Ethical Oversight of Research in Developing Countries

Abstract

by private companies on products that are regulated by the Food and Drug Administration must adhere to FDA regulations (2z CFR 50, 56), which require review by a single IRB, but do not specify where that IRB must be located. (Studies conducted for reasons other than marketing approval need not undergo ethics review.) The International Conference on Harmonisation's guidelines are frequently used for private research carried out in industrialized