Reader Comments

Post a new comment on this article

Author's Reply

Posted by plosmedicine on 30 Mar 2009 at 23:58 GMT

Author: Ezekiel Emanuel
Position: Chair, Department of Clinical Bioethics
Institution: The Clinical Center, National Institutes of Health
Submitted Date: August 20, 2006
Published Date: August 20, 2006
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

I have misstated. Obviously as a governmental agency, OHRP could not "endorse", ask WIRB to re-review protocols at institutions whose federal assurance was suspended, or advise such institutions to consult WIRB. As Dr. Schwetz reminded me, OHRP could provide information about independent or other IRBs that could help suspended institutions re-review protocols, but could not suggest which one they should employ or endorse a particular IRB. I presume OHRP would not provide information to institutions on IRBs that it deemed to have questionable practices or performance in reviewing protocols. So while as a government agency it could not provide a formal endorsement, there is an implied claim that the IRBs mentioned by OHRP conduct satisfactory reviews. Furthermore, as a matter of fact it is worthy of note that Rochester, University Colorado, Johns Hopkins and other academic institutions whose federal assurance was suspended by OHRP ended up consulting WIRB. I stand corrected.

Ezekiel J. Emanuel, M.D., Ph.D.

Competing interests declared: See competing interests statement accompanying the original article (DOI: 10.1371/journal.pmed.0030309)