Show Summary Details
- Title Pages
- Basic Bioethics
- Dedication
- Series Foreword
- Acknowledgments
- Introduction
-
1 Setting the Stage: The Past and Present of Human Subjects Research Regulations - 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 - 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 Subjects1 -
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 -
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 Considering Privacy Protections for Human Research -
17 In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data -
V aradigm 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
Introduction
Introduction
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- Title Pages
- Basic Bioethics
- Dedication
- Series Foreword
- Acknowledgments
- Introduction
-
1 Setting the Stage: The Past and Present of Human Subjects Research Regulations - 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 - 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 Subjects1 -
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 -
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 Considering Privacy Protections for Human Research -
17 In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data -
V aradigm 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
