidental Findings in Magnetic Resonance Imaging (MRI) Brain Research.Charles A. Nelson - 2008 - Journal of Law, Medicine and Ethics 36 (2):315-319.
    The use of magnetic resonance imaging to investigate brain structure and function has become increasingly common among neuroscientists, psychologists, and even economists in recent years. Yet, despite this increase in use, relatively little attention has been paid to the issue of incidental fndings. The current paper discusses these issues, and anticipates the future of incidental fndings in the context of other neuroimaging tools currently being used to investigate the living brain.
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  • Incidental Findings and Ancillary-Care Obligations.Henry S. Richardson - 2008 - Journal of Law, Medicine and Ethics 36 (2):256-270.
    Recent work on incidental fndings, concentrating on the difcult problems posed by the ambiguous results often generated by high-tech medicine, has proceeded largely independently from recent work on medical researchers' ancillary-care obligations, the obligations that researchers have to deal with diseases or conditions besides the one(s) under study. This paper contends that the two topics are morally linked, and specifcally that a sound understanding of ancillary-care obligations will center them on incidental fndings. The paper sets out and defends an understanding (...)
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  • Using Diffusion Tensor Imaging to Probe Mental Status in Legal Cases: Ethical Concerns and Lessons Learned From Other Biotechnologies.Samuel K. Powell, Nehal A. Parikh & Robin N. Fiore - 2014 - American Journal of Bioethics Neuroscience 5 (2):46-47.
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  • Two Basic Ethical Problems of Incidental Findings in Population‐Based, Non‐Intervening Magnetic Resonance Imaging (MRI) Research.Martin Hoffmann - 2013 - Journal of Evaluation in Clinical Practice 19 (3):427-432.