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The IRB scrutinizes how those risks are minimized and managed, often requiring elements such as stopping rules, independent safety monitoring, and clear plans for adverse event reporting
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Blood 95 : 23782385 Eischen CM, Kottke TJ, Martins LM, Basi GS, Tung JS, Earnshaw WC, Leibson PJ and Kaufmann SH (1997) Comparison of apoptosis in wild-type and Fas-resistant cells: chemotherapy-induced apoptosis is not dependent on Fas/Fas ligand interactions
