Tag: IRB

Blog Posts (3)

October 12, 2015

Human Subjects Research “Vulnerability”

by J.S. Blumenthal-Barby, Ph.D., MA

Revisions are being suggested to the Federal Policy for the Protection of Human Subjects through the Notice of Proposed Rulemaking (NPRM).…

April 24, 2009

A Three-Legged Dog Cannot Run an IRB No Matter How Hard Congress Tries

As if the Coast IRB sting couldn’t get more crazy, the company itself has decided to close up shop on the more than 300 clinical trials it was reviewing, according to an AP story, and transfer them to another company.…

April 19, 2009

GAO Says "Gotcha!" to Coast IRB

Who knew that GAO was so crafty? Evidently not Coast IRB, for one. Well, maybe it’s not quite SO crafty, but GAO was able to get the IRB to fall for a fake clinical trial that showed that the review board for hire was asleep at the wheel when it came time to review the phony study.…

Published Articles (7)

American Journal of Bioethics: Volume 14 Issue 5 - May 2014

Fostering IRB Collaboration for Review of International Research Francis Barchi, Megan Kasimatis Singleton & Jon F. Merz

AJOB Primary Research: Volume 4 Issue 2 - Apr 2013

Views of IRBs Concerning Their Local Ecologies: Perceptions of Relationships, Systems, and Tensions Between IRBs and Their Institutions Robert Klitzman

American Journal of Bioethics: Volume 11 Issue 4 - Apr 2011

The Research Subject As Identified Problem

American Journal of Bioethics: Volume 11 Issue 5 - May 2011

Beyond the IRB: Local Service Versus Global Oversight

American Journal of Bioethics: Volume 11 Issue 5 - May 2011

Dealing With the Long-Term Social Implications of Research

American Journal of Bioethics: Volume 8 Issue 3 - Mar 2008

A Plea for Pragmatism in Clinical Research Ethics

American Journal of Bioethics: Volume 6 Issue 5 - Sep 2006

Letter to the Editor: In Defense of the PolyHeme Trial

News (3)

March 20, 2013 5:51 pm

Stanford bioethicist speaks out about layers of stem cell regulations

Stanford bioethicist Hank Greely, JD, spoke out in an article in Nature exploring whether all these layers of approval are really still necessary.

March 7, 2013 12:19 pm

Time to ditch stand-alone stem cell oversight panels, experts say (Nature Medicine)

The vital role ESCROs have played in recent years can now be taken over by IRBs and IACUCs—both of which have existed at universities and research institutions for decades. Those two review bodies would only have to expand their remits slightly to cover hESC-specific considerations.

June 20, 2012 11:57 am

Jury Is Still Out Over Disclosing Genomic Research Findings to Patients (Genetic Engineering & Biotechnology News)

Four years after developing consensus recommendations to address responsibilities of researchers and institutional review boards (IRBs) when investigators discover IFs of potential health or reproductive importance to research participants, a group of researchers have joined on a follow-up project. The latest consensus paper, published earlier this year in Genetics in Medicine, built on the prior study by considering how to identify and manage IRRs and IFs in large-scale research involving biobanks.