I started 2009, 2010, and 2011 with complaints that OHRP had failed to act on two reform initiatives it had undertaken in 2007.
In February 2007, Bernard Schwetz promised that by the end of 2007, OHRP would issue new guidelines that would give a lot of examples and will give more guidance on how to make the decision on what is research and what is not." And in October 2007, OHRP formally requested "written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998 (63 FR 60364)."
OHRP has yet to issue Schwetz's promised examples and guidance, or to amend the expedited review list. But July's ANPRM goes so far toward honoring both of these promises that I can say with full voice, Happy New Year, OHRP! I look forward to a cooperative and productive 2012.