November 6, 2009, the Office for Human Research Protections (OHRP), Office of Public Health and Science published two notices announcing the availability of draft guidance on institutional review board (IRB) review of research. First, OHRP published a notice seeking comments on a draft policy entitled "Guidance on IRB Approval of Research with Conditions,” which would provide OHRP’s first formal guidance on this issue. In particular, the document addresses such issues as: the circumstances that permit the IRB to approve research with conditions; how the IRB should handle changes to research that are proposed after initial IRB approval; how conditions on IRB approval affect ongoing research; and documentation of conditions of IRB approval of research. Comments will be accepted until January 5, 2010. The second draft document, "Guidance on IRB Continuing Review of Research," will supersede OHRP’s January 15, 2007 document entitled "Guidance on Continuing Review." Among other things, the new draft guidance has been expanded to include a section on key IRB considerations when evaluating research undergoing continuing review and to provide more details regarding regulatory requirements and recommendations for the process for conducting continuing review. OHRP is accepting comments on the revisions until January 5, 2010.