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Human subjects research regulation : perspectives on the future

I. Glenn Cohen editor.; Holly Fernandez Lynch editor. 2014

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  • Title:
    Human subjects research regulation : perspectives on the future
  • Author: I. Glenn Cohen editor.; Holly Fernandez Lynch editor.
  • Subjects: Human experimentation in medicine -- Evaluation; Human experimentation in medicine -- Law and legislation; Medical ethics; Clinical trials; Electronic books
  • Description: ""Contents""; ""Series Foreword""; ""Acknowledgments""; ""Introduction""; ""1 Setting the Stage: The Past and Present of Human Subjects Research Regulations""; ""I Regulation of Risk""; ""Introduction to Part I â€? Regulation of Risk""; ""2 De minimis Risk: A Suggestion for a New Category of Research Risk""; ""3 Risk Level, Research Oversight, and Decrements in Participant Protections""; ""II Protection of Vulnerable Populations""; ""Introduction to Part II â€? Protection of Vulnerable Populations""; ""4 Classifying Military Personnel as a Vulnerable Population""
    ""5 Children as Research Partners in Community Pediatrics""""6 Back to the Future? Examining the Institute of Medicine�s Recommendations to Loosen Restrictions on Using Prisoners as Human Subjects""; ""III Redefining the Participant�Researcher Relationship and the Role of IRBs""; ""Introduction to Part III Redefining the Participant�Researcher Relationship and the Role of IRBs""; ""7 Toward Human Research Protection That Is Evidence Based and Participant Centered""
    ""8 Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?""""9 Subjects, Participants, and Partners: What Are the Implications for Research as the Role of Informed Consent Evolves?""; ""10 Democratic Deliberation and the Ethical Review of Human Subjects Research""; ""11 IRBs and the Problem of “Local Precedents�""; ""IV Specimens, Data, and Privacy""; ""Introduction to Part IV � Specimens, Data, and Privacy""; ""12 Biospecimen Exceptionalism in the ANPRM""
    ""13 Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?""""14 Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement""; ""15 Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens""; ""16 Reconsidering Privacy Protections for Human Research""; ""17 In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data""; ""V Paradigm Shifts in Research Ethics""; ""Introduction to Part V � Paradigm Shifts in Research Ethics""; ""18 What Is This Thing Called Research?""
    ""19 What�s Right about the “Medical Model� in Human Subjects Research Regulation""""20 Three Challenges for Risk-Based (Research)Regulation: Heterogeneity among Regulated Activities, Regulator Bias, and Stakeholder Heterogeneity""; ""21 Protecting Human Research Subjects as Human Research Workers""; ""22 Getting Past Protectionism: Is It Time to Take off the Training Wheels?""; ""Appendix: Regulatory Changes in the ANPRM""; ""Comparison of Existing Rules with Some of the Changes Being Considered""; ""Contributors""; ""Index""
    The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation and the Tuskegee syphilis study. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws. Invigorated by the U.S. government's first steps toward change in over 20 years, the book brings together leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better.
  • Publisher: Cambridge, Massachusetts ; London, England : The MIT Press
  • Creation Date: 2014
  • Format: 1 online resource (393 p.).
  • Language: English
  • Identifier: ISBN0-262-32082-7
  • OCLC Number: 884478904
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  • Network Zone MMS ID: 9911678944303366
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  • Source: 01TRAILS ALMA
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