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IRB Coverage

The Common Rule is very clear: With the exception of six specific categories of research, the Common Rule ``applies to all research involving human subjects conducted, supported or otherwise subject to regulation....''(§46.101(a))

Research is defined as ``a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge'' (§46.102(d)). Human Subject is defined as ``a living individual about whom an investigator (whether professional or student) conducting research obtains 1) Data through intervention or interaction with the individual, or 2) Identifiable private information''(§46.102(f)).

The IRB regulations allow organizations to augment the rules, adding requirements, and broadening them to include more areas of research(§46.112). At many schools, including MIT[#!mit-couhes-overview!#], Harvard[#!harvard-irb-2!#] and UC Berkeley[#!berkeley-compliance!#], IRB approval is required for any research involving human subjects, regardless of funding, and even if the research is exempt under the Common Rule.

Simson L. Garfinkel 2008-03-21