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Bartha Maria Knoppers [51]Bartha M. Knoppers [13]
  1.  17
    The ‘serious’ factor in germline modification.Erika Kleiderman, Vardit Ravitsky & Bartha Maria Knoppers - 2019 - Journal of Medical Ethics 45 (8):508-513.
    Current advances in assisted reproductive technologies aim to promote the health and well-being of future children. They offer the possibility to select embryos with the greatest potential of being born healthy (eg, preimplantation genetic testing) and may someday correct faulty genes responsible for heritable diseases in the embryo (eg, human germline genome modification (HGGM)). Most laws and policy statements surrounding HGGM refer to the notion of ‘serious’ as a core criterion in determining what genetic diseases should be targeted by these (...)
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  2.  58
    Human genetic research: emerging trends in ethics.Ruth Chadwick & Bartha Maria Knoppers - 2005 - .
    Genetic research has moved from Mendelian genetics to sequence maps to the study of natural human genetic variation at the level of the genome. This past decade of discovery has been accompanied by a shift in emphasis towards the ethical principles of reciprocity, mutuality, solidarity, citizenry and universality.
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  3.  57
    Introduction: Sharing Data in a Medical Information Commons.Amy L. McGuire, Mary A. Majumder, Angela G. Villanueva, Jessica Bardill, Juli M. Bollinger, Eric Boerwinkle, Tania Bubela, Patricia A. Deverka, Barbara J. Evans, Nanibaa' A. Garrison, David Glazer, Melissa M. Goldstein, Henry T. Greely, Scott D. Kahn, Bartha M. Knoppers, Barbara A. Koenig, J. Mark Lambright, John E. Mattison, Christopher O'Donnell, Arti K. Rai, Laura L. Rodriguez, Tania Simoncelli, Sharon F. Terry, Adrian M. Thorogood, Michael S. Watson, John T. Wilbanks & Robert Cook-Deegan - 2019 - Journal of Law, Medicine and Ethics 47 (1):12-20.
    Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.
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  4.  15
    Comparative Approaches to Biobanks and Privacy.Mark A. Rothstein, Bartha Maria Knoppers & Heather L. Harrell - 2016 - Journal of Law, Medicine and Ethics 44 (1):161-172.
    Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow (...)
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  5.  55
    The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations.Gail E. Henderson, Susan M. Wolf, Kristine J. Kuczynski, Steven Joffe, Richard R. Sharp, D. Williams Parsons, Bartha M. Knoppers, Joon-Ho Yu & Paul S. Appelbaum - 2014 - Journal of Law, Medicine and Ethics 42 (3):344-355.
    Large-scale sequencing tests, including whole-exome and whole-genome sequencing, are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human Genome Research Institute and National Cancer Institute have funded studies on clinical and research sequencing under (...)
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  6.  13
    Return of Results: Towards a Lexicon?Bartha Maria Knoppers & Amy Dam - 2011 - Journal of Law, Medicine and Ethics 39 (4):577-582.
    Currently, the return of results in the domain of biobanking constitutes an ethical and legal quagmire, whether it involves population or specific clinical research studies. In light of the fact that population biobanks are often not seen as distinct from those biobanks created for disease research, as well as the uncertainty as to what “return of results” means concretely, this lexicon attempts to demystify the terminology. The terms — results, return, clinical significance, and utility — are discussed. Through an analysis (...)
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  7.  21
    Whose Commons? Data Protection as a Legal Limit of Open Science.Mark Phillips & Bartha M. Knoppers - 2019 - Journal of Law, Medicine and Ethics 47 (1):106-111.
    Open science has recently gained traction as establishment institutions have come on-side and thrown their weight behind the movement and initiatives aimed at creation of information commons. At the same time, the movement's traditional insistence on unrestricted dissemination and reuse of all information of scientific value has been challenged by the movement to strengthen protection of personal data. This article assesses tensions between open science and data protection, with a focus on the GDPR.
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  8.  6
    Return of Results: Towards a Lexicon?Bartha Maria Knoppers & Amy Dam - 2011 - Journal of Law, Medicine and Ethics 39 (4):577-582.
    The last few years have witnessed the growth of large-scale, population genomics biobanks, which serve as longitudinal, gene-environment databases for future yet unspecified research. An international consortium, the Public Population Project in Genomics, builds harmonization tools for such biobanks and has catalogued numerous studies — at least 139 with over 10,000 banked participants and 34 with over 100,000. As their potential use for translational, clinical research draws near, it is opportune to clarify the duties of such biobanks to communicate results (...)
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  9.  56
    From the Right to Know to the Right Not to Know.Bartha Maria Knoppers - 2014 - Journal of Law, Medicine and Ethics 42 (1):6-10.
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  10.  39
    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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  11.  11
    Biobanking: International Norms.Bartha Maria Knoppers - 2005 - Journal of Law, Medicine and Ethics 33 (1):7-14.
    While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, (...)
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  12.  15
    Biobanking: International Norms.Bartha Maria Knoppers - 2005 - Journal of Law, Medicine and Ethics 33 (1):7-14.
    While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, (...)
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  13.  36
    Returning incidental findings from genetic research to children: views of parents of children affected by rare diseases.Erika Kleiderman, Bartha Maria Knoppers, Conrad V. Fernandez, Kym M. Boycott, Gail Ouellette, Durhane Wong-Rieger, Shelin Adam, Julie Richer & Denise Avard - 2014 - Journal of Medical Ethics 40 (10):691-696.
  14.  29
    Model consent clauses for rare disease research.Minh Thu Nguyen, Jack Goldblatt, Rosario Isasi, Marlene Jagut, Anneliene Hechtelt Jonker, Petra Kaufmann, Laetitia Ouillade, Fruszina Molnar-Gabor, Mahsa Shabani, Eric Sid, Anne Marie Tassé, Durhane Wong-Rieger & Bartha Maria Knoppers - 2019 - BMC Medical Ethics 20 (1):1-7.
    Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants’ overall protection. A global Task Force (...)
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  15.  20
    Reciprocity and the Quest for Meaningful Disclosure.Ma’N. H. Zawati & Bartha Maria Knoppers - 2019 - American Journal of Bioethics 19 (5):36-38.
    Volume 19, Issue 5, May 2019, Page 36-38.
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  16.  4
    Responsible Processing and Sharing of Genomic Data: Bringing Health Technologies Industries to the Table.Bartha Maria Knoppers, Shane Chase, Yann Joly, Ma’N. Zawati & Adrian Thorogood - 2023 - American Journal of Bioethics 23 (11):33-35.
    The article “Ethical Responsibilities for Companies that Process Personal Data” (McCoy et al. 2023) provides a principled and pragmatic ethical framework for companies collecting, sharing, and usin...
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  17.  19
    Criminal Prohibition of Wrongful Re‑identification: Legal Solution or Minefield for Big Data?Mark Phillips, Edward S. Dove & Bartha M. Knoppers - 2017 - Journal of Bioethical Inquiry 14 (4):527-539.
    The collapse of confidence in anonymization as a robust approach for preserving the privacy of personal data has incited an outpouring of new approaches that aim to fill the resulting trifecta of technical, organizational, and regulatory privacy gaps left in its wake. In the latter category, and in large part due to the growth of Big Data–driven biomedical research, falls a growing chorus of calls for criminal and penal offences to sanction wrongful re-identification of “anonymized” data. This chorus cuts across (...)
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  18.  13
    ‘Serious’ factor—a relevant starting point for further debate: a response.Erika Kleiderman, Vardit Ravitsky & Bartha Maria Knoppers - 2020 - Journal of Medical Ethics 46 (2):153-155.
    In this reply, we wish to defend our original position and address several of the points raised by two excellent responses. The first response questions the relevance of the notion of ‘serious’ within the context of human germline genome modification. We argue that the ‘serious’ factor is relevant and that there is a need for medical and social lenses to delineate the limits of acceptability and initial permissible applications of HGGM. In this way, ‘serious’ acts as a starting point for (...)
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  19.  9
    The Genetic Family as Patient?Bartha Maria Knoppers & Kristina Kekesi-Lafrance - 2020 - American Journal of Bioethics 20 (6):77-80.
    Volume 20, Issue 6, June 2020, Page 77-80.
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  20.  30
    Legal and Ethical Approaches to Stem Cell and Cloning Research: A Comparative Analysis of Policies in Latin America, Asia, and Africa.Rosario M. Isasi, Bartha M. Knoppers, Peter A. Singer & Abdallah S. Daar - 2004 - Journal of Law, Medicine and Ethics 32 (4):626-640.
    Human reproductive cloning has become the most palpable example of the globalization of science. Throughout the world, events and conjectures in the media, such as the birth and death in the United Kingdom of the cloned sheep Dolly and projects to clone human beings by Korean scientists, by members of the Canadian-based Raelian cult, and by the Italian physician Antinori in an undisclosed country, have galvanized the political will of individual countries to ban human reproductive cloning.Yet, international attempts to harmonize (...)
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  21.  9
    Return of “Accurate” and “Actionable” Results: Yes!Bartha Maria Knoppers & Claude Laberge - 2009 - American Journal of Bioethics 9 (6-7):107-109.
  22.  4
    INTRODUCTION: Harmonizing Privacy Laws to Enable International Biobank Research.Mark A. Rothstein & Bartha Maria Knoppers - 2015 - Journal of Law, Medicine and Ethics 43 (4):673-674.
    The Journal of Law, Medicine &Ethics, Volume 43, Issue 4, Page 673-674, Winter 2015.
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  23.  28
    One Size Does Not Fit All: Toward “Upstream Ethics”?Vural Ozdemir & Bartha Maria Knoppers - 2010 - American Journal of Bioethics 10 (6):42-44.
  24.  7
    The sIRB System: A Single Beacon of Progress in the Revised Common Rule?Vasiliki Rahimzadeh, Edward S. Dove & Bartha Maria Knoppers - 2017 - American Journal of Bioethics 17 (7):43-46.
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  25.  34
    Neuroethics, new ethics?Bartha Maria Knoppers - 2005 - American Journal of Bioethics 5 (2):33.
  26.  3
    International mHealth Research: Old Tools and New Challenges.Michael Lang, Bartha Maria Knoppers & Ma’N. H. Zawati - 2020 - Journal of Law, Medicine and Ethics 48 (S1):178-186.
    In this paper, we outline the policy implications of mobile health research conducted at the international level. We describe the manner in which such research may have an international dimension and argue that it is not likely to be excluded from conventionally applicable international regulatory tools. We suggest that closer policy attention is needed for this rapidly proliferating approach to health research.
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  27.  18
    Legal and Ethical Challenges of International Direct-to-Participant Genomic Research: Conclusions and Recommendations.Mark A. Rothstein, Ma'N. H. Zawati, Laura M. Beskow, Kathleen M. Brelsford, Kyle B. Brothers, Catherine M. Hammack-Aviran, James W. Hazel, Yann Joly, Michael Lang, Dimitri Patrinos, Andrea Saltzman & Bartha Maria Knoppers - 2019 - Journal of Law, Medicine and Ethics 47 (4):705-731.
  28.  4
    Regulation of International Direct-to-Participant Genomic Research: Symposium Introduction.Mark A. Rothstein & Bartha Maria Knoppers - 2019 - Journal of Law, Medicine and Ethics 47 (4):579-580.
  29.  16
    Genetically Enhanced Minors: Whose Responsibility?Erika Kleiderman, Audrey Boily & Bartha Maria Knoppers - 2018 - American Journal of Bioethics 18 (6):1-3.
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  30.  10
    Broad Consent for Future Research: International Perspectives.Mark A. Rothstein, Heather L. Harrell, Katie M. Saulnier, Edward S. Dove, Chien Te Fan, Tzu-Hsun Hung, Obiajulu Nnamuchi, Alexandra Obadia, Gil Siegal & Bartha Maria Knoppers - 2018 - IRB: Ethics & Human Research 40 (6):7-12.
    In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, including what effect (...)
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  31.  19
    The ethics weathervane.Bartha Maria Knoppers & Ruth Chadwick - 2015 - BMC Medical Ethics 16 (1):1-5.
    BackgroundGlobal collaboration in genomic research is increasingly both a scientific reality and an ethical imperative. This past decade has witnessed the emergence of six new, interconnected areas of ethical consensus and emphasis for policy in genomics: governance, security, empowerment, transparency, the right not to know, and globalization.DiscussionThe globalization of genomic research warrants an approach to governance policies grounded in human rights.SummaryA human rights approach activates the ethical principles underpinning genomic research. It lends force to the right of all citizens to (...)
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  32.  35
    Populations and genetics: legal and socio-ethical perspectives.Bartha Maria Knoppers (ed.) - 2003 - Boston: Martinus Nijhoff.
    This book of selected papers covers population research and banking as well as accompanying confidentiality, and governance concerns.
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  33.  7
    Storing Newborn Blood Spots: Modern Controversies.Linda Kharaboyan, Denise Avard & Bartha Maria Knoppers - 2004 - Journal of Law, Medicine and Ethics 32 (4):741-748.
    Though in existence for over thirty-five years, due to the increasing panoply of possible tests. Newborn screening programs are drawing public attention. Many jurisdictions have mandatory newborn screening programs for treatable disorders. Disorders are detected through tests on blood spots drawn from a newborn’s heel soon after birth and verified through a diagnostic test with follow-up. Unbeknownst to most parents, these blood spot cards are also stored thereafter. Indeed, while dried blood spots are primarily used for screening for health problems, (...)
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  34.  22
    The best interests of the child and the return of results in genetic research: international comparative perspectives.Ma’N. H. Zawati, David Parry & Bartha Maria Knoppers - 2014 - BMC Medical Ethics 15 (1):72.
    Paediatric genomic research raises particularly challenging questions on whether and under what circumstances to return research results. In the paediatric context, decision-making is guided by the best interests of the child framework, as enshrined in the 1989 international Convention on the Rights of the Child. According to this Convention, rights and responsibilities are shared between children, parents, researchers, and the state. These "relational" obligations are further complicated in the context of genetic research.
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  35. Genetic Information: Use and Abuse.Bartha Maria Knoppers - forthcoming - Bioethics for Scientists.
     
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  36.  40
    Currents in Contemporary Bioethics: Open Access as Benefit Sharing? The Example of Publicly Funded Large-Scale Genomic Databases.Yann Joly, Clarissa Allen & Bartha M. Knoppers - 2012 - Journal of Law, Medicine and Ethics 40 (1):143-146.
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  37.  7
    Ethical Issues in Secondary Uses of Human Biological Materials from Mass Disasters.Bartha Maria Knoppers, Madelaine Saginur & Howard Cash - 2006 - Journal of Law, Medicine and Ethics 34 (2):352-365.
    This paper addresses the ethical issues of secondary uses of samples collected for identification purposes following mass disasters. It studies norms governing secondary use of samples , ultimately concluding that limited secondary research uses of these samples should be permissible.
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  38.  3
    Routledge Handbook of Medical Law and Ethics.Yann Joly & Bartha Maria Knoppers (eds.) - 2014 - New York, NY: Routledge.
    This book explores the scope, application and role of medical law, regulatory norms and ethics, and addresses key challenges introduced by contemporary advances in biomedical research and healthcare. While mindful of national developments, the handbook supports a global perspective in its approach to medical law. Contributors include leading scholars in both medical law and ethics, who have contributed specially commissioned pieces in order to present a critical overview and analysis of the current state of medical law and ethics. Each chapter (...)
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  39.  20
    Storing Newborn Blood Spots: Modern Controversies.Linda Kharaboyan, Denise Avard & Bartha Maria Knoppers - 2004 - Journal of Law, Medicine and Ethics 32 (4):741-748.
    Though in existence for over thirty-five years, due to the increasing panoply of possible tests. Newborn screening programs are drawing public attention. Many jurisdictions have mandatory newborn screening programs for treatable disorders. Disorders are detected through tests on blood spots drawn from a newborn’s heel soon after birth and verified through a diagnostic test with follow-up. Unbeknownst to most parents, these blood spot cards are also stored thereafter. Indeed, while dried blood spots are primarily used for screening for health problems, (...)
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  40.  15
    Of the Rights and Best Interests of Future Generations.Erika Kleiderman, Minh Thu Nguyen & Bartha Maria Knoppers - 2020 - American Journal of Bioethics 20 (8):38-40.
    Volume 20, Issue 8, August 2020, Page 38-40.
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  41.  37
    ACCE, Pharmacogenomics, and Stopping Clinical Trials: Time to Extend the CONSORT Statement?Bartha M. Knoppers, Yann Joly & Vural Ozdemir - 2011 - American Journal of Bioethics 11 (3):11-13.
    (2011). ACCE, Pharmacogenomics, and Stopping Clinical Trials: Time to Extend the CONSORT Statement? The American Journal of Bioethics: Vol. 11, No. 3, pp. 11-13.
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  42.  4
    A policy Delphi study to validate the key implications of data sharing (KIDS) framework for pediatric genomics in Canada.Bartha Maria Knoppers, Gillian Bartlett & Vasiliki Rahimzadeh - 2021 - BMC Medical Ethics 22 (1):1-12.
    BackgroundThe highly sensitive nature of genomic and associated clinical data, coupled with the consent-related vulnerabilities of children together accentuate ethical, legal and social issues (ELSI) concerning data sharing. The Key Implications of Data Sharing (KIDS) framework was therefore developed to address a need for institutional guidance on genomic data governance but has yet to be validated among data sharing practitioners in practice settings. This study qualitatively explored areas of consensus and dissensus of the KIDS Framework from the perspectives of Canadian (...)
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  43. Bio-banking.Bartha Maria Knoppers & Madelaine Saginur - 2008 - In Peter A. Singer & A. M. Viens (eds.), The Cambridge Textbook of Bioethics. Cambridge University Press.
     
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  44. Biomedical research policy : back to the future?Bartha Maria Knoppers, Ruth Chadwick & Michael Beauvais - 2022 - In G. T. Laurie, E. S. Dove & Niamh Nic Shuibhne (eds.), Law and legacy in medical jurisprudence: essays in honour of Graeme Laurie. Cambridge University Press.
     
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  45. Book Reviews-Legal Rights and Human Genetic Material.Bartha Maria Knoppers, Timothy Caulfield & T. Douglas Kinsella - 1998 - Bioethics 12 (4):343.
     
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  46.  11
    Demystifying Biobanks.Bartha M. Knoppers, Edward S. Dove & Ma'N. H. Zawati - 2013 - Hastings Center Report 43 (5):4-5.
    The second of two commentaries on “Respecting Donors to Biobank Research,” from the January‐February 2013 issue.
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  47.  27
    Does policy grow on trees?Bartha M. Knoppers - 2014 - BMC Medical Ethics 15 (1):87.
    Policymaking is both an art and a science. It is a long process of research, debate and consensus . The elaboration of the Framework for Responsible Sharing of Genomic and Health-Related Data serves as an illustration of this process.
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  48.  8
    Ethical Issues in Secondary Uses of Human Biological Materials from Mass Disasters.Bartha Maria Knoppers, Madelaine Saginur & Howard Cash - 2006 - Journal of Law, Medicine and Ethics 34 (2):352-365.
    In the trauma surrounding mass disasters, the need to identify victims accurately and as soon as possible is critical. DNA identification testing is increasingly used to identify human bodies and remains where the deceased cannot be identified by traditional means. This form of testing compares DNA taken from the body of the deceased with DNA taken from their personal items or from close biological relatives. DNA identification testing was used to identify the victims of the terrorist attack on the World (...)
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  49.  11
    Genetics and stem cell research : models of international policy-making.Bartha Maria Knoppers, Emily Kirby & Rosario Isasi - 2010 - In John Elliott, W. Calvin Ho & Sylvia S. N. Lim (eds.), Bioethics in Singapore: The Ethical Microcosm. World Scientific.
  50.  3
    Harmonised consent in international research consortia: an impossible dream?Bartha M. Knoppers & Susan E. Wallace - 2011 - Genomics, Society and Policy 7 (1):1-12.
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