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Potential rewrite of human research guidelines will facilitate database studies. |
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Institute of Medicine: To first determine if research activities fall within the scope of the Common Rule, the report recommends that HHS define “human subjects research” as a systematic investigation designed to develop or contribute to generalizable knowledge that involves direct interaction or intervention with a living individual or that involves obtaining identifiable private information about an individual. Only research that fits this definition should be subject to IRB procedures and the Common Rule.
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