Friday, January 1, 2010

Two Years' Inaction at OHRP

On October 26, 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)."

By the December 26, 2007, deadline, 65 people and institutions submitted comments, two-thirds of which concerned oral history or folklore.

That was two years ago. And as far as I can tell, OHRP has taken no action on these comments.

Meanwhile, OHRP's new guidance on what constitutes research subject to regulation, which Bernard Schwetz promised before the end of 2007, is now two years overdue.

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