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Research Methods in Life Sciences Commons

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The Validity Of Animal Experiments In Medical Research, Gill Langley Nov 2014

The Validity Of Animal Experiments In Medical Research, Gill Langley

Gill Langley, PhD

Other animals, such as mice, rats, rabbits, dogs and monkeys, are widely used as surrogates for humans in fundamental medical research. This involves creating disorders in animals by chemical, surgical or genetic means, with the aim of mimicking selected aspects of human illnesses. It is a truism that any model or surrogate is not identical to the target being modelled. So, in medical research, experiments using animals or cell cultures or even healthy volunteers instead of patients (being the target population with the target illness) will inevitably have limitations, although these will be greater or lesser depending on the model.


A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley Jan 2014

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 …