Citation:Emanuel EJ (2006) Research Ethics Boards: Reply from Ezekiel Emanuel. PLoS Med 3(10): e460. doi:10.1371/journal.pmed.0030460
Published: October 31, 2006
Copyright: © 2006 Ezekiel J. Emanuel. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding:The author received no specific funding for this article.
Competing interests: EJE has spoken at and received an honorarium from many different not-for-profit academic medical centers, some that review their own protocols and others, including the University of Iowa and Johns Hopkins University, that have outsourced their protocols to a for-profit institutional review board (IRB). He has served on a subcommittee of the Dana-Farber IRB and on both commercial and noncommercial data safety monitoring boards. He was a member of the Consortium to Examine Clinical Research Ethics, which is financed by the Doris Duke Charitable Foundation to collect primary data on and critically examine human subject protection (members of the consortium are listed at http://www.ddcf.org/page.asp?pageId=302).
I have misstated. Obviously, as a governmental agency, the Office for Human Research Protections (OHRP) could not “endorse” the Western Institutional Review Board (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 the University of Rochester, the University of Colorado, Johns Hopkins University, and other academic institutions whose federal assurance was suspended by OHRP ended up consulting WIRB. I stand corrected.