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Articles 1 - 3 of 3
Full-Text Articles in Science and Technology Law
A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley
A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley
Articles
Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …
Enlightened Regulatory Capture, David Thaw
Enlightened Regulatory Capture, David Thaw
Articles
Regulatory capture generally evokes negative images of private interests exerting excessive influence on government action to advance their own agendas at the expense of the public interest. There are some cases, however, where this conventional wisdom is exactly backwards. This Article explores the first verifiable case, taken from healthcare cybersecurity, where regulatory capture enabled regulators to harness private expertise to advance exclusively public goals. Comparing this example to other attempts at harnessing industry expertise reveals a set of characteristics under which regulatory capture can be used in the public interest. These include: 1) legislatively-mandated adoption of recommendations by an advisory …
Surveillance At The Source, David Thaw
Surveillance At The Source, David Thaw
Articles
Contemporary discussion concerning surveillance focuses predominantly on government activity. These discussions are important for a variety of reasons, but generally ignore a critical aspect of the surveillance-harm calculus – the source from which government entities derive the information they use. The source of surveillance data is the information "gathering" activity itself, which is where harms like "chilling" of speech and behavior begin.
Unlike the days where satellite imaging, communications intercepts, and other forms of information gathering were limited to advanced law enforcement, military, and intelligence activities, private corporations now play a dominant role in the collection of information about individuals' …