Inconsistent Regulatory Protection under the U.S. Common Rule
U.S. regulations do not afford consistent protections to human research subjects. One complaint is that they focus on federally sponsored research, with private research covered only if it falls under the jurisdiction of the Food and Drug Administration (FDA). This paper examines a deeper problem: E...
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| Format: | Electronic Article |
| Language: | English |
| Check availability: | HBZ Gateway |
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| Published: |
Cambridge Univ. Press
2004
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| In: |
Cambridge quarterly of healthcare ethics
Year: 2004, Volume: 13, Issue: 4, Pages: 366-379 |
| Online Access: |
Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
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| 520 | |a U.S. regulations do not afford consistent protections to human research subjects. One complaint is that they focus on federally sponsored research, with private research covered only if it falls under the jurisdiction of the Food and Drug Administration (FDA). This paper examines a deeper problem: Even when the regulations do apply, they still do not afford consistent standards of protection. The U.S. Common Rule and related FDA regulations lack a workable regulatory control mechanism. | ||
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