Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century (2016)

Chapter: 9 Ethical, Legal, and Regulatory Framework for Human Subjects Research

Previous Chapter: 8 Introduction
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

There was a problem loading page 162.

Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

There was a problem loading page 163.

Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

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Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

There was a problem loading page 166.

Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

There was a problem loading page 167.

Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

There was a problem loading page 168.

Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

There was a problem loading page 169.

Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

There was a problem loading page 170.

Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 153
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 154
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 155
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 156
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 157
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 158
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 159
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 160
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 161
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 162
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 163
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 164
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 165
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 166
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 167
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 168
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 169
Suggested Citation: "9 Ethical, Legal, and Regulatory Framework for Human Subjects Research." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
Page 170
Next Chapter: 10 Reporting of Intellectual Property and Technology Transfer
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