Three 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 three 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 three years overdue.

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.

Schwetz Retires

Dr. Bernard Schwetz has announced his retirement as director of the Office for Human Research Protections (OHRP). Schwetz has led the office since February 2003. During that time, it has agreed to broad exemptions from IRB review for oral history, reneged on that agreement by publishing nonsensical guidance, then refused to discuss the matter with historians. Most recently, in February Schwetz told the New York Times that he intended to issue new guidelines by the end of 2007, a promise that now seems unlikely to be kept.