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Evaluating the science and ethics of research on humans – a guide for IRB members

Sanjay A Pai

DOI: 10.20529/IJME.2008.031


Abstract

Institutional Review Boards (IRBs) are created for the “express purpose of providing safety to participants in clinical trials” and “IRBs exist for the sole formality of passing protocols so that drug companies can get legal clearance to start their clinical trials” are two statements that I have actually heard over the past year. Contrary to what you may expect, the first was made by a pharmaceutial company doctor while the latter was made by a cynical physician-investigator in a hospital!

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