Human Subjects Research Regulation : Perspectives on the Future.

Intro -- 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 - 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 - 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.

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.